Cell-Dyn 3700 - Operations Manual

CELL-DYN® 3700 Operator’s Manual Master Table of Contents - 19140320F — April 2007

Master Table of Contents

IntroductionForeword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iCustomer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iIntended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iProprietary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iPatent Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iiInstrument Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iiPictorial Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iiAbbott Instrument Warranty . . . . . . . . . . . . . . . . . . . . . . . . iiiSafety Agency Approvals . . . . . . . . . . . . . . . . . . . . . . . . . . . . ivTrademark Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ivSymbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ivInstrument Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viiiConventions Used in This Manual . . . . . . . . . . . . . . . . . . . xiiiSafety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvRevision Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviRevision Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix

Chapter 1: System DescriptionOverview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3System Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6Data Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19Flat Panel Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23Flat Panel Display, Rear Components . . . . . . . . . . . . . . . 1-25Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27Reagent System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27Reticulocyte Reagent System . . . . . . . . . . . . . . . . . . . . . . 1-30

Controls and Calibrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31Calibrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31

Chapter 2: InstallationOverview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1Initial Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3Package Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3Space Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4Waste Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Master Table of Contents - 2 CELL-DYN® 3700 Operator’s Manual

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Printer Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7Ticket Printer Installation Procedure . . . . . . . . . . . . . . . . 2-10Sample Loader Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12Instrument Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Relocation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19

Chapter 3: Principles of OperationOverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1Sample Aspiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . .3-5

WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6Reticulocyte Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7Results Displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7Instrument Rinsed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9WIC/WOC Interaction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9WIC Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10WOC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13WBC Differential Analysis . . . . . . . . . . . . . . . . . . . . . . . . 3-19WBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25WBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26

RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27Electrical Impedance Measurements . . . . . . . . . . . . . . . . 3-27Coincidence Passage Correction . . . . . . . . . . . . . . . . . . . 3-27RER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28RBC/PLT Measurement Process . . . . . . . . . . . . . . . . . . . . 3-29RBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30RBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31Reticulocytes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32PLT Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . 3-32PLT Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33Platelet Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34

Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-35Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35Hemoglobin Measurement Process . . . . . . . . . . . . . . . . . 3-35HGB Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-36

Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . . . 3-37Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-37Interfering Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-37Instrument Fault and Status Messages . . . . . . . . . . . . . . . 3-38Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . 3-39



Introduction to WBC Flagging . . . . . . . . . . . . . . . . . . . . . 3-42Cell Populations and Flagging . . . . . . . . . . . . . . . . . . . . . 3-45

Flagging Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49WBC Descriptors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49Suspect Parameter Flags . . . . . . . . . . . . . . . . . . . . . . . . . . 3-50Suspect Population Flags . . . . . . . . . . . . . . . . . . . . . . . . . 3-54Flagging Diagnostics Screen . . . . . . . . . . . . . . . . . . . . . . . 3-59Interpretive Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-60

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-63

Chapter 4: System SpecificationOverview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1CELL-DYN 3700SL System Specifications . . . . . . . . . . . . . . . . . . . 4-3

Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 4-6Bar Code Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

CELL-DYN 3700CS System Specifications . . . . . . . . . . . . . . . . . . . 4-9Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Combined Specifications for the SL and CS Systems . . . . . . . . . 4-13Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . 4-13Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . 4-15Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . 4-20

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

Chapter 5: Operating InstructionsOverview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Instrument Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1Data Station Program Overview . . . . . . . . . . . . . . . . . . . . . 5-2Conventions Used in This Manual . . . . . . . . . . . . . . . . . . . 5-5Menu Flowcharts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Set Up Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13Date/Time Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14Patient Limits Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16Reagent Log Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19QC Set Up Menu Soft Key . . . . . . . . . . . . . . . . . . . . . . . . 5-21Operation Set Up Soft Key . . . . . . . . . . . . . . . . . . . . . . . . 5-43Units Selection Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . 5-49Customize Report Soft Key . . . . . . . . . . . . . . . . . . . . . . . . 5-51

Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-67Run Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-68Run Screen Soft Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-74Sample Collection and Handling . . . . . . . . . . . . . . . . . . . 5-87


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Sample Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-89Instrument Start Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-92Sample Analysis Using the SL Model . . . . . . . . . . . . . . . . 5-92Sample Analysis Using the CS Model . . . . . . . . . . . . . . . . 5-99Using The Work List . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-103Sample Analysis Using the Work List . . . . . . . . . . . . . . . 5-114

Using The Data Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-121Data Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-122Data Log Set Up Procedures . . . . . . . . . . . . . . . . . . . . . . 5-135Data Review from the Data Log . . . . . . . . . . . . . . . . . . . 5-140

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-143

Chapter 6: CalibrationOverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1

When to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1Open and Closed Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2Calibration Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3Calibration Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3Calibration Procedural Summary . . . . . . . . . . . . . . . . . . . 6-11Conventions Used in this Chapter . . . . . . . . . . . . . . . . . . 6-11

Calibration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13Calibration Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . 6-13Calibration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14Open Sampler/Closed Sampler Soft Key . . . . . . . . . . . . . 6-15Print Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15Main Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16Enter Factor Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16Calibration Log Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18Auto-Calibrate Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19

Pre-Calibration Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27Pre-Calibration Procedures Checklist . . . . . . . . . . . . . . . . 6-29

Auto-Cal Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33Auto-Cal Sample Capacity . . . . . . . . . . . . . . . . . . . . . . . . 6-34Auto-Cal Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34Calibration Requirements for Auto-Cal . . . . . . . . . . . . . . 6-35

Auto-Cal Using Calibrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . 6-37Collecting the Calibration Data . . . . . . . . . . . . . . . . . . . . 6-38Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-40Determining Which Parameters Need Calibration . . . . . 6-41Calibrating All Parameters . . . . . . . . . . . . . . . . . . . . . . . . 6-43Calibrating Individual Parameters . . . . . . . . . . . . . . . . . . 6-44Completing Open Mode Calibration . . . . . . . . . . . . . . . . 6-44Auto-Cal Calibration Criteria Worksheet . . . . . . . . . . . . . 6-45



Auto-Cal Using Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-47Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-47Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . 6-48Collecting the Calibration Data . . . . . . . . . . . . . . . . . . . . 6-48Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-50Determining Which Parameters Need Calibration . . . . . 6-52Calibrating All Parameters . . . . . . . . . . . . . . . . . . . . . . . . 6-54Calibrating Individual Parameters . . . . . . . . . . . . . . . . . . 6-55Completing Whole Blood Open Mode Calibration . . . . . 6-55Auto-Cal Calibration Criteria Worksheet . . . . . . . . . . . . . 6-57

Manual Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-59Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-60

Manual Calibration Procedure — Open Mode. . . . . . . . . . . . . . . 6-61Preparing for Manual Calibration . . . . . . . . . . . . . . . . . . 6-61Determining the Open Mode Mean . . . . . . . . . . . . . . . . . 6-61Calibration Factor Calculations . . . . . . . . . . . . . . . . . . . . 6-62Determining Which Parameters Need Calibration . . . . . 6-63Calibrating the Open Mode . . . . . . . . . . . . . . . . . . . . . . . 6-65Completing Manual Calibration . . . . . . . . . . . . . . . . . . . 6-66Manual Calibration Worksheet . . . . . . . . . . . . . . . . . . . . 6-68

Mode To Mode Calibration Overview . . . . . . . . . . . . . . . . . . . . . 6-71Auto-Cal Mode to Mode Calibration . . . . . . . . . . . . . . . . 6-71Manual Mode to Mode Calibration . . . . . . . . . . . . . . . . . 6-72Mode to Mode Calibration Preparation . . . . . . . . . . . . . . 6-72Closed Mode Calibration Confirmation . . . . . . . . . . . . . 6-72

Mode To Mode Auto-Cal Calibration (Closed Sampler Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-73

Determining Reference Values . . . . . . . . . . . . . . . . . . . . . 6-73Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-74Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . 6-74Collecting the Calibration Data . . . . . . . . . . . . . . . . . . . . 6-75Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-77Determining Which Parameters Need Calibration . . . . . 6-78Calibrating All Parameters . . . . . . . . . . . . . . . . . . . . . . . . 6-80Calibrating Individual Parameters . . . . . . . . . . . . . . . . . . 6-81Completing Mode to Mode Calibration . . . . . . . . . . . . . . 6-82Optional Calibration Confirmation . . . . . . . . . . . . . . . . . 6-82Mode to Mode Auto-Cal Calibration Criteria Worksheet 6-83

Manual Mode to Mode Calibration (CS or SL) . . . . . . . . . . . . . . 6-85Preparing for Manual Mode to Mode Calibration . . . . . . 6-85Determining the Open Mode Mean . . . . . . . . . . . . . . . . . 6-85Determining the Closed Mode Mean . . . . . . . . . . . . . . . . 6-86Percent Difference Calculation . . . . . . . . . . . . . . . . . . . . 6-87Determining Which Parameters Need Calibration . . . . . 6-88Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-90Calibrating the Closed Mode . . . . . . . . . . . . . . . . . . . . . . 6-90


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Completing Mode to Mode Calibration . . . . . . . . . . . . . . 6-91Optional Calibration Confirmation . . . . . . . . . . . . . . . . . 6-91Manual Mode to Mode Calibration Worksheet . . . . . . . . 6-93

Post-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-95Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-95Calibration Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-95

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-99

Chapter 7: Quality ControlOverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1

Quality Control Menu Flowchart . . . . . . . . . . . . . . . . . . . . 7-2Quality Control Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3

X-B File Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4View QC Log Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15Westgard® Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17X-B Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27

Chapter 8: HazardsOverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1

Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1Warning Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Hazard Information and Precautions. . . . . . . . . . . . . . . . . . . . . . .8-3General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3Biohazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3Handling and Disposing of Biohazardous Materials . . . . . 8-4Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5Physical and Mechanical Hazards . . . . . . . . . . . . . . . . . . . 8-6Laser Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11

Chapter 9: MaintenanceOverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1

Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . 9-2Analyzer Flow Panel Components Diagram . . . . . . . . . . . . 9-2Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . 9-4

Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5Emptying the Transducers . . . . . . . . . . . . . . . . . . . . . . . . . 9-6Draining the Reagent Reservoirs . . . . . . . . . . . . . . . . . . . . 9-7Accessing the Maintenance Log . . . . . . . . . . . . . . . . . . . . . 9-8Accessing the Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9



Disabling/Enabling the Analyzer . . . . . . . . . . . . . . . . . . . . 9-9Special Protocols Screen #2 . . . . . . . . . . . . . . . . . . . . . . . 9-10

Maintenance Log Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13Interval Set Up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 9-15Update Maintenance Log Procedure . . . . . . . . . . . . . . . . 9-16

Daily Maintenance Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19Sample Loader Aspiration Needle . . . . . . . . . . . . . . . . . . 9-21Closed Sampler Aspiration Needle . . . . . . . . . . . . . . . . . . 9-22

Weekly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . 9-23Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23Sample Aspiration Peristaltic Pump Tubing . . . . . . . . . . . 9-26Sample Loader Tray, Racks, and Safety Cover . . . . . . . . . 9-27Extended Auto Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-28

Monthly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . 9-29Reagent Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-29Analyzer Air Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-32WOC Transfer Peristaltic Pump Tubing . . . . . . . . . . . . . . 9-33Extended Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-35

As Required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3710-mL Reagent Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-37Aperture Plates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-39Hemoglobin Flow Cell Manual Cleaning . . . . . . . . . . . . . 9-43Unclogging the Open Sample Aspiration Probe . . . . . . . 9-45Bar Code Reader Window . . . . . . . . . . . . . . . . . . . . . . . . . 9-46Flushing the “Y” Fitting — Open and Closed Modes . . . . 9-47

Special Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-51Closed Sampler Tube Retainer Adjustment (CS System Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-51

Preparation for Inactivity or Shipping . . . . . . . . . . . . . . . 9-52Repackaging for Shipment . . . . . . . . . . . . . . . . . . . . . . . . 9-54

Chapter 10: TroubleshootingIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1Diagnostics Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3

Diagnostics Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . 10-4Troubleshooting Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27Troubleshooting Procedures . . . . . . . . . . . . . . . . . . . . . 10-29Replaceable Components . . . . . . . . . . . . . . . . . . . . . . . . 10-32List of Symptoms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-38Symptom Identification and Resolution . . . . . . . . . . . . 10-39List of Messages and Fault Conditions . . . . . . . . . . . . . . 10-66Messages and Fault Conditions . . . . . . . . . . . . . . . . . . . 10-68


9140320F — April 2007


Chapter 11: PrintersOverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

Graphics Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3Ticket Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

Maintenance and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 11-5Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Chapter 12: Sample LoaderOverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3

CELL-DYN Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . 12-3CELL-DYN Q Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3Bar Code Label Placement . . . . . . . . . . . . . . . . . . . . . . . . 12-3

Sample Loader Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5Main Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5Tower Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7

Operating Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9Function Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-12

Routine Operating Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . 12-15Operating Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15

Other Chapters to Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17

Chapter 13: Veterinary PackageIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1Principles of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3

The Animal Catalog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-6Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8

Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-9Vet Package Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10

Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21Run Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21Selecting the Animal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-22



Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-27Procedure: MCV or MPV Calibration . . . . . . . . . . . . . . . 13-28Pre-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . 13-28Determining the Calibration Factors for MCV and MPV 13-29Entering the Calibration Factor . . . . . . . . . . . . . . . . . . . 13-29

Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-31Adding New Animal Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-33

Adding a New Configuration File . . . . . . . . . . . . . . . . . . 13-34Customizing the Display . . . . . . . . . . . . . . . . . . . . . . . . 13-36Turning on the Gains Template . . . . . . . . . . . . . . . . . . . 13-37Preparing the Samples . . . . . . . . . . . . . . . . . . . . . . . . . . 13-38Running the Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-38Determining the Variance . . . . . . . . . . . . . . . . . . . . . . . 13-39Baso Box Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-46

Vet Package Suggestions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-49Examples of Customer-Defined Default Codes . . . . . . . 13-50

Turning The Vet Package Off . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-53References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-55

Chapter 14: Reticulocyte PackageOverview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-7Retic Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-9

Turning the Reticulocyte Package ON and OFF . . . . . . . 14-10Retic Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-14Retic Set Up Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-16Retic Data Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-30Data Review from the Retic Data Log . . . . . . . . . . . . . . 14-37Retic QC Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-39Retic Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . . . 14-47Retic Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . 14-52

Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-55Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-55Retic Run Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . . 14-56Retic Run Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-57Reticulocyte Specimens . . . . . . . . . . . . . . . . . . . . . . . . . 14-67

Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-77Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-77Mixing and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-78

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-79Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-79Operational Messages and Data Flagging . . . . . . . . . . . . 14-79High Background Counts . . . . . . . . . . . . . . . . . . . . . . . . 14-82

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-83


9140320F — April 2007


BibliographyBibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bibliography-1

Appendix A: Bar CodesOverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-1

Bar Coding Function . . . . . . . . . . . . . . . . . . . . . . Appendix A-1Understanding the Label Code . . . . . . . . . . . . . . Appendix A-2Bar Code Types and Characteristics . . . . . . . . . . Appendix A-3

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-5Bar Code Label Formats . . . . . . . . . . . . . . . . . . . . Appendix A-5Bar Code Check Digit Formats . . . . . . . . . . . . . . Appendix A-5Bar Code Label Specifications . . . . . . . . . . . . . . . Appendix A-6CELL-DYN Bar Code Labels . . . . . . . . . . . . . . . . . Appendix A-7CELL-DYN Q Labels . . . . . . . . . . . . . . . . . . . . . . . Appendix A-7Bar Code Label Placement . . . . . . . . . . . . . . . . . . Appendix A-8

Acknowledgment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-9

Appendix B: Parts ListOverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-1

CELL-DYN 3700 Accessories . . . . . . . . . . . . . . . . Appendix B-1

Appendix CAppendix C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C-1

CELL-DYN® 3700 Operator’s Manual Master Table of Contents-119140320F — April 2007

List of Figures

List of Figures

Figure 1.1: CELL-DYN 3700SL System. . . . . . . . . . . . . . . . . . . . 1-1Figure 1.2: CELL-DYN 3700 System . . . . . . . . . . . . . . . . . . . . . 1-5Figure 1.3: CELL-DYN 3700CS System Analyzer Front View . . 1-6Figure 1.4: Analyzer Flow Panel Components . . . . . . . . . . . . . 1-9Figure 1.5: Analyzer Left Side Panel Components . . . . . . . . . 1-14Figure 1.6: Analyzer Rear Panel Components . . . . . . . . . . . . . 1-17Figure 1.7: Power Supply Module Voltage

Switch Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18Figure 1.8: Data Station — Front View. . . . . . . . . . . . . . . . . . . 1-19Figure 1.9: Data Station — Rear Components . . . . . . . . . . . . . 1-21Figure 1.10: Control Button – Front View . . . . . . . . . . . . . . . . 1-23Figure 1.11: Inputs Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25Figure 1.12: Caution Label . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28

Figure 2.1: Data Station Rear Components . . . . . . . . . . . . . . . . 2-8Figure 2.2: CELL-DYN 3700SL . . . . . . . . . . . . . . . . . . . . . . . . . 2-12Figure 2.3: Tube Rack Showing Label Placement Locations. . 2-13Figure 2.4: Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16Figure 2.5: Front Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18

Figure 3.1: Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . . 3-11Figure 3.2: WOC Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14Figure 3.3: WBC Light Scatter . . . . . . . . . . . . . . . . . . . . . . . . . 3-15Figure 3.4: Optical Bench Assembly . . . . . . . . . . . . . . . . . . . . 3-17Figure 3.5: Mononuclear-Polymorphonuclear Scatter . . . . . . 3-20Figure 3.6: Neutrophil-Eosinophil Scatter. . . . . . . . . . . . . . . . 3-21Figure 3.7: Mononuclear Scatter . . . . . . . . . . . . . . . . . . . . . . . 3-22Figure 3.8: WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24Figure 3.9: WBC Data and Scatterplots . . . . . . . . . . . . . . . . . . 3-25Figure 3.10: Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . 3-28Figure 3.11: RBC Data and Histogram. . . . . . . . . . . . . . . . . . . 3-30Figure 3.12: PLT Data and Histogram . . . . . . . . . . . . . . . . . . . 3-33Figure 3.13: Flagging Diagnostics Screen . . . . . . . . . . . . . . . . 3-41Figure 3.14: Scatterplot with Increased Stroma in the

N1 Region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-43

Figure 5.1: Data Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2Figure 5.2: Main Menu Screen. . . . . . . . . . . . . . . . . . . . . . . . . . 5-3Figure 5.3: Set Up Menu Screen . . . . . . . . . . . . . . . . . . . . . . . 5-13Figure 5.4: Date/Time Set Up Screen. . . . . . . . . . . . . . . . . . . . 5-14Figure 5.5: Patient Limit Set Screen. . . . . . . . . . . . . . . . . . . . . 5-16Figure 5.6: Diluent Log Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-19

Master Table of Contents-12 CELL-DYN® 3700 Operator’s Manual

9140320F — April 2007

List of Figures

Figure 5.7: QC Set Up Menu Screen . . . . . . . . . . . . . . . . . . . . 5-21Figure 5.8: QC File Set Up (Lot Number Entry) Screen . . . . . 5-22Figure 5.9: QC File Set Up (Replicate ID Entry) Screen . . . . . 5-23Figure 5.10: QC Range Entry Screen . . . . . . . . . . . . . . . . . . . . 5-27Figure 5.11: QC Means/Limits Entry Screen . . . . . . . . . . . . . . 5-28Figure 5.12: QC Means/Limits Entry Screen Showing

the Update From File Key . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30Figure 5.13: Customize QC Display Screen. . . . . . . . . . . . . . . 5-32Figure 5.14: Customize QC Display Screen Showing

Standard Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35Figure 5.15: Customize QC Printout Screen . . . . . . . . . . . . . . 5-37Figure 5.16: X-B Set Up Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-40Figure 5.17: Operation Set Up Menu Screen. . . . . . . . . . . . . . 5-43Figure 5.18: Bar Code Set Up Screen . . . . . . . . . . . . . . . . . . . . 5-44Figure 5.19: Computer Set Up Screen . . . . . . . . . . . . . . . . . . . 5-46Figure 5.20: Units Selection Screen. . . . . . . . . . . . . . . . . . . . . 5-49Figure 5.21: Customize Displayed Report Screen . . . . . . . . . . 5-52Figure 5.22: Customize Printed Report Screen for

Pre-Printed Tickets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-56Figure 5.23: Customize Printed Report Screen for

Blank Tickets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-58Figure 5.24: Customize Printed Report Screen for the

Graphics Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-61Figure 5.25: Customize Printout Header Screen for the

Graphics Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-64Figure 5.26: Run Screen for Patient Samples . . . . . . . . . . . . . 5-68Figure 5.27: Run Screen for Auxiliary Samples . . . . . . . . . . . . 5-70Figure 5.28: Run Screen Showing Count Times and

Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-73Figure 5.29: Run Screen Showing Flagging Messages,

RBC CLOG Message, and RBC Up Time . . . . . . . . . . . . . . . 5-73Figure 5.30: Run Screen Showing Bulletin Line Message . . . . 5-74Figure 5.31: Work List Screen . . . . . . . . . . . . . . . . . . . . . . . . . 5-75Figure 5.32: Specimen Type Screen. . . . . . . . . . . . . . . . . . . . . 5-77Figure 5.33: Run Screen for Patient Samples . . . . . . . . . . . . . 5-78Figure 5.34: Run Screen for a QC File . . . . . . . . . . . . . . . . . . . 5-79Figure 5.35: Run Screen for Background Counts . . . . . . . . . . 5-80Figure 5.36: Run Screen for Electrical Background Counts . . 5-81Figure 5.37: Run Screen for Resistant RBC Specimen Type . . 5-82Figure 5.38: Auxiliary Specimen Type Screen. . . . . . . . . . . . . 5-83Figure 5.39: Run Screen for the Auxiliary Specimen Type . . . 5-85Figure 5.40: Work List Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-104Figure 5.41: Work List Set Up Screen . . . . . . . . . . . . . . . . . . 5-108Figure 5.42: Data Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . 5-121Figure 5.43: Display Specimen Screen . . . . . . . . . . . . . . . . . 5-124Figure 5.44: Data Log Search Screen . . . . . . . . . . . . . . . . . . . 5-126Figure 5.45: Data Log Screen Showing Reject From X-B Key 5-127


List of Figures

Figure 5.46: Data Log Screen Showing Accept Into X-B Key 5-128Figure 5.47: Customize Display for Data Log Screen . . . . . . 5-129Figure 5.48: Customize Display Showing Standard Groups . 5-130Figure 5.49: Customize Printout for Data Log Screen . . . . . 5-132Figure 5.50: Print Data Log Screen . . . . . . . . . . . . . . . . . . . . 5-134Figure 5.51: Customize Display for Data Log Screen

Showing Standard Groups . . . . . . . . . . . . . . . . . . . . . . . . 5-135Figure 5.52: Customize Printout for Data Log Screen

Showing Customized Print Group . . . . . . . . . . . . . . . . . . 5-138Figure 5.53: Display Specimen Screen . . . . . . . . . . . . . . . . . 5-140Figure 5.54: Edit Specimen Screen . . . . . . . . . . . . . . . . . . . . 5-142

Figure 6.1: Calibration Screen Displaying Open Mode Calibration Factors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14

Figure 6.2: Calibration Menu Screen Displaying Closed Mode Calibration Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15

Figure 6.3: Enter Calibration Factor Screen . . . . . . . . . . . . . . 6-16Figure 6.4: Calibration Log Screen . . . . . . . . . . . . . . . . . . . . . 6-18Figure 6.5: Auto-Calibration Screen for CELL-DYN 3700CS System . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19

Figure 6.6: Whole Blood Auto-Cal Screen. . . . . . . . . . . . . . . . 6-20Figure 6.7: Whole Blood Auto-Cal Screen. . . . . . . . . . . . . . . . 6-22Figure 6.8: Whole Blood Auto-Cal Results Screen . . . . . . . . . 6-23Figure 6.9: Whole Blood Auto-Cal Results Screen with Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24

Figure 6.10: Calibrator Auto-Cal Screen . . . . . . . . . . . . . . . . . 6-25Figure 6.11: Latex Auto-Cal Screen . . . . . . . . . . . . . . . . . . . . . 6-26

Figure 7.1: QC Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3Figure 7.2: The X-B RBC Data Screen . . . . . . . . . . . . . . . . . . . . 7-4Figure 7.3: The X-B RBC Graphs Screen . . . . . . . . . . . . . . . . . . 7-5Figure 7.4: The X-B WBC Data Screen. . . . . . . . . . . . . . . . . . . . 7-6Figure 7.5: The X-B WBC Graphs Screen. . . . . . . . . . . . . . . . . . 7-7Figure 7.6: The View QC Log Screen. . . . . . . . . . . . . . . . . . . . . 7-8Figure 7.7: The Levey-Jennings Menu Screen . . . . . . . . . . . . . 7-11Figure 7.8: QC Log Screen With Rejected Results. . . . . . . . . . 7-12Figure 7.9: Levey-Jennings Menu Screen Showing Westgard Rule Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18

Figure 8.1: Laser Hazard Label. . . . . . . . . . . . . . . . . . . . . . . . . . 8-8Figure 8.2: Laser Aperture and Warning Label Position -

Protective Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8Figure 8.3: Laser Warning Label Position - Flow Panel. . . . . . . 8-9Figure 8.4: Class 2 Laser Caution Label. . . . . . . . . . . . . . . . . . . 8-9Figure 8.5: Class 2 Laser Caution Label Location . . . . . . . . . . . 8-9Figure 8.6: Laser Label, Rear Panel . . . . . . . . . . . . . . . . . . . . . 8-10Figure 8.7: Class 1 Laser Product Label Location . . . . . . . . . . 8-10


9140320F — April 2007

List of Figures

Figure 9.1: Analyzer Flow Panel Components . . . . . . . . . . . . . 9-3Figure 9.2: Special Protocols Screen . . . . . . . . . . . . . . . . . . . . . 9-5Figure 9.3: Reagent Reservoir Screen . . . . . . . . . . . . . . . . . . . . 9-7Figure 9.4: Special Protocols Screen 2. . . . . . . . . . . . . . . . . . . . 9-9Figure 9.5: Maintenance Log Screen . . . . . . . . . . . . . . . . . . . . 9-13Figure 9.6: Interval Set Up Screen . . . . . . . . . . . . . . . . . . . . . . 9-15Figure 9.7: Update Maintenance Log Screen. . . . . . . . . . . . . . 9-16Figure 9.8: Special Protocols: Auto-Clean Screen . . . . . . . . . . 9-19Figure 9.9: Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23Figure 9.10: Sample Aspiration Peristaltic Pump . . . . . . . . . . 9-26Figure 9.11: WOC Syringes and Syringe Assembly . . . . . . . . . 9-29Figure 9.12: Analyzer Left Side Panel . . . . . . . . . . . . . . . . . . . 9-32Figure 9.13: WOC Transfer Peristaltic Pump . . . . . . . . . . . . . 9-33Figure 9.14: Special Protocols: Extended Auto-Clean Screen . 9-35Figure 9.15: von Behrens Transducer Assembly . . . . . . . . . . . 9-40Figure 9.16: Transducer Assembly and Aperture Plate . . . . . . 9-41Figure 9.17: The von Behrens WIC Transducer, HGB Flow

Cell, and Solenoid 13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-43Figure 9.18: Open Sample Aspiration Probe . . . . . . . . . . . . . . 9-45Figure 9.19: Flow Panel Open/Closed Mode Tubing . . . . . . . 9-48Figure 9.20: Closed Sampler Module . . . . . . . . . . . . . . . . . . . 9-51Figure 9.21: Analyzer Flow Panel: Accessing Normally

Closed Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-52

Figure 10.1: First Diagnostics Menu Screen . . . . . . . . . . . . . . 10-5Figure 10.2: Operator Correctable Fault Report Screen . . . . . 10-6Figure 10.3: Fatal Fault Report Screen. . . . . . . . . . . . . . . . . . . 10-7Figure 10.4: Fault Report — No Fault Pending Screen. . . . . . . 10-7Figure 10.5: Count Rate Summary Screen. . . . . . . . . . . . . . . . 10-8Figure 10.6: WOC Count Rate Data (Tabular Format) . . . . . . 10-9Figure 10.7: WOC Count Rate Graph . . . . . . . . . . . . . . . . . . 10-10Figure 10.8: Raw Data Summary Screen . . . . . . . . . . . . . . . . 10-11Figure 10.9: Second Diagnostics Menu Screen . . . . . . . . . . . 10-12Figure 10.10: Pump Operation Screen . . . . . . . . . . . . . . . . . 10-13Figure 10.11: Pump Operation Screen — Vacuum ON . . . . . 10-14Figure 10.12: Inhibit Pumps Screen . . . . . . . . . . . . . . . . . . . 10-15Figure 10.13: Vacuum Test Screen . . . . . . . . . . . . . . . . . . . . 10-16Figure 10.14: Drain Accumulators Screen. . . . . . . . . . . . . . . 10-17Figure 10.15: Third Diagnostics Menu Screen . . . . . . . . . . . 10-18Figure 10.16: Voltage Readings Screen . . . . . . . . . . . . . . . . . 10-19Figure 10.17: Fourth Diagnostics Menu Screen . . . . . . . . . . 10-20Figure 10.18: Fifth Diagnostics Menu Screen

(CELL-DYN 3700SL System) . . . . . . . . . . . . . . . . . . . . . . . 10-21Figure 10.19: Auto-Sampler Version Screen . . . . . . . . . . . . . 10-22Figure 10.20: Serial Test Screen. . . . . . . . . . . . . . . . . . . . . . . 10-23Figure 10.21: Serial Test Transmit Message Screen

Transmit Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25


List of Figures

Figure 10.22: Sample Loader Vent/Aspiration Needle Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-33

Figure 10.23: Sample Loader Vent/Aspiration Needle — Tubing Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-34

Figure 10.24: Volumetric Metering . . . . . . . . . . . . . . . . . . . . 10-50

Figure 12.1: Analyzer with Sample Loader . . . . . . . . . . . . . . . 12-1Figure 12.2: Rack Movement - Top View . . . . . . . . . . . . . . . . 12-2Figure 12.3: Tube Labeling Requirements. . . . . . . . . . . . . . . . 12-3Figure 12.4: Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5Figure 12.5: Operation Keyboard . . . . . . . . . . . . . . . . . . . . . . 12-6Figure 12.6: Tower Stations . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7Figure 12.7: Tube Racks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10

Figure 13.1: Operation Set Up Menu Screen. . . . . . . . . . . . . . 13-9Figure 13.2: Set Up Menu Screen . . . . . . . . . . . . . . . . . . . . . 13-11Figure 13.3: Animal Type Set Up Screen . . . . . . . . . . . . . . . . 13-12Figure 13.4: View Animal Type Set Up Screen . . . . . . . . . . . 13-13Figure 13.5: Animal Limit Set 1. . . . . . . . . . . . . . . . . . . . . . . 13-14Figure 13.6: Animal Type Catalog Screen . . . . . . . . . . . . . . . 13-16Figure 13.7: Catalog Contents, Animal Type Set Up Screen . 13-17Figure 13.8: Expected Ranges . . . . . . . . . . . . . . . . . . . . . . . . 13-18Figure 13.9: Run Screen for Animals . . . . . . . . . . . . . . . . . . . 13-21Figure 13.10: Animal Type Selection Screen. . . . . . . . . . . . . 13-22Figure 13.11: Specimen Type Screen. . . . . . . . . . . . . . . . . . . 13-23Figure 13.12: Dog Background Count. . . . . . . . . . . . . . . . . . 13-24Figure 13.13: Enter Calibration Factor Screen . . . . . . . . . . . 13-28Figure 13.14: Add New Animal Type Screen . . . . . . . . . . . . . 13-34Figure 13.15: Customized Display for Adding New Animals 13-36Figure 13.16: Gains Template . . . . . . . . . . . . . . . . . . . . . . . . 13-37Figure 13.17: Target Locations for the Neutrophil and

Lymphocyte populations . . . . . . . . . . . . . . . . . . . . . . . . . 13-39Figure 13.18: Set Point Entry Screen . . . . . . . . . . . . . . . . . . . 13-44Figure 13.19: Baso Box Set Up. . . . . . . . . . . . . . . . . . . . . . . . 13-46

Figure 14.1: Operation Set Up Menu Screen with Reticulocyte Package Disabled . . . . . . . . . . . . . . . . . . . . . . 14-10

Figure 14.2: Operation Set Up Menu Screen with Reticulocyte Package Enabled. . . . . . . . . . . . . . . . . . . . . . 14-12

Figure 14.3: Reticulocyte Main Menu Screen . . . . . . . . . . . . 14-14Figure 14.4: Reticulocyte Set Up Screen . . . . . . . . . . . . . . . . 14-16Figure 14.5: Reticulocyte Patient Limits Screen . . . . . . . . . . 14-18Figure 14.6: Reticulocyte QC Set Up Screen . . . . . . . . . . . . . 14-19Figure 14.7: Retic QC Range Entry Screen . . . . . . . . . . . . . . 14-21Figure 14.8: Retic QC Means/Limits Screen . . . . . . . . . . . . . 14-22Figure 14.9: Retic Set Up QC Screen . . . . . . . . . . . . . . . . . . . 14-25


9140320F — April 2007

List of Figures

Figure 14.10: Operation Set Up Menu Screen with Reticulocyte Package Enabled. . . . . . . . . . . . . . . . . . . . . . 14-27

Figure 14.11: Reticulocyte Units Selection Screen . . . . . . . . 14-28Figure 14.12: Reticulocyte Data Log Screen . . . . . . . . . . . . . 14-31Figure 14.13: Reticulocyte Display Specimen Screen . . . . . . 14-33Figure 14.14: Reticulocyte Data Log Search Screen . . . . . . . 14-35Figure 14.15: Reticulocyte Data Log Screen Showing the

Starting Reticulocyte Sequence Number Field . . . . . . . . . 14-36Figure 14.16: Reticulocyte Display Specimen Screen . . . . . . 14-37Figure 14.17: Reticulocyte QC Log Screen . . . . . . . . . . . . . . 14-39Figure 14.18: View Reticulocyte QC Log Screen. . . . . . . . . . 14-41Figure 14.19: The Reticulocyte Levey-Jennings Screen. . . . . 14-44Figure 14.20: View Reticulocyte QC Log Screen with

Rejected Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-45Figure 14.21: Reticulocyte Diagnostics Screen . . . . . . . . . . . 14-48Figure 14.22: Reticulocyte Count Rate Summary Screen

(Tabular Format) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-49Figure 14.23: Reticulocyte Count Rate Summary Screen

(Graphic Format) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-50Figure 14.24: Reticulocyte Raw Data Summary Screen . . . . 14-51Figure 14.25: Reticulocyte Special Protocols Screen. . . . . . . 14-53Figure 14.26: Reticulocyte Run Screen . . . . . . . . . . . . . . . . . 14-57Figure 14.27: The First Reticulocyte Patient Specimen

Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-58Figure 14.28: The Second Reticulocyte Patient Specimen

Screen (Displayed When the Specimen ID is Found) . . . 14-59Figure 14.29: The Third Reticulocyte Patient Specimen

Screen (Displayed When the Specimen ID Found is More Than Eight Hours Old) . . . . . . . . . . . . . . . . . . . . . . 14-60

Figure 14.30: The Fourth Reticulocyte Patient Specimen Screen (Displayed When the Specimen ID Is Not Found) 14-61

Figure 14.31: The Reticulocyte Run Result Screen for a Patient Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-62

Figure 14.32: Reticulocyte Run Result Screen for a QC Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-65

Figure 14.33: Reticulocyte Run Result Screen for a Background Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-66

Figure A.1: Bar Code Label Specifications . . . . . . . . . Appendix A-6Figure A.2: Tube Labeling Requirements . . . . . . . . . Appendix A-8


List of Tables

List of Tables

Table 3.1: Parameter Flagging Messages . . . . . . . . . . . . . . . . . 3-39

Table 4.1: Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3Table 4.2: Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 4-4Table 4.3: Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9Table 4.4: Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . 4-10Table 4.5: Precision of the Hemogram and Reticulocyte Parameters (N = 31) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16

Table 4.6: Precision of the WBC Differential Parameters . . . . 4-16Table 4.7: Linearity Specifications . . . . . . . . . . . . . . . . . . . . . 4-17Table 4.8: Accuracy of Hemogram Parameters . . . . . . . . . . . . 4-18Table 4.9: Accuracy of WBC Differential Parameters . . . . . . . 4-19Table 4.10: Carryover for WBC, RBC, HGB, PLT and Retics . . 4-19Table 4.11: Typical Precision for Hemogram Parameters. . . . 4-20Table 4.12: Reference Range for Distributional Flagging . . . . 4-21Table 4.13: Reference Range for Morphologic Flagging . . . . . 4-21Table 4.14: Abnormalities Evaluated. . . . . . . . . . . . . . . . . . . . 4-22Table 4.15: Flagging Analysis Truth Table . . . . . . . . . . . . . . . 4-23Table 4.16: Analysis of False Negative Results . . . . . . . . . . . . 4-23

Table 5.1: Report Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50

Table 6.1: Calibration Criteria. . . . . . . . . . . . . . . . . . . . . . . . . 6-41Table 6.2: Calibration Criteria. . . . . . . . . . . . . . . . . . . . . . . . . 6-51Table 6.3: Calibration Criteria. . . . . . . . . . . . . . . . . . . . . . . . . 6-63Table 6.4: Mode to Mode Calibration Criteria . . . . . . . . . . . . 6-78Table 6.5: Mode to Mode Calibration Criteria . . . . . . . . . . . . 6-87

Table 7.1: Troubleshooting X-B RBC. . . . . . . . . . . . . . . . . . . . 7-23Table 7.2: Default (Preset) X-B WBC Values . . . . . . . . . . . . . . 7-25

Table 13.1: Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5Table 13.2: Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-6Table 13.3: Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7Table 13.4: Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7

Table 14.1: Potential Interfering Substances. . . . . . . . . . . . . 14-69

Table B.1: CELL-DYN 3700 Accessories Kit (List Number 06H88-01) . . . . . . . . . . . . . . . . . . . . . Appendix B-1

Table B.2: CELL-DYN 3700 Sample Loader Accessories Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-2

Table B.3: CELL-DYN 3700 Optional Accessories . . . Appendix B-3Table B.4: CELL-DYN 3700 Calibrators and Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-4

Table B.5: CELL-DYN 3700 Reagents. . . . . . . . . . . . . Appendix B-4


9140320F — April 2007

List of Tables

NOTES

CELL-DYN® 3700 System Operator’s Manual i9140320F — April 2007

Introduction

Foreword

We welcome you to the role of Operator of a CELL-DYN 3700 System. Your system, which includes state-of-the-art technology, is designed to function consistently and dependably from day to day.

The CELL-DYN 3700 System is backed by dedicated professionals who excel in engineering, medical technology, training, and service. As part of the customer training program, we will teach you to operate, maintain and troubleshoot your System.

Abbott Laboratories is dedicated to manufacturing the highest quality, most reliable instrumentation available. We look forward to serving your needs in any way possible.

Customer ServiceUnited States: 1 (877) 4ABBOTT or 1 (877) 422-2688

Abbott Diagnostics DivisionCustomer Service200 Abbott Park RoadAbbott Park, IL 60064, USA

Canada: 1 (800) 387-8378

For customers outside the US, call your local Customer Service Representative.

Intended UseThe CELL-DYN 3700 System is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories.

Proprietary StatementThe entire contents are copyright 2000, 2003, 2004, and 2007 by Abbott Laboratories. Abbott Laboratories’ software programs are protected by copyright. All rights are reserved. This software was developed solely for use with Abbott Laboratories’ equipment and for in vitro diagnostic applications as specified in the operating instructions. No part of this document may be reproduced, stored, or transmitted in any form or by any means (electronic, mechanical, photocopied, recorded, or otherwise) without the prior written permission of Abbott Laboratories.

ii CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

Patent StatementThe CELL-DYN 3700 instrument system is covered by one or more of the following US Patents: 4,710,021; 4,726,237; 5,378,633; 5,510,267; 5,733,784; 5,017,497; 5,958,781; and 6,740,527.

Instrument DisclaimerAll operating instructions must be followed. In no event shall Abbott be responsible for failures, errors, or other liabilities resulting from customers’ noncompliance with the procedures and precautions outlined herein.

Abbott has designed the CELL-DYN 3700 System components for optimal performance. Substitution of reagents, calibrators, controls, and components manufactured by other companies may adversely affect the performance of the Analyzer.

Pictorial DisclaimerAll samples (printouts, graphics, displays or screens, etc.) are for information and illustration purposes only and shall not be used for clinical or maintenance evaluations.

CELL-DYN® 3700 System Operator’s Manual iii9140320F — April 2007

Abbott Instrument Warranty

For US Customers OnlyAbbott Laboratories warrants CELL-DYN 3000 Series Analyzers, sold by Abbott Sales Representatives, to be free from defects in workmanship and materials during normal use by the original purchaser excluding items subject to wear and tear and which require replacement during normal use as a matter of course. This warranty shall continue for a period of one (1) year, commencing twenty-one (21) days from the date of shipment to the original purchaser or until title is transferred from the original purchaser, whichever occurs first (the “Warranty Period”).

If any defects occur during the Warranty Period, contact Abbott Diagnostics Customer Service immediately and be prepared to furnish pertinent details concerning the defect, the model number, and the serial number.

Warranty support is provided twenty-four (24) hours a day, seven (7) days a week for all CELL-DYN 3000 Series customers.

This Warranty does not cover defects or malfunctions which:

1. Are not reported to Abbott during the Warranty Period and within one week of occurrence.

2. Result from chemical decomposition or corrosion.

3. Are caused by customer or third-party abuse, misuse, or negligence, or by failure to comply with any requirement or instruction contained in the applicable Abbott Operator’s Manual.

4. Result from maintenance, repair, or modification performed without Abbott’s authorization.

Abbott’s liability for all matters arising from the supply, installation, use, repair, and maintenance of the Instrument, whether arising under this Warranty or otherwise, shall be limited solely to the repair or (at Abbott’s sole discretion) replacement of the instrument or of components thereof. In no event shall Abbott be liable for injuries sustained by third parties, incidental or consequential damages, or lost profits. Replaced parts shall become the property of Abbott.

THE FOREGOING IS THE SOLE WARRANTY MADE BY ABBOTT REGARDING THE INSTRUMENT; AND ABBOTT SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE.

CELL-DYN 3700 Hematology Systems are manufactured by Abbott Diagnostics Division, Abbott Laboratories, 200 Abbott Park Road, Abbott Park, IL 60064, USA. Please direct all inquiries concerning information in this manual to the foregoing address.

iv CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

Safety Agency Approvals

UL 61010A-1 Approved

CSA C22.2 No. 1010.1 Approved

IEC 1010-1 Approved

Trademark StatementsCELL-DYN, and CELL-DYN HemCal are registered trademarks of Abbott Laboratories.

MAPSS is a trademark of Abbott Laboratories.

CONTRAVES, COULTER, EPSON, EPSON STYLUS, HEMOGARD, Luer-Lok, MICROLINE, OKIDATA, PLEXIGLAS, TEFLON, TYGON, VACUTAINER, and Westgard are not trademarks of Abbott Laboratories.

SymbolsThe symbols listed below are used on CELL-DYN labeling, including the instrument, reagents, calibrators, controls, and this manual. Please note that Warning and Caution symbols and statements are in this manual in Chapter 8: Hazards.

In Vitro Diagnostic Directive 98/79/EC

Legal Manufacturer Abbott LaboratoriesAbbott Park, Il 60064 USA

Authorized Representative ABBOTTMax-Planck-Ring 265205 Wiesbaden, Germany

General Instrument Symbols

Alternating Current Input

Protective Conductor (Ground) Terminal

Off

ON

CELL-DYN® 3700 System Operator’s Manual v9140320E — September 2004

Specific Instrument Symbols

Alternating Current Input

Model Number

Alarm Monitor

Auto Loader Pause

Auto Sampler Peristaltic Pump

Busy Power

Communications Port 1 RBC Metering Assembly

Communications Port 2RBC Transducer Assembly

Data Station Ready

Emergency Stop Repeat

Fault Reset

Frequency Revision

FusesRecommended Specification 232

Hard Disk Drive Service Disk

Hemoglobin Flowcell Set-up Disk

High Speed Serial Link Serial Number

Initialize Solenoid

Installation Disk Start

Keyboard Test Interface

Line Frequency Select Touch

Line Voltage Select Waste

First Parallel Printer Port Waste Chamber 1

Second Parallel Printer Port

Waste Chamber 2

Manual Mode Waste Sensor

Maximum PowerWBC Impedance Count Metering Assembly

Mixing ChamberWBC Impedance Count Transducer Assembly

AC INPUT MODEL

ALARM MONITOR

AUTO LOADER PAUSE

AUTO SAMPLER PERISTALTIC PUMP

BUSY POWER

COM 1 RBC METERING

COM 2 RBC TRANSDUCER

DATA STATION READY

E/STOP REPEAT

FAULT RESET

FREQUENCY REV

FUSES RS232

HDD SERVICE DISK

HGB FLOWCELL SET-UP DISK

HSSL SN

INIT SOL

INSTALLATION DISK START

KEYBOARD TEST INTERFACE

LINE FREQ SELECT TOUCH

LINE VOLTAGE SELECT WASTE

LPT1 WASTE CHAMBER 1

LPT2 WASTE CHAMBER 2

MAN WASTE SENSOR

MAX POWER WIC METERING

MIXING CHAMBER WIC TRANSDUCER

vi CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

Reagent related

Cyanide-Free Hemoglobin/WBC Impedance Count Lyse Reagent

Detergent Reagent

Diluent Reagent

Enzymatic Cleaner Concentrate

Hemoglobin

Hemoglobin Lyse Reagent

Hemoglobin/WBC Impedance Count Lyse

Lot Number

Sheath Reagent

Storage temperature. (Example shows “Store at 2º–8ºC”)

Use by / Expiration Date

WBC Lyse Reagent

Calibrator/Control related

Assay Value

Control

Control Assay Disk

Control, Tri-Level

Control, Low

Control, Normal

Control, High

Control, Level I

Control, Level II

Mean Range

Mean Value

Parameter

Reticulocyte Control

CN-FREE HGB/WIC LYSE

DETERGENT

DILUENT

ENZYMATIC CLEANER CONCENTRATE

HGB

HGB LYSE

HGB/WIC LYSE

LOT

SHEATH

8oC

2oC

WBC LYSE

ASSAY VALUE

CONTROL

CONTROL ASSAY

CONTROL L N H

CONTROL L

CONTROL N

CONTROL H

CONTROL I

CONTROL II

MEAN RANGE

MEAN VALUE

PARAMETER

RETIC CONTROL

CELL-DYN® 3700 System Operator’s Manual vii9140320F — April 2007

System

Whole Blood Control, Low

Whole Blood Control, Normal

Whole Blood Control, High

Whole Blood Control, Tri-Level

Whole Blood Calibrator

Whole Blood Control

Miscellaneous

Legal Manufacturer

Manufacturer

Consult instructions for use

Date of Manufacture

Authorized Representative

For In Vitro Diagnostic Use

List Number

Separate collection for electrical and electronic equipment waste per Directive 2002/96/EC in the European Union

Calibrator/Control related

SYSTEM

WB CONTROL L

WB CONTROL N

WB CONTROL H

WB CONTROL TRI-LEVEL

WB CAL

WB CONTROL

EC REP

IVD

REF

viii CELL-DYN® 3700 System Operator’s Manual

9140320E — September 2004

Instrument LabelingThe following labels are affixed to the CELL-DYN 3700 System:

Current CELL-DYN customer’s instruments are CE Marked to the European Electro-Magnetic Compliance (EMC) and Low-Voltage Directives and have the following labels:

Laser Label, Front Panel

Laser Label, Rear Panel

Serial Number Label, Rear Panel

AVOID DIRECT EXPOSURE TO BEAM.

NICHT DIREKT IN DEN LASERSTRAHL BLICKEN.

EVITER TOUTE EXPOSITION DIRECTE

AU FAISCEAU LASER.

NO SE EXPONGA DIRECTAMENTE AL RAYO LASER.

EVITARE OGNI ESPOSIZIONE DIRETTA AL RAGGIO.

LASER LIGHT WHEN OPEN.

BEI OFFENER ABDECKUNG TRITT

LASERSTRAHL AUS.

RAYON LASER SI OUVERT.

RADIACION LASER SI SE ABRE.

LUCE LASER SE APERTO.

DANGER

GEFAHR DANGER

PELIGRO PERICOLO

PN 9230701D

Class l Laser Product

per

lEC 825-1[1993]

PN 9230702A

ABBOTT DIAGNOSTICS

A wholly owned subsidiary of Abbott Laboratories

Abbott Park IL. 60064

THIS PRODUCT CONFORMS TO

THE APPLICABLE REQUIREMENTS

OF 21 CFR SUBCHAPTER J

AT THE DATE OF MANUFACTURE

MANUFACTURED DATE

MODEL NO.

SERIAL NO.

LIST NO. REV

��

CELL-DYN® 3700 System Operator’s Manual ix9140320E — September 2004

Voltage Label, Rear Panel

CE Label

Solution Container Label, Rear Panel

WARNING

WARNUNG

MISE EN GARDE

ADVERTENCIA

AVVERTENZA

: SET FOR 120 VOLTS

When operation at other line voltage is required, refer to operation manual for detailed instructions.

: FUER 120 VOLT EINGESTELLT

Ist der Betrieb mit einer anderen Netzspannung erforderlich, entnehmen Sie die genauen

Anweisungen der Bedienungsanleitung.

: PARAMETRE POUR UTILISATION SUR 120 VOLTS

Si une utilisation à une tension de réseau différente est requise, reportez-vous au Manuel

Technique pour de plus amples informations.

: CONFIGURADO PARA 120 VOLTIOS

Si se necesita otra tensión diferente a la indicada, consulte el Manual de Operaciones para

instrucciones más detalladas.

: CONFIGURATO PER 120 VOLT

Se la tensione è di voltaggio diverso, fare riferimento alle istruzioni dettagliate nel Manuale di

Impiego.PN 9230003

CAUTION: DO NOT HANDLESOLUTION CONTAINERUNLESS PROPERLYPROTECTED. REFER TOOPERATOR’S MANUAL FORINSTALLATION PROCEDURE.

PN 9230334

x CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

New CELL-DYN customer’s instruments are CE Marked to the European In Vitro Diagnostic Directive, which encompasses the requirements of the EMC and Safety Directives, and have the following labels:

Laser Label, Front Panel

Laser Label, Rear Panel

Serial Number Label, Rear Panel

Biological Risk Label, Touch Plate

CAUTION –

CLASS 3B LASER LIGHT WHEN OPEN.

AVOID EXPOSURE TO BEAM.PN 9230701

CLASS 1 LASER PRODUCTPN 9230702

ABBOTT DIAGNOSTICS DIVISIONAbbott Laboratories

Abbott Park IL, 60064 USATHIS PRODUCT CONFORMS TO

THE APPLICABLE REQUIREMENTSOF 21 CFR SUBCHAPTER J AT THE DATE

OF MANUFACTURE

DATE OF MANUFACTURE

MADE IN U.S.A. PN 9230308 REV G

PN 9231446

Biological Risk

CELL-DYN® 3700 System Operator’s Manual xi9140320E — September 2004

CE Mark Label, Rear Panel


Solution Container Label, Rear Panel

ABBOTTMax-Planck-Ring 265205 WiesbadenGermany+49-6122-580

ABBOTT LABORATORIESAbbott Park, IL 60064 USA

PN 9230751A

PN 9230003F

WARNING: SET FOR 120 VOLTS / ACHTUNG: F�R 120 VOLT EINGESTELLT /

ADVARSEL: KONFIGURERET TIL 120 V / VARNING: INST�LLD F�R 120 VOLT /

Consult instructions for use if different voltage is required. / Ist der Betrieb mit einer anderenNetzspannung erforderlich, in der Bedienungsanleitung nachlesen. / Si une utilisation � unetension diff�rente est requise, consulter les instructions d’utilisation. / Consulte las instrucciones deuso si la tensi�n es distinta. / Per un voltaggio diverso, consultare le istruzioni per l’uso. /Se for necess�ria uma voltagem diferente, consultar as instrues de utiliza�o. /Se brugermanualen, hvis der er behov for drift med en anden netsp�nding. / L s tillh�randedokumentation om en annan sp nning beh�vs. / Για χρήση σε άλλη τάση ρεύματος,συμβουλευτείτε τις οδηγίες χρήσης.

ΠΡΟΕΙΔΟΠΟΙΗΣΗ: ΧΡΗΣΗ ΣΤΑ 120 VOLTS

MISE EN GARDE : UTILISATION A 120 VOLTS / ADVERTENCIA: 120 VOLTIOS /

AVVERTENZA: CONFIGURATO A 120 VOLT / AVISO: CONFIGURADO PARA 120 VOLTS /

PN 9230334F

Consult instructions for use. / Gebrauchsanweisung beachten. / Consulter les instructionsd’utilisation. / Consulte las instrucciones de uso. / Consultare le istruzioni per l’uso. /Consultar as instrues de utiliza�o. / Se brugsanvisningen. / L s tillh�randedokumentation. / Συμβουλευτείτε τις οδηγίες χρήσης. / Viz návod k použití.

CAUTION: Do not handle Solution Container unless properly protected.VORSICHT: Die Reagenzbeh lter nur ordnungsgem � gesichert bewegen.ATTENTION : Ne pas manipuler le flacon de solution sans protectionappropri�e.

PRECAUCI�N: no maneje el recipiente de la soluci�n a menos que est� protegido adecuadamente.ATTENZIONE: Non maneggiare il recipiente della soluzione se non si � protetti in modo adeguato.ATEN��O: n�o manipular o recipiente da solu�o sem estar devidamente protegido.VIGTIGT: Beholderen med opl�sning m� ikke h�ndteres, medmindre brugeren er korrekt beskyttet.VIKTIGT: Anv nd skyddskl der vid hantering av l�sningsbeh�llarna.ΠΡΟΣΟΧΗ: Χρησιμοποιείτε το Δοχείο Ρυθμιστικού διαλύματος μόνο αφού λάβετε τιςκατάλληλες προφυλάξεις.UPOZORNĚNÍ: Nemanipulujte s nádobou obsahující roztok, pokud není řádně zabezpečena.

xii CELL-DYN® 3700 System Operator’s Manual


Small CE Mark Label, Rear of Data Station

Class 2 Laser Label, Sample Loader Cover

Serial Number Label, Rear of Data Station

ABBOTTMax-Planck-Ring 265205 WiesbadenGermany+49-6122-580

ABBOTT LABORATORIESAbbott Park, IL 60064 USA

PN 9230751APN 9230963

CAUTION - CLASS 2 LASER LIGHT WHENOPEN AND INTERLOCK IS DEFEATEDDO NOT STARE INTO THE BEAM

PN 9230323

ABBOTT DIAGNOSTICS DIVISIONAbbott Laboratories

Abbott Park IL, 60064 USA

MADE IN U.S.A. PN 9230010 REV K

CELL-DYN® 3700 System Operator’s Manual xiii9140320E — September 2004

Conventions Used in This Manual

Soft keys are also depicted as follows in margins and flowcharts:

The following conventions are used in this manual:

Information Presentation Examples

Note, Caution, Warning ALL CAPS, BOLDFACE NOTE:

Bulletin message, status, or other screen display

MONOSPACE FONT,BOLDFACE

Ready

Data entry field <Sans Serif Font, Angle Brackets> <Date/Time>Menu names SANS SERIF FONT, ALL CAPS, SET UPSoft key names [SANS SERIF FONT, ALL CAPS,

BRACKETS][SET UP]

References to other text Bold: Bold & Italics Chapter: Title, Subsection: Heading

MAIN MENUKEYS

SUBMENUKEYS

TOGGLEKEYS

TOGGLEKEYS

xiv CELL-DYN® 3700 System Operator’s Manual


Flowchart ConventionsMenus are shown as square-cornered rectangles in the flowcharts, and soft keys are shown as round-cornered rectangles:

The Page Down key is depicted as follows:

When procedures are depicted in flowcharts, shaded boxes and bold lines indicate which soft keys to press:

MAIN MENUReady

SET UP RUN DATA LOG QUALITYCONTROL

RETIC DATA LOG

PageDown

MAIN MENUReady

PATIENT REAGENTLOG

QC SETUP MENU

OPERATIONSET UP

SET UP RUN DATA LOG QUALITY

TURN ONVET PKG

TURN ONRETIC PKG

BAR CODESET UP

CONTROL

LIMITS

RETIC DATA LOG

CELL-DYN® 3700 System Operator’s Manual xv9140320E — September 2004

Safety The CELL-DYN 3700 System has been designed to minimize hazards to the operator. Operation, maintenance, and servicing of hematology systems may expose individuals to potential safety and health hazards. All work must be performed in accordance with procedures described in the CELL-DYN Operator’s Manual or as directed by an Abbott Representative. For detailed Safety information refer to Chapter 8: Hazards.

Warnings are inserted in this manual to alert personnel to potential hazards. The standard warning conventions including signal words (e.g., Caution) and symbols are described in Chapter 8: Hazards.

xvi CELL-DYN® 3700 System Operator’s Manual


Revision Status

Document Control Number(s)

Revision Date

Section(s) Revised

Pages Revised and Added

Original Issue(9140320A)

12/98 Not Applicable Not Applicable

9140320B 3/99 Chapter 10 Chapter 14

10-75, 10-76, 14-1, 14-2, 14-25,14-26, 14-29, 14-30, 14-39, 14-40, 14-43, 14-44, 14-59, 14-60, 14-61, 14-62, 14-67, 14-68, 14-71, 14-72, 14-75, 14-76, 14-77, 14-78, 14-85, 14-86, Revision Status viii.

9140320C 11/00 All All

9140320D 6/03 Master Table of Contents

All

Foreword All

1: System Description

1-6 through 1-9; 1-11; 1-17 through 1-24; 1-27

2: Installation 2-1; 2-3 through 2-5; 2-14

3: Principles of Operation

3-36

4: System Specifications

4-5 through 4-7; 4-11; 4-23

5: Operating Instructions

5-7; 5-9 and 5-10; 5-12; 5-50; 5-67; 5-88 through 5-91; 5-93 through 5-95; 5-98 through 5-102; 5-119; 5-121; 5-143

6: Calibration 6-3; 6-26; 6-40

7: Quality Control 7-17; 7-25

8: Hazards All

9: Maintenance 9-3 and 9-4; 9-23 and 9-24; 9-27 through 9-54

10: Troubleshooting 10-32; 10-35 and 10-36; 10-58; 10-60; 10-68; 10-85

12: Sample Loader 12-6 and 12-7; 12-11

13: Veterinary Package

13-44 and 13-45; 13-47; 13-52

14: Reticulocyte 14-1; 14-3; 14-69; 14-71 through 14-75, 14-77 and 14-78; 14-81

Appendix A All

Appendix B New

Index New

CELL-DYN® 3700 System Operator’s Manual xvii9140320E — September 2004

9140320E 9/2004 Master Table of Contents

All

Foreword All


1-1; 1-6; 1-9; 1-24 through 1-27

2: Installation 2-1; 2-3; 2-5; 2-9; 2-12 and 2-13; 2-15


3-36 through 3-49; 3-55 and 3-56


4-6; 4-11; 4-17; 4-19


5-17 through 5-19; 5-50; 5-87 through 5-89; 5 103; 5-110; 5-123

6: Calibration 6-1; 6-3; 6-30; 6-35; 6-38; 6-53; 6-57; 6-64; 6-68 and 6-69; 6-79; 6-82 and 6-83; 6-89 and 6-90; 6-92 through 6-96

7: Quality Control 7-15 through 7-19; 7-23; 7-26

9: Maintenance 9-2 and 9-3; 9-19 and 9-20; 9-23; 9-26 and 9-27; 9-29 and 9-30; 9-32 through 9-34; 9-36 and 9-37; 9-40; 9-43; 9-45 and 9-46; 9-48; 9-52; 9-54

10: Troubleshooting 10-23; 10-25; 10-28; 10-32; 10-34 through 10-37; 10-42; 10-57 and 10-58; 10-60 through 10-65; 10-76; 10-78 through 10-87

11: Printers 11-4; 11-6; 11-13

12: Sample Loader 12-1 and 12-3


13-8

14: Reticulocyte 14-14; 14-32 through 14-34; 14-69; 14-71; 14-82

Appendix A 7 and 8

Appendix B 1 and 2; 4

Appendix C New


Revision Date

Section(s) Revised


xviii CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

9140320F 4/2007 Master Table of Contents

All

List of Figures All

List of Tables All

Foreword i through iv; vi and vii, x, xviii through xx


1-5; 1-19 through 1-21; 1-23 through 1-32

2: Installation 2-7 through 2-20


3-1 through 3-20; 3-36; 3-39; 3-43 through 3-64


4-15; 4-17; 4-20; 4-23; 4-25


5-88; 5-90 through 5-91; 5-143

6: Calibration 6-5 and 6-6; 6-29; 6-35; 6-99

7: Quality Control 7-9; 7-16 through 7-17

9: Maintenance 9-54

10: Troubleshooting 10-61

11: Printers All


13-8

14: Reticulocyte 14-7 and 14-8; 14-68; 14-69; 14-71; 14-77 and 14-78; 14-83

Bibliography All

Appendix B B-4

Index All


Revision Date

Section(s) Revised


CELL-DYN® 3700 System Operator’s Manual xix9140320F — April 2007

Revision Log

Instructions: Use this log to provide a permanent record to verify that revised chapter(s) and/or page(s) have been added to this manual.

1. Record the document control number of the revised section in the first column. You will find the number in the footer. Make an entry for each chapter you receive and place in the manual.

2. Record the revision date, also found in the footer, in the second column.3. Record the current CELL-DYN 3700 System software version in the third column.4. Write your initials or signature in the fourth column to verify that you have placed the revised

page(s) in the manual.5. Record the date that you added the revised section to the manual in the fifth column.

Document Control Number

Revision Date

Software Version

Revision Incorporated

byDate

Incorporated

xx CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

NOTES

CELL-DYN® 3700 System Operator’s Manual 1-19140320E — September 2004

Chapter 1 System DescriptionSystem Description

Overview

The CELL-DYN 3700 System is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two versions: the CELL-DYN 3700SL System with an automated Sample Loader and the CELL-DYN 3700CS System with a manual Closed Sampler.

Figure 1.1: CELL-DYN 3700SL System

The CELL-DYN 3700SL System is equipped with an automated Sample Loader module. The Sample Loader provides continuous closed sampling for up to 100 tubes at a time. (See the preceding figure.)

The CELL-DYN 3700CS System is equipped with a built-in manual Closed Sample Aspiration Module referred to as the Closed Sampler. The Closed Sampler aspirates blood from a closed collection tube that has been inserted in the Closed Sampler Module.

Insert Color Photo

1-2 CELL-DYN® 3700 System Operator’s Manual

9140320C — November 2000

System DescriptionOverview Chapter 1

NOTES

CELL-DYN® 3700 System Operator’s Manual 1-39140320C — November 2000

Chapter 1 System Description

Intended Use

The CELL-DYN® 3700 System generates the following hematologic measurements on EDTA-anticoagulated whole blood:

WBC — White Blood Cell or Leukocyte count

NEU — Neutrophil absolute count %N — Neutrophil percent

LYM — Lymphocyte absolute count %L — Lymphocyte percent

MONO — Monocyte absolute count %M — Monocyte percent

EOS — Eosinophil absolute count %E — Eosinophil percent

BASO — Basophil absolute count %B — Basophil percent

RBC — Red Blood Cell or Erythrocyte count

HGB — Hemoglobin concentration

HCT — Hematocrit

MCV — Mean Corpuscular Volume

MCH — Mean Corpuscular Hemoglobin

MCHC — Mean Corpuscular Hemoglobin Concentration

RDW — Red Cell Distribution Width

PLT — Platelet or Thrombocyte count

MPV — Mean Platelet Volume

PDW*— Platelet Distribution Width

PCT* — Plateletcrit

RETIC % — Reticulocyte Percent

RETIC ABS — Reticulocyte Absolute

IRF — Immature Reticulocyte Fraction

* Clinical significance has not been established for these parameters. Therefore they are not reportable in the U.S. They are provided for laboratory use only.


9140320C — November 2000

System DescriptionIntended Use Chapter 1

NOTES

CELL-DYN® 3700 System Operator’s Manual 1-59140320F — April 2007

System DescriptionChapter 1 System Components

System Components

The two main modules of the CELL-DYN 3700 System are depicted in the following two figures. (The Sample Loader Module included with the CELL-DYN 3700SL System is illustrated and described in Chapter 2: Installation and Chapter 12: Sample Loader.)

Figure 1.2: CELL-DYN 3700 System

Analyzer:

The Analyzer contains the hardware to aspirate, dilute, and analyze each whole blood specimen.

Data Station:

The Data Station contains a Flat Panel Display Monitor, a Keyboard, and a CPU (Central Processing Unit).

AnalyzerData Station



System DescriptionSystem Components Chapter 1

Analyzer

OverviewThe Analyzer is the central unit of the CELL-DYN 3700 System. It aspirates and dilutes whole blood specimens, transports and analyzes the prepared dilutions, and rinses fluidic components in preparation for the next specimen. Except for those components directly related to the Closed Sample Processing Method (automated or manual), the CELL-DYN 3700CS System and CELL-DYN 3700SL System are identical. In the description of components on the following pages, those components applicable to only one of the systems will be identified as such. A complete description of the automated Sample Loader can be found in Chapter 12: Sample Loader.

Front PanelThe components visible on the front of the Analyzer are depicted in the following figure. The functional description of each component follows.

Figure 1.3: CELL-DYN 3700CS System Analyzer Front View

Left Front Cover Viewing Window

Status IndicatorPanel

Right Front Cover

TubeRetainer

Closed SampleAspiration Module

Touch Plate

Open

AspirationProbe

Sample

CELL-DYN® 3700 System Operator’s Manual 1-79140320D — June 2003


Left Front CoverThe removable Left Front Cover protects the Left Flow Panel. To remove the cover, lift up on the cover to free it from the mounting brackets. A grounding wire provides electrical continuity for shielding purposes. Disconnect the grounding wire. Access to the Left Flow Panel is necessary to view the action of the Flow Panel components and to perform certain maintenance procedures.

Right Front CoverThe removable Right Front Cover protects the Right Flow Panel. It contains a window that allows the operator to view the Shear Valve. The cover is removed by lifting it up, disconnecting the ground wires, and lifting away from the mounting brackets. Access to the Right Flow Panel is necessary to view the operation of the components and to perform certain maintenance procedures.

Status Indicator PanelThree status indicator messages (illuminated by green, yellow, and red LEDs) indicate the status of the Analyzer. The status messages are:

• Ready (green light) — The Analyzer is ready to process a specimen.

• Busy (yellow light) — The Analyzer is busy with a normal operational sequence.

• Fault (red light) — The Analyzer is unable to process specimens due to an existing fault condition.

Open Sample Aspiration ProbeThe Open Sample Aspiration Probe aspirates whole blood from an opened collection tube. The Wash Block moves down to the end of the probe and remains there whenever the Closed Mode is selected.

Touch PlateThe Touch Plate is located directly behind the Open Sample Aspiration Probe. Pressing the Touch Plate starts the selected run cycle for both the Open Mode and Closed Mode on the CELL-DYN 3700CS System. If the Closed Sampler Mode is selected on the CS instrument, the cycle will begin only if a tube has been properly inserted in the holder. On the CELL-DYN 3700SL System, the Touch Plate is used for Open Mode only.


9140320D — June 2003


Closed Sample Aspiration Module (CELL-DYN 3700CS System Only)The Closed Sample Aspiration Module aspirates whole blood from a closed collection tube. It is activated when the Closed Sampler Mode is selected. The module contains the following components:

• A Holder holds the closed collection tube.

• A Tube Retainer correctly positions the tube in the holder.

• Two Quick Adjust Levers located on either side of the Tube Retainer are used to raise or lower the Tube Retainer in order to securely hold the collection tube in the proper position.

• An Interlock Switch located in the Tube Retainer prevents activation of the Closed Sampler until a collection tube is inserted properly.

• A Needle pierces the collection tube stopper, vents vacuum or pressure from inside the tube, aspirates the whole blood, and is retracted and rinsed at the end of each Closed Sampler cycle.

Automated Sample Loader Module (CELL-DYN 3700SL System Only)See Chapter 12: Sample Loader for information about the Sample Loader Module.

Flow PanelThe major components of the Flow Panel are depicted in the following figure. The functional description of each component follows.



.

Figure 1.4: Analyzer Flow Panel Components

Aer

osol

Filte

r

WO

C M

ixin

gC

ham

ber WO

C F

low

Cel

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WO

C T

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Beh

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sem

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Was

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RB

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Lin

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WIC

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Sam

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Asp

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Syr

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(con

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(con

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gent

)

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B/W

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(con

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s H

GB/

WIC

Lys

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HG

B/W

IC D

iluen

t Syr

inge

(con

tain

s D

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t)

RB

C/P

LT D

iluen

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inge

(con

tain

s D

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t)Was

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lock

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ampl

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Prob

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Touc

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Opt

ical

Ben

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RB

C/P

LTD

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Sens

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RB

C/P

LT

von

Behr

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Tran

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Ove

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Cha

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A.C

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lock

Sw

itch

Nor

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dVa

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Mou

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gB

rack

et

Mou

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rack

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Mou

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rack

et

HG

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Wire

Clip

Mou

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9140320C — November 2000


Sample Aspiration Peristaltic PumpThe Sample Aspiration Peristaltic Pump is composed of a rotor and pump tube holder. It aspirates whole blood from either an open or closed collection tube into the Shear Valve. The pump action is controlled by the Touch Plate and an optical detector.

Shear Valve AssemblyThe three-piece ceramic Shear Valve isolates a precise volume of whole blood by means of a shearing action as the front and rear sections rotate. The aspirated blood is isolated in three separate segments — one for the WOC dilution, one for the WIC/HGB dilution, and one for the RBC/PLT dilution.

Wash BlockThe Wash Block rinses the outside of the Open Sample Aspiration Probe with Diluent. It air dries the probe and routes the external and internal rinses to a waste chamber.

Syringe AssemblyThe Syringe Assembly contains a set of five syringes: two WIC/HGB Syringes operated by the same stepper motor and three others (RBC Diluent, WOC Sheath, and WOC Metering Syringes), each operated by a separate stepper motor.

• RBC/PLT Diluent Syringe — delivers a specific volume of Diluent to transport the blood from the Shear Valve to the Mixing Chamber in the von Behrens RBC/PLT Transducer.

• WIC/HGB Diluent Syringe — delivers a specific volume of Diluent to transport the blood from the Shear Valve to the WIC/HGB Mixing Chamber in the von Behrens WIC Transducer.

• WIC/HGB Lyse Syringe — dispenses a specific volume of WIC/HGB Lyse into the WIC/HGB Mixing Chamber at the same time as the diluted sample is dispensed into the chamber.

• WOC Sheath Syringe — delivers a specific volume of Sheath Reagent to transport the blood from the Shear Valve to the WOC Mixing Chamber.

• WOC Metering Syringe — injects a specific volume of the WOC dilution into the WOC Flow Cell.

Waste ChambersTwo Waste Chambers collect the waste liquid from the Analyzer Flow Panel.



ACC Interlock SwitchAn Aperture Cleaning Circuit (ACC) Interlock Switch inhibits the operation of the Aperture Cleaning Circuit when the front covers are removed.

RBC/PLT Metering AssemblyThe RBC/PLT Metering Assembly contains a precision-bore glass tube with a set of optical detectors, one upper and one lower, mounted on it. It meters a fixed volume of the RBC/PLT dilution to ensure that an accurate volume is counted during the RBC/PLT measurement.

von Behrens RBC/PLT Transducer AssemblyThe von Behrens RBC/PLT Transducer Assembly contains the fluidics and hardware required for accurate measurement of the diluted red blood cells and platelets. The primary components of this assembly are:

• von Behrens RBC/PLT Transducer - The Transducer contains two chambers. The Mixing Chamber on the left is for mixing the RBC/PLT dilution. The Counting Chamber on the right contains the von Behrens Plate used to prevent cells that have traversed the aperture from recirculating into the sensing zone.

• Electrodes - There are two non-corrosive, electrically conductive plates, one positively charged and one negatively charged. One electrode is located in each Transducer Chamber. The electrodes conduct a constant current flow through the aperture during the RBC/PLT measurement.

• RBC/PLT Aperture Plate -This plate is inserted into a slot between the two Transducer Chambers. A jewel containing the aperture is pressure-embedded into the plate.

WIC (WBC Impedance Count) Metering AssemblyThe WIC Metering Assembly contains a precision-bore glass tube with a set of optical detectors, one upper and one lower, mounted on it. It meters a fixed volume of the HGB/WIC dilution to ensure that an accurate volume is counted during the WIC measurement.


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HGB Flow Cell AssemblyThe HGB Flow Cell Assembly contains the following components:

• A fully enclosed (light-tight), flow-through glass Cuvette

• An LED light source

• A Bandwidth Filter used to obtain the ICSH recommended wavelength of 540 nm

• A Photodetector for measuring the light transmitted

WOC (WBC Optical Count) Transfer Peristaltic PumpThe WOC Transfer Peristaltic Pump is composed of a rotor and a pump tube holder. It transports the WOC dilution to the WOC Flow Cell.

von Behrens WIC Transducer AssemblyThe von Behrens WIC Transducer Assembly contains the fluidics and hardware required for accurate measurement of the diluted white blood cells. The primary components of this assembly are:

• von Behrens WIC Transducer — The Transducer contains two chambers. The Mixing Chamber on the left is for mixing the WIC/HGB dilution. The Counting Chamber on the right contains the von Behrens Plate used to prevent cells that have traversed the aperture from recirculating into the sensing zone.

• Electrodes — There are two non-corrosive, electrically conductive plates, one positively charged and one negatively charged. One electrode is located in each transducer chamber. The electrodes conduct a constant current flow through the aperture during the WIC measurement.

• WIC Aperture Plate — This plate is inserted into a slot between the two Transducer Chambers. A jewel containing the aperture is pressure-embedded into the plate.

Aerosol FilterThe Aerosol Filter is used to filter aerosols out of the air that leaves the instrument.

Overflow ChamberThe Overflow Chamber collects excess fluid from the Mixing Chambers.



WOC Mixing ChamberThe glass WOC Mixing Chamber is for mixing the WOC dilution.

WOC Flow Cell AssemblyThe WOC Flow Cell Assembly, located behind the WOC Flow Cell cover, contains the fluidics and hardware needed to hydrodynamically focus the diluted white blood cell sample stream. The primary components of this assembly are:

• Sample Feed Nozzle — A specially designed tube is used to deliver the WOC dilution into the Sheath stream.

• WOC Flow Cell — An optically clear quartz flow-through chamber with a cone-shaped bottom and central rectangular opening focuses the sample into a single-cell stream for measurement.

Optical Bench AssemblyThe Optical Bench Assembly contains the Helium-Neon laser, the WOC Flow Cell, the optics, and the detectors required for counting and differentiating the white blood cells.


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Left Side PanelThe components on the Left Side Panel of the Analyzer are depicted in the following figure. The functional description of each component follows.

Figure 1.5: Analyzer Left Side Panel Components

Solenoid ValvesThe Solenoid Valves are used to control pressure and vacuum. The three valves in the top row control the hydraulic pressure to the system. The three valves in the bottom row control the vacuum used to fill the reagent reservoirs.

Air Intake FiltersTwo removable panels contain Air Intake Filters that are inserted from the front. The filters clean the air drawn into the Analyzer by the air circulation fans on the Rear Panel.

AnalyzerPower Switch

Sample LoaderConnector

WasteSensorPort

DiluentInlet Tube

Sheath Inlet TubeFitting

DetergentInlet Tube

WIC/HGBLyse Inlet

Analyzer SerialNumber Label

NormallyClosed Valves

Solenoid ValvesAir IntakeFilter

DiluentReservoir

SheathReservoir

DetergentReservoir

Air IntakeFilter

Fitting

Tube Fitting

Fitting

WasteOutlet TubeFitting



Diluent ReservoirThe Diluent Reservoir maintains the Diluent supply in the Analyzer.

Sheath ReservoirThe Sheath Reservoir maintains the Sheath Reagent supply in the Analyzer.

Detergent ReservoirThe Detergent Reservoir maintains the Detergent supply in the Analyzer.

Normally Closed ValvesThree Normally Closed Valves prevent the reagents in the reservoirs from draining down into the Analyzer when the Analyzer power is turned OFF.

Analyzer Serial Number LabelThe Analyzer Serial Number Label contains the manufacturer's serial number for the Analyzer.

Analyzer Power SwitchThe Analyzer Power Switch is the main power switch for the Analyzer. It is used to turn the instrument ON and OFF.

Sample Loader ConnectorThe Sample Loader Connector is used to attach the Serial Interface Cable from the Sample Loader Module to the Analyzer (used with CELL-DYN 3700SL System only).

Waste Sensor ConnectorThe Waste-Full Sensor Plug connects to the Waste Sensor Connector. When the electrical sensor is activated, the EXTERNAL WASTE FULL message is generated and the READY status is inhibited until the situation is corrected.

NOTE: The Analyzer interprets a disconnected plug as a full waste container. Therefore, if the waste is routed to a drain, a Dummy Plug must be inserted in the connector.

Diluent Inlet Tube FittingThe red color-coded Diluent Inlet Tube Fitting connects the Diluent Inlet Tube with its associated cap, sinker, and label.


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Sheath Inlet Tube FittingThe purple color-coded Sheath Inlet Tube Fitting is used to connect the Sheath Inlet Tube with its associated cap, sinker, and label.

Detergent Inlet Tube FittingThe green color-coded Detergent Inlet Tube Fitting connects the Detergent Inlet Tube with its associated cap, sinker, and label.

WIC/HGB Lyse Inlet Tube FittingThe blue color-coded WIC/HGB Lyse Inlet Tube Fitting is used to connect the WIC/HGB Lyse Inlet Tube with its associated cap, sinker, and label.

Waste Outlet Tube FittingThe black color-coded Waste Outlet Tube Fitting is used to connect the waste outlet tube.



Rear PanelThe components visible on the Rear Panel of the Analyzer are depicted in the following figure. The functional description of each component follows.

Figure 1.6: Analyzer Rear Panel Components

FansThree fans cool the internal components of the Analyzer.

Line Frequency and Line Voltage Select SwitchesThese switches are used to select the line frequency and voltage for the Analyzer.


Fans

Line Frequencyand VoltageSelect Switches

Fuse

AnalyzerPower

RS-232Test Interface

Data StationPort

Receptacle

Port

WARNING: SET FOR 120 VOLTSWhen operation at other line voltage is required,refer to Operator’s Manual for detailed instructions.

PN 9230003E


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Figure 1.7: Power Supply Module Voltage Switch Configuration

WARNING: These switches are set at the factory for 120 volts. When operation at other line voltage is required, refer to Figure 1.7.

FuseAn 8-amp (100/120V)T (Slo-Blo) or 4-amp (220/240V)T (Slo/Blo) fuse protects the Analyzer from power surges.

Analyzer Power ReceptacleThe Analyzer Power Receptacle is used to connect the Main Power Cord to the Analyzer.

RS-232 Test Interface PortThe RS-232 Test Interface Port is used by Abbott engineering and service personnel.

NOTE: This RS-232 Port can not be used for an LIS connection.

Data Station PortThe Data Station Port is used to connect the Analyzer to the Data Station.

100V 50HZ

120V 50HZ

220V 50HZ

240V 50HZ

100V 60HZ

120V 60HZ

220V 60HZ

240V 60HZ



Data StationThe CELL-DYN 3700 operations are controlled by high-speed microprocessors that monitor system status, perform the various analytical routines used by the instrument, perform diagnostic checks, and store result data.

Serial data (ASCII format) may be output to a Laboratory Information System (LIS) through an RS-232 connector. Data transmission may be performed either automatically as samples are processed or by command of the operator. Parallel data may be output to an on-line printer.

The Data Station Computer consists of:

• 80486 microprocessor (IBM AT compatible)

• 8 megabytes RAM minimum

• 1.2-gigabyte hard drive minimum

• 15-inch color monitor or flat panel display

NOTE: Components for both are described in this section.

• VGA graphics

The results are stored on the hard drive for the most recent 10,000 cycles. Complete graphical data are also stored for the most recent 10,000 cycles.

Figure 1.8: Data Station — Front View

Screen

Soft Keys

Floppy Disk Drive

Standard ComputerKeyboard

Contrast ControlBrightness Control

Monitor

CPU

MonitorPower Switch


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The Data Station and monitor components are shown in the previous figure. The Standard Computer Keyboard is also shown. The functional description of each component follows.

Monitor Front and Side Components

ScreenA 15-inch diagonal, high-resolution Screen with 16-color illumination displays all alphanumeric and graphic data.

Soft KeysA row of eight unlabeled pressure-sensitive soft keys is located directly below the screen. Each key generates an audible tone when pressed and initiates a function defined by the screen label currently displayed directly above it.

Standard Computer Keyboard: List Number - 07H96-01The Standard Computer Keyboard connects to the rear of the Data Station and contains a complete set of alphabetic, numeric, and special function keys used for data entry and manipulation. The F1 to F8 function keys on this keyboard correspond to the soft keys on the Data Station.

Floppy Disk DriveThe Floppy Disk Drive accepts 3.5-inch high-density diskettes. It is used to update the system software program and to download data.

Brightness ControlThe Brightness Control adjusts the brightness of the Data Station screen.

Contrast ControlThe Contrast Control adjusts the contrast of the Data Station screen.



Rear ComponentsThe rear components located on the Data Station and monitor are depicted in the following figure. The functional description of each component follows.

Figure 1.9: Data Station — Rear Components

Monitor Serial Number Label

The Monitor Serial Number Label contains the manufacturer’s serial number for the Monitor.

CPU Serial Number Label

The CPU Serial Number Label contains the manufacturer’s serial number for the computer.

Soft Key Interface Cable (“Touch” Port)The Soft Key Interface Cable transmits the Monitor’s Soft Key requests to the CPU for processing.

Fan

Com 2/

Com 1/

LPT 1Soft Key

PortTicket Printer

PowerOutlet

CPUVoltage Selector

Data StationPower Plug

Keyboard

Monitor

Cable

Connector

Port

Port

Graphics

MonitorPower

Soft KeyInterfaceCable

MonitorSerial Number

CPU SerialNumber Label

ExternalComputer

Analyzer

PrinterPortLPT 2

Interface

Port

Connector

Video

MonitorVideoCablePort

Port

(“Touch” Port)

RS 232


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Com 1/External Computer The Com 1/External Computer port is used to connect the Laboratory Information System (LIS) to the Data Station.

FanThe Fan cools the Data Station computer.

Monitor Video Cable and PortThe Monitor Video Cable provides video input to the monitor. It connects to the CPU Video Port.

COM 2/RS 232 PortThe RS-232 Port is used to connect the Laboratory Information System (LIS) to the Data Station.

Analyzer Port The Analyzer Port is used to connect the cable from the Data Station to the Analyzer.

Graphics Printer PortThe Graphics Printer Port is used to connect the printer cable to the Data Station for graphics printing.

Ticket Printer PortThe Ticket Printer Port is used to connect the printer cable to the Data Station for ticket printing.

Keyboard PortThe Keyboard Port is used to connect the Standard Computer Keyboard to the Data Station.

Data Station Power Plug ConnectorThe Data Station Power Plug Connector is used to connect the Main Power Cord to the Data Station.

Voltage SelectorThe Voltage Selector sets the line voltage for the Data Station.

Monitor Power Cord and Plug ConnectorThe Monitor Power Cord supplies power to the Monitor. It connects to the Monitor Power Plug Connector. The Power cord insulation rating is SVT/FT2.



Flat Panel DisplayA 15-inch, color-active matrix thin-film-transistor (TFT) liquid crystal display (LCD) panel with high contrast 16.777M color illumination displays all alphanumeric and graphic data.

Figure 1.10: Control Button – Front View

Touch ScreenThe Touch Screen allows commands to be transferred from the Flat Panel Monitor to the Data Station computer. A row of eight touch keys is displayed on the screen. Each key generates an audible tone when pressed and initiates the function defined by the screen label.

Screen ControlsControls are described in order from left to right.

1. Earphone – enables the user to connect a headset.

2. Auto Tuning – automatically sizes, centers and fine-tunes the video signal to eliminate noise and distortion.

NOTE: Refer to the procedure following the description of the controls.

3. On Screen Display (OSD) menu/select – displays the OSD menus and is used to select from the displayed options.

4. Decrease – used to decrease the value of a selected OSD option.

5. Increase – used to increase the value of a selected OSD option.

6. Power switch – powers the Flat Panel Monitor ON or OFF.

1 2 3 4 5 6


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Auto Tuning ProcedurePerform this procedure to automatically size, center and fine-tune the video signal to eliminate noise and distortion.

1. Be sure the Analyzer is in the READY state and the appropriate software language has been selected.

2. From the MAIN MENU screen, press QUALITY CONTROL (F5 on the keyboard).

3. Select a QC file that contains at least one entry and press VIEW QC LOG (F3 on the keyboard).

4. Press the Auto tuning button on the front of the LCD panel. The display will automatically be sized, centered and the video signal fine-tuned. Additionally, the 8-switch function soft keys location is optimized and the touch keys made ready for use.



Flat Panel Display, Rear Components

Figure 1.11: Inputs Diagram

Cable ConnectionsCable connections are described in order from left to right.

1. Power AC In – AC power input for 110/220 VAC power

2. 8-Switch/RS232 – 8-switch or RS232 25-pin touch screen. Note that the RS232 is for the use of ELO’s serial touch screen driver, AccuTouch (cable required).

3. PC In – VGA video input

4. USB – optional USB port for connecting ELO’s serial touch screen driver, AccuTouch, supported by a virtual COM port (VCP) driver from FTDI.

5. Audio – optional audio port (Line In) that can be connected to any stereo audio out source

6. RS232/USB – optional switch used to select RS232 or USB that must be set for RS232 or USB bidirectional communication only.

Power Cord (not shown)The AC power cord (Quail Series 1090 or equivalent) connects the monitor to the power source.


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Touch Screen Cable (not shown)The Touch Screen cable (shielded 9 conductor, 24 AWG stranded) connects to the TOUCH port.

Video Cable (not shown)The video cable (shielded 15 conductor, 24 AWG stranded) connects to the VGA port.



PrinterThe Printer is discussed in detail in Chapter 11: Printers.

Sample LoaderThe Sample Loader is discussed in detail in Chapter 12: Sample Loader.

Reagent System

OverviewThe Reagent System is formulated specifically for the CELL-DYN 3700 instrument flow systems in order to provide optimal system performance. Use of reagents other than those specified in this manual is not recommended as instrument performance can be affected. Each CELL-DYN System is checked at the factory using the specified reagents and all performance claims were generated using these reagents.

Reagents must be stored at room temperature to ensure optimal performance. All reagents should be protected from direct sunlight, extreme heat, and freezing during storage. Temperatures below 32°F (0°C) may cause reagent layering that changes the tonicity and conductivity of the reagents.

CAUTION: If any reagent has been frozen, it should not be used.

The Reagent Inlet Tubes have a cap attached that minimizes evaporation and contamination during use. However, reagent quality may deteriorate with time. Therefore, use all reagents within the dating period indicated on the label.

NOTE: Never add remaining reagent from a container being replaced to a freshly opened container. This may contaminate the new reagent.

Before operating the instrument for the first time, make sure each reagent line is connected to the appropriate inlet and reagent container.


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A facsimile of the label that is on the reagent panel is shown below in Figure 1.12.

Figure 1.12: Caution Label

CELL-DYN Reagents

DiluentCELL-DYN Diluent is formulated to meet the following requirements:

• Act as the Diluent for the WBCs (for the Impedance count only), RBCs, PLTs, and HGB.

• Maintain the stable diluted cell volume of each red cell and platelet during the count and sizing portion of the measurement cycle.

• Provide acceptable background counts equal to or less than:

WIC: 0.30 x 103/µL (109/L)

RBC: 0.03 x 106/µL (1012/L)

PLT: 10.0 x 103/µL (109/L)

HGB: 0.2 g/dL (g/L)

HGB/WIC LyseCELL-DYN HGB/WIC Lyse is formulated to meet the following requirements:

• Rapidly lyse the red blood cells and minimize the resultant stroma.

• Strip the white cell cytoplasm leaving the nuclear membrane intact so the white cell nuclei can be enumerated.

• Convert hemoglobin to a modified hemiglobincyanide complex that is measurable at 540 nm. (The quaternary ammonium lysate participates as a chromagen.)

PN 9230334F

Consult instructions for use. / Gebrauchsanweisung beachten. / Consulter les instructionsd’utilisation. / Consulte las instrucciones de uso. / Consultare le istruzioni per l’uso. /Consultar as instrues de utiliza�o. / Se brugsanvisningen. / L s tillh�randedokumentation. / Συμβουλευτείτε τις οδηγίες χρήσης. / Viz návod k použití.

CAUTION: Do not handle Solution Container unless properly protected.VORSICHT: Die Reagenzbeh lter nur ordnungsgem � gesichert bewegen.ATTENTION : Ne pas manipuler le flacon de solution sans protectionappropri�e.

PRECAUCI�N: no maneje el recipiente de la soluci�n a menos que est� protegido adecuadamente.ATTENZIONE: Non maneggiare il recipiente della soluzione se non si � protetti in modo adeguato.ATEN��O: n�o manipular o recipiente da solu�o sem estar devidamente protegido.VIGTIGT: Beholderen med opl�sning m� ikke h�ndteres, medmindre brugeren er korrekt beskyttet.VIKTIGT: Anv nd skyddskl der vid hantering av l�sningsbeh�llarna.ΠΡΟΣΟΧΗ: Χρησιμοποιείτε το Δοχείο Ρυθμιστικού διαλύματος μόνο αφού λάβετε τιςκατάλληλες προφυλάξεις.UPOZORNĚNÍ: Nemanipulujte s nádobou obsahující roztok, pokud není řádně zabezpečena.



CN-Free WIC/HGB LyseCELL-DYN Cyanide-Free WIC/HGB Lyse is formulated to meet the following requirements:

• Rapidly lyse the red blood cells and minimize the resultant stroma.

• Strip the white cell cytoplasm leaving the nuclear membrane intact so the white cell nuclei can be enumerated.

• Convert hemoglobin to a single chromagen that is measurable at 540 nm.

• Provide a background count equal to less than 0.2 g/dL.

DetergentCELL-DYN Detergent is formulated to meet the following requirements:

• Provide an optically clear solution that is needed to obtain the zero reference during the HGB measurement cycle.

• Provide proper meniscus formation in the WIC and RBC/PLT Metering Tubes and maintain it during each run cycle.

• Rinse the WIC Counting Chamber, the WIC Metering Tube, RBC/PLT Counting Chamber, the RBC/PLT Metering Tube, and the HGB Flow Cell with minimal bubble formation.

Sheath ReagentCELL-DYN Sheath Reagent is formulated to meet the following requirements:

• Osmotically lyse the red cells.

• Maintain the light scattering properties of the WBCs for the duration of the measurement period.

• Serve as a Sheath fluid for the hydrodynamic focusing process.

• Provide sufficient wetting action to prevent accumulation of air bubbles in the WOC flow system.

• Provide a WOC background count equal to or less than 0.3 x 103/µL (109/L).

Enzymatic CleanerCELL-DYN Enzymatic Cleaner is formulated to effectively remove protein buildup within the instrument.


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Reticulocyte Reagent SystemThe CELL-DYN Reticulocyte Reagent is formulated specifically for the CELL-DYN 3700 Reticulocyte Procedure in order to provide optimal system performance. Use of reagents other than those specified in this manual is not recommended, as instrument performance can be affected. Each CELL-DYN 3700 System is checked at the factory using the specified reagents and all performance claims were generated using these reagents.

Reagent must be stored in the dark at a room temperature of 15-30°C. All reagents should be protected from direct sunlight, extreme heat, and freezing during storage.

CAUTION: If any reagent has been frozen, it should not be used.

Reagent tubes have been capped to minimize evaporation. However, reagent quality may deteriorate with time. Therefore, use all reagents within the dating period indicated on the label.


System DescriptionChapter 1 Controls and Calibrator

Controls and Calibrator

Controls and Calibrator are reference materials used to test, set, and monitor CELL-DYN 3700 performance.

ControlsDay-to-day verification of System calibration is performed using CELL-DYN controls. Running these stabilized reference products every day of operation is recommended to test instrument accuracy.

NOTE: Always store controls and calibrators according to the directions in the package inserts that accompany them.

CalibratorCalibration of the directly measured parameters can be performed using CELL-DYN Calibrators. Calibration is discussed in detail in Section 6: Calibration Procedures.


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System DescriptionControls and Calibrator Chapter 1

NOTES


Chapter 2 InstallationInstallation

Overview

The CELL-DYN 3700 System should only be installed by an authorized Abbott representative to ensure that all system components are functioning correctly and to verify system performance.

NOTE: Installation of the Analyzer by an unauthorized or untrained person could result in damage to the system. Never attempt to install the system without an authorized Abbott representative present. Additionally, all service and repair must be performed by authorized ABBOTT TRAINED Abbott representatives.

This chapter contains general installation, inventory, package inspection, and relocation information. It also provides space, waste, and power requirements for installing the CELL-DYN 3700 System, and it includes procedures for setting up the Sample Loader and for installing the Graphics Printer and optional Ticket Printer.


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InstallationOverview Chapter 2

NOTES


Chapter 2 Installation

Initial Preparation

InventoryThe instrument is shipped from the factory with the following:

CELL-DYN 3700SL System• 1 crate containing the Analyzer with Sample Loader

• 1 crate containing the Data Station

• Monitor

• CPU

• 1 box containing the Accessory Kit

• 1 box containing the Color Graphics Printer

• Optional: 1 box containing the Ticket Printer

CELL-DYN 3700CS System• 1 crate containing the Analyzer

• 1 crate containing the Data Station

• 1 box containing the Color Graphics Printer

• 1 box containing the Accessory Kit

• Optional: 1 box containing the Ticket Printer

Package InspectionAll crates should be inspected for damage. If there is any damage, or if any crates or boxes are missing, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

The reagents needed for installation may be shipped separately from the instrument. This shipment includes: Diluent, HGB/WIC Lyse Reagent, Sheath Reagent, and Detergent.

The calibrator and controls needed for the installation may be shipped separately from the instrument.

The Enzymatic Cleaner is shipped separately.


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InstallationInitial Preparation Chapter 2

Space RequirementsThe CELL-DYN 3700 System requires approximately five linear feet of space on a countertop. In addition, sufficient space is required beneath for Diluent, WIC/HGB Lyse, Sheath Reagent, Detergent, and the waste container (if one is used).

Six inches of space behind and on the left side of the Analyzer must be allowed for air flow in order to maintain the constant circulating internal air stream required to cool circuitry and components whenever the power is ON. Six inches of space must also be allowed behind the Data Station for air flow. The Data Station may be placed in direct contact with the right side of the Analyzer. If possible, there should be 24 inches of space above and to either side of the Analyzer for service access.

Allow adequate space around the instrument to perform necessary maintenance procedures, to provide service access, and to allow the instrument to be easily disconnected from its power source.

In addition to these space requirements, the instrument should also be located:

• On a stable, level surface.

• On a nonporous, nonabsorbing work surface and flooring that can be easily cleaned and disinfected using recommended procedures.

• Away from direct sunlight.

• Away from the path of a cooled or heated air outlet.

• Away from any other equipment that may interfere with it, such as a centrifuge, any x-ray equipment, a CRT, a video terminal, a computer, or a copier.

Please note that the CELL-DYN 3700 System has been evaluated to EN 55011 and EN 61000 for electromagnetic emissions and immunity, respectively.

Always place the reagents below (never above) the instrument.


InstallationChapter 2 Initial Preparation

Waste RequirementsA suitable properly labeled waste container must be located near enough to the CELL-DYN 3700 System to connect to the Analyzer Waste Outlet Tube, or the instrument must be positioned to permit the waste to be routed directly to a drain. The drain must be suitable for disposal of waste with possible biological and chemical hazard. Ensure that the waste outlet tube is secured in the drain hole and all System Components are located away from possible waste overflow.

Regulations on permissible substances, and their amounts, for disposal in public sewer systems vary from state to state and even community to community. Customers are advised to be knowledgeable of all applicable local, state, and federal requirements, and the contents of the effluent streams, before disposing of waste in public sewer systems.

Make sure the waste line is connected to the appropriate outlet and routed to a suitable waste container or drain. If the waste is routed to a waste container, make sure the Waste Sensor is properly connected.

If an external waste container is used, the Waste Full Sensor Plug (attached to the cap’s electrode wires) should be inserted into the Waste Sensor Connector on the Left Side Panel of the Analyzer. If the waste tube is placed directly into a drain, the “Dummy” Plug provided in the Accessory Kit must be inserted into the Waste Sensor Connector or the EXTERNAL WASTE FULL alert will be activated.

NOTE: If a Waste Container is used, the container should be labeled with the Biohazard Symbol.

Power RequirementsThree power outlets are required for the CELL-DYN 3700SL System and three are required for the CELL-DYN 3700CS System. A grounded power outlet and voltage regulator are required for optimum performance. Refer to Chapter 4: System Specifications for the electrical requirements for each system.


9140320C — November 2000

InstallationInitial Preparation Chapter 2

NOTES


Chapter 2 Installation

Printer Installation

OverviewRemove the printer(s) from its shipping container and visually inspect it for damage. Find a suitable location adjacent to the instrument. Be sure the printer power switch is in the OFF position. Retain the manuals shipped with the printer(s) and store them in a convenient location.

NOTE: If the printer is placed on top of the instrument, be sure that the paper does not restrict air flow to the rear panel fan.

Basic installation procedures follow for the Graphics and Ticket Printers. When used with the CELL-DYN 3700, the Graphics Printer prints color or black-and-white graphic reports and the Ticket Printer prints tickets or black-and-white graphic reports. Depending on the output desired, one or both printers may be connected to the instrument.

Follow installation instructions carefully to be sure that the printer(s) is connected to the correct port. (See Figure 2.1.) For convenience, general instructions are provided for loading individual pre-printed tickets in the Ticket Printer. For a detailed description of the printer components and operating instructions, refer to the manuals that accompany the printer.

IMPORTANT: The CELL-DYN 3700 System has been configured for and tested with specific printers, such as the printer shipped with the analyzer. For additional information about specific printer capability with the CELL-DYN 3700 System, US Customers, please contact Abbott Diagnostics Customer Service at 1-877-4ABBOTT (1-877-422-2688). Customers outside the US should contact your local Customer Service representative. Use of printers other than those recommended by Abbott Laboratories may lead to erroneous printer functionality.


9140320F — April 2007

InstallationPrinter Installation Chapter 2

Figure 2.1: Data Station Rear Components

Graphics Printer Installation Procedure1. Assemble the printer as directed in the printer manual.

2. Make sure that the printer power switch is OFF. Plug the power cord into the printer. Do not plug the other end into an outlet until you are ready to load paper.

3. Make sure that the power to the Data Station is turned OFF. Remove the printer cable (which looks like a power cord with two connectors) from the Accessory kit and plug one end into the LPT1 port on the rear of the printer. Fasten the wire clips to the connector for a secure connection.

4. Plug the other end of the printer cable into the Graphics Printer port on the back of the Data Station. (See Figure 2.1) Tighten the screws on the connector for a secure connection.

NOTE: This port is configured for use as a graphics printer only. To print tickets, you may connect a Ticket Printer to the Ticket Printer port.

5. Install the ink cartridge as directed in the printer manual.

6. Load the paper as directed in the printer manual.

Fan

Com 2/

Com 1/

LPT 1Soft Key

PortTicket Printer

PowerOutlet

CPUVoltage Selector

Data StationPower Plug

Keyboard

Monitor

Cable

Connector

Port

Port

Graphics

MonitorPower

Soft KeyInterfaceCable

MonitorSerial Number

CPU SerialNumber Label

ExternalComputer

Analyzer

PrinterPortLPT 2

Interface

Port

Connector

Video

MonitorVideoCablePort

Port

(“Touch” Port)

RS 232


InstallationChapter 2 Printer Installation

Self-Test PrintoutsRun any self-test printouts (as directed in the printer manual) before using the printer for the first time. These self-tests may be run any time to verify proper printer operation.

The CELL-DYN 3700 software automatically controls and adjusts most print conditions for the Graphics Printer, including page width. If printing is not what you expect, refer to the printer manual for guidance in making adjustments. If you have additional questions or experience any problems, call Abbott Customer Service for assistance.

IMPORTANT


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Ticket Printer Installation ProcedureThe Ticket Printer is an OKIDATA MICROLINE 320 dot matrix printer or compatible printer.

The Ticket Printer is normally used to print result data on blank or pre-printed tickets but can be used to print a complete graphics report on continuous tractor-feed paper. (Blank tickets are available in continuous tractor-feed sheets. Pre-printed tickets must be loaded individually.)

1. Assemble the printer as directed in the printer manual.

2. Make sure that the printer power switch is OFF. Plug the power cord into the back of the printer and plug the other end into a grounded outlet.

3. Make sure that the power to the Data Station is turned OFF. Remove the printer cable (which looks like a power cord with two connectors) from the Accessory kit and plug one end into the port on the rear of the printer. (The port is constructed so that the connector will only fit in the proper way.) Fasten the wire clips to the connector for a secure connection.

4. Plug the other end of the printer cable into the LPT2 Ticket Printer port on the back of the Data Station. (See Figure 2.1.) Tighten the screws on the connector for a secure connection.

NOTE: This port is configured for use as a ticket printer only. To print graphics reports, you may connect a Graphics Printer to the Graphics Printer port.

5. Install the ribbon as directed in the printer manual.

6. Load the paper or blank, continuous-feed tickets as directed in the printer manual, OR, if you are using pre-printed individual tickets, continue with the following procedure.

Loading Individual Tickets in the Ticket PrinterInstructions are given for loading individual tickets. If fanfold, continuous-feed tickets are used, they should be loaded as directed in the printer manual for tractor-feed paper.

NOTE: To print on these tickets, the printer cable must be connected to the Ticket Printer Connector.



1. Be sure that the printer is turned ON and the printer cable is connected to the Ticket Printer connector on the back of the Data Station. If the connection is incorrect, turn the Data Station power OFF, change the position of the cable and turn the power back ON.

2. Set the ribbon cartridge headgap lever to adjust for the thickness of the tickets. Refer to the printer manual for detailed instructions.

3. Move the paper selection lever to the rear position to select single-feed paper.

4. Open the access cover and be sure the guide wire on the paper separator is pushed back into the locked position.

5. Raise the separator to its upright position.

6. Place a ticket on the paper separator and adjust the guides so that they barely touch the edges of the ticket.

7. Pull the bail lever forward. The ticket will automatically feed into place. Release the bail lever.

8. Be sure the printer is deselected (Sel indicator is not illuminated). Set the Top of Form by pressing and holding the TOF/Quiet key and pressing the Form Feed key to move the ticket up or pressing the Line Feed key to move the ticket down. (The ticket moves in very fine increments so it can be precisely positioned.)

NOTE: The ticket will only move down to a certain point to prevent potential ticket jams. Do not move the top of the page below the paper bail.

9. Position the ticket so that the lower red line on the paper shield (located between the print head and the paper) is positioned where the first line of printing should occur.

NOTE: When the Top of Form is set, the position is retained in the printer memory until it is reset.

10. Press the Sel key to select the printer. The printer is now ready to print.

Self-Test PrintoutsRun any self-test printouts indicated in the printer manual before using the Ticket Printer for the first time. These self-tests may be run any time to verify proper printer operation.


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Sample Loader Set UpThe Sample Loader for the CELL-DYN 3700SL System is attached to the analyzer.

Figure 2.2: CELL-DYN 3700SL

Mechanical and Electrical Set Up1. Inspect the Sample Loader module for damage.

2. Remove the power cord from the Accessory Kit, and inspect the cord and connector for damage. Connect the cord to the Power Connector on the Left Side Panel. Connect the three-prong end to an available power outlet.

CAUTION: Do not turn the Sample Loader power ON. Damage may result if the fluidics tubing has not been connected.

3. Remove the Sample Loader Interface Cable (it looks like a power cord with two connectors) from the Accessory Kit, and inspect it for damage. Connect the appropriate end of the cable to the port on the Left Side Panel of the Sample Loader and secure the screws. Connect the cable’s other end to the port labeled Auto Sampler on the Left Side Panel of the Analyzer. Secure the screws.



Tube Racks Set Up1. Remove the 11 Tube Racks from the Accessory Kit and

inspect each one for damage.

2. Remove the bar code labels provided for the Tube Racks and inspect them for damage. Apply a bar coded rack ID label to the indented area on the side of each tube rack between tube positions 1 and 2. Apply the label by starting at the top and working downward. Be sure the label is positioned in the indentation. It is suggested that the racks be labeled 1–10 and the End Rack be labeled 99.

3. Apply the rack ID number label as shown in the following figure, inside the recessed area provided on the top of the rack.

4. On one rack only, apply the black End Rack Sensor Label to the indented area on the side of the rack, and apply two black End Rack Visual Indicator Labels to the indented areas on top of the rack. These labels will identify this rack as the End Rack.

Figure 2.3: Tube Rack Showing Label Placement Locations

5. Place five racks in the open area to the left of the tower and five racks in the open area to the right of the tower. Push all of the right side racks toward the Analyzer. Pull all of the left side racks away from the Analyzer. All ten racks must be in place for proper operation.

Black End Rack Visual Indicator Label(END RACK ONLY)

Rack ID NumberLabel

TubeRack

Black End Rack Sensor Label(END RACK ONLY)

Orient Numbered EndDOWNWARD

Bar Coded RackID Label

Bar CodedPositionID Label


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NOTE: Be sure each rack is placed with its bar coded rack ID label and open slot facing toward the Analyzer.

NOTE: Liquid spills in the rack drive mechanism are a potential reason for failure of the rack to advance. Liquid spills that flow in the Sample Loader Control Panel could cause operational failure. For further assistance, call Abbott Diagnostics Customer Service (at 1-877-4ABBOTT in the US).

Power OnTurn the Sample Loader Power Switch on the Left Side Panel ON. When the initialization process is complete, the light above the Sample Loader Start key will flash. This indicates that the Sample Loader is ready to start processing samples. The message AUTO SAMPLER READY is displayed in the Data Station bulletin line.



Instrument Installation

Reagent Tubing Installation

Materials1. Lint-free pads

2. CELL-DYN Reagents

Procedure1. Place the reagents in a suitable location below the Analyzer.

Sufficient space is required below for Diluent, WIC/HGB Lyse, Sheath Reagent, Detergent, and the waste container (if one is used).

NOTE: Never place the reagents above the Analyzer, in direct sunlight, or in the path of a cooled or heated air outlet.

2. Remove the Reagent Inlet Tubing and the Waste Tubing from the Accessory Kit.

3. Inspect each length of tubing carefully for damage or cracks.

4. Attach the non-weighted end of the Detergent Tubing (the tubing with the green label) to the Green Detergent Fitting on the Left Side Panel of the Analyzer. (See the following figure.) Wipe the outside of the tubing with a damp lint-free pad and place the weighted end into the container of CELL-DYN Detergent. Secure the cap.

5. Attach the non-weighted end of the Diluent Tubing (the tubing with the red label) to the Red Diluent Fitting on the Left Side Panel of the Analyzer. Wipe the outside of the tubing with a damp lint-free pad and place the weighted end into the container of CELL-DYN Diluent. Secure the cap.

6. Attach the non-weighted end of the WIC/HGB LYSE Tubing (the tubing with the blue label) to the Blue WIC/HGB Lyse Fitting on the Left Side Panel of the Analyzer. Wipe the outside of the tubing with a damp lint-free pad and place the weighted end into the container of CELL-DYN WIC/HGB Lyse. Secure the cap.

7. Attach the non-weighted end of the Sheath Tubing (the tubing with the purple label) to the Purple Sheath Fitting on the Left Side Panel of the Analyzer. Wipe the outside of the tubing with a damp lint-free pad and place the weighted end into the container of CELL-DYN Sheath. Secure the cap.


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Figure 2.4: Left Side Panel

Waste Tubing InstallationFollow the appropriate procedure below.

Procedure If Using Waste Container1. Attach the Waste Outlet Tubing to the Waste Outlet Fitting,

located on the Left Side Panel. (See the preceding figure.)

2. Place the other end of the tubing (cap and sensor) into the waste container.

NOTE: The Waste Container should be labeled with the Biohazard Symbol.

3. Secure the cap and sensor.

4. Ensure that the waste container is adequately labeled.

5. Locate and insert the Waste-Full Sensor Plug (attached to the cap) into the Waste Sensor Connector, located on the Left Side Panel of the Analyzer. Attach cable shielding connector to ground plug.

NOTE: If no plug is inserted into the Waste Sensor Connector, the External Waste Full message will be displayed.

Waste OutletFitting

Waste SensorConnector

Normally ClosedValves



Procedure If Using External Drain1. Remove the cap and sensor from the Waste Outlet Tubing

and place the tubing into a drain suitable for the collection of waste with possible biological and chemical hazard.

2. Insert the “Dummy” Plug (provided in the Accessory Kit) into the Waste Sensor Connector, located on the Left Side Panel of the Analyzer.

NOTE: If no plug is inserted into the Waste Sensor Connector, the External Waste Full message will activate.

3. Fasten the tubing to the drain securely to prevent accidental spillage.

Normally Closed ValvesBefore shipment, the tubing for the Normally Closed Valves is removed. (See the preceding and following figures.) Follow the directions below to reinstall the tubing.

1. Locate one of the Normally Closed Valves. Fully stretch one length of the tubing and insert it into the top of the valve’s slot. Work the stretched tubing vigorously back and forth with a flossing motion, until it is completely seated in the bottom of the slot.

2. Repeat step 1 for each of the remaining Normally Closed Valves.


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Figure 2.5: Front Flow Panel

Normally ClosedValves


InstallationChapter 2 Relocation

Relocation

Your CELL-DYN 3700® System has some fragile components, and you must follow this relocation procedure to ensure proper instrument function after relocation.

1. Shut down the system according to the procedure described in Chapter 9: Maintenance, Subsection: Special Procedures, Preparation for Inactivity or Shipping.

2. Prepare the new location site before moving the system. Refer to the following subsections within Initial Preparation at the beginning of this chapter:

• Space Requirements

• Waste Requirements

• Power Requirements

3. Move the CELL-DYN 3700 System to the new location.

CAUTION: The CELL-DYN 3700SL weighs 288 pounds and the CELL-DYN 3700CS weighs 190 pounds. Obtain assistance when moving and/or use a mechanical lifting device.

4. Install the system in the new location according to Installation within this chapter.

5. Turn the system ON according to the process described in Chapter 10: Troubleshooting: Troubleshooting Procedure, Power ON.

NOTE: All system and hematology data file information is saved when power to the system is removed, including date, time, and calibration. However, if new reagents are installed upon relocation the appropriate Reagent Logs should be updated, and instrument performance confirmed as described below, before running any patient samples.

6. Run five backgrounds and confirm that they are acceptable before running controls or patient samples. If backgrounds or controls are unacceptable, refer to Chapter 10: Troubleshooting and follow established laboratory operating procedures.


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InstallationRelocation Chapter 2

NOTES


Chapter 3 Principles of OperationPrinciples of Operation

Overview

The principles used by the CELL-DYN® 3700 System to measure, count, and calculate the hematologic parameters are discussed generally in the first section of this chapter as part of an overview of the four measurement cycles. The parameters are then discussed individually in relation to the methodology used. At the end of the chapter is a discussion of operational messages and flags that pertain to the parameter measurements and data results.

Four independent measurements are used in the CELL-DYN® 3700 System to obtain the hematologic parameters.

• The WBC Optical Count (WOC) and the WBC Differential data are measured in the Optical Flow channel.

• The WBC Impedance Count (WIC) is measured in one Electrical Impedance channel.

• The RBC and PLT data are measured in a second Electrical Impedance channel.

• The HGB is measured in the Spectrophotometric channel.

During each instrument cycle, the sample is aspirated, diluted, and mixed, and the measurements for each parameter are performed.


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Principles of OperationOverview Chapter 3

NOTES


Chapter 3 Principles of Operation

Sample Aspiration

The CELL-DYN 3700 System performs whole blood sample aspiration using two modes. The operator selects the desired mode from the Data Station RUN Screen.

• The Open Sampler Mode is used to aspirate the sample from a collection tube that has been opened and is held under the Open Sample Aspiration Probe.

• The manual Closed Sampler Mode or automated Sample Loader Mode is used to aspirate the blood directly from a capped collection tube by piercing the tube stopper.

The aspiration volumes are:

Open Mode 130 µL ± 5%

Closed Mode (CS) 240 µL ± 5%

Sample Loader (SL) 355 µL ± 5%

Once the mode of aspiration has been selected, the whole blood sample is aspirated into the Analyzer by the Aspiration Peristaltic Pump. The pump aspirates the sample through the Shear Valve. Optical sensors check the integrity of the sample stream.


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Principles of OperationSample Aspiration Chapter 3

NOTES



Sample Analysis Cycle Overview

NOTE: Sample and reagent volumes given in this section are stated as the nominal values. Slight differences between instruments may cause these volumes to vary. These differences are compensated for by factory-set internal dilution factors.

To begin the sample analysis cycle, the sample is aspirated into the Shear Valve. The Shear Valve then rotates in order to isolate the whole blood sample into three segments:

• 32 µL for the WOC dilution

• 20 µL for the WIC/HGB dilution

• 0.74 µL for the RBC/PLT dilution

WBC AnalysisWBCs are analyzed in two separate channels: Optical (WOC) and Impedance (WIC).

WOC MeasurementWBC Optical Count (WOC) measurement is performed as follows:

1. The WOC Sheath Syringe dispenses 1.6 mL of Sheath Reagent through the Shear Valve, where it picks up the 32-µL WOC sample segment.

2. The sample segment and sheath are then routed to the WOC Mixing Chamber, where the dilution is bubble-mixed. The final dilution is 1:51.

NOTE: The ratio 1:51 represents 1 part in a total of 51 parts, not 1 part plus 51 parts.

3. The WOC Peristaltic Pump transfers the WOC dilution from the WOC Mixing Chamber to the Sample Feed Nozzle in the WOC Flow Cell.

4. A stream of WOC Sheath Reagent is directed through the Flow Cell.

5. The WOC Metering Syringe injects 78 µL of the WOC dilution into the Flow Cell sheath stream. The dilution is hydrodynamically focused into a narrow stream. (Hydrodynamic focusing is discussed later in this chapter.)


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Principles of OperationSample Analysis Cycle Overview Chapter 3

6. A laser beam is focused on the Flow Cell. As the sample stream intersects the laser beam, the light scattered by the cells is measured at four different angular intervals. (Light scatter is discussed later in this chapter.)

WIC MeasurementWBC Impedance Count (WIC) measurement is performed as follows:

1. The WIC/HGB Diluent Syringe dispenses 5.25 mL of Diluent through the Shear Valve, where it picks up the 20-µL WIC/HGB sample segment.

2. The segment and Diluent are then routed to the Mixing Chamber in the von Behrens WIC Transducer. At the same time, the WIC/HGB Lyse Syringe delivers 0.75 mL of WIC/HGB Lyse to the Mixing Chamber.

3. The dilution is then bubble-mixed. The final WIC/HGB dilution is 1:301.

4. The dilution is pulled through the aperture by vacuum. A process known as volumetric metering (discussed later in this chapter) ensures that 200 µL of the dilution are used for the measurement.

5. Electrical Impedance (discussed later in this chapter) is used to count the WBCs as they traverse the aperture.

6. When the count portion of the cycle is completed, the aperture is automatically cleaned by the Aperture Cleaning Circuit.

RBC/PLT Analysis1. The RBC Diluent Syringe dispenses 7.2 mL of Diluent

through the Shear Valve, where it picks up the 0.74-µL RBC/PLT sample segment.

2. The sample segment and Diluent are then routed to the Mixing Chamber of the von Behrens RBC/PLT Transducer, where the dilution is bubble-mixed. The final dilution is 1:9,760.

3. The dilution is pulled through the aperture by vacuum. The volumetric metering process ensures that 100 µL of the dilution are used for the measurement.

4. Electrical Impedance (discussed later in this chapter) is used to count the RBCs and PLTs as they traverse the aperture.

Reticulocyte AnalysisReticulocytes are discussed in Chapter 14: Reticulocyte Package.


Principles of OperationChapter 3 Sample Analysis Cycle Overview

Hemoglobin Analysis1. After 200 µL of the WIC/HGB dilution are metered through

the WIC aperture, the remaining dilution is transferred to the HGB Flow Cell.

2. The HGB concentration is measured spectrophotometrically. This process is discussed in detail later in this chapter.

Results DisplayedAll data are transmitted to the Data Station for analysis. Results are computed for all parameters and are displayed on the Data Station RUN Screen. Results are also stored in a log format called the Data Log.

Instrument Rinsed1. The Open Sample Aspiration Probe is rinsed internally and

externally with Diluent.

2. The needle used in both the automated and the manual Closed Mode is rinsed internally and externally with Diluent.

3. The WIC Mixing Chamber and the RBC/PLT Mixing Chamber are rinsed with Diluent.

4. The WOC Mixing Chamber is rinsed with Sheath Reagent.

5. The WIC Metering Tube and the RBC/PLT Metering Tube are rinsed with detergent.

6. The HGB Flow Cell is rinsed with detergent.


9140320F — April 2007

Principles of OperationSample Analysis Cycle Overview Chapter 3

NOTES



WBC Analysis

Two WBC values are provided by the CELL-DYN 3700 System:

• The WIC (WBC Impedance Count)

• The WOC (WBC Optical Count)

The WOC is the primary value reported as the WBC count. Whenever a clinically significant difference between WIC and WOC is present, the data is further evaluated to determine the most accurate value.

WIC/WOC InteractionThe WIC (WBC Impedance Count) interacts with the WOC (WBC Optical Count) to produce the final reported WBC value. Two methods are provided because both measurements have strengths and limitations. Because the limitations of each method differ, providing both methods enhances the instrument’s ability to provide a more accurate WBC count in the presence of certain interfering substances and pathological conditions. A data analysis algorithm automatically evaluates each measurement and selects the appropriate result to report. The algorithm used by the CELL-DYN 3700 System is divided into three main areas: 1) the WOC decision tree, to analyze and output the WOC data; 2) the WIC decision tree, to analyze and output the WIC data; and 3) a WIC/WOC comparison decision tree, to compare the two outputs.

The WOC decision tree calculates the WOC result for the WBC count and the Differential count. It evaluates the results for correctness and flagging. Finally, the algorithm outputs the WOC with appropriate flags to the WIC/WOC comparison decision tree.

The WIC decision tree evaluates the WIC for correctness and flagging and outputs the WIC to the WIC/WOC comparison decision tree.

The WIC/WOC comparison decision tree compares the two outputs for a difference between the results. If a clinically significant difference exists, results are further evaluated to determine the cause. Depending on the nature of the cause (the type of interference), the algorithm reports either the WOC value or the WIC value, whichever is more accurate, with the appropriate flags (or no flags) as the reported WBC.


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Principles of OperationWBC Analysis Chapter 3

WIC Measurement

OverviewThe WBC Impedance Channel is used for the determination of the WIC. A 1:301 dilution of the sample is made with Diluent and WIC/HGB Lyse. The WIC/HGB Lyse Reagent lyses the RBCs and strips the cytoplasm from the WBCs. The WBC nuclei are counted using the impedance method as they pass through the 100 x 77–µm aperture in the von Behrens WIC Transducer. The 200-µL volume of sample that is analyzed is precisely regulated by the WIC Metering Assembly. WIC data are collected in 256 channels. The WIC data may be presented in a histogram at the request of the operator.

NOTE: If NRBCs are present, they are lysed and their nuclei are included in the WIC. Consequently, when NRBCs are present the WIC data provide a total nucleated cell count including the NRBCs.

Electrical Impedance MeasurementsWBC nuclei are counted and sized by the Electrical Impedance method. This method is based on the measurement of changes in electrical current which are produced by a particle, suspended in a conductive liquid, as it passes through an aperture of known dimensions. An electrode is submerged in the liquid on either side of the aperture in order to create an electrical pathway through it.

As each particle passes through the aperture, a transitory change in the resistance between the electrodes is produced. This change produces a measurable electrical pulse. The number of pulses generated is indicative of the number of particles that traversed the aperture. The amplitude of each pulse is essentially proportional to the volume of the particle that produced it.

Each pulse is amplified and compared to internal reference voltage channels. These channels are delineated by calibrated size discriminators to accept only pulses of a certain amplitude. Thus, the pulses are sorted into various size channels according to their amplitude.


Principles of OperationChapter 3 WBC Analysis

Coincidence Passage CorrectionTwo or more cells can enter the aperture sensing zone simultaneously during a measurement cycle. The resistance change created in this situation generates a single pulse with a high amplitude and increased pulse area. Thus, it appears that one large cell has passed through the aperture. Consequently, the cell count is falsely decreased. This count reduction, referred to as Coincidence Passage Loss, is statistically predictable because it has a direct relationship to the effective volume of the aperture and the amount of dilution. Each WIC is automatically corrected for Coincidence Passage Loss.

Volumetric MeteringAn absolute cell count cannot be obtained unless the precise volume of diluted whole blood that passes through the aperture during the count cycle is known.1 The CELL-DYN 3700 System utilizes the Volumetric Metering process to regulate the count cycle and ensure that a precise volume of sample is analyzed for the WIC measurement.

The WIC Metering Assembly contains a precision-bore glass tube fitted with two optical detectors. (See the following figure.) The distance between the detectors is set to precisely measure 200 µL. Detergent is added to the Diluent in the metering tube to create a meniscus in the liquid. When the WIC cycle is initiated, the liquid flows down the metering tube.

Figure 3.1: Volumetric Metering

Meniscus

CountTime

StartDetector(CountInitiated)

StopDetector(CountCompleted)


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The count portion of the cycle is initiated when the meniscus reaches the upper detector. The count cycle stops when the meniscus reaches the lower detector. The amount of time required for the meniscus to travel from the upper to the lower detector is called the WIC Count Time. The computer also monitors the time it takes the meniscus to reach the upper detector once the WIC cycle is initiated. This is called the WIC Upper Metering Time.

The WIC Count Time (WCT) and the WIC Upper Metering Time (WUT) are automatically monitored to detect variation from the expected values. Variation may be caused by debris in the aperture, vacuum fluctuation, or air bubbles in the metering tube. If significant variation is detected, the bulletin line on the Data Station RUN screen displays the message: WIC METERING FAULT — CLOG or FLOW ERROR and the WBC and Differential data are suppressed.

At the end of each cycle, the WIC Count Time is displayed on the Data Station RUN screen below and to the right of the BASO results. If a WIC metering fault was detected, one of two messages is displayed and printed: the WIC CLOG message if either time is too slow or the WIC FLOW ERROR message if either time is too fast. Both the WIC Upper Metering Time (WUT) and the WIC Count Time (WCT) are printed when a WIC metering fault occurs.

WIC Measurement ProcessThe 1:301 WIC/HGB dilution is delivered to the Mixing Chamber in the von Behrens WIC Transducer where it is bubble-mixed. A 200-µL metered volume of the dilution is drawn through the 100-µm aperture by vacuum. The WBCs are counted by impedance. If the pulse generated is above the WBC lower threshold (channel 40), it is counted as a WBC. The WIC count data are also stored in a 256-channel histogram, in which each channel is equal to 0.5 fL.

As cells exit from the aperture, they tend to swirl around and may reenter the sensing zone and be counted a second time, causing the counts to be falsely elevated. The von Behrens Plate located in the von Behrens WIC Transducer Counting Chamber minimizes the effect of these recirculating cells.

The WIC is corrected for Coincidence Passage Loss (discussed earlier in this chapter) and compared to the WOC by the algorithm.



WOC AnalysisThe CELL-DYN 3700 System uses laser-based flow cytometric techniques to analyze the WBC subpopulations. The first part of this section gives a brief introduction to the principles of flow cytometry.2 The second part of this section gives a detailed description of the WOC measurement and the WBC differential analysis.

Introduction to Laser-Based (Optical) Flow CytometryFlow Cytometry can be defined as “a process in which individual cells or other biological particles are made to pass in single file in a fluid stream by a sensor or sensors which measure physical or chemical characteristics of the cells or particles.”3

Clinical and Laboratory Standards Institute (formerly NCCLS) recently defined Flow Cytometry as “A methodologically oriented subdiscipline of analytical cytology that measures cells in suspension in a liquid vehicle as they pass typically one cell at a time, by a measurement station. The measurement represents transformations of changes in the output of a detector (or detectors) due to changes in scattered light, absorbed light, or light emitted (fluorescence) by the cell, or changes in electrical impedance, as the cell passes through the measuring station.”4

Flow Cytometry enables the rapid screening of large numbers of cells beyond the capability of traditional methods, and it provides quantitative cell analysis at the single-cell level.

The basic components of a Flow Cytometer include the following:

• A sample collector and transporter

• A flow system

• A sensing zone

• Signal detectors

• Data collection and storage capabilities

• Data display and analysis capabilities

The CELL-DYN 3700 System uses optical flow cytometric technology to obtain the WBC Optical Count (WOC) and analyze the WBC subpopulations (neutrophils, lymphocytes, monocytes, eosinophils, and basophils) for the WBC Differential.


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Figure 3.2: WOC Flow Cell

In a flow cytometer, the cell suspension is pumped from the specimen container through a sample tube into a special flow chamber with a small opening at the tip. The suspension is then injected into a stream of fast-moving, cell-free liquid (sheath fluid). Since the two liquids travel at different rates of speed, they do not intermingle. This is called laminar flow. The special geometry of the Flow Cell and the flow rate of the sheath fluid forces the cells into single file. This process is known as hydrodynamic focusing. (See the preceding figure for a drawing of the WOC Flow Cell.)

As the cells enter the view volume (specific viewing area), they interact with the laser beam. The cells scatter the laser light at different angles, yielding information about cell size, internal structure, granularity, and surface morphology. The optical signals the cells generate are detected and converted to electrical impulses which are then stored and analyzed by the computer.

Flow cytometers generally measure two angles of scatter. Forward angle light scatter is roughly a measure of cell size. Right angle (orthogonal) light scatter is a measure of cell surface and internal structure but is primarily a measurement of internal granularity. Combining the information from the two scatter measurements provides more accurate discrimination between cell populations than either single measurement.

FocusedLaser Beam

SampleFeed Nozzle

Various Anglesof Scattered Light

Sample Stream

Sheath Stream



Figure 3.3: WBC Light Scatter

The CELL-DYN 3700 System measures four angles of scatter (see the preceding figure):

• Forward Angle Light Scatter (measured at 0°), which can be used to measure cell size

• Narrow-Angle Light Scatter (measured at 10°), which can be used to measure cell complexity

• Orthogonal or Ninety-Degree Light Scatter (measured at 90°), which can be used to measure cell surface and internal structure (lobularity)

• Orthogonal or Ninety-Degree Depolarized Light Scatter (measured at 90°D, using a depolarizing filter), which can be used to measure certain types of cell granularity

Combining the information from multiple scatter measurements provides more accurate discrimination between cell populations than any single measurement would provide.

FocusedLaser Beam

Various Anglesof Scattered Light

0° Scatter

10° Scatter

90° Scatter

90°D Scatter


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WOC Measurement ProcessThis section gives an overview of the WOC measurement. The details are discussed in Detection with the Optical Bench and WBC Differential Analysis within this chapter.

The Optical Channel is used for the determination of WOC data. A 1:51 dilution of the sample is made with the Sheath Reagent. The WOC Metering Syringe injects a metered volume of this dilution into the sheath stream. The sample stream is then hydrodynamically focused to align the cells in single file as they pass through the WOC Flow Cell, which is an optically clear quartz chamber. A vertically polarized Helium-Neon Laser is the light source.

The instrument measures the traditional forward angle light scatter (1–3°, referred to as 0°) and orthogonal light scatter (70–110°, referred to as 90°) parameters. Two additional scatters, narrow-angle light scatter (7–11°, referred to as 10°) and ninety-degree depolarized scatter (70–110°, referred to as 90°D), are measured. This is referred to as MAPSS™ (for Multi-Angle Polarized Scatter Separation) technology. Various combinations of these four measurements are used to classify the WBC subpopulations and provide morphological flagging.

NOTE: Data from the WIC channel are also used to enhance the flagging algorithms.

The WBC count is determined by enumerating the number of events above the computer-generated threshold in the 0° channel. The information from all four measurements is used to differentiate the WBCs into five subpopulations:

Neutrophils

Lymphocytes

Monocytes

Eosinophils

Basophils

The WOC data are presented graphically as a scatterplot. It may also be presented in two histograms at the operator’s request.

Sheath ReagentThe Sheath Reagent is an integral part of the WOC analysis. WBCs diluted in the Sheath Reagent maintain cellular integrity that is close to their native state. The structure of the basophils changes slightly due to the water-soluble nature of the basophilic granules.



RBCs, however, are altered by the Sheath Reagent because the osmotic pressure of the RBC is higher than that of the Sheath Reagent. Therefore the hemoglobin in the RBC diffuses out of the cell and water from the Sheath Reagent diffuses into the cell. The cell membrane remains intact but the RBC now has the same refractive index as the sheath, thereby rendering it invisible to the laser.

Figure 3.4: Optical Bench Assembly

Detection with the Optical BenchThe Optical Bench Assembly (depicted in the preceding figure) contains the components that make up the Flow Cytometer. The main purpose of the Optical Bench is to detect the light that is scattered by the cells as they pass through the Flow Cell. The detection process is discussed in this section.

The light source is a vertically polarized 5-mW Helium-Neon Laser with a wavelength of 632.8 nm. The laser beam passes through a cylindrical lens that changes the shape from a circle to an ellipse. The beam is then directed through a 125-µm slit which blocks the weaker outer edges. This process yields a uniformly intense beam approximately 80 µm wide. Consequently, the cell stream may wander slightly in the Flow Cell and yet still be exposed to the same light intensity. An imaging lens centers the focused laser beam onto the quartz Flow Cell.

90° LightScatterPMT

90° DepolarizedLight ScatterPMT Polarizer

(Horizontal)

Helium-Neon Laser(632.8 nm) PolarizedVertically

Beam Splitter

10° LightScatterPhotodiode

0° LightScatterPhotodiode

PerforatedMirror

ObscurationBar

WBCFlowCell

ImagingLens

FrontSurfaceMirror

CylindricalLens

700 μmSlit

FrontSurfaceMirror

125 μmVerticalSlit


9140320F — April 2007


The WOC Metering Syringe slowly injects 78 µL of the WOC dilution into the Sheath stream in the WOC Flow Cell. The sample is hydrodynamically focused into a small stream approximately 30 µm in diameter. This focused stream aligns the diluted cells in single file as they pass through the sensing region, which allows them to be analyzed one at a time.

Since the average WBC is much smaller than the focused laser beam, the cells do not scatter much laser light. If the remaining so-called axial light were allowed to reach the 0° detector, it would saturate the electronics. Therefore, it is blocked from the detector by the obscuration bar. The forward angle scatter is directed to a perforated mirror. The 0° light scatter passes through the mirror to the 0° silicon photodiode detector. The 10° light scatter is deflected off the mirror to the 10° silicon photodiode detector.

The orthogonal scatter is directed through a 700-µm slit, which blocks the scatter from the walls of the Flow Cell. A beam splitter then separates the orthogonal light scatter into two portions. One portion of the light is directed to the 90° PMT (photomultiplier tube). The remaining light is directed through a horizontal polarizer. Only light that has changed polarization (depolarized light) can pass through the polarizer to the 90°D PMT. (PMTs are used because relatively little light is scattered at this high angle.)

The light signals collected by each detector are converted into electrical signals or pulses. The pulses are digitized based on intensity and sorted into 256 channels for each angle of light measured.

If a pulse falls above the hardware threshold (channel 23) in the 0° detector, the cell counter counts the pulse and stores it for further evaluation. Pulses that fall below this threshold are not included in the count and, therefore, are not included in the differential. If this raw count is estimated to be below a predetermined value, the instrument automatically continues to count WBCs for an extended count period. The results from the two count periods are averaged.

The information from each detector is collected in list mode. This format stores the channel information from each of the four dimensions. The data are then used to determine the differential.



WBC Differential AnalysisThe light scatter information is graphically presented in the form of scatterplots. (The data can also be presented in histograms, available at the operator’s request.) Each cell analyzed is represented by a dot on the scatterplot. The dots are plotted at a point determined by the intersection of the channel information designated on the X and Y axes. For example, if a cell falls in channel 50 on the X axis and channel 50 on the Y axis, it is plotted at the intersecting point of the two channels.

The scatter information may be plotted in various combinations to yield different information. The CELL-DYN 3700 System uses the scatterplots to differentiate the WBCs into five color-coded subpopulations:

Neutrophils (yellow)

Lymphocytes (blue)

Monocytes (purple)

Eosinophils (green)

Basophils (white)

NOTE: The basophils are displayed as white dots but appear as black dots on color printouts.


9140320F — April 2007


WBC Scatterplots

Figure 3.5: Mononuclear-Polymorphonuclear Scatter

Mononuclear-Polymorphonuclear SeparationThe scatter information is plotted with the 90° scatter on the Y axis and the 10° scatter on the X axis. (The 90°/10° scatterplot is shown in the preceding figure.) Two populations of cells are clearly seen on the display. The mononuclear cells fall in the cluster in the lower left corner of the scatterplot and the polymorphonuclear cells fall in the cluster above and to the right of them.

The instrument uses a dynamic threshold to determine the best separation between the two populations. Each cell is then identified as a MONO or a POLY. Once each cell is identified, it retains this classification no matter where it appears on other scatterplots.

Mononuclear – PolymorphonuclearIdentification

Mononuclear – PolymorphonuclearSeparation

10° Complexity10° Complexity

90

° Lo

bu

lari

ty

90

° L

obu

lari

ty



Figure 3.6: Neutrophil-Eosinophil Scatter

Polymorphonuclear SeparationThe scatter information is plotted with the 90°D scatter on the Y axis and the 90° scatter on the X axis. (The 90°D/90° scatterplot is shown in the preceding figure.) Only the polymorphonuclear cells are plotted on this scatterplot. The mononuclear cells have been identified and therefore do not interfere in the further classification of the polymorphonuclear cells.

Two populations of polymorphonuclear cells are clearly seen on the display. The neutrophils fall in the lower of the two clusters. The eosinophils fall in the upper cluster. The instrument uses a dynamic threshold to determine the best separation between the two populations. Each cell is then classified as a NEUT or an EOS.

All cells scatter a certain amount of 90°D light. The eosinophils scatter more 90°D light than any of the other cells because of the unique nature of granules they contain. This property of the eosinophils is used to positively identify them and thus clearly differentiate them from the neutrophil population.

Neutrophil – EosinophilIdentification

Neutrophil – EosinophilSeparation

90° Lobularity90° Lobularity

90

° D

epo

lari

zed

Gra

nu

lari

ty

90

° D

epo

lari

zed

Gra

nu

lari

ty


9140320C — November 2000


Figure 3.7: Mononuclear Scatter

Mononuclear SeparationThe scatter information is plotted with the 0° scatter on the Y axis and the 10° scatter on the X axis. (The 0°/10° scatterplot is shown in the following figure.) The mononuclear cells are plotted on this scatterplot. The algorithm also uses the orientation of the neutrophil cluster to aid in classifying the mononuclears. Three populations of mononuclear cells are clearly seen on the display.

There are three populations of mononuclears because basophils are included in the mononuclear cluster. Typically, basophils are granulated cells and therefore more complex than the mononuclear cells. However, the basophilic granules are water soluble and dissolve in the Sheath Reagent. Consequently, the degranulated basophil becomes a less complex cell that falls into the mononuclear cluster.

MononuclearIdentification

MononuclearSeparation

10° Complexity10° Complexity

0°

Size

0°

Size



The lymphocytes fall in the lowest large cluster. (The small population of cells below the lymphocytes contains particles that are unlikely to be WBCs.) The basophils fall in the cluster above and slightly to the right of the lymphocytes. The monocytes fall in the cluster above the lymphocytes and basophils. The instrument uses dynamic thresholds to determine the best separation between the three main populations. Each cell is then classified as a LYMPH, a MONO or a BASO.

Finally, the instrument evaluates the area below the lymphocyte cluster but above the hardware threshold (channel 23). Any particles that fall in this area are separated from the lymphocytes by a dynamic threshold. The following cell types may be present in this region:

NRBCs

Unlysed RBCs

Giant PLTs

PLT clumps

NOTE: Information from the WIC channel is used to assist in discriminating these particles.

All particles in this region are excluded from the WBC count and the Differential.

Other Scatterplots90°/0°

The scatter information is plotted with the 90° scatter on the Y axis and the 0° scatter on the X axis.

90°D/0°

The scatter information is plotted with the 90°D scatter on the Y axis and the 0° scatter on the X axis.

90°D/10°

The scatter information is plotted with the 90°D scatter on the Y axis and the 10° scatter on the X axis.

All scatterplots may be displayed and printed at operator request.


9140320C — November 2000


WBC HistogramsThe CELL-DYN 3700 System can also present the WBC scatter information as two histograms. The WIC can also be presented in histogram format (shown in the following figure). These histograms can be displayed and printed at the operator's request.

Figure 3.8: WBC Histograms

MONO-POLY HistogramThe Mononuclear-Polymorphonuclear Scatter information is plotted with the relative number of cells on the Y axis and the mononuclear and polymorphonuclear size distribution data on the X axis.

NWBC-LYM-MONO HistogramThe Non-WBC-Lymphocyte-Monocyte Scatter information is plotted with the relative number of cells on the Y axis and the non-WBC, lymphocyte, and monocyte size distribution data on the X axis.

WIC HistogramThe WIC data are plotted with the relative number of cells on the Y axis and the WIC size distribution data on the X axis.



WBC Parameters

Figure 3.9: WBC Data and Scatterplots

The WBC data are generally displayed as depicted in the preceding figure. All numeric and graphical data are automatically displayed on the Data Station RUN screen in the format selected by the operator. After the WBC scatter information has been plotted and the cells have been classified into the five subpopulations, the instrument determines the WOC by counting the pulses above the dynamic threshold in the 0° channel and comparing the data to the WIC data. The algorithms then determine the WBC and the percent of cells in each subpopulation.


9140320C — November 2000


Once the WBC count is determined, the absolute number of cells in each subpopulation is calculated by multiplying that WBC count by the percentage. The results are expressed as follows:

WBC # x 103/µL (109/L)

NEU # x 103/µL (109/L) and %

LYM # x 103/µL (109/L) and %

MONO # x 103/µL (109/L) and %

EOS # x 103/µL (109/L) and %

BASO # x 103/µL (109/L) and %

The decimal point moves to display up to three decimal places for the absolute number and percent.

The WBC scatter information is usually displayed in the two scatterplots shown in the preceding figure:

SIZE/COMPLEXITY The size information (0° scatter) is plotted on the Y axis and the complexity information (10° scatter) is plotted on the X axis.

GRANLRTY/LOBULARITY The granularity information (90°D scatter) is plotted on the Y axis and the lobularity information (90° scatter) is plotted on the X axis.

WBC FlaggingFor a detailed discussion of the WIC/WOC algorithm and all of the WBC flagging messages, refer to Operational Messages and Data Flagging within this chapter.



RBC/PLT Analysis

OverviewAn impedance channel is used for the determination of RBC and PLT data. A 1:9,760 dilution of the sample is made with the Diluent. The cells are counted and sized using the impedance method as they pass through the 60 x 70–µm aperture in the von Behrens RBC/PLT Transducer. Dynamic thresholding separates the PLTs from the RBCs. The 100-µL volume of sample that is analyzed is precisely regulated by the RBC/PLT metering assembly. Data is collected in 256 channels for both RBCs and PLTs.

Electrical Impedance MeasurementsRBCs and PLTs are counted and sized by the Electrical Impedance method. This method is based on the measurement of changes in electrical current which are produced by a particle, suspended in a conductive liquid, as it passes through an aperture of known dimensions. An electrode is submerged in the liquid on either side of the aperture in order to create an electrical pathway through it.

As each particle passes through the aperture, a transitory change in the resistance between the electrodes is produced. This change produces a measurable electrical pulse. The number of pulses generated is indicative of the number of particles that traversed the aperture. The amplitude of each pulse is essentially proportional to the volume of the particle that produced it.

Each pulse is amplified and compared to internal reference voltage channels. These channels are delineated by calibrated size discriminators to accept only pulses of a certain amplitude. Thus, the pulses are sorted into various size channels according to their amplitude.

Coincidence Passage CorrectionTwo or more cells can enter the aperture sensing zone simultaneously during a measurement cycle. The resistance change created in this situation generates a single pulse with a high amplitude and increased pulse area. Thus, it appears that one large cell has passed through the aperture. Consequently, the cell count is falsely decreased. This count reduction, referred to as Coincidence Passage Loss, is statistically predictable because it has a direct relationship to the effective volume of the aperture and the amount of dilution. Each total cell count for RBCs and PLTs is automatically corrected for Coincidence Passage Loss.


9140320C — November 2000

Principles of OperationRBC/PLT Analysis Chapter 3

RERThe RER (Red Cell Editing Ratio) is a process of pulse editing that is applied to the RBC pulses before the MCV is derived. The instrument compensates for the aberrant pulses produced by the non-axial and coincidence passage of the RBCs through the aperture. These pulses are included in the RBC count but eliminated from the RBC sizing determination.

Volumetric MeteringAn absolute cell count cannot be obtained unless the precise volume of diluted whole blood that passes through the aperture during the count cycle is known.1 The CELL-DYN 3700 System utilizes the Volumetric Metering process to regulate the count cycle and ensure that a precise volume of sample is used for the RBC/PLT measurement.


The RBC/PLT metering assembly contains a precision-bore glass tube fitted with two optical detectors. (See the preceding figure.) The distance between the detectors is set to precisely measure 100 µL. Detergent is added to the Diluent in the metering tube to create a meniscus in the liquid. When the RBC/PLT cycle is initiated, the liquid flows down the metering tube.

Meniscus

CountTime




Principles of OperationChapter 3 RBC/PLT Analysis

The count portion of the cycle is initiated when the meniscus reaches the upper detector. The count cycle stops when the meniscus reaches the lower detector. The amount of time required for the meniscus to travel from the upper to the lower detector is called the RBC Count Time. The computer also monitors the time it takes the meniscus to reach the upper detector once the RBC/PLT cycle is initiated. This is called the RBC Upper Metering Time. (For convenience, these times are referred to as “RBC” times. Both times actually monitor the RBC/PLT metering process.)

The RBC Count Time (RCT) and the RBC Upper Metering Time (RUT) are automatically monitored to detect variation from the expected values. Variation may be caused by debris in the aperture, vacuum fluctuation or air bubbles in the metering tube. If significant variation is detected, the bulletin line on the Data Station RUN screen displays the message RBC METERING FAULT-CLOG or FLOW ERROR and the RBC and PLT data are suppressed.

At the end of each cycle, the RBC Count Time is displayed on the Data Station RUN screen to the right of the MPV result. If an RBC metering fault was detected, one of two messages is displayed and printed: the RBC CLOG message if either time is too slow or the RBC FLOW ERROR message if either time is too fast. Both the RBC Upper Metering Time (RUT) and the RBC Count Time (RCT) are displayed and printed when an RBC metering fault occurs.

RBC/PLT Measurement ProcessThe 1:9,760 RBC/PLT dilution is delivered to the mixing chamber in the von Behrens RBC/PLT Transducer where it is bubble mixed. A 100-µL metered volume of the dilution is drawn through the 60 x 70–µm aperture by vacuum. The RBCs and PLTs are counted by impedance. If the pulse generated is above the PLT lower threshold (1), it is counted as a PLT. If the pulse generated is above the RBC lower threshold (35), it is counted as an RBC. There are 256 size channels for each of the parameters, each RBC size channel being equivalent to 1 fL and each PLT size channel being equivalent to 0.137 fL.

As cells exit from the aperture, they tend to swirl around and may reenter the sensing zone and be counted a second time, causing the counts to be falsely elevated. The von Behrens Plate located in the von Behrens RBC/PLT Transducer counting chamber minimizes the effect of these recirculating cells.

The RBC count is corrected for coincidence and the pulses are edited by the RER before the MCV is derived. The PLT pulses are analyzed by the PLT algorithm as discussed in PLT Measurement within this chapter.


9140320C — November 2000


RBC Parameters

Figure 3.11: RBC Data and Histogram

All numeric and frequency size distribution data are automatically displayed on the Data Station RUN screen in the format selected. The size distribution data for the red cells are displayed graphically as a histogram with the distribution data plotted on the X axis and the relative number of cells normalized and plotted on the Y axis. The RBC data are shown in the preceding figure.

RBC CountThe red blood cell count (RBC count) is directly measured, gives the number of RBCs, and is expressed as follows:

RBC = # x 106/µL (1012/L)

Counts below 1.0 x 106/µL (1012/L) are displayed to three decimal places.

The RBC count is automatically corrected for the WBC count, and the corrected RBC count is displayed on the main RUN screen.



MCVThe mean corpuscular volume (MCV) is the average volume of the individual red blood cells. The MCV is derived from the RBC size distribution data and is expressed in femtoliters.

HCTThe hematocrit (HCT) is the ratio of red blood cells to plasma and is expressed as a percentage of the whole blood volume. The HCT is calculated from the RBC count and the MCV as follows:

HCT = (RBC x MCV)/10

MCHThe mean corpuscular hemoglobin (MCH) is the average amount of hemoglobin contained in the red blood cell, expressed in picograms. The MCH is calculated from the RBC and the HGB as follows:

MCH = (HGB/RBC) x 10

MCHCThe mean corpuscular hemoglobin concentration (MCHC) is the ratio of the weight of hemoglobin to the volume of the average red blood cell, expressed in percent. It is calculated from the HGB and the HCT as follows:

MCHC = (HGB/HCT) x 100

RDWRed cell distribution width (RDW) is a measure of the heterogeneity of the RBC population. The CELL-DYN 3700 System reports a relative RDW equivalent to a CV in percent. The RDW is derived from the RBC histogram using the width of the RBC distribution at 50% of the peak height.

RBC FlaggingFor a detailed discussion of the RBC flagging messages, refer to Operational Messages and Data Flagging within this chapter.


9140320C — November 2000


ReticulocytesReticulocytes are transitional red cells between nucleated red cells (NRBCs) and the so-called mature erythrocytes. The CELL-DYN 3700 System reports the reticulocyte percent, the Immature Reticulocyte Fraction (IRF), and will report the reticulocyte absolute number if the RBC value is entered.

Reticulocytes and Reticulocyte flagging are discussed in detail in Chapter 14: Reticulocyte Package.

PLT Measurement ProcessPulses counted in the RBC/PLT dilution between 1 and 35 fL are included in the platelet (PLT) data. If the raw PLT count is estimated to be below a predetermined value, the instrument automatically continues to count PLTs for an extended count period. The results from the two count periods are then averaged. The PLT data are plotted as a histogram. An algorithm analyzes the histogram to eliminate interference and determine the lower and upper thresholds for the count.

If no interference is detected, the lower and upper thresholds are set at 2 and 30 fL respectively. If interference is detected, the thresholds float to determine the best separation between the interference and the PLT population. The lower threshold floats in the 1–3 fL region and the upper threshold floats in the 15–35 fL region. Once the thresholds have been determined, the PLT count is derived from the data between them.

Interference in the upper threshold region is generally caused by microcytic RBCs. Therefore, after the PLT upper threshold has been determined, the data between it and the RBC lower threshold are reevaluated. If the PLT upper threshold is less than 35 fL, the counts above it (but less than the RBC lower threshold) are added to the RBC count.

If the interference in either threshold region exceeds a predetermined limit, the PLT count is flagged accordingly. PLT flags are discussed in Operational Messages and Data Flagging within this chapter.



PLT Parameters

Figure 3.12: PLT Data and Histogram

All numeric and frequency size distribution data are automatically displayed on the Data Station RUN screen in the format selected. The size distribution data for the platelets are displayed graphically as a histogram with the size distribution data plotted on the X axis and the relative number of cells normalized and plotted on the Y axis. The PLT data and histogram are shown in the preceding figure.

PLT CountThe platelet count (PLT count) is derived from the PLT histogram after the PLT data have been analyzed by the platelet algorithm. The PLT count is expressed as follows:

PLT = # x 103/µL (109/L)

MPVThe mean platelet volume (MPV) is derived from the PLT histogram after the PLT count has been determined. The MPV is expressed in femtoliters.


9140320C — November 2000


PCTThe plateletcrit (PCT) is the product of the PLT count and the MPV, and it is analogous to the hematocrit. It is expressed in percent and is calculated as follows:

PCT = (PLT x MPV)/10,000

PDWThe platelet distribution width (PDW) is a measure of the heterogeneity of the PLT population. It is expressed as the geometric standard deviation.

NOTE: Clinical significance has not been established for PCT and PDW. Therefore, they are not reportable in the U.S. They are provided for laboratory use only.

Platelet FlaggingFor a detailed discussion of the PLT flagging messages, refer to Operational Messages and Data Flagging within this chapter.



Hemoglobin Analysis

OverviewThe HGB channel is used for the colorimetric determination of hemoglobin. A 1:301 dilution of the sample is made with the Diluent and the WIC/HGB lyse reagent in the mixing chamber of the WIC transducer. This dilution is used for the WIC count and the HGB measurement. Traditionally, the HGB concentration is measured using a modified hemiglobincyanide method. However, in an effort to create a safe, environmentally-responsible atmosphere, the CELL-DYN 3700 System can use a cyanide-free reagent. This reagent converts HGB to a hemiglobinhydroxylamine complex. A filtered LED with a wavelength of 540 nm is the light source. A photodetector measures the light that is transmitted.

Hemoglobin Measurement ProcessThe WIC/HGB lyse reagent lyses the diluted red blood cells and converts the hemoglobin that is released to a stable chromagen. After the WIC count is completed, the sample is transferred to the hemoglobin Flow Cell where the hemoglobin concentration is measured. The sample enters the Flow Cell from the bottom. This allows any bubbles present to float to the surface so they will not interfere with the reading.

The LED shines through the Flow Cell and a 540-nm narrow bandwidth filter onto a photodetector. The hemoglobin concentration is directly proportional to the absorbance of the sample at 540 nm. Five separate HGB readings are made on each sample. The lowest and highest are eliminated and the remaining three are averaged to give the final HGB sample reading. After the hemoglobin readings have been made, the HGB flow cell is rinsed with detergent.

The rinse is drained and more detergent is delivered to the Flow Cell. A zero or blank reading is then obtained on the detergent to provide a reference to which the sample signal is compared. Five separate blank readings are made on each sample. The lowest and highest are eliminated and the remaining three are averaged to give the final HGB reference reading.

The reference and sample readings are compared to determine the HGB concentration of the sample. The HGB result is expressed in grams of hemoglobin per deciliter of whole blood. Up to two decimal places may be displayed for hemoglobin results less than 10 g/dL.


9140320F — April 2007

Principles of OperationHemoglobin Analysis Chapter 3

HGB ParametersThe Hemoglobin is directly measured and is expressed in grams of hemoglobin per deciliter of whole blood.

When the WBC is >30 K/µL, the hemogobin value is automatically corrected for the WBC Count. The corrected hemoglobin value is displayed on the main RUN screen.

The hemoglobin value is suppressed, with <<<< displayed for the hemoglobin result, whenever the WBC count is greater than 250 x 103/µL (WOC) or 99.9 x 103/µL (WIC).

NOTE: Never use a hemoglobin standard designed for use with reference cyanmethemoglobin methodology directly on the CELL-DYN 3700 System. The CELL-DYN 3700 System uses a modified hemiglobincyanide or modified hemiglobin-hydroxylamine method, which is not designed to analyze these standards directly.



Operational Messages and Data Flagging

IntroductionOperational messages and data flags appear on the Data Station RUN screen and on printed reports. They can also be transmitted to a laboratory computer system. The CELL-DYN 3700 System monitors instrument conditions and data criteria that may affect the displayed results. These messages and flags are used to alert the operator. Instructions for interpreting all flags and numeric, scatter, and histogram data should be incorporated into the laboratory’s procedure and used to determine the need for further action and/or review of results. Messages are divided into the following categories:

• Instrument Fault and Status Messages

• Parameter Flagging Messages

Dispersional Data Alerts

Suspect Parameter Flags

Suspect Population Flags

Interpretive Messages

Detailed descriptions of these messages are given in this section.

NOTE: Reticulocyte Flags are described in Chapter 14: Reticulocyte Package.

Interfering SubstancesIt is important to note that there are commonly occurring interfering substances that can affect the results reported by hematology analyzers. While the CELL-DYN 3700 has been designed to detect and flag many of these substances, it may not always be possible to do so. The following indicates the substances that may interfere with each of the listed parameters.

WBC: Fragile WBCs, neutrophil aggregates, lytic-resistant RBCs, NRBCs, PLT clumps, cryofibrinogen, cryoglobulin, paraproteins

RBC: Elevated WBC count, increased numbers of giant PLTs, auto-agglutination, in vitro hemolysis

HBG: Elevated WBC count, increased plasma substances (triglycerides, bilirubin, in vivo hemolysis), lytic-resistant RBCs.

MCV: Elevated WBC count, hyperglycemia, in vitro hemolysis, increased numbers of giant PLTs.



Principles of OperationOperational Messages and Data Flagging Chapter 3

PLT: WBC fragments, in vitro hemolysis, microcytic RBCs, cryofibrinogen, cryoglobulins, PLT clumping, increased numbers of giant PLTs.

For additional information on interfering substances, refer to the table provided in Appendix C.

For a detailed description of the flags that are generated, refer to Section 3: Principles of Operation; Subsection: Operational Messages and Data Flagging.

Instrument Fault and Status MessagesThe Instrument Fault and Status Messages are discussed in detail in Chapter 10: Troubleshooting. These messages are displayed when the instrument detects an inappropriate condition during specimen processing. When necessary, data are suppressed. When any of these messages is displayed, refer to the Troubleshooting Guide in Chapter 10: Troubleshooting for assistance. Follow the instructions given and take the appropriate corrective action. When the problem is corrected, rerun the specimen.


Principles of OperationChapter 3 Operational Messages and Data Flagging

Parameter Flagging MessagesThe following table summarizes all of the parameter flagging messages by parameter and category.

* One of the WBC descriptors (WIC or WOC) will be displayed next to the WBC value either, when the WIC and WOC differ by a clinically significant percentage or when the declining rate is detected and the count in the N1 (stroma) region of the scatterplot is less than 2.9% of the total WBC. The WBC value is reportable if there are no additional Suspect Parameter Flags present. If no descriptor or WBC Suspect Parameter Flag is present, the value selected is the WOC.

Table 3.1: Parameter Flagging Messages

Parameter Dispersional Data Alerts

Suspect Parameter

Flags

Suspect Population

FlagsInterpretive

Messages

WBC* Result displays in yellow if below lower limit

Result displays in purple if above upper limit

Result underlined on graphics printout when

limits exceeded

Result underlined on blank ticket when limits exceeded

Result marked with asterisk (*) on pre-printed ticket when results exceeded

WBC NWBCFWBCNRBCRRBC

LeukopeniaLeukocytosis

DifferentialNEULYM

MONOEOS

BASO

Same as WBC

DFLT (NLMEB)

BANDIG

BLASTVARLYM

NeutropeniaNeutrophiliaLymphopeniaLymphocytosisMonocytosisEosinophiliaBasophilia

RBCMCVRDWMCH

MCHC

Same as WBC

RBC MORPH AnemiaPolycythemia

Microcytic RBCMacrocytic RBCHypochromicHyperchromicAnisocytosis

PLT MPV Same as WBC

LRIURILURIPLTR

MPV Suppressed (not displayed or

printed)

ThrombocytopeniaThrombocytosisMicrocytic PLTMacrocytic PLT




Dispersional Data AlertsDispersional Data Alerts are triggered by the numeric limits entered into the four Patient Limit Sets (see Set Up Instructions in Chapter 5: Operating Instructions for an explanation) or taken from the instrument’s preset linearity limits. If results for a parameter exceed these limits, they are flagged on the screen and on the report. Dispersional alerts are displayed or printed as follows:

Screen display: Result below lower limit shown in yellowResult above upper limit shown in purple

Linearity Exceeded: Result displayed as >>>>

NOTE: When the WBC result exceeds the linearity (>>>>), the HGB result is displayed as <<<< to indicate possible interference with the HGB due to the elevated WBC result.

Graphic Report: Results outside limits underlined

Blank Ticket: Results outside limits underlined

Preprinted Ticket: Results outside limits marked with an asterisk (*)

Specimens with results that exceed the linearity should be diluted with Diluent according to the laboratory’s procedure and repeated. (Be sure to correct the results for the dilution factor used.) If desired, diluted specimens may be run in the Auxiliary Mode. Refer to the directions given in Chapter 5: Operating Instructions, Subsection: Specimen Type Soft Key, Auxiliary Soft Key.

NOTE: MCV, MCH, MCHC, and MPV are unaffected by dilution and do not require correction.

It is suggested that one Patient Limit Set be used to enter instrument-specific laboratory action limits. If the Interpretive Report option is enabled, the Interpretive messages, such as leukocytosis, anemia, thrombocytopenia, etc., will be displayed when a result falls outside the appropriate limit. A result that falls outside a laboratory action limit can also indicate the need for the operator to follow a laboratory protocol, such as repeating the sample, notifying the physician or performing a smear review. In cases where a cellular abnormality is present that alters cellular morphology to the point that the cells do not fit the criteria used by the instrument to generate a flag, dispersional data alerts may be the only flag(s) that will alert the operator to a potentially erroneous result.



WIC and WOC LinearityThe WIC count is linear to 99.9 K/µL. If the WIC value is selected as the reported value and it exceeds the linearity, the WBC is reported as overrange (>>>>).

The WOC value is linear to 250 K/µL. If the WOC value is selected as the reported value and it exceeds the linearity, the WBC is reported as overrange (>>>>).

NOTE: When the WBC result exceeds the linearity (>>>>), the HGB result is displayed as <<<< to indicate possible interference with the HGB due to the elevated WBC result.

Flagging Diagnostics ScreenThe Flagging Diagnostics screen shown in the following figure is provided for laboratory use only, to assist in the review of abnormal samples. It is displayed by pressing the Page Down key on the keyboard while the RUN screen or the Data Log DISPLAY SPECIMEN screen is displayed. The screen may be printed by pressing the [PRINT] soft key or the Print Screen key on the keyboard. Both the [PRINT] soft key and the Print Screen key on the keyboard will print in a horizontal (landscape) format.

Figure 3.13: Flagging Diagnostics Screen

Spec ID ------------

Sequence #

BAND FLAG ESTIMATEREGION %:

IG FLAG ESTIMATEREGION %:

BLAST FLAG ESTIMATEREGION %:

VAR LYM FLAG ESTIMATEREGION %:

NRBC FLAG REGION ESTIMATE PER 100 WBCS:

PRINT RETURN

FLAGGING DIAGNOSTICSReady Nov 19 1998

Operator IDSequence #

16:00BLC1471

Open Sampler

GRANLRTY

90deg

MONO-POLY LOBULARITY

10 deg 0 deg

For Laboratory Use Only

90deg




The Specimen ID and Sequence Number for the specimen currently displayed are indicated in the upper left-hand corner. The information displayed in the upper right-hand corner indicates the current operational status of the Analyzer including the current date, time, operator ID, Sequence Number, and Sampler Mode (Open or Closed).

The region percentage estimates for the Suspect BAND, IG, BLAST and VAR LYM flags are displayed on the left side of the screen. Each percentage is an estimate of the number of cells present in the region of scatter on the 0°/10° plot where that population is typically located. The NRBC estimate is expressed in #/100 WBC. Consequently, this percentage information is included in the criteria used to generate these Suspect Population Flags, which are displayed on the RUN screen and the Data Log DISPLAY SPECIMEN screen. The Flagging Diagnostics information is provided to indicate the possible severity of the Suspect flag.

The graphs located on the right side of the screen are determined by the parameter set the operator selected for the displayed specimen. The number of the selected parameter set is indicated on the RUN screen and the Data Log DISPLAY SPECIMEN screen. The parameter set can be edited after the sample is processed by using the [EDIT SPECIMEN] key on the Data Log DISPLAY SPECIMEN screen.

The Flagging Diagnostics information is provided for laboratory use only, and it is suggested that the information be incorporated into the laboratory's review criteria.

Introduction to WBC FlaggingThe WIC/WOC algorithm evaluates the WIC and the WOC counts to determine whether WIC is equal to or different from WOC, and all subsequent decisions are made based on this initial determination. When WIC is equal to WOC, subsequent decisions follow one decision tree, and when WIC and WOC differ, the decisions follow another decision tree. When WIC and WOC are equal, the WOC is selected as the reported WBC. When WIC and WOC differ, the algorithm evaluates the difference and selects the most appropriate value for the reported WBC.

All WBC flags result from either the evaluation of the WOC analysis (BAND, IG, BLAST, VAR LYM, NWBC, DFLT) or the evaluation of the WIC and WOC data (WBC, FWBC, NRBC, RRBC). This section discusses each count and how they interact to produce the reported WBC value and generate appropriate flags. A discussion of the cell populations responsible for some of the flags is included, and all of the individual flags are described in Flagging Summary within this chapter. An overview of WIC/WOC interaction is given in WBC Analysis within this chapter.



WBC DescriptorsThe descriptors discussed in this section are displayed on the screen to provide additional information about the reported WBC value. A descriptor is displayed next to the WBC value only when the WIC and WOC differed by a clinically significant percentage and, consequently, the appropriate WBC as indicated by the descriptor is displayed. If no descriptor or WBC Suspect Parameter Flag is present, the WOC is the chosen value.

WICThere is a clinically significant difference between the WIC and WOC values and the algorithm selected the WIC count as the most accurate WBC. Refer to Subsection: Flagging Summary, WBC Descriptors within this section for action to be taken when the WIC Descriptor is displayed.

WOCThere is a clinically significant difference between the WIC and WOC values and the algorithm selected the WOC count as the most accurate WBC. Refer to Subsection: Flagging Summary, WBC Descriptors within this section for action to be taken when the WOC Descriptor is displayed.

WIC/WOC Flagging Decisions

Figure 3.14: Scatterplot with Increased Stroma in the N1 Region

DynamicThreshold

N1Region

SIZE

COMPLEXITY


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WIC = WOC (WIC Is Equal to WOC)When WIC=WOC, the WOC value is selected as the reported WBC value. The algorithm then evaluates the area below the dynamic WBC lower threshold on the size/complexity (0°/10°) scatterplot to determine whether there is a significant number of particles in the N1 region. (The N1 region is the region in the lower left corner of the scatterplot below the dynamic threshold but above the hardware threshold. See the preceding figure.) If the count in the N1 region is greater than 2.9% of the total WBC, the NWBC (Non-WBC) flag is displayed. The NWBC flag indicates the presence of a non-WBC population of interest in the N1 region below the WBC threshold. This population may include the following:

• Low levels of NRBCs

• Unlysed RBCs

• PLT clumps

• Giant PLTs

WIC ≠ WOC (WIC Is Not Equal to WOC)In order to understand the function of the WIC/WOC algorithm when WIC and WOC differ, it is necessary to evaluate the underlying pathology responsible for the difference between the values. Experience has shown that generally when WIC is higher than WOC, the presence of NRBCs is suspected. When WOC is higher than WIC, the presence of lyse-resistant RBCs is generally suspected. When fragile WBCs are present, WIC may be higher than WOC due to the kinetic decline in the WOC count rate caused by the disintegration of the fragile cells in the Sheath Reagent. The instrument automatically selects the WIC value when a significant declining count rate is detected and the count in the N1 (stroma) region of the scatterplot is less than 2.9% of the total WBC. The reasoning for each of these determinations will be discussed in the following paragraphs.

Algorithm Decision CriteriaThe following factors are considered by the algorithm to evaluate the specimen results, identify the pathology responsible for a difference between WIC and WOC, and select the most accurate WBC value and most appropriate flags.

• Is the WIC value greater than the WOC value?

• Is the WIC value greater than 99.9 K/µL (WIC linearity limit)?

• Is the WOC value greater than the WIC value?



• Was the specimen run in the Resistant RBC mode?

• Is the Lymphocyte % greater than 60?

• Is there a kinetic decline in the WOC count?

• Is the count in the area (N1 region) below the dynamic WBC threshold (0°/10° scatterplot) greater than 2.9% of the total WBC count?

The flags that result from the instrument’s evaluation of the above criteria are discussed in the following section. The individual flags, including cause and corrective action, are also discussed in Flagging Summary at the end of this chapter.

Cell Populations and Flagging

Fragile WBCs (WIC > WOC or WOC > WIC)When fragile WBCs are present, the WIC or the WOC may be the higher value due to the gradual destruction of the fragile cells by both of the lysing agents. Typically, the fragile WBCs are lymphocytes that are present in chronic lymphocytic leukemia and are the smudge cells that appear when the blood smear is made. These lymphocytes cause a kinetic decline in the WOC count rate. When the declining rate is detected and the count in the N1 (stroma) region of the scatterplot is less than 2.9% of the total WBC, the algorithm selects the WIC as the reported value. In this case, WIC is assumed to be the most accurate result and is reported with the WBC Suspect Parameter Flag.

NOTE: Mechanical and chemical trauma may increase cellular destruction. Consequently, specimens containing fragile WBCs should not be run in the Resistant RBC cycle because the extended lysing time may increase cellular destruction. However, if the reported WBC exceeds the linearity, it is appropriate to run the diluted specimen in the Auxiliary Mode to obtain the WBC value. Always compare the results and flags displayed in the Auxiliary Mode to those obtained in the Patient Run Mode and evaluate the individual flags displayed in both modes as described in Flagging Summary within this chapter.


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NRBCs (WIC > WOC)When the WIC count is higher than the WOC count, nucleated red blood cells (NRBCs) are usually present. NRBCs are usually, but not always, eliminated from the WOC count by a dynamic threshold. All nucleated cells that are larger than the WIC threshold are included in the WIC count. Therefore, when significant numbers of NRBCs are present they elevate the WIC value and cause a clinically significant difference between WIC and WOC. In this case, the WOC count is selected and the NRBC flag is displayed. When the NRBC flag is displayed, refer to the FLAGGING DIAGNOSTICS screen to obtain an estimate of the NRBCs present. (For further information about the FLAGGING DIAGNOSTICS screen, refer to Operational Messages and Data Flagging, Parameter Flagging Messages, Flagging Diagnostics Screen within this chapter.) The difference between WIC and WOC is used to calculate the NRBC region estimate provided on the FLAGGING DIAGNOSTICS screen:

NRBC Flag Region estimate = (WIC - WOC) x 100WOC

Lyse-Resistant RBCs (WOC > WIC)When the WOC count is higher than the WIC count, lyse-resistant RBCs are usually present. The “hard” detergent lyse used to obtain the WIC count generally is strong enough to lyse RBCs that may be resistant to other lytic agents. However, the “soft” osmotic lysing ability of the Sheath Reagent is usually insufficient to lyse these cells in the time allotted for the WOC count. Consequently, the unlysed RBCs are erroneously included in the WOC count resulting in a falsely elevated value. In all cases there is usually a significant amount of stroma (>2.9% of the total WBC count) present in the N1 region below the WBC dynamic threshold on the 0°/10° scatterplot.

When the stroma is >2.9% of the total WBC and WOC is higher than WIC, the WIC count is selected and the RRBC (Resistant RBC) flag is displayed alerting the user to run the specimen in the Resistant RBC Mode. The WOC count time is extended in the Resistant RBC Mode, enabling complete lysis of the lyse-resistant RBCs in order to produce a correct WOC value.

NOTE: A higher incidence of false positive band flags may be evident on specimens run in the Resistant RBC Mode.



NRBC and RRBC Flags Displayed TogetherThe NRBC and Resistant RBC flags may be displayed together on some results for example from neonates, since both cell types can be present in these specimens. The NRBC flag indicates that WIC may be incorrect and the RRBC flag indicates that WOC may be incorrect. Consequently, the clinical picture is unclear and therefore, the WBC flag would also be displayed indicating that the reported WBC is suspect.

When the specimen is run in the Resistant RBC Mode, the interference caused by the lyse-resistant RBCs is eliminated. This results in the WIC value being higher than the WOC, which indicates the presence of NRBCs. Consequently, the WOC value is selected and the NRBC flag is displayed.

DFLT (NLMEB)The DFLT flag indicates that default (preset) criteria were used to determine the five-part differential. This is caused by the presence of abnormal cell clusters that the instrument cannot reliably discriminate between, or by a low number of cells in a specific subpopulation. Descriptors in parentheses are added to the flag to indicate which subpopulation(s) is (are) suspect, based on the criteria used. The descriptors are N, L, M, E, and B. (N=Neutrophils, L=Lymphocytes, M=Monocytes, E=Eosinophils, and B=Basophils.) The following criteria can cause the DFLT flag:

1. A default (preset) value or threshold was used to determine the five-part differential.

2. A valley was not detected within the region that usually separates a given cell population from another cell population.

3. There is an abnormally low number of cells in a specific subpopulation.


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NOTES



Flagging Summary

WBC DescriptorsA descriptor is displayed next to the WBC value to indicate that WIC and WOC differed by a clinically significant percentage and the appropriate WBC as indicated by the descriptor is displayed.

WIC

Cause Action

There is a clinically significant difference between the WIC and WOC values, and/or a kinetic decline in the WOC count rate was detected, and the count in the N1 (stroma) region of the scatterplot is less than 2.9% of the total WBC. The algorithm selected the WIC count as the most accurate WBC.

Review a stained smear and follow your laboratory’s protocol to confirm the WIC result.

WOC

Cause Action

There is a clinically significant difference between the WIC and WOC values and, therefore, the algorithm selected the WOC count as the most accurate WBC.

Review a stained smear and follow your laboratory’s protocol to confirm the WOC result.


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Principles of OperationFlagging Summary Chapter 3

Suspect Parameter FlagsSuspect Parameter Flags are generated after the instrument evaluates the measured data for a particular parameter or group of parameters. The result may be suspect due to interfering substances or because the instrument is unable to measure a particular parameter due to a sample abnormality. The name of each flag, the location of the flag on the display, the cause of the flag, and action to be taken are given in the following explanations.

WBC Flags

WBC Flag — displayed next to the WBC result

Cause Action

1. A clinically significant difference exists between the WIC and WOC values and the algorithm is unable to determine the most accurate WBC value. The algorithm selects what is estimated to be the best count for the reported WBC value and the WBC flag is displayed indicating that the result is suspect.

If the NRBC and/or RRBC flags are displayed with the WBC flag, repeat the specimen using the Resistant RBC cycle to eliminate interference caused by lytic-resistant RBCs. If the flag persists, review a stained smear for the presence of NRBCs which may affect the WIC count and verify the LYM value. Verify the WBC value by an alternate method according to your laboratory’s protocol.


Principles of OperationChapter 3 Flagging Summary

2. There is a kinetic decline in the WOC count rate. A kinetic decline generally indicates the presence of fragile WBCs that gradually disintegrate in the Sheath Reagent. When a kinetic decline is detected and the count in the N1 (stroma) region of the scatterplot is less 2.9% of the total WBC, then:

• WIC, which is estimated to be the most accurate result, is the reported WBC. (Over range will be displayed if the value is greater than 99.9 x 103/µL.)

• The WBC Suspect Parameter Flag is displayed next to the WBC result.

• The FWBC or RRBC Suspect Population Flag may also be displayed.

• No WBC Differential results are displayed.

• If the WBC result is greater than 99.9 x 103/µL., the hemoglobin result is suppressed and displayed as <<<<.

• When the hemoglobin result is displayed as <<<<, MCH and MCHC results are not displayed.

WBC Flag — displayed next to the WBC result (Continued)

Cause Action


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DFLT (NLMEB) — displayed next to the BASO %

Cause Action

Default (preset) criteria were used to determine the five-part differential and therefore, some of the populations are suspect. Descriptors, in parentheses, are added to the flag to indicate which subpopulation(s) is (are) suspect, based on the criteria used. The descriptors are N, L, M, E, and B. (N=Neutrophils, L=Lymphocytes, M=Monocytes, E=Eosinophils, B=Basophils.) The following criteria can cause the DFLT flag:

1. A default (preset) value or threshold was used to deter-mine the five-part differential.

2. A valley was not detected within the region that usually separates a given cell population from an-other cell population.

3. There is an abnormally low number of cells in a specific subpopulation.

Examine a stained smear to verify the differential values for the subpopulation(s) identified by the descriptor(s).



PLT Flags

LRI (Lower Region Interference) — displayed next to the MPV result

Cause Action

Interference in the lower threshold region (1–3 fL) is greater than a predetermined limit. This is generally non-biologic interference. The flag may be caused by:

Debris (dirty aperture)

Contaminated reagent

Electronic noise

Microbubbles

Check the background count. If it exceeds the limits, troubleshoot accordingly. If it is within limits, repeat the specimen. If the flag persists, review a stained smear to determine the cause of the interference and verify the PLT count.

URI (Upper Region Interference) — displayed next to the MPV result

Cause Action

Interference in the upper threshold region (15–35 fL) is greater than a predetermined limit. This is generally biologic interference. The flag may be caused by:

Microcytic RBCs

Schistocytes

Giant Platelets

Sickle Cells

Platelet Clumps

Review the MCV and the PLT histogram. If the MCV is low and/or the histogram indicates an overlap (poor separation at the upper discriminator) in the RBC and PLT populations, review a stained smear to determine the cause and verify the PLT count.

NOTE: A “bumpy” platelet histogram may indicate the presence of platelet clumps.


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Suspect Population FlagsThese flags are generated when the instrument’s evaluation of the measured data for a particular parameter or group of parameters indicate the possible presence of an abnormal subpopulation. A stained smear should be reviewed whenever a suspect population flag is present. Therefore, instructions for interpreting these flags should be incorporated into the laboratory’s review criteria for abnormal samples.

NOTE: The word SUSPECT will be displayed and printed above any displayed WBC Suspect Population Flags.

LURI (Lower and Upper Region Interference) — displayed next to the MPV result

Cause Action

Interference is present in both the upper and lower regions of the PLT histogram.

Follow the guidelines given above for the LRI and URI flags.

PLTR (Platelet Recount) – displayed next to the platelet count

Cause Action

The PLT count was <120 K/µL and, therefore, a platelet recount was performed. The difference between the count and recount values exceeds expected limits.

Repeat the specimen. If the flag is no longer displayed and there are no other data invalidating flags, the PLT count is reportable. If the flag persists, review a stained smear and verify the PLT count



WBC Flags

BAND — displayed next to the NEU %

Cause Action

1. The count in the region of scatter (on the 0°/10° plot) where bands are typically located is >12.5% of the total WBC count.

2. The ratio of suspected bands to mature neutrophils is >50%.

3. The CV of the neutrophil cluster on the 0° axis exceeds expected criteria.

Review a stained smear for the presence of bands and follow your laboratory’s review criteria. When bands are present, they are included in the total neutrophil count.

IG (Immature Granulocyte) — displayed next to the NEU %

Cause Action

The count in the region of scatter (on the 0°/10° plot) where immature granulocytes are typically located is >3% of the total WBC count.

Review a stained smear for the presence of immature granulocytes and follow your laboratory’s review criteria. When IGs are present, they are included in the total neutrophil count.

BLAST — displayed next to the LYM %

Causes Action

The count in the region of scatter (on the 90°/0° plot) where blasts are typically located is >1% of the total WBC count.

Review a stained smear for the presence of blasts and follow your laboratory’s review criteria. When blasts are present, they are typically included in the monocyte count.


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NOTE: This flag may be displayed singly or in combination with the blast flag. If the flag is displayed with the blast flag, it is displayed as VLYM/BLAST.

VAR LYM — displayed next to the LYM %

Cause Action

1. The count in the region of scatter on the size/complexity (0°/10°) scatterplot where variant Lymphs are typically located is >10% of the total WBC count.

2. The absolute lymphocyte or the absolute mononuclear (including basophils) count exceeds expected criteria and the ratio of lymphocytes to monocytes exceeds a predetermined limit.

3. The ratio of neutrophils to lymphocytes falls below expected criteria.

4. The WIC/WOC comparison indicates the suspected presence of variant lymphocytes.

Review a stained smear for the presence of variant lymphocytes and/or smudge cells and follow your laboratory's review criteria. When variant lymphocytes or smudge cells are present, they are included in the lymphocyte count.



NOTE: Mechanical and chemical trauma may increase cellular destruction. Consequently, specimens containing fragile WBCs should not be run in the Resistant RBC cycle because the extended lysing time will increase cellular destruction. However, if the reported WBC value exceeds the linearity, it is appropriate to run the diluted specimen in the Auxiliary Mode to obtain the WBC value. Always compare the results and flags displayed in the Auxiliary Mode to those obtained in the Patient Run Mode, and evaluate the individual flags displayed in both modes as described in this section.

NWBC (Non–White Blood Cell) — displayed next to the Mono % result

Causes Action

A non-WBC population is present in the N1 region below the dynamic WBC threshold on the size/complexity (0°/10°) scatterplot. The count in the N1 region is greater than 2.9% of the total WBC. The WIC value is equal to the WOC value and WOC is the reported WBC. The cell types that may be present in the N1 region are:

Low levels of NRBCs

Unlysed RBCs

PLT clumps

Giant PLTs

Review a stained smear and follow your laboratory's review criteria to determine the cause of the elevated count in the N1 region. If NRBCs are present and correction of the WBC is required, correct the WIC value and use the resultant number to confirm the WOC. If no other Suspect Parameter flags are present, the corrected WIC (or confirmed WOC) value is reportable. If something other than NRBCs caused the elevated count in the N1 region, follow your laboratory’s protocol for reporting the WBC result.

FWBC (Fragile White Blood Cells) — displayed next to the Mono % result

Causes Action

The presence of fragile WBCs is suspected. A kinetic decline in the WOC count rate was detected and the count in the N1 (stroma) region of the scatterplot is less than 2.9% of the total WBC. The algorithm selects WIC, estimated to be the best count for the reported WBC value, and displays the WBC flag to indicate that the result is suspect.

Review a stained smear and follow your laboratory's review criteria to confirm the LYM values and the reported WBC value. If no suspect parameter flags are present, the confirmed WBC and Differential may be reported.


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NRBC (Nucleated Red Blood Cells) — displayed next to the MONO %

Causes Action

The presence of NRBCs is suspected. The WIC count is higher than the WOC and the WOC is the reported value. The count in the N1 region, below the dynamic WBC threshold on the size/complexity (0°/10°) scatterplot, is greater than 2.9% of the total WBC. Cell types that may be present in the N1 region:

NRBCs

PLT clumps

Giant PLTs.

Review a stained smear for the presence of NRBCs and follow your laboratory's review criteria. If NRBCs are present they should be quantified according to your laboratory's procedure. If correction of the WBC is required, correct the WIC value and use the resultant number to confirm the WOC result. If no other Suspect Parameter Flags are present, the corrected WIC (or confirmed WOC) value is reportable. If the WBC flag is displayed with the NRBC flag, repeat the specimen using the Resistant RBC cycle to eliminate possible interference from any lytic-resistant RBCs that may be present with the NRBCs.

RRBC (Resistant Red Blood Cells) — displayed next to the Mono % result

Causes Action

The presence of lyse-resistant RBCs is suspected. The WOC count is higher than the WIC count and there is a significant amount of stroma present (>2.9% of the total WBC) in the N1 region, below the dynamic WBC threshold on the size/complexity (0°/10°) scatterplot.

Repeat the specimen using the Resistant RBC cycle to eliminate interference from any lytic-resistant RBCs that may be present. (The Resistant RBC cycle reduces the number of flags generated. However, an increase in false positive band flags may be evident.) The appropriate WBC value is selected as indicated by the descriptor. If the WBC flag is displayed, review a stained smear to determine the cause of the interference. Verify the WBC value by an alternate method according to your laboratory’s protocol.



RBC Flag

PLT Flag

Flagging Diagnostics ScreenThe FLAGGING DIAGNOSTICS screen is provided for laboratory use only to assist in the review of abnormal samples. It is displayed by pressing the Page Down key on the keyboard while the RUN screen or the Data Log DISPLAY SPECIMEN screen is displayed. For additional information, refer to the discussion in Parameter Flagging Messages, Flagging Diagnostics Screen earlier in this chapter.

RBC MORPH — displayed next to the HCT result

Cause Action

One or more of the following parameters exceeds expected limits:

MCV <80 fL or >100 fL

MCH <25 pg or >34 pg

MCHC <29 g/dL or >37 g/dL

RDW >18.5%

Review a stained smear for abnormal RBC or PLT morphology and follow your laboratory’s review criteria.

No MPV result displayed (data suppressed)

Cause Action

The PLT histogram did not meet expected criteria (non-log normal distribution).

Review a stained smear for abnormal PLT morphology or the presence of PLT aggregates and follow your laboratory’s review criteria. Verify the PLT count.


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Interpretive MessagesInterpretive messages appear only on the graphics report and are generated when the numeric limits entered in the Patient Limit Sets are exceeded. (See Set Up Instructions in Chapter 5: Operating Instructions for an explanation). These messages are printed only when the Interpretive Report option is selected on the CUSTOMIZE REPORT Screen. The Interpretive messages are summarized below.

WBC Messages

Message Cause

Leukopenia Result falls below the lower limit for WBC.

Leukocytosis Result exceeds the upper limit for WBC.

Neutropenia Result falls below the lower limit for Neutrophil absolute number.

Neutrophilia Result exceeds the upper limit for Neutrophil absolute number.

Lymphopenia Result falls below the lower limit for Lympho-cyte absolute number.

Lymphocytosis Result exceeds the upper limit for Lymphocyte absolute number.

Monocytosis Result exceeds the upper limit for Monocyte absolute number.

Eosinophilia Result exceeds the upper limit for Eosinophil absolute number.

Basophilia Result exceeds the upper limit for Basophil absolute number.



RBC Messages

PLT Messages

Message Cause

Anemia Result falls below the lower limit for RBCs.

Polycythemia Result exceeds the upper limit for RBCs.

Microcytic RBC Result falls below the lower limit for MCV.

Macrocytic RBC Result exceeds the upper limit for MCV.

Hypochromic Result falls below the lower limit for MCHC.

Hyperchromic Result exceeds the upper limit for MCHC.

Anisocytosis Result exceeds the upper limit for RDW.

Message Cause

Thrombocytopenia Result falls below the lower limit for PLTs.

Thrombocytosis Result exceeds the upper limit for PLTs.

Microcytic PLT Result falls below the lower limit for MPV.

Macrocytic PLT Result exceeds the upper limit for MPV.


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NOTES



References

1. International Committee For Standardization in Haematology (ICSH). The Assignment of Values to Fresh Blood Used for Calibrating Automated Cell Counters. Clinical and Laboratory Hematology 1988; 10:203-212.

2. American Society of Clinical Pathologists (ASCP). Clinical Applications of Flow Cytometry. ASCP National Meeting. Spring 1990.

3. Shapiro Howard. Practical Flow Cytometry. New York: LISS. 1985.

4. Clinical and Laboratory Standards Institute/NCCLS. Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline – Second Edition. CLSI/NCCLS document H44-A2 (ISBN 1-56238-527-5) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2004.


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Principles of OperationReferences Chapter 3

NOTES


Chapter 4 System SpecificationsSystem Specification

Overview

This chapter includes physical, power, and operational specifications for both the CELL-DYN® 3700SL System and the CELL-DYN 3700CS System. It also includes bar code specifications for the CELL-DYN 3700SL System. In addition, measurement specifications, performance specifications, and performance characteristics are included for both systems.


9140320C — November 2000

System SpecificationsOverview Chapter 4

NOTES


System SpecificationsChapter 4 CELL-DYN 3700SL System Specifications

CELL-DYN 3700SL System Specifications

Physical Specifications

Table 4.1: Dimensions

Analyzer with Sample Loader CPU

Display Monitor Ticket Printer

Graphics Printer

Height 27" (68 cm) 6.4” (16.3 cm) 15” (38.1 cm) 6" (15 cm) 13" (33 cm)

Width 30" (76 cm) 16.9” (42.9 cm) 14” (35.5 cm) 16.5" (41 cm) 19" (48 cm)

Depth 31" (79 cm) 17.3” (43.9 cm) 16” (40.6 cm) 14.5" (39 cm) 24" (61 cm)

Weight 288 lb (131kg) 32 lb (14.5 Kg) 30 lb (13.6 Kg) 16.5 lb (7.5 kg) 14.3 lb (6.5 kg)


9140320C — November 2000

System SpecificationsCELL-DYN 3700SL System Specifications Chapter 4

Power Specifications

Table 4.2: Power Specifications

Analyzer Input Requirements

Setting Range Frequency

100 90–110 VAC 50/60 Hz

120 110–130 VAC 50/60 Hz

220 200–240 VAC 50/60 Hz

240 220–260 VAC 50/60 Hz

Data Station Input Requirements


120 90–130 VAC 50/60 Hz

240 180–260 VAC 50/60 Hz

Printer Input Requirements(Graphics)

Setting Frequency

120 VAC 50/60 Hz

240 VAC 50/60 Hz

Printer Input Requirements(Ticket)

Setting Frequency

120 VAC 50/60 Hz

Sample Loader Input Requirements


100 90–110 VAC 50 Hz

100 90–110 VAC 60 Hz

115 105–125 VAC 60 Hz

215 195–235 VAC 50 Hz

230 210–250 VAC 50 Hz



ConsumptionAnalyzer: 900 watts

Data Station: 300 watts

Graphics Printer: 110 watts

Ticket Printer: 145 watts

Sample Loader: 50 watts

1550 watts maximum (5200 BTU per hour)

Transport and Storage SpecificationsThere are no specific environmental conditions for transport or storage.




Operational Specifications

Operating EnvironmentIndoor UseTemperature Patient Samples:

Room Temperature (15–30°C)

Monocyte values exhibit a change at lower and higher temperatures. A 1.5% decrease is seen in the total monocyte percent at lower temperatures (<18°C). A 6% increase will be seen at higher temperatures (>32°C).

Background values for RBC and PLT may exhibit an increase at lower environmental temperatures (<18°C).

Instrument: 15–30°C

Relative Humidity 10% to 85%, RHNC

Complete Cycle TimesAuto-Startup (from Standby) Approximately 3.5 minutes

Auto-Startup (from power OFF) Approximately 5 minutes*

Run, Open Mode 37 seconds (READY to READY)

Run, Sample Loader Approximately 37 seconds

Shutdown (to Standby) 4.5 minutes

* The laser requires a 15-minute warm-up time. If the power has been OFF longer than 5 minutes, wait 10 minutes after the Auto-Startup Cycle is complete before processing samples.

Approximate Aspiration Volumes (Whole Blood)Open Mode 130 µL (Auxiliary Specimen Type 300 µL)

Sample Loader 355 µL

Batch Size1–100 tubes per batch



ThroughputMaximum throughput = 90 samples/hour

NOTE: Maximum throughput is achieved with normal samples that do not generate any instrument operational messages.

Collection Tube and Sample Volume13 mm diameter x 75 mm high with a HEMOGARDTM closure

• Minimum sample volume = 1 mL

• Maximum sample volume = 3 mL

NOTE: The sample volume in the tube must be within the specified limits for adequate mixing and sampling.

Bar Code Specifications

Bar Code FormatThe following formats, with or without check digits, are acceptable:

• Code 39

• Interleave 2 of 5

• Codabar

• Code 128

Bar Code Label SpecificationsBar code labels must meet the following specifications:

• Printed on good quality label stock

• 0.25-inch minimum quiet zone on each end

• 0.01-inch (10 mils) minimum narrow bar width

• 2:1 to 3:1 wide to narrow bar ratio

• 0.5-inch minimum bar length

• 2-inch maximum label length

• 1.25-inch maximum label width

• Maximum possible contrast between bars and background label

NOTE: Refer to Appendix A: Bar Codes for complete information on bar code label formats, check digits, and specifications.


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NOTES


System SpecificationsChapter 4 CELL-DYN 3700CS System Specifications

CELL-DYN 3700CS System Specifications

Physical Specifications

Table 4.3: Dimensions

Analyzer CPUDisplay Monitor Ticket Printer

Graphics Printer

Height 24" (61 cm) 6.4” (16.3 cm) 15” (38.1 cm) 6" (15 cm) 13" (33 cm)

Width 30" (76 cm) 16.9” (42.9 cm) 14” (35.5 cm) 16.5" (41 cm) 19" (48 cm)

Depth 22" (56 cm) 17.3” (43.9 cm) 16” (40.6 cm) 14.5" (39 cm) 24" (61 cm)

Weight 190 lb (86 kg) 32 lb (14.5 Kg) 30 lb (13.6 Kg) 16.5 lb (7.5 kg) 14.3 lb (6.5 kg)


9140320C — November 2000

System SpecificationsCELL-DYN 3700CS System Specifications Chapter 4

Power Specifications

ConsumptionAnalyzer: 900 watts

Data Station: 300 watts

Graphics Printer: 110 watts

Ticket Printer: 145 watts

1550 watts maximum (5200 BTU per hour)

Table 4.4: Power Specifications

Analyzer Input Requirements


100 90–110 VAC 50/60 Hz

120 110–130 VAC 50/60 Hz

220 200–240 VAC 50/60 Hz

240 220–260 VAC 50/60 Hz

Data Station Input Requirements


120 90–130 VAC 50/60 Hz

240 180–260 VAC 50/60 Hz

Printer Input Requirements(Graphics)

Setting Frequency

120 VAC 50/60 Hz

240 VAC 50/60 Hz

Printer Input Requirements(Ticket)

Setting Frequency

120 VAC 50/60 Hz


System SpecificationsChapter 4 CELL-DYN 3700CS System Specifications

Operational Specifications

Operating EnvironmentTemperature Patient Samples:

Room Temperature (15–30°C)

Monocyte values exhibit a change at lower and higher temperatures. A 1.5% decrease is seen in the total monocyte percent at lower temperatures (<18°C). A 6% increase will be seen at higher temperatures (>32°C).

Instrument: 15–30°C

Background values for RBC and PLT may exhibit an increase at lower environmental temperatures (<18°C).

Relative Humidity 10% to 85%, RHNC

Complete Cycle TimesAuto-Startup (from Standby) Approximately 3.5 minutes

Auto-Startup (from power OFF) Approximately 5 minutes*

Run, Open Mode 37 seconds (READY to READY)

Run, Closed Mode Approximately 40 seconds

Shutdown (to Standby) 4.5 minutes

* The laser requires a 15 minute warm up time. If the power has been OFF longer than 5 minutes, wait 10 minutes after the Auto-Startup Cycle is complete before processing samples.

Approximate Aspiration Volumes (Whole Blood)Open Mode 130 µL (Auxiliary Specimen Type 300 µL)

Closed Mode 240 µL


9140320C — November 2000

System SpecificationsCELL-DYN 3700CS System Specifications Chapter 4

NOTES


System SpecificationsChapter 4 Combined Specifications for the SL and CS Systems

Combined Specifications for the SL and CS Systems

Measurement Specifications

Measurement Channels• Laser Optics for WOC (WBC Optical Count) and WBC

Differential

• Two impedance channels, one for WIC (WBC Impedance Count) and one for both RBC and PLT

• Hemoglobin Absorbance

WBC and DifferentialWIC: Method Electrical Impedance

Aperture Size 100 µm (diameter) x 77 µm (length)

Dilution 1:301 of blood in Diluent and WIC/HGB Lyse

Data Collection 256 channels, each channel = 0.5 fL

WOC: Method Laser light scatter

Light Source Vertically polarized 5–10 mW helium-neon laser

Wavelength 632.8 nm

Dilution 1:51 of blood in Sheath Reagent

Data Collection Four angles measured:0°, 10°, 90°, and 90° depolarized.Data collected in 256 channels for each angle of light scatter.


9140320C — November 2000

System SpecificationsCombined Specifications for the SL and CS Systems Chapter 4

RBCs and PLTsMethod Electrical Impedance

Aperture Size 60 µm (diameter) x 72 µm (length)

Dilution 1:9,760 of blood in Diluent

Data Collection 256 channels for RBCs,each RBC channel = 1 fL

256 channels for PLTs,each PLT channel = 0.137 fL

HGBMethod Modified hemiglobincyanide or modified

hemiglobinhydroxylamine

Light Source Light Emitting Diode, wavelength: 555 nm

Filter Interference FilterCenter wavelength: 540 nmBandwidth (at 1/2 peak): 22 nm

Dilution 1:301 of blood in Diluent and WIC/HGB Lyse or WIC/HGB Cyanide-Free Lyse

Data Collection Average of 5 absorbance readings for the detergent blank, average of 5 absorbance readings for the sample dilution



Performance Specifications

Background Counts (Acceptable Up to Limits Listed)WIC <0.30

WOC <0.30

RBC <0.03

HGB <0.20

PLT <10.0

RETIC <100 counts/count cycle

NOTE: Background counts must be within acceptable limits before running controls and patient specimens.

PrecisionSamples that are used to verify precision specifications should have results that fall within the laboratory's normal range. These samples should not display any of the following WBC descriptors or Suspect Parameter Flags:

WBC

WIC

WOC

RBC MORPH

LRI

URI

LURI

PLTR

Fragile RBCs

ERL

ENC

The stated precision values are applicable to the Open, Closed Sampler, and Sample Loader Modes.


9140320C — November 2000


Hemogram ParametersPrecision specifications for the hemogram parameters are given as a 95% confidence limit for the Coefficient of Variation (CV) of at least 31 determinations of the same sample.

NOTE: If the reported WBC is not accompanied by a WBC descriptor (WIC or WOC), the WBC (WOC) precision specification applies because WOC is the primary reported value when WIC and WOC values are equal.

WBC Differential ParametersPrecision specifications for the WBC Differential parameters are given as a 95% confidence limit for the difference of individual results in N = 31 determinations of the same sample from the mean of the determinations. The mean of sample’s WBC subpopulations should fall within the ranges listed below.

Table 4.5: Precision of the Hemogram and Reticulocyte Parameters (N = 31)

Parameter CV

WBC (WOC) <2.5%

WBC (WIC) <2.8%

RBC <1.5%

HGB <1.2%

MCV <1.0%

RDW <5.0%

PLT <5.0%

MPV <6.1%

RETIC % <15.0 %

Table 4.6: Precision of the WBC Differential Parameters

Cell Type RangeDifference from Mean of N = 31

Neutrophil % 45–70% ± 2.1

Lymphocyte % 20– 40% ± 2.6

Monocyte % 3.5–11.5% ± 2.4

Eosinophil % 0.5– 8.0% ± 1.0

Basophil % 0.5–2.0% ± 1.0



LinearityLinearity specifications were determined by analyzing dilutions of a commercially available linearity control material that contains no interfering substances. Specifications are determined by taking multiple measurements for each dilution to minimize the effect of imprecision. The stated limits (refer to the following table) are determined by regression through the origin (0,0), throughout the linear reportable range.

Reticulocyte linearity was determined by running six levels of reticulocyte control material prepared by mixing varying concentrations of two stock preparations. The general method described in CLSI/NCCLS Document EP6-A, Evaluation of the Linearity of Quantitative Analytical Methods, was used.1 Specifically, six concentration levels were run in quadruplicate, and the method of least squares regression was used for analysis of the reticulocyte percentage result.

NOTE: Results that exceed the linear range must be confirmed by diluting the specimen until the result falls within the appropriate linear range and then correcting that result for the dilution in order to obtain a reportable result.

Table 4.7: Linearity Specifications

Parameter Linear Range

Acceptable Limits (whichever is

greater)

WBC{ WICWOC

0–99.9 K/µL +0.4 or 3.0%

0–250 K/µL +0.4 or 4.0%

RBC 0–8 M/µL +0.1 or 2.5%

HGB 0–24 g/dL +0.3 or 2.0%

MCV 50–200 fL +3.0 or 3.0%

PLT 0–2000 K/µL +10.0 or 7%

MPV 5–18 fL +1.0 or 6.0%

RETIC % 0–30 % +1.1 or 7.0%


9140320C — November 2000


AccuracyThe CELL-DYN 3700 System can be calibrated to agree with reference values within the allowable calibration ranges. Both modes of operation, Open and Closed (CS and SL), may be calibrated. Thus, it is possible to compensate for differences between modes due to differing aspiration pathways. When each mode is properly calibrated according to the directions given in this manual, bias between the modes is clinically insignificant.

Accuracy specifications are determined by correlation to reference values obtained from comparison analyzers or analysis by reference methodology. Samples that are used for correlation studies should not display any Suspect Parameter Flags.

Hemogram Parameters

Due to differences in methodology, the bias results from clinical studies showed that the CELL-DYN 3700 IRF does not have the same sensitivity as a fluorescent method, such as that used on the CELL-DYN 4000 System. This is especially true at low and low-normal threshold levels.

Table 4.8: Accuracy of Hemogram Parameters

Parameter Correlation Coefficient

WBC >0.99

RBC >0.98

HGB >0.98

MCV >0.98

PLT >0.98

MPV >0.92

RETIC % >0.90



WBC Differential Parameters

CarryoverCarryover is determined by running samples with high concentrations of WBCs, RBCs, HGB, PLTs and Retics. Each sample is run in triplicate followed by three background cycles.

Reticulocyte carryover was determined by running specimens with high reticulocyte or RBC counts. Each specimen was run in triplicate followed by three background cycles. Since reticulocyte background results are given as count/count cycle, the specimen value used in the calculation is the List Mode WOC value which is displayed on the RETICULOCYTE RAW DATA SUMMARY screen. This screen is accessed from the RETICULOCYTE DIAGNOSTICS screen.

The percent carryover is calculated using the following formula:

Table 4.9: Accuracy of WBC Differential Parameters

Parameter Correlation Coefficient

Neutrophil # and % >0.95

Lymphocyte # and % >0.94

Monocyte # and % >0.86

Eosinophil # and % >0.84

Basophil # and % >0.73

Table 4.10: Carryover for WBC, RBC, HGB, PLT and Retics

WBC RBC HGB PLT RETIC %

Level 90K/µL 7.5M/µL 22.5g/dl 1000K/µL

30,000 list mode

counts

Carryover(in % or

Absolute)

<1.0% or <0.1 K/µL

<1.0% or <0.03 M/µL

<1.0% or <0.1 g/dL

<1.0% or <10 K/µL

<0.5%

Background1 – Background3% Carryover = x 100Sample3 – Background3

The Absolute Carryover is calculated as follows:

Absolute Carryover = |Background1 - Background3|


9140320F — April 2007


Performance Characteristics

Typical PrecisionThe pooled precision values (CVs) for the hemogram parameters are based on the analysis of data from replicate runs of N=31. The data were obtained from several CELL-DYN 3700 Systems over a period of weeks and derived using samples with results in the normal range. These precision values represent the typical performance that can be expected from instruments that are maintained properly, are operating in acceptable environmental conditions, and are using only recommended reagents and supplies.

Sensitivity and Specificity of WBC Differential FlagsThe sensitivity and specificity of the WBC Differential parameters were evaluated using the procedures outlined in CLSI/NCCLS Document H20-A, Reference Leukocyte Differential Count (Proportional) and Evaluation of Instrumental Methods as a guideline.2 The statistics were determined by comparing the CELL-DYN 3700 System results with a manual, 400 cell microscopic differential.

The following tables show the Reference Ranges used for the Normal/Abnormal Determinations. The first table outlines the ranges used for distributional sensitivity, and the second table outlines the ranges used for morphologic sensitivity.

Table 4.11: Typical Precision for Hemogram Parameters

Parameter Typical CV

WBC 1.9%

RBC 1.0%

HGB 0.7%

MCV 0.8%

RDW 3.2%

PLT 3.1%

MPV 3.6%



* Immature granulocytes include metamyelocytes, myelocytes, and promyelocytes.

Table 4.12: Reference Range for Distributional Flagging

Parameter Reference Range

Neutrophil % 46.5%–88.7%

Lymphocyte % 12.0%–44.0%

Monocyte % 0–11.2%

Eosinophil % 0–9.5%

Basophil % 0–2.5%

Table 4.13: Reference Range for Morphologic Flagging

Parameter Reference Range

Variant Lymphocytes 0–3%

Bands 0–12%

Immature Granulocytes* 0–1%

Blasts 0–1%

NRBCs 0–1/100 WBCs


9140320C — November 2000


Abnormalities EvaluatedTable 4.16 lists the abnormalities and the number of cases of each abnormality that were evaluated during the testing period.

Table 4.14: Abnormalities Evaluated

Abnormality Number of Cases

Granulocytosis 40

Granulocytopenia 27

Lymphocytosis 21

Lymphocytopenia 106

Monocytosis 31

Eosinophilia 4

Basophilia 4

Bands >12% 28

Metamyelocytes >1% 32

Myelocytes >1% 13

Promyelocytes >1% 10

Blasts >1% 12

Variant Lymphocytes >3% 22

NRBCs >1/100 WBCs 5



Truth TableThe Truth Table showing the sensitivity and specificity and the analysis of the false negative results is presented in this section. The data are based on the evaluation of a total of 374 cases, many of which had multiple abnormalities. Arbitration using the 95% confidence envelope at the upper limit of the range was applied to the manual differential results.

In the following table:

TP = True Positive

TN = True Negative

FP = False Positive

FN = False Negative

Agreement = 82.9%

False Positives = 27.0%

False Negatives = 2.0%

NOTE: The false positive and false negative ratios shown above express the results as a percentage of the total true positive and total true negative results, respectively, in accordance with CLSI/NCCLS Document H20-A.2 The previous version of this manual expressed the results as a percentage of the total specimens evaluated.

Table 4.15: Flagging Analysis Truth Table

CELL-DYN 3700 Normal

CELL-DYN 3700 Morphological

Positive

CELL-DYN 3700 Distributional

Positive Total

Reference Normal 165 TN 35 FP 26 FP 226

Reference Morphological Positive

2 FN 46 TP 9 TP 57

Reference Distributional Positive

1 FN 38 TP 52 TP 91

Total 168 119 87 374

Table 4.16: Analysis of False Negative Results

Manual Differential CELL-DYN 3700 Differential

Morphological False Negative 2% Metamyelocytes4% Metamyelocytes

No Flag generatedNo Flag generated

Distributional False Negative 6.3% Lymphocytes 12.0% Lymphocytes


9140320C — November 2000


NOTES


System SpecificationsChapter 4 References

References

1. Clinical and Laboratory Standards Institute/NCCLS. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI/NCCLS document EP6-A (ISBN 1-56238-498-8) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2003.

2. Clinical and Laboratory Standards Institute. Reference Leukocyte Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard. CLSI/NCCLS document H20-A (ISBN 1-56238-131-8) NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 1992.


9140320C — November 2000

System SpecificationsReferences Chapter 4

NOTES


Chapter 5 Operating InstructionsOperating Instructions

Overview

This chapter discusses the operation of the CELL-DYN® 3700 System. It is divided into four sections. The first section, the Overview, contains (1) instructions for an Instrument Logbook, (2) a Data Station Program Overview, and (3) a Menu Flowchart showing the different screens that are available on the Data Station.

The other three sections in this chapter are identified by subtabs: Set Up Instructions, Routine Operation, and Using the Data Log. These three sections describe three of the major menus used in operating the instrument: the SET UP MENU, the RUN menu, and the DATA LOG menu.

The other major menus are described in other chapters. The QUALITY CONTROL menu is described in Chapter 7: Quality Control. The CALIBRATION menu is described in Chapter 6: Calibration. The DIAGNOSTICS menu is described in Chapter 10: Troubleshooting. And the SPECIAL PROTOCOLS menu is described in Chapter 9: Maintenance.

Instrument LogbookCreate a logbook for the instrument. This logbook should contain all necessary calibration documentation and other information that is pertinent to your instrument. Suggested sections that you may wish to include in the logbook are:

Installation documentation

Your laboratory’s operating procedure

Quality control

Calibration

Maintenance

Reagent lot number changes

Troubleshooting and problem resolution

Printed fault reports

Service calls and problem resolution/service performed

Software upgrades

This logbook should be stored near the instrument and be accessible to all operators and Abbott Service Personnel.


9140320C — November 2000

Operating InstructionsOverview Chapter 5

Data Station Program Overview

Figure 5.1: Data Station

The Data Station menus are presented as key labels displayed across the bottom of the screen. Each menu is accessed by pressing the soft key located directly below the label. (From left to right, these soft keys correspond to keys F1– F8 on the standard computer keyboard.)

Screen

Soft Keys


Operating InstructionsChapter 5 Overview

Main Menu Screen

Figure 5.2: Main Menu Screen

When the Data Station is turned ON, the MAIN MENU screen, depicted in the preceding figure, is displayed. The key labels displayed across the bottom of this screen are used to access all of the submenus that are available. The MAIN MENU screen displays the following soft key labels:

SET UPRUNDATA LOGRETIC DATA LOG*QUALITY CONTROLCALIBRATIONDIAGNOSTICSSPECIAL PROTOCOLS

* The Retic Data Log is discussed in Chapter 14, Reticulocyte Package.


CALIBRA-TION

DIAG-NOSTICS PROTOCOLS

CD 3700SL MAIN MENUReady

Dec 05 1998Operator IDSequence #

15:50

0067

Version X.XXsh

SPECIALRETICDATA LOG


9140320C — November 2000


Each of these MAIN MENU keys, in turn, accesses its own hierarchy of screens and options. The different menus allow the operator to perform various functions, such as configuring the system for operation, running specimens, performing calibration and diagnostic functions, reviewing data, and printing customized reports.

The MAIN MENU screen is depicted in the preceding figure. The upper left-hand corner shows the current version of the instrument software. The upper right-hand corner shows the current date and time, the operator ID, and the sequence number. The information in the upper right corner is displayed on every screen during operation.

NOTE: The cursor is positioned at the <OPERATOR ID> entry field when the MAIN MENU screen is displayed. An operator ID of up to three alphanumeric characters may be entered. (An operator ID may also be entered from the CALIBRATION screen.) This operator ID will be displayed on all other screens and printed on all reports.

The Status Box is displayed in the top center of the screen. This box appears on every screen to show the following:

• Menu in use (such as MAIN MENU)

• Analyzer status (such as READY)

• Other applicable information such as report or file identity and any existing fault messages

Finally, the MAIN MENU key labels are displayed across the bottom of the MAIN MENU screen.



Conventions Used in This Manual

Soft keys are also depicted as follows in margins and flowcharts:


The following conventions are used in this manual:

Information Presentation Examples

Note, Caution, Warning ALL CAPS, BOLDFACE NOTE:

Bulletin message, status, or other screen display

MONOSPACE FONT,BOLDFACE

Ready

Data entry field <Sans Serif Font, Angle Brackets> <Date/Time>

Menu names SANS SERIF FONT, ALL CAPS SET UP

Soft key names [SANS SERIF FONT, ALL CAPS, BRACKETS]

[SET UP]

References to other text Bold: Bold & Italics Chapter: Title, Subsection: Heading

MAIN MENU

KEYS

SUBMENU

KEYS

TOGGLE

KEYS

TOGGLE

KEYS

MAIN MENUReady

SET UP RUN QUALITYCONTROL

RETIC DATA LOGDATA LOG


9140320C — November 2000


Menu FlowchartsAfter pressing one of the MAIN MENU soft keys, the appropriate submenu is displayed. From the submenus, more options are available. The MAIN MENU options flowchart is shown on this page. On the following pages, flowcharts show the submenus under each MAIN MENU option.

Main Menu Flowchart

MAIN MENUReady

SET UP DIAG- SPECIALPROTOCOLS

RUN CALIBRA-DATA LOG QUALITYCONTROL TION NOSTICS

RETICDATA LOG



Set Up Menu Flowchart

TOGGLE

SET UP MENUReady

UNITSOPERATIONSET UP

PATIENTLIMITS SELECTION

REAGENTLOG

QC SET UPMENU

RETURNLIMIT PRINTLIMITSET 2

LIMITSET 3

LIMITSET 4

RETURNUSAUNITS

SELECTUNITS

SIUNITS

SI MODUNITS

SET 1UNITS

SET 1

DATE/TIME

MAINCUSTOMIZEREPORT

PRINT DETERGENTLOG

DILUENTLOG LOG

WIC/HGBLYSE LOG

SHEATHLOG

DELETEENTRY

RETURN

CUSTOMIZEDISPLAY

CUSTOMIZELAB IDSET UP PRINTOUT

QCLIMITS

SET UPQC FILESET UP

X-B MAIN

PRINTTURN X-BWBC ON

RETURN

PRINTRANGEENTRY

LOADFROM DISK

MEANS/LIMITS

RETURN

PRINTTOGGLEON/OFF

RETURN

STANDARDSELECT PARAMETER

CANCELSELECTION SELECTION

PLACE PARAMETER

RETURN

STANDARDSELECT PARAMETER

CANCELSELECTION GROUPS

PLACE PARAMETER

RETURN

RESTORE HEADER

BLANK HEADER

CUSTOMIZE DISPLAY

SET UPPRINTOUTCUSTOMIZE

CUSTOMIZE PRINTOUT HEADERReady

RETURN (to MAIN)

BAR CODESET UP SET UP

COMPUTERTURN ONVET PKG

PARAM SET 1

PARAM SET 2

PARAM SET 3 PRINTOUT

CUSTOMIZE SET UPSELECTGRAPH SET 4

PARAMHEADER

CUSTOMIZE

PARAM SET 1

PARAM SET 2


CUSTOMIZE SET UPPLACEGRAPH SET 4

PARAMGRAPHCANCEL

CUSTOMIZE DISPLAYED REPORTReady

TICKETPRINTER

STOP PRINTING

CUSTOMIZE DISPLAY

CANCELSTOP

CONFIRMSTOP

TOGGLE ON/OFF

SET UPCUSTOMIZEHEADER

CUSTOMIZE PRINTED REPORTReady

TURN X-BWBC OFF

CANCELSTOP

CONFIRMSTOP

TOGGLEREINIT INTERFACE

STOPTRANSMISS ON/OFF

SET UP

RETURNLOADHIGH

LOADNORMAL

TURN X-BRBC ON

TURN X-BRBC OFF

LOADLOW

RESTORE HEADER

PRE-PRNTD TICKET PRINTER

GRAPHICS

BLANKTICKET

UPDATEFROM FILE

TURN ONRETIC PKG

TURN OFFVET PKG

TURN OFFRETIC PKG

SET 2UNITS

TOGGLE ONE/ALL

CUSTOM PLACEMENTLOT

NUMBERCONFIRMUPDATE

CANCELUPDATE

WBC GROUP

RBC GROUP

PLT GROUP GROUP

DIFF RETURNCUSTOMIZEPRINTOUT

REPLICATEID

ONE/ALL

TOGGLEON/OFF

SETUP

SETLATEX


9140320C — November 2000


Run Menu Flowchart

Data Log Menu Flowchart

CANCELCONFIRMDELETION DELETION

RUNReady

MAINCLEARAPERTURES

PRINTTICKET

PRINTREPORT

WORKLIST

CHANGESAMPLER

SPECIMENTYPE

CUSTOMIZEREPORT

CLEARFAULT

PRIME

COLORPRINT

PATIENT RESISTANTRBC

RETURN

QCSPECIMEN

LATEXBACK-GROUND

ELECTRICLBACKGRND

RETURNWORK LISTON

WORK LISTSET UP

PRINTWORK LIST

BAR CODEON

PURGECOMPLETED

INSERT/DELETE

DELETEALL

see CUSTOMIZE REPORTof SET UP MENU

RETURNINSERT DELETE

WORK LISTOFF

BAR CODEOFF

CANCELCONFIRMPURGE PURGE

AUXILIARY

RETURNTOGGLEON/OFF

EDITID

FIND SPECIMEN

PREVIOUS SPECIMEN

NEXT SPECIMEN

EDIT SPECIMEN SPECIMEN

TRANSMIT

DATA LOGReady

DISPLAYSPECIMEN

MAIN TRANSMIT DATA

PRINTDATA LOG

RETURNPRINTREPORT

CUSTOMIZEDATA LOG

REPORTCUSTOMIZE

TICKETPRINT

see CUSTOMIZE REPORTof SET UP MENU

SELECT PARAMETER

STANDARD GROUPS

RETURN

CANCELCONFIRM

PRINTOUTCUSTOMIZE

WBC GROUP

RBC GROUP

PLT GROUP GROUP

DIFF RETURNCUSTOMIZEPRINTOUTPLACEMENT

CUSTOM

REJECTFROM X-B

ACCEPTINTO X-B

RETURNSELECTPARAMETER

STANDARDGROUPS

RETURNPLACEPARAMETER

CANCELSELECTION

RETURNPLACEPARAMETER

CANCELSELECTION

COLORPRINT



Quality Control Menu Flowchart

UPDATECANCELCONFIRM

UPDATE

UPDATEFROM FILE

PURGECANCELCONFIRM

PURGE

QC MENUReady

CUSTOMIZEVIEWQC LOG

QCLIMITS DISPLAY

SET UPQC FILE

RETURNPURGEQC LOG

PRINTQC LOG

LEVEY-JENNINGS

MOVESPECIMEN

REJECTSPECIMEN

DELETESPECIMEN

ACCEPTSPECIMEN

RETURNRANGEENTRY

PRINT

RETURNPRINTTOGGLEON/OFF

RETURNPRINTGROUP3

GROUP4

X-B CUSTOMIZE PRINTOUT

MAINFILE

X-BSET UP

LOAD

MEANS/LIMITS

FROM DISK

WRITE QCTO DISK

GROUP2

GROUP1

RETURNPRINTTURN ONX-B WBC

TURN OFFX-B WBC

RETURNPRINTX-B WBCGRAPHS

X-B WBCDATA

DELETIONCANCELCONFIRM

DELETION

RETURNSTANDARDSELECTION

CANCELSELECTION

SELECTPARAMETER

RETURNWRITEHIGH

WRITENORMAL

WRITELOW

PLACEPARAMETER

RETURNSTANDARDGROUPS

CANCELSELECTION

SELECTPARAMETER

PLACEPARAMETER

CANCELMOVE

MOVE TOFILE

X-B RBCGRAPHS

X-B RBCDATA

TURN ONX-B RBC

TURN OFFX-B RBC

WBC GROUP

RBC GROUP

PLT GROUP GROUP


LOT NUMBER

TOGGLEONE/ALL

RETURNLOADLOADNORMAL

LOADLOW HIGH

PLACEMENTCUSTOM

REPLICATEID

TOGGLEONE/ALL

SETLATEX


9140320D — June 2003


Calibration Menu Flowchart

CANCELREPEAT

CONFIRMREPEAT

CALIBRATIONReady

ENTERFACTOR

MAIN

CALIBRATNLOG

PRINTAUTO-CALIBRATE

CLOSEDSAMPLER

OPENSAMPLER

RESTOREFACTORS

RESET ALLTO 1.000

RETURN

RETURN

PRINTLOG

CLOSEDSAMPLER

OPENSAMPLER

CALIBRATRWHOLEBLOOD

RETURN

MPVLATEX

QUITAUTO-CAL

CONTINUEAUTO-CAL

RETURN

PRINTSUMMARY

CLEARREF VALS

STARTAUTO-CAL

EDITREF VAL

CANCELQUIT

CONFIRMQUIT

QUITAUTO-CAL

INTERRUPTAUTO-CAL

RETURN

PRINTACCEPTMEANS

REPEATSPECIMEN

NEXTSPECIMEN

PREVIOUSSPECIMEN

CONTINUEAUTO-CAL

CANCELACCEPT

CONFIRMACCEPT

QUITAUTO-CAL

CONTINUEAUTO-CAL

RETURN

PRINTSUMMARY

CLEARREF VALS

STARTAUTO-CAL

EDITREF VAL

CHANGESAMPLER

(CS MODEL ONLY)

CANCELQUIT

CONFIRMQUIT

PRINTSUMMARY

CANCELQUIT

CONFIRMQUIT

PRINTSUMMARY



Diagnostics Menu Flowchart

DIAGNOSTICS MENUReady

PRINTFAULTREPORT

MORE

EXECUTIONTIMES

RAW DATASUMMARY

CNT RATESUMMARY

CLEARFAULTS

MAIN

PRINTWICCNT RATE

PLTCNT RATE

WOCCNT RATE

RBCCNT RATE

RETURN

MAINMOTOROPERATION

MORE

SOLENOIDOPERATION

INITIAL-IZATION

PUMPOPERATION

DRAINACCUMULAT

DIAG-STEPSOLENOID

CYCLEBANK NOSTICS

PRESSUREVACUUMTEST

INHIBITPUMPS TEST

VACUUMON

PRESSUREON

DIAG-NOSTICS

PRINTDIGITALREADINGS

MORE

VOLTAGEREADINGS

GAINADJUSTMNT

MAIN

WICCNT GRAPH

PLTCNT GRAPH

WOCCNT GRAPH

RBCCNT GRAPH

PRINTMORE

WOCDATA

WICDATA

RBCDATA

PLTDATA

MAIN

ENABLEPUMPS

VACUUMOFF

PRESSUREOFF


MORE

VOLTAGEREADINGS

GAINADJUSTMNT

MAINFINISHSELECT

SELECT

PRINTSIGNALGENERATOR

VERIFYGAINS

CURRENTSETTINGS

ENTERSETTINGS

AUTO GAINADJUSTMNT

DIAG-NOSTICS

PRINTWIMTESTING

MAMTESTING

RETURNSPMTESTING

PRINTMORE

AUTO-SAMPVERSION

SERIALTEST

BAR CODEALIGNMENT

BAR CODEVERIFY

MAIN

WICHISTOGRAM

RBCHISTOGRAM

PLTHISTOGRAM

PRINTWOC 1DATA

EXTENDEDWOC COUNT

WOC 2DATA

SMOOTHINGON/OFF

CALCCV

SCATTERGRAPHS

DIAG-NOSTICS

DIAG-NOSTICS

TRANSMITMESSAGE

STOPTRANSMISS

WOC 1HISTOGRAM

WOC 2HISTOGRAM

PRINTSHEAR VALDISPENSE

MOTOR PWRCHECKING

SHEAR VALTIME

HOMEMOTORS

EXERCISEMOTOR

DIAG-NOSTICS

SHEAR VALASPIRATE


9140320D — June 2003


Special Protocols Menu Flowchart

SPECIAL PROTOCOLSReady

MOREDISABLEANALYZER

CLEANSHEAR VAL

EMPTYWOC

RESTORESHEAR VAL

ENABLEANALYZER

EMPTYXDUCERS

MAINTENLOG

REAGENTRESERVOIR

MAIN

FILLWOC

RETURNPRINT & PURGE

PRINTLOG

UPDATELOG

INTERVALSET UP

RETURNEMPTY SHEATH

EMPTYDETERGENT

EMPTYLYSE

EMPTYDILUENT

MAINFLUSHSHEATH

EXTEND AUTOCLEAN

MORE

AUTOCLEAN

CLEANNEEDLE

DAILYSHUTDOWN

PREPARESHIPPING

FILLXDUCERS

FILL SHEATH

FILLDETERGENT

FILLLYSE

FILLDILUENT

PRINT RETURN


Operating InstructionsChapter 5 Set Up Instructions

Set Up Instructions

When the [SET UP] key on the MAIN MENU screen is pressed, the SET UP MENU screen is displayed. (See the following figure.) The options accessible from this screen are used to configure the system according to the laboratory’s requirements. The function of each soft key is discussed on the following pages, and setup procedures are included where applicable.

Figure 5.3: Set Up Menu Screen

The [SET UP] key is used to display the SET UP MENU screen. The following soft key labels are displayed on this screen:

DATE/TIMEPATIENT LIMITSREAGENT LOGQC SET UP MENUOPERATION SET UPUNITS SELECTIONCUSTOMIZE REPORTMAIN

These keys are used to set up the system for operation.

DATE/TIME

PATIENTLIMITS

REAGENTLOG

QC SET UPMENU

OPERATIONSET UP

UNITSSELECTION

CUSTOMIZEREPORT

MAIN

SET UP MENUReady


15:51

0067wam

SET UP


9140320C — November 2000

Operating InstructionsSet Up Instructions Chapter 5

Date/Time Soft Key

Figure 5.4: Date/Time Set Up Screen

The [DATE/TIME] key on the SET UP MENU is used to display the DATE/TIME SET UP screen (shown in the preceding figure). This screen is used to enter the date and time. This screen allows the operator to select the format for displaying the date and to change the date and time as required. Four different date formats are available. The circled numbers shown in the preceding figure correspond to the following numbered options:

1. The Display Format Selection Box is used to select the format in which the date is displayed:

1: Month/Day/Year

2: Day/Month/Year

3: Year/Month/Day

4: Year/Day/Month

2. The <DATE> entry field contains the operator-entered date.

3. The <TIME> entry field contains the operator-entered time.

RETURN

DATE/TIME SET UPReady


15:52

0067

Enter desired date display option and/or set date and time:

1 1: Month/Day/Year2: Day/Month/Year3: Year/Month/Day4: Year/Day/Month

Date (Month/Day/Year): --/--/--

Time (00:00 to 23:59): --:--

2

1

3

rls

DATE/

TIME



The desired format is selected by typing the corresponding number in the entry field displayed to the left of the list (1). When the Enter key on the keyboard is pressed, the selected format is displayed in the <DATE> entry field (2) and the cursor moves to the entry position of this field. After the date has been entered, the cursor moves to the <TIME> entry field (3).

Procedure: Date/Time1. From the SET UP MENU screen, press the [DATE/TIME] key to

display the DATE/TIME SET UP screen.

2. Type the number of the desired format at the cursor.

3. Press the Enter key on the keyboard to save the entry and advance the cursor to the <DATE> entry field.

4. Type the date in the selected format using one or two digits. Separate the day, month, and year with a slash (/) or a period (.). The entry order of the date should conform to the date format just selected.

5. Press the Enter key on the keyboard to save the entry and advance the cursor to the <TIME> entry field.

6. Type the time in the 24-hour (military) time format using one or two digits. Separate the hours and minutes with a colon (:) or a period (.).

7. Press the Enter key on the keyboard to save the entry.

8. Press the [RETURN] key to return to the SET UP MENU screen.


9140320C — November 2000


Patient Limits Soft Key

Figure 5.5: Patient Limit Set Screen

The [PATIENT LIMITS] key on the SET UP MENU is used to display one of the four LIMIT SET screens. (See the preceding figure.) These screens are used to enter upper and lower flagging limits for groups of patient samples. (For example, limits may be entered for adult males, adult females, neonates, etc.) The following soft key labels are displayed when the [PATIENT LIMITS] key is pressed:

LIMIT SET 1*LIMIT SET 2*LIMIT SET 3*LIMIT SET 4*PRINTRETURN

* The key label for the limit set displayed on the screen is not shown.

Whenever one of the four limit set soft keys is pressed, a screen for that limit set is displayed and the soft key for that limit set is no longer displayed. Four different sets of limits can be entered.

LIMITSET 2

LIMITSET 3

LIMITSET 4

PRINT RETURN

LIMIT SET 1Ready


11:157326799

WBCNEULYM

MONOEOS

BASORBCHGBHCTMCVMCH

MCHCRDW

PLTMPVPCT

PDW

Lower Limits Upper Limits4.62.00.60.00.00.0

4.0412.237.780.027.031.811.6142.

0.00.00

0.0

K/uLK/uLK/uLK/uLK/uLK/uLM/uLg/dL%fLpgg/dL%K/uLfL%10(GSD)

37.010.0

0.00.00.0

%N%L%M%E%B

10.26.93.40.90.70.2

6.1318.153.797.031.235.414.8424.99.99.9999.9


80.050.012.0

7.02.5

%N%L%M%E%B

PATIENT

LIMITS



Whenever a parameter result falls outside the entered limits, the result is displayed in color on the screen to alert the operator. Results displayed in yellow are below the limit, and results displayed in purple are above the limit. The flagged result is underlined on the graphics report and the blank ticket report. The flagged result is marked with an asterisk (*) on the preprinted ticket report.

It is suggested that one Patient Limit Set be used to enter instrument-specific laboratory action limits. If the Interpretive Report option is enabled, the Interpretive messages, such as leukocytosis, anemia, thrombocytopenia, etc., will be displayed when a result falls outside the appropriate limit. A result that falls outside a laboratory action limit can also indicate the need for the operator to follow a laboratory protocol, such as repeating the sample, notifying the physician or performing a smear review. In cases where a cellular abnormality is present that alters cellular morphology to the point that the cells do not fit the criteria used by the instrument to generate a flag, dispersional data alerts may be the only flag(s) that will alert the operator to a potentially erroneous result.

Interpretive Report MessagesIn addition to the color-coded results and flags that alert the operator to violations of limits, there is also a set of interpretive report messages that can be displayed on the Patient Report. These Interpretive Report Messages give causal indications for the limit violation (for example, leukopenia for low WBC, anemia for low RBC, thrombocytopenia for low PLT).

To set the system up to print Interpretive Report Messages, the Print Interpretive Report option on the CUSTOMIZE PRINTED REPORT screen must be selected.

If the Print Interpretive Report option on the CUSTOMIZE PRINTED REPORT screen for the Graphics Printer is enabled, Interpretive Report messages are printed on the report. This screen and its options are discussed later in this section. The messages generated by results that fall outside of the Patient Limits are listed in the following sections.

WBC MessagesLeukopenia Result falls below the lower limit for WBC.

Leukocytosis Result exceeds the upper limit for WBC.

Neutropenia Result falls below the lower limit for neutrophil absolute number.

Neutrophilia Result exceeds the upper limit for neutrophil absolute number.




Lymphopenia Result falls below the lower limit for lymphocyte absolute number.

Lymphocytosis Result exceeds the upper limit for lymphocyte absolute number.

Monocytosis Result exceeds the upper limit for monocyte absolute number.

Eosinophilia Result exceeds the upper limit for eosinophil absolute number.

Basophilia Result exceeds the upper limit for basophil absolute number.

RBC MessagesAnemia Result falls below the lower limit for RBCs.

Polycythemia Result exceeds the upper limit for RBCs.

Microcytic RBC Result falls below the lower limit for MCV.

Macrocytic RBC Result exceeds the upper limit for MCV.

Hypochromic Result falls below the lower limit for MCHC.

Hyperchromic Result exceeds the upper limit for MCHC.

Anisocytosis Result exceeds the upper limit for RDW.

PLT MessagesThrombocytopenia Result falls below the lower limit for PLTs.

Thrombocytosis Result exceeds the upper limit for PLTs.

Microcytic PLT Result falls below the lower limit for MPV.

Macrocytic PLT Result exceeds the upper limit for MPV.

Procedure: Patient Limit Sets1. From the SET UP MENU screen, press the [PATIENT LIMITS] key

to display one of the four LIMIT SET screens.

NOTE: When a Patient Limit Set is displayed on the screen, the set number (Limit Set 1, Limit Set 2, etc.) is displayed in the Status Box. The other Limit Sets may be selected by pressing the appropriate soft key.

2. Use the arrow keys on the keyboard to move the cursor to the desired limit entry field and type the desired number.

3. Press the Enter key on the keyboard to save the entry and automatically advance the cursor to the next entry position.

4. Repeat steps 2 and 3 until all desired entries have been made.

5. To obtain a printout of the Limit Set, press the [PRINT] key.



NOTE: Retaining a hard copy of each Limit Set is recommended, because the screens do not display names or categories for the Limit Sets.

6. Press the appropriate soft key to select another Limit Set and repeat steps 2–5 to enter the desired limits.


Reagent Log Soft Key

Figure 5.6: Diluent Log Screen

The [REAGENT LOG] key is used to display one of the reagent logs. (The name of the displayed log is indicated in the Status Box.) Any one of the other three reagent logs may be displayed by pressing the appropriate soft key. The following soft key labels are displayed when the [REAGENT LOG] key is pressed:

DELETE ENTRYDILUENT LOG*WIC/HGB LYSE LOG*SHEATH LOG*DETERGENT LOG*PRINT LOGMAIN

* The soft key for the reagent log currently displayed on the screen is not shown.

DELETEENTRY

WIC/HGBLYSE LOG

SHEATHLOG

DETERGENTLOG

PRINTLOG

MAIN

DILUENT LOGReady


16:30sh0630

List Number

--------------------

Lot Number

013511013511------------------------------------------------------------------------

Expiration Date

02/28/2002/28/20

--/--/----/--/----/--/----/--/----/--/----/--/----/--/----/--/--

Open Date

12/02/9812/17/98

--/--/----/--/----/--/----/--/----/--/----/--/----/--/----/--/--

REAGENT

LOG


9140320C — November 2000


Each reagent log can hold 10 entries. The following information may be entered for each reagent:

List Number Lot Number

Expiration Date Open Date

Procedure: Reagent Log Entry1. From the SET UP MENU screen, press the [REAGENT LOG] key to

display a REAGENT LOG screen.

2. Use the appropriate soft key to select the desired reagent log if it is not displayed.

3. Use the arrow keys on the keyboard to move the cursor to the desired entry field.

4. Type the appropriate information.

NOTE: Entries for each field of information are optional. Dates should be entered with a slash (/) or a period (.) separating the month, day, and year.

5. Press the Enter key on the keyboard to save the entry and advance the cursor.

6. Repeat steps 3–5 until all desired entries have been made.

7. To obtain a printout of the log, press the [PRINT LOG] key.

8. If desired, press the appropriate soft key to select another reagent log and repeat steps 2–7 to enter data.

Procedure: Deleting EntriesWhen the log is full (the log can hold 10 entries), an existing entry must be deleted or overwritten to create space for a new entry. Abbott suggests that the log be printed for documentation purposes when it is full.

1. From the SET UP MENU screen, press the [REAGENT LOG] key to display a REAGENT LOG screen.

2. Move the cursor to the oldest entry in the log.

3. Press the [DELETE ENTRY] key. The [COMPLETE DELETION] and the [RESTORE ENTRY] keys will be displayed.

4. Press the [COMPLETE DELETION] key to delete the selected entry and create a space at the bottom of the log.

5. If desired, a new entry may then be made as directed in the preceding Reagent Log Entry Procedure.

NOTE: New entries may also be made by typing over old entries without deleting them.




QC Set Up Menu Soft Key

Figure 5.7: QC Set Up Menu Screen

The [QC SET UP MENU] key is used to display a list of the QC files (see the preceding figure). This is the first of a series of screens and menu options that allow the operator to set up the QC files. The following soft key labels are displayed when the [QC SET UP MENU] key is pressed:

X-B SET UPLAB ID SET UPQC LIMITSSET UP QC FILECUSTOMIZE DISPLAYCUSTOMIZE PRINTOUTRETURN

NOTE: QC Set up for Reticulocytes is described in Chapter 14: Reticulocyte Package.

X-BSET UP

LAB IDSET UP

QCLIMITS

SET UPQC FILE

CUSTOMIZEDISPLAY

CUSTOMIZEPRINTOUT

RETURN

QC SET UP MENUReady


15:57

0067

1.2.3.4.5.6.7.8.9.

10.

File Name

Select a QC file with the arrow keys or enter a new file name.

FILE 1FILE 2FILE 3FILE 4FILE 5FILE 6FILE 7FILE 8FILE 9FILE 10

0000000000

# Specimens

11.12.13.14.15.16.17.18.19.20.

File Name

FILE 11FILE 12FILE 13FILE 14FILE 15FILE 16FILE 17FILE 18FILE 19FILE 20

0000000000

# Specimens

ebb

QC SET UP

MENU


9140320C — November 2000


Set Up QC File Soft Key

Figure 5.8: QC File Set Up (Lot Number Entry) Screen

REPLICATEID

PRINT RETURN

QC FILE SET UPReady

Nov 20 1998Operator IDSequence #

15:33sh0630

Lot Number:

FOR Low

12345Expiration Date (Month/Day/Year): 12/30/98

WESTGARD RULE SELECTION:

ON

ON

ON

ON

ON

ON

RULE 1:

RULE 2:

RULE 3:

RULE 4:

RULE 5:

RULE 6:

Value outside 3 SD.

Two consecutive values outside SAME 2 SD.

Two consecutive values outside OPPOSITE 2 SD.

Two of three consecutive values outside SAME 2 SD.

Four consecutive values outside SAME 1 SD.

Ten consecutive values on SAME side of mean.

2

3

TOGGLEON/OFF



Figure 5.9: QC File Set Up (Replicate ID Entry) Screen

The [SET UP QC FILE] key is used to configure the selected QC file. Pressing this key will display a QC FILE SET UP screen from which the lot number or replicate ID can be entered, and the Westgard Rules selected. If the file is used for a commercial control, the lot number and expiration date may be entered by pressing the [LOT NUMBER] key. If the file is used for a patient control, the ID number of the control may be entered by pressing the [REPLICATE ID] key. When the [SET UP QC FILE] key is pressed, the following soft key labels are displayed:

REPLICATE ID or LOT NUMBER (This key label alternates between

these two selections when the soft key is pressed.)

TOGGLE ON/OFF (This key label is present only when the cursor is in one of the Westgard Rule Selection fields.)

PRINTRETURN

LOTNUMBER

TOGGLEON/OFF

PRINT RETURN

QC FILE SET UPReady


13:33sh0630

Replicate ID: ------------

FOR Low


ON

ON

ON

ON

ON

ON

RULE 1:

RULE 2:

RULE 3:

RULE 4:

RULE 5:

RULE 6:

Value outside 3 SD.






1

3

SET UP

QC FILE


9140320C — November 2000


The QC FILE SET UP screens for <LOT NUMBER> entry and <REPLICATE ID> entry are shown in the preceding two figures.The numbers on these screens correspond to the following numbered options:

1. <REPLICATE ID> entry field.

This entry field is displayed when the [REPLICATE ID] key is pressed. This designation is intended for QC files that are used for patient controls.

2. <LOT NUMBER> and <EXPIRATION DATE> entry fields.

These entry fields are displayed when the [LOT NUMBER] key is pressed. This designation is intended for QC files that are used for commercial controls.

3. WESTGARD RULE SELECTION:

RULE 1: Value outside 3 SD.

RULE 2: Two consecutive values outside SAME 2 SD.

RULE 3: Two consecutive values outside OPPOSITE 2 SD.

RULE 4: Two of three consecutive values outside SAME 2 SD.

RULE 5: Four consecutive values outside SAME 1 SD.

RULE 6: Ten consecutive values on SAME side of mean.

NOTE: Westgard Rules are discussed in detail in Chapter 7: Quality Control within this manual.

The Westgard Rule selections are available on either of the QC FILE SET UP screens.

Procedure: Set Up QC File1. From the SET UP MENU screen, press the [QC SET UP MENU] key

to display the QC SET UP MENU screen.

2. Use the arrow keys on the keyboard to move the cursor to the desired QC file.

3. Type the desired alphanumeric file name. (Up to 12 characters may be entered.)

4. Press the Enter key on the keyboard to save the entry and advance the cursor to the next QC file.



5. Use the arrow keys on the keyboard to move the cursor back into the selected file.

6. Press the [SET UP QC FILE] key to display the QC FILE SET UP screen.

Procedure: Lot Number Entry1. From the QC FILE SET UP screen, press the [LOT NUMBER] key

if required to display the <Lot Number> and <Expiration Date> entry fields.

2. The cursor begins in the <Lot Number> entry field. Type the lot number and press the Enter key on the keyboard to save the entry. The cursor is now on the <Expiration Date> entry field.

3. Type the expiration date in the format indicated using one or two digits. This is the same format selected on the DATE/TIME SET UP screen. Separate the digits with a slash (/) or a period (.).

4. Press the Enter key on the keyboard to save the entry and advance the cursor to the <WESTGARD RULE SELECTION> entry fields.

5. Use the arrow keys on the keyboard to position the cursor at the desired Westgard Rule.

6. Press the [TOGGLE ON/OFF] key to enable or disable the rule and advance the cursor.

7. Repeat steps 5 and 6 until all desired rule selections have been made.

8. To obtain a printout of the entries, press the [PRINT] key.

9. Press [RETURN] to return to the QC FILE SET UP screen.

Procedure: Replicate ID Entry1. From the QC FILE SET UP screen, press the [REPLICATE ID] key

if required to display the <Replicate ID> entry field.

2. The cursor begins in the <Replicate ID> entry field. Type the sample ID number. (Up to 12 alphanumeric characters may be entered.) Press the Enter key on the keyboard to save the entry and advance the cursor to the <WESTGARD RULE SELECTION> entry fields.

3. Select the Westgard Rules as directed in the preceding procedure (Procedure: Lot Number Entry).


9140320C — November 2000


Lab ID Set Up Soft KeyThe [LAB ID SET UP] key enables the entry of QC limits into a QC file from a floppy disk.

The [LAB ID SET UP] key on the QC SET UP MENU is used to enter Laboratory identification information for the QC files. This information is necessary for participants in the CELL-DYN Interlaboratory QC Program who wish to submit their results on a floppy disk. Laboratory Identification information must be entered before QC data can be transferred to the floppy disk.

Procedure: Lab ID Set Up Soft Key1. From the MAIN MENU screen, press the [SET UP] key followed

by [QC SET UP MENU]2. From the QC SET UP screen, press [LAB ID SET UP] to display

the LAB ID SET UP screen.

3. Type the appropriate information and press the Enter key on the keyboard after each entry to save it and advance the cursor to the next entry field.

4. If desired, press the Print Screen key on the keyboard to obtain a printout of the entered information.

5. Press [RETURN] to return to the QC SET UP screen.

QC Limits Soft KeyThe [QC LIMITS] key is used to display the QC MEANS/LIMITS ENTRY screen and the following soft key labels:

RANGE ENTRY or MEANS/LIMITS (This key label alternates between these

two selections when the soft key is pressed.)

UPDATE FROM FILELOAD FROM DISKPRINTRETURN

QC limits are entered by pressing the [QC LIMITS] key. This key is available on both the QC SET UP MENU screen and the QC MENU screen. The QC MENU screen is discussed in Chapter 7: Quality Control. Two types of QC limits are available:

LAB ID

SET UP

QC

LIMITS



Range Entry The [RANGE ENTRY] key is used to enter the upper and lower flagging limits as absolute numbers (see the following figure).

Means and Limits The [MEANS/LIMITS] key is used to enter the mean value and a ± range value that defines the upper and lower flagging limits (see Figure 5.11, QC Means/Limits Entry Screen).

If the RANGE ENTRY screen is selected by pressing the [RANGE ENTRY] key, the current upper and lower limits for the selected file will be displayed as described above. If the MEANS/LIMITS screen is selected by pressing the [MEANS/LIMITS] key, the current means and limits for the selected file will be displayed as described above.

Figure 5.10: QC Range Entry Screen

Procedure: Range Entry1. Select a file from the QC SET UP MENU screen by using the

arrow keys on the keyboard to move the cursor into the desired file.

2. Press the [QC LIMITS] key (followed by the [RANGE ENTRY] key if required) to display the QC RANGE ENTRY screen for the selected file.

MEANS/LIMITS

UPDATEFROM FILE

LOADFROM DISK

PRINT RETURN

QC RANGE ENTRYReady


16:247579110FOR LOW

WOCWIC

WBCNEU%N

LYM%L

MONO%M

EOS%E

BASO

Lower Limits Upper Limits2.02.02.01.1

66.50.07.60.03.40.00.00.0

K/uLK/uLK/uLK/uL%NK/uL%LK/uL%MK/uL%EK/uL

2.62.62.62.3

80.50.9

21.60.4

13.40.15.00.5


%BRBCHGBHCTMCVMCH

MCHCRDW

PLTMPVPCT

PDW

Lower Limits Upper Limits0.0

2.336.6

18.578.825.831.413.8

43.9.4

0.0514.8

%BM/uLg/dL%fLpgg/dL%K/uLfL%10(GSD)

6.52.63

7.221.582.829.837.417.8

61.11.40.0716.2



9140320C — November 2000



4. Type the appropriate numbers and press the Enter key on the keyboard to save each entry and advance the cursor to the next entry field.

5. Repeat step 4 until all entries have been made.

6. To obtain a printout of the entered values, press the [PRINT] key.

7. Press [RETURN] to save the entries and return to the QC SET UP MENU screen.

NOTE: When the entries are saved, the software automatically checks to see if any entries would result in the upper limit being less than the lower limit. If this situation occurs, the limits will automatically be reversed and the Bulletin line will display the following message:LIMITS WERE EXCHANGED TO MAKE UPPER > LOWER.

Figure 5.11: QC Means/Limits Entry Screen

RANGEENTRY

UPDATEFROM FILE

LOADFROM DISK

PRINT RETURN

QC MEANS/LIMITS ENTRYReady


11:35C034300FOR CONTROL H

WOCWIC

WBCNEU%N

LYM%L

MONO%M

EOS%E

BASO

Means Limits(+/-)50.050.050.050.050.050.050.050.050.050.050.050.0


50.050.050.050.050.050.050.050.050.050.050.050.0


%BRBCHGBHCTMCVMCH

MCHCRDW

PLTMPVPCT

PDW

Means Limits(+/-)5.0050.050.0500.50.050.050.0500.50.05.0050.050.0


5.0050.050.0500.50.050.050.0500.50.05.0050.050.0




Procedure: Means/Limits Entry1. Select a file from the QC SET UP MENU screen by using the


2. Press the [QC LIMITS] key (followed by the [MEANS/LIMITS] key if required) to display the QC MEANS/LIMITS ENTRY screen for the selected file.


4. Type the appropriate numbers and press the Enter key on the keyboard to save each entry and advance the cursor to the next entry field.

5. Repeat step 4 until all entries have been made.

6. Press the [RETURN] key to save the entries and return to the QC SET UP MENU screen.

NOTE: When the entries are saved, the software automatically checks to see if any entries would result in a negative number for the lower limit (for example, mean = 1.0 and limit = 2.0). If a negative number is found, the values are automatically edited to adjust the lower limit to zero and the bulletin line will display the following message: LIMITS WERE CHANGED TO CORRECT OUT-OF-RANGE VALUES.

In the above example, the mean would be adjusted to 1.5 and the limit would be adjusted to 1.5.

7. If desired, press the [QC LIMITS] key to return to the MEANS/LIMITS ENTRY screen and press the [PRINT] key to obtain a printout of the entered values.


9140320C — November 2000


Update From File Soft Key

Figure 5.12: QC Means/Limits Entry Screen Showing the Update From File Key

The [UPDATE FROM FILE] key is displayed on the QC MEANS/LIMITS ENTRY and QC RANGE ENTRY screens (see the preceding figure). Pressing this key will cause the bulletin line to display the message USE CONFIRM UPDATE TO SET MEANS AND LIMITS FROM QC FILE, and the following soft key labels will be displayed:

CONFIRM UPDATECANCEL UPDATE

These keys are used to confirm or cancel the Update From File command.

NOTE: A message <Cannot UPDATE from FILE. File must have at least 2 valid values per parameter> is displayed on the bulletin line if there are less than 2 results in the file.

RANGEENTRY

UPDATEFROM FILE

LOADFROM DISK

PRINT RETURN

QC MEANS/LIMITS ENTRYReady


16:24sh0630FOR Normal

WICWOCWBCNEU%N

LYM%L

MONO%M

EOS%E

BASO

Means Limits(+/-)7.57.57.54.8

64.01.5

20.80.8

10.70.22.70.2


0.60.60.61.57.00.8

10.00.53.50.21.50.2


%BRBCHGBHCTMCVMCH

MCHCRDW

PLTMPVPCT

PDW

Means Limits(+/-)2.7

4.2112.539.192.929.732.015.6229.10.35.0050.0


2.70.18

0.42.43.02.03.02.225.1.0

4.9950.0


UPDATE

FROM FILE



If the [CONFIRM UPDATE] key is pressed, the mean value for each parameter will be computed from the values in the file. The parameter limits are set as follows:

WBC, PLT, RDW, and MPV: ± 10% of the computed mean

NEU, LYM, and MONO: ± 40% of the computed mean

Remaining Parameters: ± 5% of the computed mean

Load From Disk Soft Key

The [LOAD FROM DISK] key is used to enter the lot number, expiration date, and assay values into a QC file directly from a floppy disk. When this option is used, the lot number, expiration date, mean value and limits (either for QC Range entry or QC Means/Limits entry) are automatically entered in the selected file. The values may be edited after they are displayed on the screen.

NOTE: The information is entered for each level, one level at a time.

Procedure: Load From Disk1. Press [QUALITY CONTROL] to display a list of QC files.

2. Use the arrow keys on the keyboard to move the cursor to the desired file. Type the file name (e.g., Low L0036) and press the Enter key on the keyboard to save the name and advance the cursor to the next file.

NOTE: The file must be empty in order to load the information from the disk.

3. When the desired files have been named, use the Arrow keys on the keyboard to move the cursor back to the first file desired for data entry.

4. Press [QC LIMITS] followed by [MEANS/LIMITS] or [RANGE ENTRY] to display the QC MEANS/LIMITS ENTRY or RANGE ENTRY screen for the selected file.

5. Press [LOAD FROM DISK] to display the LOAD FROM DISK screen.

6. Insert the disk containing the assay information for the relevant lot number into the Data Station disk drive.

NOTE: Be certain to carefully check lot numbers. Be sure the lot number on the disk matches the lot number that is being put into use. If the lot number is included in the filename, be sure the disk contains assay information for that lot number.

LOAD

FROM DISK


9140320C — November 2000


7. Check the status box to be sure the correct file is selected and press the appropriate soft key:

[LOAD LOW] to load the low control assay data.

[LOAD NORMAL] to load the normal control assay data.

[LOAD HIGH] to load the high control assay data.

8. The limits are displayed for the selected file. If desired, the limits may be edited.

9. Press [RETURN] to return to the QC MENU screen.

10. Select the next file and repeat steps 7 and 8 to load the assay data for the appropriate level of control.

11. When all the assay data has been loaded, remove the disk from the disk drive.

Customize Display Soft Key

Figure 5.13: Customize QC Display Screen

SELECTPARAMETER

TOGGLE GROUPS

RETURN

CUSTOMIZE QC DISPLAYReady


16:23

0067FOR FILE 1

WBC NEU LYM MONO EOS BASO

RBC HGB HCT MCV MCH MCHC RDW

PLT MPV PCT PDW

WBC %N %L %M %E %B

WBC NEU LYM MONO EOS BASORBC HGB HCT MCV MCH MCHC RDWPLT MPV PCT PDW

%N %L %M %E %BRUT1 RUT2 RCT1 RCT2WUT WCT WIC WOC EMPTY

Group 1:

Group 2:

Group 3:

Group 4:

STANDARDONE/ALL

Customize QC display for all QC files



The [CUSTOMIZE DISPLAY] key is used to display the CUSTOMIZE QC DISPLAY screen for the selected file. This screen allows the operator to customize the display of information in the QC logs. (See the preceding figure.) The following soft key labels are displayed on the CUSTOMIZE QC DISPLAY screen:

SELECT PARAMETERSTANDARD GROUPSTOGGLE ONE/ALLRETURN

The screen displays a matrix showing the groups of parameters that are currently selected. A list of all available parameters is displayed under the matrix. There are several additional parameters included in the list that may be displayed in the QC file if desired. These include the following:

RUT1 and RUT2 RUT1 is the RBC/PLT Upper Metering Time. RUT2 is the RBC/PLT Upper Metering Time for an extended count.

RCT1 and RCT2 RCT1 is the RBC/PLT Count Time. RCT2 is the RBC/PLT Count Time for an extended count.

WUT WUT is the WIC Upper Metering Time.

WCT WCT is the WIC Count Time.

WIC WIC is the WBC Impedance Count.

WOC WOC is the WBC Optical Count.

EMPTY EMPTY inserts an empty column in the display.

The [SELECT PARAMETER] key is used to select parameters and place them in the desired location.

The [STANDARD GROUPS] key is used to select a predetermined group of parameters that will be placed on a designated page.

The display may be customized by selecting the individual parameters, standard groups of parameters, or a combination of the two.

On the CUSTOMIZE QC DISPLAY screen, the selections included in Parameter Group 1 will be displayed (in the order indicated from left to right) on the first VIEW QC LOG screen. The remaining groups will be displayed on subsequent screens that are accessed by pressing the right arrow key on the keyboard. The left arrow key is used to page back through the screens to the first screen. The VIEW QC LOG screen is discussed in Chapter 7: Quality Control.

The [TOGGLE ONE/ALL] key is used to customize one file only or all files the same way.

CUSTOMIZE

DISPLAY

SELECT

PARAMETER

STANDARD

GROUPS

TOGGLE

ONE/ALL


9140320C — November 2000


Procedure: Customize QC Log Display1. Select a file from the QC SET UP MENU screen by moving the

cursor to the desired file.

2. Press the [CUSTOMIZE DISPLAY] key to display the CUSTOMIZE QC DISPLAY screen for the selected file.

3. If necessary, press the [CUSTOM PLACEMENT] key to display the CUSTOMIZE QC DISPLAY screen and the [SELECT PARAMETER] key.

4. Use the arrow keys on the keyboard to move the cursor to the desired parameter in the listing under the matrix.

5. Press the [SELECT PARAMETER] key. The selected parameter will be highlighted and the cursor will move to the first position in <Group 1>.

NOTE: The key label will change to [PLACE PARAMETER], and a [CANCEL SELECTION] key will be displayed.

6. If necessary, use the arrow keys on the keyboard to move the cursor to the desired location and press the [PLACE PARAMETER] key.

NOTE: When the [PLACE PARAMETER] key is pressed, the selected parameter is displayed in the position indicated by the cursor and the cursor is then advanced to the next parameter in the listing under the matrix.

7. Repeat steps 4–6 until all selections have been made.

8. If desired, press the Print Screen key on the keyboard to obtain a printout of the selected groups.

9. Press the [RETURN] key to return to the QC SET UP MENU screen.

10. Repeat this procedure to customize the display for other QC logs.

NOTE: Use the [TOGGLE ONE/ALL] key to customize one file only or all files in the same manner.



Standard Groups Soft Key

Figure 5.14: Customize QC Display Screen Showing Standard Groups

Predetermined groups of parameters, called Standard Groups, may be selected by pressing the [STANDARD GROUPS] key. The preceding figure shows the CUSTOMIZE QC DISPLAY screen with the Standard Groups displayed. The following soft key labels are displayed when the [STANDARD GROUPS] key is pressed:

WBC GROUPRBC GROUPPLT GROUPDIFF GROUPLATEX SETCUSTOM PLACEMENT (This key is used to return to the

CUSTOMIZE QC DISPLAY screen for operator-selected placement.)

TOGGLE ONE/ALLRETURN

WBCGROUP

RBCGROUP

PLTGROUP

DIFFGROUP

LATEXSET

CUSTOMPLACEMENT

RETURN

CUSTOMIZE QC DISPLAYReady


16:23

0067FOR FILE 1



PLT MPV PCT PDW

WBC %N %L %M %E %B



Group 1:

Group 2:

Group 3:

Group 4:

Customize QC display for the current file

TOGGLE ONE/ALL

STANDARD

GROUPS


9140320C — November 2000


The WBC, RBC, PLT, and DIFF Standard Groups are shown in the preceding figure. They contain the following parameters:

WBC Group (Group 1):WBC, NEU, LYM, MONO, EOS, BASO

RBC Group (Group 2): RBC, HGB, HCT, MCV, MCH, MCHC, RDW

PLT Group (Group 3): PLT, MPV, PCT, PDW

DIFF Group (Group 4): WBC, %N, %L, %M, %E, %B

Procedure: Customize QC Log Display (Standard Groups)1. Select a file from the QC SET UP MENU screen by moving the


2. Press the [CUSTOMIZE DISPLAY] key to display the CUSTOMIZE QC DISPLAY screen for the selected file.

3. Press the [STANDARD GROUPS] key to display the CUSTOMIZE QC DISPLAY screen and key labels for Standard Groups.

4. Use the arrow keys on the keyboard to move the cursor to the desired group location (1–4).

NOTE: This number indicates the order in which the group of parameters will be displayed (Group 1 on the first screen, Group 2 on the second, etc.).

5. Press the soft key corresponding to the desired parameter group. This group will be displayed in the position indicated by the cursor.

6. Repeat steps 4 and 5 until all desired groups have been selected.

7. To obtain a printout of the configuration, press the Print Screen key on the keyboard.


9. Repeat this procedure to select Standard Groups for other QC logs.

Latex Set Soft KeyThe [LATEX SET] key is used to customize the QC file to store information generated by polystyrene microspheres. Information is stored for each of the four angles of scatter used to determine the differential. This key is intended for Abbott service personnel.


LATEX

SET

TOGGLE

ONE/ALL



Customize Printout Soft Key

Figure 5.15: Customize QC Printout Screen

The [CUSTOMIZE PRINTOUT] key on the QC SET UP MENU screen is used to display the CUSTOMIZE QC PRINTOUT screen, which is used to customize the printout format for the QC logs. (See the preceding figure.) The following soft key labels are displayed on this screen:

SELECT PARAMETER orPLACE PARAMETER (This key label alternates between

these two selections.)

STANDARD SELECTIONTOGGLE ONE/ALLRETURN

SELECTPARAMETER

STANDARDSELECTION

RETURN

CUSTOMIZE QC PRINTOUTReady


16:23sh0630FOR Normal



WBC %N %L %M %E %B RBC HGB HCT MCV MCH MCHC

RDW PLT MPV PCT PDW

Customize QC PRINTOUT for the current QC file

TOGGLEONE/ALL

CUSTOMIZE

PRINTOUT


9140320C — November 2000


The CUSTOMIZE QC PRINTOUT screen displays the group of parameters that is currently selected. A list of all available parameters is displayed under the selected group. The following parameters are also included in this list and can be printed in the QC Log if desired:




WCT WCT is the WIC Count Time.

WIC WIC is the WBC Impedance Count.

WOC WOC is the WBC Optical Count.

The [SELECT PARAMETER] key is used to select parameters and place them in the desired location.

The [STANDARD SELECTION] key is used to automatically arrange the parameters in the predetermined print group shown in the preceding figure.


Procedure: Customize QC Log Printout1. Select a file from the QC SET UP MENU screen by moving the


2. Press the [CUSTOMIZE PRINTOUT] key to display the CUSTOMIZE QC PRINTOUT screen for the selected file.

3. Use the arrow keys on the keyboard to move the cursor to the desired parameter in the list under the printout group.

4. Press the [SELECT PARAMETER] key. The selected parameter will be highlighted and the cursor will move to the first position in the group.

NOTE: The key label will change to [PLACE PARAMETER] and a [CANCEL SELECTION] key will be displayed.

SELECT

PARAMETER

STANDARD

SELECTION

TOGGLE

ONE/ALL




NOTE: When the [PLACE PARAMETER] key is pressed, the selected parameter will be displayed in the position indicated by the cursor and the cursor will then be advanced to the next parameter in the list under the printout group.

6. Repeat steps 3–5 until all entries have been made.



9. Repeat this procedure to customize the printout for other QC Logs.


9140320C — November 2000


X-B Set Up Soft Key

Figure 5.16: X-B Set Up Screen

The [X-B SET UP] key on the QC SET UP MENU screen is used to display the X-B SET UP screen. (See the preceding figure.) This screen is used to enter upper and lower acceptance limits, target values, and action limits for the X-B Moving Average QC Program. The following soft key labels are displayed when the [X-B SET UP] key is pressed:

TURN X-B RBC ON orTURN X-B RBC OFF (This key label alternates between


TURN X-B WBC ON orTURN X-B WBC OFF (This key label alternates between


PRINTRETURN

TURN X-BRBC OFF

PRINT RETURN

X-B SET UPReady


08:49

0067

ParameterMCVMCH

MCHC

LYM 0DLYM 10DNEU 0DNEU 10DNEU 90DNEU 90DEPNEU-EO

Lower/Upper Limits55.0/125.20.0/40.024.0/44.0

48/ 7051/ 67

141/179128/170

87/16311/ 31

14.0/ 32.0

Target Value Action LimitfLpgg/dL

ChannelChannelChannelChannelChannelChannelDegree

89.930.533.9

5959

160149125

2123.0

fLpgg/dL

ChannelChannelChannelChannelChannelChannelDegree

3.0 %3.0 %3.0 %

7.0 %5.0 %4.0 %5.0 %

10.0 %19.0 %13.0 %

321

Parameter Lower/Upper Limits Target Value Action LimitThe X-B WBC program is ON.

The X-B RBC program is ON.

TURN X-BWBC OFF

X-B

SET UP



The numbers on the X-B SET UP screen shown in the preceding figure correspond to the following numbered options:

1. Lower/Upper Limits

The Lower and Upper Limits determine which patient results will be used in the X-B RBC and WBC Moving Average calculations. Results that fall outside these limits are automatically excluded from the appropriate X-B calculations. These limits should be set wide to exclude grossly abnormal samples that would bias the calculation, but the limits should include at least 95% of the patient results.

2. Target Value

The Target Values for the X-B RBC and WBC Analyses are similar to the assay values for commercial controls. They are derived from the patient populations that are analyzed on the instrument.

3. Action Limit

The Action Limits are the acceptable limits of variation around the X-B RBC and X-B WBC target values.

NOTE: The X-B Program is discussed in detail in Chapter 7: Quality Control.

Procedure: X-B Set Up1. From the QC SET UP MENU screen, press the [X-B SET UP] key

to display the X-B SET UP screen.


3. Type the appropriate numbers and press the Enter key on the keyboard to save the entry and advance the cursor to the next entry field.

4. Repeat steps 2 and 3 until all entries have been made.

5. To obtain a printout of the entered values, press the [PRINT] key.

6. Press the [TURN X-B RBC ON] key to enable the X-B RBC Program if this key label is displayed.

NOTE: When the X-B RBC Program is enabled, the screen displays the message THE X-B RBC PROGRAM IS ON, and the [TURN X-B RBC OFF] key is displayed.


9140320C — November 2000


7. Press the [TURN X-B WBC ON] key to enable the X-B WBC Program if this key label is displayed.

NOTE: When the X-B WBC Program is enabled, the screen displays the message The X-B WBC Program is ON, and the [TURN X-B WBC OFF] key is displayed.




Operation Set Up Soft Key

Figure 5.17: Operation Set Up Menu Screen

The [OPERATION SET UP] key on the SET UP MENU screen is used to display the OPERATION SET UP MENU screen (see the preceding figure). This screen allows the operator to select the type of bar code used and configure the transmission to an on-line computer. The Veterinary Package and the Reticulocyte Package for the CELL-DYN 3700 System can be enabled or disabled from this screen. The following soft key labels are displayed on the OPERATION SET UP MENU screen:

TURN ON VET PKG or TURN VET PKG OFF (This key label alternates between


TURN ON RETIC PKG or TURN OFF RETIC PKG (This key label alternates between


BAR CODE SET UPCOMPUTER SET UPRETURN

TURN ONVET PKG

TURN ONRETIC PKG

BAR CODESET UP

COMPUTERSET UP

RETURN

OPERATION SET UP MENUReady


16:11

0067rwe

To turn on the RETIC PKG you must enter to operator ID and the instrument must be in Open mode. To turn on the VET PKG you must exit the RETIC PKG.

OPERATION

SET UP


9140320C — November 2000


Turn ON Vet Package Soft KeyThe [TURN ON VET PKG] or [TURN VET PKG OFF] key enables or disables the Veterinary Package. This option is used to configure the instrument to run various types of animal specimens. The Veterinary Package is discussed in detail in Chapter 13: Veterinary Package.

Turn ON Retic Package Soft KeyThe [TURN ON RETIC PKG] or [TURN OFF RETIC PKG] key enables or disables the Reticulocyte Package. This option is used to analyze a whole blood specimen for reticulocytes. The Reticulocyte Package is discussed in Chapter 14: Reticulocyte Package.

Bar Code Set Up Soft Key

Figure 5.18: Bar Code Set Up Screen

TURN ON

VET PKG

TURN VET

PKG OFF

TURN ON

RETIC PKG

TURN OFF

RETIC PKG

SET UP

BAR CODE SET UPReady


16:12

0068

ON1

Bar Code Check DigitBar Code Symbology (1=CODE39, 2=I2OF5, 3=CODABAR, 4=CODE128)

agw



The [BAR CODE SET UP] key is used to display the BAR CODE SET UP screen, which is used to select the type of bar code to be read and to enable or disable the Check Digit option for a specific bar code. (See the preceding figure.) If the Check Digit option is enabled, the Analyzer reads only the type of bar code selected. If the option is disabled, the Analyzer ignores the selected bar code and reads all four types of bar codes (Code 39, Interleaved 2 of 5, Codabar, and Code 128).

NOTE: For more information about Check Digits and bar codes, refer to Appendix A: Bar Codes.

Procedure: Bar Code Set Up1. From the OPERATION SET UP MENU screen, press the

[BAR CODE SET UP] key to display the BAR CODE SET UP screen.

2. Place the cursor on the Bar Code symbology line and type the number for the type of bar code that will be used:

1 — Code 39

2 — Interleaved 2 of 5

3 — Codabar

4— Code 128

Press the Enter key on the keyboard to save the entry and advance the cursor.

3. When the cursor is next to the <BAR CODE CHECK DIGIT> entry field, a [TOGGLE ON/OFF] key is displayed. Press this key to enable or disable the Check Digit option. When the Check Digit option is turned off, the Bar Code symbology line is not displayed.

NOTE: The [TOGGLE ON/OFF] key is displayed only when the cursor is positioned next to the <BAR CODE CHECK DIGIT> entry field.

4. Press the [SET UP] key to return to the OPERATION SET UP MENU screen.

BAR CODE

SET UP


9140320C — November 2000


Computer Set Up Soft Key

Figure 5.19: Computer Set Up Screen

The [COMPUTER SET UP] key on the OPERATION SET UP MENU screen is used to display the COMPUTER SET UP screen (see the preceding figure) and the following soft key labels:

REINIT INTERFACESTOP TRANSMISSTOGGLE ON/OFFSET UP

The CELL-DYN 3700 System has the capability to transmit data to an on-line computer (Laboratory Information System, or LIS). Data can be transmitted automatically as each sample is run, or data can be transmitted at the operator’s request. The CELL-DYN 3700 System can also receive patient information that is transmitted to it by the on-line computer.

The COMPUTER SET UP screen is used to configure the transmission format to meet the requirements of the LIS or on-line computer. Instructions for using this option are given after the following description of the soft keys.

REINITINTERFACE

STOPTRANSMISS

TOGGLEON/OFF

SET UP

COMPUTER SET UPReady


16:13

0070

OFFOFFOFFOFFOFF8100.39600

Auto-transmission of ALERTED parameter dataAuto-transmission of NON-ALERTED parameter dataAuto-transmission of ALERTED graph dataAuto-transmission of NON-ALERTED graph dataTransmission CTS enabledTransmission Data bits (7, 8)Transmission Stop bits (1, 2)Transmission Parity (0=None, 1=Odd, 2=Even)Transmission time out (0.1 to 9.9)Computer Baud Rate (300, 600, 1200, 2400, 4800, 9600)

12345

smw

COMPUTER

SET UP



Reinitialize Interface Soft KeyThe [REINIT INTERFACE] key on the COMPUTER SET UP screen is used to initialize the RS-232 Interface for the displayed transmission configuration after it is entered.

NOTE: Refer to the Interface Specification (L/N 02H33-01) for complete information on interfacing.

Stop Transmiss Soft KeyThe [STOP TRANSMISS] key stops the current data transmission to the on-line computer. When the [STOP TRANSMISS] key is pressed, the following soft key labels are displayed:

CONFIRM STOPCANCEL STOP

These keys confirm or cancel the Stop Transmission command.

Toggle ON/OFF Soft KeyThe [TOGGLE ON/OFF] key enables or disables the first five options in the list displayed on the COMPUTER SET UP screen.

The numbers on the COMPUTER SET UP screen shown in the preceding figure correspond to the following numbered options:

1. Auto-transmission of ALERTED parameter data

When this option is enabled, a report is automatically transmitted to the LIS for any sample with flagged parameter results.

2. Auto-transmission of NON-ALERTED parameter data

When this option is enabled, a report is automatically transmitted to the LIS for any sample without flagged parameter results.

3. Auto-transmission of ALERTED graph data

When this option is enabled, histograms are automatically transmitted to the LIS for any sample with flagged results.

4. Auto-transmission of NON-ALERTED graph data

When this option is enabled, histograms are automatically transmitted to the LIS for any sample without flagged results.

REINIT

INTERFACE

STOP

TRANSMISS

TOGGLE

ON/OFF


9140320C — November 2000


5. The remaining options are configured according to the transmission requirements of the LIS:

• Transmission CTS enabled

• Transmission Data bits (7, 8)

• Transmission Stop bits (1, 2)

• Transmission Parity (0=None, 1=Odd, 2=Even)

• Transmission time out (0.1 to 9.9)

• Computer Baud Rate (300, 600, 1200, 2400, 4800, 9600)

The numbers in parentheses after the options indicate the selections available.

NOTE: Refer to the Interface Specification (L/N 02H33-01) for complete information on interfacing.

Procedure: Computer Set Up1. From the OPERATION SET UP MENU screen, press the

[COMPUTER SET UP] key to display the COMPUTER SET UP screen.

2. For the first five options on the list, use the arrow keys on the keyboard to move the cursor to the desired selection and press the [TOGGLE ON/OFF] key to enable or disable the selection.

NOTE: The [TOGGLE ON/OFF] key is displayed when the cursor is positioned in any of the first five entry fields.

3. For the last five options on the list, type the appropriate information and press the Enter key on the keyboard to save the entry and advance the cursor.

4. When all the information has been entered, press the [REINIT INTERFACE] key to initialize the interface for the selected configuration.


6. Press the [SET UP] key to return to the OPERATION SET UP MENU screen.

7. Press the [RETURN] key to return to the MAIN MENU screen.



Units Selection Soft Key

Figure 5.20: Units Selection Screen

The [UNITS SELECTION] key on the SET UP MENU screen is used to display the UNITS SELECTION screen. This screen allows the selection of the report units for the indicated parameters. Units may be selected for each parameter individually or a set of units may be selected by pressing the appropriate soft key. (See the preceding figure.) The following soft key labels are displayed on the UNITS SELECTION screen:

USA UNITSSI UNITSSI MOD UNITSSET 1 UNITSSET 2 UNITSSELECT UNITSRETURN

USAUNITS

SIUNITS

SI MODUNITS

SET 2UNITS

SELECTUNITS

RETURN

UNITS SELECTIONReady


16:16

0070

Parameters

WBCRBCHGBHCTRDWPLTPCT

USA SI SI MOD

K/µLM/µLg/dL%%K/µL%

SET 1

G/LT/Lg/LL/L%CVG/LmL/L

10e9/L10e12/Lmmol/LL/L%CV10e9/LmL/L

10e3/µL10e6/µLg/L%%CV10e3/µL%

rsj

SET 1UNITS

SET 2

10e2/µL10e4/µLg/dL%%10e4/µL%

UNITS

SELECTION




The units selected by each of the soft keys are shown on the screen display in the preceding figure. The following table shows an example of the same sample displayed with each of the four units selections. Refer to Section: Reticulocyte Package, Subsection: Retic Units Selection Softkey for information on reticulocyte units.

*NEU, LYM, MONO, EOS, and BASO are reported in the same units as the WBC.**Report Unit is Geometric Standard Deviation.***Clinical significance has not been established for these parameters. Therefore, they are not

reportable in the US.

Procedure: Units Selection1. From the SET UP MENU screen, press the [UNITS SELECTION]

key.

2. Choose one of the following options:

• Press the appropriate soft key to select the desired units. The group of selected units is highlighted on the screen.

• For individual unit selection, use the arrow keys on the keyboard to move the cursor to the desired units.

3. Press the [SELECT UNITS] key to enter the selection. The chosen selection is highlighted on the display.

4. Use the arrow keys on the keyboard to move the cursor to the next unit to be selected.

5. Repeat steps 3 and 4 until all selections have been made.

Table 5.1: Report Units

Parameter

USA SI SI MOD SET 1 SET 2

Value Units Value Units Value Units Value Units Value Units

WBC* 5.32 K/µL 5.32 G/L 5.32 10e9/L 5.32 10e3/µL 53.2 10e2/µL

RBC 5.15 M/µL 5.15 T/L 5.15 10e12/L 5.15 10e6/µL 515. 10e4/µL

HGB 16.2 g/dL 162 g/L 10.1 mmol/L 162 g/L 16.2 g/dL

HCT 47.6 % 0.476 L/L 0.476 L/L 47.6 % 47.6 %

MCV 92.3 fL 92.3 fL 92.3 fL 92.3 fL 92.3 fL

MCH 31.5 pg 31.5 pg 1.96 fmol 31.5 pg 31.5 pg

MCHC 34.1 g/dL 341 g/L 21.2 mmol/L 341 g/L 34.1 g/dL

RDW 12.5 % 12.5 %CV 12.5 %CV 12.5 %CV 12.5 %

PLT 323 K/µL 323 G/L 323 10e9/L 323 10e3/µL 32.3 10e4/µL

MPV 8.26 fL 8.26 fL 8.26 fL 8.26 fL 8.26 fL

PCT*** 0.267 % 2.67 mL/L 2.67 mL/L 0.267 % 0.267 %

PDW**, *** 17.5 10GSD 17.5 10GSD 17.5 10GSD 17.5 10GSD 17.5 10GSD



6. To obtain a printout of the selected units, press the Print Screen key on the keyboard.


Customize Report Soft KeyThe [CUSTOMIZE REPORT] key on the SET UP MENU screen is used to customize the displayed and printed reports. From this screen, the parameters and graphs to be displayed on reports can be selected, the header can be customized, and the type of printout can be selected.

When the [CUSTOMIZE REPORT] key is pressed, one of three possible screens will be displayed (whichever one was used last). The three possible screens are the CUSTOMIZE DISPLAYED REPORT screen, the CUSTOMIZE PRINTED REPORT screen, and the CUSTOMIZE PRINTOUT HEADER screen. (See the following flowchart.)

Each one of these three possible screens displays two of the following three soft key labels:

CUSTOMIZE DISPLAY CUSTOMIZE PRINTOUTCUSTOMIZE HEADER

Each of these three screens is explained individually on the following pages.

NOTE: The [CUSTOMIZE REPORT] key can also be accessed from the RUN screen and the DISPLAY SPECIMEN screen in the Data Log.

CUSTOMIZE

REPORT

CUSTOMIZE REPORT

SET UP MENUReady

RESTORE HEADER

BLANK HEADER

CUSTOMIZE DISPLAY

SET UPPRINTOUTCUSTOMIZE


PARAM SET 1

PARAM SET 2


CUSTOMIZE SET UPSELECTGRAPH SET 4

PARAMHEADER

CUSTOMIZE

PARAM SET 1

PARAM SET 2


CUSTOMIZE SET UPPLACEGRAPH SET 4

PARAMGRAPHCANCEL


TICKETPRINTER

STOP PRINTING

CUSTOMIZE DISPLAY

CANCELSTOP

CONFIRMSTOP

TOGGLE ON/OFF

SET UPCUSTOMIZEHEADER


RESTORE HEADER

PRE-PRNTD TICKET PRINTER

GRAPHICS

BLANKTICKET


9140320C — November 2000


Customize Displayed Report

Figure 5.21: Customize Displayed Report Screen

The CUSTOMIZE DISPLAYED REPORT screen (see the preceding figure) for the indicated parameter set will be displayed when the [CUSTOMIZE DISPLAY] key is pressed. The following soft key labels are displayed on the CUSTOMIZE DISPLAYED REPORT screen:

PARAM SET 1*PARAM SET 2*PARAM SET 3*PARAM SET 4*CUSTOMIZE PRINTOUTCUSTOMIZE HEADER orCANCEL GRAPH (This key label alternates between

these two selections when the [SELECT GRAPH] key is pressed.)

SELECT GRAPH or PLACE GRAPH or TOGGLE PARAMETER (This key label alternates between

these three selections when the softkey is pressed.)

SET UP*The soft key label for the parameter set currently displayed on the screen is not shown.

PARAMSET 2

PARAMSET 3

PARAMSET 4

CUSTOMIZEPRINTOUT

CUSTOMIZEHEADER

SELECTGRAPH

SET UP



16:57SH0630

ON WBCON NEU ON %NON LYM ON %LON MONO ON %MON EOS ON %EON BASO ON %B

ON RBCON HGBON HCTON MCVON MCHON MCHCON RDW

ON PLTON MPV

PARAMETER SET 1 SELECTED

Size-Cmp (0-10)Grn-Lob (90D-90)10 deg-90 deg0 deg-90 deg10 deg-90 deg D0 deg-90 deg D

N-L-M HistogramM-P Histogram

RBC HistogramPLT HistogramWIC HistogramEmpty

Size-Cmp (0-10) Grn-Lob (90D-90)

RBC Histogram PLT Histogram

Auto-Sampler Busy

CUSTOMIZE

DISPLAY



Using the [PARAM SET “X”] key, the display can be customized for four different sets of parameters. Up to 20 individual parameters and up to four scatterplots and/or histograms can be displayed in each set. (The “empty” selection may be used to “blank” the scatterplot or histogram display at the selected position.) Individual parameters are listed in the left portion of the screen, and the scatterplots and histograms are listed in the right portion.

Procedure: Customize Display1. From the SET UP MENU screen, press the [CUSTOMIZE REPORT]

key and if necessary, press the [CUSTOMIZE DISPLAY] key to display a parameter set.

2. If desired, press the [PARAM SET “X”] key to select a different parameter set.

3. Use the arrow keys on the keyboard to move the cursor to the desired parameter in the list displayed in the left portion of the screen.

4. Press the [TOGGLE PARAMETER] key to turn the display OFF or ON and advance the cursor to the next parameter. The cursor moves through the entire list of parameters in this portion of the screen and, when at the bottom, returns to the top of this list.

NOTE: The [TOGGLE PARAMETER] key is displayed only when the cursor is positioned in the list of individual parameters displayed in this portion of the screen.

5. When all parameter selections have been made, move the cursor to the top of the parameter list and use the arrow keys on the keyboard to move the cursor to the desired scatterplot or histogram listed on the left side of this portion of the screen.

6. Press the [SELECT GRAPH] key to select it. The scatterplot or histogram name is highlighted and the cursor moves to a display position. The key label changes to [PLACE GRAPH] and the [CANCEL GRAPH] key is displayed.

7. If necessary, use the arrow keys on the keyboard to move the cursor to the desired display position.

8. Press the [PLACE GRAPH] key to display the selection at the indicated position.

9. The cursor moves through the entire list of scatterplots and histograms. Repeat steps 3–8 until all selections have been made for the current Parameter Set.

PARAM

SET “X”


9140320C — November 2000


10. To obtain a printout of the selected Parameter Set, press the Print Screen key on the keyboard.

11. To select another Parameter set, press the [PARAM SET “X”] key. To customize the display for it, repeat steps 3–10.

12. Press the [SET UP] key to return to the SET UP MENU screen.

Customize Printed ReportThe CUSTOMIZE PRINTED REPORT screen will be displayed when the [CUSTOMIZE PRINTOUT] key is pressed. This screen is used to customize the printout for the Graphics Printer or the Ticket Printer. The following soft key labels are displayed when the [CUSTOMIZE PRINTOUT] key is pressed:

GRAPHICS PRINTER or TICKET PRINTER (This key label alternates

between these two selections when the soft key is pressed.)

CUSTOMIZE DISPLAYSTOP PRINTINGCUSTOMIZE HEADERTOGGLE ON/OFFSET UP

When the [TICKET PRINTER] key is pressed, the key label changes to [GRAPHICS PRINTER] and the following soft key labels are also displayed:

BLANK TICKET or PRE-PRNTD TICKET (This key label alternates

between these two selections when the soft key is pressed.)

RESTORE HEADER (This key label appears only when the [BLANK TICKET] key is selected.)

When the [CUSTOMIZE PRINTOUT] key is pressed, the screen that was used for the last entry is displayed. A brief description of the function of the soft keys is given in this section. For ease of explanation, the keys are grouped according to the type of printer selected. This section contains the following subsections:

• General Purpose Soft Keys

• Ticket Printer Soft Keys

• Graphics Printer Soft Keys

CUSTOMIZE

PRINTOUT



General Purpose Soft KeysThe [CUSTOMIZE DISPLAY] key is used to switch to the CUSTOMIZE DISPLAYED REPORT screen (discussed in the preceding section).

The [STOP PRINTING] key is used to stop printing that is in progress. When the [STOP PRINTING] key is pressed, the following soft key labels are displayed:

CONFIRM STOPCANCEL STOP

These keys confirm or cancel the Stop Printing command. If the [CONFIRM STOP] key is pressed, the print buffer (the memory area where the material is stored while awaiting printing) is cleared and the bulletin line displays the following message: PRINTING STOPPED. RESET PAPER TO THE TOP OF THE PAGE.

The [CUSTOMIZE HEADER] key is used to move to the CUSTOMIZE PRINTOUT HEADER screen (discussed in the following section).

The [TOGGLE ON/OFF] key enables or disables the option selected by the position of the cursor. The key label is not displayed when a numeric entry is required.

The [SET UP] key is used to return to the SET UP MENU screen.

Ticket Printer Soft KeysTwo options are available when the [TICKET PRINTER] key is pressed:

BLANK TICKET or PRE-PRNTD TICKET (This key label alternates between


The [PRE-PRNTD TICKET] key is used to customize the printed report for a preprinted ticket. The [BLANK TICKET] key is used to customize the printed report for a blank ticket.

CUSTOMIZE

DISPLAY

STOP

PRINTING

CUSTOMIZE

HEADER

TOGGLE

ON/OFF

SET UP

TICKET

PRINTER

BLANK

TICKET

PRE-PRINTD

TICKET


9140320C — November 2000


Pre-Printed Ticket Soft Key

Figure 5.22: Customize Printed Report Screen for Pre-Printed Tickets

The [PRE-PRNTD TICKET] key is used to display the CUSTOMIZE PRINTED REPORT screen for preprinted tickets. The numbers on the screen shown in the preceding figure correspond to the following numbered options:

1. TICKET PRINTER — PRE-PRINTED TICKET

When this option is enabled, the Ticket Printer is configured for a preprinted ticket. (The blank ticket option is automatically turned OFF.)

2. AUTO-PRINT results for ALERTED specimens

When this option is enabled, results for flagged specimens are automatically printed as tickets are inserted in the printer. Flagged results are marked with an asterisk (*).

3. AUTO-PRINT results for NON-ALERTED specimens

When this option is enabled, results for specimens that are not flagged are automatically printed as tickets are inserted in the printer.

BLANKTICKET

GRAPHICSPRINTER

CUSTOMIZEDISPLAY

STOPPRINTING

CUSTOMIZEHEADER

TOGGLEON/OFF

SET UP



08:58sh0630

OFF

OFFOFFOFF

TICKET PRINTER - PRE-PRINTED TICKET

AUTO-PRINT results for ALERTED specimensAUTO-PRINT results for NON-ALERTED specimensPrint PCT, PDW results

1

234

PRE-PRINTD

TICKET



4. Print PCT, PDW results

When this option is enabled, the PCT and PDW are printed on the ticket.

NOTE: Clinical significance has not been established for these parameters. Therefore, they are not reportable.

Procedure: Customize Pre-Printed Ticket1. From the CUSTOMIZE PRINTED REPORT screen, if necessary,

press the [PRE-PRNTD TICKET] key to display the CUSTOMIZE PRINTED REPORT screen for the Ticket Printer using preprinted tickets.

2. Use the arrow keys on the keyboard to move the cursor to the desired option.

3. Press the [TOGGLE ON/OFF] key to enable or disable the selected option.


5. To obtain a printout of the selections, press the Print Screen key on the keyboard.


NOTE: When the preprinted ticket is selected the blank ticket is automatically turned off, and vice versa. Both cannot be on at the same time.


9140320C — November 2000


Blank Ticket Soft Key

Figure 5.23: Customize Printed Report Screen for Blank Tickets

The [BLANK TICKET] key is used to display the CUSTOMIZE PRINTED REPORT screen for blank tickets. The numbers on the screen shown in the preceding figure correspond to the following numbered options:

1. TICKET PRINTER — BLANK TICKET

When this option is enabled, the Ticket Printer is configured for a blank ticket. (The preprinted ticket option is automatically turned OFF.)


When this option is enabled, a ticket is automatically printed for any sample with flagged results. Flagged results are indicated by the letters “AL” (for alert) on the printout when the Print Specific Alerts option is turned OFF (see number 6 below). Results that fall outside of Patient Limits are underlined on the printout.


When this option is enabled, a report is automatically printed for any sample without flagged results.

RESTOREHEADER

PRE-PRNTDTICKET

GRAPHICSPRINTER

CUSTOMIZEDISPLAY

STOPPRINTING

CUSTOMIZEHEADER

TOGGLEON/OFF

SET UP



08:57sh0630

ON

OFFOFFOFFOFFOFFOFFOFF682

TICKET PRINTER - BLANK TICKET

AUTO-PRINT results for ALERTED specimensAUTO-PRINT results for NON-ALERTED specimensPrint PCT, PDW resultsPrint Limits ReportPrint Specific AlertsPrint Manual Differential Grid for ALERTED specimensPrint Manual Differential Grid for NON-ALERTED specimensLine-feeds per page for ticket printer (1 to 99)Number of lines for the customize ticket header (0 to 2)

. . . . . . . . . 1 . . . . . . . . . .2 . . . . . . . . . . 3. . . . . . . . . . . . .

1

23456789

10

BLANK

TICKET



4. Print PCT, PDW Results

When this option is enabled, the results for PCT and PDW are printed on the report.


5. Print Limits Report

When this option is enabled, the Patient Limits Set that was applied to the results is printed on the report.

6. Print Specific Alerts

When this option is enabled, the specific flag (BAND, LRI, etc.) replaces the “AL” on the printout.

7. Print Manual Differential Grid for ALERTED specimens

When this option is enabled, a grid that can be used to report a manual differential is printed on the report for any specimen that is flagged.

8. Print Manual Differential Grid for NON-ALERTED specimens

When this option is enabled, a grid that can be used to report a manual differential is printed on the report for any specimen that is not flagged.

9. Line-feeds per page for ticket printer (1 to 99)

This option is used to select the size of the printed report. (A blank ticket typically has 68 lines.)

10. Number of lines for the customize ticket header (0 to 2)

This option is used to select the number of lines for the header on the blank ticket. The numbers across the top of the header can be used to center the header information on the ticket. Centering the information under the number 2 centers it on the ticket.

Procedure: Customize Blank Ticket1. From the CUSTOMIZE PRINTED REPORT screen, if necessary,

press the [BLANK TICKET] key or the [TICKET PRINTER] key to display the CUSTOMIZE PRINTED REPORT screen for the blank tickets.


9140320C — November 2000


2. Use the arrow keys on the keyboard to move the cursor to the desired selection.

3. Press the [TOGGLE ON/OFF] key to enable or disable the selection.


5. A numeric entry is required for the <Line-feeds per page for ticket printer> entry field (a blank ticket typically has 68 lines) and for the <Number of lines for the customize ticket header> entry field.

6. Type the desired number of line-feeds in the entry field and press the Enter key on the keyboard to save the entry and advance the cursor.

7. Type the desired number of lines for the header and press the Enter key on the keyboard to save the entry and advance the cursor.

8. Type the first line of the header and press the Enter key on the keyboard to save the entry and advance the cursor. Each line holds 35 characters. If desired, type a second line and press the Enter key on the keyboard to save the entry and advance the cursor.





Graphics Printer Soft Keys

Figure 5.24: Customize Printed Report Screen for the Graphics Printer

The [GRAPHICS PRINTER] key is used to display the CUSTOMIZE PRINTED REPORT screen for the Graphics Printer. The numbers on the CUSTOMIZE PRINTED REPORT screen shown in the preceding figure correspond to the following numbered options:


When this option is enabled, a report is automatically printed for any sample with flagged results.


When this option is enabled, a report is automatically printed for any sample without flagged results.

3. Print graphs for ALERTED specimens only

When this option is enabled, scatterplots and histograms are printed only for samples with flagged results.

4. Print PCT, PDW results

When this option is enabled, the results for PCT and PDW are printed on the report.


TICKETPRINTER

CUSTOMIZEDISPLAY

STOPPRINTING

CUSTOMIZEHEADER

TOGGLEON/OFF

SET UP



16:58sh0630

OFFOFFOFFOFFONONOFFOFFOFFOFF66OFF

AUTO-PRINT results for ALERTED specimensAUTO-PRINT results for NON-ALERTED specimensPrint graphs for ALERTED specimens onlyPrint PCT, PDW resultsPrint X-B RBC Program statusPrint X-B WBC Program statusPrint Interpretive ReportPrint Limits ReportPrint Manual Differential Grid for ALERTED specimensPrint Manual Differential Grid for NON-ALERTED specimensLine-feeds per page for graphics printer (1 to 99)Color Printing

GRAPHICS PRINTER

123456789

1110

12

GRAPHICS

PRINTER


9140320C — November 2000


5. Print X-B RBC Program status

When this option is enabled, the status of the X-B RBC program is printed on the report. The X-B RBC status (for example, X-B RBC: 13/OUT2) is printed at the top of the page.

6. Print X-B WBC Program status

When this option is enabled, the status of the X-B WBC program is printed on the report. The X-B WBC status (for example, X-B WBC: 13/OUT2) is printed at the top of the page.

7. Print Interpretive Report

When this option is enabled, the Interpretive Report messages are printed on the report. These messages are generated when results exceed the Patient Limits and/or instrument-generated flags are present. For an explanation of the Interpretive Report messages, refer to Chapter 3: Principles of Operation, Subsection: Operational Messages and Data Flagging. (Also see the [PATIENT LIMITS] key discussion earlier in this section.)

8. Print Limits Report

When this option is enabled, the Patient Limits Set that was applied to the results is printed on the report.

9. Print Manual Differential Grid for ALERTED specimens

When this option is enabled, a grid that can be used to report a manual Differential is printed on the report for any specimen that is flagged.

10. Print Manual Differential Grid for NON-ALERTED specimens

When this option is enabled, a grid that can be used to report a manual Differential is printed on the report for any specimen that is not flagged.

11. Line-feeds per page for graphics printer (1 to 99)

This option is used to select the size of the printed report. The line-feeds should be 66 lines for 8 ½” x 11” paper.

12. Color printing

When this option is enabled, a color printout can be obtained on the CELL-DYN 3700 System by pressing the [COLOR PRINT] key. It is not possible to automatically obtain color printouts.



Procedure: Customize Graphics Report1. From the CUSTOMIZE PRINTED REPORT screen, if necessary,

press the [GRAPHICS PRINTER] key to display the CUSTOMIZE PRINTED REPORT screen for the Graphics Printer. (See the preceding figure.)

2. Use the arrow keys on the keyboard to move the cursor to the desired selection.

3. Press the [TOGGLE ON/OFF] key to enable or disable the selection.


5. A numeric entry is required for the <LINE-FEEDS PER PAGE FOR GRAPHICS PRINTER> entry field. Type the desired number of line-feeds in the entry field and press the Enter key on the keyboard to save the entry and advance the cursor. (An 8.5" x 11" sheet of paper has 66 lines per page.)


7. If desired, press the [SET UP] key to return to the SET UP MENU screen, or continue with the following procedure for customizing the header, Customize Printout Header.


9140320C — November 2000


Customize Printout Header

Figure 5.25: Customize Printout Header Screen for the Graphics Report

The CUSTOMIZE PRINTOUT HEADER screen is displayed when the [CUSTOMIZE HEADER] key is pressed. (See the preceding figure.) This screen is used to customize the printout header for the graphics report. Any report printed in a graphics format will be printed with this header. The following soft key labels are displayed on the CUSTOMIZE PRINTOUT HEADER screen:

RESTORE HEADERBLANK HEADERCUSTOMIZE DISPLAYCUSTOMIZE PRINTOUTSET UP

The [BLANK HEADER] key is used to erase the current header.

RESTOREHEADER

BLANKHEADER

CUSTOMIZEDISPLAY

CUSTOMIZEPRINTOUT

SET UP



16:58sh0630

Please enter the number of lines for the customize header (0..4) : 0Print current Date/Time and Software Version : OFF. . . . . . . 1. . . . . . . . 2 . . . . . . . . . 3 . . . . . . . . 4 . . . . . . . . 5 . . . . . . . . 6 . . . . . . . . 7 . . . .

CUSTOMIZE

HEADER

BLANK

HEADER



The [RESTORE HEADER] key is used to restore the header to the previous entry. This key is only functional immediately after a new header has been entered. Once a new header is entered and the CUSTOMIZE PRINTOUT HEADER screen has been exited, the previous header is removed from the memory.

The [CUSTOMIZE DISPLAY] key is used to switch to the CUSTOMIZE DISPLAYED REPORT screen (discussed in the preceding section).

The [CUSTOMIZE PRINTOUT] key is used to switch to the CUSTOMIZE PRINTED REPORT screen (discussed in the preceding section).

The [SET UP] key is used return to the SET UP MENU screen.

Procedure: Customize Graphics Header1. From any CUSTOMIZE PRINTED REPORT screen, press the

[CUSTOMIZE HEADER] key to display the CUSTOMIZE PRINTOUT HEADER screen.

2. Type the desired number of lines for the header in the indicated field. The header can include up to four lines.

3. Press the Enter key on the keyboard to save the entry and advance the cursor to the next entry field.

4. Press the [TOGGLE ON/OFF] key to enable or disable the Print Current Date/Time and Software Version option and advance the cursor to the next entry field.

5. Type the information to be displayed on the first line of the header. Each line holds 77 characters. (Existing information may be typed over, or an existing header may be deleted by pressing the [BLANK HEADER] key.)

NOTE: The numbers displayed above the header box on the screen indicate the position of the header on the printed page. For example, centering the header information under the number 4 centers the header on the page.

6. Press the Enter key on the keyboard to save the entry and advance the cursor to the next entry field.

7. Repeat steps 5 and 6 for each line of the header.


RESTORE

HEADER

CUSTOMIZE

DISPLAY

CUSTOMIZE

PRINTOUT

SET UP


9140320C — November 2000


NOTES


Operating InstructionsChapter 5 Routine Operation

Routine Operation

The routine operation of the CELL-DYN 3700® System proceeds from the RUN screen, which is accessed from the MAIN MENU screen. (See the flowcharts at the beginning of this chapter.) Information and procedures related to the RUN screen and the submenus accessed from it are presented in this section. These include the following:

• A description of the RUN menu and soft keys

• Sample analysis information and procedures

• Daily start up

• Daily QC checks

• Running samples

• Daily shutdown

• How to set up the Work List

• Sample analysis using the Work List

Some of the operating procedures differ between the CELL-DYN 3700SL System and the CELL-DYN 3700CS System. Where the two systems are identical, as in the RUN screen, only one description is presented. Where there are differences, as in the sample analysis and Work List descriptions, a complete description is presented for the CELL-DYN 3700SL System followed by a complete description for the CELL-DYN 3700CS System.

For more detailed information about the Sample Loader and the use of bar codes labels, refer to Chapter 12: Sample Loader and Appendix A: Bar Codes, respectively.


9140320C — November 2000

Operating InstructionsRoutine Operation Chapter 5

Run Menu

Figure 5.26: Run Screen for Patient Samples

The [RUN] key on the MAIN MENU screen is used to display the RUN screen. (See the preceding figure.) The following soft key labels are displayed on the RUN screen:

CLEAR APERTURES or CLEAR FAULT or PRIME (This key label alternates between

these three selections.)WORK LISTSPECIMEN TYPECUSTOMIZE REPORTCHANGE SAMPLER or TOGGLE AUTO ID (This key label alternates between

these two selections.)PRINT TICKETPRINT REPORT or COLOR PRINT (This key label changes to [COLOR

PRINT] when the color printing option is selected.)

MAIN

CLEARAPERTURES

WORKLIST

SPECIMENTYPE

CUSTOMIZEREPORT

CHANGESAMPLER

PRINTTICKET

PRINTREPORT

MAIN

RUNReady


09:02sh0630

Next ID ------------ AutoPatient ----------------Sex(M/F):- DOB:--/--/--Dr ----------------------Param : 1 Limits: 1

WBC K/uLNEU %NLYM %L

MONO %MEOS %E

BASO %B

RBC M/uLHGB g/dLHCT %MCV fLMCH pg

MCHC g/dLRDW %

PLT K/uLMPV fL

Open Sampler

GRANLRTY

SIZE

COMPLEXITY LOBULARITY

PLT RBC

XB RBC: WL:OFF

12345

XB WBC:

RUN



Run ScreensThere are seven possible RUN screens, each customized for one of the following different types of specimen: Patient, QC Specimen, Background, Electrical Background, Latex, Resistant RBC, and Auxiliary. These customized screens are accessed by pressing the [SPECIMEN TYPE] key on each RUN screen and then choosing the desired specimen type.

Specimen Type: PatientThe Patient RUN screen is described, as this is the one most often used by operators. The upper left-hand corner of the RUN screen for patient specimens displays the following data entry fields on lines 1–5 (see the preceding figure):

1. <NEXT ID> Used to enter the ID number for the next specimen to be run. (Up to 12 characters may be entered). If the Auto-Increment feature is active, AUTO is highlighted at the end of the field. Refer to the discussion in the Sample Analysis section for more information about this feature.

2. <PATIENT> Used to enter the patient’s name or identification. (Up to 16 characters may be entered.)

NOTE: If the resistant RBC RUN screen is selected, <RES RBC> will be displayed on this entry field.

3. <SEX (M/F):/DOB: --/--/--> Used to enter the sex and birth date of the patient.

4. <DR> Used to enter the name of the patient’s physician. (Up to 22 characters may be entered.)

XB RBC orXB WBC: If the XB RBC and/or XB WBC

Analysis is enabled, the file status is displayed to the right of the <DR> entry field.

WL: The status (OFF/ON) of the Work List is displayed after the X-B status field.

5. <PARAM:/LIMITS:> Displays the number (1–4) of the Parameter and Limit Sets that will be applied to the sample results.

NOTE: Both Parameter and Limit Sets may be changed after the sample has been run. Refer to the description of the [EDIT SPECIMEN] key given in Using the Data Log within this chapter.


9140320C — November 2000


Figure 5.27: Run Screen for Auxiliary Samples

Specimen Type: AuxiliaryThe upper left-hand corner of the RUN screen for the Auxiliary specimen type displays the following data entry fields on lines 1-5. (See the preceding figure.)

1. <NEXT ID> Used to enter the ID number for the next specimen to be run. (Up to 12 alphanumeric characters may be entered).

2. <AUXILIARY> Indicates that the Auxiliary Specimen Type is selected. If desired, the patient’s name may be entered in this field. (Up to 16 alphanumeric characters may be entered.)

3. <NOTE>* It is suggested that this field be used to identify the parameter(s) that fell outside the linearity limits. (Up to 7 alphanumeric characters may be entered.)

4. <DOB: --/--/--> Used to enter the birth date of the patient.

5. <RSLTS MULTIPLIED BY>* Used to enter the dilution factor used for the specimen run.

CLEARAPERTURES

SPECIMENTYPE

CUSTOMIZEREPORT

PRINTREPORT

MAIN

RUNReady


09:43022547

Next ID ------------ Auxiliary----------------NOTE-------------- DOB:--/--/--Rslts Multiplied by 1.00Param: 1 Limits: 1

WBCNEU %NLYM %L

MONO %MEOS %E

BASO %B


MCHC g/dLRDW %

PLT K/uLMPV fL

Open Sampler

GRANLRTY

SIZE


PLT RBC

WL:OFF

12356

4



6. <PARAM:/LIMITS:> Displays the number (1–4) of the Parameter and Limit Sets that will be applied to the sample results.

* The information in these fields is entered on the AUXILIARY SPECIMEN TYPE screen.

Specimen Type: QC, Background, and LatexIf the QC SPECIMEN, BACKGROUND, ELECTRICL BKGND, or LATEX screens are displayed, the following information is displayed. (See Figures 5.34, 5.35, and 5.36.)

• Type Indicates Background, Electrical Background, or the name of the selected QC file. The number of runs in the QC file and total file space is displayed to the right of the type as in the following example: 31/120.

• Param Set: Indicates the Parameter Set applied to the results.

Status BoxThe Status Box is displayed in the top center of every RUN screen. It contains the following information:

• Menu in use

• The Status of the Analyzer — the Ready, Not Ready and Fault messages are displayed here

• Report or file identity for results currently displayed

The Status Box also displays status and instructive messages during the RUN cycle, such as the following:

Aspirating

Remove specimen

Dispensing

Counting

Extended Count

Rinsing

Ready


9140320C — November 2000


The top right-hand corner of the RUN screen displays the following information:

• Current date and time

• Operator ID — identification of the current operator

• Sequence # — automatically incremented as samples are run

• Work List status — OFF/ON

• Selected sampler mode — Open Sampler or Closed Sampler

The center section of the RUN screen displays the results. A list of the parameters and results is displayed on the left side. Scatterplots and histograms are displayed on the right side. The area between the parameter data and the graphic data is used to display suspect flagging messages and count times. Examples of the count times and some of the suspect flagging messages are shown in the following two figures.

A detailed explanation of all flagging messages is given in Chapter 3: Principles of Operation, Subsection: Operational Messages and Data Flagging, Parameter Flagging Messages.



Figure 5.28: Run Screen Showing Count Times and Flagging Messages

Figure 5.29: Run Screen Showing Flagging Messages, RBC CLOG Message, and RBC Up Time

PLT

CLEARAPERTURES

WORKLIST

SPECIMENTYPE

CUSTOMIZEREPORT

CHANGESAMPLER

PRINTTICKET

PRINTREPORT

MAIN

RUNReady


16:29rcs0843

Next ID ------------ AutoPatient ----------------Sex(M/F):- DOB:--/--/--Dr ----------------------Param: 1 Limits: 1 SUSPECT

WBC 8.34 K/uLNEU 4.97 59.6 %NLYM 2.50 29.9 %L VAR LYM

MONO .551 6.61 %MEOS .208 2.50 %E

BASO .114 1.36 %B DFLT (LM)

RBC 5.69 M/uLHGB 16.1 g/dLHCT 49.3 %MCV 86.7 fLMCH 28.4 pg

MCHC 32.7 g/dLRDW 14.1 %

PLT 360. K/uLMPV 10.4 fL

XBRBC: 13/IN XBWBC: 4/IN WL: OFF

GRANLRTY

SIZE


RBC

WCT:4.45

RCT:6.63

Open Sampler

Auto-Sampler Ready

PLT

CLEARAPERTURES

WORKLIST

SPECIMENTYPE

CUSTOMIZEREPORT

CHANGESAMPLER

PRINTTICKET

PRINTREPORT

MAIN

RUNReady


16:27rcs0842

Next ID ------------ AutoPatient ----------------Sex(M/F):- DOB:--/--/--Dr ----------------------Param: 1 Limits: 1

WBC 7.93 K/uLNEU 4.71 59.4 %NLYM 2.39 30.1 %L

MONO .557 7.03 %MEOS .178 2.25 %E

BASO .092 1.16 %B

RBC M/uLHGB 16.1 g/dLHCT %MCV fLMCH pg

MCHC g/dLRDW % RBC CLOG

PLT K/uLMPV fL


GRANLRTY

SIZE


RBC

WCT: 4.43

RCT: 0.00

Open Sampler

Auto-Sampler Ready

RUT: 8.86


9140320C — November 2000


Figure 5.30: Run Screen Showing Bulletin Line Message

Bulletin LineThe Bulletin Line is displayed immediately above the soft key labels. Messages appear in this line to identify status or fault conditions. An example of a Bulletin Line message (Auto-Sampler Pause) is shown in the preceding figure.

Run Screen Soft KeysA brief description of the function of each key displayed on the PATIENT RUN screen is given in this section. Instructions for using these keys to run samples and use the Work List are given later in the Sample Analysis sections of this chapter.

PLT

CLEARAPERTURES

WORKLIST

SPECIMENTYPE

CUSTOMIZEREPORT

CHANGESAMPLER

PRINTTICKET

PRINTREPORT

MAIN

RUNReady Dec 21 1998


16:29rcs0843

Next ID ------------ AutoPatient ----------------Sex(M/F):- DOB:--/--/--Dr ----------------------Param: 1 Limits: 1 SUSPECT

WBC 8.34 K/uLNEU 4.97 59.6 %NLYM 2.50 29.9 %L VAR LYM

MONO .551 6.61 %MEOS .208 2.50 %E






GRANLRTY

SIZE


RBC

WCT:4.45

RCT:6.63

Open Sampler

Auto-Sampler Pause

Report for XXX



Clear Apertures/Clear Fault/Prime Soft KeysThe [CLEAR APERTURES] key is used to initiate a special cleaning sequence that flushes the WIC and RBC/PLT Apertures to remove obstructions. The sequence takes approximately 35 seconds. When the [CLEAR APERTURES] key is pressed, the message CLEARING APERTURES is displayed in the Status Box.

The [CLEAR APERTURES] key label changes to [CLEAR FAULT] whenever a system fault occurs (for example, Diluent Empty). This key is used to clear the fault message and return the Analyzer to the Ready status after corrective action has been taken.

NOTE: A message describing the fault appears in the Bulletin Line. A list of fault conditions and corrective action is given in Chapter 10: Troubleshooting.

When the system enters the Standby state while the RUN screen is displayed, the [CLEAR APERTURES/CLEAR FAULT] key label will change to the [PRIME] key label. Pressing the [PRIME] key primes the system and brings it to the Ready state.

Work List Soft Key

Figure 5.31: Work List Screen

CLEAR

APERTURES

CLEAR

FAULT

PRIME

WORK LISTON

BAR CODEOFF

INSERT/DELETE

DELETEALL

PURGECOMPLETED

WORK LISTSET UP

PRINTWORK LIST

RETURN

WORK LISTReady


09:48sh0630

#

1

4DIG SPECIMEN SPECIMEN

Work List OFF

BC ID NAMEL P S RACK/

1 1

BAR CODE ON

TUBEDOCTOR DATE OF

BIRTH

--/--/--


9140320C — November 2000


The [WORK LIST] key is used to display the WORK LIST screen (see the preceding figure). The following soft key labels are displayed on the WORK LIST screen:

WORK LIST ON or WORK LIST OFF (This key label alternates between

these two selections.)BAR CODE ON or BAR CODE OFF (This key label alternates between

these two selections.)INSERT/DELETEDELETE ALLPURGE COMPLETEDWORK LIST SET UPPRINT WORK LISTRETURN

These keys are used to create the Work List, which is used to preassign specimen identification, display, and print criteria for specimens that will be run. It is essentially a list of specimens (including the preassigned information) that the operator intends to run on the instrument. The Work List may be used with or without bar code labels on the tubes. The functions of the Work List keys are described in Routine Operation, Using the Work List within this chapter.

WORK

LIST



Specimen Type Soft Key

Figure 5.32: Specimen Type Screen

The [SPECIMEN TYPE] key on the RUN screen is used to select the type of specimen that will be run. (See the preceding figure.) When the [SPECIMEN TYPE] key is pressed, the screen displays a list of the QC files and the following soft key labels:

PATIENTQC SPECIMENBACKGROUNDELECTRICL BACKGRNDLATEXRESISTANT RBCAUXILIARYRETURN

The function of each key is discussed in the following section.

PATIENT QCSPECIMEN

BACK-GROUND

ELECTRICLBACKGRND

LATEX RESISTANTRBC

AUXILIARY RETURN

SPECIMEN TYPEReady


09:55sh0630

1.2.3.4.5.6.7.8.9.

10.

File Name

Press QC SPECIMEN key to select QC FILE at cursor position.

LowNormalHighlownormalhighReplicateFILE 8FILE 9FILE 10

111300000000

# Specimens

11.12.13.14.15.16.17.18.19.20.

File Name

PatientFile 12FILE 13FILE 14FILE 15FILE 16FILE 17LOW 11NORMAL 11HIGH 11

30000000000

# Specimens

SPECIMEN

TYPE


9140320C — November 2000


Patient Soft Key

Figure 5.33: Run Screen for Patient Samples

The [PATIENT] key on the SPECIMEN TYPE screen is used to display the RUN screen for patient samples. (See the preceding figure.) Patient identification and demographics may be entered on the RUN screen after this key is pressed. Results from this run option are stored in the Data Log.

CLEARAPERTURES

WORKLIST

SPECIMENTYPE

CUSTOMIZEREPORT

CHANGESAMPLER

PRINTTICKET

PRINTREPORT

MAIN



16:30sh0630

Next ID ------------ AutoPatient ----------------Sex(M/F):-DOB:--/--/--Dr ----------------------Param: 1 Limits: 1


MONO %MEOS %E

BASO %B


MCHC g/dLRDW %

PLT K/uLMPV fL

GRANLRTY

SIZE


PLT RBC

Closed SamplerXBRBC: 13/IN XBWBC: 4/IN WL: OFF

Auto-Sampler Ready

WCT:

RCT:

PATIENT



QC Specimen Soft Key

Figure 5.34: Run Screen for a QC File

The [QC SPECIMEN] key on the SPECIMEN TYPE screen is used to select a QC file designated by the position of the cursor on the screen. After the cursor is moved to the desired file, the [QC SPECIMEN] key is pressed to display the RUN screen for the selected file. (See the preceding figure.) Results from this run option are stored in the selected file and in the Data Log.

NOTE: The selected QC file is identified on the same line as the <Patient> entry field. It will also be identified in the Status Box after the specimen has been run.

RUNReady


09:52sh0630

Type Low 11/120Param Set: 1


MONO %MEOS %E

BASO %B


MCHC g/dLRDW %

PLT K/uLMPV fL

WL:OFF

GRANLRTY

SIZE


PLT RBC

CLEARAPERTURES

WORKLIST

SPECIMENTYPE

CUSTOMIZEREPORT

CHANGESAMPLER

PRINTTICKET

PRINTREPORT

MAIN

WCT:

RCT:

Open Sampler

QC

SPECIMEN


9140320C — November 2000


Background Soft Key

Figure 5.35: Run Screen for Background Counts

The [BACKGROUND] key on the SPECIMEN TYPE screen is used to display the RUN screen for background counts. (See the preceding figure.) Results from this run option are identified by the designation BACKGROUND in the Data Log and are automatically excluded from the X-B Analysis.

RUNReady


09:52sh0630

Type BACKGROUNDParam Set: 1


MONO %MEOS %E

BASO %B


MCHC g/dLRDW %

PLT K/uLMPV fL

WL:OFF

GRANLRTY

SIZE


PLT RBC

CLEARAPERTURES

WORKLIST

SPECIMENTYPE

CUSTOMIZEREPORT

CHANGESAMPLER

PRINTTICKET

PRINTREPORT

MAIN

WCT:

RCT:

Open Sampler

BACK-

GROUND



Electrical Background Soft Key

Figure 5.36: Run Screen for Electrical Background Counts

The [ELECTRICL BACKGRND] key on the SPECIMEN TYPE screen is used to select the run mode for electrical background counts. (See the preceding figure.) Electrical backgrounds are used to check for electrical interference in the system. (Aperture current is turned OFF during this cycle.) Results from this run option are identified by the designation ELEC BKGND in the Data Log and are automatically excluded from the X-B Analysis.

Latex Soft KeyThe [LATEX] key is used to select the Run mode for polystyrene microspheres. This key is used by Abbott service personnel. (No screen shown.)

RUNReady


09:52sh0630

Type ELEC BKGNDParam Set: 1


MONO %MEOS %E

BASO %B


MCHC g/dLRDW %

PLT K/uLMPV fL

WL:OFF

GRANLRTY

SIZE


PLT RBC

CLEARAPERTURES

WORKLIST

SPECIMENTYPE

CUSTOMIZEREPORT

CHANGESAMPLER

PRINTTICKET

PRINTREPORT

MAIN

WCT:

RCT:

Open Sampler

ELECTRICL

BACKGRND

LATEX


9140320C — November 2000


Resistant RBC Soft Key

Figure 5.37: Run Screen for Resistant RBC Specimen Type

The [RESISTANT RBC] key is used to select the Resistant RBC mode. This mode is used to process specimens containing RBCs that are lyse resistant. The sample is held in the WOC Mixing Chamber for approximately 15 seconds longer than the normal mixing time. The extra time enhances the osmotic lysing effect of the Sheath Reagent and reduces interference from the lyse-resistant RBCs. (The interference caused by these RBCs frequently generates WBC and Differential flags. The Resistant RBC cycle reduces the number of WBC and Differential flags generated.)

This key is available only when the Open Mode is selected.

Procedure: Resistant RBC1. If necessary, from the RUN screen, press the

[CHANGE SAMPLER] key to select the Open Mode.

2. Press the [SPECIMEN TYPE] key followed by the [RESISTANT RBC] key to select the Resistant RBC cycle.

3. Enter the appropriate patient ID information on the line labeled <RES RBC:>.

4. Run the sample in the Open Mode.

5. When the cycle is complete, press the [SPECIMEN TYPE] key followed by the [PATIENT] key to return to the normal run cycle.

RUNReady


09:52022547

Next ID _ _ _ _ _ _ _ _ AutoResRBCSex (M/F): _ DOB: - -/- -/- -Dr: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Param : 1 Limits: 1

WBCNEU %NLYM %L

MONO %MEOS %E

BASO %B


MCHC g/dLRDW %

PLT K/uLMPV fL

WL:OFF

GRANLRTY

SIZE


PLT RBC

CLEARAPERTURES

WORKLIST

SPECIMENTYPE

CUSTOMIZEREPORT

CHANGESAMPLER

PRINTTICKET

PRINTREPORT

MAIN

Open SamplerXBRBC: 1/IN XBWBC: 0/IN

RESISTANT

RBC



Auxiliary Soft KeyThe [AUXILIARY] key on the SPECIMEN TYPE screen is used to select the Auxiliary Specimen Type, which allows the operator to run a diluted specimen. This Specimen Type is used to process samples that exceed the instrument linearity limit and require dilution. The Auxiliary Specimen Type allows the operator to enter the dilution factor and will automatically calculate the result based on the dilution factor that was entered.

NOTE: The [AUXILIARY] key is available only in the Open Mode with the Work List turned OFF.

Figure 5.38: Auxiliary Specimen Type Screen

Procedure: Auxiliary 1. Dilute the specimen with Diluent according to your

laboratory’s procedure.

2. If necessary, from the RUN screen press the [CHANGE SAMPLER] key to select the Open Mode.

3. Press the [SPECIMEN TYPE] key followed by the [AUXILIARY] key to select the Auxiliary Specimen Type.

AUXILIARY

AUXILIARY SPECIMEN TYPEReady


09:421233185

Note: WBC

Diluted sample results multiplied by: 3.00 (1.00 to 99.99)

Warning, during processing in this mode, Sample Sensor checks are not performed for: Incomplete Aspiration.

Press CONFIRM SPECIMEN to select entries and enter Run Menu.Press CANCEL SPECIMEN to cancel entries and return to the Specimen Menu.

CONFIRMSPECIMEN

CANCELSPECIMEN


9140320C — November 2000


4. The AUXILIARY SPECIMEN TYPE screen is displayed (see the preceding figure), and the cursor is positioned in the <NOTE> entry field, which can hold up to 7 characters. It is suggested that this field be used to identify the parameter(s) that exceeded the linearity limits.

5. Press Enter on the keyboard to advance the cursor to the <DILUTION> entry field (the line that reads Diluted sample results multiplied by:).

6. Type the desired dilution factor. (For example, type “3” for a 1:3 dilution, etc.) Press Enter to save the entry.

NOTE: Exercise caution when evaluating HGB results that have been diluted by ratios greater than 1:4.

7. Press the [CONFIRM SPECIMEN] key to save the entries and display the RUN screen for the Auxiliary Specimen Type. (See the following figure.)

8. The dilution factor and the information entered in the <NOTE> entry field on the previous screen are displayed in the upper left-hand corner of the Auxiliary RUN screen. Confirm that these entries were made correctly.

9. Enter the appropriate Patient ID number in the <Next ID> entry field.

10. If desired, the patient name may be entered in the <Auxiliary> entry field.

11. Run the diluted specimen in the Open Mode.

12. When the cycle is complete, the instrument automatically exits from Auxiliary and returns to the patient RUN screen.

13. The corrected results for all parameters (results that have been multiplied by the dilution factor) are displayed.

NOTE: If chevrons (>>>>) are displayed for the parameter that exceeded the linearity, further dilution is required because the result, before it is multiplied by the dilution factor, still exceeds the linearity.

NOTE: Always compare the results and flags displayed in Auxiliary to those obtained in the Patient Run Mode and evaluate the individual flags displayed in both modes as described in Chapter 3: Principles of Operation, Subsection: Operational Messages and Data Flagging.

14. To run another dilution, repeat steps 1-13.



Figure 5.39: Run Screen for the Auxiliary Specimen Type

Customize Report Soft KeyThe [CUSTOMIZE REPORT] key on the RUN screen is discussed earlier in this chapter, in Set Up Instructions, Customize Report Soft Key.

Change Sampler Soft KeyThe [CHANGE SAMPLER] key on the RUN screen is used to select the Open or Closed Mode of operation. When the key is pressed, the mode changes from the one currently selected to the other operating mode. The Status Box displays the messageSELECTING OPEN MODE or SELECTING CLOSED MODE.

When the cursor is positioned on the word AUTO (at the end of the <NEXT ID> entry field), this key label changes to [TOGGLE AUTO ID] and the auto increment feature is enabled (the word AUTO is highlighted) or disabled. Refer to the Sample Analysis section of this chapter for a discussion of the auto increment feature.

RUNReady


09:52sh0630

Next IDAuxiliaryNote DOB:Rslts Multiplied by 3.00Param: Limits:


MONO %MEOS %E

BASO %B


MCHC g/dLRDW %

PLT K/uLMPV fL

WL:OFF

GRANLRTY

SIZE


PLT RBC

CLEARAPERTURES

SPECIMENTYPE

CUSTOMIZEREPORT

PRINTREPORT

MAIN

WCT:

RCT:

Open Sampler

CUSTOMIZE

REPORT

CHANGE

SAMPLER


9140320C — November 2000


Print Ticket Soft KeyThe [PRINT TICKET] key on the RUN screen is used to print a report on a ticket when the Ticket Printer is connected to the Data Station. The report is printed on the type of ticket that is selected from the CUSTOMIZE PRINTED REPORT screen (discussed in Set Up Instructions within this chapter).

Print Report Soft KeyThe [PRINT REPORT] key on the RUN screen is used to print a graphics report when the Graphics Printer is connected to the Data Station. When the Color Graphics Printer is connected to the Data Station and the color printing option (on the CUSTOMIZE PRINTED REPORT screen) is ON, the key label changes to [COLOR PRINT]. (The CUSTOMIZE PRINTED REPORT screen is discussed earlier in this chapter, in Set Up Instructions, Customize Report Soft Key.) A color graphics report is printed when the [COLOR PRINT] key is pressed.

Main Soft KeyThe [MAIN] key is used to return to the MAIN MENU screen.

PRINT

TICKET

PRINT

REPORT

COLOR

PRINT

MAIN



Sample Collection and Handling

AnticoagulantAll performance claims given in this manual were generated from specimens collected in K3EDTA anticoagulant. Specimens collected in Heparin or Sodium Citrate may be run with no adverse effect on the instrument. Certain results can be affected by the use of these anticoagulants. Therefore, each laboratory should develop protocols for handling specimens collected in these anticoagulants.

Specimen StabilityFresh whole blood specimens are recommended. The International Committee for Standardization in Haematology (ICSH) defines a fresh blood specimen as one processed within four hours after collection.1

The hemogram parameters —RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, and MPV— are stable (±5%) for up to 24 hours after collection. The total WBC is stable (±5%) for up to 12 hours after collection. The stability of the total WBC decreases to ±7% at 24 hours after collection.

The WBC Differential parameters — NEU, LYM, MONO, EOS, and BASO — are stable (±10%) for up to 12 hours after collection. An increase in false positive Suspect Population Flags may be seen on samples processed less than 30 minutes after collection time or more than 4 hours after collection time.

Stability studies conducted at Abbott indicate that specimens exhibit increased stability when they are stored at room temperature rather than in a refrigerator.

The stability of capillary specimens collected in microtainers may vary depending on the microtainer manufacturer. Refer to the manufacturer’s package insert for stability claims.

NOTE: Reticulocyte stability is discussed in Chapter 14: Reticulocyte Package.


9140320F — April 2007


Specimen CollectionAll specimens should be collected using proper technique and following the tube manufacturer’s recommendations.

NOTE: For additional information on collecting venous and capillary specimens, refer to CLSI/NCCLS Standards, H3-A52 and H4-A5.3

Specimens that will be run on the Sample Loader must be collected in 13 x 75-mm tubes. The recommended tube is a 13 x 75-mm tube with a HEMOGARD closure that draws 1–3 mL of blood. The specimen volume in this tube ensures proper mixing by the Sample Loader.

A minimum of 180 µL should be collected for capillary specimens. This ensures an adequate amount of blood for the Open Mode aspiration (130 µL).

WARNING: Potential Biohazard. Consider all specimens, controls, calibrators, surfaces, or components that contain or have contacted blood, serum, or other bodily fluid as potentially infectious. Wear gloves, a lab coat, and protective eyewear, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030) or other equivalent biosafety procedures.

Interfering SubstancesIt is important to note that there are commonly occurring interfering substances that can affect the results reported by hematology analyzers. While the CELL-DYN 3700 has been designed to detect and flag many of these substances, it may not always be possible to do so. The following indicates the substances that may interfere with each of the listed parameters.

WBC: Fragile WBCs, neutrophil aggregates, lytic-resistant RBCs, NRBCs, PLT clumps, cryofibrinogen, cryoglobulin, paraproteins

RBC: Elevated WBC count, increased numbers of giant PLTS, auto-agglutination, in vitro hemolysis

HGB: Elevated WBC count, increased plasma substances (triglycerides, bilirubin, in vivo hemolysis), lytic-resistant RBCs.

MCV: elevated WBC count, hyperglycemia, in vitro hemolysis, increased numbers of giant PLTs.

PLT: WBC fragments, in vitro hemolysis, microcytic RBCs, cryofibrinogen, cryoglobulins, PLT clumping, increased numbers of giant PLTs.



Retics: Leukocyte fragments, Howell-Jolly bodies, Heinz bodies, Pappenheimer bodies, basophilic stippling, abnormal RBCs, NRBCs > 200/100 WBC, autoagglutinins, cold agglutinins, platelet clumps, paraproteins, malaria, and babesiosis.

For additional information on interfering substances, refer to the table provided in Appendix C.

For a detailed description of the flags that are generated, refer to Chapter 3: Principles of Operation, Subsection: Operational Messages and Data Flagging.

Sample AnalysisCertain general guidelines should be followed when running samples on either the Sample Loader or the Closed Sampler instruments.

• Samples should not be run until the instrument has been properly started up and daily QC checks have been performed.

• The Ready message must be displayed in the Status Box on the Data Station RUN screen before samples can be analyzed.

• Samples should be well mixed (a rotary mixer is preferred) before they are run in the Open Mode or the Closed Mode on the CELL-DYN 3700CS System. The Sample Loader automatically mixes the samples before aspiration. However, samples must be well mixed before they are placed in the Sample Loader racks.

Operator IDThe operator should enter an Operator ID before running samples. The Operator ID is displayed on all screens and printed on the graphics report and the blank ticket report. It is also retained in the QC Logs and the Data Log.

The operator ID can be entered from the MAIN MENU screen or the CALIBRATION screen. When either screen is selected, the cursor is positioned in the <OPERATOR ID> entry field. Type up to three alphanumeric characters and press the Enter key on the keyboard to save the ID number.

Specimen IdentificationA specimen identification name or number can be entered in the upper left-hand corner of the RUN screen. These entry fields are made available by pressing the [SPECIMEN TYPE] key followed by the [PATIENT] key.

1. A Specimen ID name or number of up to 12 characters can be entered in the <NEXT ID> entry field.


9140320F — April 2007


2. An Auto-Increment feature is available, which automatically increments the Specimen ID number by 1 each time a sample is run. It is selected by moving the cursor to the word AUTO (displayed at the end of the <NEXT ID> entry field). The [CHANGE SAMPLER] key changes to [TOGGLE AUTO ID]. Press the [TOGGLE AUTO ID] key to turn the feature ON or OFF. If the word AUTO is highlighted, the feature is enabled. Enabling this feature automatically increments the ID number after the first entry is made.

NOTE: Up to 12 characters can be entered, but the Auto-Increment feature is limited by the number of characters currently entered. The number changes to zeros when the maximum value is reached. For example, if a three-digit ID number is entered, the number changes from 999 to 000. If a five-digit number is entered, the number changes from 99999 to 00000. Therefore, leading zeros should precede the number to maximize the use of this feature. (For example, 00099.)

3. The remaining patient demographic information may be entered in the other data entry fields at the operator’s discretion.

4. The results of the run will be displayed and printed using Parameter Set 1 and Patient Limit Set 1 if no changes are made in these entry fields. When the results are displayed (but before the next sample is run), other parameter and limit sets can be displayed by moving the cursor to the appropriate field and typing the desired number.

NOTE: When the results have been stored in the Data Log, other parameter and limit sets may be selected by using the [EDIT SPECIMEN] key on the DISPLAY SPECIMEN screen accessed through the DATA LOG screen. For complete instructions, refer to Using the Data Log within this chapter.

Alerts and IndicatorsThis section describes information displayed on the screen as the samples are analyzed and/or when reports are printed.

NOTE: This section does not discuss how to interpret parameter flags, which are displayed after the sample is run. For detailed explanations of each flag, refer to Chapter 3: Principles of Operation. For a complete explanation of metering faults, refer to Chapter 3: Principles of Operation.

• Results that fall outside the range of the selected limit set are displayed in color. Yellow indicates that the result fell below the lower limit, and purple indicates that the result exceeded



the upper limit. These results are underlined on the graphics and blank ticket printouts. They are indicated by an asterisk on pre-printed tickets.

NOTE: Quality Control results that fall at the boundaries of the selected limit set may be colored differently in the QC and Data Logs. This is possible due to differences in numerical rounding between the two logs. The result that will be displayed, printed and reported is the same in both logs and is accurate. Use the color in the data log view to determine whether the results are outside the entered limits.

• Results that exceed a parameter’s linear range are indicated by >>>> in place of the result.

• If a WIC or RBC/PLT metering fault occurs, results are suppressed for the affected parameters and the appropriate CLOG or FLOW ERROR message is displayed. The upper metering time (WUT or RUT) and count time (WCT or RCT) are also displayed. These messages and times are also printed in the graphics report.

• If a WOC Flow Error occurs, results are suppressed for the WBC and Differential, the WOC FLOW ERROR message is displayed on the Bulletin Line, and the WBC scatterplots are displayed in red.

• The message SAMPLING ERROR-INCOMPLETE ASPIRATION is displayed on the Bulletin Line if insufficient sample was detected during aspiration. SAMPLING ERROR is displayed on the screen and “Sampling Err” is printed on the graphics report to the right of the MCHC. The same message is printed to the right of the WBC on the pre-printed ticket and printed above the list of parameters on the blank ticket.

NOTE: The Sample Loader automatically stops if four consecutive incomplete aspirations or metering faults occur. The message AUTO SAMPLER/DATA FAULT is displayed on the Bulletin Line.

NOTE: Sample sensors are automatically disabled during the processing of Auxiliary specimens. Sample sensor checks are not performed for Incomplete Aspiration.

• If a fault condition is detected, the [CLEAR FAULT] key on the RUN screen is displayed and a message appears in the Status Box (for example: DILUENT EMPTY). The word “Fault” on the Analyzer Status Indicator Panel is illuminated in red. The Status Box displays the message FAULT: SEE DIAG or SEE SPECIAL to direct the operator to the DIAGNOSTICS screen or the SPECIAL PROTOCOLS screen for further instructions.

NOTE: After the problem has been corrected, pressing the [CLEAR FAULT] key will allow the instrument to resume operation.


9140320C — November 2000


Instrument Start UpThe Analyzer and Data Station power switches should be left ON at all times. The instrument has been designed to automatically maintain itself when it is idle. If the instrument is idle for five minutes, a cleaning cycle will be automatically initiated. If the instrument is idle for four hours, an automatic Shutdown Cycle will be initiated. The instrument will be placed in the Standby state at the end of the automatic Shutdown Cycle.

Power to the Printer may be left ON or OFF at the operator’s discretion. For complete instructions on Printer operation, refer to Chapter 11: Printers.

Power to the Sample Loader may be left ON or OFF at the operator’s discretion. For complete instructions on Sample Loader operation, refer to Chapter 12: Sample Loader.

A complete procedure for turning the system ON or OFF is given in Chapter 10: Troubleshooting.

Sample Analysis Using the SL Model

Daily Start Up ProcedureThe automatic Start Up Cycle is designed to prime the flow system and check the background counts whenever the Standby or Initialized message appears in the Status Box on the RUN screen. The cycle takes approximately 3.5 minutes and is activated by pressing the [RUN] key or the [PRIME] key. (If the RUN screen is displayed before initialization is complete, the [PRIME] key will be displayed instead of the [CLEAR APERTURES] key.)

Before beginning this procedure, ensure that power to all components is ON. The power to the Analyzer should always be ON.

1. Be sure that the word READY on the Analyzer Status Indicator Panel is illuminated in green and the Ready message is displayed in the Status Box on the RUN screen.

2. If the Status Box on the RUN screen displays Standby or Initialized, press the [RUN] key or the [PRIME] key to initiate the automatic Start Up Cycle.

3. Be sure that all 10 racks are in the Sample Loader Tray (5 on each side) and the Safety Cover is in place.

4. Turn the Sample Loader power switch ON. When the Sample Loader initialization cycle is completed, the indicator on the Sample Loader Start key will blink and the Bulletin Line on the RUN screen will display the message AUTO-SAMPLER READY.



5. When the automatic Start Up Cycle is completed, a background count is automatically performed and the Open Mode is selected.

6. Verify that the background counts are acceptable. If the background counts are unacceptable, repeat the background cycle. If the counts are still unacceptable, troubleshoot accordingly, as directed in Chapter 10: Troubleshooting, Subsection: Troubleshooting Guide.

NOTE: Background counts may be repeated by pressing the Touch Plate.

7. Perform the daily quality control procedures as directed in the following section, Daily Quality Control Procedures.

NOTE: Whenever the CELL-DYN 3700 System has been in standby, before running any control or patient specimen in the Closed Sampler or Sample Loader Mode, it is recommended that a prime specimen be run in the Closed Sampler or Sample Loader Mode first.

Sample Loader Operating Tips1. All Sample Loader tubing must be connected before turning

ON the Sample Loader, initializing it, or changing modes.

2. All samples must be properly mixed before they are placed in the Sample Loader racks.

3. Spaces must be left between tubes with rubber stoppers when they are placed in the Sample Loader Rack. If the tubes are placed side by side, mixing errors will occur because the rubber stoppers will touch each other when the tubes spin.

4. If a tube has multiple labels on it, spin the tube by hand after it is put in a rack to be sure it will spin freely and therefore mix properly. (For labeling requirements, refer to Chapter 12: Sample Loader.)

Daily Quality Control ProceduresQuality control procedures (which confirm calibration) should be performed on a daily basis according to the laboratory’s protocol. Commercial control materials should be properly warmed and mixed according to the manufacturer’s recommendations. Patient controls should be handled according to the laboratory’s protocol.

Open Mode QC Procedure1. From the RUN screen, press the [SPECIMEN TYPE] key.

2. Move the cursor to the desired QC file and press the [QC SPECIMEN] key.


9140320D — June 2003


3. If necessary, press the [CHANGE SAMPLER] key to select the Open Mode.

4. Run the control.

NOTE: For complete instructions on running samples, refer to Running Samples within this chapter (following the QC procedures).

5. Verify that the results are acceptable.

NOTE: Out-of-range results are displayed in color.

6. If the results are unacceptable, repeat the run. If the results are still unacceptable, obtain a new bottle of the control, be sure that it is warmed and mixed properly, and again repeat the run. If the results are still unacceptable, run the other levels of control material. If the results on all levels are unacceptable, troubleshoot accordingly, as directed in Chapter 10: Troubleshooting, Subsection: Troubleshooting Guide.

7. When the control results are acceptable, patient samples may be analyzed.

Closed Mode QCQC samples can be run on the Sample Loader using the “Q Labels,” which are bar code labels that are available for the Sample Loader. Each label is designated Qx, where x indicates the file number. If these labels are placed on the control tubes, the results are automatically transmitted to the file indicated by the label. QC samples can also be run on the Sample Loader without these labels.

NOTE: Be sure the Work List is OFF before beginning these procedures. If necessary, refer to Work List within this chapter for instructions.

Closed Mode QC Procedure with Q Labels1. Label each control tube with the Q Label that indicates the

desired QC file.

2. Be sure that the word READY on the Analyzer Status Indicator Panel is illuminated in green and the Ready message is displayed in the Status Box on the RUN screen.

3. Place the labeled tubes in the Sample Loader End Rack and load the rack in the Sample Loader tray.

4. If necessary, press the [RUN] key to display the RUN screen.

5. If necessary, press the [CHANGE SAMPLER] key to select the Closed Mode.



6. Be sure that all 10 racks (5 on each side) and the Safety Cover are in place and press the Start key on the Sample Loader.

7. The Sample Loader reads the Q Label and transmits the results to the appropriate QC file.

8. When all controls have been run, press the [MAIN] key followed by the [QUALITY CONTROL] key.

9. Use the arrow keys on the keyboard to move the cursor to the desired file.

10. Press the [VIEW QC LOG] key to display the QC log.



12. Repeat steps 8–10 for all controls that were run.

13. If the results are unacceptable, repeat the run. If the results are still unacceptable, obtain a new tube of control, be sure that it is warmed and mixed properly according to the manufacturer’s recommendations, and again repeat the run. If the results are still unacceptable, run the other levels of control material. If the results on all levels are unacceptable, troubleshoot accordingly, as directed in Chapter 10: Troubleshooting, Subsection: Troubleshooting Guide.


Closed Mode QC Procedure without Q LabelsThe operator must manually pause the Sample Loader as directed in this procedure when different levels of controls are run without Q Labels.

NOTE: If all QC data are going to the same file, steps 6–10 may be omitted.

1. From the RUN screen, press the [SPECIMEN TYPE] key.

2. Use the arrow keys on the keyboard to move the cursor to the appropriate QC file and press the [QC SPECIMEN] key.


4. Place the controls in the Sample Loader End Rack in the order in which they are to be run.

NOTE: Leave a space between the control tubes to prevent mixing errors caused by the stoppers touching each other.


9140320C — November 2000


5. Be sure that all 10 racks (5 on each side) and the Safety Cover are in place and press the Start key on the Sample Loader.

6. After the first control is aspirated, press the Pause key on the Sample Loader.

7. After the results are displayed, press the [SPECIMEN TYPE] key.

8. Use the arrow keys on the keyboard to move the cursor to the file for the next control to be run and press the [QC SPECIMEN] key.

9. Press the Start key on the Sample Loader.

10. Repeat steps 6–9 until all levels of controls have been run.

11. When all of the controls have been run, press the [MAIN] key followed by the [QUALITY CONTROL] key.

12. Use the arrow keys on the keyboard to move the cursor to the desired file.

13. Press the [VIEW QC LOG] key to display the QC Log.



15. Repeat steps 11–14 for all levels of controls that were run.

16. If the results are unacceptable, repeat the run. If the results are still unacceptable, obtain a new tube of control, be sure that it is warmed and mixed properly, and again repeat the run. If the results are still unacceptable, run the other levels of control material. If the results on all levels are unacceptable, troubleshoot accordingly, as directed in Chapter 10: Troubleshooting, Subsection: Troubleshooting Guide.


Running SamplesTwo modes of running samples are available with the SL Model:

• Open Mode Analysis

The Open Sampler Mode aspirates the sample from an opened collection tube. OPEN SAMPLER is displayed in the upper right corner of the RUN screen when this mode is selected. The Open Sample Aspiration Probe is available only when this mode is selected.



• Closed Mode Analysis

The Closed Sampler Mode on Sample Loader (SL) instruments aspirates the sample from a closed collection tube that has been placed in a Sample Loader Rack and loaded into the Sample Loader. CLOSED SAMPLER is displayed in the upper right corner of the RUN screen when this mode is selected. The Bulletin Line displays the message AUTO-SAMPLER READY and the Sample Loader Start key indicator blinks when the Sample Loader is ready. The Wash Block moves down to the end of the Open Sample Aspiration Probe when this mode is selected.

NOTE: The last group of samples in a run should be placed in the Sample Loader rack designated as the End Rack, which automatically signals the Analyzer to stop processing. This rack has black dots on the top and a black bar on the left edge.

Open Mode Procedure1. If necessary, from the RUN screen press the

[CHANGE SAMPLER] key to select the Open Mode.

2. Be sure that the word READY is illuminated on the Analyzer Status Indicator Panel and Ready is displayed in the Status Box on the RUN screen.

3. Open the well-mixed specimen tube and immerse the Open Sample Aspiration Probe in the specimen.

4. Press the Touch Plate located behind the probe to start the cycle. The word BUSY on the Analyzer Status Indicator Panel will be illuminated in yellow, and the Status Box on the RUN screen will display messages to indicate the various stages of the cycle.

5. Remove the tube when the beep sounds. The Wash Block will move down the probe and clean it.

6. When the cycle is completed, the Wash Block will move up the probe, the word READY on the Analyzer Status Indicator Panel will be illuminated in green, and the results will be displayed on the RUN screen.

7. If automatic report printing has been specified, a report will be printed according to the options selected during setup. If this has not been specified, a report can be printed by pressing the [PRINT REPORT] key.

NOTE: To obtain a color printout, press the [COLOR PRINT] key. (The color printing option on the CUSTOMIZE PRINTED REPORT screen must be ON.) If automatic report printing has been specified, the reports will be printed in black and white.

8. Repeat this procedure for subsequent samples.


9140320D — June 2003


Closed Mode Procedure1. Be sure that the word READY on the Analyzer Status

Indicator Panel is illuminated in green and Ready is displayed in the Status Box on the RUN screen. The Bulletin Line should display the message AUTO-SAMPLER READY.

2. If necessary, from the RUN screen press the [CHANGE SAMPLER] key to select the Closed Mode.

3. Place the well-mixed specimens in the Sample Loader racks in the order in which they are to be run.

NOTE: The racks and tube positions are identified by the bar code label on the rack and indicated as RxTx. These numbers appear as the Specimen ID number if bar code labels are not used. (If the Work List is used, the Specimen ID number is taken from it. Refer to Work List within this chapter for more information.)

4. Place the racks in the Sample Loader Tray with the slotted side facing the Analyzer.

NOTE: All 10 racks must be in the tray (5 on each side) for the Sample Loader to operate.

5. Put the Sample Loader Safety Cover in place.

NOTE: The Sample Loader will not operate without the Safety Cover.


7. The Sample Loader automatically processes all the samples. Processing stops when the End Rack is finished.

Daily ShutdownIt is not necessary to perform a Daily Shutdown Procedure, as the instrument automatically goes into a Standby state if it has been idle for four hours. If desired, the operator may place the instrument in the Standby state by pressing the [DAILY SHUTDOWN] key on the second SPECIAL PROTOCOLS screen.

NOTE: The instrument should not be turned off unless directed to do so by an authorized Abbott Representative or in case of emergency.

When the key is pressed or when the Automatic Shutdown is initiated, the cycle:

• Rinses the Flow System.

• Sets the timer control that periodically opens all of the solenoid valves to prevent pinched tubing.



Sample Analysis Using the CS Model

Daily Start Up ProcedureThe automatic Start Up Cycle is designed to prime the flow system and check the background counts whenever the Standby or Initialized message appears in the Status Box on the RUN screen. The cycle takes approximately 3.5 minutes and is activated by pressing the [RUN] key or the [PRIME] key. (If the RUN screen is displayed before initialization is complete, the [PRIME] key will be displayed instead of the [CLEAR APERTURES] key.)

Before beginning this procedure, ensure that power to all components is ON. The power to the Analyzer should always be ON.

1. Be sure that the word READY on the Analyzer Status Indicator Panel is illuminated in green.

2. If the Status Box on the RUN screen displays Standby or Initialized, press the [RUN] key or the [PRIME] key to initiate the automatic Start Up Cycle.

3. When the cycle is complete, a background count is automatically performed and the Open Mode is selected.

4. Verify that the background counts are acceptable. If the background counts are unacceptable, repeat the background cycle. If the counts are still unacceptable, troubleshoot accordingly, as directed in Chapter 10: Troubleshooting, Subsection: Troubleshooting Guide.

NOTE: Background counts may be repeated by pressing the Touch Plate.

5. Perform the daily quality control procedure as directed in the following section, Daily Quality Control Procedure.

NOTE: Whenever the CELL-DYN 3700 System has been in standby, before running any control or patient specimen in the Closed Sampler or Sample Loader Mode, it is recommended that a prime specimen be run in the Closed Sampler or Sample Loader Mode first.

Daily Quality Control ProcedureThe Quality Control Procedure (which confirms calibration) should be performed on a daily basis according to the laboratory’s protocol. Commercial control materials should be properly warmed and mixed according to the manufacturer’s recommendations. Patient controls should be handled according to the laboratory’s protocol.


9140320D — June 2003


QC Procedure (Open or Closed Mode)1. From the RUN screen, press the [SPECIMEN TYPE] key.

2. Move the cursor to the desired QC file and press the [QC SPECIMEN] key.

3. If necessary, press the [CHANGE SAMPLER] key to select the desired mode.

4. Run the control.

NOTE: For complete instructions on running samples, refer to the next section in this chapter, Running Samples.



6. If the results are unacceptable, repeat the run. If the results are still unacceptable, obtain a new bottle of the control, be sure that it is warmed and mixed properly, and again repeat the run. If the results are still unacceptable, run the other levels of control material. If the results on all levels are unacceptable, troubleshoot accordingly, as directed in Chapter 10: Troubleshooting.


Running SamplesTwo modes of running samples are available with the CS Model:

• Open Mode Analysis

The Open Sampler Mode aspirates the sample from an opened collection tube. OPEN SAMPLER is displayed in the upper right corner of the RUN screen when this mode is selected. The Open Sample Aspiration Probe is available only when this mode is selected.

• Closed Mode Analysis

The Closed Sampler Mode on Closed Sampler (CS) instruments aspirates the sample from a closed collection tube that has been inserted in the Closed Sampler Module. CLOSED SAMPLER is displayed in the upper right corner of the RUN screen when this mode is selected. The Wash Block moves down to the end of the Open Sample Aspiration Probe when this mode is selected.



Open Mode Procedure1. If necessary, from the RUN screen press the [CHANGE

SAMPLER] key to select the Open Mode.

2. Be sure that the word READY is illuminated on the Analyzer Status Indicator Panel and Ready is displayed in the Status Box on the RUN screen.

3. Open the well-mixed specimen tube and immerse the Open Sample Aspiration Probe in the specimen.

4. Press the Touch Plate located behind the probe to start the cycle. The word BUSY on the Analyzer Status Indicator Panel will be illuminated in yellow. The Status Box on the RUN screen will display messages to indicate the various stages of the cycle.


6. When the cycle is completed, the Wash Block will move up the probe, the word READY on the Analyzer Status Indicator Panel will be illuminated in green, and the results will be displayed on the RUN screen.

7. If automatic report printing has been specified, a report will be printed according to the options selected during setup. If this has not been specified, a report can be printed by pressing the [PRINT REPORT] key.

NOTE: To obtain a color printout, press the [COLOR PRINT] key. (The color printing option on the CUSTOMIZE PRINTED REPORT screen must be ON.) If automatic report printing has been specified, the reports will be printed in black and white.


Closed Mode Procedure1. Be sure that the word READY is illuminated on the Analyzer

Status Indicator Panel and Ready is displayed in the Status Box on the RUN screen.

2. If necessary, from the RUN screen press the [CHANGE SAMPLER] key to select the Closed Mode.


9140320D — June 2003


3. Invert the well-mixed specimen and place the stoppered end down into the Closed Sampler Module. Push the end of the tube securely into the Tube Retainer.

NOTE: Place the tube cap-down and make sure it is seated correctly. (The Touch Plate will not operate if the tube is not seated correctly.) For instructions on adjusting the Tube Retainer, refer to Chapter 9: Maintenance, Subsection: Special Procedures.

4. Press the Touch Plate located behind the probe to start the cycle. The word BUSY on the Analyzer Status Indicator Panel will be illuminated in yellow.

5. Remove the tube when the beep sounds.

6. When the cycle is completed, the word READY on the Analyzer Status Indicator Panel will be illuminated in green, and the results will be displayed on the RUN screen.


Daily ShutdownIt is not necessary to perform a Daily Shutdown Procedure, as the instrument automatically goes into a Standby state if it has been idle for four hours. If desired, the operator may place the instrument in the Standby state by pressing the [DAILY SHUTDOWN] key on the second SPECIAL PROTOCOLS screen.

When the key is pressed or when the Automatic Shutdown is initiated, the cycle:

• Rinses the Flow System.

• Sets the timer control that periodically opens all of the solenoid valves to prevent pinched tubing.



Using The Work ListThe Work List is used to preassign sample identification and to display and print criteria for samples that will be run. It is essentially a list of the samples (including the preassigned information) that the operator intends to run on the instrument. A Work List can be downloaded from a host computer to the CELL-DYN 3700 System. Its use is optional.

The Work List can be used with or without bar coded specimens. Instructions for both methods are presented under the specific Work List discussions. Instructions are also given for handling STAT samples with and without bar code labels.

CAUTION: If bar code labels are not used, samples must be processed in the same order in which the information is listed on the Work List.

The following bar code symbologies may be used:

• Codabar, Interleaved 2 of 5, Code 39, or Code 128

These bar code labels are often generated by the laboratory and are typically used when the bar code number is the Specimen ID number.

• CELL-DYN 4-Digit Bar Code (Code 39)

These bar code labels are provided with the Sample Loader and may be used for sample identification when the bar code number is not the same as the Specimen ID number. This option must be selected in the Work List setup.

NOTES 1. The bar code reader searches for a readable code when it reads a bar code label. It then performs multiple reads to verify that the code has been read correctly. If a second bar code label from a different patient is applied to the tube, it may be ignored by the bar code reader. Consequently, the possibility for misidentification exists. Good laboratory practice mandates that each specimen is labeled with information traceable to one patient only. Therefore, it is recommended that only one bar code label is used on each tube for correct specimen identification.

NOTES 2. For complete information on the use of bar codes, refer to Appendix A: Bar Codes.

As the samples are processed, the Work List is accessed, and the entered information is displayed on the RUN screen with the results stored in the Data Log. The information is also printed on the report.

When using the Work List feature, set up a laboratory procedure to require that any unprocessed Work List entries be viewed and cleared at the end of each shift or day. This will reduce the opportunity for any unprocessed Specimen IDs, left in the Work List for an extended time, to be matched with a different patient with the same Specimen ID.


9140320C — November 2000


Work List ScreenThe [WORK LIST] key on the Data Station RUN screen is used to display the WORK LIST screen. (See the following figure.) The following soft key labels are displayed on the WORK LIST screen:

WORK LIST ON or WORK LIST OFF (This key label alternates between

these two selections.)BAR CODE ON or BAR CODE OFF (This key label alternates between

these two selections.)INSERT/DELETEDELETE ALLPURGE COMPLETEDWORK LIST SET UPPRINT WORK LISTRETURN

Figure 5.40: Work List Screen

WORK

LIST

WORK LISTOFF

BAR CODEOFF

INSERT/DELETE

DELETEALL

PURGECOMPLETED

WORK LISTSET UP

PRINTWORK LIST

RETURN

WORK LISTReady


12:097530330

123456

Work List ON

123456234567345678456789567890

111111

111111

Bar Code ON

Jones, MarySmith, JohnWhite, BobBlack, SueGreen, Kermit

NAF

1

23 4 5 6 7 8 9 10

#

1

4DIG SPECIMEN SPECIMENBC ID NAME

L P S RACK/

1 1

TUBEDOCTOR DATE OF

BIRTH

--/--/--

11 12



The numbers on the WORK LIST screen (shown in the preceding figure) correspond with the following numbered options:

1. <WORK LIST>The status of the Work List (OFF or ON) is displayed in this field.

2. <BAR CODE>The status of the Bar Code selection (OFF or ON) is displayed in this field.

3. <#>The sequential number of the Work List entries is displayed in this field. The Work List holds 800 entries. When the Work List is full, existing entries must be deleted before additional entries can be made.

4. <4DIG BC> (4-Digit Bar Code)

If the 4-digit bar code was selected from the WORK LIST SET UP screen and the Bar Code option is ON, the bar code number must be entered in this field.

5. <SPECIMEN ID>A bar code number, specimen identification number, or name can be entered in this field. Up to 12 characters can be entered. The sample is identified on the RUN screen, in the Data Log, and on the printed report using the information entered in this field.

NOTE: An entry must be made in this field to create a Work List.

6. <SPECIMEN NAME>The name entered in this field should be associated with the identification number entered in the <SPECIMEN ID> field. Up to 16 characters can be entered in this field.

7. <L> (Limit Set)

This field is used to enter the number of the Patient Limit Set that will be used for flagging the sample. If no entry is made, the default (pre-selected) Patient Limit Set will be used.

8. <P> (Parameter Set)

This field is used to enter the number of the Parameter Set that will be used for the sample. If no entry is made, the default (preselected) Parameter Set will be used.


9140320C — November 2000


9. <DOCTOR>This field is used to enter the name of the patient’s physician.

10. <DATE OF BIRTH>This field is used to enter the date of birth of the patient.

11. <S> (Status)

As the samples are processed, the status is indicated in this field. The operator cannot enter information in this field. The following codes may be displayed:

N Non-AlertedThe sample was not flagged in any way.

A AlertedThe sample was flagged because results exceeded the selected Patient Limits or because a morphological flag was generated.

F FaultA Metering Fault (for WIC or RBC/PLT) or a Sampling Error message was generated as the sample was processed, either with or without the Sample Loader; or a Mixing Error message was generated as the sample was processed (only when using the Sample Loader).

12. <RACK/TUBE>As samples are processed on the Sample Loader, the rack number and tube number (position of the tube in the rack) are displayed in this field. The operator cannot enter information in this field. The display shows RxTx (where x indicates the number of the rack or tube).

Work List Soft KeysThe function of each of the soft keys displayed on the WORK LIST screen is as follows:

Work List ON/Work List OFF Soft KeyThe [WORK LIST ON] key is used to turn on the Work List feature. The key label changes to [WORK LIST OFF] when the Work List feature is enabled. The upper left-hand corner of the screen indicates the status of the Work List.

WORK

LIST ON

WORK

LIST OFF



Bar Code ON/Bar Code OFF Soft KeyThe [BAR CODE ON] key is used to create a Work List for samples that are identified with bar code labels. The key label changes to [BAR CODE OFF] when the Bar Code feature is enabled. The upper left corner of the screen indicates the status of the Bar Code feature.

Insert/Delete Soft KeyWhen the [INSERT/DELETE] key is pressed, the following soft key labels are displayed:

INSERTDELETE

Insert Soft KeyThe [INSERT] key is used to insert a line of information into the Work List. The line is inserted at the cursor position, and the remainder of the Work List is moved down one line.

Delete Soft KeyThe [DELETE] key is used to delete a line of information from the Work List. (When information is deleted, the line remains blank.) When the [DELETE] key is pressed, the following soft key labels are displayed:

CONFIRM DELETIONCANCEL DELETION

These keys are used to confirm or cancel the [DELETE] command.

Delete All Soft KeyThe [DELETE ALL] key is used to delete all data from the Work List. When the [DELETE ALL] key is pressed, the following soft key labels are displayed:


These keys are used to confirm or cancel the [DELETE ALL] command.

BAR CODE

ON

BAR CODE

OFF

INSERT/

DELETE

INSERT

DELETE

DELETE

ALL


9140320C — November 2000


Purge Completed Soft KeyThe [PURGE COMPLETED] key is used to delete all Work List entries for samples that have been successfully run through the Analyzer (marked with an N or A in the Status field). When the [PURGE COMPLETED] key is pressed, the Bulletin Line displays the following message:

ALL SPECIMENS MARKED WITH ‘N’ OR ‘A’ WILL BE PURGED

The following soft key labels are displayed:

CONFIRMCANCEL

These keys are used to confirm or cancel the [PURGE COMPLETED] command.

NOTE: The Purge Completed option is not available when the Bar Code feature is OFF.

Work List Set Up Soft Key

Figure 5.41: Work List Set Up Screen

PURGE

COMPLETED

TOGGLEON/OFF

RETURN

WORK LIST SET UPReady


10:09sh0630

1

OFF

OFF1

OFF1

OFF

OFF

Bar Code ID associated with :1 = 4-digit bar code2 = Laboratory Specimen ID

Specimen Name entry selected

Patient Limits entry selectedDefault Patient Limit Set (1..4)

Parameter Set entry selectedDefault Parameter Set (1..4)

Doctor Name entry selected

Date of Birth entry selected

1

2

34

56

7

8



The [WORK LIST SET UP] key on the WORK LIST screen is used to display the WORK LIST SET UP screen shown in the preceding figure. The numbers on the screen correspond to the following numbered options:

1. <Bar Code ID associated with:>1 = 4-digit bar code2 = Laboratory Specimen IDThis field is used to specify the type of bar code that will be used when the Bar Code feature is ON. If option 2 is selected, the bar code number must be entered in the <Specimen ID> field.

2. <Specimen Name entry selected>This field is used to specify whether a specimen name will be entered in the Work List.

3. <Patient Limits entry selected>This field is used to specify which Patient Limits are assigned to each sample. The default Patient Limit Set will be used if no specification is made.

4. <Default Patient Limit Set (1..4)>This field is used to specify the default (preassigned) Patient Limit Set that will be automatically assigned to each sample unless otherwise indicated in the Work List.

5. <Parameter Set entry selected>This field is used to specify which Parameter Set will be assigned to each sample. The Default Parameter Set will be used if no specification is made.

6. <Default Parameter Set (1..4)>This field is used to specify the default (preassigned) Parameter Set that is automatically assigned to each sample unless otherwise indicated in the Work List.

7. <Doctor Name entry selected>This field is used to specify whether a doctor name will be entered in the Work List.

8. <Date of Birth entry selected>This field is used to specify whether the patient’s date of birth will be entered in the Work List.

WORK LIST

SET UP




Print Work List Soft KeyThe [PRINT WORK LIST] key is used to print the Work List.

Return Soft KeyThe [RETURN] key is used to return to the RUN screen.

Work List Set Up ProceduresThe CELL-DYN 3700 Work List is used to enter and then display demographic information for specimens that will be processed. The Work List is created by downloading the demographic information from an LIS system or by manually entering the information into selected fields. In either case, the Work List connects the demographics to the appropriate specimen and displays them on the specimen report.

Work List Set Up With A Laboratory Information System (LIS)The directions for setting up the Work List by downloading information from an LIS are included in the Host Interface Specification, List No. 02H33-01. Please note that all fields should be transmitted; therefore, selections in the Work List Setup menu are not used for this option and no data entry procedure is needed.

When using the LIS communication feature to receive work orders from the LIS or send records to the LIS:

DO NOT use a Specimen ID with trailing spaces in the Work List entry. Trailing spaces will be removed and may result in entries remaining in the Work List.

DO NOT use a comma in the bar code string, if you use a Sample Loader instrument AND Code 128-type bar codes. A comma will cause the Specimen ID to be truncated at the point where the comma is located within the ID. This will result in an erroneous Specimen ID or Rack and Tube Number, without any error notification.

PRINT

WORK LIST

RETURN



Work List Set Up with Manual EntryThe first step in generating a work list is to select the demographic items that will be displayed on the specimen report. All selections are optional; however, certain selections may be required by the laboratory. The operator customizes (Sets up) the work list to accommodate the laboratory’s requirements. When the Work List Set Up is complete, the selected fields are highlighted indicating that information must be entered. The second step in generating the work list is the manual entry of information in each highlighted field.

The following procedure is used to make the selections for manual entry.

Manual Entry Procedure1. From the RUN screen, press the [WORK LIST] key followed by

the [WORK LIST SET UP] key to display the WORK LIST SET UP screen.

2. Select the type of bar code that will be used.

• Type 1 to use the CELL-DYN Series 4-digit bar code.

• Type 2 to use a laboratory-generated bar code.

Press the Enter key on the keyboard to save the selection and advance the cursor.

3. The cursor advances to the Specimen Name entry field. Press the [TOGGLE ON/OFF] key to select (or deselect) a Specimen Name entry. The cursor advances to the <Patient Limits> entry field.

4. Press the [TOGGLE ON/OFF] key to select (or deselect) the Patient Limits entry option. The cursor advances to the <Default Patient Limit Set> entry field.

5. Select a Patient Limits Set to be used for the default (pre-assigned) limit as follows:

Type the number of the desired Limit Set (1-4) and press the Enter key on the keyboard. The cursor advances to the <Parameter Set> entry field.

6. Press the [TOGGLE ON/OFF] key to select (or deselect) the Parameter Set entry option. The cursor advances to the <Default Parameter Set> entry field.

7. Select a Parameter Set to be used for the default (pre-assigned) set as follows:


9140320C — November 2000


Type the number of the desired Limit Set (1-4) and press the Enter key on the keyboard. The cursor advances to the <Doctor Name> entry field.

8. Press the [TOGGLE ON/OFF] key to select (or deselect) the Doctor Name entry option. The cursor advances to the <Date of Birth> entry field.

9. Press the [TOGGLE ON/OFF] key to select (or deselect) the <Date of Birth> entry option. The cursor advances to the next entry field.

Using the Work List with Bar Code NumbersWhen the Work List ON option is selected, the samples are automatically matched with the created Work List.

When the Bar Code ON option is selected, the bar code labeled samples may be run in any order after the Work List has been created.

The Work List is accessed randomly as the samples are processed. After a bar code label is read, the software searches the Work List for a matching specimen. When a match is found, the entered information is transferred from the Work List to the appropriate field(s) on the RUN screen and is also retained in the Data Log.

The samples may be run in any order since the Work List searches for the match between the bar code and the appropriate information in the Work List. The specimen identification number entered in the Work List <SPECIMEN ID> field is used to identify the sample on the RUN screen and in the Data Log.

NOTE: Special Bar Code labels, Q Labels, are available to identify QC samples. The Q Label identifies the sample as a QC sample so the results are automatically transmitted to the appropriate QC file. Consequently, QC samples should not be entered in the Work List. To run QC samples, turn the Work List OFF and refer to Routine Operation, Sample Analysis, Daily Quality Control Procedures, within this chapter for instructions for running QC samples.

1. If necessary, from the main WORK LIST screen, press the [WORK LIST ON] key to enable the Work List.

2. If necessary, press the [BAR CODE ON] key to enable the bar code reading function.



As indicated earlier in the Work List section, two types of bar code labels can be used on the Cell-Dyn 3700 as described in the following paragraphs.

Cell-Dyn 4-Digit Bar Code Number LabelsCELL-DYN 4-digit bar code number labels are available for laboratories that do not generate their own bar code labels but would like to process bar code labeled specimens for more accurate identification. Consequently, when a CELL-DYN 4-digit bar code number is used, the number must be typed in the Work List <4-DIGIT BAR CODE> field in order for the instrument to recognize it as a bar code. Additionally, a specimen ID number must be entered in the Work List <SPECIMEN ID> field for proper identification by Specimen ID on the RUN screen and in the Data Log.

Procedure for 4-Digit Bar Code Numbers1. With the cursor in the <4DIG BC> field, type in the first 4-

digit bar code number and press the Enter key on the keyboard. The cursor advances to the <SPECIMEN ID> field.

2. Type the corresponding Specimen ID in the <SPECIMEN ID> field. Press the Enter key on the keyboard to save the entry and advance the cursor to the next field highlighted for data entry.

NOTE: A Specimen ID must be entered into the Specimen ID field to properly identify each specimen. The 4-digit bar code only provides a link to the Work List in order to access the demographic information.

3. Type the appropriate information into the other selected (highlighted) Work List fields.

4. After each entry, press the Enter key on the keyboard to save the entry and advance the cursor.

5. Continue to enter the 4-digit bar code numbers and the corresponding specimen information as described above.

Laboratory-Generated Bar Code NumbersMany laboratories generate their own bar code labels. These bar code numbers are used to identify specimens for processing. In other words, the bar code number is equivalent to the Specimen ID number. Consequently, when a laboratory-generated bar code number is used, it must be typed in the Work List <SPECIMEN ID> field. The samples will then be properly identified by Specimen ID on the RUN screen and in the Data Log.


9140320C — November 2000


Procedure for Laboratory Generated Bar Code Numbers1. With the cursor in the <SPECIMEN ID> field, type in the first

laboratory-generated bar code number and press the Enter key on the keyboard. The cursor advances to the next selected (highlighted) field.

2. Type the appropriate information into the other selected (highlighted) Work List fields.

3. After each entry, press the Enter key on the keyboard to save the entry and advance the cursor.

4. Continue to enter the code numbers and the corresponding specimen information as described above.

Sample Analysis Using the Work ListThe Work List is available in the Open and Closed Modes on both the SL and CS models of the CELL-DYN 3700. The Work List option may be used with or without bar code labeled tubes. When bar code labeled tubes are used, Work List use in all modes is identical except that the Sample Loader automatically reads the bar code label on the tube with a built-in bar code reader. A hand held bar code reader is available to read bar code labeled tubes for the Open Mode on the CS or SL and the Closed mode on the CS instrument.

NOTE: Special bar code labels, Q Labels, are available to identify QC samples so results are automatically transmitted to the appropriate file. Consequently, QC samples should not be entered in the work list.

Refer to Appendix A: Bar Codes for a complete discussion of bar code specifications, bar code labels, and instructions for placing labels on the tubes correctly.

Sample Analysis Procedures for the Cell-Dyn 3700SLThe Work List may be used in the Open and Closed Modes on the SL Model and use is similar in each mode. For ease of understanding, the modes are discussed independently in this section.

NOTE: If a sample needs to be repeated, turn the Work List OFF before running the sample again. When the repeat run is completed, turn the Work List ON and continue to process samples in the order in which they were entered in the Work List.



Procedure: Sample Analysis with Bar Codes in the Closed Mode1. After the information for all samples has been entered, place

the samples in the Sample Loader Racks. Samples may be placed in the racks in any order since the bar code labels will be used to identify them

NOTE: The last group of samples should be placed in an End Rack so the Sample Loader will stop when all the samples have been processed

2. Install the Sample Loader Safety Cover.

3. Press the [RETURN] key to return to the RUN screen.

4. Press the [SPECIMEN TYPE] key followed by the [PATIENT] key.



NOTE: Samples can be run with the WORK LIST screen displayed. As the samples are processed, the status of each sample will be displayed in the <STATUS> field on the Work List. Additional entries can be made to the Work List while processing takes place.

7. The samples are automatically processed in the order in which they were placed in the racks. If the last samples were placed in an End Rack, the Sample Loader will automatically stop when processing is finished.

Procedure: Sample Analysis with Bar Codes in the Open Mode1. After the information for all samples has been entered, press

the [RETURN] key to return to the RUN screen


3. If necessary, press the [CHANGE SAMPLER] key to select the Open mode.

4. Ensure that the cursor is in the <NEXT ID> field.

5. Using the hand held bar code reader, scan the bar code label on the tube. If the hand held reader is unavailable, type the Specimen ID in the <NEXT ID> field.

6. Aspirate the sample.


9140320C — November 2000


NOTE: Samples can be run with the WORK LIST screen displayed. As the samples are processed, the status of each sample will be displayed in the <STATUS> field on the Work List. Additional entries can be made to the Work List while processing takes place.

7. As each sample is processed, the Work List is searched for the bar code number. When a match is found, the entered information is transferred from the Work List to the RUN screen and is also displayed in the Data Log.

Running STAT SamplesA STAT sample with a laboratory generated bar code label may be run at any time in any mode. A specimen with 4-digit bar code label must be added to the Work List with a Specimen ID so that it will be properly identified. The demographics for a STAT sample may be added to the Work List at any time unless the Work List is full (The Work List holds 800 entries.).

Sample Analysis Procedures for the Cell-Dyn 3700CSThe Work List may be used in the Open and Closed Modes on the CS Model. On CS instruments, use of the Work List is identical in both modes; therefore, they are described as one in this section.

The CS model has a hand held Bar Code reader which can be used to read the bar code labels for tubes processed in either mode.

NOTE: If a sample needs to be repeated, turn the Work List OFF before running the sample again. When the repeat run is completed, turn the Work List ON and continue to process samples in the order in which they were entered in the Work List.

Procedure: Sample Analysis with Bar Codes in the Closed Mode1. After the information for all samples has been entered in the

Work List, press the [RETURN] key to return to the RUN screen



4. Ensure that the cursor is in the <NEXT ID> field.



5. Using the hand held bar code reader, scan the bar code label on the tube. If the hand held reader is unavailable, type the Specimen ID in the next ID field.


NOTE: Samples can be run with the WORK LIST screen displayed. As the samples are processed, the status of each sample is displayed in the <STATUS> field on the Work List. Additional entries can be made to the Work List while processing takes place.


Procedure: Sample Analysis with Bar Codes in the Open Mode1. After the information for all samples has been entered, press

the [RETURN] key to return to the RUN screen.



4. Using the hand held bar code reader, scan the bar code label on the tube. If the hand held reader is unavailable, type the Specimen ID in the next ID field.


NOTE: Samples can be run with the WORK LIST screen displayed. As the samples are processed, the status of each sample is displayed in the <STATUS> field on the Work List. Additional entries can be made to the Work List while processing takes place.



9140320C — November 2000


Running STAT SamplesA STAT sample with a laboratory generated bar code label may be run at any time in any mode. A specimen with 4-digit bar code label must be added to the Work List with a Specimen ID so that it will be properly identified. The demographics for a STAT sample may be added to the Work List at any time unless the Work List is full (The Work List holds 800 entries.).

Using the Work List Without Bar CodesWhen the Bar Code OFF option is selected, the Work List is accessed sequentially as the samples are processed: therefore, samples must be run in the order in which the information has been entered in the Work List.

Samples are identified from the information entered in the <SPECIMEN ID> field on the Work List. If no entries are made in the <SPECIMEN ID> field, the Sample Loader will identify the sample by the Rack and Tube number (position of the tube in the rack). This identification will be displayed as RxTx (where x indicates the number of the rack or tube).

CAUTION: If a Sample Loader fault occurs that necessitates re-initialization of the Sample Loader, remove all samples that have been processed before reinitializing the Sample Loader. If these samples are not removed, the remaining samples will be misidentified.

On both the Cell-Dyn 3700SL and Cell-Dyn 3700CS instruments, use of the Work List without bar codes is identical; therefore, they are described together in the following procedure.

Procedure: Sample Analysis Without Bar Codes1. After the information for all samples has been entered in the

Work List, press the [RETURN] key to return to the RUN screen.


3. If necessary, press the [CHANGE SAMPLER] key to select the desired mode.

4. Press the [WORK LIST] key to select the Work List screen.



NOTE: Misidentification of samples can occur if they are not processed in the order of entry into the Work List. Consequently, it is recommended that the WORK LIST screen be displayed or printed. when running samples without bar codes. The status of each sample is displayed in the <STATUS> field on the Work List and additional entries can be made while processing takes place.


6. As each sample is processed, the entered information for the next sequential specimen ID number is transferred from the Work List to the RUN screen and is also displayed in the Data Log. Therefore, samples must be processed in the order in which information has been entered into the Work List, to avoid misidentification.

Running STAT SamplesIt is important to turn the Work List OFF before running a STAT sample. When the STAT sample run is completed, turn the Work List ON and continue to process samples in the order in which they were entered in the Work List.


9140320C — November 2000


NOTES


Operating InstructionsChapter 5 Using The Data Log

Using The Data Log

The Data Log stores all data and demographic information in a log format for the last 10,000 cycles run on the CELL-DYN 3700 System. This record information is stored chronologically by sequence number. Scatterplots and histograms are also stored for all 10,000 records.

Figure 5.42: Data Log Screen

NOTE: Press the F12 key followed by the F1 key on the keyboard to toggle between this Data log screen and the Retic Data Log screen.

EDITID

DISPLAYSPECIMEN

FINDSPECIMEN

REJECTFROM X-B

CUSTOMIZEDATA LOG

TRANSMITDATA

PRINTDATA LOG

MAIN

DATA LOGReady


16:32rcs0844

833834835836837838839840841842843844

USE < OR > FOR MORE DATA

rrrrrr

wb

Seq Specimen ID191258443619109522411912077932191176432119118155011911187621low ctrllow ctrllow ctrl

BACKGROUND

3.837.50.1926.264.377.078.067.968.217.938.34.079

2.304.53.0524.992.756.024.714.784.864.714.97

.3152.16.116.828.984.6122.442.322.452.392.50

1.04.536.012.252.519.218.621.601.598.557.551

.012

.106

.002

.019

.001

.069

.213

.183

.204

.178

.208

.173

.141

.010

.176

.116

.150

.074

.080

.099

.092

.114

WBC NEU LYM MONO EOS BASOC07/21/98 14:40 rcsC07/21/98 14:40 rcsC07/21/98 14:41 rcsC07/21/98 14:42 rcsC07/21/98 14:43 rcsC07/21/98 14:43 rcsO07/21/98 16:20 rcsO07/21/98 16:20 rcsO07/21/98 16:21 rcsK07/21/98 16:26 rcsO07/21/98 16:28 rcsO07/21/98 16:30 rcs

Date Time Op

WBC NEU LYM MONO EOS BASO Date Time OpSeq Specimen ID


9140320C — November 2000

Operating InstructionsUsing The Data Log Chapter 5

Data Log MenuThe [DATA LOG] key on the MAIN MENU is used to display the DATA LOG screen (see the preceding figure) and the following soft key labels:

EDIT ID (This key label is displayed only if the cursor is positioned next to a patient record.)

DISPLAY SPECIMENFIND SPECIMENREJECT FROM X-B (This key label is displayed if the sequence

number of the patient record is preceded by a b, r, or w. See the preceding figure.)

CUSTOMIZE DATA LOGTRANSMIT DATAPRINT DATA LOGMAINInformation that can be viewed from the DATA LOG screen includes the following:

• Sequence number and specimen ID assigned to the sample (left portion of screen). A b, r, or w may appear to the left of the sequence number.

b – Specimen is included in both X-B WBC and X-B RBC Analysis

r – Specimen is included in X-B RBC Analysis

w – Specimen is included in X-B WBC Analysis

• Set of parameter data that can be customized by pressing the [CUSTOMIZE DATA LOG] key (center portion of screen).

• Date and time sample was run and operator ID (right portion of screen).

DATA

LOG



Also listed in the right portion of the DATA LOG screen, immediately to the left of the date, is a letter. This letter represents the following Data Log codes that identify conditions of the sample run:

O — Sample was run in the Open Mode

C — Sample was run in the Closed Mode

N — Incomplete aspiration in the Open Mode

I — Incomplete aspiration in the Closed Mode

K — WIC or RBC/PLT metering fault (Clog or Flow Error)

M — Mixing error on the Sample Loader

R — Resistant RBC key was used to run this sample

V — Sample was run in the Veterinary mode

B — Blood in line

A — Auxiliary

The keys and functions accessible from the DATA LOG screen are described on the following pages.

Edit ID Soft KeyThe [EDIT ID] key is used to edit the specimen ID displayed on the DATA LOG screen. When the [EDIT ID] key is pressed, the cursor moves into the <SPECIMEN ID> field and all key labels are blank. Edits are saved by pressing the Enter key on the keyboard after the new ID is entered.

NOTE: The [EDIT ID] key is available only when the cursor is positioned next to a patient record. It is not available for background or QC records.

When using the Edit Specimen ID feature in the Data Log, set up a laboratory procedure to verify any Specimen ID that has been manually edited in the Data Log by showing the content of the Specimen ID before and after editing.

Such verification could be:

Printouts of the Data Log summary reports that show the edited ID. These printouts should be signed, dated and saved to ensure tracking of any changes to specimen identification within your laboratory.

or

Re-running any specimen unintentionally identified with a Rack and Tube Number, via Open or Closed Mode, to confirm that the correct Specimen ID is applied.

EDIT

ID


9140320C — November 2000


Display Specimen Soft Key

Figure 5.43: Display Specimen Screen

The [DISPLAY SPECIMEN] key on the DATA LOG screen is used to display the results for the record indicated by the cursor position. (See the preceding figure.) The following soft key labels are displayed on the DISPLAY SPECIMEN screen:

PREVIOUS SPECIMEN This label key is not displayed when the first specimen in the log is on the screen.

NEXT SPECIMEN This label key is not displayed when the last specimen in the log is on the screen.

EDIT SPECIMEN This label key is displayed for the patient records only.

CUSTOMIZE REPORTTRANSMIT SPECIMENPRINT TICKETPRINT REPORT or COLOR PRINT (The key label alternates between

these two selections, depending on whether the Color Print option has been enabled.)

RETURN

PLT

PREVIOUSSPECIMEN

NEXTSPECIMEN

EDITSPECIMEN

CUSTOMIZEREPORT

TRANSMITSPECIMEN

PRINTTICKET

PRINTREPORT

RETURN

DISPLAY SPECIMENReady


08:19baC0863

Spec ID R7 T4Patient ----------------Sex(M/F):- DOB:--/--/--Dr ----------------------Param: 2 Limits: 1 SUSPECT

WBC 7.28 K/uL (WOC)NEU 4.51 62.0 %NLYM 1.81 24.9 %L VAR LYM

MONO .745 10.2 %M NRBCEOS .097 1.33 %E





Sequence # 826

GRANLRTY

SIZE


RBC

WCT:4.46

RCT:6.53

Closed Sampler

Auto-Sampler Ready

DISPLAY

SPECIMEN



Previous Specimen Soft KeyThe [PREVIOUS SPECIMEN] key on the DISPLAY SPECIMEN screen is used to display the results for the sequence number preceding the one currently displayed without returning to the main DATA LOG screen.

Next Specimen Soft KeyThe [NEXT SPECIMEN] key is used to display the results for the sequence number following the one currently displayed without returning to the main DATA LOG screen.

Edit Specimen Soft KeyThe [EDIT SPECIMEN] key is used to edit patient demographic information for the selected record. It may also be used to edit and display the results using a Parameter Set or Patient Limit Set different from the one currently displayed. The following soft key labels are displayed when the [EDIT SPECIMEN] key is pressed:

CONFIRMCANCEL

These keys are used to [CONFIRM] or [CANCEL] the edits. The Bulletin Line displays the following message: PRESS CONFIRM TO SAVE CHANGES OR CANCEL TO CANCEL CHANGES. When the [CONFIRM] key is pressed, the edited record is displayed.

Customize Report Soft KeyThe [CUSTOMIZE REPORT] key is used to customize the RUN screen display, header, and printout as described in Set Up Instructions within this chapter.

Transmit Specimen Soft KeyThe [TRANSMIT SPECIMEN] key is used to transmit the displayed report to a Laboratory Information System or on-line computer.

Print Ticket Soft KeyThe [PRINT TICKET] key is used to print a ticket (in the currently selected format) for the displayed record.

PREVIOUS

SPECIMEN

NEXT

SPECIMEN

EDIT

SPECIMEN

CUSTOMIZE

REPORT

TRANSMIT

SPECIMEN

PRINT

TICKET


9140320C — November 2000


Print Report Soft KeyThe [PRINT REPORT] key is used to print a graphics report (in the currently selected format) for the displayed record.

NOTE: If color printing has been selected (refer to Set Up Instructions within this chapter), the key label changes to [COLOR PRINT].

Return Soft KeyThe [RETURN] key is used to return to the main DATA LOG screen.

Find Specimen Soft Key

Figure 5.44: Data Log Search Screen

The [FIND SPECIMEN] key on the DATA LOG screen is used to locate a particular record by entering the sequence number, specimen ID number, or patient name for the desired record. When this key is pressed, the DATA LOG SEARCH screen is displayed. (See the preceding figure.) If the record is not found in the Data Log, the Bulletin Line displays the message NO ENTRY FOUND.

PRINT

REPORT

COLOR

PRINT

RETURN

EDITID

DISPLAYSPECIMEN

FINDSPECIMEN

REJECTFROM X-B

CUSTOMIZEDATA LOG

TRANSMITDATA

PRINTDATA LOG

MAIN

DATA LOG SEARCHReady


15:56rcs0711

700701702703704705706707708709710711

br

r

r

Seq Specimen IDBACKGROUND191193723119113593311911883246LATEXLATEXBACKGROUND1912696001191118762119123950011910851733BACKGROUND

.0069.425.5211.43.253.25.0357.968.106.889.53.013

.0069.896.4411.91.711.64.0098.218.237.759.91.013

.0069.425.5211.43.253.25.0357.968.106.889.53.013

0.003.763.88

0.000.000.003.333.293.773.77.001

.02710.110.210.1.081.061.0279.549.9411.510.7.027

82.081.4

89.890.591.985.8

WBC WIC WOC RBC HGB MCVO07/20/98 14:38 rcsC07/20/98 14:42 rcsC07/20/98 14:43 rcsK07/20/98 14:43 rcsO07/20/98 14:50 rcsO07/20/98 14:51 rcsO07/20/98 14:53 rcsC07/20/98 14:57 rcsC07/20/98 14:57 rcsC07/20/98 14:58 rcsC07/20/98 14:59 rcsO07/20/98 15:47 rcs

Date Time Op

WBC WIC WOC RBC HGB MCV Date Time OpSeq Specimen ID

16.813.3

14.815.413.116.4

RDW

RDW

SEQ #:SPEC ID:NAME:

FIND

SPECIMEN



Reject From X-B/Accept Into X-B Soft KeyThe letter b, r, or w will appear to the left of the sequence number for certain samples.

b – Specimen is included in both X-B WBC and X-B RBC Analysis

r – Specimen is included in X-B RBC Analysis

w – Specimen is included in X-B WBC Analysis

If the cursor is positioned at a sample identified with a b, r, or w preceding the sequence number (indicating that the results are included in the X-B Analysis), the [REJECT FROM X-B] key label is displayed on the DATA LOG screen. (See the preceding figure.) When the [REJECT FROM X-B] key is pressed, the sample is marked with an R located on the right side of the specimen ID. The results are excluded from the X-B Analysis (the b, r, or w is deleted) and the key label changes to [ACCEPT INTO X-B]. (See the following figure.)

If the [ACCEPT INTO X-B] key is pressed, the R is deleted, a b, r, or w is displayed, and results are now included in the X-B Analysis.

Figure 5.45: Data Log Screen Showing Reject From X-B Key

REJECT

FROM X-B

ACCEPT

INTO X-B

EDITID

DISPLAYSPECIMEN

FINDSPECIMEN

REJECTFROM X-B

CUSTOMIZEDATA LOG

TRANSMITDATA

PRINTDATA LOG

MAIN

DATA LOGReady


15:56rcs0711

700701702703704705706707708709710711


br

r

r

Seq Specimen IDBACKGROUND191193723119113593311911883246LATEXLATEXBACKGROUND19126960011911187621 R19123950011910851733 RBACKGROUND

.0069.425.5211.43.253.25.0357.968.106.889.53.013

.0069.896.4411.91.711.64.0098.218.237.759.91.013

.0069.425.5211.43.253.25.0357.968.106.889.53.013

0.003.763.88

0.000.000.003.333.293.773.77.001

.02710.110.210.1.081.061.0279.549.9411.510.7.027

82.081.4

89.890.591.985.8


Date Time Op


16.813.3

14.815.413.116.4

RDW

RDW

Auto-Sampler Pause


9140320C — November 2000


Figure 5.46: Data Log Screen Showing Accept Into X-B Key

EDITID

DISPLAYSPECIMEN

FINDSPECIMEN

ACCEPTINTO X-B

CUSTOMIZEDATA LOG

TRANSMITDATA

PRINTDATA LOG

MAIN

DATA LOGReady


15:56rcs0711

700701702703704705706707708709710711


brw

rbr

Seq Specimen IDBACKGROUND191193723119113593311911883246LATEXLATEXBACKGROUND19126960011911187621 R1912395001 1910851733 RBACKGROUND

.0069.425.5211.43.253.25.0357.968.106.889.53.013

.0069.896.4411.91.711.64.0098.218.237.759.91.013

.0069.425.5211.43.253.25.0357.968.106.889.53.013

0.003.763.88

0.000.000.003.333.293.773.77.001

.02710.110.210.1.081.061.0279.549.9411.510.7.027

82.081.4

89.890.591.985.8


Date Time Op


16.813.3

14.815.413.116.4

RDW

RDW

Auto-Sampler Pause



Customize Data Log Soft Key

Figure 5.47: Customize Display for Data Log Screen

The [CUSTOMIZE DATA LOG] key on the DATA LOG screen is used to customize the Data Log display. The CUSTOMIZE DISPLAY for Data Log screen (see the preceding figure) and the following soft key labels are displayed when the [CUSTOMIZE DATA LOG] key is pressed:

SELECT PARAMETER or PLACE PARAMETER (This key label alternates between

these two selections.)STANDARD GROUPS or CUSTOM PLACEMENT (This key label alternates between

these two selections.)CUSTOMIZE PRINTOUTRETURN

SELECTPARAMETER

STANDARDGROUPS

CUSTOMIZEPRINTOUT

RETURN

CUSTOMIZE DISPLAYReady


10:29sh0630FOR DATA LOG



PLT MPV PCT PDW

WBC %N %L %M %E %B



Group 1:

Group 2:

Group 3:

Group 4:

CUSTOMIZE

DATA LOG


9140320C — November 2000


The CUSTOMIZE DISPLAY (for Data Log) screen displays a matrix showing the four parameter groups and a list of the available parameters. Parameter Group 1 is displayed (in the order indicated from left to right) on the first DATA LOG screen. The remaining groups are displayed on subsequent screens that are accessed by pressing the Right arrow key on the keyboard. The Left arrow key is used to page back through the screens to the first screen. Setting up the CUSTOMIZE DISPLAY screen is discussed more fully later in this section, in Data Log Set Up Procedures.

Select Parameter Soft KeyThe [SELECT PARAMETER] key is used to select a parameter designated by the cursor. When the key is pressed, the selected parameter will be highlighted, the label will change to [PLACE PARAMETER], and a [CANCEL SELECTION] key will be displayed. The [PLACE PARAMETER] key is used to display the parameter in the location indicated by the position of the cursor.

Cancel Selection Soft KeyThe [CANCEL SELECTION] key is used to cancel the selection and display the [SELECT PARAMETER] key again.

Standard Groups Soft Key

Figure 5.48: Customize Display Showing Standard Groups

SELECT

PARAMETER

PLACE

PARAMETER

CANCEL

SELECTION

WBCGROUP

RBCGROUP

PLTGROUP

DIFFGROUP

CUSTOMPLACEMENT

CUSTOMIZEPRINTOUT

RETURN






PLT MPV PCT** PDW**

WBC %N %L %M %E %B



Group 1:

Group 2:

Group 3:

Group 4:



Predetermined groups of parameters, called Standard Groups, may be selected by pressing the [STANDARD GROUPS] key on the CUSTOMIZE DISPLAY screen. The preceding figure shows the CUSTOMIZE DISPLAY screen with the Standard Groups displayed. The following soft key labels are displayed when the [STANDARD GROUPS] key is pressed:

WBC GROUPRBC GROUPPLT GROUPDIFF GROUPCUSTOM PLACEMENT*CUSTOMIZE PRINTOUTRETURN

* The [CUSTOM PLACEMENT*] key is used to display the CUSTOMIZE DISPLAY for Data Log screen for operator-selected placement.

** Clinical significance has not been established for these parameters. Therefore, they are not reportable in the U.S.

The preceding figure shows the WBC Group placed in GROUP 1, the RBC Group placed in GROUP 2, the PLT Group placed in GROUP 3, and the Diff Group placed in GROUP 4.

When each soft key is pressed, the designated parameter group will be placed in the position indicated by the cursor.

STANDARD

GROUPS


9140320C — November 2000


Customize Printout Soft Key

Figure 5.49: Customize Printout for Data Log Screen

The [CUSTOMIZE PRINTOUT] key on the CUSTOMIZE DISPLAY for Data Log screen is used to customize the printout format of the Data Log. (See the preceding figure.) The following soft key labels are displayed when the [CUSTOMIZE PRINTOUT] key is pressed:

SELECT PARAMETER or PLACE PARAMETER (This key label alternates between

these two selections.)STANDARD SELECTIONRETURN

The CUSTOMIZE PRINTOUT for Data Log screen shows the order (from left to right) in which the indicated parameters will be printed. Procedures for Customizing the Data Log Printout are included later in this section under Data Log Set Up Procedures.

SELECTPARAMETER

STANDARDSELECTION

RETURN

CUSTOMIZE PRINTOUTReady




%N %L %M %E %BRUT1 RUT2 RCT1 RCT2WUT WCT WIC WOC

WBC %N %L %M %E %B RBC HGB HCT MCV MCH MCHC

RDW PLT MPV PCT PDW

CUSTOMIZE

PRINTOUT



Select Parameter Soft KeyThe [SELECT PARAMETER] key on the CUSTOMIZE PRINTOUT screen is used to select a parameter designated by the cursor. When the key is pressed, the selected parameter is highlighted, the label changes to [PLACE PARAMETER], and a [CANCEL SELECTION] key is displayed. The [PLACE PARAMETER] key is used to display the parameter in the location indicated by the position of the cursor.

The [CANCEL SELECTION] key is used to cancel the selection and display the [SELECT PARAMETER] key again.

Standard Selection Soft KeyThe [STANDARD SELECTION] key on the CUSTOMIZE PRINTOUT for Data Log screen is used to configure the printout in the predetermined print group shown in the preceding figure. When the key is pressed, the print group will be changed to the Standard Selection.

Return Soft KeyThe [RETURN] key is used to return to the main DATA LOG screen.

Transmit Data Soft KeyThe [TRANSMIT DATA] key on the DATA LOG screen is used to transmit a record to a Laboratory Information System or on-line computer. When the [TRANSMIT DATA] key is pressed, the screen will prompt the operator to enter the starting and ending sequence numbers (from the lowest to the highest) for the desired transmission. Records may be transmitted singly or in batches as designated by the sequence number(s).

SELECT

PARAMETER

PLACE

PARAMETER

CANCEL

SELECTION

STANDARD

SELECTION

RETURN

TRANSMIT

DATA


9140320C — November 2000


Print Data Log Soft KeyThe [PRINT DATA LOG] key on the DATA LOG screen is used to print the Data Log. When the [PRINT DATA LOG] key is pressed, the screen prompts the operator to enter the starting and ending sequence numbers (from the lowest to the highest) for the desired printout. (See the following figure.) When the Enter key is pressed after the sequence numbers have been entered, the screen will become a DATA LOG screen for the record(s) and a time indicator will appear in the upper right-hand corner to record the printing progress.

Figure 5.50: Print Data Log Screen

PRINT

DATA LOG

EDIT DISPLAY FINDSPECIMEN

REJECTFROM X-B

CUSTOMIZE TRANSMIT PRINT MAIN

DATA LOGReady


16:33rcs0844

833834835836837838839840841842843844


rrrrrr

b

Seq Specimen ID191258443619109522411912077932191176432119118155011911187621low ctrllow ctrllow ctrl

BACKGROUND

3.837.50.1926.264.377.078.067.968.217.938.34.079

2.304.53.0524.992.756.024.714.784.864.714.97

.3152.16.116.828.984.6122.442.322.452.392.50

1.04.563.012.252.519.218.621.601.598.557.551

.012

.106

.002

.019

.001

.069

.213

.183

.204

.178

.208

.173

.141

.010

.176

.116

.150

.074

.080

.099

.092

.114

WBC NEU LYM MONO EOS BASOC12/21/98 14:40 rcsC12/21/98 14:40 rcsC12/21/98 14:41 rcsC12/21/98 14:42 rcsC12/21/98 14:43 rcsC12/21/98 14:43 rcsO12/21/98 16:20 rcsO12/21/98 16:20 rcsO12/21/98 16:21 rcsK12/21/98 16:26 rcsO12/21/98 16:28 rcsO12/21/98 16:30 rcs

Date Time Op

Seq Specimen ID WBC NEU LYM MONO EOS BASO

Starting Sequence #: 834

Date Time OpAuto-Sampler Ready

ID SPECIMEN DATA LOG DATA DATA LOG

Ending Sequence #:



Data Log Set Up ProceduresThe Data Log may be configured to display and print results in the order selected by the operator. This section gives instructions for customizing the display and printout.

Customizing the Data Log DisplayThe CUSTOMIZE DISPLAY for Data Log screen displays a matrix showing the four groups of parameters that will be consecutively displayed on the four Data Log screens. (The following figure shows the Standard Groups in the matrix.) A list of all available parameters is displayed under the matrix. These parameters can be selected from the list and placed in the desired group to customize the display.

Figure 5.51: Customize Display for Data Log Screen Showing Standard Groups

* Clinical significance has not been established for these parameters. Therefore, they are not reportable in the U.S.

SELECTPARAMETER

STANDARDGROUPS

CUSTOMIZEPRINTOUT

RETURN






PLT MPV PCT* PDW*

WBC %N %L %M %E %B



Group 1:

Group 2:

Group 3:

Group 4:

Auto-Sampler Ready


9140320C — November 2000


The display may be customized by selecting the individual parameters, Standard Groups of parameters, or a combination of the two. In addition to the usual hematologic parameters, the following parameters may also be displayed in the Data Log:




WCT WCT is the WIC Count Time. WIC WIC is the WBC Impedance Count.WOC WOC is the WBC Optical Count.EMPTY An empty column is inserted in the

display.

Procedure: Customize Data Log Display1. From the main DATA LOG screen, press the

[CUSTOMIZE DATA LOG] key to display the CUSTOMIZE DISPLAY for Data Log screen.

2. If necessary, press the [CUSTOM PLACEMENT] key to display the CUSTOMIZE DISPLAY for Data Log screen and key labels for custom placement.

3. Use the arrow keys on the keyboard to move the cursor to the desired parameter in the listing under the matrix.

4. Press the [SELECT PARAMETER] key. The selected parameter highlights and the cursor will move to the first position in Group 1.

NOTE: The key label changes to [PLACE PARAMETER] and a [CANCEL SELECTION] key is displayed.


NOTE: When the [PLACE PARAMETER] key is pressed, the selected parameter will be displayed in the position indicated by the cursor, and the cursor will then advance to the next position in the group.




7. To obtain a printout of the selected groups, press the Print Screen key on the keyboard.

8. Press the [RETURN] key to return to the DATA LOG screen.

9. The Data Log will be displayed configured with the selected parameters.

Standard GroupsThe Data Log display may also be customized using predetermined groups of parameters (Standard Groups) by pressing the [STANDARD GROUPS] key on the CUSTOMIZE DISPLAY for Data Log screen. The preceding figure shows the WBC Group placed in GROUP 1, the RBC Group placed in GROUP 2, the PLT Group placed in GROUP 3, and the Diff Group placed in GROUP 4.

Procedure: Standard Groups1. From the main DATA LOG screen, press the

[CUSTOMIZE DATA LOG] key to display the CUSTOMIZE DISPLAY for Data Log screen.

2. Press the [STANDARD GROUPS] key to display the CUSTOMIZE DISPLAY for Data Log screen and key labels for Standard Groups.

3. Use the arrow keys on the keyboard to move the cursor to the desired group location (1–4).

NOTE: This number indicates the order in which the group of parameters will be displayed (Group 1 on the first screen, Group 2 on the second, etc.).

4. Press the soft key corresponding to the desired parameter group. This group will be displayed in the position indicated by the cursor position.

5. Repeat steps 3 and 4 until all desired groups have been selected.


7. Press the [RETURN] key to return to the DATA LOG screen.

8. The Data Log is displayed configured with the Standard Groups of parameters.


9140320C — November 2000


Customizing the Printout

Figure 5.52: Customize Printout for Data Log Screen Showing Customized Print Group

* Clinical significance has not been established for these parameters. Therefore, they are not reportable in the U.S.

SELECTPARAMETER

STANDARDSELECTION

RETURN

CUSTOMIZE PRINTOUTReady

Jul 21 1998Operator IDSequence #


WBC NEU LYM MONO EOS BASORBC HGB HCT MCV MCH MCHC RDWPLT MPV PCT* PDW*

%N %L %M %E %BRUT1 RUT2 RCT1 RCT2WUT WCT WIC WOC

WBC WIC WOC %N %L %M %E %B RBC HGB HCT MCV

MCH MCHC RDW PLT MPV

Auto-Sampler Ready



The CUSTOMIZE PRINTOUT for Data Log screen (see the preceding figure) shows the group of parameters that will be printed on a Data Log printout. A list of the available parameters is displayed under the group. The parameters can be selected from the list and placed in the desired position to customize the printout. In addition to the usual hematologic parameters, the following parameters can also be printed in the Data Log:



WUT WUT is the WIC Upper Metering Time. WCT WCT is the WIC Count Time. WIC WIC is the WBC Impedance Count.WOC WOC is the WBC Optical Count.

Procedure: Customize Data Log Printout1. From the main DATA LOG screen, press the

[CUSTOMIZE DATA LOG] key followed by the [CUSTOMIZE PRINTOUT] key.

2. Use the arrow keys on the keyboard to move the cursor to the desired parameter in the list displayed under the printout group.

3. Press the [SELECT PARAMETER] key. The selected parameter will be highlighted and the cursor will move to the first position in the group.

NOTE: The key label will change to [PLACE PARAMETER] and a [CANCEL SELECTION] key will be displayed.


NOTE: When the [PLACE PARAMETER] key is pressed, the selected parameter will be displayed in the position indicated by the cursor and the cursor will then advance to the next parameter in the list displayed under the printout group.



7. Press the [RETURN] key twice to return to the DATA LOG screen.


9140320C — November 2000


Data Review from the Data Log

Scrolling Through the Data LogThe Page Up and Page Down keys on the keyboard may be used to scroll rapidly through the records stored in the Data Log. Pressing the Page Up key scrolls backward, and pressing the Page Down key scrolls forward.

Displaying a RecordA copy of the RUN screen may be displayed for all 10,000 records in the CELL-DYN 3700 System Data Log. A record is displayed by positioning the cursor at the desired record in the Data Log listing and pressing the [DISPLAY SPECIMEN] key. The Status Box indicates DISPLAY SPECIMEN on results displayed (or printed) from the Data Log record. (See the following figure.)

Figure 5.53: Display Specimen Screen

Procedure: Record Display1. From the MAIN MENU screen, press the [DATA LOG] key.

2. If the desired record is not displayed on the screen, press the [FIND SPECIMEN] key to display the DATA LOG SEARCH screen.

PREVIOUSSPECIMEN

NEXTSPECIMEN

EDITSPECIMEN

CUSTOMIZEREPORT

TRANSMITSPECIMEN

PRINTTICKET

PRINTREPORT

RETURN



11:14sh0630

Spec ID ------------ 9742/BPatient ----------------Sex(M/F):- DOB:--/--/--Dr ----------------------Param Set: 1 Limits: 1

WBC 4.97 K/uLNEU 3.53 71.0 %NLYM .813 16.4 %L

MONO .450 9.05 %MEOS .103 2.07 %E

BASO .074 1.49 %B

RBC 5.48 M/uLHGB 15.7 g/dLHCT 58.2 %MCV 106. fLMCH 28.7 pg



Sequence # 346

GRANLRTY

SIZE


PLT RBCRCT:6.09

BANDS

DFLT (NLMEB)

RBC MORPH

WCT:4.29

Closed Sampler

SUSPECT



3. Use the arrow keys on the keyboard to move the cursor to the desired identifier: sequence number, specimen ID number, or name.

4. Type the appropriate information and press the Enter key on the keyboard to start the search.

NOTE: If necessary, you may press the Escape (ESC) key or the Enter key on the keyboard to exit from the search function and return to the DATA LOG screen.

5. If the requested record is available, the screen will display the Data Log page containing it. (The cursor will be located at the sequence number of the record.)

6. Press the [DISPLAY SPECIMEN] key to display the RUN screen for the selected record.

7. To obtain a printout, press the [PRINT REPORT] key.

NOTE: If color printing has been selected, the key label will change to [COLOR PRINT] and a color printout will be generated when the key is pressed.

8. The [PREVIOUS SPECIMEN] or [NEXT SPECIMEN] key may now be used to display records listed in the Data Log which are adjacent to the one currently displayed.


9140320C — November 2000


Editing a RecordThe Patient Demographics and the Parameter and Patient Limit Sets may be edited for each record. (See the following figure.)

Figure 5.54: Edit Specimen Screen

Procedure: Edit a Record1. From the MAIN MENU screen, press the [DATA LOG] key.

2. Locate the desired record and press the [DISPLAY SPECIMEN] key followed by the [EDIT SPECIMEN] key.

3. Use the arrow keys on the keyboard to move the cursor to the line that will be edited, and type the appropriate information. Press the Enter key on the keyboard to save the entry.

4. Press the [CONFIRM] key to display the RUN screen for the edited result.

5. To obtain a printout, press the [PRINT REPORT] key or the [COLOR PRINT] key.

PREVIOUSSPECIMEN

NEXTSPECIMEN

EDITSPECIMEN

CUSTOMIZEREPORT

TRANSMITSPECIMEN

PRINTTICKET

PRINTREPORT

RETURN



11:14sh0630

Spec ID ------------ 9742/BPatient ----------------Sex(M/F):- DOB:--/--/--Dr ----------------------Param Set: 1 Limits: 1

WBC 4.97 K/uLNEU 3.53 71.0 %NLYM .813 16.4 %L

MONO .450 9.05 %MEOS .103 2.07 %E

BASO .074 1.49 %B

RBC 5.48 M/uLHGB 15.7 g/dLHCT 58.2 %MCV 106. fLMCH 28.7 pg



Sequence # 346

GRANLRTY

SIZE


PLT RBCRCT:6.09

BANDS

DFLT (NLMEB)

RBC MORPH

WCT:4.29

Closed Sampler

Press CONFIRM to save changes or CANCEL to cancel changes.

SUSPECT


Operating InstructionsChapter 5 References

References

1. International Committee for Standardization in Haematology (ICSH). Protocol for Evaluation of Automated Blood Cell Counters. Clinical and Laboratory Hematology. 1984; 6:69–84.

2. Clinical and Laboratory Standards Institute/NCCLS. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard – Fifth Edition. CLSI/NCCLS document H3-A5 (ISBN 1-56238-515-1) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2003.

3. Clinical and Laboratory Standards Institute/NCCLS. Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard – Fifth Edition. CLSI/NCCLS document H4-A5 (ISBN 1-56238-538-0) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2004.


9140320C — November 2000

Operating InstructionsReferences Chapter 5

NOTES


Chapter 6 CalibrationCalibration

Overview

The CELL-DYN 3700 System is calibrated at the factory just prior to shipment. An Abbott Field Service Representative will assist the operator in confirming this calibration during instrument installation. The instrument is very stable and should not require frequent recalibration when it is operated and maintained according to the recommendations in this manual.

The following parameters may be calibrated: WBC (WIC and WOC), RBC, HGB, MCV, PLT and MPV.

This Overview contains the following subsections:

• When to Calibrate

• Open and Closed Modes

• Calibration Methods

• Calibration Materials

• Conventions Used in This Chapter

The rest of this chapter contains the following subsections:

• Calibration Procedural Summary

• Calibration Menus

• Pre-Calibration Procedures

• Auto-Cal Calibration

• Manual Calibration

• Mode-to-Mode Calibration

• WIC/WOC

• Post-Calibration Procedures

When to CalibrateScheduled calibration of the CELL-DYN 3700 System should conform to the guidelines established by regulatory agencies.

Calibration should be confirmed by running controls on a regular basis according to the requirements governing quality control in your laboratory. In keeping with good laboratory practices, this should include daily confirmation and following a reagent lot number change.

Unscheduled calibration is indicated following service adjustments performed by Abbott Field Service Representatives such as major component changes.


9140320C — November 2000

CalibrationOverview Chapter 6

Unscheduled calibration is also necessary when indicated by the results of the Quality Control program. However, calibration should be considered as the very last step in a troubleshooting sequence. Performing unnecessary calibrations may mask an underlying problem with instrument performance.

On-board Quality Control programs are designed to provide continual monitoring and verification of instrument calibration. The laboratory should make the decision to recalibrate based on the performance of the CELL-DYN 3700 System in these Quality Control programs. The programs include (1) statistical computations and Westgard Rules for commercial or patient controls and (2) monitoring of patient samples for WBC parameters with moving averages and RBC parameters using Bull’s Moving Average Program (X-B).

Confirmation of calibration is also recommended following the replacement of any major instrument component (for example, the Shear Valve) that could affect calibration. Calibration may be confirmed by running appropriate commercial controls or by using fresh whole blood samples that were analyzed on a reliably calibrated hematology analyzer or by reference methodology.

Open and Closed ModesThe CELL-DYN 3700 System has three modes of operation:

• Open Mode

• Closed Mode — Sample Loader version

• Closed Mode — Closed Sampler version

NOTE: Each CELL-DYN 3700 System has only one Closed Mode of operation.

Both the Open and Closed Modes must be calibrated individually. There are several ways to accomplish the total calibration, depending only on the preference of the operator.


CalibrationChapter 6 Overview

Calibration MethodsTwo methods can be used to calibrate the CELL-DYN 3700 System:

• Auto-Cal is an automatic calibration program that is incorporated into the Data Station software.

NOTE: Auto-Cal is available in the Open Mode only on the CELL-DYN 3700SL System. Therefore, all references to Closed Mode calibration with Auto-Cal pertain to the CELL-DYN 3700CS System.

• Manual Calibration is an alternative to Auto-Cal calibration.

The instrument’s Open Mode is calibrated with the calibration material of choice, using the method of choice. The Closed Mode is then calibrated to match it, with fresh whole blood samples using the Mode to Mode Calibration method of choice.

Calibration MaterialsTwo calibration materials can be used to calibrate the CELL-DYN 3700 System:

• Commercial Calibrator

Calibration with CELL-DYN Calibrator is most efficiently performed by calibrating the Open Mode. The Closed Mode is then calibrated to match the Open Mode using fresh whole blood samples.

• Fresh Whole Blood

Calibration with fresh whole blood is accomplished by performing multiple analyses of each specimen by acceptable reference methodology and calculating the mean reference value for each parameter. The same specimens are then analyzed on the CELL-DYN 3700 System in the Open Mode. The Closed Mode is then calibrated to match the Open Mode using another set of fresh whole blood specimens. A detailed discussion of Reference Whole Blood Calibration is given in the next section.

Commercial Calibrator GuidelinesFor commercial calibrators, follow the directions given in the package insert. Be certain to carefully read and follow directions given for warming and mixing.


9140320C — November 2000


Whole Blood Calibration Guidelines

OverviewCalibration with fresh whole blood samples is an alternative to calibration with a commercial calibrator. Since specimens used in place of a calibrator are ‘assayed’ by reference methods, this is referred to as a Reference Whole Blood Calibration.

Fresh whole blood samples may also be used for an Instrument to Instrument Calibration after each instrument has been independently calibrated with a commercial calibrator or a Reference Whole Blood Calibration.

The first part of this section gives the requirements for fresh whole blood samples used for calibration. The second part discusses the requirements for a Reference Whole Blood Calibration and the reference methods that should be used. The last part describes the requirements and procedure for an Instrument to Instrument Calibration.

Requirements for Fresh Whole Blood SpecimensThe following requirements should be observed for fresh whole blood specimens used for calibration:

• The ICSH recommends that fresh specimens be less than four hours old.1 Specimen age must not exceed eight hours at the conclusion of the calibration procedure.

All parameter values should be within the laboratory’s normal range. The following ranges are programmed for the reference values that may be entered in the Auto-Cal program. Results outside these limits cannot be entered.

WBC 1.99–25.0 K/µL (WIC and WOC)

RBC 2.00–6.50 M/µL

HGB 3.99–24.0 g/dL

MCV 70.0–100.0 fL

PLT 50.0–600.0 K/µL

• All cellular morphology must be normal.

• No known interfering substances should be present (for example, lipemia, icterus, drugs).

• All specimens must be properly collected in tubes containing the EDTA anticoagulant used by the laboratory.

• Each tube should contain at least 90% of the nominal collection volume of blood.



Requirements for Reference Whole Blood CalibrationMinimum requirements for a Reference Whole Blood Calibration are described in the following list. Specimens used must meet the requirements for fresh whole blood samples described earlier in this section. Additional specimens and/or more repetitions of the specimens may be used to achieve calibration accuracy beyond CLSI/NCCLS recommendations.

1. A minimum of five specimens is required for adequate whole blood calibration.

2. Specimens must be assayed at least in triplicate by reference methodology and on the CELL-DYN 3700 System.

3. No more than two hours should elapse between the CELL-DYN 3700 System run and the assay by reference methodology. If specimens are run on the CELL-DYN 3700 System first, assay by reference methodology should be completed within one hour. (Certain reference methodologies are sensitive to RBC swelling caused by in vitro deoxygenation.)

4. Mean values should be calculated for each parameter for each sample from the reference assay results. These mean parameter values can then be entered in the Auto-Cal program as reference values for each sample.

5. If Auto-Cal is not being used, the mean parameter values should be averaged to obtain the cumulative mean value for each parameter.

A worksheet is provided at the end of this section. This worksheet may be used to assist with calculation of the reference mean values and may be duplicated as needed.

Reference MethodsReference values for a Reference Whole Blood Calibration should be determined according to the following ICSH recommendations.

WBC, RBC, and PLTReference values for white blood cells, red blood cells, and platelets may be determined using multiple counts from a certified hemocytometer, from a counter that meters a fixed, calibrated sample volume, or from a reliably calibrated hematology analyzer.

NOTE: Enter the reference value for WBC as the WIC reference value and enter the same value as the WOC reference value.


9140320F — April 2007


HGBReference values for hemoglobin may be determined using either the reference cyanmethemoglobin method or a reliably calibrated hemoglobinometer or hematology analyzer.

NOTE: DO NOT attempt to calibrate the CELL-DYN 3700 System with a hemoglobin standard designed for the calibration of specific reference cyanmethemoglobin methods. The instrument uses a modified hemiglobincyanide or a modified hemiglobinhydroxyalamine method which is not designed to analyze these standards directly.

MCVReference values for the mean cell volume may be determined by calculation from the reference microhematocrit and RBC measurements or from multiple analyses on a reliably calibrated hematology analyzer.

NOTE: Reference microhematocrit values may be determined by multiple analyses using the CLSI/NCCLS method for Packed Cell Volume (PCV).2 Use only plain (non-anticoagulated) capillary tubes. Be certain to verify the proper operation of the microhematocrit centrifuge and the timer as recommended by CLSI/NCCLS.



Instrument to Instrument CalibrationSpecimens used for an Instrument to Instrument Calibration must meet the requirements for fresh whole blood samples described earlier in this section, except that specimens may be used within 6 hours of collection time. Sample age must not exceed 8 hours at the completion of the procedure.

1. Select 10 samples that meet all requirements.

2. Confirm that the calibration of each instrument is acceptable. It is preferable that Instrument to Instrument Calibration be performed immediately after each instrument is calibrated with the calibration material and method of choice.

3. Choose one instrument to be the primary (reference) instrument and designate the other instrument as the secondary instrument. The secondary instrument will be calibrated to match the primary instrument.

NOTE: It is suggested that Instrument to Instrument Calibration be performed in the Open Mode on the secondary instrument prior to performing the Mode to Mode Calibration procedure.

4. Follow the directions in Manual Mode to Mode Calibration (CS or SL), substituting the primary instrument for the Open Mode and the secondary instrument for the Closed Mode.

5. Calibrate the Open Mode of the secondary instrument to match the primary instrument.

6. After the Instrument to Instrument Calibration for the Open Mode on the secondary instrument is confirmed, perform the Mode to Mode Calibration on the instrument.


9140320C — November 2000


NOTES



Whole Blood Calibration Reference Values

Whole Blood Calibration Reference Values Worksheet

Date:___________________________________Parameter:_________________________________________

Technologist:____________________________Method:__________________________________________

___________________________________________________________________________________________

Sample ID

Reference Assays

Mean1 2 3 4 5 6 7 8 9 10

Cumulative Parameter Mean


9140320C — November 2000


NOTES



Calibration Procedural Summary

* Be sure to read Calibration Materials, Whole Blood Calibration Guidelines within the Overview of this chapter for complete information on fresh whole blood sample requirements.

Conventions Used in this ChapterA description of the conventions used in this chapter is given in the Introduction in this manual.

Step Choices

1. Read appropriate overview • Auto-Cal Calibration• Manual Calibration• Mode to Mode Calibration

2. Complete Pre-Calibration Procedures

Pre-Calibration Procedures Checklist

3. Open Mode Calibration Procedures

Choose ONE:

• Auto-Cal Using Commercial Calibrator

• Auto-Cal Using Fresh Whole Blood*• Manual Calibration*

4. Closed Mode Calibration Procedures

Choose ONE:

• Auto-Cal Mode to Mode Calibration for CELL-DYN 3700CS*

• Manual Mode to Mode Calibration for CELL-DYN 3700SL or CS*

5. Complete Post-Calibration Procedures

Complete both Quality Control and Calibration Backup


9140320C — November 2000


NOTES


CalibrationChapter 6 Calibration Menu

Calibration Menu

Calibration Menu Flowchart

CANCELREPEAT

CONFIRMREPEAT

CALIBRATIONReady

ENTERFACTOR

MAIN

CALIBRATNLOG

PRINTAUTO-CALIBRATE

CLOSEDSAMPLER

OPENSAMPLER

RESTOREFACTORS

RESET ALLTO 1.000

RETURN

RETURN

PRINTLOG

CLOSEDSAMPLER

OPENSAMPLER

CALIBRATRWHOLEBLOOD

RETURN

MPVLATEX

QUITAUTO-CAL

CONTINUEAUTO-CAL

RETURN

PRINTSUMMARY

CLEARREF VALS

STARTAUTO-CAL

EDITREF VAL

CANCELCLEAR

CONFIRMCLEAR

CANCELQUIT

CONFIRMQUIT

QUITAUTO-CAL

INTERRUPTAUTO-CAL

RETURN

PRINTACCEPTMEANS

REPEATSPECIMEN

NEXTSPECIMEN

PREVIOUSSPECIMEN

CONTINUEAUTO-CAL

CANCELACCEPT

CONFIRMACCEPT

QUITAUTO-CAL

CONTINUEAUTO-CAL

RETURN

PRINTSUMMARY

CLEARREF VALS

STARTAUTO-CAL

EDITREF VAL

CHANGESAMPLER

(CS MODEL ONLY)

CANCELQUIT

CONFIRMQUIT


9140320C — November 2000

CalibrationCalibration Menu Chapter 6

Calibration Screen

Figure 6.1: Calibration Screen Displaying Open Mode Calibration Factors

The CALIBRATION screen is accessed from the MAIN MENU screen by pressing the [CALIBRATION] key. The CALIBRATION screen displays the current calibration factors for the mode indicated, the calibration method used, the date and time the factors were entered, and the operator ID.

The following soft key labels are displayed on the CALIBRATION screen:

ENTER FACTORCALIBRATN LOGAUTO-CALIBRATEOPEN SAMPLER or CLOSED SAMPLER (This key label alternates between


PRINTMAIN

ENTERFACTOR

CALIBRATNLOG

AUTO-CALIBRATE

CLOSEDSAMPLER

PRINT MAIN

CALIBRATIONReady


16:01rcs0711

Open Sampler

Open Sampler Calibration Factors:

Parameter Method Factor Date Time Operator

WOC ENTER FACTOR 1.054 12/20/98 14:15 rcs

WIC ENTER FACTOR 0.958 12/20/98 14:15 rcs

RBC ENTER FACTOR 0.841 12/20/98 14:15 rcs

HGB ENTER FACTOR 0.924 12/20/98 14:15 rcs

MCV ENTER FACTOR 0.878 12/20/98 14:15 rcs

PLT ENTER FACTOR 0.787 12/20/98 14:15 rcs

MPV FACTORY 1.000 --/--/-- --:-- ---

CALIBRA-

TION



The function of each key is discussed briefly in this section. The Auto-Cal Calibration Procedures provide detailed instructions for using the Auto-Cal program.

NOTE: For ease of explanation, the key labels may not always be discussed in the order in which they appear on the screen.

Figure 6.2: Calibration Menu Screen Displaying Closed Mode Calibration Factors

Open Sampler/Closed Sampler Soft KeyThe [OPEN SAMPLER/CLOSED SAMPLER] key is used to display the current calibration factors for the mode selected (see the two preceding figures).

NOTE: The key is labeled for the sampler mode that is NOT currently displayed.

Print Soft KeyThe [PRINT] key is used to print the Current Whole Blood Factors displayed on the CALIBRATION screen.

ENTERFACTOR

CALIBRATNLOG

AUTO-CALIBRATE

OPENSAMPLER

PRINT MAIN

CALIBRATIONReady

Open Sampler

Closed Sampler Calibration Factors:

Parameter Method Factor Date Time Operator

WOC ENTER FACTOR 1.054 12/20/98 14:15 rcs

WIC ENTER FACTOR 0.958 12/20/98 14:15 rcs

RBC ENTER FACTOR 0.841 12/20/98 14:15 rcs

HGB ENTER FACTOR 0.924 12/20/98 14:15 rcs

MCV ENTER FACTOR 0.878 12/20/98 14:15 rcs

PLT ENTER FACTOR 0.787 12/20/98 14:15 rcs

MPV FACTORY 1.000 --/--/-- --:-- ---


16:01rcs0711

OPEN

SAMPLER

CLOSED

SAMPLER

PRINT


9140320C — November 2000


Main Soft KeyThe [MAIN] key is used to return to the MAIN MENU screen.

Enter Factor Soft KeyThe [ENTER FACTOR] key is used to display the ENTER CALIBRATION FACTOR screen showing the current Open and Closed Calibration Factors (see the following figure). Calibration factors may be changed on this screen by moving the cursor to the desired position, typing the new factor, and pressing the Enter key on the keyboard. The following soft key labels are displayed on this screen:

RESTORE FACTORSRESET ALL TO 1.000RETURN

Figure 6.3: Enter Calibration Factor Screen

MAIN

ENTER

FACTOR

RESTOREFACTORS

RESET ALLTO 1.000

RETURN

ENTER CALIBRATION FACTORReady

Open Sampler Closed SamplerParameter (Factor Range) Factor Factor

WOC (0.70…1.30) 1.008 1.056WIC (0.70…1.30) 1.008 1.056RBC (0.80…1.20) 1.071 1.060HGB (0.70…1.30) 1.124 1.136MCV (0.70…1.30) 0.985 0.985PLT (0.70…1.30) 1.028 0.939MPV (0.70…1.30) 1.000 1.000


16:01rcs0711



Restore Factors Soft KeyThe [RESTORE FACTORS] key is used to restore the previous calibration factors. This key is only active immediately after factors have been changed.

Reset All to 1.000 Soft KeyThe [RESET ALL TO 1.000] key is used to reset all of the calibration factors to 1.000.

Return Soft KeyThe [RETURN] key is used to return to the CALIBRATION screen.

RESTORE

FACTORS

RESET ALL

TO 1.000

RETURN


9140320C — November 2000


Calibration Log Soft Key

Figure 6.4: Calibration Log Screen

The [CALIBRATN LOG] key is used to display the CALIBRATION LOG screen for the Open or Closed Mode. The following soft key labels are displayed when the [CALIBRATN LOG] key is pressed:

OPEN SAMPLER or CLOSED SAMPLER (This key label alternates between

these two selections.)PRINT LOGRETURN

Open Sampler/Closed Sampler Soft KeyThe [OPEN SAMPLER/CLOSED SAMPLER] key is used to display the calibration log for the selected mode.

NOTE: The key is labeled for the sampler mode that is NOT currently displayed.

Print Log Soft KeyThe [PRINT LOG] key is used to print the Calibration Log for the displayed mode.

CLOSEDSAMPLER

PRINTLOG

RETURN

CALIBRATION LOGReady

Open SamplerOpen Sampler Calibration Log

Date Time OpID WOC WIC RBC HGB MCV PLT MPV12/20/98 14:15 rcs 1.05(E) 0.96(E) 0.84(E) 0.92(E) 0.88(E) 0.79(E) 1.00(F)

Comments:


16:01rcs0711

CALIBRATN

LOG

OPEN

SAMPLER

CLOSED

SAMPLER

PRINT

LOG




Auto-Calibrate Soft Key

Figure 6.5: Auto-Calibration Screen for CELL-DYN 3700CS System

The [AUTO-CALIBRATE] key is used to access the Auto-Calibration program. The AUTO-CALIBRATION screen and the following soft key labels are displayed when this key is pressed:

WHOLE BLOODCALIBRATRMPV LATEXCHANGE SAMPLER (This key is available on the CELL-DYN

3700CS System only.)RETURN

Change Sampler Soft KeyThe [CHANGE SAMPLER] key is used to change the Sample Aspiration Mode of the Analyzer from the currently selected mode that is indicated on the screen.

NOTE: This key is available on the CELL-DYN 3700CS System only.

RETURN

WHOLEBLOOD

CALIBRATR MPVLATEX

CHANGESAMPLER

RETURN

AUTO-CALIBRATIONReady

Open SamplerOpen sampler is selected. To calibrate using the

closed sampler (SL), refer to the manual mode to modecalibration procedure given in the operator’s manual.

To proceed, press the key for the specimen type being used (WHOLE BLOOD, CALIBRATR, or MPV LATEX).


16:03rcs0711

AUTO-

CALIBRATE

CHANGE

SAMPLER


9140320C — November 2000



Whole Blood Soft Key

Figure 6.6: Whole Blood Auto-Cal Screen

The [WHOLE BLOOD] key is used to display the WHOLE BLOOD AUTO-CAL screen. This screen accesses the Auto-Cal program that is used to calibrate the instrument with fresh whole blood samples. The following soft key labels are displayed on this screen:

EDIT REF VALSTART AUTO-CALQUIT AUTO-CALCLEAR REF VALSPRINT SUMMARYRETURN

RETURN

EDITREF VAL

STARTAUTO-CAL

QUITAUTO-CAL

CLEARREF VALS

PRINTSUMMARY

RETURN

WHOLE BLOOD AUTO-CALReady

Open Sampler

Enter reference value for each parameter to be calibrated: (up to 10 specimens)Spec ID RUNS WOC WIC RBC HGB MCV PLT

Min 1 1.99 1.99 2.00 3.99 70.0 50.0Max 10 25.0 25.0 6.50 24.0 100. 600.

CAL#01 3 7.30 7.30 4.24 12.9 90.0 244.CAL#02 3 ---- ---- ---- ---- ---- ----


16:01rcs0711

WHOLE

BLOOD



Edit Reference Value Soft KeyThe [EDIT REF VAL] key is used to edit the displayed reference value indicated by the position of the cursor. The key deletes the existing value and the cursor remains in position for the new entry.

Clear Reference Values Soft KeyThe [CLEAR REF VALS] key is used to delete the reference values that are currently displayed. The following soft key labels are displayed when the [CLEAR REF VALS] key is pressed:

CONFIRM CLEARCANCEL CLEAR

These keys are used to confirm or cancel the Clear Reference Values command.

Print Summary Soft KeyThe [PRINT SUMMARY] key is used to print the entered reference values.

Return Soft KeyThe [RETURN] key is used to return to the AUTO-CALIBRATION screen.

Start Auto-Cal Soft KeyThe [START AUTO-CAL] key starts the Auto-Cal program by initiating three background counts.

EDIT

REF VAL

CLEAR

REF VALS

PRINT

SUMMARY

RETURN

START

AUTO-CAL


9140320C — November 2000


Continue Auto-Cal Soft Key

Figure 6.7: Whole Blood Auto-Cal Screen

The [CONTINUE AUTO-CAL] key is displayed after the background counts are completed. (See the preceding figure.)

The key label changes to [INTERRUPT AUTO-CAL] after the key is pressed.

The WHOLE BLOOD AUTO-CAL RESULTS screen (see the following figure) and the following soft key labels are displayed when the [CONTINUE AUTO-CAL] key is pressed:

INTERRUPT AUTO-CALQUIT AUTO-CALPRINTRETURN

EDITREF VAL

CONTINUEAUTO-CAL

QUITAUTO-CAL

CLEARREF VALS

PRINTSUMMARY

RETURN

WHOLE BLOOD AUTO-CALReady for calibration

Open Sampler

Enter reference value for each parameter to be calibrated: (up to 10 specimens)Spec ID RUNS WOC WIC RBC HGB MCV PLT

Min 1 1.99 1.99 2.00 3.99 70.0 50.0Max 10 25.0 25.0 6.50 24.0 100. 600.

CAL#01 3 7.30 7.30 4.24 12.9 90.0 244.CAL#02 3 ---- ---- ---- ---- ---- ----


16:01rcs0711

CONTINUE

AUTO-CAL

INTERRUPT

AUTO-CAL



Interrupt Auto-Cal Soft Key

Figure 6.8: Whole Blood Auto-Cal Results Screen

The [INTERRUPT AUTO-CAL] key is used to interrupt (pause) the Auto-Cal program.

Quit Auto-Cal Soft KeyThe [QUIT AUTO-CAL] key is used to exit from the Auto-Cal program before it is completed. When the [QUIT AUTO-CAL] key is pressed, the Bulletin Line displays the message ALL EXISTING DATA AND RESULTS WILL BE CLEARED. The following soft key labels are displayed:

CONFIRM QUITCANCEL QUIT

These keys are used to confirm or cancel the Quit Auto-Cal command.

Print Soft KeyThe [PRINT] key is used to print the WHOLE BLOOD AUTO-CAL RESULTS screen.

INTERRUPTAUTO-CAL

QUITAUTO-CAL

PRINT RETURN

WHOLE BLOOD AUTO-CALReady for Calibration

Open SamplerRESULTS FOR SPECIMEN #1

Spec 1 Mean FactorParameter Value RUN1 Factor Factor(1) %Diff

WOC 7.30 ---- ---- ---- ----WIC 7.30 ---- ---- ---- ----RBC 4.24 ---- ---- ---- ----HGB 12.9 ---- ---- ---- ----MCV 90.0 ---- ---- ---- ----PLT 244. ---- ---- ---- ----

SPEC ID CAL#01-01NO OF RUNS 331


16:01rcs0711

INTERRUPT

AUTO-CAL

CONTINUE

AUTO-CAL

QUIT

AUTO-CAL

PRINT


9140320C — November 2000


Return Soft KeyThe [RETURN] key is used to return to the REFERENCE VALUE ENTRY screen.

Repeat Specimen Soft Key

Figure 6.9: Whole Blood Auto-Cal Results Screen with Results

The [REPEAT SPECIMEN] key is displayed when the first run of the first specimen is completed (see the preceding figure). This key is used to delete all results (runs) for the current specimen.

NOTE: This key deletes ALL RESULTS for ALL RUNS of the current specimen. It does not delete one run only.

RETURN

REPEATSPECIMEN

INTERRUPTAUTO-CAL

QUITAUTO-CAL

PRINT RETURN

WHOLE BLOOD AUTO-CALReady for Calibration

Open SamplerRESULTS FOR SPECIMEN #1

Spec 1 Mean FactorParameter Value RUN1 RUN2 RUN3 Factor Factor(1) %Diff

WOC 7.30 7.42 ---- ---- 0.980 ---- ----WIC 7.30 7.42 ---- ---- 0.980 ---- ----RBC 4.24 4.39 ---- ---- 0.970 ---- ----HGB 12.9 13.0 ---- ---- 0.990 ---- ----MCV 90.0 91.0 ---- ---- 0.990 ---- ----PLT 244. 254. ---- ---- 0.960 ---- ----

SPEC ID CAL#01-01NO. OF RUNS 3


16:01rcs0711

REPEAT

SPECIMEN



Calibrator Soft Key

Figure 6.10: Calibrator Auto-Cal Screen

The [CALIBRATR] key is used to display the CALIBRATOR AUTO-CAL screen (see the preceding figure). This screen accesses the Auto-Cal program that is used to calibrate the instrument with a commercial calibrator. The following soft key labels are displayed on this screen:

EDIT REF VALSTART AUTO-CALQUIT AUTO CALCLEAR REF VALSPRINT SUMMARYRETURN

These soft keys have the same functions as described for the WHOLE BLOOD AUTO-CAL screen.

NOTE: If Auto-Cal was last performed with a calibrator, the following key labels are displayed when the [WHOLE BLOOD] key is pressed:

CONFIRM SELECTIONCANCEL SELECTION

Open Sampler

Enter reference value for each parameter to be calibrated: (up to 10 specimens)Spec ID Runs WOC WIC RBC HGB MCV PLT MPV

Min 1 4.59 4.59 3.00 10.0 85.0 150. 4.99Max 10 10.2 10.2 5.50 15.5 97.0 400. 20.0

CAL#01 3 7.30 7.30 4.46 13.2 85.4 257. 8.00CAL#02 3 ---- ---- ---- ---- ---- ----

EDITREF VAL

STARTAUTO-CAL

QUITAUTO-CAL

CLEARREF VALS

PRINTSUMMARY

RETURN

CALIBRATOR AUTO-CALReady


16:01rcs0711

CALIBRATR


9140320D — June 2003


These keys are used to confirm or cancel the Whole Blood Auto-Cal selection. The Bulletin Line displays the following message:

PRESS CONFIRM SELECTION TO CLEAR PREVIOUS AUTO-CAL REFERENCE VALUES.

MPV Latex Soft Key

Figure 6.11: Latex Auto-Cal Screen

The [MPV LATEX] key is used to display the MPV LATEX AUTO-CAL screen (see the preceding figure).

Open Sampler

Enter latex reference value for MPV: (up to 10 specimens)Spec ID RUNS MPV

Min 1 4.99Max 10 20.0

CAL#01 3 7.30CAL#02 3 ----

EDITREF VAL

STARTAUTO-CAL

QUITAUTO-CAL

CLEARREF VALS

PRINTSUMMARY

RETURN

MPV LATEX AUTO-CALReady


16:01rcs0711

MPV

LATEX


CalibrationChapter 6 Pre-Calibration Procedures

Pre-Calibration Procedures

It is advisable to perform calibration at a time when it can be completed without interruption. The Pre-Calibration procedures in this section verify proper instrument performance to ensure a successful calibration. These steps should be completed just prior to beginning the calibration procedure itself. If problems are detected during these checks, do not attempt to calibrate the instrument. If necessary, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the U.S.). After the problems have been resolved, repeat the Pre-Calibration procedures to verify proper performance.

The Pre-Calibration Procedures Checklist included in this section may be duplicated as needed.

Calibration Guidelines1. Always perform the daily, weekly, and monthly scheduled

maintenance as directed in Chapter 9: Maintenance before calibrating the instrument. Instrument cleanliness is essential for accurate calibration. Therefore, each laboratory should perform any additional maintenance according to its requirements.

2. Use only recommended CELL-DYN reagents.

3. Verify the precision for the Open and Closed Modes prior to calibration as directed in the Pre-Calibration Procedures Checklist.

4. Precision should be verified for both WIC and WOC. This is accomplished by configuring a QC file to display and print both results.

NOTE: If necessary, refer to the directions for customizing the display and printout of a QC file given in Chapter 5: Operating Instructions, Subsection: Set-Up Instructions.

5. Select and process all whole blood samples according to the requirements given in the Overview, Calibration Materials, Whole Blood Calibration Guidelines within this chapter.

6. Be certain that any calibrator material is brought to room temperature and mixed according to the manufacturer’s instructions given in the package insert.

7. Be certain that the operator performing the calibration has read and understands the information contained in the package insert for the calibrator.

8. Be certain that the operator performing the calibration has read and understands the calibration procedure(s).


9140320C — November 2000

CalibrationPre-Calibration Procedures Chapter 6

NOTES



CELL-DYN 3700 System

Pre-Calibration Procedures ChecklistInstrument:______________________________________ Date:_________________________________________

Operator: ______________________________________

1._______ Perform all required maintenance.

2._______ Verify that all reagent containers are at least 1/3 full.

3._______ Verify that the reagents have not reached the expiration date.

Diluent: Lot #____________ Exp. date _______

WIC/HGB Lyse: Lot #____________ Exp. date _______

Sheath Reagent: Lot #____________ Exp. date _______

Detergent: Lot #____________ Exp. date _______

4._______ If applicable, verify that the calibrator has not reached the expiration date.

Lot #____________ Exp. date _______

5._______ After the maintenance has been completed, verify that the background counts are within the acceptable limits. Record the background counts below or attach a printout to this document.

WIC <0.3 ________

WOC <0.3 ________

RBC <0.03 ________

HGB <0.2 ________

PLT <10.0 ________

6._______ Verify that the WIC Count Time is at the baseline value. Record the count time below.

WIC Count Time __________

7._______ Verify that the RBC Count Time is at the baseline value. Record the count time below.

RBC Count Time __________

8._______ From the DIAGNOSTICS MENU, obtain a printout of the VOLTAGE READINGS screen. Attach the printout to these worksheets.

9._______ Prime the instrument with five normal whole blood samples that are less than eight hours old.




10.______ Confirm the Open Mode precision by analyzing a fresh, normal, whole blood sample 10 times in succession. Run the sample in an empty control file and record the CVs below or attach a file printout to this document.

PARAMETER CV% LIMIT CV

WIC <2.8% ________

WOC <2.5% ________

RBC <1.5% ________

HGB <1.2% ________

MCV <1.0% ________

PLT <5.0% ________

11.______ a. CELL-DYN 3700SL System: Confirm the Closed Mode precision of the Sample Loader by obtaining 15 mL of blood from the same donor. Aliquot the blood into five 5-mL tubes that contain no anticoagulant. Run each tube twice in succession. Run the samples in an empty control file and record the CVs below or attach a file printout to this document.


WIC <2.8% ________

WOC <2.5% ________

RBC <1.5% ________

HGB <1.2% ________

MCV <1.0% ________

PLT <5.0% ________

b. CELL-DYN 3700CS System: Confirm the precision of the Closed Sampler by analyzing a fresh, normal, whole blood sample 10 times in succession. Run the samples in an empty control file and record the CVs below or attach a file printout to this document.


WIC <2.8% ________

WOC <2.5% ________

RBC <1.5% ________

HGB <1.2% ________

MCV <1.0% ________

PLT <5.0% ________

12.______ If any problems are detected during the procedures outlined above, document them on the following page.



Problems Detected_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

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_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

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9140320C — November 2000


NOTES


CalibrationChapter 6 Auto-Cal Overview

Auto-Cal Overview

The Auto-Cal program provides an automated calibration method that prepares the CELL-DYN 3700 System for calibration, calculates new calibration factors, and calibrates the instrument. The Auto-Cal program allows calibration with commercial calibrators or whole blood samples. Auto-Cal may be performed in either of the following two modes:

• Open Mode

• Closed Mode (CELL-DYN 3700CS System only)

On the CELL-DYN 3700SL System, Auto-Cal is available in the Open Mode only. Therefore, all references to Closed Mode calibration with Auto-Cal pertain to the CELL-DYN 3700CS System.

Some parameters may not need to be calibrated. Therefore, each procedure includes specific criteria that are used to determine which parameters require calibration. The criteria are:

• Validation Range — Calibration not required

• Calibration Limit — Do not calibrate, possible instrument problem exists

• Calibration Range — Calibration is required

Complete instructions for using these criteria and a Calibration Criteria Chart are included with each procedure to facilitate the decision.

The calibration procedures have been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section.

Worksheets are provided at the end of each procedure to assist in determining which parameters require calibration. For manual calibration, worksheets can be used to assist in making the necessary calculations. These worksheets can be duplicated as needed.

NOTE: Always complete the Pre-Calibration procedures before beginning any calibration.


9140320C — November 2000

CalibrationAuto-Cal Overview Chapter 6

Auto-Cal Sample CapacityAuto-Cal accepts up to ten consecutive sample runs on up to ten different samples as indicated in the following table.

Auto-Cal MethodologyThe Auto-Cal program automatically computes a calibration factor based on all acceptable data. (New factors are calculated using 1.000 as the reference.)

NOTE: Because the instrument uses 1.000 as the reference, results generated in the Auto-Cal mode may not correlate with results previously seen in the RUN mode. This DOES NOT indicate a problem.

New calibration factors are computed for each parameter by comparing each mean to the reference value entered for that sample. If more than one sample is used, factors are computed for each parameter from each of the samples. All of these factors are averaged to obtain the final calibration factor for a given parameter.

NOTE: When calibrating with whole blood, the reference WBC value must be entered for WIC and WOC in order to compute calibration factors for both parameters.

The program computes the percent difference between the existing calibration factor and the new one it computed. The operator either accepts or rejects the new factors based on the calibration criteria listed in Table 6.1, Calibration Criteria Chart.

Auto-Cal Program Sample Capacity

Specimen Type

Specimen Limit

Maximum Number of Consecutive Runs

Open Closed (Closed Sampler only)

WholeBlood 10 10 5

CommercialCalibrator 10 10 5


CalibrationChapter 6 Auto-Cal Overview

Calibration Requirements for Auto-CalThe Open Mode should be calibrated with the CELL-DYN Calibrator. The Closed Mode is then calibrated to match the Open Mode using fresh, normal, whole blood samples. The following requirements must be met in order to achieve an accurate calibration. Additional samples and/or more repetitions of the specimens may be used to achieve calibration accuracy beyond CLSI/NCCLS recommendations.

• Calibrator Calibration

The Calibrator should be cycled for a minimum of 6 and a maximum of 10 consecutive runs in the Open Mode. In order to most efficiently use the Auto-Cal program, it is suggested that the calibrator be cycled for nine consecutive runs as if it were three separate calibrators. This is accomplished by entering three for the number of runs for each ‘calibrator’ and entering the assay value three times.

NOTE: For parameters with assigned values that exceed the Auto-Calibration pre-set entry limits, use the manual method for calibration.

• Whole Blood Calibration

At least five different, fresh, normal whole blood specimens should be used. Each sample must be cycled for a minimum of three consecutive runs. Whole blood samples may be run in the Open or Closed Mode.

NOTE: Refer to Overview, Calibration Materials, Whole Blood Calibration Guidelines within this chapter for detailed instructions on performing a reference whole blood calibration.

• Closed Mode Calibration (CS only)

Ten normal whole blood samples should be used. After the Open Mode has been calibrated, each sample is cycled once in each mode. The results from these samples are then used to calibrate the Closed Mode.

NOTE: Complete directions for calibration of the Closed Mode are given in Mode to Mode Calibration within this chapter.


9140320C — November 2000

CalibrationAuto-Cal Overview Chapter 6

NOTES


CalibrationChapter 6 Auto-Cal Using Calibrator

Auto-Cal Using Calibrator

This calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section.

NOTE: Before beginning this procedure, be sure to perform the Pre-Calibration procedures and read Auto-Cal Overview within this chapter.

Starting Auto-Cal1. From the MAIN MENU screen, press the [CALIBRATION] key.

2. If necessary, press the [OPEN SAMPLER] key to display the Open Sampler calibration factors.

3. To obtain a printout of the Open Sampler Calibration Factors displayed on the screen, press the [PRINT] key.

NOTE: These calibration factors are retained in the Auto-Cal Calibration Log until 10 entries have been made. As each subsequent entry is made, the oldest existing entry will be deleted.

4. Press the [AUTO-CALIBRATE] key to select the AUTO-CALIBRATION screen.


6. Press the [CALIBRATR] key to select Calibrator Auto-Cal.

Entering the Reference ValuesEnter the reference (assay) values for the calibrator as follows:

1. Delete the existing values. Press the [CLEAR REF VALS] key followed by the [CONFIRM CLEAR] key.

2. Type the lot number of the calibrator in the <SPEC ID> field. Press the Enter key on the keyboard to save the entry and advance the cursor.



CalibrationAuto-Cal Using Calibrator Chapter 6

3. Type the desired number in the <# OF RUNS> field. Press the Enter key on the keyboard to save the entry and advance the cursor.

NOTE: The calibrator should be cycled for a minimum of 6 and a maximum of 10 consecutive runs in the Open Mode. In order to most efficiently use the Auto-Cal program, it is suggested that the calibrator be cycled for 9 consecutive runs as if it were three separate calibrators. This is accomplished by entering three for the number of runs for each calibrator and entering the assay value three times.

4. Type the assay value for each parameter in the appropriate parameter reference values field. Press the Enter key on the keyboard after each entry to save the entry and advance the cursor.

NOTE: For parameters with assigned values that exceed the Auto-Calibration pre-set entry limits, use the manual method for Calibration.

5. To obtain a printout of the reference values, press the [PRINT SUMMARY] key.

Collecting the Calibration Data1. Press the [START AUTO-CAL] key.

The instrument automatically performs three background counts. The screen will display the following message on the Bulletin Line: PREPARING ANALYZER FOR CALIBRATION, PLEASE WAIT...

• If the data from the background counts are acceptable, the displayed message will change to the following: READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL KEY. START SAMPLES. Proceed to step 5.

• If the data from the background counts are unacceptable, the displayed message will alternate between BACKGROUND COUNTS EXCEED LIMITS. PERFORM MAINTENANCE TO CLEAR BACKGROUND and READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL KEY. START SAMPLES. Proceed to step 2.

2. Press the [QUIT AUTO-CAL] key followed by the [CONFIRM QUIT] key to exit Auto-Cal.

3. Check the background results and troubleshoot out-of-range parameters.

4. When the problem has been resolved, return to the CALIBRATION screen and press the [AUTO-CALIBRATE] key followed by the [CALBRATR] key and the [START AUTO-CAL] key.

NOTE: The information entered in steps 2–4 of Entering the Reference Values is retained.



5. When the background results are acceptable, press the [CONTINUE AUTO-CAL] key.

6. Prepare the calibrator for use according to the directions given in the package insert. Be certain to carefully read and follow directions given for warming and mixing.

7. Run the calibrator one time. The reference value, VALUE, and the results of the analysis, RUN1, will be displayed on the CALIBRATOR AUTO-CAL, RESULTS FOR SPECIMEN (N) screen.

The Auto-Cal program automatically compares the results of the first run of the calibrator with the Parameter Reference Values entered for that specimen, to verify that the difference is within acceptable limits.

• If the first run passes this internal Reference Check, proceed to step 10.

• If the first run fails the Reference Check for any parameter, the results are highlighted and the Bulletin Line displays the following message: THIS RESULT IS OUTSIDE THE ALLOWED LIMITS. REPEAT THIS SPECIMEN. Proceed to step 8.

8. The run may be repeated at this time by pressing the [REPEAT SPECIMEN] key followed by the [CONFIRM REPEAT] key. When the repeat function is used, all the results for that specimen will be automatically deleted.

• If the run passes the Reference Check, proceed to step 10.

• If the repeated run also fails the Reference Check, the results will be highlighted and no calibration factor will be calculated for that parameter. Proceed to step 9.

• If all parameters fail the Reference Check, results of that run are not displayed and the Bulletin Line displays following the message: ABANDON CAL FOR SPECIMEN 1 - RESULT NOT INCLUDED IN MEAN. Proceed to step 9.

9. If necessary, repeat the run as directed in step 8.


• If all parameters on the repeated run also fail the Reference Check, confirm that the reference values were entered correctly. If the reference values are correct, discard the calibrator vial. Obtain a new vial (be sure that it is properly warmed and mixed) and repeat the procedure. If all parameters fail again, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the U.S.).


9140320D — June 2003


10. After a run has passed the internal Reference Check, consecutively run the calibrator for the remaining runs.

Each subsequent run must pass the Reference Check and an additional internal Precision Check. If a run fails either check, the result for that parameter is highlighted and no calibration factor will be calculated for the parameter. Calibration must be repeated for the highlighted parameter. Calibration factors will be calculated for the remaining parameters.

NOTE: Five runs are displayed on the screen. Press the Left arrow key on the keyboard to view the first runs. Press the Right arrow key on the keyboard to view the last runs.

Calibration Factor CalculationAs each run of the calibrator is completed, a calibration factor is calculated and updated. This factor is displayed in the column labeled SPEC (N) FACTOR.

The column labeled MEAN FACTOR (N) contains the average of the calibration factors for each parameter for all of the calibrators used in the calibration. The number after mean factor indicates the number of calibrators used to compute that mean factor.

NOTE: If only one calibrator is used, the specimen factor and the mean factor are the same.

The FACTOR % DIFF column displays the difference between the calibration factor currently in the instrument and the mean factor computed by the Auto-Cal program.

When all runs of the calibrator have been completed, the following message will be displayed on the Bulletin Line:

TO UPDATE CURRENT CAL FACTORS WITH MEAN FACTORS SHOWN ABOVE, PRESS THE [ACCEPT MEANS] KEY.

1. To obtain a printout of the SPEC and MEAN FACTORS and the FACTOR % DIFF, press the [PRINT] key.

NOTE: Once this screen is exited, these resuls are no longer available for review or printout.

2. Enter the factor % difference for each parameter in the Auto-Cal Calibration Criteria Worksheet provided at the end of this procedure. (This worksheet may be duplicated as needed.) The calibration criteria are depicted in the following table.

NOTE: Delete the sign of the Factor % Diff value before entering it on the worksheet.



3. To determine which parameters require calibration, continue with the next section in this chapter, Determining Which Parameters Need Calibration.

Determining Which Parameters Need Calibration

Validation RangeIf the factor % difference is equal to or less than the following values, then calibration is not required for that parameter because the value is within the Validation Range.

Results equal to or less than the Validation Range:

WIC/WOC <1.5%

RBC <1.0%

HGB <1.0%

MCV <1.0%

PLT <3.0%

If the results for all parameters are less than the values given above, press the [QUIT AUTO-CAL] key followed by the [CONFIRM QUIT] key.

If desired, the Calibrator Auto-Cal Calibration results may be documented in the Auto-Cal Calibration Log. The Auto-Cal Calibration Log is available for comments only when a calibration factor is changed or reentered. Therefore, to document the calibration in the <COMMENTS> line, access the log as follows.

1. From the CALIBRATION screen press the [ENTER FACTOR] key.

2. Retype any existing Cal Factor. Ensure that the cursor is in the <Open Sampler Factor> column. Press the Enter key on the keyboard to save the entry and advance the cursor.

Table 6.1: Calibration Criteria

Calibration Criteria

Validation Range (Cal Not Required)

Calibration Range (Cal Required)

Calibration Limit (Do Not Cal)

WOC <1.5% >1.5% but <10% >10%

WIC <1.5% >1.5% but <10% >10%

RBC <1.0% >1.0% but <10% >10%

HGB <1.0% >1.0% but <10% >10%

MCV <1.0% >1.0% but <10% >10%

PLT <3.0% >3.0% but <15% >15%


9140320C — November 2000


3. Press the [RETURN] key.

4. When the CALIBRATION LOG screen is displayed, indicate in the <COMMENTS> line that instrument calibration was confirmed and no changes were required. Press the Enter key on the keyboard to save the entry and advance the cursor.

5. Be certain to retain all necessary documentation in the instrument logbook.

Calibration LimitIf the factor % difference for a particular parameter is greater than the following value, the value has exceeded the Calibration Limit and there may be an instrument problem.

Results greater than the Calibration Limit:

WIC/WOC >10%

RBC >10%

HGB >10%

MCV >10%

PLT >15%

1. Check to see if any component that could affect the calibration was changed, as this could cause the factor % difference to exceed the above limits. For example:

Shear Valve RBC/PLT Transducer

WOC Flow Cell RBC/PLT Aperture Plate

WIC Transducer Hemoglobin Flow Cell

WIC Aperture Plate Syringe(s)

• If a component has been changed, then calibrate the instrument as needed according to the directions in this procedure.

• If no components have been changed and the factor % difference exceeds these limits, do not calibrate. Confirm that all Pre-Calibration procedures were completed, and then call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the U.S.).


3. Troubleshoot accordingly. Be certain to retain all necessary documentation in the instrument logbook.



Calibration RangeIf the factor % difference falls within the following Calibration Range, calibration is required for that parameter. That is, a new calibration factor must be entered. Calibrate the Open Mode as directed in this procedure, either for all parameters or for specific parameters.

Results within the Calibration Range:

WIC/WOC >1.5% but < 10%

RBC >1.0% but < 10%

HGB >1.0% but < 10%

MCV >1.0% but < 10%

PLT >3.0% but < 15%

If all parameters require calibration, continue with the next section in this procedure, Calibrating All Parameters. If only specific parameters require calibration, skip to Calibrating Individual Parameters within this chapter.

Calibrating All ParametersIf the factor % difference for all parameters falls within the acceptable Calibration Range limits, perform this procedure.

1. Be certain that all desired printouts have been made.

2. Press the [ACCEPT MEANS] key.

The following message will be displayed on the Bulletin Line:ALL DATA AND RESULTS WILL BE DELETED

3. Press the [CONFIRM ACCEPT] key to save the mean factors and complete the Auto-Cal Procedure.

The CALIBRATION LOG screen will be automatically displayed.

NOTE: The log holds 10 entries. (The screen displays five entries. To display the other five, press the Page Up key on the keyboard.) When the log is full, subsequent entries will cause the oldest entry to be deleted and the remaining entries to move up one line so that the current factors will be added to the bottom of the list. Therefore, the log should be printed periodically for purposes of documentation.

The log displays the date, time, operator ID, calibration factors, and a line for comments.

NOTE: The letters in parentheses after each factor indicate the method of factor derivation: A = Auto-Cal, F = Factory, E = Enter Factor (manual factor entry).


9140320C — November 2000


4. Type any comments in the <COMMENTS> field. Press the Enter key on the keyboard to save the entry and advance the cursor.

NOTE: Comments may be added to the Calibration Log only after a calibration factor is changed or reentered.

5. To obtain a printout of the Calibration Log for documentation, press the [PRINT LOG] key.

Calibrating Individual ParametersIf only certain individual parameters require calibration, perform this procedure.


2. Press the [RETURN] key twice to display the CALIBRATION screen.

3. Press the [ENTER FACTOR] key to display the ENTER CALIBRATION FACTOR screen.

4. Type any mean factors computed by Auto-Cal for those parameters that require calibration in the appropriate fields. (Refer to the printout made in step 1 of the Calibration Factor Calculation section of this chapter.) Move the cursor to the desired position, type the factor, and press the Enter key on the keyboard to save the entry and advance the cursor.


6. When the CALIBRATION LOG screen is displayed, indicate the parameters that required calibration in the <COMMENTS> line. Press the Enter key on the keyboard to save the entry and advance the cursor.

NOTE: Manually entered factors are followed by the letter E in parentheses to indicate “Enter Factor.”


Completing Open Mode Calibration1. Press the [RETURN] key to display the CALIBRATION screen.

2. Press the [MAIN] key to exit the CALIBRATION screen.

3. Confirm the calibration of the Open Mode by running commercial controls as directed in Post-Calibration Procedures within this chapter.



CELL-DYN® 3700 System

Auto-Cal Calibration Criteria WorksheetInstrument: ___________________________________ Date: _______________________________________

Operator: _____________________________________

____________________________________________________________________________________________

* Delete the sign of the factor % difference before entering it on the worksheet.

** Do not calibrate. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the U.S.).

Auto-Cal Calibration Criteria

Factor %Diff*



Calibration Limit (Do Not Cal**)

Cal? Y/N

WOC <1.5% >1.5% but <10% >10%

WIC <1.5% >1.5% but <10% >10%

RBC <1.0% >1.0% but <10% >10%

HGB <1.0% >1.0% but <10% >10%

MCV <1.0% >1.0% but <10% >10%

PLT <3.0% >3.0% but <15% >15%


9140320C — November 2000


NOTES


Chapter 6 Calibration

Auto-Cal Using Whole Blood


NOTE: Before beginning this procedure, be sure to complete the Pre-Calibration procedures and read Overview, Calibration Materials, Whole Blood Calibration Guidelines and Auto-Cal Overview within this chapter.


2. If necessary, press the [OPEN SAMPLER] key to display the Open Mode calibration factors.

3. To obtain a printout of the Open Mode Calibration Factors displayed on the screen, press the [PRINT] key.

NOTE: These calibration factors are retained in the Auto-Cal Calibration Log until 10 entries have been made. As each subsequent entry is made, the oldest existing entry is deleted.

4. Press the [AUTO-CALIBRATE] key to select the AUTO-CALIBRATION screen.

5. If necessary, press the [CHANGE SAMPLER] key to select the Open Mode. (CS Mode only)

6. Press the [WHOLE BLOOD] key to select Whole Blood Auto-Cal.


9140320C — November 2000

CalibrationAuto-Cal Using Whole Blood Chapter 6

Entering the Reference ValuesEnter the reference values for the whole blood samples as follows:

1. Delete any existing values. Press the [CLEAR REF VALS] key followed by the [CONFIRM CLEAR] key.

2. Type the appropriate information in the <SPEC ID> field, the <# OF RUNS> field, and the parameter reference values field for each whole blood sample to be used for the calibration. Press the Enter key on the keyboard after each entry to save it and advance the cursor.

NOTE: The <# OF RUNS> entered indicates the number of times the sample will be consecutively cycled through the instrument. Each sample may be run a maximum of 10 times.

3. To obtain a printout of the reference values, press the[PRINT SUMMARY] key.


The instrument automatically performs three background counts. The screen will display the following message on the Bulletin Line: PREPARING ANALYZER FOR CALIBRATION,PLEASE WAIT...

• If the data from the background counts are acceptable, the displayed message will change to the following: READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL KEY. START SAMPLES. Proceed to step 5.

• If the data from the background counts are unacceptable, the displayed message will alternate between BACKGROUND COUNTS EXCEED LIMITS, PERFORM MAINTENANCE TO CLEAR BACKGROUND and READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL KEY. START SAMPLES. Proceed to step 2.




CalibrationChapter 6 Auto-Cal Using Whole Blood

4. When the problem has been resolved, return to the CALIBRATION screen and press the [AUTO-CALIBRATE] key followed by the [WHOLE BLOOD] key and the [START AUTO-CAL] key.

NOTE: The information entered in step 2 of Entering the Reference Values will be retained.

5. When the background results are acceptable, press the [CONTINUE AUTO-CAL] key.

6. Run the first whole blood specimen one time. The reference value, VALUE, and the results of the analysis, RUN1, will be displayed on the WHOLE BLOOD AUTO-CAL, RESULTS FOR SPECIMEN (N) screen.

The Auto-Cal program automatically compares the results of the first run of each whole blood specimen with the Parameter Reference Values entered for that specimen, to verify that the difference is within acceptable limits.


• If the first run fails the Reference Check for any parameter, the results are highlighted and the Bulletin Line displays the following message: THIS RESULT IS OUTSIDE THE ALLOWED LIMITS. RERUN THIS SPECIMEN. Proceed to step 7.

7. The specimen may be repeated at this time by pressing the [REPEAT SPECIMEN] key followed by the [CONFIRM REPEAT] key. When the repeat function is used, all the results for that specimen will be automatically deleted.



• If all parameters fail the Reference Check, results of that run are not displayed and the Bulletin Line displays the following message: ABANDON CAL FOR SPECIMEN 1 - RESULT NOT INCLUDED IN MEAN. Proceed to step 8.


9140320C — November 2000


8. If necessary, repeat the specimen as directed in step 7.

NOTE: Check to be sure the correct specimen was run before repeating it.


• If all parameters on the repeated run also fail the Reference Check, discard that sample and continue with the next calibration sample. If desired, a replacement sample may be added after the remaining samples have been run.

9. After a run has passed the internal Reference Check, run each sample for the number of runs entered in step 2 of Entering the Reference Values.


10. When all runs of a sample have been completed, the Bulletin Line displays the following message: NEW CAL FACTOR COMPUTED. READY FOR NEXT CAL SPECIMEN.

11. Press the [NEXT SPECIMEN] key to run the next sample.

Calibration Factor CalculationAs each run of a whole blood sample is completed, a calibration factor is calculated and updated. This factor is displayed in the column labeled <SPEC (N) FACTOR>.

The column labeled <MEAN FACTOR (N)> contains the average of the calibration factors for all whole blood samples used in the calibration. The number in parentheses after mean factor indicates the number of samples used to compute that mean factor.

The <FACTOR % DIFF> column displays the difference between the calibration factor currently in the instrument and the mean factor computed by the Auto-Cal program.

When all runs of all whole blood samples have been completed, the following message is displayed on the Bulletin Line: NEW CAL FACTOR COMPUTED – READY FOR ACCEPTANCE.



1. Press the [PREVIOUS SPECIMEN] key and/or the [NEXT SPECIMEN] key to review and/or print the results of all whole blood samples that were analyzed.

NOTE: These results are only available for review and printout before the [ACCEPT MEANS] key is pressed.

2. Press the [PRINT] key to obtain a printout of the SPEC and MEAN FACTORS and the FACTOR % DIFF.

NOTE: Once this screen is exited, these results are no longer available for review or printout.

3. Enter the factor % difference for each parameter in the Auto-Cal Calibration Criteria Worksheet provided at the end of this procedure. (This worksheet may be duplicated as needed.) The calibration criteria are depicted in the following table.

NOTE: Delete the sign of the factor % difference value before entering it on the worksheet.

To determine which parameters require calibration, continue with the next section in this chapter, Determining Which Parameters Need Calibration.



Validation Range Cal Not Required

Calibration Range Cal Required

Calibration Limit Do Not Cal

WOC <1.5% >1.5% but <10% >10%

WIC <1.5% >1.5% but <10% >10%

RBC <1.0% >1.0% but <10% >10%

HGB <1.0% >1.0% but <10% >10%

MCV <1.0% >1.0% but <10% >10%

PLT <3.0% >3.0% but <15% >15%


9140320C — November 2000





WIC/WOC <1.5%

RBC <1.0%

HGB <1.0%

MCV <1.0%

PLT <3.0%


If desired, the Whole Blood Auto-Cal Calibration results may be documented in the Auto-Cal Calibration Log. The Auto-Cal Calibration Log is available for comments only when a calibration factor is changed or reentered. Therefore, to document the calibration in the <COMMENTS> line, access the log as follows.

1. From the CALIBRATION screen, press the [ENTER FACTOR] key.







Calibration LimitIf the factor % difference for a particular parameter is greater than the following value, as the value has exceeded the Calibration Limit and there may be an instrument problem.


WIC/WOC >10%

RBC >10%

HGB >10%

MCV >10%

PLT >15%

1. Check to see if any component that could affect the calibration has been changed, as this could cause the factor % difference to exceed the above limits. For example:






• If no components have been changed and the factor % difference exceeds these limits, do not calibrate. Confirm that all Pre-Calibration procedures were completed, and then call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).




9140320C — November 2000


Calibration RangeIf the factor % difference falls within the following Calibration Range, calibration is required for that parameter. That is, a new Calibration Factor must be entered. Calibrate the Open Mode as directed in this procedure, either for all parameters or for specific parameters.


WIC/WOC >1.5% but <10%

RBC >1.0% but <10%

HGB >1.0% but <10%

MCV >1.0% but <10%

PLT >3.0% but <15%

If all parameters require calibration, continue with the next section in this chapter, Calibrating All Parameters. If only specific parameters require calibration, skip to Calibrating Individual Parameters within this chapter.

Calibrating All ParametersIf the factor % difference for all parameters falls within the acceptable Calibration Range Limits, perform this procedure.



The following message is displayed on the Bulletin Line: ALL DATA AND RESULTS WILL BE DELETED.

3. Press the [CONFIRM ACCEPT] key to save the mean factors and complete the Auto-Cal procedure.

The CALIBRATION LOG screen is automatically displayed.

NOTE: The log holds 10 entries. (The screen displays five entries. To display the other five, press the Page Up key on the keyboard.) When the log is full, subsequent entries cause the oldest entry to be deleted and the remaining entries to move up one line so that the current factors are added to the bottom of the list. Therefore, the log should be printed periodically for purposes of documentation.










2. Press the [RETURN] key twice to return to the CALIBRATION screen.


4. Type any mean factors computed by Auto-Cal for those parameters that require calibration in the appropriate fields. (Refer to the printout made in step 2 of the Calibration Factor Calculation subsection of this procedure, Auto-Cal Using Whole Blood.) Move the cursor to the desired position, type the factor, and press the Enter key on the keyboard to save the entry and advance the cursor.





Completing Whole Blood Open Mode Calibration1. Press the [RETURN] key to return to the CALIBRATION screen.




9140320C — November 2000


NOTES




Auto-Cal Calibration Criteria Worksheet

Instrument: ___________________________________ Date: _______________________________________

Operator: _____________________________________

____________________________________________________________________________________________

* Delete the sign of the factor % difference before entering it on the worksheet.

** Do not calibrate. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

Auto-Cal Calibration Criteria

Factor %Diff*




Cal? Y/N

WOC <1.5% >1.5% but <10% >10%

WIC <1.5% >1.5% but <10% >10%

RBC <1.0% >1.0% but <10% >10%

HGB <1.0% >1.0% but <10% >10%

MCV <1.0% >1.0% but <10% >10%

PLT <3.0% >3.0% but <15% >15%


9140320C — November 2000


NOTES



Manual Calibration Overview

The Open Mode of the CELL-DYN 3700 System may be calibrated without using the Auto-Cal program. CELL-DYN Calibrator or whole blood samples may be used for Manual Calibration. Whole blood samples should meet the requirements outlined in Overview, Calibration Materials, Whole Blood Calibration Guidelines within this chapter.

Manual Calibration is accomplished by running the calibrator or whole blood samples into a control file and using the parameter means to manually compute the calibration factors. The new calibration factors are then entered manually from the ENTER FACTOR screen in the CALIBRATION menu.

NOTE: The QC files used for Manual Calibration should be configured to display and print values for WIC and WOC. If necessary, refer to the directions for customizing display and printout given in Chapter 5: Operating Instructions, Subsection: Set-Up Instructions.

Some parameters may not need to be calibrated. Therefore, each procedure includes specific criteria that are used to determine which parameters require calibration. The criteria are:

• Validation Range — Calibration not required

• Calibration Limit — Do not calibrate, possible instrument problem exists

• Calibration Range — Calibration is required

Complete instructions for using these criteria and a Calibration Criteria Chart are included with each procedure to facilitate the decision.

The calibration procedures have been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section.

Worksheets are provided at the end of each procedure to assist in determining which parameters require calibration. For manual calibration, worksheets can be used to assist in making the necessary calculations. These worksheets can be duplicated as needed.

NOTE: Always complete the Pre-Calibration procedures before beginning any calibration.


9140320C — November 2000

CalibrationManual Calibration Overview Chapter 6

Guidelines• The CELL-DYN Calibrator must be warmed and mixed

according to the directions given in the package insert and run a minimum of six and a maximum of 10 times.

NOTE: For instructions on running the calibrator, refer to Auto-Cal Overview, Calibration Requirements for Auto-Cal within this chapter.

• If performing a reference whole blood calibration:

– A minimum of five different, fresh, whole blood specimens must be used for this procedure.

– Each specimen must be assayed a minimum of three times by reference methodology and on the CELL-DYN 3700 System.

– No more than two hours should elapse between the reference run and the CELL-DYN 3700 System run.

NOTE: Refer to Overview, Calibration Materials, Whole Blood Calibration Guidelines within this chapter for detailed information about the requirements for reference whole blood calibration.



Manual Calibration Procedure — Open Mode


NOTE: Before beginning this procedure, be sure to complete the Pre-Calibration procedures and read Overview, Calibration Materials, Whole Blood Calibration Guidelines and Manual Calibration Overview within this chapter.

Preparing for Manual Calibration1. From the MAIN MENU screen, press the [CALIBRATION] key.

2. If necessary, press the [OPEN SAMPLER] key to display the Open Sampler calibration factors.

3. Press the [PRINT] key to obtain a printout of the OPEN SAMPLER CALIBRATION FACTORS displayed on the screen.

4. Press the [MAIN] key to return to the MAIN MENU screen.

Determining the Open Mode Mean1. From the MAIN MENU screen, press the [RUN] key.


3. Press the [SPECIMEN TYPE] key.

4. Use the arrow keys on the keyboard to move the cursor to an empty QC file and type “CD MEAN” in the <FILE NAME> field.

5. Press the Enter key on the keyboard to save the name. Use the Up arrow key on the keyboard to move the cursor back into the “CD MEAN” file.

NOTE: The QC files used for Manual Calibration should be configured to display and print values for WIC and WOC. If necessary, refer to the directions for customizing display and printout given in Chapter 5: Operating Instructions, Subsection: Set Up Instructions.

6. Press the [QC SPECIMEN] key to return to the RUN screen.

7. Run each sample the appropriate number of times into the “CD MEAN” QC file.


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CalibrationManual Calibration Procedure — Open Mode Chapter 6

NOTE: Ensure that the worklist is turned off before running samples in QC file “CD Mean.”

8. Press the [MAIN] key followed by the [QUALITY CONTROL] key and the [VIEW QC LOG] key.

9. To obtain a printout of the data, press the [PRINT QC LOG] key.

10. Press the [RETURN] key followed by the [MAIN] key to display the MAIN MENU screen.

Calibration Factor Calculations1. For the calibration factor calculations, use the mean value

for each parameter from the CD MEAN file printout and the Current Open Mode Calibration Factor printout from step 3 of Preparing for Manual Calibration.

2. Enter the information from step 1 on the Manual Calibration Worksheet provided at the end of this procedure (Manual Calibration Procedure — Open Mode) to calculate the New Open Mode Calibration Factor for each parameter as follows. (This worksheet may be duplicated as needed.)

• Calibrator Calibration:

• Reference Whole Blood Calibration:

3. Referring to the New Open Mode Cal Factor from the previous step and the Current Open Mode Cal Factor from the printout, use the appropriate chart on the worksheet to compute the factor % difference as follows:

x 100 = Factor % Difference

4. Enter the factor % difference for each parameter in the Manual Calibration Criteria chart on the Manual Calibration Worksheet provided at the end of this procedure.

Assay Value

CELL-DYN Meanx Current Open Mode = New Open Mode

Cal Factor Cal Factor

Reference Mean

CELL-DYN Meanx Current Open Mode = New Open Mode

Cal Factor Cal Factor

New Open Mode – Current OpenCal Factor Mode Cal Factor

Current Open Mode Cal Factor


CalibrationChapter 6 Manual Calibration Procedure — Open Mode






WIC/WOC <1.5%

RBC <1.0%

HGB <1.0%

MCV <1.0%

PLT <3.0%

If desired, the manual calibration results may be documented in the Auto-Cal Calibration Log. The Auto-Cal Calibration Log is available for comments only when a calibration factor is changed or reentered. Therefore, to document the calibration in the <COMMENTS> line, access the log as follows.








Calibration Limit (Do Not Cal)

WOC <1.5% >1.5% but <10% >10%

WIC <1.5% >1.5% but <10% >10%

RBC <1.0% >1.0% but <10% >10%

HGB <1.0% >1.0% but <10% >10%

MCV <1.0% >1.0% but <10% >10%

PLT <3.0% >3.0% but <15% >15%






Calibration LimitIf the factor % difference for a particular parameter is greater than the following value, there may be a computation error or an instrument problem as the value has exceeded the Calibration Limit.


WIC/WOC >10%

RBC >10%

HGB >10%

MCV >10%

PLT >15%

1. Recheck the numbers entered on the worksheet and then recheck all calculations.

2. Check to see if any component has been changed that could affect the calibration, as this could cause the factor % difference to exceed the above limits. For example:






• If no components have been changed, the calculations are correct, and the factor % difference exceeds these limits, do not calibrate. Confirm that all Pre-Calibration procedures were completed, and then call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

Calibration RangeIf the factor % difference falls within the following Calibration Range, calibration is required for that parameter. Calibrate the Open Mode as directed in this procedure.




WIC/WOC >1.5% but <10%

RBC >1.0% but <10%

HGB >1.0% but <10%

MCV >1.0% but <10%

PLT >3.0% but <15%

Calibrating the Open Mode1. From the MAIN MENU screen, press the [CALIBRATION] key.


3. Type the New Open Mode Calibration Factors for the parameters that require calibration into the appropriate fields in the <OPEN SAMPLER> column. Move the cursor to the desired position, type the factor, and press the Enter key on the keyboard to save the factor and advance the cursor.

4. After the New Open Mode Calibration Factors have been entered, press the [RETURN] key.

5. The CALIBRATION LOG screen is automatically displayed. The log holds 10 entries. (The screen displays five entries. To display the other five, press the Page Up key on the keyboard.) When the log is full, subsequent entries cause the oldest entry to be deleted and the remaining entries to move up one line, so that the current factors are added to the bottom of the list. Therefore, the log should be printed periodically for purposes of documentation.







9140320C — November 2000


Completing Manual Calibration1. Press the [RETURN] key twice to return to the CALIBRATION screen.


3. Retain all necessary documentation in the instrument logbook.




NOTES





Manual Calibration Worksheet

Instrument: ___________________________________ Date: _______________________________________

Operator: _____________________________________

____________________________________________________________________________________________

* Current factor as printed in this Manual Calibration procedure.

** If factor falls outside limits, do not calibrate. Check all calculations and call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

Calculate All Factors To Three Decimal Places

New Open Mode Calibration Factors

Assay or Ref MeanCELL-DYN Mean

x Current Open Mode Cal Factor* = New Open Mode Cal Factor

Assay Value or

Ref Mean /Open Mode

Mean x

Current Open Mode Cal Factor* =

NewOpen Mode Cal Factor Range**

WOC / x = 0.700–1.300

WIC / x = 0.700–1.300

RBC / x = 0.800–1.200

HGB / x = 0.700–1.300

MCV / x = 0.700–1.300

PLT / x = 0.700–1.300



.

* The Current Open Mode Factor is printed at the start of this calibration procedure.

* Delete the sign of the % Diff value before entering it in the chart.


Factor % Difference

NewOpen Mode

Factor –

Current Open Mode

Factor* /

CurrentOpen Mode

Factor x 100 = % Diff

WOC – / x 100 =

WIC – / x 100 =

RBC – / x 100 =

HGB – / x 100 =

MCV – / x 100 =

PLT – / x 100 =

Manual Calibration Criteria

Factor %Diff*




Cal? Y/N

WOC <1.5% >1.5% but <10% >10%

WIC <1.5% >1.5% but <10% >10%

RBC <1.0% >1.0% but <10% >10%

HGB <1.0% >1.0% but <10% >10%

MCV <1.0% >1.0% but <10% >10%

PLT <3.0% >3.0% but <15% >15%

New Open Mode Factor – Current Open Mode FactorCurrent Open Mode Factor x 100 = % Diff


9140320C — November 2000


NOTES



Mode To Mode Calibration Overview

The Open Mode of the CELL-DYN® 3700 System is calibrated with either a commercial calibrator or fresh whole blood specimens. The Closed Mode is calibrated to match the Open Mode using 10 different, fresh, normal whole blood specimens. Specimens used for Mode to Mode calibration should meet the requirements outlined in Overview, Calibration Materials, Whole Blood Calibration Guidelines within this chapter.

Single runs of 10 specimens can be used because calibration differences between modes are usually very small. Specimens may be run more than once if desired, but specimens should be run the same number of times in each mode. Calibration of the Closed Mode with fewer than 10 specimens is not recommended because it may introduce a bias between the modes.

Worksheets are provided within this section (at the end of each procedure) to assist in determining which parameters require calibration. For manual calibration, worksheets may be used to assist in making the necessary calculations. These worksheets may be duplicated as needed.

Auto-Cal Mode to Mode CalibrationAuto-Cal is not available for the Closed Mode on the CELL-DYN 3700SL System. Therefore, the Closed Mode on the CELL-DYN 3700SL System must be calibrated using the Manual Mode to Mode procedure.

After the Open Mode has been calibrated, or Open Mode calibration is confirmed, each specimen is run one time in the Open Mode. For ease of identification, specimens should be run as patient specimens.

NOTE: The Data Log should be configured to display and print values for WIC and WOC. If necessary, refer to the directions for customizing display and printout given in Chapter 5: Operating Instructions, Subsection: Using the Data Log.

The Open Mode values for each sample are entered as the reference values in the Auto-Cal program for the Closed Mode. The samples are then run in the Closed Mode. The factor percent difference computed by the Auto-Cal program is used to determine which Closed Mode parameters require calibration.


9140320C — November 2000

CalibrationMode To Mode Calibration Overview Chapter 6

Manual Mode to Mode CalibrationAfter the Open Mode has been calibrated, or Open Mode calibration is confirmed, the samples are run into quality control files in the Open and Closed Modes.

NOTE: The quality control files used for Manual Calibration should be configured to display and print values for WIC and WOC. If necessary, refer to the directions for Customizing Display and Printout given in the Set Up Instructions section of Chapter 5.

The automatically calculated parameter means from each mode are used to manually compute the calibration bias and the new calibration factors. The new calibration factors are then entered manually from the ENTER FACTOR screen in the CALIBRATION menu.

Mode to Mode Calibration Preparation1. Confirm the calibration of the Open Mode before calibrating

the Closed Mode.

2. Select 10 different fresh whole blood specimens that meet the following requirements:

• Each specimen should have sufficient volume to be run once in the Open Mode and twice in the Closed Mode. Therefore, try to select full, 13 x 75 mm, 3-mL tubes.

• Specimens must be less than eight hours old at the completion of the procedure. If possible, select specimens that are less than four hours old.

• All parameter values should be within the laboratory’s normal range.

3. Perform the Pre-Calibration Procedures outlined within this chapter.

Closed Mode Calibration ConfirmationAn optional confirmatory step is included at the end of the Mode to Mode Calibration procedures which use whole blood specimens. After Closed Mode calibration is completed, instructions are given for rerunning the whole blood specimens that were used for calibration. These “Post-Calibration results” are then used to confirm the accuracy of the Closed Mode calibration. Closed Mode calibration may also be confirmed by running commercial controls. Either method is satisfactory for confirming the calibration.



Mode To Mode Auto-Cal Calibration(Closed Sampler Only)

The calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section.

NOTE: Confirm the calibration of the Open Mode before performing this procedure.

NOTE: Before beginning this procedure, be sure to complete the Pre-Calibration procedures and read Overview, Calibration Materials, Whole Blood Calibration Guidelines and Mode to Mode Calibration Overview within this chapter.

Determining Reference ValuesThe specimens used for the calibration should be run in the Open Mode as patient specimens in order to properly identify them. A printout of the Data Log for those sequence numbers can be used to enter the reference values and may be retained for documentation.

NOTE: The Data Log should be configured to display and print values for WIC and WOC. If necessary, refer to the directions for customizing display and printout given in Chapter 5: Operating Instructions, Subsection: Using the Data Log, Customize Data Log Soft Key.

1. From the MAIN MENU screen, press the [RUN] key.



4. Type the specimen identification for the first specimen in the <NEXT ID> field. Press the Enter key on the keyboard to save the entry and advance the cursor. Run the sample, noting the Sequence Number.

5. Repeat step 4 for each sample. Note the Sequence Number of the last sample.

6. Access the Data Log. Press the [PRINT DATA LOG] key.

7. Type the range of Sequence Numbers for the calibration samples in the indicated fields to obtain the printout.


9140320C — November 2000

CalibrationMode To Mode Auto-Cal Calibration (Closed Sampler Only) Chapter 6


2. If necessary, press the [CLOSED SAMPLER] key to display the Closed Mode Calibration Factors.

3. To obtain a printout of the Closed Mode Calibration Factors displayed on the screen, press the [PRINT] key.

NOTE: These calibration factors are retained in the Auto-Cal Calibration Log until 10 entries have been made. As each subsequent entry is made, the oldest existing entry will be deleted.

4. Press the [AUTO-CALIBRATE] key to display the AUTO-CALIBRATION screen.


6. Press the [WHOLE BLOOD] key to select Whole Blood Auto-Cal.

Entering the Reference ValuesEnter the reference values for the whole blood samples as follows:

1. Delete any existing values. Press the [CLEAR REF VALS] key followed by the [CONFIRM CLEAR] key.

2. For each specimen used, type the appropriate information in the <SPEC ID> field and the <RUNS> field. Press the Enter key on the keyboard after each entry to save it and advance the cursor.

NOTE: The <RUNS> entered indicates the number of times the specimen will be consecutively cycled through the instrument. Each sample may be run a maximum of 5 times. For Mode to Mode Calibration, each specimen should be run once but specimens may be run more than one time if desired. However, specimens should be run the same number of times in each mode.

3. Type the Open Mode value for each parameter in the appropriate parameter reference values field. Press the Enter key on the keyboard after each entry to save it and advance the cursor.

4. To obtain a printout of the reference values, press the [PRINT SUMMARY] key.


CalibrationChapter 6 Mode To Mode Auto-Cal Calibration (Closed Sampler Only)


The instrument automatically performs three background counts. The screen will display the following message on the Bulletin Line:

PREPARING ANALYZER FOR CALIBRATION, PLEASE WAIT...

• If the data from the background counts are acceptable, the displayed message will change to the following:READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL KEY. START SAMPLES. Proceed to step 5.

• If the data from the background counts are unacceptable, the displayed message will alternate between BACKGROUND COUNTS EXCEED LIMITS. PERFORM MAINTENANCE TO CLEAR BACKGROUND and READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL KEY. START SAMPLES. Proceed to step 2.



4. When the problem has been resolved, return to the CALIBRATION screen and press the [AUTO-CALIBRATE] key followed by the [WHOLE BLOOD] key and the [START AUTO-CAL] key.

NOTE: The information entered in steps 2 and 3 of Entering the Reference Values will be retained.

5. When background results are acceptable, press the [CONTINUE AUTO-CAL] key.


9140320C — November 2000


6. Run the first whole blood specimen one time. The reference value, VALUE, and the results of the analysis, RUN1, will be displayed on the WHOLE BLOOD AUTO-CAL, RESULTS FOR SPECIMEN (N) screen.

The Auto-Cal program automatically compares the results of the first run of each whole blood specimen with the Parameter Reference Values entered for that specimen, to verify that the difference is within acceptable limits.


• If the first run fails the Reference Check for any parameter, the results are highlighted and the Bulletin Line displays the following message: RESULT IS OUTSIDE THE REFERENCE LIMITS. REPEAT THIS SPECIMEN. Proceed to step 7.

7. The specimen may be repeated at this time by pressing the [REPEAT SPECIMEN] key followed by the [CONFIRM REPEAT] key.

NOTE: When the repeat function is used, all the results for that specimen will be automatically deleted.



• If all parameters fail the Reference Check, results of that run are not displayed and the Bulletin Line displays the following message: ABANDON CAL FOR SPECIMEN 1 - RESULT NOT INCLUDED IN MEAN. Proceed to step 8.

8. If necessary, repeat the specimen as directed in step 7.

NOTE: Check to be sure the correct specimen was run before repeating it.


• If all parameters on the repeated run also fail the Reference Check, discard that specimen and continue with the next calibration specimen. If desired, a replacement specimen may be added after the remaining specimens have been run.

9. After a run has passed the internal Reference Check, run each specimen for the number of runs entered in step 2 of Entering the Reference Values within this chapter.




10. When all runs of a specimen have been completed, the Bulletin Line displays the following message: NEW CAL FACTOR COMPUTED. READY FOR NEXT CAL SPECIMEN.

11. Press the [NEXT SPECIMEN] key to run the next specimen.

Calibration Factor CalculationAs each run of the whole blood samples is completed, a calibration factor is calculated and updated. This factor is displayed in the column labeled <SPEC (N) FACTOR>.

The column labeled <MEAN FACTOR (N)> contains the average of the calibration factors for all of the whole blood samples used in the calibration. The number in parentheses after mean factor indicates the number of samples used to compute that mean factor.

The <FACTOR % DIFF> column displays the difference between the calibration factor currently in the instrument and the mean factor computed by the Auto-Cal Program.

When all runs of all whole blood samples have been completed, the following message is displayed on the Bulletin Line: NEW CAL FACTOR COMPUTED. READY FOR ACCEPTANCE.

1. Press the [PREVIOUS SPECIMEN] key and/or the [NEXT SPECIMEN] key to review and/or print the results of all whole blood samples analyzed.

NOTE: These results are only available for review and/or printing before the [ACCEPT MEANS] key is pressed.

2. Press the [PRINT] key to obtain a printout of the SPEC and MEAN FACTORS and the FACTOR % DIFF.

3. Enter the factor % difference for each parameter in the Mode to Mode Auto-Cal Calibration Criteria Worksheet provided at the end of this procedure. (This worksheet may be duplicated as needed.) The calibration criteria are depicted in the following table.



9140320C — November 2000


To determine which parameters require calibration, continue with the next section in this chapter, Determining Which Parameters Need Calibration.




WIC/WOC <1.75%

RBC <1.25%

HGB <1.25%

MCV <1.25%

PLT <3.50%


If desired, the calibration results may be documented in the Auto-Cal Calibration Log. The Auto-Cal Calibration Log is available for comments only when a calibration factor is changed or reentered. Therefore, to document the calibration in the <COMMENTS> line, access the log as follows.

1. From the CALIBRATION screen, press the [ENTER FACTOR] key.

2. Retype any existing Cal Factor. Ensure that the cursor is in the <Closed Sampler Factor> column. Press the Enter key on the keyboard to save the entry and advance the cursor.

Table 6.4: Mode to Mode Calibration Criteria

Mode to Mode Calibration Criteria




WOC <1.75% >1.75% but <10% >10%

WIC <1.75% >1.75% but <10% >10%

RBC <1.25% >1.25% but <10% >10%

HGB <1.25% >1.25% but <10% >10%

MCV <1.25% >1.25% but <10% >10%

PLT <3.50% >3.50% but <20% >20%






Calibration LimitIf the factor % difference for a particular parameter is greater than the following value, the value has exceeded the Calibration Limit and there may be an instrument problem.


WIC/WOC >10%

RBC >10%

HGB >10%

MCV >10%

PLT >20%

1. Check to see if any component that could affect the calibration was changed, as this could cause the factor % difference to exceed the above limits. For example:





• If a component was changed, then calibrate the instrument as needed according to the directions in this procedure.

• If no components have been changed and the factor % difference exceeds these limits, do not calibrate. Confirm that all Pre-Calibration procedures were completed, and call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).




9140320C — November 2000


Calibration RangeIf the factor % difference falls within the following Calibration Range, calibration is required for that parameter. That is, a new Calibration Factor must be entered. Calibrate the Closed Mode as directed in this procedure, either for all parameters or for specific parameters.


WIC/WOC >1.75% but <10%

RBC >1.25% but <10%

HGB >1.25% but <10%

MCV >1.25% but <10%

PLT >3.50% but <20%

If all parameters require calibration, continue with the next section in this chapter, Calibrating All Parameters. If only specific parameters require calibration, skip to Calibrating Individual Parameters within this chapter.

Calibrating All ParametersIf the factor % difference for all parameters falls within the acceptable Calibration Range limits, perform this procedure.



The following message will be displayed on the Bulletin Line: ALL DATA AND RESULTS WILL BE DELETED.

3. Press the [CONFIRM ACCEPT] key to save the mean factors and complete the Auto-Cal procedure.

The CALIBRATION LOG screen will be automatically displayed. The log holds 10 entries. (The screen displays five entries. To display the other five, press the Page Up key on the keyboard.) When the log is full, subsequent entries cause the oldest entry to be deleted and the remaining entries to move up one line so that the current factors are added to the bottom of the list. Therefore, the log should be printed periodically for purposes of documentation.










2. Press the [RETURN] key twice to display the CALIBRATION screen.


4. Move the cursor to the <Closed Sampler Factor> column.

5. Type any mean factors computed by Auto-Cal for those parameters that require calibration in the appropriate fields. (Refer to the printout made in step 2 of the Calibration Factor Calculation subsection of this section, Mode to Mode Auto-Cal Calibration.) Move the cursor to the desired position, type the factor, and press the Enter key on the keyboard to save the factor and advance the cursor.








Completing Mode to Mode Calibration1. Press the [RETURN] key to return to the CALIBRATION screen.



4. Confirm the calibration of the Closed Mode by running commercial controls as directed in Post-Calibration Procedures within this chapter.

Optional Calibration Confirmation1. If desired, the Closed Mode calibration may also be

confirmed by returning to the AUTO-CALIBRATION screen and running the specimens again as directed in this procedure.

NOTE: The information entered in step 3 of Entering the Reference Values is retained, but the results from the previous runs of the specimens will have been deleted.

2. The Post-Calibration factor % difference must be equal to or less than the following:

WIC/WOC <1.75%

RBC <1.25%

HGB <1.25%

MCV <1.25%

PLT <3.50%

If the Post-Calibration factor % difference exceeds these limits, verify that the new calibration factors were entered correctly. If no errors are detected, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).




Mode to Mode Auto-Cal Calibration Criteria WorksheetInstrument: ___________________________________ Date: _______________________________________

Operator: _____________________________________

____________________________________________________________________________________________

* Delete the sign of the factor % difference value before entering it on the worksheet.


Mode to Mode Auto-Cal Calibration Criteria

Factor %Diff*




Cal? Y/N

WOC <1.75% >1.75% but <10% >10%

WIC <1.75% >1.75% but <10% >10%

RBC <1.25% >1.25% but <10% >10%

HGB <1.25% >1.25% but <10% >10%

MCV <1.25% >1.25% but <10% >10%

PLT <3.50% >3.50% but <20% >20%


9140320C — November 2000


NOTES



Manual Mode to Mode Calibration (CS or SL)

The calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section.

NOTE: Confirm the calibration of the Open Mode before performing this procedure.

NOTE: Before beginning this procedure, be sure to complete the Pre-Calibration procedures and read Overview, Calibration Materials, Whole Blood Calibration Guidelines and Mode to Mode Calibration Overview within this chapter.

Preparing for Manual Mode to Mode Calibration1. From the MAIN MENU screen, press the [CALIBRATION] key.

2. If necessary, press the [CLOSED SAMPLER] key to display the Closed Mode Calibration Factors.

3. Press the [PRINT] key to obtain a printout of the Closed Sampler Calibration Factors displayed on the screen.

4. Press the [RETURN] key followed by the [MAIN] key to return to the MAIN MENU screen.

Determining the Open Mode Mean1. From the MAIN MENU screen, press the [RUN] key.



4. Use the arrow keys on the keyboard to move the cursor to an empty QC file and type “OPEN MEAN” in the <FILE NAME> field.

5. Press the Enter key on the keyboard to save the name. Use the Up arrow key on the keyboard to move the cursor back into the “OPEN MEAN” file.

NOTE: The QC files used for Manual Mode to Mode Calibration should be configured to display and print values for WIC and WOC. If necessary, refer to the directions for customizing display and printout given in Chapter 5: Operating Instructions, Subsection: Set-Up Instructions.


9140320C — November 2000

CalibrationManual Mode to Mode Calibration (CS or SL) Chapter 6

6. Press the [QC SPECIMEN] key to display the RUN screen.

7. Run each sample one time into the “OPEN MEAN” QC file.




Determining the Closed Mode Mean1. From the MAIN MENU screen, press the [RUN] key.



4. Use the arrow keys on the keyboard to move the cursor to an empty QC file and type “CLOSED MEAN” in the <FILE NAME> field.

5. Press the Enter key on the keyboard to save the name. Use the Up arrow key on the keyboard to move the cursor back into the “CLOSED MEAN” file.

NOTE: The QC files used for Manual Mode to Mode Calibration should be configured to display and print values for WIC and WOC. If necessary, refer to the directions for customizing display and printout given in Chapter 5: Operating Instructions, Subsection: Set-Up Instructions.

NOTE: If necessary, refer to the directions for running QC specimens in the CS or Sl mode given in Chapter 5: Operating Instructions, Subsection: Sample Analysis.

6. Press the [QC SPECIMEN] key to display the RUN screen.

7. Run each sample one time into the “CLOSED MEAN” QC file.





CalibrationChapter 6 Manual Mode to Mode Calibration (CS or SL)

Percent Difference Calculation1. Use the mean value for each parameter from the “OPEN

MEAN” and “CLOSED MEAN” file printouts for these calculations.

2. Enter the information from step 1 on the Manual Mode to Mode Calibration Worksheet and calculate the Mode to Mode Calibration Bias for each parameter as follows:

x 100 = % Difference

3. On the worksheet, enter the % difference for each parameter in the Mode to Mode Calibration Criteria Chart (depicted in the following table).

NOTE: Delete the sign of the % difference before entering it on the chart.


Table 6.5: Mode to Mode Calibration Criteria





WOC <1.75% >1.75% but <10% >10%

WIC <1.75% >1.75% but <10% >10%

RBC <1.25% >1.25% but <10% >10%

HGB <1.25% >1.25% but <10% >10%

MCV <1.25% >1.25% but <10% >10%

PLT <3.50% >3.50% but <20% >20%

Closed Mode Mean – Open Mode Mean

Open Mode Mean


9140320C — November 2000



Validation RangeIf the % difference is equal to or less than the following values, then calibration is not required for that parameter because the value is within the Validation Range.


WIC/WOC <1.75%

RBC <1.25%

HGB <1.25%

MCV <1.25%

PLT <3.50%

If desired, the Manual Mode to Mode Calibration results may be documented in the Auto-Cal Calibration Log. The Auto-Cal Calibration Log is available for comments only when a calibration factor is changed or reentered. Therefore, to document the calibration in the <COMMENTS> line, access the log as follows.


2. Retype any existing Cal Factor. Ensure that the cursor is in the <Closed Sampler Factor> column. Press the Enter key on the keyboard to save the entry and advance the cursor.




Calibration LimitIf the factor % difference for a particular parameter is greater than the following values, the value has exceeded the Calibration Limit and there may be a computation error or instrument problem.




WIC/WOC >10%

RBC >10%

HGB >10%

MCV >10%

PLT >20%

1. Recheck the numbers entered on the worksheets and then recheck all calculations.

2. Check to see if any component was changed which could affect the calibration, as this could cause the factor % difference to exceed the above limits. For example:





• If a component was changed, then calibrate the instrument as needed according to the directions in the following sections.

• If no components have been changed, the calculations are correct, and the % difference exceeds these limits, do not calibrate. Confirm that all Pre-Calibration procedures were completed and then call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

Calibration RangeIf the factor % difference falls within the following Calibration Range, calibration is required for that parameter. Calibrate the instrument as directed in the following sections, either for all parameters or for specific parameters.


WIC/WOC >1.75% but <10%

RBC >1.25% but <10%

HGB >1.25% but <10%

MCV >1.25% but <10%

PLT >3.50% but <20%




Calibration Factor CalculationUse the appropriate worksheet to calculate the New Closed Mode Calibration Factor for the parameters that require calibration. (Use the Current Closed Mode Cal Factor that was printed in Preparing for Mode to Mode Calibration at the start of this procedure.)

x Current Closed Mode Cal Factor = New Closed Factor

• If the New Closed Mode Calibration Factor falls within the acceptable range given on the worksheet, calibrate the Closed Mode as directed in the next section of this chapter, Calibrating the Closed Mode.

• If the New Closed Mode Calibration Factor for a given parameter falls outside the acceptable range, there may be a computation error. Do not calibrate that parameter. Recheck all calculations and then call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

Calibrating the Closed Mode1. From the MAIN MENU screen, press the [CALIBRATION] key.


3. Type the New Closed Mode Calibration Factors for the parameters that require calibration in the appropriate fields in the <CLOSED SAMPLER> column. Move the cursor to the desired position, type the factor, and press the Enter key on the keyboard to save the factor and advance the cursor.

4. After the New Closed Mode Calibration Factors have been entered, press the [RETURN] key.

5. The CALIBRATION LOG screen will be automatically displayed. The log holds 10 entries. (The screen displays five entries. To display the other five, press the Page Up key on the keyboard.) When the log is full, subsequent entries cause the oldest entry to be deleted and the remaining entries to move up one line, so that the current factors are added to the bottom of the list. Therefore, the log should be printed periodically for purposes of documentation.



Open Mode Mean

Closed Mode Mean






Completing Mode to Mode Calibration1. Press the [RETURN] key to display the CALIBRATION screen.



4. Confirm the calibration of the Closed Mode by running commercial controls as directed in Post-Calibration Procedures within this chapter.

Optional Calibration ConfirmationIf desired, the Closed Mode calibration may also be confirmed by repeating the whole blood specimens as directed in the following two sections, Delete the Existing Data and Calibration Confirmation.

Delete the Existing Data1. From the MAIN MENU screen, press the [QUALITY CONTROL] key.

2. Use the arrow keys on the keyboard to move the cursor to the “CLOSED MEAN” file and press the [VIEW QC LOG] key.

NOTE: Be certain all desired printouts have been made before the data are deleted.

3. Delete the information in the file: press the [PURGE QC LOG] key followed by the [CONFIRM PURGE] key.




Calibration Confirmation1. Run the same whole blood specimens into the “CLOSED

MEAN” file again by repeating the steps in Manual Mode to Mode Calibration, Determining the Closed Mode Mean within this chapter.

2. The Post-Calibration difference must be equal to or less than the following:

WIC/WOC <1.75%

RBC <1.25%

HGB <1.25%

MCV <1.25%

PLT <3.50%

Calculate the Post-Calibration difference using the Mode to Mode Post-Calibration Difference chart on the Manual Mode to Mode Worksheet.

If the Post-Calibration difference exceeds these limits, verify that all calculations were correct and that the new factors were entered correctly. If no errors are detected, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).




Manual Mode to Mode Calibration WorksheetInstrument: ___________________________________ Date: _______________________________________

Operator: _____________________________________

____________________________________________________________________________________________

Calculate All Factors To Three Decimal Places

* Delete the sign of the % difference value before entering it on the worksheet.


Mode to Mode Calibration Difference

Closed Mode Mean - Open Mode MeanOpen Mode Mean

x 100 = % Diff

Closed Mode Mean –

Open Mode Mean /

Open Mode Mean x 100 = % Diff

WOC – / x 100 =

WIC – / x 100 =

RBC – / x 100 =

HGB – / x 100 =

MCV – / x 100 =

PLT – / x 100 =


%Diff*Validation Range

(Cal Not Required)Calibration Range

(Cal Required)Calibration Limit (Do Not Cal**)

Cal? Y/N

WOC <1.75% >1.75% but <10% >10%

WIC <1.75% >1.75% but <10% >10%

RBC <1.25% >1.25% but <10% >10%

HGB <1.25% >1.25% but <10% >10%

MCV <1.25% >1.25% but <10% >10%

PLT <3.50% >3.50% but <20% >20%




* Current factor as printed by the operator in the Preparing for Manual Mode to Mode Calibration section within thisprocedure (Manual Mode to Mode Calibration).

** If factor exceeds limits, do not calibrate. Check all calculations and call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

* Mean after calibration.** If % Diff exceeds limits, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

New Closed Mode Calibration Factors

Open Mode MeanClosed Mode Mean

x Current Closed Mode Cal Factor* = New Closed Mode Cal Factor

Open Mode Mean /

Closed Mode Mean x

Current Closed Mode Cal Factor* =

New Closed Mode

Cal Factor Range**

WOC / x = 0.700–1.300

WIC / x = 0.700–1.300

RBC / x = 0.800–1.200

HGB / x = 0.700–1.300

MCV / x = 0.700–1.300

PLT / x = 0.700–1.300

Mode to Mode Post-Calibration Difference

Closed Mode Mean - Open Mode MeanOpen Mode Mean

x 100 = % Difference

Closed ModeMean* –

Open ModeMean /

Open ModeMean x 100 = % Diff Range**

WOC – / x 100 = <1.75%

WIC – / x 100 = <1.75%

RBC – / x 100 = <1.25%

HGB – / x 100 = <1.25%

MCV – / x 100 = <1.25%

PLT – / x 100 = <3.50%


CalibrationChapter 6 Post-Calibration Procedures

Post-Calibration Procedures

If calibration was changed, complete the procedures in this section.

Quality ControlConfirm calibration changes by running all levels of controls into the appropriate QC files. If any parameters fall outside the limits, proceed as follows:

1. Obtain new vials of the controls.

2. Warm and mix them properly and again run them into the appropriate QC files.

If parameters still exceed the limits, proceed as follows:

1. Collect all the calibration documentation including the Pre-Calibration worksheets. (Be certain you have recorded lot numbers where indicated.)

2. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

NOTE: Inform the Customer Support Specialist if a reagent and/or lot number of reagent was changed just prior to the calibration procedure.

3. Include documentation as to the resolution of the problem in the instrument logbook.

Calibration BackupThe current calibration factors should be saved on the CELL-DYN 3700 Set-Up Disk #1 whenever calibration is changed. Data should also be saved whenever any setup information is changed and after any service work is performed. The backup procedure copies the following setup information from the Data Station to the Set-Up Disk:

• Calibration Factors

• QC Limits

• Patient Limits

• Analyzer Module Set Points (for example, gains, dil factors the [internal calibration factors] key, thresholds, pressure/vacuum settings)

• RBC Editing Ratio

• Units Selection



CalibrationPost-Calibration Procedures Chapter 6

To back up the calibration factors, proceed as follows:

1. Perform the Daily Shutdown Procedure described in Chapter 5: Operating Instructions, Subsection: Routine Operation.

2. Turn the Data Station power switch OFF.

3. Obtain the Set-Up Disk #1 from the diskette box located behind the Upper Front Cover of the Analyzer.

4. Insert the Set-Up Disk #1 in the Data Station disk drive.

5. Turn the Data Station power switch ON.

The Data Station screen displays the following:THIS IS THE CD3700 SETUP DISKTO USE, TYPE EITHER SAVE the [ENTER] OR RESTORE [ENTER] AND FOLLOW THE INSTRUCTIONS.

NOTE: The restore option copies setup information from the Set-Up Disk to the Data Station hard disk. This option is used when a hardware or software failure occurs and should only be used at the direction of Technical Service or Abbott Diagnostics Customer Service.

6. Type SAVE. Press the Enter key on the keyboard.

The screen will display the following:

THIS UTILITY WILL SAVE YOUR DATA FILES ONTO YOUR SETUP DISK TO KEEP THEM BACKED UP SAFELY.

THE FOLLOWING FILES WILL BE SAVED:

(1) NONVOL

(2) QC LOG

(3) CALIBRATION LOG

(4) MAINTENANCE LOG

(5) ANIMAL TYPE CONFIGURATION (CD3700 ONLY)

PROCEED (Y/N)?


CalibrationChapter 6 Post-Calibration Procedures

7. Type Y. Press the Enter key on the keyboard.

The setup information is copied from the Data Station hard disk onto the setup disk. Previous setup information that was stored on the disk is overwritten.

When the copy process is complete, the “a:>” prompt will be displayed on the screen.

8. Remove the Set-Up Disk #1 from the disk drive and return it to the diskette box.

9. Turn the Data Station power switch OFF.

10. Wait five seconds and then turn the Data Station power switch ON.


9140320C — November 2000

CalibrationPost-Calibration Procedures Chapter 6

NOTES


CalibrationChapter 6 References

References

1. International Committee for Standardization in Haematology (ICSH). Protocol for Evaluation of Automated Blood Cell Counters. Clinical and Laboratory Hematology 1984; 6:69-84.

2. Clinical and Laboratory Standards Institute/NCCLS. Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard – Third Edition. CLSI/NCCLS document H7-A3 (ISBN 1-56238-413-9) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2000.


9140320C — November 2000

CalibrationReferences Chapter 6

NOTES


Chapter 7 Quality ControlQuality Control

Overview

The first section of this chapter describes the functions of the keys in the QC MENU. Interpretation of the QC data is then discussed in the Quality Control Guide.

The CELL-DYN® 3700 System offers three Quality Control options to monitor and validate instrument performance:

QC Files Statistical and graphical analyses of the data in each of 20 QC files calculate the mean, standard deviation, and coefficient of variation.

Westgard Rules A multi-rule system is applied to the data in each of the QC files.

X-B Analysis Bull’s Moving Average Program is applied to the RBC Indices and a similar moving average calculation is applied to some WBC Differential optical parameters.

The options may be used independently or in combination at the operator’s discretion. The QC files are discussed in Quality Control Menu, View QC Log Soft Key within this chapter. X-B Analysis and Westgard Rules are discussed in the Quality Control Guide within this chapter. The Quality Control Guide also includes information about Running Controls.


9140320C — November 2000

Quality ControlOverview Chapter 7

Quality Control Menu Flowchart

UPDATECANCELCONFIRM

UPDATE

UPDATEFROM FILE

PURGECANCELCONFIRM

PURGE

QC MENUReady

CUSTOMIZEVIEWQC LOG

QCLIMITS DISPLAY

SET UPQC FILE

RETURNPURGEQC LOG

PRINTQC LOG

LEVEY-JENNINGS

MOVESPECIMEN

REJECTSPECIMEN

DELETESPECIMEN

ACCEPTSPECIMEN

RETURNRANGEENTRY

PRINT

RETURNPRINTTOGGLEON/OFF

RETURNPRINTGROUP3

GROUP4

X-B CUSTOMIZE PRINTOUT

MAINFILE

X-BSET UP

LOAD

MEANS/LIMITS

FROM DISK

WRITE QCTO DISK

GROUP2

GROUP1

RETURNPRINTTURN ONX-B WBC

TURN OFFX-B WBC

RETURNPRINTX-B WBCGRAPHS

X-B WBCDATA

DELETIONCANCELCONFIRM

DELETION

RETURNSTANDARDSELECTION

CANCELSELECTION

SELECTPARAMETER

RETURNWRITEHIGH

WRITENORMAL

WRITELOW

PLACEPARAMETER

RETURNSTANDARDGROUPS

CANCELSELECTION

SELECTPARAMETER

PLACEPARAMETER

CANCELMOVE

MOVE TOFILE

X-B RBCGRAPHS

X-B RBCDATA

TURN ONX-B RBC

TURN OFFX-B RBC

WBC GROUP

RBC GROUP

PLT GROUP GROUP


LOT NUMBER

TOGGLEONE/ALL

RETURNLOADLOADNORMAL

LOADLOW HIGH

PLACEMENTCUSTOM

REPLICATEID


Chapter 7 Quality Control

Quality Control Menu

The [QUALITY CONTROL] key on the MAIN MENU screen is used to display the QC MENU screen. The options available from this screen can be used to set up the QC files. QC files can also be set up using the QC SET UP MENU described in Chapter 5: Operating Instructions, Subsection: Set Up Instructions.

Figure 7.1: QC Menu Screen

The following soft key labels are displayed on the QC MENU screen:

X-B SET UP*X-B FILEVIEW QC LOGQC LIMITS*SET-UP QC FILE*CUSTOMIZE DISPLAY*CUSTOMIZE PRINTOUT*MAIN

*These keys are discussed in Chapter 5: Operating Instructions, Subsection: Set Up Instructions, QC Set Up Menu Soft Key.

File Name # Specimens

1. Low 112. Normal 133. High 04. FILE 4 05. FILE 5 06. FILE 6 07. FILE 7 08. FILE 8 09. FILE 9 0

10. FILE 10 0

X-BSET UP

X-BFILE

VIEWQC LOG

QCLIMITS

SET UPQC FILE

CUSTOMIZEDISPLAY

CUSTOMIZEPRINTOUT

MAIN

QC MENUReady

File Name # Specimens

11. Patient 3012. FILE 12 013. FILE 13 014. FILE 14 015. FILE 15 016. FILE 16 017. FILE 17 018. FILE 18 019. FILE 19 020. FILE 20 0

Select a QC file with the arrow keys or enter a new file name.


16:01rcs0711

QUALITY

CONTROL


9140320C — November 2000

Quality ControlQuality Control Menu Chapter 7

X-B File Soft KeyThe following soft key labels are displayed when the [X-B FILE] key is pressed:

X-B RBC DATA or X-B RBC GRAPHS (The key label alternates between these

two selections.)X-B WBC DATA or X-B WBC GRAPHS (The key label alternates between these

two selections.)PRINTRETURN

X-B RBC Data Soft Key

Figure 7.2: The X-B RBC Data Screen

The [X-B RBC DATA] key is used to display the X-B data for RBC indices on the X-B FILE DISPLAY screen. (See the preceding figure.) This screen displays the results for X-B batches 1–10 and the lower and upper limits. The date and time that each batch was completed are also displayed. The Page Down key on the keyboard is used to display batches 11–20. When batches 11–20 are displayed, the Page Up key on the keyboard is used to display batches 1–10.

NOTE: The X-B RBC data can also be viewed as graphs by pressing the [X-B RBC GRAPHS] key.

X-B

FILE

BATCH MCV MCH MCHC DATE TIME

1 90.10 30.19 33.52 12/10/98 14:422 90.51 30.54 33.56 12/10/98 17:213 90.50 30.43 33.52 12/10/98 21:054 89.47 30.11 33.50 12/11/98 04:075 89.72 30.26 33.56 12/11/98 06:026 89.71 30.24 33.56 12/11/98 07:267 89.57 30.11 33.54 12/11/98 08:248 89.93 30.11 33.45 12/11/98 09:299 91.61 30.63 33.45 12/11/98 11:0510 91.83 30.80 33.52 12/11/98 11:54

Upper 92.39 31.21 34.71Lower 87.01 29.39 32.69

X-B RBCGRAPHS

X-B WBCGRAPHS

PRINT RETURN

X-B FILE DISPLAYStandby Dec 12 1998


11:47abc1491

X-B RBC DATA

PAGE UP/DN FOR MORE DATA

X-B RBC

DATA

X-B RBC

GRAPHS


Quality ControlChapter 7 Quality Control Menu

X-B RBC Graphs Soft KeyThe [X-B RBC GRAPHS] key is used to display the X-B graphs for RBC indices on the X-B FILE DISPLAY screen. (See the following figure.) This screen displays the results for X-B batches 1–20 and the lower and upper limits.

NOTE: The X-B RBC data can also be viewed as data in tables by pressing the [X-B RBC DATA] key.

Figure 7.3: The X-B RBC Graphs Screen

X-B WBC Data Soft KeyThe [X-B WBC DATA] key is used to display the X-B data for WBC differential optical parameters on the X-B FILE DISPLAY screen. (See the following figure.) This screen displays the results for X-B batches 1–10 and the lower and upper limits. The date and time that each batch was completed are also displayed. The Page Down key on the keyboard is used to display batches 11–20. When batches 11–20 are displayed, the Page Up key on the keyboard is used to display batches 1–10.

NOTE: The X-B WBC data can also be viewed as graphs by pressing the [X-B WBC GRAPHS] key.

X-B RBC

GRAPHS

X-B RBC

DATA

MCV

92.3989.7087.01

X-B RBCDATA

X-B WBCGRAPHS

PRINT RETURN

MCH

31.2130.3029.39

MCHC

34.7133.7032.69

X-B FILE DISPLAYStandby


11:47abc1491

X-B RBC GRAPHS

X-B WBC

DATA

X-B WBC

GRAPHS


9140320C — November 2000


Figure 7.4: The X-B WBC Data Screen

X-B WBC Graphs Soft KeyThe [X-B WBC GRAPHS] key is used to display the X-B graphs for WBC differential optical parameters on the X-B FILE DISPLAY screen. (See the following figure.) This screen displays the results for X-B batches 1–20 and the lower and upper limits.

NOTE: The X-B WBC data can also be viewed as data in tables by pressing the [X-B WBC DATA] key.

BATCH L0D L10D N0D N10D N90D N90DEP NEU-EO DATE TIME

1 62 64 151 142 111 17 21.2 12/10/98 14:422 62 63 151 142 114 18 21.4 12/10/98 17:213 62 64 152 144 117 18 21.2 12/10/98 21:054 62 62 152 135 117 18 21.1 12/11/98 04:075 62 68 151 130 116 18 20.7 12/11/98 06:026 62 63 150 136 115 18 20.7 12/11/98 07:267 62 63 152 146 115 17 20.4 12/11/98 08:248 62 63 154 147 116 17 20.4 12/11/98 09:299 64 63 159 149 120 18 20.4 12/11/98 11:0510 63 62 155 147 119 18 20.4 12/11/98 11:54

Upper 74 73 176 168 137 20 27.3Lower 50 49 118 112 91 14 14.7

X-B RBCGRAPHS

X-B WBCGRAPHS

PRINT RETURN


11:47abc1491

X-B WBC DATA


PAGE UP/DN FOR MORE DATA

X-B WBC

GRAPHS

X-B WBC

DATA



Figure 7.5: The X-B WBC Graphs Screen

Print Soft KeyThe [PRINT] key is used to print the X-B data and graphs. When this key is pressed, the data and graphs for all 20 batches are automatically printed if the data or graphs are displayed.

Return Soft KeyThe [RETURN] key is used to return to the QC MENU screen.

PRINT RETURN



11:47abc1491

X-B WBC GRAPHS

N10D168140112

N90D137114

91

N90DEP201714

L0D746250

L10D736149

N0D176147118

NEU-EO27.321.014.7

X-B RBCGRAPHS

X-B WBCDATA

PRINT

RETURN


9140320C — November 2000


View QC Log Soft Key

Figure 7.6: The View QC Log Screen

The [VIEW QC LOG] key is used to display the QC Log indicated by the position of the cursor. Each QC Log display shows the following information (see the preceding figure):

1. Upper Left Corner

Lot Number and Expiration Date if the file was configured for this type of control. If the file was configured for a Replicate ID, it is displayed here.

File name, the number of runs currently in the file, and the file capacity (e.g.: 29/120 indicates that the file contains 29 runs out of a possible 120).

The page number of the display and the total number of pages in the file.

2. Status Box

Screen name, system status, and USE < OR > FOR MORE DATA. This message indicates that the Left and Right arrow keys on the keyboard should be used to display the other groups of data.

Upper Limits: 8.60 8.60 8.60 4.51 13.6 91.7 270.Lower Limits: 7.40 7.40 7.40 4.15 12.8 85.7 220.Target Mean: 8.00 8.00 8.00 4.33 13.2 88.7 245.

Seq WBC WOC WIC RBC HGB MCV PLT Date Time Op6627 8.12 8.12 7.96 4.32 13.3 89.5 225. O 11/20/98 10:10 7326628 7.80 7.80 7.68 4.32 13.3 98.7 231. O 11/20/98 10:12 732

WBC WOC WIC RBC HGB MCV PLTN: 27 27 27 27 27 27 27File Mean: 8.03 8.03 7.76 4.31 13.3 89.7 235.Std Dev: .110 .110 .150 .055 .101 .465 7.27

CV (./.): 1.4 1.4 1.9 1.3 0.8 0.5 3.1

PURGEQC LOG

LEVEY-JENNINGS

REJECTSPECIMEN

DELETESPECIMEN

MOVESPECIMEN

WRITE QCTO DISK

PRINTQC LOG

RETURN


10:46 7326632

Lot Number: N0041Exp. Date: 12/06/98

Norm 41 OPEN: 29/120Page 4 of 4

VIEW QC LOGReady


5

321

4

6

VIEW

QC LOG



3. Upper Right Corner

The current date, time, and operator ID are displayed along with the last sequence number that was used.

4. The remainder of the screen displays the file information and the data. The Upper and Lower Limits and Target Mean entered are displayed immediately above the parameter names. The sequence number for each result is displayed to the left of the data, and the results are displayed below the parameter. The date, time, and operator ID when the sample was run are displayed to the right of the data.

5. The following QC Log codes are displayed in the column immediately preceding the date. These codes are the same as those used in the Data Log:

O — Sample was run in the Open Mode

C — Sample was run in the Closed Mode

N — Incomplete aspiration in the Open Mode

I — Incomplete aspiration in the Closed Mode

K — Metering fault (Clog or Flow Error)

M — Mixing error on the Sample Loader

V — Sample was run in the Veterinary Mode

B — Blood in line

6. The statistics are displayed below the data as follows:

N: The number of runs used in the calculation

FILE MEAN: The mean value for the number of runs used in the calculation

STD DEV: The standard deviation for the number of runs used in the calculation

CV (%): The Coefficient of Variation in percent for the number of runs used in the calculation

NOTE: Quality Control results that fall at the boundaries of the selected limit set may be colored differently in the QC and Data Logs. This is possible due to differences in numerical rounding between the two logs. The result that will be displayed, printed and reported is the same in both logs and is accurate. Use the color in the data log view to determine whether the results are outside the entered limits.


9140320C — November 2000


The following soft key labels are displayed on the VIEW QC LOG screen:

PURGE QC LOGLEVEY-JENNINGSREJECT SPECIMEN or ACCEPT SPECIMEN (This key label alternates between


DELETE SPECIMENMOVE SPECIMENWRITE QC TO DISKPRINT QC LOGRETURN

Purge QC Log Soft KeyThe [PURGE QC LOG] key is used to delete the contents of the QC Log. When the [PURGE QC LOG] key is pressed, the following soft key labels are displayed:

CONFIRM PURGECANCEL PURGE

These keys are used to confirm or cancel the [PURGE QC LOG] command.

PURGE

QC LOG



Levey-Jennings Soft Key

Figure 7.7: The Levey-Jennings Menu Screen

The [LEVEY-JENNINGS] key accesses the LEVEY-JENNINGS MENU screen, which is used to display the Levey-Jennings graphs of the data in the QC file. (See the preceding figure.) The following soft key labels are displayed on the LEVEY-JENNINGS MENU screen:

GROUP 1*GROUP 2GROUP 3GROUP 4PRINTRETURN

* The soft key for the group currently shown on the screen is not displayed.

Each of these keys is used to select the graphs for a group of data that corresponds to the groups selected in the Customize QC Display option. Subsequent groups can be selected by pressing the appropriate soft keys.

HGB:

13.613.212.8

LEVEY-JENNINGS MENUReady

WBC:

8.608.007.40

GROUP2

GROUP3

GROUP4

PRINT RETURN


10:467326632

QC file: NORM 41 OPENSeq num: 5597 to 6628

WOC:

8.608.007.40

WIC:

8.608.007.40

RBC:

4.514.334.15

MCV:

91.788.785.7

PLT:

270.245.220.

LEVEY-

JENNINGS

GROUP

1– 4


9140320C — November 2000


The [PRINT] key is used to print the Levey-Jennings graphs. When the [PRINT] key is pressed, all of the graphs are automatically printed.

The [RETURN] key is used to return to the VIEW QC LOG screen.

Reject Specimen/Accept Specimen Soft Key

Figure 7.8: QC Log Screen With Rejected Results

The [REJECT SPECIMEN] key is used to exclude the results for the specimen indicated by the cursor position. When the key is pressed, the key label changes to [ACCEPT SPECIMEN], an “R” is displayed in the column immediately left of the results, and the statistics are recomputed excluding those results. (See the preceding figure.) The data are still displayed and stored in the file but are excluded from the statistical calculation.

When the [ACCEPT SPECIMEN] key is pressed, the “R” is deleted and the statistics are recomputed including those results.

PRINT

RETURN

Upper Limits: 8.60 8.60 8.60 4.51 13.6 91.7 270.Lower Limits: 7.40 7.40 7.40 4.15 12.8 85.7 220.Target Mean: 8.00 8.00 8.00 4.33 13.2 88.7 245.

Seq WBC WOC WIC RBC HGB MCV PLT Date Time Op6627 R 8.12 8.12 7.96 4.32 13.3 89.5 225. O 11/20/98 10:10 7326628 7.80 7.80 7.68 4.32 13.3 89.7 231. O 11/20/98 10:12 732

WBC WOC WIC RBC HGB MCV PLTN: 26 26 26 26 2 6 26 26File Mean: 8.02 8.02 7.75 4.31 13.3 89.7 236.Std Dev: .111 .111 .147 .056 .103 .471 7.14

CV (./.): 1.4 1.4 1.9 1.3 0.8 0.5 3.0

PURGEQC LOG

LEVEY-JENNINGS

ACCEPTSPECIMEN

DELETESPECIMEN

MOVESPECIMEN

WRITE QCTO DISK

PRINTQC LOG

RETURN


10:48 7326632

Lot Number: N0041Exp. Date: 12/06/98

Norm 41 OPEN: 29/120Page 4 of 4

V IEW QC LOGReady


REJECT

SPECIMEN

ACCEPT

SPECIMEN



Delete Specimen Soft KeyThe [DELETE SPECIMEN] key is used to delete the results for the specimen indicated by the cursor position. When the [DELETE SPECIMEN] key is pressed, the following key labels are displayed:


These keys are used to confirm or cancel the delete command. When the [CONFIRM DELETION] key is pressed, the results are deleted from the file (the data are not displayed or stored in the file) and the statistics are recomputed excluding those results.

Move Specimen Soft KeyThe [MOVE SPECIMEN] key is used to move the QC result indicated by the cursor position to another QC file. When the [MOVE SPECIMEN] key is pressed, the QC MENU screen is displayed, allowing the desired file to be selected. When the [MOVE TO FILE] key is pressed from the QC MENU screen, the result is moved to the indicated file.

Move Specimen Procedure1. From the QC MENU screen, use the arrow keys on the

keyboard to move the cursor to the file containing the specimen to be moved.

2. Press the [VIEW QC LOG] key.

3. Use the arrow keys on the keyboard to position the cursor at the result that is to be moved.

4. Press [MOVE SPECIMEN] to again display the QC MENU screen.

5. Use the arrow keys on the keyboard to move the cursor to the file in which the results are to be placed.

6. Press [MOVE TO FILE] to move the results to the designated file.

NOTE: The result is moved to the end of the list of data that are currently in the file.

7. The VIEW QC LOG screen of the original file is displayed showing that the results have been moved.

DELETE

SPECIMEN

MOVE

SPECIMEN


9140320C — November 2000


Write QC to Disk Soft KeyThe [WRITE QC TO DISK] key enables the download of data from a QC file to a floppy disk.

Procedure: Write QC to Disk1. From the MAIN MENU screen, press [QUALITY CONTROL].2. Place the cursor on the desired file and press [VIEW QC LOG].3. Place the disk to be returned to the CELL-DYN

Interlaboratory QC Program in to the Data Station disk drive,

4. Press [WRITE LOW] to transfer data into the low control disk file [WRITE NORMAL] to transfer data into the normal control disk file [WRITE HIGH] to transfer data into the high control disk file.

5. Press [RETURN] and select another file.

6. Repeat steps 3-5 until all QC data has been loaded onto the disk.

7. Remove the disk from the drive and send to the appropriate address for the Interlaboratory comparison program.

Print QC Log Soft KeyThe [PRINT QC LOG] key is used to print the entire QC Log.

Return Soft KeyThe [RETURN] key is used to return to the QC MENU screen.

WRITE QC

TO DISK

PRINT

QC LOG

RETURN



Quality Control Guide

The first section of this Guide gives information about running controls and guidelines for basic assay verification. The section on Westgard Rules defines the rules used on the CELL-DYN 3700 System and gives guidance for their application in the hematology laboratory. X-B analysis is discussed in detail in the last section.

All QC data should be reviewed according to your laboratory’s protocol. Refer to the section on Westgard Rules for suggestions on how to use them in a review protocol. Refer to the section on X-B Analysis for suggestions and guidelines for interpreting X-B results for RBC and WBC data.

Running Controls

Control MaterialAbbott recommends using the CELL-DYN control materials for performing quality control checks on the CELL-DYN 3700 System. These controls should be run:

• After daily start up procedures are completed.

• After a reagent lot number change.

• After calibration (confirmatory step).

• After a service call or component replacement.

• In accordance with the laboratory’s quality control protocol.

• According to regulatory requirements.

The CELL-DYN controls can be run in any mode of operation: Open Mode, CS Mode, or SL Mode.

NOTE: Controls for the Sample Loader and Closed Sampler Modes are packaged in tubes with pierceable caps.

Mixing and HandlingAlways mix and handle commercial control materials according to the directions given in the package insert. As the directions may vary from manufacturer to manufacturer, pay particular attention to the following:

• Check the condition of the control material when it is received in the laboratory. Be sure the tubes are at the proper temperature and are not leaking. Check for hemolysis.


9140320F — April 2007

Quality ControlQuality Control Guide Chapter 7

• Store the controls at recommended temperatures. Storage in a central location in the refrigerator, away from the door if it is opened frequently, is advisable.

• Carefully warm and resuspend the product according to the directions given in the package insert. Proper mixing is essential for accurate results.

• Check the open-tube stability dating and do not use products longer than is recommended, or results may be compromised.

• Never subject a tube to excessive heat or agitation.

Assay VerificationNew lots of control material should be analyzed in parallel with current lots prior to their expiration dates. This may be accomplished by running the new controls twice a day for five days. The mean of the ten runs is then used to confirm the assay value. A control file is set up for the new lot number to easily establish the mean. If desired, this same control file can then be used to run the control for the remainder of the dating period. Creating another file is not required.

The expected ranges published by manufacturers are generally too broad for effective quality control.1 Therefore, each laboratory should establish acceptable ranges. These ranges may be determined by evaluating three to six months of data (data from the Interlaboratory QC Program may be used) for a particular level of control. The individual SD values may be averaged as follows:

N = number of values in a group

SD = Standard Deviation of the values in that group

i = the last group of values

The resultant long-term instrument SD and the laboratory-established mean for each lot number should be used to monitor instrument performance.

NOTE: Entry of the laboratory-established ranges is restricted by the allowable limits available in the QC Range Entry Screen. An explanation of this screen is provided in Chapter 5: Operating Instructions, subsection: Set Up Instructions, QC Limits Soft Key.

(N1 SD1)+(N2 SD2)+...(Ni SD)(N1 + N2 + ...Ni) - 1

2 2 2× × ×Average SD =

(N1 x SD12) + (N2 x SD22) + ... (Ni x SDi2)

(N1 + N2 + ...Ni) - 1


Quality ControlChapter 7 Quality Control Guide

Westgard RulesA control rule tests the control result against control limits to determine whether the CELL-DYN 3700 System shows acceptable accuracy and precision. The limits are derived from the mean and standard deviation of control measurements obtained when instrument performance is stable and acceptable. The most common rule used in hematology quality control is the mean ± 2SD limits. Ninety-five percent of the control results should fall within the ± 2SD limits.

Quality control rules detect random or systematic error. Random error may be defined as an increase in the SD (loss of precision). Systematic error may be defined as a shift in the mean value (loss of accuracy). A multi-rule quality control procedure combines several control rules to improve the detection of both types of error.

J. Westgard recommended a multi-rule approach to evaluating quality control results.2 This approach has long been used in the clinical laboratory3. A set of modified Westgard Rules can be used to monitor quality control results on the CELL-DYN 3700 System.

NOTE: Do not use the values for mean range provided on the control assay sheet in conjunction with Westgard Rules. Before using Westgard Rules with commercial controls, establish the SD for each parameter on your instrument and enter limits based on these SDs. Refer to Assay Verification within this section for how to establish a long-term SD.

CELL-DYN 3700 System Westgard RulesThe rules (Westgard’s nomenclature is given in parentheses) available on the System Software are:

Rule 1 (13s): Value outside 3SDA control result exceeded the mean ± 3SD.

Rule 2 (22s): Two consecutive values outside the same 2SDTwo consecutive results fell outside 2SD on the same side of the mean.

Rule 3 (R4s): Two consecutive values outside opposite 2SDOne result was greater than 2SD above the mean and the next result was greater than 2SD below the mean. Consequently, the range between the results is greater than 4SD.

Rule 4 (2 of 32s): Two of three consecutive values outside same 2SDTwo consecutive results of the last three results fell outside 2SD on the same side of the mean.




Rule 5 (41s): Four consecutive values outside same 1SDFour consecutive results fell outside 1SD on the same side of the mean.

Rule 6 (10x): Ten consecutive values on the same side of meanTen consecutive results fell on the same side of the mean.

The rules may be used singly or in combination, depending on operator preference. Selections are made on the QC FILE SET UP screen.

When a rule is selected, a plus sign is displayed to the right of the parameter name on the LEVEY-JENNINGS MENU screens. (See the following figure.) Six plus signs indicate that all six rules are selected in order from left to right. A minus sign is displayed if a rule is not selected.

Figure 7.9: Levey-Jennings Menu Screen Showing Westgard Rule Violations

Whenever a rule is violated, the Bulletin Line displays the following message in the VIEW QC LOG screen:WESTGARD WARNINGS: SEE LEVEY-JENNINGS.

The number of the rule that was violated is displayed in place of the plus sign. The preceding figure shows examples of the plus and minus signs and rule-violation indications.

PLT:+-+-++

248.226.204.

MCV:+-+-++

104.99.394.4

HGB:+-+-+6

16.015.314.6

LEVEY-JENNINGS MENUReady

WBC:+-+-+6

4.804.404.40

GROUP2

GROUP3

GROUP4

PRINT RETURN


15:06sh0630

QC file: PatientSeq num: 14 to 42

RBC:+-+-++

5.144.904.66

WOC:+-+-+6

4.804.404.40

WIC:+-+-+6

4.804.404.40



Rule ViolationsOnly the directly measured parameters need to be monitored with multiple rules.4 In reference 4 (pp. 190–192), Cembrowski suggests a protocol for using the Westgard Rules in hematology. The following is a synopsis of that protocol.

Since three levels of control are typically used to monitor a hematology analyzer, it is reasonable to consider all three runs at the same time. In other words, check for rule violations across the three levels, not just within a particular level. If the same rule is violated for more than one level, determine whether the violation indicates a loss of precision or a loss of accuracy, and troubleshoot accordingly.

Cembrowski suggests that the results for all three levels first be checked to see if they are within their 2SD limits. If all three levels meet this criterion, the instrument is in control.

If any control result exceeds the 2SD limits, check to see if it exceeds the 3SD limits. If a result exceeds 3SD, there are two possibilities. There is either an instrument problem or a problem with the particular level of control. Therefore, if a result exceeds 3SD, run another bottle of that control. If the problem persists, then additional investigation is required.

Check to see if either the 2 of 32s or R4s rules have been violated for any level or across levels. If the problem is confined to one level of control, check for a 22s rule violation for that level. Again, if the violations are confined to one level of control, use another bottle and possibly another lot. Check expiration dates and data entry. Check to be sure that the control is run into the correct file.

If a combination of rules has been violated across the three levels, determine whether the violations indicate a loss of precision or a loss of accuracy, and troubleshoot accordingly. If necessary, call Abbott Diagnostics Customer Service (at 1-877-4ABBOTT in the US) for assistance.

When the problem has been resolved, Cembrowski suggests that all levels be run again in duplicate to confirm that the problem has in fact been corrected.


9140320C — November 2000


X-B Analysis

OverviewX-B analysis is an automated means of monitoring instrument performance by using the known stability of the red cell indices.

“X-B” is used to indicate XB, which is the symbol for a moving average of hematology values calculated using an algorithm developed by Dr. Brian Bull of Loma Linda University. X-B RBC analysis uses the Bull algorithm to monitor instrument performance by tracking data in the patient population analyzed on the instrument.

X-B RBC analysis works well using the data from the RBC indices due to the narrow dynamic range of the indices in human populations. However, it is difficult to use this approach when the algorithm is applied to results that have a wide dynamic range of values, such as the WBC Differential subpopulations. Consequently, there has been no means of monitoring the WBC Differential parameters in a similar manner.

A method of X-B analysis for WBC Differential parameters has been developed for the CELL-DYN 3700 System using data obtained with the MAPSSTM technology. This method uses a moving average calculation that is similar to the one used in Dr. Bull’s algorithm. For convenience, the method is called X-B WBC, even though it was not developed by Dr. Bull. A detailed description is contained in X-B Analysis for WBC within this chapter.

X-B Terminology

Lower/Upper Acceptance LimitsThe lower and upper limits determine which patient results will be used in the X-B Moving Average calculation. They should be set widely to exclude grossly abnormal samples but should include at least 95% of the patient results. Only results that fall within the set limits are used in the calculation.

Target ValueThe Target Value for X-B RBC is similar to the assay value for a commercial control. It is derived from the patient population analyzed on the instrument.

Action LimitThe Action Limit is the acceptable limit of variation around the target value.



X-B Analysis for RBC

OverviewThe red cell indices (MCV, MCH, and MCHC) are known to be stable because the red cell apparently functions best in a very narrow range of size and hemoglobin content. Therefore, the body exerts tight physiologic control and will vary the number of red cells before altering the average volume or hemoglobin concentration of those red cells. Consequently, the average red cell indices of a given patient population will vary no more than 0.5 percent from day to day and even year to year, providing the population does not change.5 The X-B algorithm provides a means of utilizing this information for quality control on the CELL-DYN 3700 System.

The X-B algorithm analyzes the indices on the patient samples run through the instrument in batches of 20. The mean of each batch is compared to a target value, and a percent deviation is computed and compared to the acceptable limits. This is similar to comparing the results of a commercial control run to the appropriate assay value to determine whether the result falls within the 2SD range. If the percent deviation exceeds acceptable limits, the message: X-B OUT is displayed on the screen.

Establishing the X-B RBC Target ValueA recent study6 by Dr. Bull collected data from 1,767 hospitals and yielded the following mean values:

MCV 89.9 fL

MCH 30.5 pg

MCHC 33.9 g/dL

These values confirmed values that Bull had published in an earlier study.7 Consequently, the values shown above can be used as the Target Values to initiate the X-B analysis program.

Laboratories seeing specialized patient populations (for example, pediatric hospitals or tumor centers) may need to verify these values due to “abnormal” patient populations. Target values may be verified by evaluating approximately 500 samples and comparing the X-B means for those samples to the entered target values.

The CV on 500 samples for each index should be < 1.5%. (Dr. Bull’s study found CVs from 0.5% to 1.2%. The 1.5% is one-half the allowable ± 3% action limit, which is acceptable for this confirmatory step.) If the CVs are >1.5%, an additional 500 samples should be evaluated.


9140320C — November 2000


Each laboratory should establish its own target value for the RBC indices. It is suggested that the process be started by using the default values (preset values from Dr. Bull’s earlier studies) displayed on the X-B SET UP screen or by entering the values from Dr. Bull’s recent study described above. The 3% action limits may be used or widened to 5% during the study and tightened to 3% when the Target Values are confirmed. The default values for the Lower/Upper Limits may also be used or widened depending on the specimen population analyzed by the laboratory.

Collect data from 20 batches of 20 specimens each for a total of 400 specimens. Data collection should be from specimens which represent the typical specimen population that is processed through the instrument. When all 20 batches are complete, print the X-B DATA DISPLAY screen for RBC. Calculate the mean, standard deviation (SD), and coefficient of variation (CV) for MCV, MCH, and MCHC. The CV for each index should be < 1.5%. If the CV for each index meets these criteria, enter the calculated mean value as the target value and set the action limits to 3%.

NOTE: Laboratories analyzing specialized patient populations (as described above) may need to widen the action limits slightly to accommodate results from these abnormal patients.

If the CV for each index is >1.5%, evaluate another 400 specimens and repeat the calculations.

When an acceptable target value has been entered, evaluate data from an additional 400 specimens to confirm the entered values.

Troubleshooting X-B RBC ResultsWhen XB-RBC results are out of control, data should be reviewed for shifts and trends in the results.

Shifts in results are usually caused by a non-random batch of 20 specimens such as those from dialysis or pediatric units. Multiple repeats of the same abnormal specimen within a given batch of 20 may also cause a non-random population in that batch. Review the Data Log for the last 20 specimens and determine if this is the case. Shifts caused by non-random data will usually be corrected in the next batch of 20 as long as those data are random.

Shifts may also be caused by a change in reagent container or a lot number change. Review the Reagent Log to see if this is true for Diluent or WIC/HGB Lyse. If containers or lot numbers recently changed, try another container and see if the problem persists.



Calibration changes may also cause a shift in results. If a shift cannot be explained as described above, run commercial controls or run a patient selected from a previous batch when X-B results were in control. If values are within acceptable limits, a calibration shift is not the cause of the problem.

Trends in X-B results are usually caused by instrument problems. A recent component change may also cause a trend in results. Use the following table to determine the directly measured parameter(s) involved, and troubleshoot accordingly. If a problem is not readily identified, perform routine maintenance and repeat the commercial and patient controls to see if results are acceptable.

Since two of the RBC indices are calculated parameters, their inter-relationships can be used to assist in troubleshooting. The following table uses the mathematical relationships between the indices to aid in determining which directly measured parameter(s) are involved when X-B is out of control. When the directly measured parameter(s) are identified, refer to Chapter 10: Troubleshooting for troubleshooting assistance with these parameters.

Table 7.1: Troubleshooting X-B RBC

If all efforts fail to bring results within acceptable limits, contact Abbott Diagnostics Customer Service (at 1-877-4ABBOTT in the US) for assistance.

Interpreting X-B RBC ResultsA suggested protocol and guidelines for interpreting X-B data can be found in Chapter 1 of Laboratory Hematology: An Account of Laboratory Techniques, edited by I. Chanarin.8

X-BPattern

If the MCV If the RBC If the HGB

Index Derivation

isincreased

isdecreased

isincreased

isdecreased

isincreased

isdecreased

MCVwill be

High Low N/A N/A N/A N/A MCV

MCHwill be

N/A N/A Low High High Low HGB/RBC

MCHCwill be

Low High Low High High Low HGB/HCT


9140320C — November 2000


X-B Analysis for WBC

OverviewSince the WBC Differential parameters have a wide dynamic range, it is difficult to use a moving average algorithm to control these results. Therefore, the CELL-DYN 3700 System uses data obtained from the MAPSSTM technology used for the WBC Differential measurement.

Five main subpopulations of WBCs, which can vary widely in absolute number and percentage values, are identified by the CELL-DYN 3700 System. Even though these parameters have varying dynamic ranges, they maintain a relatively constant modal position on each axis of the scatterplots. It is expected that these optical characteristics of the WBC Differential subpopulations will remain stable over time without impact from the wide dynamic ranges of the individual parameters. This constant modal position, which is sensitive to changes in the instrument’s optical measurement process, can be monitored by the instrument and used to control the WBC Differential parameters in much the same way that the RBC indices are used to control the RBC parameters.

The CELL-DYN 3700 System monitors the modal positions of the lymphocyte and neutrophil clusters on each axis of the 0°/10° scatterplot. It also monitors the modal positions of the neutrophil cluster on each axis and the angle of the neutrophil/eosinophil separation on the 90°/90° depolarized scatterplot. These seven measurements are then averaged for each batch of 20 patients using a moving average calculation similar to that developed by Dr. Bull for the RBC indices. For convenience, this process is called X-B WBC.

Establishing the X-B WBC Target ValueThe Target Values for X-B WBC can be established in the same way as the Target Values for the RBC indices.

Each laboratory should establish its own target value for the X-B WBC parameters. It is suggested that the process be started by using the default (preset) values displayed in the following table. The action limits in the table may be used or widened during the study. Reenter the default action limits shown in the following table when the Target Values are confirmed. The values for the action limits may be widened depending on the specimen population analyzed by the laboratory. The values for the Lower/Upper Acceptance Limits may also be used or widened depending on the specimen population analyzed by the laboratory.



Collect data from 20 batches of 20 specimens each for a total of 400 specimens. Data collection should be from specimens which represent the typical specimen population that is processed through the instrument. When all 20 batches are complete, print the X-B DATA DISPLAY screen for WBC. Calculate the mean, standard deviation (SD), and coefficient of variation (CV) for each parameter. The CV for LYM 0°, LYM 10°, NEU 0°, and NEU 10° should be <2.5%. The CV for NEU 90°, NEU 90° depolarized, and NEU-EOS should be <5%. If the CV for each index meets these criteria, enter the calculated mean value as the target value and set the action limits to 5% for LYM 0°, LYM 10°, NEU 0°, and NEU 10°, and to 10% for NEU 90°, NEU 90° depolarized, and NEU-EOS.

NOTE: Laboratories analyzing specialized patient populations (as described above) may need to widen the action limits slightly to accommodate results from these abnormal patients.

If the CV for each index is more than the limits described above, evaluate another 400 specimens and repeat the calculations.

When an acceptable target value has been entered, evaluate data from an additional 400 specimens to confirm the entered values.

Table 7.2: Default (Preset) X-B WBC Values

Parameter Acceptance Limits Target Mean Action Limit

LYM 0° 48 - 70 59 7

LYM 10° 51 - 67 59 5

NEU 0° 141 - 179 160 4

NEU 10° 128 - 170 149 5

NEU 90° 87 - 163 125 10

NEU 90 DEP° 11 - 31 21 19

NEU-EOS° 14 - 32 23 13




Troubleshooting X-B WBC ResultsTroubleshooting X-B WBC results that are out-of-range can be done using the same logic that is applied to troubleshooting X-B RBC out-of-range results. Review previous batches of data for non-random specimens, check the appropriate reagents, run controls to determine whether a calibration change has occurred, check to see if service was recently performed on the optical system or a component was recently changed, perform appropriate routine maintenance procedures, and refer to Chapter 10: Troubleshooting for assistance.

If all efforts fail to bring results within acceptable limits, contact Abbott Diagnostics Customer Service (at 1-877-4ABBOTT in the US) for assistance.



References

1. Cembrowski GS, Carey RN. Laboratory Quality Management. Chicago: ASCP Press. 189. 1989.

2. Westgard JO et al. A Multi-Rule Shewhart Chart for Quality Control in Clinical Chemistry. Clinical Chemistry 1981; 27:3:493–501.

3. Cembrowski GS, et al. Use of a Multirule Control Chart for the Quality Control of PT and APTT Analyses. Laboratory Medicine June 1989; 418–421.

4. Cembrowski GS, Carey RN. Laboratory Quality Management. Chicago: ASCP Press. 190. 1989.

5. Bull BS, Korpman RA. Intralaboratory Quality Control Using Patients’ Data. Quoted in Cavill I, ed, Quality Control (Edinburgh: Churchill Livingstone, 1982), 121–150.

6. Bull BS, Jones AR, Gibson M, Twedt D. A Method for the Independent Assessment of the Accuracy of Hematology Whole Blood Calibrators. American Journal of Clinical Pathology 1992; 98:623-29.

7. Bull BS, Hay KL. Are Red Blood Cell Indexes International? Archives of Pathology and Laboratory Medicine 1985; 109:604–606.

8. Chanarin I, ed. Laboratory Hematology: An Account of Laboratory Techniques. New York: Churchill Livingstone. 3-7. 1989.


9140320C — November 2000

Quality ControlReferences Chapter 7

NOTES


Chapter 8 HazardsHazards

Overview

Hazards

Operation, maintenance, and servicing of automated hematology systems may expose individuals to potential safety and health hazards. All work must be performed as described in the Abbott Laboratories CELL-DYN Operator’s Manual or as directed by an Abbott Representative.

This section provides precautionary warnings and information necessary for the safe use of the CELL-DYN 3700 System. Supplementary warnings are inserted throughout this manual and on the instrument to alert personnel to potential hazards. Whenever hazard symbols are encountered on the instrument, users must consult the Operator’s Manual to determine the nature of the potential hazard and actions that must be taken.

The standard warning conventions including signal words (e.g., caution) and symbols are described below. Safety symbols appear next to signal words that identify hazards.

Warning Conventions

Signal Words

DANGER: Denotes an immediate hazard which, if not avoided, could result in serious injury or death.

WARNING: Denotes a hazard which, if not avoided, could result in moderate to serious injury.

CAUTION: Denotes potential hazards that could result in a minor injury. Also, used for conditions or activities which could interfere with proper functioning of the instrument.

NOTE: Denotes special operator/service information or standard practices.


9140320D — June 2003

HazardsOverview Chapter 8

SymbolsThe general hazard symbol identifies an activity or area that may present a hazard to personnel or equipment.

The electrical hazard symbol alerts personnel to the possibility of electrical shock if procedural or engineering controls are not observed.

The biohazard symbol identifies an activity or area where personnel may be exposed to infectious substances if procedural engineering controls are not observed.

The laser hazard symbol identifies an activity or area where personnel will be exposed to an eye hazard if procedural or engineering controls are not observed.


HazardsChapter 8 Hazard Information and Precautions

Hazard Information and Precautions

GeneralAutomated hematology instruments require the handling of whole blood and blood components by laboratory personnel. In addition, personnel must conduct maintenance to ensure proper performance of the instrument. These activities result in potential contact with infectious substances and other hazards. The following are warnings, precautions, and standard practices to help prevent injury.

CAUTION: If the instrument is used or modified in a manner not specified by the manufacturer, the protection provided by the instrument may be impaired.

BiohazardsWARNING: Potential Biohazard. Consider all clinical specimens, reagents, controls, surfaces or components that contain or have contacted blood, serum, or other bodily fluid as potentially infectious. Wear gloves, lab coats, and safety glasses, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule (29CFR Part 1910.1030) or other equivalent biosafety procedures.

WARNING: Potential Biohazard. The aspiration needle and probe are sharp and potentially contaminated with infectious material. Avoid contact with the tips of the probe and needle.

Spills of potentially infectious materials should be cleaned up in accordance with established biosafety practices. A generally accepted procedure for cleaning such spills is to absorb the spill with toweling or other absorbent material, wipe the area with an appropriate tuberculocidal disinfectant such as 0.5% sodium hypochlorite solution (refer to formula in Chapter 9: Maintenance, Subsection: Decontamination Procedures).


9140320D — June 2003

HazardsHazard Information and Precautions Chapter 8

Prior to maintenance, service, or shipping, the instrument should be decontaminated in accordance with the procedures specified in Chapter 9: Maintenance, Subsection: Decontamination Procedures and/or Preparation for Inactivity or Shipping as appropriate. Remove and dispose of contaminated disposables in accordance with local, state, and federal regulations.

Handling and Disposing of Biohazardous MaterialsDispose of liquid and solid waste in accordance with local, state, and federal regulations. Probes, needles, broken glass, and other sharps that are contaminated with potentially infectious substances should be collected in a “sharps” container for disposal as regulated medical waste. Contaminated gloves, wipes, swabs, and other disposables should be placed in a standard medical waste container.

Chemical HazardsPrevent exposure to chemicals used in the operation and maintenance of the CELL-DYN 3700 System (including reagents) by using appropriate personal protective equipment, work procedures, and information on Material Safety Data Sheets (MSDS). Refer to Chapter 2: Installation, for an installation procedure for chemical containers.



Electrical HazardsBasic electrical hazard awareness is essential to the safe operation of any hematology analyzer. Appropriate personnel (including facilities personnel) should practice good habits of electrical safety, which include the following:

• Periodically inspect electrical cabling into and on the instrument for signs of wear or damage.

• When moving equipment, lift all power cables clear of all System components.

CAUTION: Electrical Hazard. Do not disconnect any electrical connection while the power is on. Follow instructions for correctly powering down the instrument and all connected equipment before performing maintenance on parts which require protective covers to be removed for access. Use only approved power cords and electrical accessories, supplied with the instrument, or provided by Abbott, to protect against electrical shock.

CAUTION: Electrical Hazard. Turn off the power to the instrument and disconnect the power cord before removing any instrument panel that is securely fastened in place by screws or prior to replacing fuses. Replace only the externally accessible fuse located immediately above the power cord connector on the rear panel of the instrument. Use replacement fuses only of the specified type and electrical rating.

• Keep liquids away from all electrical connectors (such as electrical outlets) or communication connectors (such as the LIS connector).

• Keep the floor dry.

• The electrical circuit spacing of the CELL-DYN 3700 System is based on pollution degree (1) and altitude [up to 2000 M (6500 ft)] as per IEC 61010-1. Pollution degree 1 is defined as an environment where there is no pollution or only dry, non-conductive pollution.

CAUTION: If the instrument is used or modified in a manner not specified by the manufacturer, the protection provided by the instrument may be impaired.

For details about power requirements, refer to Chapter 4: System Specifications, Subsection: Power Specifications.


9140320D — June 2003


Physical and Mechanical HazardsObserve these basic rules for mechanical safety:

• Carefully follow all procedures and instructions.

• Keep all protective covers in place when processing specimens.

• Never allow any part of your body to enter the region of movement of any mechanical component when the instrument is operating.

• Do not wear articles of clothing or accessories that could catch on the System; keep pockets free of items that could fall into the System; keep long hair from catching on the System.

• Wear powder-free gloves, labcoat and safety glasses when maintaining or repairing the instrument.

• Avoid contact with needle tips at all times.

• Use professional assistance when moving or lifting the instrument, to prevent injury.

• Use proper lifting technique to prevent injury when moving reagent cubtainers.

Laser HazardsThe CELL-DYN 3700 Analyzer and Sample Loader are Class 1 (Class I) Laser Products per IEC 60825-1. However, the analyzer contains Class 3B and Class 2 lasers as well.

CAUTION: Class 3B Laser Light when open — Avoid Exposure to Beam. Do not look directly into the laser beam or any reflections of the beam from a mirror-like surface. When the access door, or other inner protective covers are removed, Helium-Neon laser power up to 10 mW continuous wave at 632.8 nm in a beam with 1mR divergence could be accessible in the interior of the optics bench. This amount of energy, with insignificant attentuation with distance, is sufficient to cause eye damage. The laser aperture is located on the left end of the laser head (refer to Figure 8.3). This Class 3B laser system is classified to EN 60825-1/A2:2001, the standard for Safety of Laser Products.



CAUTION: Barcode Laser Light —Do not stare into beam. Do not stare directly into the barcode laser beam or any reflections of the beam from a mirror-like surface. The laser beam is capable of causing eye damage. When the Left Front Cover or the Tower Cover is removed, Class 2 laser light up to 1 mW continuous wave at 670 nm could be accessible from the bar code reader. The bar code reader is located behind the Tower Unit. The laser aperture is located on the right side of the bar code reader. This Class 2 laser system is classified to EN 60825-1:1994+All:1996, the standard for Safety of Laser Products. The Class 2 Laser Label applies only to the CELL-DYN 3700SL.

CAUTION: Use of controls adjustments or performance of procedures other than those specifified herein may result in hazardous laser light exposure. The sample loader’s safety cover has an interlock switch that prevents sample loader operation when the cover is not in place. Lifting the cover while the sample loader is operating causes an immediate emergency stop condition. Do not bypass the interlock switch to operate the sample loader without the safety cover.

During normal operation the inner protective covers are to remain in place to prevent laser light exposure from the optics bench. The inner protective covers should be removed only during servicing by qualified personnel.

The inner protective cover laser warning labels must not be removed and are to remain legible. The protective housing label (Abbott P/N 9230701), shown in Figure 8.1 consists of black lettering against a yellow background.


9140320D — June 2003


Figure 8.1: Laser Hazard Label

This label is located in two places: on the L-shaped optical baffle cover on the left side of the optical bench (under the Top Cover) (refer to Figure 8.2), and on the upper left side of the Flow Panel (refer to Figure 8.3).

Figure 8.2: Laser Aperture and Warning Label Position - Protective Cover

CAUTION –

CLASS 3B LASER LIGHT WHEN OPEN.

AVOID EXPOSURE TO BEAM.PN 9230701

Laser Warning LabelLaser Aperture

ProtectiveCover



Figure 8.3: Laser Warning Label Position - Flow Panel

The Class 2 Laser Caution Label (Abbott P/N 9230323) is shown in Figure 8.13. The label consists of black lettering against a yellow background.

Figure 8.4: Class 2 Laser Caution Label

This label is located on the top surface of the sample loader. (Refer to Figure 8.5.

Figure 8.5: Class 2 Laser Caution Label Location

Laser Warning Label

CAUTION - CLASS 2 LASER LIGHT WHENOPEN AND INTERLOCK IS DEFEATEDDO NOT STARE INTO THE BEAM

PN 9230323

Class 2 Laser Caution Label


9140320D — June 2003


The Class 1 Laser Product Label (Abbott P/N 9230702) shown in Figure 8.6 consists of black lettering against a yellow background.

Figure 8.6: Laser Label, Rear Panel

The label is located on the left section of the instrument’s Rear Panel and is positioned in a clearly visible location, as shown in Figure 8.7.

Figure 8.7: Class 1 Laser Product Label Location

CLASS 1 LASER PRODUCTPN 9230702

Class 1 LaserProduct WarningLabel


HazardsChapter 8 References

References

1. Occupational Safety and Health Administration, Department of Labor. 29 CFR Part 1910.1030. Occupational Exposure to Bloodborne Pathogens.

2. IEC 60825-1, International Electrotechnical Commission — World Standards for Electrical and Electronic Engineering, 60825: — Safety of Laser Products, 60825-1 (1993) Part 1: Equipment Classification, Requirements, and Users Guide.


9140320D — June 2003

HazardsReferences Chapter 8

NOTES


Chapter 9 MaintenanceMaintenance

Overview

The CELL-DYN® 3700 System is designed to require minimal routine maintenance. For example:

• The fluidics are automatically rinsed between samples.

• A thorough system rinse is performed automatically when the unit has been idle for five minutes after the last cycle is completed.

• An automatic Aperture Cleaning Circuit cleans the WIC aperture after each count cycle.

• The instrument is automatically placed in STANDBY if it has been idle for four hours after the last cycle is completed.

The operator is encouraged to routinely perform the scheduled maintenance procedures described in this chapter in order to ensure optimum performance. This chapter also give instructions for preparing the instrument for a prolonged period of inactivity.

Many required preventive maintenance procedures have been automated on the CELL-DYN 3700 System. These programs can be accessed by pressing the [SPECIAL PROTOCOLS] key on the Data Station. The SPECIAL PROTOCOLS screen is discussed in the next section.

The maintenance schedule outlined on the following page will minimize operational problems with the CELL-DYN 3700 System. The recommended intervals are based on instruments operating in laboratories that process samples from a general patient population. The intervals are affected by the volume of samples processed, the workload schedule, the operating environment and the patient population that is analyzed. Each laboratory must assess its own situation and modify these recommended intervals as necessary.

Overdue maintenance is usually indicated by an increase in imprecision of one or more of the directly measured parameters. This increase is due to carryover or dilution/sampling inconsistencies. If this occurs on more than a random basis, the appropriate maintenance should be performed more frequently. A diagram of the Analyzer Flow Panel is included to assist in component identification and location.



MaintenanceOverview Chapter 9

Preventive Maintenance ScheduleThe following procedures should be performed at the scheduled time intervals or as determined by each individual laboratory:

Daily1. Run the Auto-Clean Cycle.

2. Clean the Aspiration Needle.

Weekly1. Clean the Shear Valve.

2. Replace the Sample Aspiration Peristaltic Pump Tubing.

3. Clean the Sample Loader Tray, Racks, and Safety Cover.

4. Run the Extended Auto-Clean Cycle if routinely running reticulocyte counts.

Monthly1. Clean the Reagent Syringes.

2. Clean the Analyzer Air Filters.

3. Replace the WOC Transfer Peristaltic Pump Tubing.

4. Run the Extended Auto-Clean Cycle.

As Required (for Troubleshooting or Corrective Action)1. Clean the 10-mL Reagent syringe.

2. Clean the WIC and RBC/PLT Aperture Plates.

3. Clean the HGB Flow Cell.

4. Unclog the Open Sample Aspiration Probe.

5. Clean the Bar Code Reader Window.

6. Flush the "Y" Fitting.

Special Procedures1. Adjust the Closed Sampler Tube Retainer (CS only).

2. Prepare for Inactivity or Shipping.

3. Repackage for Shipment.

Analyzer Flow Panel Components DiagramA diagram of the Analyzer Flow Panel components has been included on the next page. This diagram can be used to assist in locating components.


MaintenanceChapter 9 Overview

Figure 9.1: Analyzer Flow Panel Components

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9140320D — June 2003

MaintenanceOverview Chapter 9

Decontamination ProceduresThe OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030) requires the decontamination of laboratory equipment prior to servicing or shipment:

• Decontaminate the instrument by performing the Auto-Clean cycle. This cycle flushes all of the fluid pathways with reagents to purge any waste from the fluid pathways. The Open Mode Sample Probe and the Closed Sample Needle (CS Model) or Sample Loader Needle (SL Model) are automatically rinsed after every cycle. The surfaces of the instrument should be wiped with a nonabrasive detergent solution to remove any soiling, then wiped with a tuberculocidal disinfectant, such as a 0.5% sodium hypochlorite solution.

To calculate the percent (%) sodium hypochlorite concentration desired see the following formula:

A = Percent (%) of sodium hypochlorite solution desired

B = Percent (%) of sodium hypochlorite stock solution (as purchased)

X = Parts of water to be mixed with one part of the sodium hypochlorite stock solution

Example:

If you need a 0.5% solution of sodium hypochlorite for a cleaning procedure, and the label on the bottle of bleach states that it is 5.25% sodium hypochlorite, then:

Add 9.5 parts deionized water to 1 part bleach to obtain a 0.5% sodium hypochlorite solution, or 9.5 mL of deionized water to 1.0 mL of bleach (5.25% sodium hypochlorite) to obtain 10.5 mL of a 0.5% solution of sodium hypochlorite.

If the instrument is to be shipped, it must be decontaminated prior to shipment. This is accomplished by pressing the [PREPARE SHIPPING] key in the SPECIAL PROTOCOLS menu. Instructions for this procedure are given in Special Procedures, Subsection: Preparation for Inactivity or Shipping.

X = B - AA

X = 5.25 - .5.5 X = 9.5


MaintenanceChapter 9 Special Protocols Menu

Special Protocols Menu

Figure 9.2: Special Protocols Screen

The SPECIAL PROTOCOLS screen is accessed from the MAIN MENU screen by pressing the [SPECIAL PROTOCOLS] key. The following soft key labels are displayed:

EMPTY XDUCERS orFILL XDUCERS (The soft key label alternates

between these two selections.)REAGENT RESERVOIR

EMPTY WOC or FILL WOC (The soft key label alternates between these two selections.)

MAINTEN LOGCLEAN SHEAR VAL or RESTORE SHEAR VAL (The soft key label alternates

between these two selections.)DISABLE ANALYZER or ENABLE ANALYZER (The soft key label alternates

between these two selections.)MOREMAIN

EMPTYXDUCERS

REAGENTRESERVOIR

EMPTYWOC

MAINTENLOG

CLEANSHEAR VAL

DISABLEANALYZER

MORE MAIN



16:01rcs0711

SPECIAL

PROTOCOLS


9140320C — November 2000

MaintenanceSpecial Protocols Menu Chapter 9

A brief description of the function of each soft key follows. Instructions for the detailed use of each key are given in the appropriate maintenance procedure.

Emptying the TransducersThe [EMPTY XDUCERS] key is used to empty both chambers in the von Behrens WIC Transducer and both chambers in the von Behrens RBC/PLT Transducer prior to removing the Aperture Plates. When the transducers are empty, the key label changes to [FILL XDUCERS].

When the [FILL XDUCERS] key is pressed, the transducers are refilled with reagent.

EMPTY

XDUCERS

FILL

XDUCERS



Draining the Reagent Reservoirs

Figure 9.3: Reagent Reservoir Screen

The [REAGENT RESERVOIR] key is used to drain the reagent reservoirs located on the Left Side Panel of the Analyzer. When the [REAGENT RESERVOIR] key is pressed, the following soft key labels are displayed:

EMPTY DILUENT or FILL DILUENTEMPTY LYSE or FILL LYSEEMPTY SHEATH or FILL SHEATHEMPTY DETERGENT or FILL DETERGENTRETURN

The screen displays the message shown in the preceding figure.

When the [EMPTY DILUENT], [EMPTY DETERGENT] or [EMPTY SHEATH] key is pressed, the appropriate reagent reservoir is drained. The [EMPTY LYSE] key is used to drain the WIC/HGB Lyse supply tubing. When the reservoir (or tubing) is empty, the appropriate [FILL] key is displayed.

When the [FILL DILUENT], [FILL DETERGENT] or [FILL SHEATH] key is pressed, the appropriate reagent reservoir is refilled. When the [FILL LYSE] key is pressed, the lyse supply tubing is refilled.

EMPTYDILUENT

EMPTYLYSE

EMPTYSHEATH

EMPTYDETERGENT

RETURN

REAGENT RESERVOIRReady

Press the appropriate EMPTY soft key to empty the reagent reservoir.Stay on this screen until the "FILL" key appears

After the appropriate FILL soft key is displayed, remove reagent linefrom existing container and place in new container.

Press the FILL soft key to fill the reagent reservoir.

Run 5 background cycles.Confirm background results are acceptable before running samples.


16:01rcs0711

REAGENT

RESERVOIR


9140320C — November 2000


Draining the Optical Flow CellThe [EMPTY WOC] key is used to drain the reagent from the WOC Flow Cell. When the Flow Cell is empty, the key label changes to [FILL WOC]. When the [FILL WOC] key is pressed, the Flow Cell is refilled with reagent.

Accessing the Maintenance LogThe [MAINTEN LOG] key is used to set up, review, and print the Maintenance Log. If the Maintenance Log feature is used, the screen displays a Bulletin Line prompt when scheduled maintenance should be performed. The Maintenance Log Set Up Procedure and the Maintenance Log screens are discussed in Maintenance Log Set Up within this chapter.

When the [MAINTEN LOG] key is pressed, the following soft key labels are displayed:

INTERVAL SET UPUPDATE LOGPRINT & PURGEPRINT LOGRETURN

The [INTERVAL SET UP] key is used to configure the maintenance schedule.

The [UPDATE LOG] key is used to indicate when maintenance was performed and to add comments to the Maintenance Log.

The [PRINT & PURGE] key is used to print the completed log and then delete it. When the [PRINT & PURGE] key is pressed, the following soft key labels are displayed:

CONFIRMCANCEL

These keys are used to [CONFIRM] or [CANCEL] the Print & Purge command.

The [PRINT LOG] key is used to print the Maintenance Log.

The [RETURN] key is used to return to the main SPECIAL PROTOCOLS screen.

A detailed Maintenance Log Set Up Procedure and illustrations of the Maintenance Log screens are presented at the end of this section.

EMPTYWOC

MAINTEN

LOG

INTERVAL

SET UP

UPDATE

LOG

PRINT &PURGE

PRINTLOG

RETURN



Accessing the Shear ValveThe [CLEAN SHEAR VAL] key is used to prepare the Shear Valve for cleaning. When the key is pressed, the syringes partially empty, which flushes the reagents out of the Shear Valve and the associated tubing. The Shear Valve then rotates into the position necessary for its removal. When the rotation is complete, the key label changes to [RESTORE SHEAR VAL].

When the [RESTORE SHEAR VAL] key is pressed, the syringes refill the Shear Valve and the associated tubing, and the Shear Valve rotates back to its operational position. When the rotation is complete, the key label changes to [CLEAN SHEAR VAL].

Disabling/Enabling the AnalyzerThe [DISABLE ANALYZER] key is used to prevent the Analyzer from cycling while certain maintenance procedures are performed. When the Analyzer is disabled, the key label changes to [ENABLE ANALYZER].

When the [ENABLE ANALYZER] key is pressed, the Analyzer is returned to the READY state.

Figure 9.4: Special Protocols Screen 2

CLEAN

SHEAR VAL

RESTORE

SHEAR VAL

DISABLE

ANALYZER

ENABLE

ANALYZER

FLUSHSHEATH

AUTOCLEAN

DAILYSHUTDOWN

PREPARESHIPPING

CLEANNEEDLE

EXTENDAUTOCLEAN

MORE MAIN



16:01rcs0711


9140320C — November 2000


Special Protocols Screen #2When the [MORE] key on the SPECIAL PROTOCOLS screen is pressed, the second SPECIAL PROTOCOLS screen and the following soft key labels are displayed:

FLUSH SHEATHAUTO CLEANDAILY SHUTDOWNPREPARE SHIPPINGCLEAN NEEDLEEXTEND AUTOCLEANMOREMAIN

The [FLUSH SHEATH] key is used to flush the WOC Flow Cell with Sheath Reagent.

The [AUTO CLEAN] key is used to initiate the Auto-Clean Cycle. The Shear Valve, the WOC Mixing Chamber, the WOC Flow Cell, the von Behrens WIC Transducer, the von Behrens RBC/PLT Transducer, the HGB Flow Cell and all of the associated fluidics are automatically cleaned and rinsed during the cycle.

When the [AUTO CLEAN] key is pressed, the screen displays the message shown in Figure 9.8 in the Daily Maintenance section. The following soft key labels are displayed:

STARTCANCEL

These keys are used to [START] or [CANCEL] the Auto-Clean Cycle.

The [DAILY SHUTDOWN] key is used to initiate the Daily Shutdown cycle. During the cycle, the fluidics are automatically drained and rinsed. At the end of the cycle, the Analyzer is placed in STANDBY. The electronic solenoid valves are automatically opened periodically while the Analyzer is in STANDBY to prevent the tubing from becoming pinched.

The [PREPARE SHIPPING] key is used to prepare the Analyzer for shipment or a period of inactivity. The cycle drains all of the reagents from the system and then rinses the fluidics with deionized water.

MORE

FLUSH

SHEATH

AUTO

CLEAN

DAILY

SHUTDOWN

PREPARESHIPPING



The [CLEAN NEEDLE] key is used to clean the needles used in either of the Closed Modes (CS or SL) of operation. When this key is pressed, the needle is forcefully rinsed with diluent.

The [EXTEND AUTOCLEAN] key is used to initiate the Extended Auto-Clean cycle, which is a longer version of the Auto-Clean cycle.

When the [EXTEND AUTOCLEAN] key is pressed, the screen displays the message shown in Figure 9.17, Special Protocols: Extended Auto-Clean Screen in the Monthly section within this chapter. The following soft key labels are displayed:

STARTCANCEL

These keys are used to [START] or [CANCEL] the Extended Auto-Clean cycle.

The [MORE] key is used to return to the first SPECIAL PROTOCOLS screen.

CLEAN

NEEDLE

EXTEND

AUTO-CLEAN

MORE


9140320C — November 2000


NOTES


Chapter 9 Maintenance

Maintenance Log Set Up

The Maintenance Log is used to keep a record of the maintenance procedures that have been performed on the instrument. It can also be configured to notify the operator when a scheduled maintenance procedure should be performed.

Figure 9.5: Maintenance Log Screen

The MAINTENANCE LOG screen is accessed from the SPECIAL PROTOCOLS screen by pressing the [MAINTEN LOG] key. When the [MAINTEN LOG] key is pressed and scheduled maintenance is due, a Bulletin Line on the MAINTENANCE LOG screen will display the following message:

MAINTENANCE DUE: — followed by the name(s) of the components(s) requiring maintenance

NOTE: The bulletin message will disappear when any key is pressed.

SHEAR AIR APERTURES PUMP TUBING EXTDate Time OpID VALVE FILTR SYNG WIC RBC ASPR WOC SL AUTO AUTO OTHER10/09/98 08:30 sh X X XComments: Weekly Maintenance

10/16/98 08:32 jg X X XComments: Weekly Maintenance

10/23/98 08:33 td X X X X X X XComments: Weekly Maintenance

INTERVALSET UP

UPDATELOG

PRINT &PURGE

PRINTLOG

RETURN

MAINTENANCE LOGReady


16:01rcs0711

MAINTEN

LOG


9140320C — November 2000

MaintenanceMaintenance Log Set Up Chapter 9

The log displays the following entry fields: <Date>, <Time>, <OpID>, <SHEAR VALVE>, <AIR FILTR>, <SYNG>, <APERTURES> (<WIC> and <RBC>), <PUMP TUBING> (<ASPR> and <WOC>), <SL>, <EXT AUTO>, <AUTO>, <OTHER>, and a line for <Comments>. (Up to 70 characters may be entered in the <Comments> line.) The log holds 40 entries, but the screen displays only the 5 most current. Other entries can be displayed by pressing the Page Up or Page Down keys on the keyboard.

Each time an entry is made, the current date, time, and operator ID are automatically entered in the log. When the UPDATE MAINTENANCE LOG screen (illustrated in Figure 9.7, Update Maintenance Log Screen) is displayed, the cursor is automatically positioned in the <Op ID> entry field. If desired, the ID may be edited. Entries are made by moving the cursor with the arrow keys on the keyboard to the desired entry field and pressing the Enter key on the keyboard. An “X” is displayed to indicate the completed maintenance and the cursor advances to the next entry field.

NOTE: Entries can also be made by moving the cursor to the desired location, typing an “X”, and pressing the Enter key on the keyboard.

An incorrectly placed “X” can be deleted by moving the cursor to it and pressing the Space Bar on the keyboard.

Comments may be entered in the <Comments> entry field of the Maintenance Log if entries have been made in the other fields. Comments and maintenance entries (Xs) can also be edited after they have been made. However, once the [RETURN] key has been pressed, the changes are saved and changes can no longer be made.

A printout can be made at any time, but when the log is full all entries must be deleted before new ones can be added. When the log is full, a Bulletin Line will display the following message:

MAINTENANCE LOG IS FULL, NO MORE ENTRIES CAN BE CREATED

The [PRINT & PURGE] key is used to print the log and delete all entries.


MaintenanceChapter 9 Maintenance Log Set Up

Interval Set Up Procedure

Figure 9.6: Interval Set Up Screen

NOTE: Before the Interval Setup feature of the Maintenance Log will function, an initial Maintenance Log must be created as a reference for Interval implementation. This log should be accessed, the operator’s initials entered, and an X placed under every procedure listed at the top of the log by placing the cursor in the first field and pressing the Enter key on the keyboard. The cursor will advance to the next field automatically. By continuing to press the Enter key, the X’s may be placed under each procedure. Once all the procedures have been selected, the log has a reference point for future notification of maintenance that is due.

1. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS] key followed by the [MAINTEN LOG] key.

2. Press the [INTERVAL SET UP] key to display the INTERVAL SET UP screen.

3. Use the arrow keys on the keyboard to move the cursor to the desired maintenance procedure.

PRINT RETURN

INTERVAL SET UPReady


12:24sh0630

Specify a maintenance interval if you want the instrument to prompt you when it is time to do the maintenance.

Enter the maintenance interval (in days) for each of the following: (enter 0 for no interval)

SHEAR VALVE 7AIR FILTERS 30SYRINGES 30WIC APERTURE 30RBC APERTURE 90ASPIRATION PUMP TUBING 90WOC PUMP TUBING 30SAMPLE LOADER TRAY AND RACKS 30EXTENDED AUTO-CLEAN 30AUTO-CLEAN 7


9140320C — November 2000


4. Type the desired interval in days, and press the Enter key on the keyboard to save the entry and advance the cursor.

5. If desired, press [PRINT] to obtain a printout of the entered intervals.

6. Press [RETURN] twice to return to the SPECIAL PROTOCOLS screen.

7. Press [MAIN] to return to the MAIN MENU screen.

Update Maintenance Log Procedure

Figure 9.7: Update Maintenance Log Screen

After the maintenance procedure has been performed, access the log as directed in this procedure.

1. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS] key followed by the [MAINTEN LOG] key.

2. Press the [UPDATE LOG] key. The cursor is positioned in the <OPERATOR ID> entry field. (See the preceding figure.) If necessary, edit the operator ID at this time.


RETURN

UPDATE MAINTENANCE LOGReady


12:31sh0630

SHEAR AIR APERTURES PUMPTUBING EXTDate Time Op ID VALVE FILTR SYNG WIC RBC ASPR WOC SL AUTO AUTO OTHER11/10/98 08:30 sh X X XComments: Weekly Maintenance

11/10/98 08:32 sh X X XComments: Weekly Maintenance

11/10/98 08:33 sh X X X X X X XComments: Weekly Maintenance

11/10/98 10:30 shComments:


MaintenanceChapter 9 Maintenance Log Set Up

4. Press the Enter key on the keyboard. An “X” will be displayed to indicate the completed maintenance and the cursor will advance to the next entry field.

NOTE: An incorrectly placed “X” can be deleted by moving the cursor to it and pressing the Space Bar on the keyboard.

5. Repeat steps 3 and 4 to make other entries.

6. When all entries have been made, use the arrow keys on the keyboard to move the cursor to the <Comments> entry field.

7. Type any comments (up to 65 characters) and press the Enter key on the keyboard.

NOTE: All current entries may be edited before the screen is exited. When the [RETURN] key is pressed, all the entries will be saved and cannot be changed.

8. Press [RETURN] twice to return to the main SPECIAL PROTOCOLS screen.



9140320C — November 2000


NOTES



Daily Maintenance Procedures

NOTE: The Auto-Clean Cycle should be run after performing any maintenance procedure.

Auto-CleanThe Auto-Clean Cycle is a fully automated cycle designed to clean the Shear Valve, the WOC Mixing Chamber, the WOC Flow Cell, the von Behrens WIC Transducer, the von Behrens RBC/PLT Transducer, the HGB Flow Cell, the needle in the CS or SL system, and all the associated fluidics. The forward and reverse action of the peristaltic pumps is used during this cycle to gently scrub and remove any fibrin or debris within the system. The Auto-Clean Cycle takes approximately 11 minutes.

Figure 9.8: Special Protocols: Auto-Clean Screen

Materials Required1. CELL-DYN Enzymatic Cleaner (cleaner should be at room

temperature)

2. Clean test tube or container

3. Lint-free pads

START CANCEL



12:10CO34249

Hold a tube of Cell-Dyn Enzymatic Cleaner under the probe,and press the START key

After the auto-clean cycle is completedthree or more background counts will be run.

This cleaning process takes about 11 minutes.



MaintenanceDaily Maintenance Procedures Chapter 9

4. Warm water

5. Appropriate personal protective equipment

Procedure1. Select the Open Sampler Mode.

2. Carefully wipe the outside of the Open Sampler Aspiration Probe and the bottom of the Wash Block with a pad dampened with warm water and a few drops of CELL-DYN Enzymatic Cleaner.

3. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS] key followed by the [MORE] key to access the Auto-Clean function.

4. Press the [AUTO CLEAN] key. Instructions for performing the procedure are given on the screen.

5. Dispense approximately 1.5 mL of Enzymatic Cleaner into a clean container and hold the container under the Open Sample Aspiration Probe.

6. Press the [START] key.

NOTE: Do not press the Touch Plate. The Auto-Clean Cycle is only initiated by the [START] key.

7. Continue to hold the container under the probe until a beep is heard. Remove the container and discard the remaining Enzymatic Cleaner.

8. When the Auto-Clean cycle is completed, carefully wipe the outside of the Open Sampler Aspiration Probe and the bottom of the Wash Block with a lint-free pad dampened in warm water to remove any traces of enzymatic cleaner.

9. If necessary, use a dry, lint-free pad to remove any water that remains on the Probe or the Wash Block.

10. Press [MAIN] to return to the MAIN MENU screen. Check that the background counts are acceptable before running controls or patient samples. If the counts are unacceptable, troubleshoot accordingly.


MaintenanceChapter 9 Daily Maintenance Procedures

Sample Loader Aspiration NeedleThe Aspiration Needle on the Sample Loader version of the CELL-DYN 3700 System should be cleaned regularly to remove protein buildup or debris and to reduce the possibility of a blockage.

NOTE: A convenient way to perform this procedure is to add the tubes needed for the procedure to the end of the last run of the day.

Materials Required1. CELL-DYN® Enzymatic Cleaner

2. Diluent or deionized water

3. Three empty VACUTAINER® tubes


Procedure1. Aliquot approximately 2 mL of Enzymatic Cleaner into one

of the VACUTAINER® tubes.

2. Aliquot approximately 2 mL of fresh diluent each into the other two VACUTAINER® tubes.

3. If necessary, from the Data Station RUN screen, press the [CHANGE SAMPLER] key to select the Closed Mode.

4. Press the [SPECIMEN TYPE] key followed by the [BACKGROUND] key.

5. Place the Enzymatic Cleaner tube followed by the two diluent tubes in a Sample Loader end rack.

6. Position the rack in the Sample Loader tray and install the Sample Loader Safety Cover.

CAUTION: The Sample Loader will not operate unless the Safety Cover is in place.

7. Press the START key on the Sample Loader Control Panel to initiate processing.

8. Audible beeps indicate that processing is completed.

9. Run at least five background counts before running controls or patient samples. If the counts are unacceptable, troubleshoot accordingly.


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MaintenanceDaily Maintenance Procedures Chapter 9

Closed Sampler Aspiration NeedleThe Aspiration Needle on the Closed Sampler version of the CELL-DYN 3700 System should be cleaned regularly to remove protein buildup or debris and reduce the possibility of a blockage.

Materials Required1. CELL-DYN® Enzymatic Cleaner

2. Diluent or deionized water

3. Three empty VACUTAINER® tubes


Procedure1. Aliquot approximately 2 mL of Enzymatic Cleaner into one

of the VACUTAINER® tubes.

2. Aliquot approximately 2 mL of fresh diluent each into the other two VACUTAINER® tubes.

3. If necessary, from the Data Station RUN screen, press the [CHANGE SAMPLER] key to select the Closed Mode.

4. Press the [SPECIMEN TYPE] key followed by the [BACKGROUND] key.

5. Run the Enzymatic Cleaner.

6. Run the diluent tubes.

7. Run at least five background counts before running controls or patient samples. If the counts are unacceptable, troubleshoot accordingly.



Weekly Maintenance Procedures

NOTE: The Auto-Clean Cycle described in Daily Maintenance Procedures, Auto-Clean Cycle within this chapter should be run after performing any maintenance procedure.

Shear Valve

Figure 9.9: Shear Valve

Regular cleaning of the Shear Valve ensures accurate and precise performance. Any reagent or blood residue may cause the valve to leak or function improperly. The Shear Valve Assembly is depicted in the preceding figure.

The Shear Valve is made of a ceramic material and consists of three separate sections — front, center, and rear. The rear and front sections are connected to the CELL-DYN 3700 System by tubing that should not be removed.

NOTE: The center section is not connected to the Analyzer by tubing and must be handled carefully, as it will break if it is dropped. Care should be taken to avoid chipping, scratching, or otherwise damaging any of the sections.

Materials Required1. Deionized water

2. Lint-free pads


Front Section

Center SectionRear Section

Mounting Guide

Rim Notch

Retaining Screw

Tubing Loop


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MaintenanceWeekly Maintenance Procedures Chapter 9

Procedure1. Remove the Left Front Cover to gain access to the Shear

Valve.

NOTE: It is necessary to also remove the Tower Cover on the SL model to access the Shear Valve.

2. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS] key followed by the [CLEAN SHEAR VAL] key. This prepares the Shear Valve for removal and puts the Analyzer into a NOT READY state.

3. Turn the Shear Valve Retaining Screw counterclockwise until it can be removed.

4. Grasp the entire valve assembly firmly and pull it forward with a slight rocking motion until it is free of the Mounting Guide.

5. Rotate the center and front sections in the opposite direction from the rear section to release any suction and free the rear section.

NOTE: Be careful to keep a firm grip on the center section, as it is not attached to the front or rear sections and it may break or crack if dropped. Avoid crimping any of the attached tubing in the front and rear ceramic sections.

6. Place the rear section with its attached tubes on a clean lint-free pad in the Shear Valve compartment.

7. Rotate the center and front sections in opposite directions to separate the sections.

8. Place the center section in a container of deionized water and allow it to soak for the remainder of the cleaning procedure.

NOTE: Do not soak the center section in bleach as it may damage the ceramic.

9. Place the front section with its attached tubes on a clean lint-free pad in the Shear Valve compartment.

10. Clean the Mounting Guide with lint-free pad dampened with deionized water to remove any blood or residue. Wipe the guide dry.

11. Wipe the inner surfaces of the front and rear sections with a clean lint-free pad dampened with deionized water. Use care to avoid scratching any of the inner surfaces.

NOTE: Hold the sections by the edges to avoid getting fingerprints on the inner surfaces.


MaintenanceChapter 9 Weekly Maintenance Procedures

12. Align the lock notch of the rear section with the back panel of the Shear Valve Assembly. Carefully slide the section back as far as it will go. Avoid crimping any of the attached tubing.

13. Remove the center section from the deionized water, and wipe the surfaces with a lint-free pad dampened in deionized water. Do not dry.

14. View each surface under reflective light to confirm that it is clean, and free of lint and fingerprints.

15. Align the center section so that the Rim Notch in the outer edge faces to the right.

CAUTION: Be certain the Rim Notch faces to the right. (See Figure 9.9, Shear Valve for correct center section orientation.) Erroneous results will be obtained if specimens are analyzed when the center section is installed backwards.

16. Carefully slide the center section onto the Mounting Guide and push it back until it touches the rear section.

17. Align the lock notch of the front section with the Mounting Guide. Carefully slide it back until it touches the center section.

18. Firmly hold the three valve sections in place and replace the Shear Valve Retaining Screw. Turn the screw clockwise until it stops.

19. Press the [RESTORE SHEAR VAL] key. The valve automatically rotates several times. The instrument is returned to the READY state when the rotation is finished.

20. Visually inspect the Shear Valve to ensure that the Rim Notch of the center Shear Valve section faces to the right. (Refer to Figure 9.9, Shear Valve for correct center section orientation.)

21. Replace the Left Front Cover.

22. Press the [MAIN] key to return to the RUN screen.

23. Run at least five background counts before running controls or patient samples. If the counts are unacceptable, troubleshoot accordingly as directed in Chapter 10: Troubleshooting.




Sample Aspiration Peristaltic Pump TubingThe tubing in the two Peristaltic Pumps needs to be replaced on a regular basis to ensure proper fluid movement through the instrument. The Sample Aspiration Pump Tubing requires more frequent replacement than the larger WOC Transfer Peristaltic Pump Tubing. However, the frequency of replacement depends on instrument use in each laboratory. Abbott recommends changing the Sample Aspiration Pump Tubing weekly and the WOC Transfer Peristaltic Pump Tubing monthly. A Peristaltic Pump is depicted in the following figure.

Figure 9.10: Sample Aspiration Peristaltic Pump

Materials Required1. Sample Aspiration Peristaltic Pump Tubing.

NOTE: The Sample Aspiration Pump Tubing has a smaller diameter and is identified by the orange collar on each end.


Tubing

Collar

Pump ShoePump Wheel

Metal BracketsPump Rollers


MaintenanceChapter 9 Weekly Maintenance Procedures

Procedure1. From the SPECIAL PROTOCOLS screen, press the [DISABLE

ANALYZER] key.

2. Remove the Left and Right front covers to gain access to the Peristaltic Pumps.

3. Locate the Sample Aspiration Pump to the left of the Shear Valve.

4. Hold the Pump Shoe away from the pump wheel and remove the tubing from under the pump wheel by lifting the collars out of the metal brackets that hold them. Pull the tubing completely out from under the pump wheel. (Refer to Figure 9.10)

5. Disconnect the tubing at the plastic connector.

6. Connect the new tubing to the plastic connector.

7. Place the collars on the ends of the pump tubing into the metal brackets as shown in Figure 9.10. Hold the Pump Shoe open and insert the tubing back under the pump rollers. Make sure the tubing is positioned in the center of the rollers. When the tubing is centered, release the Pump shoe.

8. Replace the Front Covers.

9. Press the [ENABLE ANALYZER] key.


11. Run at least five background counts before running controls or patient samples. If the background counts are unacceptable, troubleshoot accordingly.

Sample Loader Tray, Racks, and Safety CoverThe Sample Loader Tray, Racks, and Safety Cover should be cleaned on a regular basis. Blood spills in the tray or racks should be cleaned up immediately to allow proper movement of the racks. Weekly cleaning is recommended, but more frequent cleaning may be indicated by the laboratory workload.

Materials Required1. Container (large enough to hold a rack) filled with a mild

detergent solution made with warm (not hot) water

2. Clean, warm water for rinse

3. Lint-free pads



9140320D — June 2003


Procedure1. Remove the racks from the Sample Loader tray.

2. Wash the racks in the detergent solution. Do not allow them to soak in the solution, as the labels will come off.

NOTE: When cleaning the racks, do not use an automated washing system that operates at elevated tempertures as this may damage the racks.

3. Rinse the racks with warm water and dry thoroughly with lint-free pads or towels.

4. Wipe the stainless steel tray area with a lint-free pad moistened with water. Dry the tray with a lint-free pad or towel.

5. Wipe the stainless steel plate behind the vent/aspirate and mixing stations with a lint-free pad moistened with water. Dry the plate with a lint-free pad.

6. Clean the mixing heads with a lint-free pad moistened with water. Dry the heads with a lint-free pad.

7. Wash the Safety Cover with the detergent solution, rinse, and dry it.

Extended Auto CleanThe Extended Auto Clean cycle should be run weekly when routinely running reticulocytes. Directions for running Extended Auto Clean, which takes approximately 2.5 hours to complete, are included in the monthly maintenance section of this chapter.



Monthly Maintenance Procedures

NOTE: The Auto-Clean Cycle described in Daily Maintenance Procedures, Auto-Clean within this chapter should be run after performing any maintenance procedure.

Reagent SyringesThe Reagent Syringes need to be cleaned on a regular basis to prevent reagent residue buildup, which may cause leakage or improper functioning. Syringes should be cleaned one at a time to ensure that each syringe is replaced in the correct position. Replace each syringe after it is cleaned and then remove the next one to be cleaned. The Syringe Assembly is depicted in Figure 9.11.

The 10-mL Syringe should be cleaned as required; the 0.5mL and 2.5 mL syringe should be cleaned monthly.

Figure 9.11: WOC Syringes and Syringe Assembly

WOC MeteringSyringe

WOC SheathSyringe

Flange

Syringe Assembly

V-Block Holder

Pedestal Assembly



MaintenanceMonthly Maintenance Procedures Chapter 9

2.5-mL Syringe and 0.5-mL Syringe

Materials Required1. A large container filled with approximately 500 mL of

deionized water

2. Lint-free pads (or other lint-free pads)

3. Deionized water

4. Small container of appropriate reagent to refill the clean syringes


Procedure1. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS]

key followed by the [DISABLE ANALYZER] key.

2. Remove the front covers to gain access to the Syringe Assembly.

3. Lift the syringe out of the snap-in bracket. Note the liquid level in the syringe so that it can be refilled after cleaning to approximately this same level. (For example, a piece of tape may be attached to the syringe barrel to note the position of the plunger tip.)

4. Grasp the metal Luer Lock fitting at the tip of the syringe that attaches it to the tubing. Carefully turn the syringe clockwise to release it from the fitting. Use lint-free pads to absorb excess reagent.

5. Dispense the reagent into a sink or an appropriate waste container.

6. Aspirate deionized water into the syringe until it is full. Continue to pull on the plunger until it is removed from the barrel.

NOTE: Do not push or pull on the plunger when the syringe is dry, as it may damage the plunger. Avoid touching the plunger because oil from the fingers may cause it to move erratically.

7. Rinse the plunger and barrel thoroughly with deionized water. Carefully reinsert the plunger into the wet barrel.

8. Refill the syringe with the appropriate reagent to the level noted in step 3 above. Hold the syringe upright and tap the side gently to dislodge any bubbles that may adhere to the tip of the plunger.

9. Carefully adjust the position of the plunger as necessary to insert it into the pedestal assembly that moves it up and down during the cycle.


MaintenanceChapter 9 Monthly Maintenance Procedures

10. Insert the syringe tip into the Luer Lok® fitting and turn the syringe counterclockwise until the fitting is finger-tight. Be careful to not overtighten the fitting or crimp the associated tubing.

11. Insert the syringe into the bracket and the end of the plunger into its slot in the pedestal assembly. Position the horizontal flange on the back of the syringe into the slot at the base of the bracket.

12. When the syringe has been reinstalled, press the [ENABLE ANALYZER] key.


14. Run several background counts and observe the action of each syringe during the cycle. The plunger should move smoothly up and down and the syringe should not leak.

15. Replace the front covers after the operation of the syringes has been verified.





Analyzer Air FiltersThe Left Side Panel of the Analyzer contains a set of Air Inlet Filters that clean the air entering the Analyzer. These filters require monthly removal and cleaning to maintain a constant, unrestricted air flow. More frequent cleaning is required whenever the instrument is located in a particularly dusty or warm area.

Figure 9.12: Analyzer Left Side Panel

Materials Required1. Running water

2. Lint-free pads

3. Small vacuum cleaner (optional)


Procedure1. Remove the Front Covers to gain access to the filter holders

on the Left Side Panel. (See the preceding figure.)

2. Grasp the upper filter and slide the holder forward to remove it. The lower filter is removed the same way.

Air InletFilters

NormallyClosed Valves



3. Choose one of the following two options:

• Remove the filters from the frames and rinse with warm water from the inside to the outside to remove the dust. Blot each filter with lint-free pads or towels to dry the filters before replacing them.

• Clean the filters by vacuuming them.

4. Insert the upper filter holder into its slot (metal frame side toward the instrument). Slide it back into place until the holder is flush with the Front Panel. Repeat this process to install the lower filter holder.


WOC Transfer Peristaltic Pump TubingThe tubing in the two Peristaltic Pumps needs to be replaced on a regular basis to ensure proper fluid movement through the instrument. The Sample Aspiration Pump Tubing requires more frequent replacement than the larger WOC Transfer Peristaltic Pump Tubing. However, the frequency of replacement depends on instrument use in each laboratory. Abbott recommends changing the Sample Aspiration Pump Tubing weekly and the WOC Transfer Peristaltic Pump Tubing monthly. A Peristaltic Pump is depicted in the following figure.

Figure 9.13: WOC Transfer Peristaltic Pump

Metal Brackets

Pump Rollers

Pump Shoe

Pump Tubing

Collar




Materials Required1. WOC Transfer Peristaltic Pump Tubing.

NOTE: The WOC Transfer Pump Tubing has a larger diameter than the Sample Aspiration Pump Tubing (orange collar) and is identified by the clear collar on each end.


Procedure1. From the SPECIAL PROTOCOLS screen, press the [DISABLE

ANALYZER] key.

2. Remove the upper front cover to gain access to the Peristaltic Pumps.

3. Locate the WOC Transfer Peristaltic Pump to the far left of the Flow Panel.

4. Hold the Pump Shoe away from the pump wheel and remove the tubing from under the pump wheel by lifting the collars out of the metal brackets that hold them. Pull the tubing completely out from under the pump wheel. (Refer to Figure 9.13)

5. Disconnect the tubing at the plastic connector.

6. Connect the new tubing to the plastic connector.

7. Place the collars on the ends of the pump tubing into the metal brackets as shown in Figure 9.13. Hold the Pump Shoe open and insert the tubing back under the pump rollers. Make sure the tubing is positioned in the center of the rollers. When the tubing is centered, release the Pump shoe.

8. Replace the Upper Front Cover.

9. Press the [ENABLE ANALYZER] key.


11. Check that the background counts are acceptable before running controls or patient samples. If the background counts are unacceptable, troubleshoot accordingly.



Extended Auto-CleanThe Extended Auto-Clean Cycle is a fully automated cycle designed to clean the Shear Valve, the WOC Mixing Chamber, the WOC Flow Cell, the von Behrens WIC Transducer, the von Behrens RBC/PLT Transducer, the HGB Flow Cell, the needle in the CS or SL version, and all the associated fluidics. The forward and reverse action of the Peristaltic Pumps is used during this cycle to gently scrub and remove any fibrin or debris within the system.

The Extended Auto-Clean cycle takes approximately 2.5 hours to complete. During this time, the instrument is not available to process samples or manipulate data. (When the process is complete, the instrument is automatically put in the STANDBY state.) The cycle may be canceled after 38 minutes by pressing the [CANCEL] key, which is displayed at this time.

IMPORTANT: It is not possible to exit the SPECIAL PROTOCOLS screen when the Extended Auto-Clean cycle is in progress. The screen may be exited only after the [CANCEL] key (displayed after 38 minutes) is pressed or when the cycle is complete.

Figure 9.14: Special Protocols: Extended Auto-Clean Screen

START CANCEL



12:25sh0630

Hold a tube of Cell-Dyn Enzymatic Cleaner under the probeand press the START key

The Extended Auto-Clean process takes 2.5 hours to complete. During this time, the system is unavailable for processing samples or manipulating data. When the Extended Auto-Clean process is complete, the instrument will go into STANDBY.

It is important to begin with a sufficient reagent supply and a half empty waste container in order to successfully complete the Extended Auto-Clean process.

After 38 minutes a CANCEL key is displayed. Press this key to cancel the Extended Auto-Clean process and return to the operating mode.




Materials Required1. CELL-DYN Enzymatic Cleaner (should be at room temperature)

2. Clean test tube or container

3. Lint-free pads

4. Warm water


Procedure1. Select the Open Sampler Mode.

2. Carefully wipe the outside of the Open Sample Aspiration Probe and the bottom of the Wash Block with a lint-free pad dampened with warm water and a few drops of CELL-DYN Enzymatic Cleaner. Wipe any dried reagent or blood off the bottom of the Wash Block.

3. Press the [SPECIAL PROTOCOLS] key followed by the [MORE] key to access the Extended Auto-Clean function.

4. Press the [EXTEND AUTOCLEAN] key. Instructions for performing the procedure are given on the screen.

5. Dispense approximately 1.5 mL of Enzymatic Cleaner into a clean container and hold the container under the Open Sample Aspiration Probe.

6. Press the [START] key.

NOTE: Do not press the Touch Plate. The Extended Auto-Clean cycle is initiated only by the [START] key.

7. Continue to hold the container under the probe until a beep is heard. Remove the container and discard the remaining Enzymatic Cleaner.

NOTE: The complete procedure takes 2½ hours but may be terminated after 38 minutes by pressing the [CANCEL] key. If the [CANCEL] key is pressed, a rinse cycle is initiated that prepares the instrument for sample processing. Proceed to Step 8.

8. When the rinse cycle finishes, carefully wipe the outside of the Open Sampler Aspiration Probe and the bottom of the Wash Block with a lint-free pad dampened in warm water to remove any traces of enzymatic cleaner.

9. If necessary, use a dry, lint-free pad to remove any water that remains on the Probe or the Wash Block.


NOTE: At the end of the 2½ hours, the instrument automatically goes into the STANDBY state. Press the [RUN] key to bring the Analyzer out of STANDBY and prepare it for sample processing. Run at least five background counts before running controls or patient samples. If the backgrounds counts are unacceptable, troubleshoot accordingly.


MaintenanceChapter 9 As Required

As Required

NOTE: The Auto-Clean cycle described in Daily Maintenance Procedures, Auto-Clean within this chapter should be run after performing any maintenance procedure.

10-mL Reagent Syringe The 10 mL Reagent Syringe requires minimal maintenance. Cleaning is required only if reagent residue builds up and interferes with the performance of the syringe. The Syringe Assembly is depicted in the Figure 9.11, WOC Syringes and Syringe Assembly.

Materials Required1. A large container filled with approximately 500 mL of

deionized water

2. Lint-free pads

3. Deionized water

4. Small container of diluent to refill the clean syringe



key followed by the [DISABLE ANALYZER] key.

2. Remove the front covers to gain access to the Syringe Assembly.

3. Grasp the plastic Luer-Lok fitting at the tip of the syringe that attaches it to the tubing. Carefully turn the luer nut on the syringe counterclockwise to release it from the fitting. Use lint-free pads to absorb excess reagent.

4. Grasp the Syringe barrel below the Luer-Lok with one hand. With the other hand, grasp the syringe plunger below the metal band. Pull straight out to remove the syringe from the snap-in bracket.

5. Note the liquid level in the syringe so that it can be refilled after cleaning to approximately this same level. (For example, a piece of tape may be attached to the syringe barrel to note the position of the plunger tip.)


9140320D — June 2003

MaintenanceAs Required Chapter 9

6. Dispense the diluent into a sink or an appropriate waste container.

7. Immerse the tip of the syringe in a container of deionized water.

8. Aspirate deionized water into the syringe until it is full, and dispnse the water into a sink or an appropriate waste container.

NOTE: Do not pull the plunger out of the barrel. Do not push or pull on the plunger when the syringe is dry, as it may damage the plunger. Avoid touching the plunger because oil from the fingers may cause it to move erratically.

9. Repeat step 8 as necessary.

10. Refill the syringe with diluent to the level noted in step 5 above. Hold the syringe upright and tap the side gently to dislodge any bubbles that may adhere to the tip of the plunger.

11. Carefully adjust the position of the plunger as necessary to insert it into the pedestal assembly which moves the plunger up and down during operation.

12. Insert the syringe Luer-Lok® nut into the fitting and turn the syringe clockwise until the fitting is finger-tight. Be careful to not overtighten the fitting or crimp the associated tubing.

13. Place the end of the plunger into its slot in the pedestal assembly. Position the horizontal flange on the back of the syringe into the flange slot on the syringe bracket. Align one rib of the syringe in the rib slot on the syringe bracket. Carefully push and twist the syringe into the bracket until it snaps into position.

14. When the syringe has been reinstalled, press the [ENABLE ANALYZER] key. Press the [MAIN] key to return to the MAIN MENU screen.

15. Run several background counts and observe the action of the syringe during the cycle. The plunger should move smoothly up and down and the syringe should not leak.

16. Replace the front covers after the operation of the syringe has been verified.

17. Run at least five background counts before running controls or patient samples. If the background counts are unacceptable, troubleshoot accordingly. Refer to Chapter 10: Troubleshooting.

18. Run Controls and confirm that results are within acceptable limits. If results are outside acceptable limits, follow your laboratory’s quality control protocol for out of range results.



Aperture PlatesThe WIC Aperture Plate and the RBC/PLT Aperture Plate are automatically cleaned during the Auto-Clean cycle. (The WIC Aperture Plate is also cleaned at the end of every count cycle by the Aperture Cleaning Circuit.) However, it may also be necessary to remove them occasionally for cleaning. Refer to the instrument logbook to find the latest baseline count time(s) obtained from a diluent sample with an acceptable background count. Use the baseline count time(s) to determine the frequency of cleaning needed.

NOTE: Both count times are displayed on the RUN screen. The WIC count time is displayed below and to the right of the BASO results. The RBC count time is displayed to the right of the MPV result. The count times are also displayed on the RAW DATA SUMMARY screen accessible from the DIAGNOSTICS MENU screen.

The WIC Aperture Plate should be cleaned if the count time differs from the baseline value by more than 0.3 seconds or if there are frequent WIC CLOG messages. The WIC Aperture Plate is located in the von Behrens WIC Transducer Assembly and is identified by "WBC" etched on the plate.

The RBC/PLT Aperture Plate should be cleaned if the count time differs from the baseline value by more than 0.4 seconds or if there are frequent RBC CLOG messages. The RBC/PLT Aperture Plate is located in the von Behrens RBC/PLT Transducer Assembly and is identified by "R/P" etched on the plate.

NOTE: The apertures are different sizes, therefore, the Aperture Plates are NOT interchangeable.

The following procedure is applicable to either aperture. A Transducer Assembly is depicted in the following figure.




Figure 9.15: von Behrens Transducer Assembly

Materials Required1. Cleaning solutions:

Either of the following solutions may be used to clean the Aperture Plate. Because they will deteriorate over time, each solution should be prepared fresh just before use.

a. Mix 20 drops of Enzymatic Cleaner and 20 mL of warm water in a container that is large enough to hold the Aperture Plate.

b. Make a 25% bleach solution (1.25% sodium hypochlorite) by adding 5 mL of bleach to 15 mL of deionized water in a container that is large enough to hold the Aperture Plate.

2. Aperture brush from the Accessory Kit

3. Squirt bottle of deionized water

4. Lint-free pads

5. Sonic cleaner (optional)


Mixing Chamber

Aperture Plate

Release Lever(Closed Position)

Counting Chamber



Procedure1. Remove the Front Covers to gain access to the von Behrens

WIC or RBC/PLT Transducer Assembly.

2. Confirm that the Analyzer is in the READY state.

3. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS] key followed by the [EMPTY XDUCERS] Key. This will drain the liquid from both the Transducer Assemblies.

NOTE: DO NOT attempt to remove the Aperture Plates without first emptying the Transducer Assemblies.

4. When the Empty Transducer cycle stops, place a lint-free pad or gauze under the transducer to prevent liquid from dripping onto the solenoids located directly below it.

5. Pull the red Release Lever located in front of the transducer out and to the right to release the Aperture Plate. (See the following figure.)

Figure 9.16: Transducer Assembly and Aperture Plate

6. Pull the Aperture Plate straight out from between the Transducer Chambers to remove it from the assembly. Note the orientation of the plate, as it must be replaced correctly. (See the preceding figure.)

Mixing Chamber

Aperture Plate

Release Lever(Open Position)

Counting Chamber

OrientationNotch


9140320D — June 2003


7. If necessary, clean any debris from the Aperture Plate by rotating the aperture brush in the opening. (The opening is located inside the red jewel embedded in center of the plate).

NOTE: DO NOT use anything but the aperture brush provided in the Accessory Kit to clean the aperture. Using other implements may damage the aperture.

8. Place the Aperture Plate into the container of freshly prepared cleaning solution. Submerge the Aperture Plate completely in the solution and rotate the aperture brush in the opening to ensure the cleaning solution penetrates it completely. Allow the plate to soak for five minutes.

NOTE: If desired, the container (with the Aperture Plate and cleaning solution) may be placed in a sonic cleaner for two to three minutes instead of cleaning the Aperture Plate with a brush. DO NOT leave the Aperture Plate in the sonic cleaner longer than three minutes as prolonged cleaning may loosen the aperture jewel.

9. When the plate is clean, remove it from the cleaning solution and thoroughly rinse it with a stream of deionized water.

10. Insert the plate between the transducer chambers with the Orientation Notch on the bottom leading edge. Carefully push the Aperture Plate into place. Be sure that it is completely seated between the chambers.

11. Move the release lever back to the left to securely hold the plate in place. (See Figure 9.15, von Behrens Transducer Assembly.)

12. Press the [FILL XDUCERS] key to refill the Transducer Assemblies and the associated tubing.

13. Replace the Upper and Lower Front Covers.

14. Press [MAIN] followed by [RUN] to return to the RUN screen.


16. When an acceptable background count has been obtained, record the count time(s) on that diluent sample in the instrument logbook. This is the baseline count time for the instrument.

NOTE: The baseline value may only be obtained immediately after the WIC or RBC/PLT Aperture Plate has been cleaned.



Hemoglobin Flow Cell Manual CleaningNOTE: This is not a routine cleaning/maintenance procedure. It should only be performed if routine methods fail or at the request of Abbott Diagnostics Customer Service.

Under normal circumstances, the Auto-Clean Cycle is sufficient to ensure the cleanliness of the HGB Flow Cell. However, if the Auto-Clean Cycle fails to adequately clean the Flow Cell, this procedure may be used. The HGB Flow Cell, the von Behrens WIC Transducer, and Solenoid 13 are depicted in the following figure.

Figure 9.17: The von Behrens WIC Transducer, HGB Flow Cell, and Solenoid 13

Materials Required1. Cleaning Solution:

Make a 25% bleach solution (1.25% sodium hypochlorite) by adding 5 mL of bleach to 15 mL of deionized water.

2. 15-mL syringe with a piece of tubing attached


Mixing Chamber

Counting Chamber

HGB Flow CellAssembly

WIC TransducerAssembly

Solenoid 13


9140320D — June 2003


Procedure1. Remove the front covers to gain access to the von Behrens

WIC Transducer and HGB Flow Cell Assembly.

2. Be sure that the Analyzer is in the READY state.

3. Manually open Solenoid 13 to completely drain all the liquid from the von Behrens WIC Transducer and HGB Flow Cell. (If necessary, refer to the preceding figure to locate Solenoid 13.)

4. Close Solenoid 13.

5. Press the [SPECIAL PROTOCOLS] key followed by the [DISABLE ANALYZER] key to disable the Analyzer.

6. Disconnect the clear TYGON® tubing from the fitting on the top right of the von Behrens WIC Transducer Mixing Chamber. (See the preceding figure.)

7. Fill the syringe with the cleaning solution and connect it to the fitting on the top of the von Behrens WIC Transducer Mixing Chamber. Dispense the cleaning solution into the transducer until it is approximately half full.

8. Remove the syringe and reconnect the TYGON® tubing.

9. Manually open Solenoid 13 and allow approximately half of the bleach solution to drain into the HGB Flow Cell.

10. Manually close Solenoid 13 to hold the bleach solution in the Flow Cell.

11. Allow the bleach solution to remain in the transducer and Flow Cell for 5 minutes.

12. When the time has elapsed, manually open Solenoid 13 to drain the bleach solution from the transducer and Flow Cell.

13. Press [ENABLE ANALYZER] followed by [MAIN] to return to the MAIN MENU screen.

14. Rinse the bleach solution out of the system by running a minimum of five background counts. Check the TYGON® tubing on the top of the von Behrens WIC Transducer Mixing Chamber during the cycles to be sure it is properly attached and does not leak.

15. Verify that the background counts are acceptable before running controls or patient specimens. If the background counts are unacceptable, troubleshoot accordingly.




Unclogging the Open Sample Aspiration Probe

Figure 9.18: Open Sample Aspiration Probe

The Open Sample Aspiration Probe is thoroughly cleaned whenever the Auto-Clean Cycle is performed. If a blockage is suspected, it may be cleared as directed in the following procedure.

Materials Required1. Wire stylet, gauge #23 (not provided)

2. Empty VACUTAINER tube

3. CELL-DYN Enzymatic cleaner


Aspiration ProbeTubing Connection

Open SampleAspiration Probe




ProcedureWARNING: Potential Biohazard. The probe is sharp and potentially contaminated with infectious materials. Avoid any contact with the tip of the probe.

1. Disable the Analyzer.

2. Remove the tubing from the top of the Open Sample Aspiration Probe as indicated in the preceding figure.

3. Carefully insert the stylet into the probe and push it down through the probe until it extends from the end. If a clot has been pushed out of the probe, remove it from the stylet.

4. Remove the stylet from the probe.

5. Reconnect the tubing to the top of the probe.

6. Perform an Auto-Clean Cycle. (If necessary, refer to the directions given earlier within this chapter.)

7. When the Auto-Clean Cycle is complete, run several background counts and a blood sample and check for complete aspiration. (There should be a minimum of one inch of blood on either side of the Shear Valve.)

8. If aspiration is not complete, call Abbott Diagnostics Customer Service (at 1-877-4ABBOTT in the US).

9. Verify that the background counts are acceptable before running controls or patient specimens. If the background counts are unacceptable, troubleshoot accordingly.

Bar Code Reader Window

Materials Required1. Applicator swabs (non-sterile)

2. Microscope lens tissues

3. Deionized water


Procedure1. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS] key.

2. From the SPECIAL PROTOCOLS screen, press the [DISABLE ANALYZER] key.

3. Turn OFF the Sample Loader.

NOTE: The ON/OFF toggle switch is located on the left end panel of the Sample Loader unit.



4. Remove all racks from the Sample Loader tray.

5. Wrap an applicator swab with lens tissue.

6. Moisten the tissue with deionized water.

7. Locate the front Bar Code Reader Window under the Sample Loader Tower and wipe the glass window with a moistened swab.

8. Wipe the window dry with the clean swab that has also been wrapped with lens tissue.

9. Visually inspect the window to be sure debris, smudges, and blood have been removed.

10. Return the 10 racks to the Sample Loader Tray.

11. Turn the Sample Loader to the ON position.

12. Press the [ENABLE ANALYZER] key to bring the CELL-DYN 3700 System to the READY state. And resume normal Sample Loader operation procedures.

Flushing the “Y” Fitting — Open and Closed ModesThis procedure may be used to remove buildup or fibrin, which may have formed in the plastic “Y” fitting and tubing located behind the Analyzer Status Indicator Panel.




Figure 9.19: Flow Panel Open/Closed Mode Tubing

Materials Required1. 10-mL syringe filled with cleaning solution:

Make a 25% bleach solution (1.25% sodium hypochlorite) by adding 5 mL of bleach to 15 mL of deionized water.

2. Tubing, two sizes to be used as a temporary drain line:

• TEFLON, 12"–18", small diameter

• Silicon, 2"–12", same diameter as pinch valve tubing

3. Paper towels/gauze


Shear ValveInlet Tubing

Solenoid 96

TEFLON® Tubingfor Drainage

Containerfor Drainage

Solenoid 95

Closed ModeValve Fitting

"Y" Fitting



Procedure1. From the MAIN MENU screen, select in the following order:

[DIAGNOSTICS], [MORE], [SOLENOID OPERATION], then [STEP SOLENOID].

2. Place absorbent paper towels/gauze below the probe area to catch any potential spills.

3. Place a container underneath the Open Probe to recover the flushing solution.

4. Disconnect the Shear Valve Inlet Tubing from the front section of the Shear Valve.

5. Flush the Open Mode tubing.

a. On the keyboard, type 95. Press Enter. Solenoid 95 (Open Mode) will open.

b. Inject the cleaning solution through the tubing and into the container underneath the probe. A “push/pull” motion may be used to facilitate cleaning action.

6. Flush the Closed Mode tubing.

a. Refill the syringe with the cleaning solution and reconnect to the Shear Valve Inlet Tubing.

b. Disconnect the Closed Mode Aspiration Tubing from the Closed Mode Valve Fitting. Attach a piece of TEFLON® tubing to the tubing in the Closed Mode Valve. Place the other end of the tubing into a container for drainage.

c. On the keyboard, press the Up arrow key. Solenoid 95 will close; Solenoid 96 (Closed Mode) will open.

d. Using the syringe, inject the cleaning solution through the tubing and into the container. A “push/pull” motion may be used to facilitate cleaning action.

7. Remove syringe and reattach the Shear Valve Inlet Tubing.

8. Remove the TEFLON® drainage tubing from the Closed Mode Valve Fitting.

9. Reinstall the Closed Mode Aspiration Tubing to the tubing going through the Closed Mode Valve — the tubing on the valve’s right side.

10. From the screen, select [DIAGNOSTICS], then [INITIALIZATION].11. After Initialization is complete, press [MAIN] to return to the

MAIN MENU screen.

12. Run five background counts. Check that the background counts are acceptable before running controls or patient samples. If the background counts are unacceptable, troubleshoot accordingly.


9140320D — June 2003


NOTES


MaintenanceChapter 9 Special Procedures

Special Procedures

Closed Sampler Tube Retainer Adjustment (CS System Only)It is necessary to adjust the Tube Retainer on the CELL-DYN 3700CS System to accommodate different sized VACUTAINER® tubes. The Closed Sampler Module is depicted in the following figure.

Figure 9.20: Closed Sampler Module

Materials Required1. An empty VACUTAINER® tube


Procedure 1. Squeeze the Release Levers on the sides of the Tube Retainer

between the thumb and forefinger to loosen the Tube Retainer, and slide the clamp up.

2. Insert the VACUTAINER® tube upside down into the Cap Piercer Well.

3. Slide the clamp down to hold the tube snugly in place.

4. Release the Release Levers when the Tube Retainer has been properly positioned.

5. Check the height adjustment with several VACUTAINER® tubes to be certain that it is correct.

Release Levers

Tube Retainer

Cap Piercer Well



MaintenanceSpecial Procedures Chapter 9

Preparation for Inactivity or ShippingThe Prepare For Shipping Cycle must be run if the instrument will not be used for two weeks or more. This cycle must also be run prior to shipping the instrument or relocating it. Salt deposits and reagent residue may clog the flow system if they are not removed prior to a period of inactivity or shipment. In addition, the tubing should be removed from all of the Normally Closed Valves. Leaving this tubing in the valves while the instrument is inactive may cause it to crimp permanently. The Normally Closed Valves on the Analyzer Flow Panel are shown in the following figure.

Figure 9.21: Analyzer Flow Panel: Accessing Normally Closed Valves

Normally Closed Valves


MaintenanceChapter 9 Special Procedures

Materials Required1. Container with approximately 500 mL of deionized water.

2. If the instrument will be shipped, the following are also needed:

• Shear Valve Dummy Center Section (this is stored in the disk storage container located on the Analyzer Flow Panel to the right of the WOC Flow Cell Access Cover)

• Four plastic bags to hold the reagent inlet and waste outlet tubes



key followed by the [MORE] key followed by the [PREPARE SHIPPING] key.

2. Place the reagent lines in the container of deionized water and then press the [START] key. The flow system will be automatically rinsed. (This process takes about 10 minutes.)

NOTE: The message CLEAN FOR SHIPPING IS IN PROGRESS is displayed during the rinsing process.

3. When the process is complete, the message CLEAN FOR SHIPPING HAS COMPLETED is displayed. Turn OFF the power to the instrument.

4. Carefully remove the reagent inlet tubes from the Normally Closed Valves under the reagent reservoirs located on the Left Side Panel of the Analyzer. (If necessary, refer to Figure 9.12, Analyzer Left Side Panel for the location of these Normally Closed Valves.)

5. Carefully remove the tubing from the Normally Closed Valves on the Analyzer Flow Panel. There are two Normally Closed Valves located to the right of the Shear Valve (only the lower one is present on the CS Model) and another located above the lower Aperture Cleaning Circuit Interlock Switch. (See the preceding figure for the location of these valves.)

NOTE: To gain access to the Normally Closed Valves located by the Shear Valve, loosen one screw and remove the other screw that holds the Status Indicator Panel in place and rotate the panel upward.

6. Remove the Peristaltic Pump tubing from the Sample Aspiration Pump and the WOC Transfer Peristaltic Pump.


9140320F — April 2007

MaintenanceSpecial Procedures Chapter 9

If the instrument is to be shipped, perform the following steps:

7. Obtain the Shear Valve Dummy Center Section from the disk storage container.

8. Clean the Shear Valve as directed in Steps 3-8 in the procedure given in the weekly maintenance section of this chapter. Reassemble the Shear Valve using the Dummy Center Section.

9. Wrap the ceramic center section carefully for protection and place it in the Accessory Kit.

10. Disconnect the power cords and put them in the Accessory Kit.

11. Remove the reagent inlet and waste outlet tubes. Place each tube in a protective plastic bag and put the bags in the Accessory Kit.

WARNING: Potential Biohazard. Waste in the outlet tubes may be infectious. Wear powder-free, disposable gloves and follow established, good laboratory working practices when handling this material.

Repackaging for ShipmentWhen the CELL-DYN 3700 System is to be shipped and the original packaging is available, repackage the instrument as it was originally shipped.

When the instrument is to be shipped and the original packaging is unavailable, call Abbott Diagnostics Customer Service (at 1-877-4ABBOTT in the US) for assistance with repackaging the unit for shipment.


Chapter 10 TroubleshootingTroubleshooting

Introduction

This chapter gives instructions for troubleshooting. The CELL-DYN® 3700 System continuously monitors the status of the system and displays pertinent information in the Status Box or on the bulletin line. If a problem is detected, the Status Box displays the message: FAULT: SEE DIAG or SEE SPECIAL, the bulletin line displays a message, and the word FAULT on the Analyzer status indicator panel is illuminated in red. A description of the fault can be obtained by pressing the [FAULT REPORT] key on the DIAGNOSTICS MENU screen.

The first section of this chapter discusses the DIAGNOSTICS MENU soft keys. The remainder of the chapter is devoted to the Troubleshooting Guide.

The Troubleshooting Guide is designed to assist the operator in identifying and resolving instrument problems. Instructions are also given for obtaining technical assistance from Abbott Diagnostics Customer Service. The Guide includes Troubleshooting Tips and Techniques, Troubleshooting Procedures, and Instructions for Component Replacement. The last section describes the Instrument Messages and Fault Conditions. The tables in this section include instructions for corrective action.

For information about interfering substances, refer to Chapter 5: Operating Instructions, Subsection: Routine Operation, Sample Collection and Handling, Interfering Substances.


9140320C — November 2000

TroubleshootingIntroduction Chapter 10

NOTES


Chapter 10 Troubleshooting

Diagnostics Menu

This section describes the soft keys displayed on the DIAGNOSTICS MENU screens. These keys enable the operator or service representative to obtain information and execute programs that assist in troubleshooting and identify corrective actions.

Several keys listed are described as “For Service Use Only.” The data these keys provide are meaningful only to trained Field Service Representatives and are not useful to the operator. If certain keys are pressed inadvertently, the system may have to be initialized.

There are five primary screens in the DIAGNOSTICS MENU. For ease of explanation, the keys are discussed screen by screen.


9140320C — November 2000

TroubleshootingDiagnostics Menu Chapter 10

Diagnostics Menu Flowchart


PRINTFAULTREPORT

MORE

EXECUTIONTIMES

RAW DATASUMMARY

CNT RATESUMMARY

CLEARFAULTS

MAIN

PRINTWICCNT RATE

PLTCNT RATE

WOCCNT RATE

RBCCNT RATE

RETURN

MAINMOTOROPERATION

MORE

SOLENOIDOPERATION

INITIAL-IZATION

PUMPOPERATION

DRAINACCUMULAT

DIAG-STEPSOLENOID

CYCLEBANK NOSTICS

PRESSUREVACUUMTEST

INHIBITPUMPS TEST

VACUUMON

PRESSUREON

DIAG-NOSTICS


MORE

VOLTAGEREADINGS

GAINADJUSTMNT

MAIN

WICCNT GRAPH

PLTCNT GRAPH

WOCCNT GRAPH

RBCCNT GRAPH

PRINTMORE

WOCDATA

WICDATA

RBCDATA

PLTDATA

MAIN

ENABLEPUMPS

VACUUMOFF

PRESSUREOFF


MORE

VOLTAGEREADINGS

GAINADJUSTMNT

MAINFINISHSELECT

SELECT

PRINTSIGNALGENERATOR

VERIFYGAINS

CURRENTSETTINGS

ENTERSETTINGS

AUTO GAINADJUSTMNT

DIAG-NOSTICS

PRINTWIMTESTING

MAMTESTING

RETURNSPMTESTING

PRINTMORE

AUTO-SAMPVERSION

SERIALTEST

BAR CODEALIGNMENT

BAR CODEVERIFY

MAIN

WICHISTOGRAM

RBCHISTOGRAM

PLTHISTOGRAM

PRINTWOC 1DATA

EXTENDEDWOC COUNT

WOC 2DATA

SMOOTHINGON/OFF

CALCCV

SCATTERGRAPHS

DIAG-NOSTICS

DIAG-NOSTICS

TRANSMITMESSAGE

STOPTRANSMISS

WOC 1HISTOGRAM

WOC 2HISTOGRAM

PRINTSHEAR VALDISPENSE

MOTOR PWRCHECKING

SHEAR VALTIME

HOMEMOTORS

EXERCISEMOTOR

DIAG-NOSTICS

SHEAR VALASPIRATE


TroubleshootingChapter 10 Diagnostics Menu

Figure 10.1: First Diagnostics Menu Screen

The first DIAGNOSTICS MENU screen (see the preceding figure) and the following soft key labels are displayed when the [DIAGNOSTICS] key is pressed:

FAULT REPORTEXECUTION TIMESCNT RATE SUMMARYCLEAR FAULTSRAW DATA SUMMARYMOREPRINTMAIN

FAULTREPORT

EXECUTIONTIMES

CNT RATESUMMARY

CLEARFAULTS

RAW DATASUMMARY

MORE PRINT MAIN



10:20sh0630

DIAG-

NOSTICS


9140320C — November 2000


When the [FAULT REPORT] key is pressed, information regarding the pending fault is displayed on the screen. The screen displays the words Operator correctable fault report: (see the following figure) or Fatal fault report: (see Figure 10.3, Fatal Fault Report Screen) and any additional information available. If there is no fault, the screen displays the words No fault pending. (See Figure 10.4, Fault Report — No Fault Pending Screen.)

Figure 10.2: Operator Correctable Fault Report Screen

FAULT

REPORT

FAULTREPORT

EXECUTIONTIMES

CNT RATESUMMARY

CLEARFAULTS

RAW DATASUMMARY

MORE PRINT MAIN

DIAGNOSTICS MENUDetergent empty


12:287322715

Operator correctable fault report :

Detergent empty

Detergent Empty



Figure 10.3: Fatal Fault Report Screen

Figure 10.4: Fault Report — No Fault Pending Screen

FAULTREPORT

EXECUTIONTIMES

CNT RATESUMMARY

CLEARFAULTS

RAW DATASUMMARY

MORE PRINT MAIN

DIAGNOSTICS MENUFault: See DIAG


12:207322713

Fatal fault report :

RBC diluent syringe overpressure

RBC diluent syringe overpressure

FAULTREPORT

EXECUTIONTIMES

CNT RATESUMMARY

CLEARFAULTS

RAW DATASUMMARY

MORE PRINT MAIN



15:58maa1917

No fault pending


9140320C — November 2000


Operator correctable faults (for example, Waste Full, Diluent Empty) can be cleared by pressing the [CLEAR FAULTS] key after taking the appropriate corrective action. After the corrective action has been taken for a fatal fault, the system must be initialized.

This key is for service use only.

Figure 10.5: Count Rate Summary Screen

When the [CNT RATE SUMMARY] key is pressed, the following soft key labels (see the preceding figure) are displayed:

WOC CNT RATE or WOC CNT GRAPH*

RBC CNT RATE or RBC CNT GRAPH*

PLT CNT RATE or PLT CNT GRAPH*

WIC CNT RATE or WIC CNT GRAPH*

PRINTRETURN* These key labels alternate between the two selections when the soft key is pressed.

EXECUTION

TIMES

WOCCNT RATE

RBCCNT RATE

PLTCNT RATE

WICCNT RATE

PRINT RETURN



12:297322715

CNT RATE

SUMMARY



NOTE: The count rate and graphical data is available for the previously run specimen only.

Figure 10.6: WOC Count Rate Data (Tabular Format)

Each key displays kinetic data for the selected parameter from the last cycle run. When each key is pressed, the count rate data is displayed (see the preceding figure) and the key label changes to [CNT GRAPH] for that parameter.

Count rate data from the last cycle is displayed in a tabular format. The total count, time segments, and rate per second are displayed for multiple data points from that cycle. (See the preceding figure.) When the [CNT GRAPH] key for a particular parameter is pressed, the rate-per-second data is displayed as a graph. (See the following figure.) The kinetic data and graph are useful when troubleshooting problems related to these parameters.

WOCCNT GRAPH

RBCCNT RATE

PLTCNT RATE

WICCNT RATE

PRINT RETURN



12:307322716

WOC : TOTAL COUNT: 5934TIME: 0.50 1.05 1.55 2.07 2.57 3.08 3.62 4.12COUNT: 361 808 1183 1576 1989 2359 2799 3225RATE: 714.85 827.78 742.57 755.77 826.00 725.49 822.43 843.56TIME: 4.63 5.14 5.67 6.21 6.73 7.24 7.50COUNT: 3666 4074 4500 4924 5342 5743 5934RATE: 864.71 800.00 811.43 777.98 803.85 794.06 720.75


9140320C — November 2000


Figure 10.7: WOC Count Rate Graph

When the [CLEAR FAULTS] key is pressed, the Analyzer returns to the Ready state if the corrective action taken resolved the problem. If the corrective action did not correct the problem, the fault status does not change.

NOTE: Only operator correctable faults can be cleared with the [CLEAR FAULTS] key.

WOCCNT RATE

RBCCNT RATE

PLTCNT RATE

WICCNT RATE

PRINT RETURN



12:297322716

WOC CNT GRAPH

864.7

756.6

648.5

540.4

432.4

324.3

216.2

108.1

0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5

CLEAR

FAULTS



Figure 10.8: Raw Data Summary Screen

When the [RAW DATA SUMMARY] key is pressed, detailed information pertaining to the last cycle run is displayed. An example of the RAW DATA SUMMARY screen is shown in the preceding figure. The most useful information for the operator, the metering times and the HGB Reference and Sample readings, is highlighted on the screen shown in the preceding figure.

The information on metering times may be used to assist in troubleshooting chronic Clog or Flow Error messages. The HGB Reference and Sample readings may be used to assist in troubleshooting erratic or imprecise HGB results.

When the [MORE] key is pressed, the second DIAGNOSTICS MENU screen is displayed. The [MORE] keys on the remaining screens to be discussed always display the next DIAGNOSTICS MENU screen. Consequently, they are discussed last in each section.

When the [PRINT] key is pressed, a Diagnostic Report is printed. This report contains information pertinent to the data displayed on the screen at the time the key is pressed. If no data is displayed on the screen, the report prints the current fault status.

FAULTREPORT

EXECUTIONTIMES

CNT RATESUMMARY

CLEARFAULTS

RAW DATASUMMARY

MORE PRINT MAIN



12:337573143

List Mode WOC: 4350 RBC: 23598 PLT: 2682 WIC: 2956Raw Count WOC: 4206 RBC: 31166 PLT: 2741 WIC: 3038 WIC Bubble: 94

RBC Times Upper: 3.53 Count: 6.23 Avg: 6.22 Timeout: 6.41

WIC Times Upper: 1.53 Count: 4.69 Avg: 4.69 Timeout: 4.89

HGB Sample 1: 1218 2: 1218 3: 1219 4: 1219 5: 1219HGB Ref 2255 2254 2255 2255 2258

RBC Alg RER : 33.9% Lo thr: 40 CTRUE : 342.4WOC Alg % Tot : 98.6%

PLT Alg Adj cnt: 2728 Lo thr: 8 Hi thr: 219

RAW DATA

SUMMARY

MORE

PRINT


9140320C — November 2000


The [PRINT] key functions in this way on each screen. Therefore, it will not be discussed again in this section.

The [MAIN] key is used to return to the MAIN MENU screen. The [MAIN] key appears on each primary DIAGNOSTICS MENU screen and works the same way on each screen. Consequently, it will not be discussed again in this section.

Figure 10.9: Second Diagnostics Menu Screen

When the [MORE] key on the first DIAGNOSTICS MENU screen is pressed, the second DIAGNOSTICS MENU screen (see the preceding figure) and the following soft key labels are displayed:

MOTOR OPERATIONSOLENOID OPERATIONPUMP OPERATIONDRAIN ACCUMULATINITIALIZATIONMOREMAIN

MAIN

MOTOROPERATION

SOLENOIDOPERATION

PUMPOPERATION

DRAINACCUMULAT

INITIAL-IZATION

MORE MAIN



10:20sh0630

MORE



This key is for service use only. The system must be initialized after this key is pressed.

This key is for service use only. The system must be initialized after this key is pressed.

Figure 10.10: Pump Operation Screen

When the [PUMP OPERATION] key is pressed, the following soft key labels (see the preceding figure) are displayed:

VACUUM ON or VACUUM OFF (The key label alternates between these two

selections.)

PRESSURE ON or PRESSURE OFF (The key label alternates between these two

selections.)

INHIBIT PUMPS*

VACUUM TESTPRESSURE TESTDIAGNOSTICS* This key is displayed after either key listed above it is pressed.

MOTOR

OPERATION

SOLENOID

OPERATION

VACUUMON

PRESSUREON

VACUUMTEST

PRESSURETEST

DIAG-NOSTICS

DIAGNOSTICS MENUNot Ready: See DIAG


12:347573143

PUMP

OPERATION


9140320C — November 2000


Figure 10.11: Pump Operation Screen — Vacuum ON

When the [VACUUM ON] key is pressed, the key label changes to [VACUUM OFF], the vacuum pump is turned ON, and the screen displays the message: Vacuum is on. (See the preceding figure.) Press the [VACUUM OFF] key to turn the pump OFF.

NOTE: The pump is automatically turned OFF and control of the pump is returned to the instrument when the screen is exited.

This key is useful for troubleshooting vacuum problems. If the pump does not turn ON when the key is pressed, the vacuum pump may be the cause of the vacuum problem.

NOTE: The system must be initialized after this key is pressed.

When the [PRESSURE ON] key is pressed, the key label changes to [PRESSURE OFF], the pressure pump is turned ON, and the screen displays the message: Pressure is on. Press the [PRESSURE OFF] key to turn the pump OFF.

NOTE: The pump is automatically turned OFF and control of the pump is returned to the instrument when this screen is exited.

VACUUMOFF

PRESSUREON

INHIBITPUMPS

VACUUMTEST

PRESSURETEST

DIAG-NOSTICS



12:367322716

Vacuum is on

VACUUM

ON

VACUUM

OFF

PRESSURE

ON

PRESSURE

OFF



This key is useful for troubleshooting pressure problems. If the pump does not turn ON when the key is pressed, the pressure pump may be the cause of the pressure problem.


Figure 10.12: Inhibit Pumps Screen

When the [INHIBIT PUMPS] key is pressed, the key label changes to [ENABLE PUMPS], operation of the pumps is inhibited (no vacuum and pressure are produced), and the screen displays the message: Pressure and vacuum are inhibited. (See the preceding figure.) Press the [ENABLE PUMPS] key to enable pump operation.

NOTE: The pumps are automatically enabled and control of them is returned to the instrument when this screen is exited.

This key is useful when performing maintenance or troubleshooting procedures that require a vacuum or pressure line to be removed.


VACUUMOFF

PRESSUREOFF

ENABLEPUMPS

VACUUMTEST

PRESSURETEST

DIAG-NOSTICS



12:367573143

Pressure and vacuum are inhibited

INHIBIT

PUMPS

ENABLE

PUMPS


9140320C — November 2000


Figure 10.13: Vacuum Test Screen

When the [VACUUM TEST] key is pressed, the system releases the vacuum into the atmosphere and then determines the amount of time required for it to return to the correct level. The key labels disappear and the incrementing time is displayed on the screen. (See the preceding figure.) When the test is complete, the time stops incrementing and the key labels are displayed.

A vacuum recovery time greater than 5 seconds may indicate a vacuum problem.


When the [PRESSURE TEST] key is pressed, the system releases the pressure into the atmosphere and then monitors the amount of time required for it to return to the correct level. The key labels disappear and the incrementing time is displayed on the screen. When the test is complete, the time stops incrementing and the key labels are displayed.

A pressure recovery time greater than 4 seconds may indicate a pressure problem.


DIAGNOSTICS MENUVacuum Recovery Time Test


12:397322716

Time elapsed : 3.3

VACUUM

TEST

PRESSURE

TEST



Figure 10.14: Drain Accumulators Screen

When the [DRAIN ACCUMULAT] key is pressed, the internal vacuum accumulators are drained of accumulated fluid. This key is used to correct the Vacuum Accumulator Wet fault. (See the preceding figure.)

When the process is completed, the system must be initialized and primed. A prime cycle and background are automatically run whenever the [RUN] key is pressed after the system is initialized. Run an additional five background counts.

When the [INITIALIZATION] key is pressed, the Analyzer is initialized. This is necessary when a fatal fault has occurred.

When the Analyzer is initialized, a prime cycle must be run.

NOTE: A prime cycle and background are automatically run whenever the [RUN] key is pressed after the system is initialized.

MOTOROPERATION

SOLENOIDOPERATION

PUMPOPERATION

DRAINACCUMULAT

INITIAL-IZATION

MORE MAIN

DIAGNOSTICS MENUDraining accumulator


12:417322716

After draining the accumulators, press the INITIALIZATION key, prime,run 5 Background Counts and confirm that the background results are

acceptable before running samples.

DRAIN

ACCUMULAT

INITIAL-

IZATION


9140320C — November 2000


Figure 10.15: Third Diagnostics Menu Screen

When the [MORE] key is pressed, the third DIAGNOSTICS MENU screen (see the preceding figure) and the following soft key labels are displayed:

DIGITAL READINGSVOLTAGE READINGSGAIN ADJUSTMNTMOREPRINTMAIN

This key is for service use only.

DIGITALREADINGS

VOLTAGEREADINGS

GAINADJUSTMNT

MORE PRINT MAIN



10:21sh0630

MORE

DIGITAL

READINGS



Figure 10.16: Voltage Readings Screen

When the [VOLTAGE READINGS] key is pressed, the voltage and vacuum/pressure value from a test point, measured at the moment when the key was pressed, is displayed. (See the preceding figure.) The following additional soft key labels are displayed:

FINISH SELECT*

SELECT*

*These two keys are for service use only.

The data provided by the VOLTAGE READINGS screen can be useful in determining if a problem is caused by a hardware malfunction.

This key is for service use only. The system may have to be initialized after this key is pressed.

FINISHSELECT

SELECT DIGITALREADINGS

VOLTAGEREADINGS

GAINADJUSTMNT

MORE PRINT MAIN



12:407573143

slf-tst f/DAC:0.00 99mv refrence:0.08 15v/2 pwr sp :7.49 5v pwr sp :5.14

Arrow keys to move around, SELECT key to select, FINISH SELECT key to go

slf-test ramp:9.99 9.901v refrnc:9.86 -15v/2 pwr sp:-7.55WOC threshold:0.85 SPM tst f/DAC:0.00 WOC ch 1 peak:0.00 RBC peak :0.00RBC threshold:0.57 5v supply :5.12 WOC ch 2 peak:0.00 RBC intgrl:0.00PLT L thrshld:0.53 10v refrence :9.97 WOC ch 3 peak:0.00 PLT peak :0.04PLT H thrshld:9.97 -10v refrence:-10.0WOC ch 4 peak:0.00ch 1 offset :0.20 ch 5 offset :-2.06electrode v/2:0.41 laser ref :0.00ch 2 offset :0.97 ch 6 offset :-3.00apt crrnt set:-0.05ch 3 offset :0.64 ch 3-Vdyn/100:6.14 tstpuls H set:-0.05ch 4 offset :0.27 ch 4-Vdyn/100:5.65 tstpuls L set:-0.00press 1 psi :12.0 press 3 psi :4.88 vac 1 in. Hg :11.8 pos rf prs:5.00press 2 psi :9.01 vac 2 in. Hg :11.7 pos rf prs:-5.07HGB output :5.53WIC offset v :-3.26WIC H thrshld:7.30 WIC apt cr st:0.00 WIC peak :0.00WIC elctd v/2:0.66 WIC L thrshld:1.54 WIC test puls:0.00

DCM:

SPM:

MAM:

VPM:

FCM:WIC:

VOLTAGE

READINGS

GAIN

ADJUSTMNT


9140320C — November 2000


Figure 10.17: Fourth Diagnostics Menu Screen

When the [MORE] key is pressed, the fourth DIAGNOSTICS MENU screen (see the preceding figure) and the following soft key labels are displayed:

WOC DATARBC DATAPLT DATAWIC DATAMOREPRINTMAIN

These keys are for service use only.

WOCDATA

RBCDATA

PLTDATA

WICDATA

MORE PRINT MAIN



10:21sh0630

MORE



Figure 10.18: Fifth Diagnostics Menu Screen (CELL-DYN 3700SL System)

When the [MORE] key is pressed, the fifth and last DIAGNOSTICS MENU screen (see the preceding figure) and the following soft key labels are displayed:

AUTO SAMP VERSION*BAR CODE ALIGNMENT*BAR CODE VERIFY*SERIAL TESTMOREPRINTMAIN

*These keys are displayed on the CELL-DYN 3700SL System only.

AUTO-SAMPVERSION

BAR CODEALIGNMENT

BAR CODEVERIFY

SERIALTEST

MORE PRINT MAIN



12:49C033122

MORE


9140320C — November 2000


Figure 10.19: Auto-Sampler Version Screen

This key is used to display the software version currently installed in the Sample Loader. The Sample Loader must be ON before the key is pressed. When the [AUTO-SAMP VERSION] key is pressed, the screen displays the following message (see the preceding figure):

Auto-Sampler Software: [followed by the version information]

NOTE: This key is displayed on the CELL-DYN 3700SL System only.

This key is for service use only and is displayed on the CELL-DYN 3700SL System only.

This key is for service use only and is displayed on the CELL-DYN 3700SL System only.

AUTO-SAMPVERSION

BAR CODEALIGNMENT

BAR CODEVERIFY

SERIALTEST

MORE PRINT MAIN



12:50C033122

Auto-Sampler Software : X:VER X.XX XX-XX-XX

AUTO-SAMP

VERSION

BAR CODE

ALIGNMENT

BAR CODE

VERIFY



Figure 10.20: Serial Test Screen

The [SERIAL TEST] key is used to test the functionality of the RS232 port (referred to as the “serial interface connector”) at the rear of the Data Station. This test is designed to assist in troubleshooting problems related to interfacing with a Laboratory Information System (LIS). The loop-back connector must be connected to the Data Station RS232 port before performing the test.

NOTE: If the laboratory does not have an LIS, the loop-back connector may remain connected to the RS232 port for convenience, as it does not interfere with routine operation. If an LIS is usually connected, the loop-back connector should be stored near the instrument when the connector is not in use.

When the [SERIAL TEST] key is pressed, the following soft key labels (see the preceding figure) are displayed:

STOP TRANSMISSTRANSMIT MESSAGEDIAGNOSTICS

The DIAGNOSTICS MENU screen for Serial Test displays the following message:

STOPTRANSMISS

TRANSMITMESSAGE

DIAG-NOSTICS



12:51C033122

Serial Interface Test1. See Interface Specification.2. If transmission in progress, press “STOP TRANSMISS” key first3. Attach Loop-back connector to the serial interface

connector on back of the Data Station.4. Press the “TRANSMIT MESSAGE” key to start the test.

SERIAL

TEST


9140320C — November 2000


Serial Interface Test

1. See Interface Specification.

2. If transmission in progress, press “STOP TRANSMISS” key first.

3. Attach Loop-back connector to the serial interface connector on back of the Data Station.

4. Press the “TRANSMIT MESSAGE” key to start the test.

The [STOP TRANSMISS] key is used to abort any transmission that is in progress to an LIS.

STOP TRANSMISS



Figure 10.21: Serial Test Transmit Message Screen Transmit Message

When the [TRANSMIT MESSAGE] key is pressed, the message: CELL-DYN serial interface test is transmitted from the Data Station to the RS232 port, through the loop-back connector and back to the Data Station. The DIAGNOSTICS MENU screen then displays the message (see the preceding figure):

Message sent: CELL-DYN serial interface test

If the test is successful, the screen displays the message:

Message received: CELL-DYN serial interface test

This message indicates that the Data Station is communicating properly. If the test is not successful, no message will be displayed.

The [DIAGNOSTICS] key is used to return to the previous DIAGNOSTICS MENU screen.

STOPTRANSMISS

TRANSMITMESSAGE

DIAG-NOSTICS



12:52C033122

Message sent : CELL-DYN serial interface test.Message received :

TRANSMIT

MESSAGE

DIAG-

NOSTICS


9140320C — November 2000


NOTES


Chapter 10 Troubleshooting

Troubleshooting Guide

OverviewGood troubleshooting skills are learned by using a logical, step-by-step approach to problem solving. The first step in the process is understanding normal instrument operation and preventive maintenance. A good working knowledge of the instrument is essential for identifying and resolving operational problems.

Logical troubleshooting may be divided into three steps:

1. Problem Identification

2. Problem Isolation

3. Corrective Action

Step 1, Problem Identification, involves not only identifying what is wrong but also noting what is right. The investigator should identify the problem area and eliminate areas that are working correctly. Once this is done, the troubleshooting process moves quickly to the next step.

Step 2, Problem Isolation, further classifies the problem. Instrument problems are generally divided into three categories:

Measurement — related to sample analysis

Software — computer program related

Hardware — component related

Measurement problems are generally operator correctable. This category is further subdivided into problems related to sample handling, maintenance, or calibration. Typically, software and hardware problems are corrected by an authorized service representative.

Step 3, Corrective Action, involves taking appropriate action to correct the problem. If the operator can correct the problem, with or without technical assistance, normal operation can quickly resume.

This Troubleshooting Guide is designed to enhance the troubleshooting process by providing information to assist in problem identification, isolation, and corrective action.



TroubleshootingTroubleshooting Guide Chapter 10

Troubleshooting Tips and TechniquesEffective troubleshooting is possible only when the problem is clearly recognized and the probable cause is isolated. This is always facilitated by obtaining sufficient information and data pertaining to the specific problem. Carefully observe the situation. Document the steps that have been taken and record all results.

This Troubleshooting Guide is designed to guide the operator through a logical series of steps to obtain information regarding the nature of the problem. If it is necessary to call for technical assistance, this information should be made available to the Customer Support Specialist.

The procedures referred to throughout this section are described in this chapter or in Chapter 9: Maintenance.

For additional assistance on any troubleshooting procedure, contact Abbott Diagnostics Customer Service (at 1-877-4ABBOTT in the US).

Obtaining Technical AssistanceTechnical Assistance is obtained by calling Abbott Diagnostics Customer Service. It is important to provide the Customer Support Specialist with a clear and detailed description of the problem. When assistance is needed, please be prepared to provide the following information for the Customer Support Specialist:

1. Instrument model number

2. Serial number of the Analyzer and software version in use

3. Description of the problem (whenever possible, print the Fault Status Report obtainable from the DIAGNOSTICS MENU screen)

4. The lot numbers and expiration dates of the CELL-DYN Reagents and Controls currently in use

5. Sufficient examples of data to facilitate the discussion

Customer Support CenterUnited States: 1-877-4ABBOTT (1-877-422-2688)

Abbott Diagnostics Customer Service:200 Abbott Park RoadAbbott Park, IL 60064, USA

Canada: 1-800-387-8378

Customers outside the US: call your local Customer Service Representative.


TroubleshootingChapter 10 Troubleshooting Guide

Troubleshooting ProceduresThe procedures in this section are for troubleshooting purposes only. A specific procedure should be performed when indicated in this chapter or at the request of an Abbott Customer Support Specialist.

Power ON ProcedureIMPORTANT: If the power has been OFF more than five minutes, the laser must be allowed to warm up for 15 minutes once the power is turned back ON. Do not process samples during this warm-up period.

1. Verify that all components are properly installed (for example, syringes, Shear Valve, etc.).

2. Verify that all reagents are properly installed.

3. Verify that all necessary cables and power cords are properly connected.

4. Verify that the Analyzer covers are properly installed. If the instrument is a CELL-DYN 3700SL System, verify that the Sample Loader safety cover is in place.

5. If applicable, verify that the cause of the power OFF situation has been corrected.

6. Turn the power switches ON in the following order:

a. Analyzer

b. Data Station

c. Sample Loader, if present

d. Printer

7. When the INITIALIZED message appears in the Status Box on the Data Station screen, prime the system by pressing [PRIME] or [RUN], whichever is displayed.

Power OFF ProcedureIt is not necessary to turn the system OFF under routine operating conditions. The system should be turned OFF if certain services are performed, if the system is moved, or if the system will be inactive for an extended period of time (longer than seven days).

When controlled conditions (such as emergency power tests) require the power to be turned OFF, use the following procedure.


9140320C — November 2000


1. Perform any required maintenance that is due.

2. Perform an Auto-Clean Cycle. (If necessary, refer to the directions given in Chapter 9: Maintenance, Subsection: Daily Maintenance Procedures, Auto-Clean.)

3. When the Auto-Clean cycle is complete, press [DAILY SHUTDOWN]. When the Daily Shutdown cycle is complete, the Status Box displays the message: Standby.

NOTE: If the instrument will be inactive for more than seven days, perform the Preparation for Inactivity or Shipping cycle instead of the Daily Shutdown cycle. Refer to the instructions given in Chapter 9: Maintenance, Subsection: Special Procedures, Preparation for Inactivity or Shipping.

4. Turn the power switches OFF in the following order:

a. Data Station

b. Analyzer

c. Sample Loader, if present

d. Printer

NOTE: In an emergency situation, turn OFF the power switches, in any order, as quickly as possible. Follow the Power ON procedure as described earlier in this section when the emergency is over.

Initializing the SystemThe term initialization refers to the automatic process that is necessary after certain problems have been corrected. Initialization is a two-step process:

1. Initializing the hardware and software

2. Priming the system with reagents

The system is initialized by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. The system is automatically initialized whenever the power is turned ON.

During the initialization process, the Data Station software is accessed and downloaded to the Analyzer. Once this is accomplished, all Analyzer motors and pumps are moved to their “home” positions. (Increased motor noises are normal during this process.) When the initialization has been successfully completed, the message INITIALIZED is displayed in the Status Box.



The reagent priming step is necessary after any initialization. This is accomplished by pressing [RUN] or [PRIME], whichever is displayed. All reagents are primed automatically, a background cycle is performed, and the results are displayed on the RUN screen. After the reagents are primed and auto background is performed, the message Ready is displayed in the Status Box.

On the CELL-DYN 3700SL System, the Sample Loader may be initialized by pressing the INT key on the Sample Loader operation keyboard. It may also be initialized by turning the Sample Loader power switch OFF and ON. (The Sample Loader is automatically initialized every time the power switch is turned ON.)

Replacing ReagentsIf a reagent (or reagents) is suspected as the cause of a particular problem, replace the container. However, the Analyzer has reservoirs that contain a small amount of reagent to maintain the supply within the system. This supply must be depleted before installing the new reagent.

NOTE: There is no reservoir for the WIC/HGB lyse reagent. The amount of lyse contained in the lyse supply tubing is sufficient to maintain the system’s supply. The lyse tubing is drained and filled with the [EMPTY LYSE] and [FILL LYSE] keys displayed on the REAGENT RESERVOIR screen, using the procedure described below.

To ensure that only new reagent is in the system, proceed as follows:

1. From the first SPECIAL PROTOCOLS screen, press [REAGENT RESERVOIR].

2. From the REAGENT RESERVOIR screen, follow the instructions given on the screen.

3. Wipe the reagent line with a lint-free wipe before placing it in the new container. Place the line in the container and secure the cap.

4. To refill, follow the instructions given on the screen.

5. Run five background counts before assessing the results.




Replaceable ComponentsProcedures are given in this section for those components that may be replaced by the operator. All other components must be replaced by an Authorized Service Representative.

WARNING: Potential Biohazard. Components may be contaminated with infectious materials. Wear appropriate personal protective equipment and follow biosafety practices as specified in the OSHA Bloodborne Pathogen Rule (29 CFR 1910.1030) or equivalent biosafety procedures.

Fuse ReplacementThe CELL-DYN 3700 System has a fuse located above the Power Cord Connector on the Rear Panel. It should only be replaced with the following types of fuses:

For 220-volt operation, a 4-amp T (slow-blow) fuse

For 110-volt operation, an 8-amp T (slow-blow) fuse

Replacement fuses are provided in the Accessory Kit.

Materials RequiredFlathead screwdriver

ProcedureWARNING: Electrical Shock Hazard. Always turn the System OFF and disconnect the Power Cord from the receptacle before checking or changing the fuse.

1. Turn the Analyzer power switch OFF and disconnect the power cord from the receptacle.

2. Insert a flathead screwdriver into the Fuse Holder Slot on the Rear Panel of the Analyzer.

3. Push in and turn the Fuse Holder counterclockwise to remove it.

4. Pull on the fuse to remove it from the holder.

5. Check the fuse. If it has obviously failed, replace it. If it has not obviously failed, verify that it is the correct type of fuse.

NOTE: If you are not sure if the fuse has failed, replace it and see if the problem is corrected.



6. Check that the fuse is fully inserted into the Fuse Holder and replace the holder.

7. Insert a flathead screwdriver into the Fuse Holder Slot and push in, turning clockwise to lock it in place.

8. Reconnect the power cord to the receptacle and turn the Analyzer power switch ON.

Sample Loader Vent Needle/Aspiration Needle Replacement

Figure 10.22: Sample Loader Vent/Aspiration Needle Assembly

The Sample Loader Vent/Aspiration Needle should be replaced if it is bent, or if it cannot be unclogged. The Sample Loader Vent/Aspiration Needle Assembly tubing connections are depicted in the preceding figure. The Vent and Aspiration Tubing connections are shown in the following figure.

WARNING: Potential Biohazard. The needles are sharp and are potentially contaminated with infectious materials. Handle with extreme caution.

Pulley BeltBlood Sensor

Silicon Tubing

Locking

MountingBlock

Vent/

Needle

Vent

Sample

Vent ReservoirSide Fitting

Vent Reservoir

Sleeve

Aspiration

Screw

V

ATubingAspiration

Tubing




Figure 10.23: Sample Loader Vent/Aspiration Needle — Tubing Connections

Materials Required1. Sample Loader Vent/Aspiration Needle, L/N 03H99-01

(provided in the Accessory Kit)

2. Enzymatic Cleaner in a VACUTAINER tube

3. Gauze

4. A 2.5-mm Allen wrench

5. Two VACUTAINER tubes approximately half full of Diluent

6. Small needle nose pliers or similar tool.

Procedure1. Perform the Auto-Clean procedure as directed in Chapter 9:

Maintenance, Subsection: Daily Maintenance Procedures, Auto-Clean. When the cycle is complete, turn the Sample Loader power switch OFF.

2. Remove all racks from the tray.

3. Place some gauze under the Vent/Aspiration Needle to catch any liquid.

AspirationTubingSilicon Sleeve

Vent VTubing

Sample ATubingAspiration



4. Disable the Analyzer by pressing the [DISABLE ANALYZER] key on the SPECIAL PROTOCOLS screen.

5. Disconnect the Sample Aspiration Tubing from the Analyzer.

NOTE: The tubing connection is located below the Status Panel to the left side of the Open Sample Aspiration Probe.

6. Remove the Sample Loader Tower Cover.

7. Manually rotate the Pulley Belt counterclockwise until the needle is fully bottomed.

8. Mark the sets of tubing connected to the top of the vent and aspirate parts of the needle “V” and “A” to aid in proper reconnection.

NOTE: The needle is divided into the aspiration section (straight) and the vent section (slanted).

9. Disconnect the “A” tubing from the needle. Slide the silicon tubing sleeve onto the aspiration tubing before disconnecting it. (See the preceding figure.) Disconnect the “V” tubing from the Vent/Aspiration Needle.

10. Use the Allen wrench to remove the locking screw on the mounting bracket. (See Figure 10.22, Sample Loader Vent/Aspiration Needle Assembly.)

11. Using the needle nose pliers, grip the holding clip on the mounting block and carefully pull it forward until it clears the block.

12. Remove the needle by pulling it up through the Wash Block and the mounting block.

WARNING: Potential Biohazard. The needles are sharp and are potentially contaminated with infectious materials. Handle with extreme care.

CAUTION: Use care when removing or inserting the needle to avoid skin puncture.

13. Insert the new needle through the mounting bracket and down through the Wash Block until the wide collar at the top of the needle is flush with the top of the mounting bracket.

NOTE: Be sure that the vent section (slanted) is facing the analyzer.




14. Slide the holding clip back onto the mounting block and push in until it is snug against the block.

15. Using the Allen wrench, replace and tighten the locking screw in the mounting bracket.

16. Reconnect the vent tubing and the aspiration tubing.

NOTE: When connected, the aspiration tubing must be placed at least 1/4 inch over the top of the needle to cover it. The silicon tubing sleeve must slide over this connection for a proper seal.

17. Reconnect the Sample Aspiration Tubing to the Analyzer.

CAUTION: Be careful not to crimp or bend the tubing when reconnecting it. Do not use excessive force.

18. Replace the tower cover and check all tubing to ensure it is not pinched or crimped.

19. Reinstall all Sample Loader Racks. Prepare the first rack to run two diluent tubes. Install Safety Cover.

20. Enable the Analyzer by pressing the [ENABLE ANALYZER] key on the SPECIAL PROTOCOLS screen.

21. Turn the Sample Loader power switch ON.

22. Run the two diluent tubes and verify proper needle movement. Check to be sure the background count is acceptable on the last cycle.

NOTE: If the background count is unacceptable, clean the aspiration needle as directed in Chapter 9: Maintenance, Subsection: Daily Maintenance Procedures and repeat the background count. If any problems are encountered, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

AperturesIt may be necessary to replace the WIC Aperture Plate and/or the RBC/PLT Aperture Plate if no other solution to a related problem is found.

WIC apertures are identified by “WBC” etched on the Aperture Plate. RBC/PLT apertures are identified by “R/P” etched on the Aperture Plate.

NOTE: The Aperture Plates are NOT interchangeable.



Procedure1. Remove the old Aperture Plate as directed in the aperture

cleaning procedure described in Chapter 9: Maintenance, Subsection: As required, Aperture Plates.

2. Confirm that the replacement Aperture Plate is the correct one.

3. Clean the new Aperture Plate and install it as directed in the aperture cleaning procedure described in Chapter 9: Maintenance, Subsection: As Required, and follow the remaining steps in that procedure.

CAUTION: Changing the Aperture Plate may alter the instrument calibration. Therefore, confirm the calibration by running commercial controls before processing samples. If necessary, recalibrate the instrument as directed in Chapter 6: Calibration.

4. Repeat the samples that were running when the problem was detected to determine if it has been resolved. If the problem is not resolved, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

SyringesIt may be necessary to replace a syringe to correct a problem, for example, if a syringe is cracked or broken.

Procedure1. Remove the syringe in question as directed in the

appropriate syringe cleaning procedure described in Chapter 9: Maintenance and set it aside.

2. Remove the screw from the base of the plunger on the old syringe. Install the screw on the base of the new syringe before installing the syringe on the instrument.

3. Install the new syringe as directed in the appropriate syringe cleaning procedure and follow the remaining steps in that procedure.

4. Repeat the samples that were in process when the problem was detected to determine if it has been resolved. If the problem is not resolved, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).


9140320C — November 2000


List of SymptomsTroubleshooting Background Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-39

Platelet background out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-40WOC background out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-41WIC background out of specification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-42RBC background out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-43Hemoglobin background out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-44Multiple background counts out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-45

Troubleshooting Incomplete Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-46Sampling Error — Incomplete Aspiration: Open Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . .10-47Sampling Error — Incomplete Aspiration: Closed Mode (Cap Piercer System) . . . . . . . . 10-48Sampling Error — Incomplete Aspiration: Closed Mode (Sample Loader System) . . . . . . .10-49

Troubleshooting Clog and Flow Error Messages for RBC/PLT and WIC . . . . . . . . . . . . . . . . . . . . 10-50RBC/PLT clog or flow errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-51WIC clog or flow errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-52

Troubleshooting WOC Flow Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-53WOC flow errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54

Troubleshooting Imprecise or Inaccurate Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-55RBC/MCV/PLT data are imprecise or inaccurate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-56WOC data are imprecise or inaccurate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-58WIC data are imprecise or inaccurate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-59Hemoglobin data are imprecise or inaccurate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-60>>>> appear in place of the result for WBC, RBC, HGB, or PLT . . . . . . . . . . . . . . . . . . . . .10-61

Observable Fault Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-62Analyzer or Data Station will not power ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-62No screen display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-62The MAIN MENU screen is not displayed after initialization . . . . . . . . . . . . . . . . . . . . . 10-63The word FAULT on the Analyzer Status Indicator Panel is illuminated in red . . . . . . . . 10-63Instrument will not stop cycling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-64The Data Station keyboards, membrane (including soft keys) and external,

are not operational . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-64The Sample Loader does not power ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-65The Sample Loader beeps and the Start key is not illuminated . . . . . . . . . . . . . . . . . . . . 10-65Shear Valve problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-65



Symptom Identification and Resolution

Troubleshooting Background CountsThe following list contains some general guidelines for troubleshooting background counts.

• Determine which parameter(s) exceed the background count specifications: WIC, WOC, RBC, PLT, HGB. If more than one parameter is out of specification, refer to Multiple background counts out of specification at the end of the Troubleshooting Background Counts subsection.

• Check the Data Log to determine when the problem first occurred.

• Check the Reagent Log, Maintenance Log, and if applicable, service reports to see if the problem occurred immediately after a specific action. For example, did the problem occur immediately after the reagent was changed?

• Ensure that all covers are in place and ground wires are connected.

• Check the background count in the Open and Closed Modes to see if the problem is common to both modes.

• Run the electrical background and obtain a printout. Note whether the count is within acceptable limits.

NOTE: The electrical background cycle turns off the current to the apertures. This cycle is used to assist in determining if the electronics are causing the problem.

• Note the lot number of the reagent. Is it a new lot?

• Configure the RUN screen to display the appropriate graph for the parameter(s) for which the background count exceeds the system specifications and print the appropriate graph.

Parameter Appropriate Graph

WIC WIC histogram

WOC Size/Complexity scatterplot and the NWBC-LYM-MONO histogram

RBC RBC and PLT histograms

PLT RBC and PLT histograms

HGB WIC, RBC and PLT histograms

NOTE: Instructions for customizing the RUN screen display are given in Chapter 5: Operating Instructions.

• Refer to the following tables for the appropriate corrective action.


9140320C — November 2000


Platelet background out of specification

Probable Cause(s) Corrective Action

Electrical Interference If the Analyzer covers have been removed, replace covers, reattach the ground wires, and rerun the background count.

Perform an electrical background count.

Clean the Fan Filters (as directed in Chapter 9).

Drain the Vacuum Accumulator.

Check for any equipment near the CELL-DYN 3700 System that may be causing electrical interference.

Contaminated Reagent Empty the RBC/PLT Diluent Reservoir.

Replace the Diluent Reagent.

NOTE: To prevent contamination, place the Reagent tubing on a clean surface.

Dirty RBC/PLT Aperture Plate Clean the RBC/PLT Aperture Plate (as directed in Chapter 9).

Contaminated/dirty RBC/PLT Diluent Syringe

Clean the RBC Diluent Syringe (as directed in Chapter 9).

Salt buildup around RBC/PLT von Behrens Transducer Assembly

Perform Auto-Clean or Extended Auto-Clean.

NOTE: After performing any maintenance or troubleshooting procedures, run at least 5 background counts. Ensure that the controls are in range.



WOC background out of specification


Bubbles in WOC Flow Cell

Bubbles in WOC Syringes

Contaminated WOC Syringes

Empty WOC Flow Cell.

Clean the WOC Sheath Syringe and the WOC Metering Syringe (as directed in Chapter 9).

Dirty WOC Flow Cell Perform the Auto-Clean Procedure (as directed in Chapter 9).

Contaminated Reagent Empty the Sheath Reservoir.

Replace the Sheath Reagent.


Faulty WOC Peristaltic Pump Tubing Replace the WOC Transfer Peristaltic Pump Tubing (as directed in Chapter 9).





WIC background out of specification






Dirty WIC Aperture Plate Clean the WIC Aperture Plate (as directed in Chapter 9).

Contaminated Reagent Empty the Diluent Reservoir.


Empty the Detergent Reservoir.

Replace the Detergent Reagent.

Empty the WIC/HGB Lyse.


Contaminated/dirty WIC/HGB Diluent Syringe

Clean the WIC/HGB Diluent Syringe (as directed in Chapter 9).

Contaminated/dirty WIC/HGB Lyse Syringe

Clean the WIC/HGB Lyse Syringe (as directed in Chapter 9).

Faulty Aperture Clean Circuit Call Abbott Diagnostics Customer Service (at 1-877-4ABBOTT in the US).




RBC background out of specification









NOTE: To prevent contamination, place the reagent tubing on a clean surface.

Contaminated/dirty RBC/PLT Diluent Syringe

Clean the RBC/PLT Diluent Syringe (as directed in Chapter 9).



9140320C — November 2000


Hemoglobin background out of specification


Dirty HGB Flow Cell Clean the HGB Flow Cell (as directed in Chapter 9).

Check HGB reference reading by pressing the [RAW DATA SUMMARY] key on the DIAGNOSTICS MENU screen.

Malfunctioning HGB Flow Cell Check HGB reference reading by pressing the [RAW DATA SUMMARY] key on the DIAGNOSTICS MENU screen.

Contaminated Reagent Empty the Diluent Reservoir.


Empty the WIC/HGB Lyse Reservoir.

Replace the WIC/HGB Lyse Reagent.


Contaminated/dirty WIC/HGB Diluent Syringe

Clean the WIC/HGB Diluent Syringe.




Multiple background counts out of specificationNOTE: The WBC background count is always the highest of the two (WIC or WOC)

measurements. If the WBC background exceeds the limits, check the WIC and WOC values and determine which method to troubleshoot. (To check WIC and WOC, the Data Log must be configured to display them according to the directions given in Chapter 5: Operating Instructions.)

Probable Cause Corrective Action

1. The Analyzer front covers are removed. 1. Verify that the ground wires are securely connected and replace the front covers. Repeat the background count.

2. Debris is present in the system or on the Aperture Plate.

2. From the second SPECIAL PROTOCOLS screen, press [AUTO CLEAN] to clean the system. When the cycle is complete, repeat the background count. Remove and clean the appropriate Aperture Plate (as directed in Chapter 9). Repeat the background count.

3. The reagents are cold.

NOTE: If reagents were frozen — discard.

3. Allow the reagents to warm to room temperature and then repeat the background count.

4. There is liquid in the Vacuum Accumulator.

4. From the second DIAGNOSTICS MENU screen, press the [DRAIN ACCUMULAT] key. When the cycle is complete, initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. Repeat the background count.

5. There are bubbles in the Diluent Syringe.

5. Clean the Diluent Syringe (as directed in Chapter 9).

6. The Shear Valve is dirty. 6. Clean the Shear Valve (as directed in Chapter 9). Repeat the background count.


9140320C — November 2000


Troubleshooting Incomplete AspirationIf the sample is not detected by the Blood Sensor, an aspiration error occurs. The message Sampling Error — Incomplete Aspiration appears on the screen. The following list contains some general guidelines for troubleshooting aspiration errors.

• Check to see if the problem occurs in both the Open and Closed Modes of operation. If the problem is confined to one mode only, the other may be eliminated as the cause of the problem.

• Determine whether the problem is a true incomplete aspiration. Run a sample and verify that blood is visible in the sample tubing above the appropriate probe or needle.

• Verify that blood is pulled through the Shear Valve. Blood should be visible in the lines (approximately one inch) on both sides of the Shear Valve before it rotates.

• Refer to the following tables for the appropriate corrective action.



Sampling Error – Incomplete Aspiration: Open Mode


Inadequate blood is aspirated. Check for sufficient sample in specimen tube.

Check for clotted sample.

Flush Open Sample Aspiration Probe.

Check “Y” fitting behind Status Panel for clogs. Flush if needed.

Clean the Shear Valve (as directed in Chapter 9).

Replace the Sample Aspiration Peristaltic Pump Tubing (as directed in Chapter 9).

The trailing edge of the sample is pulled completely through the Shear Valve before it rotates.

Check that the Sample Aspiration Peristaltic Pump tubing is inserted correctly in the Peristaltic Pump.


Adequate blood is aspirated. Specimen may be very viscous (for example, Myeloma or Polycythemia) or very “thin” (for example, severe anemia or dialysis). The aspiration error may continue with these types of samples.

Rerun sample and ensure that blood is visible in the Sample Tubing above the appropriate probe or needle.

Rerun sample and ensure that blood is visible on both sides of the Shear Valve.

Check Blood Sensors.



9140320C — November 2000


Sampling Error – Incomplete Aspiration: Closed Mode(Cap Piercer System)




Flush probe.



Clean the SL Aspiration needle (as directed in Chapter 9).


Sample is pulled completely through the Shear Valve before the sample cut is made.

Check that the Sample Aspiration Peristaltic Pump tubing is inserted correctly into the Sample Aspiration Peristaltic Pump.







TroubleshootingChapter 10

Sampling Error – Incomplete Aspiration: Closed Mode(Sample Loader System)




Flush probe.



Clean the SL Aspiration needle (as directed in Chapter 9).


Sample is pulled completely through the Shear Valve before the sample cut is made.

Check that the Sample Aspiration Peristaltic Pump tubing is inserted correctly into the Sample Aspiration Peristaltic Pump.







9140320C — November 2000


Troubleshooting Clog and Flow Error Messages for RBC/PLT and WICThe following list contains some general guidelines for troubleshooting RBC/PLT and WIC clog and flow errors.

• Determine which metering process exhibits the problem, WIC or RBC/PLT.

• Remove the front covers and observe the appropriate metering tube while a cycle is in progress. (Refer to the following figure.) Approximately 10–15 seconds after the start of the cycle, the metering tube should be flushed of all liquid. Observe that the liquid is completely flushed from the tube.

After flushing, a liquid column with a meniscus at the leading edge should travel down the tube. Observe that the meniscus is visible at the leading edge. A complete flush of the tube and a uniform meniscus are important to correct metering.


• Print the RUN screen to record the metering times. The upper metering time and the count time are both important in troubleshooting clogs or flow errors.

• The metering times are automatically stored in the Data Log. Configure the Data Log to display and print the appropriate upper metering time and count time. (If necessary, refer to the directions given in Chapter 5: Operating Instructions.)

Meniscus

CountTime





• Additional information regarding the count times from the previously run cycle can be found on the RAW DATA SUMMARY screen.

NOTE: The information is only available immediately after the cycle is completed. Therefore, the screen should be printed immediately after the clog or flow error occurs.

From the first DIAGNOSTICS MENU screen, press [RAW DATA SUMMARY] followed by [PRINT] to obtain a printout.

• Information pertaining to the vacuum level in the Analyzer can be found on the VOLTAGE READINGS screen.

From the third DIAGNOSTICS MENU screen, press [VOLTAGE READINGS] followed by [PRINT] to obtain a printout.

RBC/PLT clog or flow errors


RBC/PLT Aperture Plate Press [CLEAR APERTURES] (RUN screen menu function).

Clean the RBC/PLT Aperture Plate (as directed in Chapter 9).

Check aperture microscopically using low power objective for scratches or cracks.

Check volumetric metering tube for appropriate meniscus.

Check to make sure the Aperture Plate is properly installed.

Check for appropriate installation of correct Reagents.

Check sample for clots.

RBC/PLT Transducer Observe bubble mix during run cycle.

Verify Transducer is emptying correctly.



9140320C — November 2000


WIC clog or flow errors


WIC Aperture Plate Press [CLEAR APERTURES] (RUN screen menu function).

Clean the WIC Aperture Plate (as directed in Chapter 9).

Check aperture microscopically using low power objective for scratches or cracks.

Check volumetric metering tube for appropriate meniscus.

Check to make sure the Aperture Plate is properly installed.

Check for appropriate installation of correct reagents.

Check sample for clots.

WIC Transducer Observe bubble mix during run cycle.

Verify WIC Transducer is draining completely.




Troubleshooting WOC Flow ErrorsThe following list contains some general guidelines for troubleshooting WOC flow errors.

• The message: WOC FLOW ERROR indicates a problem with the kinetic rate of the WOC measurement. The kinetic information is shown on the COUNT RATE SUMMARY screen, which is available only immediately after the cycle is complete. Therefore, the COUNT RATE SUMMARY screen should be printed immediately after the WOC flow error occurs.

• From the first DIAGNOSTICS MENU screen, press [CNT RATE SUMMARY].

• Press the [WOC CNT RATE] key to display the data for the kinetic rate followed by the [PRINT] key to obtain a printout.

• Press the [WOC CNT GRAPH] key to display the graph of the kinetic data followed by the [PRINT] key to obtain a printout.

• Configure the RUN screen to display the Size/Complexity scatterplot and the NWBC-LYM-MONO histogram. This information can help to determine if the flow is erratic or just momentarily interrupted. (If necessary, refer to the instructions given in Chapter 5: Operating Instructions.)


9140320C — November 2000


WOC flow errors


Inappropriate kinetic rate of the WOC measurement

Obtain kinetic rate information from count rate summary in the DIAGNOSTICS MENU.

NOTE: Kinetic information is only available immediately after the cycle is complete. Therefore the screen should be accessed after the WOC flow error occurs.

Replace the WOC Transfer Peristaltic Pump Tubing (as directed in Chapter 9).

Check the WOC Metering Syringe for smooth movement during the cycle.

Check the WOC Metering Syringe for bubbles.

Check the WOC Sheath Syringe for bubbles.

Clean the WOC Sheath and WOC Metering Syringes (as directed in Chapter 9).




Troubleshooting Imprecise or Inaccurate DataThe following list contains some general guidelines for troubleshooting imprecision.

• Obtain a normal blood sample. Select an empty QC file and run a minimum of 10 Open Mode runs into the file. Obtain a printout.

• Run a minimum of 10 Closed Mode runs into the same file. Use the [REJECT SPECIMEN] key to reject the Open Mode runs and obtain a printout. This information can be used to determine if the problem is mode or measurement related.

• Obtain a printout of the RAW DATA SUMMARY screen immediately after the problem sample is run. From the first DIAGNOSTICS MENU screen, press the [RAW DATA SUMMARY] key followed by the [PRINT] key to obtain a printout.

Obtain a printout of the X-B RBC or X-B WBC data. From the MAIN MENU screen, press the [QUALITY CONTROL] key followed by the [X-B FILE] key. If necessary, press the [X-B RBC DATA] or [X-B WBC DATA] key to display the appropriate X-B data and press the [PRINT] key to obtain a printout.


9140320C — November 2000


RBC/MCV/PLT data are imprecise or inaccurate

Cause of Inaccurate Result Corrective Action

Worn Sample Aspiration Peristaltic Pump Tubing


Shear Valve is not operating smoothly Clean the Shear Valve (as directed in Chapter 9).

Bubbles or malfunction in RBC/PLT Diluent Syringe


Replace the RBC/PLT Diluent Syringe (as directed in Chapter 9).

Dirty specimen path Perform the Auto-Clean Procedure (as directed in Chapter 9).


Inadequate mixing and/or draining in the RBC/PLT mixing chamber

Trace air inlet lines for obstructions or crimps.

Clean the RBC/PLT Aperture Plate (as directed in Chapter 9).

Fragmented RBCs falsely elevate the platelet count

Review a stained blood smear for the presence of fragmented RBCs.

Perform the platelet count by an alternate method.

Extremely microcytic RBCs may be counted as platelets

Review a stained blood smear for the presence of extremely microcytic RBCs.

Perform the platelet count by an alternate method.

The RBCs are hyperosmolar in comparison to the diluent; therefore, water is drawn into the RBCs causing the RBCs to swell and falsely increase the MCV

Rerun the specimen.

Use a microhematocrit procedure to determine the HCT value and calculate the MCV and MCHC.

Red blood cell aggregates falsely decrease the RBC count

NOTE: The MCV should be accurate because of Red Cell Editing Ratio (RER).

Warm the specimen and rerun.

NOTE: The MCV should not change significantly after rerun.



Platelet clumps falsely decrease the platelet count

Check the specimen for clots and/or the stained blood smear for platelet clumps.

Recollect the specimen using proper technique.

Rerun the specimen.

Electrical interference If Analyzer covers have been removed, replace them and reconnect the ground wires.





Replace the reagent with a new box of reagent.



The RBC/PLT Diluent Syringe contains salt crystals





WOC data are imprecise or inaccurate




Worn WOC Transfer Peristaltic Pump Tubing

Replace the WOC Transfer Peristaltic Pump Tubing (as directed in Chapter 9).


Bubbles or malfunction in WOC Sheath Syringe or WOC Metering Syringe

Clean the appropriate WOC Syringe (as directed in Chapter 9).

Replace the appropriate WOC Syringe (as directed in Chapter 9).



Dirty WOC Flow Cell Perform the Auto-Clean Procedure.

Clean the WOC Sheath Syringe.

Bubbles in WOC Flow Cell Empty and refill the WOC Flow Cell using SPECIAL PROTOCOLS menu features.

Incorrect, contaminated, or expired reagents

Verify that the reagent lines are inserted into the correct reagent containers.

Verify that the reagents have not expired.

Replace Sheath Reagent if necessary.

Inadequate mixing in the WOC Mixing Chamber

Trace pressure and air inlet lines for obstructions or crimps.

Check the pressure on Pressure Pump #3 (listed on the VOLTAGE READINGS SUMMARY screen under VPM press 3 psi).

Voltage drift Check Channels 1, 2, 3, and 4 offset of the MAM (Main Amp Module). (On the VOLTAGE READING SUMMARY screen in the DIAGNOSTICS screen under MAM: Ch 1 offset:, etc.)

If any MAM Offset reading is greater than 2.00, perform Auto-Clean. If the MAM Offset reading remains greater than 2.00, Contact Abbott Diagnostics Customer Service.



Certain red blood cells (for example, hypochromic RBC or RBC containing large amounts of HGB S, C, or F) may not be completely lysed by the Sheath Reagent and cause interference with the WOC count.

Rerun specimen under [RESISTANT RBC].

Laser light is not on Check MAM 1, 2, 3, and 4 Offset readings on the VOLTAGE READING SUMMARY screen in the DIAGNOSTICS MENU.

If the readings are 0.0, the laser or laser power supply has malfunctioned.

WIC data are imprecise or inaccurate





Malfunction in WIC/HGB Diluent Syringe or WIC/HGB Lyse Syringe

Clean the appropriate Syringe (as directed in Chapter 9).

Replace the appropriate Syringe (as directed in Troubleshooting Procedures within this chapter).

Bubbles in WIC/HGB Diluent Syringe or WIC/HGB Lyse Syringe







Replace reagent as required.

Inadequate mixing in the von Behrens WIC/HGB Transducer





Hemoglobin data are imprecise or inaccurateCause of Inaccurate Result Corrective Action



Malfunctioning WIC/HGB Diluent Syringe or WIC/HGB Lyse Syringe


Replace the appropriate Syringe (as directed in Chapter 9).

Bubbles in WIC/HGB Diluent Syringe or WIC/HGB Lyse Syringe







Replace reagent as required.

Inadequate mixing in the von Behrens WIC/HGB Transducer


A dirty Hemoglobin Flow Cell Perform the Auto-Clean Cycle (as directed in Chapter 9).

Run a background count and a normal blood specimen; check the Hemoglobin Reference in the RAW DATA SUMMARY screen in the DIAGNOSTICS MENU. Verify that the Hemoglobin Reference values are within 2050 ± 200.

Clean the Hemoglobin Flow Cell if the Reference Value is < 1850. If the Hemoglobin Reference Value is > 2250, call Abbott Diagnostics Customer Service.

Elevated triglycerides may cause turbidity in the HGB dilution

A high bilirubin absorbs enough light at 540 nm to increase the HGB

OR

Free plasma HGB from in vivo hemolysis

Centrifuge the specimen. Remove a specific volume of plasma and replace with an equal volume of diluent. Resuspend the red blood cells. Rerun.

OR

Determine the plasma HGB and calculate the corrected HGB concentration: Corrected HGB = Whole Blood HGB - [Plasma HGB x (1-HCT)] and Recalculate the MCH and MCHC.



>>>> appear in place of the result for WBC, RBC, HGB or PLTNOTE: When the WOC or WIC result is replaced with >>>>, the HGB result is suppressed. <<<< displays to indicate that the HGB is affected by the elevated WOC or WIC value.


Data exceed linear range for that parameter

For RBC or HGB: Dilute a 0.5-mL aliquot of well-mixed whole blood with 0.5 mL of diluent (1:2 ratio). Close the container and invert it 10 to 15 times to mix. Run the specimen as usual. Multiply the RBC or HGB result by 2 to obtain a reportable value.

For WBC or PLT: Dilute a 0.5-mL aliquot of well-mixed whole blood with 0.5 mL of diluent (1:2 ratio) or 1 mL (1:3), 1.5 mL (1:4), or 4.5 mL (1:10) of diluent as required. Close the container and invert it 10 to 15 times to mix. Run the specimen as usual. Multiply each WBC or PLT result by 2, 3, 4, or 10 (per ratio of diluent to blood used above) to obtain a reportable value.




Observable Fault Conditions

Analyzer or Data Station will not power ON.


1. Power source is defective. 1. Verify that the power switch is turned OFF and connect the system to a different power source.

2. Power cord is not securely connected to the Analyzer or is not connected to the power outlet.

2. Ensure that the power cord is securely connected to the Analyzer or Data Station and verify that it is connected to the power outlet.

3. Analyzer fuse is blown or incorrect. 3. The Analyzer fuse is located above the power cord connector on the rear panel. Check the fuse as directed in Troubleshooting Procedures within this chapter.

WARNING: Electrical Shock Hazard. Always turn the Analyzer power switch OFF and disconnect the power cord from the receptacle before checking or replacing any fuse.

4. Defective power switch or other system malfunction.


No screen display.


1. Monitor power switch is turned OFF. 1. Turn the monitor power switch ON.

2. Data Station power switch is turned OFF.

2. Turn the power switch ON.

3. Brightness control is turned down. 3. Adjust the brightness control on the Data Station until the image is visible.

4. Defective Data Station or other component.




The MAIN MENU screen is not displayed after initialization.


1. There is a floppy disk in the Data Station disk drive.

1. If a disk is present, remove it and initialize the Data Station by turning the power switch OFF and ON.

2. A file is missing or is incorrect on the Data Station’s hard drive.


3. There is a hardware or software malfunction.


The word Fault on the Analyzer Status Indicator Panel is illuminated in red.


1. The Analyzer has detected a fault situation and has inhibited operation.

1. From the first DIAGNOSTICS MENU screen, press [FAULT REPORT]. Print a copy of the report and perform the indicated corrective action. When the action is completed, initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen.

2. If the fault report does not indicate a message or action, document the situation and initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen.




Instrument will not stop cycling.


1. The touch plate is stuck or being held down in some way.

1. Check the touch plate and remove any obstructions. Verify that it is not sticking by pressing it several times.

2. Circuitry malfunction. 2. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

The Data Station keyboard and the soft keys are not operational.


1. The computer is performing a function that inhibits the keys.

1. No action required. Refer to the screen for the current Status Box message.

2. There is an incomplete operator entry. 2. Complete the operator entry or press the Esc key on the keyboard.

3. A data transmission to the printer or laboratory computer is in progress.


4. Keyboard entry is not possible on the displayed screen.


5. Data Station computer, keyboard and/or circuitry malfunction.

5. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. If necessary, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).



The Sample Loader does not power ON.



The Sample Loader beeps and the Start key is not illuminated.


1. The cable that connects the Sample Loader to the Analyzer is loose or disconnected.

1. Check that each end of the cable is securely connected. If necessary, remove the cable and reconnect it. Press the INT key on the Sample Loader operation keyboard to initialize the Sample Loader.


Shear Valve problems.

Observable Condition: Corrective Action

The Shear Valve is leaking. Clean the Shear Valve (as directed in Chapter 9).

Check the Shear Valve tubing for crimps.

Check the Shear Valve sections for damage.

The Shear Valve does not rotate smoothly. Clean the Shear Valve (as directed in Chapter 9).

Check Shear Valve sections for damage.

NOTE: After performing any maintenance or troubleshooting procedures, run at least 5 background counts and control material and ensure that the controls are in range.


9140320C — November 2000


List of Messages and Fault ConditionsOverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-68

Status Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-69Auto-Sampler Busy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-69Auto-Sampler cannot be started if the safety cover is off. . . . . . . . . . . . . . . . . . . . . . . . . .10-69Auto-Sampler Emergency stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-69Auto-Sampler Initializing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-69Auto-Sampler Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-69Auto-Sampler Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-70Auto-Sampler Ready . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-70Bar Code flag not allowed to change unless Work List is purged . . . . . . . . . . . . . . . . . . .10-70Change Sampler in Ready State Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-70Change Sampler when Auto-Sampler is not busy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-70Change Specimen Type when Auto-Sampler is not busy . . . . . . . . . . . . . . . . . . . . . . . . . .10-71Clearing Apertures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-71Clearing Fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-71Duplicate 4-digit Bar Code ID on the new line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-71Duplicate Specimen ID on the new line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-71Entering Standby. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-72Entries making upper limit = lower limit were rejected . . . . . . . . . . . . . . . . . . . . . . . . . . .10-72Extended Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-72Initialized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-72Limits were changed to correct out-of-range values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-73Limits were exchanged to make upper > lower. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-73Maintenance Due: name of component(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-73No entry found . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-73Ready . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-74Samples Completed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-74Selecting Open/Closed Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-74Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-74Unpinching Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-75Westgard Warning — See Levey Jennings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-75



General Fault Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-76Auto-Sampler alarm, condition <x,x>; see DIAG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-76Auto-Sampler command negatively acknowledged . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-76Auto-Sampler consecutive data faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-77Auto-Sampler/Data fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-77Bad checksum in nonvolatile RAM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-78Bad monitor command . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-78Blood in Auto-Sampler Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-78Blood in Shear Valve Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-79Data acquisition overlap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-79Detergent empty: See Diluent, Lyse, Sheath, or Detergent empty . . . . . . . . . . . . . . . . . . 10-80Diluent empty: See Diluent, Lyse, Sheath, or Detergent empty . . . . . . . . . . . . . . . . . . . . 10-80Diluent, Lyse, Sheath, or Detergent empty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-80External waste full. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-81Flow sequence time out <x,x>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-81Initalization Failed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-82List mode data phase error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-82Lyse empty: See Diluent, Lyse, Sheath, or Detergent empty . . . . . . . . . . . . . . . . . . . . . . . 10-80Message acknowledgment time out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-82Message reception time out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-83Mixing Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-83Not Ready: See Diag or Not Ready: See Special. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-84Printer (Graphics or Ticket) unavailable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-84RBC diluent syringe overpressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-85RBC Metering fault — clog or flow error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-85Sampling Error — Incomplete Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-86Shear Valve position fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-86Sheath empty: See Diluent, Lyse, Sheath, or Detergent empty . . . . . . . . . . . . . . . . . . . . . 10-80Uninitalized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-87Vacuum accumulator wet (1 or 2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-87WIC Metering fault — clog or flow error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-88WOC Metering fault — flow error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-88


9140320D — June 2003


Messages and Fault Conditions

OverviewInstrument messages may be displayed in the RUN screen Status Box or on the Bulletin Line. Parameter Flagging messages are discussed in Chapter 3: Principles of Operation, Subsection: Operational Messages and Data Flagging.

Instrument messages fall into two categories:

1. Status Conditions inform the operator of the instrument’s status or prompt the operator to take action relative to the last operator entry.

2. General Fault Conditions indicate fault or error detection.



Status Conditions

Auto-Sampler BusyThis message is displayed in the Bulletin Line.

Explanation/Action

An action was requested during Sample Loader operation and the Sample Loader cannot perform it.

Press the Sample Loader PAUSE key before requesting the desired action.

Auto-Sampler cannot be started if the safety cover is offThis message is displayed in the Bulletin Line.

Explanation/Action

The Sample Loader START key was pressed and the safety interlock switch did not sense that the Safety Cover was in place.

Replace the Safety Cover and then press the START key.

Auto-Sampler Emergency stopThis message is displayed in the Bulletin Line.

Explanation/Action

The Sample Loader E–STOP key was pressed during operation and the Sample Loader is stopped.

Press the INT key (if the light on the key is blinking) to initialize the Sample Loader. If the INT key light is not blinking, turn the Sample Loader power switch OFF and ON to initialize. Press the [CLEAR FAULT] key on the Data Station to resume processing.

Auto-Sampler InitializingThis message is displayed in the Bulletin Line.

Explanation/Action

The Sample Loader hardware initialization cycle is in progress.

Wait for the cycle to be completed.

Auto-Sampler OffThis message is displayed in the Bulletin Line.

Explanation/Action

Power to the Sample Loader is turned OFF.

Turn ON the Power Switch and wait for the initialization cycle to be completed.


9140320C — November 2000


Auto-Sampler PauseThis message is displayed in the Bulletin Line.

Explanation/Action

The Sample Loader PAUSE key was pressed during operation and therefore, operation is suspended.

Press the Sample Loader START key to initiate processing.

Auto-Sampler ReadyThis message is displayed in the Bulletin Line.

Explanation/Action

The Sample Loader initialization cycle is complete and samples may be processed.

Press the Sample Loader START key to initiate processing.

Bar Code flag not allowed to change unless Work List is purgedThis message is displayed in the Bulletin Line.

Explanation/Action

The [BAR CODE ON] or [BAR CODE OFF] key was pressed and there is an existing Work List.

Delete all samples from the Work List before turning the bar code ON or OFF.

Change Sampler in Ready State OnlyThis message is displayed in the Bulletin Line.

Explanation/Action

The [CHANGE SAMPLER] key was pressed while the Analyzer was busy.

The [CHANGE SAMPLER] key can only be pressed when the Analyzer is in the READY state.

Change Sampler when Auto-Sampler is not busyThis message is displayed in the Bulletin Line.

Explanation/Action

The [CHANGE SAMPLER] key was pressed while the Sample Loader was busy.

Press the Sample Loader PAUSE key before pressing [CHANGE SAMPLER].



Change Specimen Type when Auto-Sampler is not busyThis message is displayed in the Bulletin Line.

Explanation/Action

The [SPECIMEN TYPE] key was pressed while the Sample Loader was busy.

Press the Sample Loader PAUSE key before pressing [SPECIMEN TYPE].

Clearing AperturesThis message is displayed in the Status Box

Explanation/Action

The [CLEAR APERTURES] key was pressed or the instrument automatically performed the Clear Apertures function in response to a clog or flow problem.

Wait until the READY message is displayed in the Status Box and repeat the sample.

Clearing FaultThis message is displayed in the Status Box

Explanation/Action

The [CLEAR FAULT] key was pressed after an operator correctable fault was detected.

Resume operation when READY is displayed in the Status Box and the word READY on the Status Indicator Panel is illuminated in green.

Duplicate 4-digit Bar Code ID on the new lineThis message is displayed in the Bulletin Line.

Explanation/Action

The Work List already contains the 4-digit bar code ID number that has been entered.

It is not possible to enter the same 4-digit bar code ID number twice in the Work List. If appropriate, delete the previous entry and reenter the number.

Duplicate Specimen ID on the new lineThis message is displayed in the Bulletin Line.

Explanation/Action

The Work List already contains the specimen ID number that has been entered.

It is not possible to enter the same specimen ID number twice in the Work List. If appropriate, delete the previous entry and reenter the number.


9140320C — November 2000


Entering StandbyThis message is displayed in the Status Box

Explanation/Action

The instrument has been idle for four hours and therefore is automatically performing a cleaning cycle before entering the STANDBY state. (The [DAILY SHUTDOWN] key also initiates this message.)

When the cycle is complete, press [PRIME] or [RUN] to initiate the priming cycle and return the instrument to the READY state. Resume operation when the cycle is complete.

Entries making upper limit = lower limit were rejectedThis message is displayed in the Bulletin Line.

Explanation/Action

A mathematically incorrect limit was manually entered (using [RANGE ENTRY]) during setup of a QC file. The currently entered numbers are not accepted and the previously entered numbers for the parameter(s) remain.

Check to make sure the entered values are correct.

Extended CountThis message is displayed in the Status Box

Explanation/Action

A low value has been detected for the WBC and/or PLT count. The Analyzer is automatically extending the cycle to count more cells. The Extended Count message is displayed while running a specimen in the Auxiliary Mode.

Resume processing when the READY message is displayed in the Status Box.

InitializedThis message is displayed in the Status Box

Explanation/Action

The Analyzer hardware initialization is complete.

Press [PRIME] or [RUN] to initiate the priming cycle and return the instrument to the READY state. Resume operation when the cycle is complete.



Limits were changed to correct out-of-range valuesThis message is displayed in the Bulletin Line.

Explanation/Action

A mathematically incorrect limit was manually entered (using [MEANS/LIMITS]) during setup of a QC file. The numbers entered generated a range containing a number greater than the largest number allowed or less than zero. Therefore, the limits were automatically changed.

Check to make sure the entered values are correct. If appropriate, recalculate the mean and limits and enter correct values.

Limits were exchanged to make upper > lowerThis message is displayed in the Bulletin Line.

Explanation/Action

A mathematically incorrect limit was manually entered (using [RANGE ENTRY]) during setup of a QC file. The entered numbers caused the upper limit to be less than the lower limit. Therefore, the numbers were automatically exchanged.

Check to make sure the entered values are correct. If appropriate, enter correct values.

Maintenance Due: name of components(s)(This message is displayed in the Bulletin Line on the MAINTENANCE LOG screen only.)

Explanation/Action

The maintenance interval programmed in the Maintenance Log for the listed component(s) is exceeded. Therefore, the maintenance needs to be done.

Perform the maintenance and indicate in the Maintenance Log that it is complete.

No entry foundThis message is displayed in the Bulletin Line.

Explanation/Action

The number (Sequence Number or specimen ID number) entered on the DATA LOG SEARCH screen is not present in the Data Log.

Check that the entry was correct. If appropriate, enter the correct number.


9140320C — November 2000


ReadyThis message is displayed in the Status Box

Explanation/Action

The Analyzer is ready to process samples.

Samples CompletedThis message is displayed in the Bulletin Line.

Explanation/Action

The Sample Loader has completed processing samples in the End Rack and has stopped automatically.

Selecting Open/Closed ModeThis message is displayed in the Status Box

Explanation/Action

The [CHANGE SAMPLER] key was pressed and the Analyzer is changing to the selected mode of operation.


StandbyThis message is displayed in the Status Box

Explanation/Action

The instrument has entered the STANDBY state.

Press [PRIME] or [RUN] to initiate the priming cycle and return the instrument to the READY state. Resume operation when the cycle is complete.



Unpinching ValvesThis message is displayed in the Status Box

Explanation/Action

The Analyzer was idle for a predetermined time period and therefore the valves are being exercised to be sure that tubing is not pinched shut.


Westgard Warning — See Levey Jennings(This message is displayed in the Bulletin Line on the VIEW QC LOG screen only.)

Explanation/Action

The Westgard Rules were selected during set up of the QC file and the data in the file has violated one or more of the selected rules.

Review the data in the QC file and take appropriate action.




General Fault ConditionsInformation for each message is listed in order from the most likely cause of the message to the least likely cause of the message. Therefore, always troubleshoot a problem in this order. If a problem cannot be resolved by the corrective action indicated in this table, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

Auto-Sampler alarm, condition <x,x>; see DIAGThis message is displayed in the Bulletin Line.NOTE: The characters in the brackets identify the condition.


1. The Sample Loader detected a hardware fault and ceased operation.

1. From the first DIAGNOSTICS MENU screen, press [FAULT REPORT] followed by [PRINT] to obtain a printout describing the problem. Initialize the Sample Loader by turning the power OFF and then ON. Samples may be processed if the fault does not recur.

CAUTION: If the Sample Loader needle does not retract properly from the specimen vacutainer, discard this specimen, collect a new one, and repeat the test to ensure accurate patient results.

Auto-Sampler command negatively acknowledgedThis message is displayed in the Bulletin Line.


1. The Sample Loader did not respond to an Analyzer command.

1. Ensure that the Sample Loader power cord is connected to the Sample Loader and that the cord is connected to the power outlet. Initialize the Sample Loader by pressing the INT key on the Sample Loader operation keyboard.

Check the connections of the cable that connects the Sample Loader to the Analyzer. If necessary, secure the connections. Initialize the Sample Loader by pressing the INT key on the Sample Loader operation keyboard.




Auto-Sampler consecutive data faultsThis message is displayed in the Bulletin Line.


1. During sample processing, four consecutive incomplete aspiration or metering faults were detected and the Sample Loader halted.

1. Correct the situation on the Analyzer as follows:

•Check the appropriate tubing for a plug or pinch.

•Press [CLEAR APERTURES] to clear the apertures.

•Clean the Sample Loader needle. (If necessary, refer to the instructions given in Chapter 9.)

2. Press the [CLEAR FAULTS] key displayed on the RUN screen. The Sample Loader automatically resumes processing.

Auto-Sampler/Data faultThis message is displayed in the Bulletin Line.


1. Four sequential clog or flow messages occurred during Sample Loader operation.

1. Follow the instructions given in Symptom Identification and Resolution within this chapter for troubleshooting clog, flow, or incomplete aspiration messages.

2. Four sequential incomplete aspiration messages occurred during Sample Loader operation.




Bad checksum in nonvolatile RAMThis message is displayed in the Bulletin Line.


1. When the system was powered ON, the Analyzer did not transmit the correct message to the Data Station.

1. Turn the power OFF to the Data Station and Analyzer. Turn ON the power to the Analyzer, then turn ON the power to the Data Station. If the fault recurs, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

Bad monitor commandThis message is displayed in the Bulletin Line.


1. The Analyzer did not initialize properly when the system was turned ON.

1. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. If the fault recurs, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

Blood in Auto-Sampler LineThis message is displayed in the Bulletin Line.


1. At the end of the count cycle, the instrument detects blood in the sample line that runs from the top of the Sample Loader tower to the Shear Valve. When this occurs, the system automatically cleans the needle and the sample line. If blood is still present in the line, the Analyzer halts.

1. Check the sample line to see if it contains blood. If it does, clean or replace the Sample Loader needle or sample line.

2. Check for a crimp in the sample aspiration tubing between the Sample Loader and the Analyzer.

NOTE: If necessary, samples can be processed in the Open Mode, as it is not affected by this problem. To run samples in the Open Mode, first initialize the system as directed in the initialization procedure provided in Troubleshooting Procedures within this chapter. When initialization is complete, the Open Mode is automatically selected and samples can then be processed.



Blood in Shear Valve LineThis message is displayed in the Bulletin Line.


1. At the end of the count cycle, the instrument detects blood at one of the sensors near the Shear Valve. When this occurs, the system automatically cleans the needle and the Sample Aspiration Line. If blood is still present in the line, the Analyzer halts.

1. Clean the Shear Valve (as directed in Chapter 9).

Data acquisition overlapThis message is displayed in the Bulletin Line.


1. The timing of communication between the Analyzer and the Data Station is incorrect. Current specimen data is received while previous specimen data is being processed.

1. Document what was happening when the message was displayed and report the problem to Abbott Diagnostics Customer Service. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. Resume processing if the fault does not recur.

NOTE: The error may occur when several tasks are requested in rapid sequence. For example, print data log, transmit result, sample processing, print ticket, print report, etc.




Diluent, Lyse, Sheath, or Detergent emptyThis message is displayed in the Status Box and Bulletin Line.


1. Container is empty. 1. Install a new container of reagent and then press [CLEAR FAULTS]. Run 5 or more background counts and review results.NOTE:Do not pour any remaining reagent into the new container.

2. Reagent inlet tubing is crimped or obstructed.

2. Inspect the inlet tubing to ensure it is not crimped and/or remove any obstruction. Run 5 or more background counts and review results.

3. Reagent line is not on the bottom of the container.

3. Ensure that the line is properly inserted in the container and the sinker is on the bottom of the container. Run 5 or more background counts and review results.

4. An incorrect reagent or a nonconductive liquid is connected to the inlet tube.

4. Check the label on the reagent container to be sure the correct reagent is installed. Trace the line to the inlet connector and ensure that it is connected to the correct one. Check the connection to be sure it is secure and then press [CLEAR FAULTS]. Run 5 or more background counts and review results.




External waste fullThis message is displayed in the Status Box.


1. Waste container full. 1. Empty the waste container and/or replace it. Press [CLEAR FAULTS] to resume operation.

2. Waste sensor connector is loose or disconnected.

2. Reconnect the waste sensor connector and then press [CLEAR FAULTS].

3. Shorted wire(s) or electrode(s) on the waste cap.

3. Inspect wires and electrodes and call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).


Flow sequence time out <x,x>This message is displayed in the Bulletin Line.

NOTE: Characters in the brackets identify the problem flow sequence number and flow sequence name.


1. An internal Analyzer flow sequence was not completed in the allotted time.

1. Record the characters in the brackets. Turn the power OFF to the Data Station and Analyzer. Turn ON the power to the Analyzer, then turn ON the power to the Data Station. If the fault recurs, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).




Initialization Failed This message is displayed at the bottom of the screen. (MAIN MENU is not displayed.)


1. The Data Station was unable to initialize. The CELL-DYN software does not display the MAIN MENU screen.

1. Initialize the Analyzer by following the instructions in Power OFF Procedure and Power ON Procedure in Troubleshooting Procedures within this chapter. If the Data Station does not initialize, press the Print Screen key on the computer keyboard to document any screen messages and call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

List mode data phase errorThis message is displayed in the Bulletin Line.


1. The order of the data received by the Data Station during a measurement was incorrect.


Message acknowledgment time outThis message is displayed in the Bulletin Line.


1. Communication between the Analyzer and the Data Station did not occur when expected.




Message reception time outThis message is displayed in the Bulletin Line.


1. Communication between the Analyzer and the Data Station did not occur when expected.

1. Make sure the cable between the analyzer and Data Station is securely connected.


Mixing ErrorThis message is displayed in the Bulletin Line.

MIX ERROR is displayed on the RUN screen to the right of the MCH result.

“MIXING ERR” is printed on the graphics report. A mixing error is always accompa-nied by a sampling error; therefore, “SAMPLING ERR” is printed on all reports.


1. The Sample Loader mixing head(s) detected resistance when attempting to mix a sample. Therefore, no sample was aspirated and results appear to be a background count.

1. Check to be sure that the sample tube can spin freely in the Sample Loader rack. If necessary, remove excess labels or obstructions. Repeat the sample.

2. One or both mixer motors is binding and generating resistance.





Not Ready: See Diag or Not Ready: See SpecialThis message is displayed in the Status Box.

The word FAULT on the Analyzer Status Indicator Panel is illuminated in red.


1. A situation that prevents the Ready state has been detected. See the DIAGNOSTICS MENU screen or the SPECIAL PROTOCOLS MENU screen, whichever is indicated, for more information.

1. From the first DIAGNOSTICS MENU screen, press [FAULT REPORT] followed by [PRINT] to obtain a printout describing the problem. Refer to the appropriate table for corrective action.

2. A diagnostic test was run using one of the DIAGNOSTICS MENU screen keys.

2. The instrument must be initialized when the diagnostic test in progress is complete. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen.

3. A Special Protocols procedure is in progress.

3. Check the SPECIAL PROTOCOLS MENU screen and perform the action necessary to complete the procedure.

4. System malfunction. 4. Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

Printer (Graphics or Ticket) unavailableThis message is displayed in the Bulletin Line.


1. The print buffer (the memory area where the material is stored while awaiting printing) is full.

1. Press the [STOP PRINTING] key on the CUSTOMIZE PRINTED REPORT screen for the appropriate printer.

2. The printer is turned OFF. 2. Turn the printer power switch ON.

3. The printer is not on-line. 3. Check that the printer “on-line” indicator is illuminated. If necessary, refer to the printer manual for assistance.

4. The printer is disconnected or the connection is loose.

4. Check the printer cable connection on the back of the Data Station and on the back of the printer. If necessary, secure the connections. Press [PRINT REPORT]. If the message is still displayed, turn the printer power switch OFF and ON to reset the printer.



RBC diluent syringe overpressureThis message is displayed in the Status Box.


1. The Shear Valve did not rotate completely or in the time allotted.


2. The center section of the Shear Valve is installed backwards.

2. Verify that the center section of the Shear Valve is installed correctly.

3. Tubing connected to RBC/PLT Diluent Syringe is twisted or crimped.

3. Check tubing connected to the RBC/PLT Diluent syringe.

4. Excessive pressure was detected during the up-stroke of the RBC Diluent Syringe.

4. a. Remove the RBC diluent syringe from its bracket (make sure syringe stays connected to the luer fitting) to release pressure.

b. Cycle power to Initialize.

c. DO NOT press RUN Key.

d. Go directly to Special Protocols and select “Clean Shear Valve,” then “Reinstall Shear Valve.”

e. Run Background.

5. If the problem persists, Call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).

RBC Metering fault — clog or flow errorThis message is displayed in the Bulletin Line.RBC CLOG or RBC FLOW ERROR is displayed on the RUN screen to the right of the RDW result. “RBC CLOG” or “RBC FLOW” is printed on the graphics report.Results for RBC, PLT and related parameters are suppressed.


1. The timing for the RBC/PLTMetering was outside acceptable limits.

1. Repeat the sample. If the problem was caused by debris in the aperture, the automatic clearing cycle will have corrected it.

2. Clean the RBC/PLT aperture as directed Chapter 9.

3. Ensure that the detergent reagent is properly connected to the inlet connector.

NOTE: The Analyzer automatically clears the RBC/PLT aperture after a metering fault is detected. CLEARING APERTURES is displayed in the Status Box.




Sampling Error — Incomplete AspirationThis message is displayed in the Bulletin Line.SAMPLING ERROR is displayed on the RUN screen to the right of the MCHC result.

“SAMPLING ERR” is printed on all reports.


1. The blood sensors did not detect a sufficient amount of sample on either side of the Shear Valve after aspiration.

1. Check the sample tube to be sure it contains a sufficient quantity of blood.

2. Clean the Open Sample Aspiration Probe or the Closed Mode needle (CS or SL) as directed in Chapter 9 to remove any obstructions.

3. Change the Sample Aspiration Peristaltic Pump Tubing as directed in Chapter 9.

4. Clean the Shear Valve as directed in Chapter 9.


NOTE: Samples with RBC results below 1.00 x 106/µL may generate this fault because the sample is translucent. The fault may also occur when running diluted samples. Observe the Shear Valve. If there is a minimum of one inch of blood on both sides of the valve when it rotates, results should be correct.

Shear Valve position faultThis message is displayed in the Bulletin Line.


1. The Shear Valve did not rotate properly or in the allotted time.




UninitializedThis message is displayed in the Status Box.


1. Data Station has power but the Analyzer is not responding.

1. Ensure that the Analyzer power cord is connected to the Analyzer and that the cord is connected to the power outlet. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen.

2. Communication malfunction between the Analyzer and Data Station.

2. Check the cable that connects the Analyzer to the Data Station. If necessary, secure the connections. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen.

Vacuum accumulator wet (1 or 2)This message is displayed in the Bulletin Line.


1. The internal vacuum accumulator has filled with liquid beyond allowable limits.

1. From the second DIAGNOSTICS MENU screen, press the [DRAIN ACCUMULAT] key. When the cycle is complete, initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. If the fault recurs, repeat this action. If the fault persists, call Abbott Diagnostics Customer Service for assistance (at 1-877-4ABBOTT in the US).


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WIC Metering fault — clog or flow errorThis message is displayed in the Bulletin Line.WIC CLOG or WIC FLOW ERROR is displayed on the RUN screen to the right of the LYM results. “WIC CLOG” or “WIC FLOW” is printed on the graphics report.Results for WBC and Differential are suppressed.


1. The timing for the WIC metering was outside acceptable limits.

1. Repeat the sample. If the problem was caused by debris in the aperture, the automatic clearing cycle will have corrected it.

2. Clean the WIC Aperture Plate as directed in Chapter 9.

3. Ensure that the detergent reagent is properly connected to the inlet connector.

4. Run several background counts.

NOTE: The Analyzer automatically clears the WIC aperture after a metering fault is detected. CLEARING APERTURES is displayed in the Status Box.

WOC Metering fault — flow errorThis message is displayed in the Bulletin Line.WOC FLOW ERROR is displayed on the RUN screen to the right of the NEU results.“WOC FLOW” is printed on the graphics report. Results for WBC and Differential are suppressed.


1. An increasing WOC count rate was detected in the WOC flow cell during the WOC measurement.

1. Repeat the sample.

2. Replace the WOC Transfer Peristaltic Pump Tubing as directed in Chapter 9.

3. Clean the WOC Metering Syringe as directed in Chapter 9.


Chapter 11 Printers

Overview

The CELL-DYN 3700 system is configured with a color Graphics Printer (known in this manual as the Graphics Printer). The printer is set up to print reports, including complete graphic information, on 8.5" X 11" paper. The printer may be set up to print graphic information in color or black only.

If ticket printing is desired for the CELL-DYN 3700, a second printer (known as the Ticket Printer) can also be connected to the system at the same time as the Graphics Printer. Results are automatically printed at the completion of each run cycle or are printed on command by the operator. The Ticket Printer can be used to print reports with graphic information in black only, but the connection to the Data Station must be changed.

IMPORTANT: The CELL-DYN 3700 System has been configured for and tested with specific printers, such as the printer shipped with the analyzer. For additional information about specific printer capability with the CELL-DYN 3700 System, US Customers, please contact the Customer Service Center at 1-877-4ABBOTT (1-877-422-2688). Customers outside the US should contact your local Customer Service representative. Use of printers other than those recommended by Abbott Laboratories may lead to erroneous printer functionality.

Refer to Chapter 2: Installation; Subsection: Printer Installation for instructions on installing both printers.

Complete directions for customizing the printout type and format are given in Chapter 5: Operating Instructions, Subsection: Set Up Instructions.


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NOTES


Chapter 11 Printers

Routine Operation

Graphics PrinterThe CELL-DYN 3700 software automatically controls and adjusts most print conditions, including page width. If printing is not what you expect, refer to the printer manual for guidance in making adjustments. If you have additional questions or experience any problems, call Abbott Diagnostics Customer Service for assistance.

Ticket PrinterFor detailed information about loading continuous-feed tickets or paper and changing the ribbon in the Ticket Printer, refer to the manuals that accompany the printer. In particular, note the important safety instructions. This section gives information about ticket printing and instructions for loading individual pre-printed tickets in the Ticket Printer.

The Ticket Printer can be used to print a complete graphics report on continuous tractor-feed paper or to print result data on blank or pre-printed tickets. (Blank tickets are available in continuous tractor-feed sheets. Pre-printed tickets are loaded individually.) To print the graphics report, the printer cable must be connected to the Graphics Printer connector on the back of the Data Station.

Printing TicketsTo print tickets, the printer cable must be connected to the Ticket Printer connector on the back of the Data Station. (See Figure 2.5 for the location of these connectors.) Refer to Chapter 5: Operating Instructions, Subsection: Set Up Instructions for instructions for customizing either type of printout.

Loading Individual TicketsInstructions are given for loading individual tickets. If fan-fold, continuous-feed tickets are used, they should be loaded as directed in the printer manual for tractor-feed paper.

1. Be sure that the printer is turned ON and the printer cable is connected to the Ticket Printer Connector on the back of the Analyzer. If the connection is incorrect, turn the Analyzer power OFF, change the position of the cable and turn the power back ON.


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PrintersRoutine Operation Chapter 11

2. Set the ribbon cartridge headgap lever to adjust for the thickness of the tickets. Refer to the printer manual for the location of the headgap lever and for detailed instructions.

3. Move the paper selection lever to the rear position to select single-feed paper.

4. Open the access cover and be sure the guide wire on the paper separator is pushed back into the locked position.

5. Raise the separator to its upright position.

6. Place a ticket on the paper separator and adjust the guides so that they barely touch the edges of the ticket.

7. Pull the bail lever forward. The ticket will automatically feed into place. Release the paper bail lever.

8. Be sure the printer is deselected (Sel indicator is not illuminated) and set the Top of Form by pressing and holding the TOF/Quiet key and pressing the Form Feed key to move the ticket up or pressing the Line Feed key to move the ticket down. (The ticket moves in very fine increments so it can be precisely positioned.)

NOTE: The ticket will only move down to a certain point to prevent potential ticket jams. Do not move the top of the page below the paper bail.

9. Position the ticket so that the lower red line on the paper shield (located between the print head and the paper) is positioned where the first line of printing should occur.

NOTE: When the Top of Form is set, the position is retained in the printer memory until it is reset.

10. Press the Sel key to select the printer. The printer is now ready to print.


PrintersChapter 11 Maintenance and Troubleshooting

Maintenance and Troubleshooting

This section gives a brief overview of printer maintenance and troubleshooting. Instructions for installation are given in Chapter 2: Installation; Subsection: Printer Installation. For a detailed description of the printer components and instructions on changing the ink cartridges or ribbon, and loading paper, refer to the manuals that accompany the printer.

CleaningEvery six months (or after about 300 hours of operation) turn the printer OFF and use a clean, dry cloth to dust the area around the carriage shaft and platen. Be sure to remove any loose particles of paper. Do not use solvents or strong detergents on the cabinet.

TroubleshootingRefer to the printer manuals for a list of the most common printer problems and how to solve them. If the problem is not resolved, contact the Abbott Diagnostics Customer Service Center for assistance.

If, during routine system operation, the message PRINTER UNAVAILABLE is displayed on the bulletin line, check to see that the printer cable is securely connected to the Data Station, the printer power switch is turned ON, and that the printer status is on-line. Press the [PRINT] key. If the message is still displayed, turn the printer power OFF, wait about five seconds, turn the power ON again and press the [PRINT] key. If the message is still displayed, there may be an internal printer error. Contact Abbott Diagnostics Customer Service for assistance.


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NOTES


Chapter 12 Sample LoaderSample Loader

Overview

The Sample Loader for the CELL-DYN 3700SL System is an automated microprocessor-based sample-handling system designed to fit directly in front of the Analyzer. (See the following figure.) The Analyzer communicates electronically with the Sample Loader and vice versa. The Sample Loader delivers blood samples (and their identification information) to the CELL-DYN 3700SL System for analysis. The sample tubes are transported in racks that keep the tubes in an upright position. The Sample Loader processes up to 100 samples at a time with or without bar code labels.

Figure 12.1: Analyzer with Sample Loader


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When the START key on the Sample Loader is pressed, the tube racks advance to move each tube through the three processing stations located in the base of the tower:

• Station 1: Pre-Mixing. The tube is sensed and the sample is pre-mixed by counter-rotation for approximately 30 seconds.*

• Station 2: Mixing. The bar code label is read (if present) and the sample is mixed again for approximately 30 seconds.*

• Station 3: Vent/Aspiration. The plunger positions the tube, the tube stopper is punctured, the tube is vented, and the sample is aspirated.

* The first tube in a series skips Station 1 and is advanced to Station 2 for complete mixing (for approximately 60 seconds).

Figure 12.2: Rack Movement - Top View

As illustrated in the preceding figure, the tube racks move from the right side of the tray, through the three tower stations, and over to the left side of the tray. Consequently, the rack on the right side at the back of the tray is the first to be processed. When the last tube in this rack is at Station 2, the next rack is moved into position for processing. Racks are continuously moved to ensure that tubes are always present in the three tower stations.

Fluids travel between the Analyzer and the Sample Loader through four tubes. These tubes carry blood and waste to the Analyzer and diluent to the Sample Loader for cleaning. A cable is connected to the Analyzer to provide bidirectional communication.

Station 3:Vent/AspirationNeedle

Station 1:Pre-Mixing

Station 2:Mixing

Tower

Front


Sample LoaderChapter 12 Bar Code Labels

Bar Code Labels

CELL-DYN Bar Code LabelsCELL-DYN 4-digit bar code labels are available for the Sample Loader. These labels may be used for positive specimen identification when laboratory-generated bar code labels are unavailable.

CELL-DYN Q LabelsSpecial bar code labels are available to identify QC specimens. These “Q” labels (numbers Q1 – Q20) automatically select QC files 1 to 20 and, therefore, should be used to process only QC specimens.

Bar Code Label PlacementAll labels should be placed on the tubes securely and without flaps or edges sticking out. Labels should not cover the cap (high collar) or the bottom of the tube (tail). (See the following figure.) Excessive numbers of labels may prevent tubes from mixing properly.

Figure 12.3: Tube Labeling Requirements

PROPERLY LABELED TUBESTop SurfaceShould BeDry

16.5 mm Dia.Width Limit forMultipleLabels

ClearTape

BarCodedLabel

ExposedBottom

EdgesPeeledLoose

Flap

Tail

HighCollarIMPROPERLY LABELED TUBES


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The bar code label should be placed on the tube just below the stopper, with the bars perpendicular to the length of the tube, so that the entire bar code can be viewed through the slot in the rack as the tube rotates. See the preceding figure for proper placement.

NOTE: Refer to Appendix A: Bar Codes for complete information on Bar Codes, Check Digits, and specifications.


Chapter 12 Sample Loader

Sample Loader Components

The Sample Loader consists of a Main Module and a Tower Unit, as depicted in the following figure.

Figure 12.4: Sample Loader

Main ModuleThe Main Module contains:

• Power ON/OFF Switch

• Operation Keyboard

• Safety Cover

• Tray to hold the Tube Racks

Safety Cover

Tube Racks

Tower Unit

Operation Keyboard

Main Module

Power ON/OFF Switch


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Sample Loader Operation Keyboard KeysThe operator controls the Sample Loader using the Primary Keys on the Operation Keyboard. The Manual Keys are used by authorized Abbott service representatives. The operator may, in the course of troubleshooting, be directed by an Abbott representative to access the Manual Keys.

Figure 12.5: Operation Keyboard

Primary KeysThe red and yellow Primary Keys on the Sample Loader are:

INIT— (Initialize.) Activates the initialization cycle.(Yellow)

START— Initiates processing whenever the (Yellow) CELL-DYN 3700SL System is in the READY state.

PAUSE— Pauses the processing after the current cycle is (Yellow) completed. This key can be used any time the

processing needs to be interrupted.

REPEAT— Does not function.(Yellow)

RESET— Resets the Sample Loader and activates the INT (Red) key, usually in conjunction with an activated

alarm situation.

E/STOP— (Emergency Stop.) Terminates the processing (Red) immediately. Any sample being processed when

this key is pressed must be repeated.

ManualOperationKeys

PrimaryKeys

Phillips screws Plexiglass cover


Sample LoaderChapter 12 Sample Loader Components

Tower UnitThe Tower Unit illustrated in the following figure contains the following:

• Two Mixing Heads

• Vent/Aspiration Needle and Vent/Aspiration Needle Wash Block

• Tube Detector

• Vial Positioning Mechanism (referred to as the Plunger)

• Bar Code Reader Window

NOTE: A detailed functional description of all components is given in Operating Principles, Functional Description within this chapter.

Figure 12.6: Tower Stations

Station 3:

(Vent/Aspiration)Needle

Station 1:Mixing Head 1(Pre-Mixing)

Station 2:Mixing Head 2(Mixing)

Blood Sensor

Wash Block Tube Detector

Bar CodeReader Window

Bar Code ReaderWindow Cover Plate

Vial PositioningMechanism


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NOTES



Operating Principles

Functional DescriptionThe Sample Loader is attached to the Analyzer as shown in Figure 12.1, Analyzer with Sample Loader.

Three stations located at the base of the Sample Loader Tower are used to pre-mix, mix, and vent/aspirate each specimen tube. (See Figure 12.6, Tower Stations.) The mixing process is performed by counter-rotation of the tubes at the first two stations. A Mixing Head extends to pre-mix the specimen at Station 1 for approximately 30 seconds. A second Mixing Head extends to mix the specimen for approximately 30 seconds more at Station 2. (The first tube in a series skips Station 1 and is advanced to Station 2 for complete mixing for approximately 60 seconds.) A Mixing Monitor checks to ensure that both mixers are operating properly. If the tube cannot spin properly, a MIX ERROR is displayed. The Vent/Aspiration Needle then extends to puncture the tube stopper, vent the tube, and aspirate the mixed specimen at Station 3.

When the tube is at the Vent/Aspiration Station, a Plunger (a vial positioning mechanism) positions the tube vertically in the rack and holds it while the tube is vented and the sample aspirated. This enables the tube stopper to be pierced in the center and the rack to accommodate tubes with varying numbers of labels.

Ten Tube Racks must be in place for Sample Loader operation. The End Rack is marked with black dots on top and a black mark on the left end of the rack. (See the following figure.) The End Rack is used to indicate the last rack of a specific run. The Sample Loader automatically stops after the last tube in the End Rack is processed.

A clear plexiglass Safety Cover fits on top of the main Sample Loader Module. It covers the processing stations to prevent aerosol contamination, and to prevent operator exposure to the bar code reader laser and the needle while the Sample Loader is processing specimens.

NOTE: The Sample Loader has an Interlock Switch that prevents operation when the Safety Cover is not in place. The operator must press the PAUSE key and wait for the Sample Loader to stop processing before lifting or removing the cover. Lifting the cover while the Sample Loader is operating causes an immediate Emergency Stop condition.


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CAUTION: If a Sample Loader fault occurs that necessitates initialization of the Sample Loader, remove all samples that have been processed before restarting the Sample Loader. If these samples are not removed, misidentification of the remaining samples will occur.

When the Sample Loader sensors detect the End Rack, the Sample Loader emits audible beeps for three seconds to alert the operator. The message SAMPLES COMPLETED appears in the Data Station Bulletin Line. If continuous processing is desired, an unmarked rack should be substituted for the End Rack.

Figure 12.7: Tube Racks

The tube racks are identified by a bar code label which must be in place between the first and second tube position. (See the preceding figure.)

Black End Rack Visual Indicator Label(END RACK ONLY)

Rack ID NumberLabel

TubeRack

Black End Rack Sensor Label(END RACK ONLY)Orient Numbered End

DOWNWARD

Bar Coded RackID Label

Bar CodedPositionID Label


Sample LoaderChapter 12 Operating Principles

NOTE: The Tube Rack Bar Code Label is read when the tube in the first position is moved to the vent/aspirate station. If there is no bar code label on the rack or the label is unreadable, the Sample Loader stops, and the message: AUTO SAMPLER DATA FAULT is displayed on the Bulletin Line. Bar code labels on tube racks are essential for proper Sample Loader operation. They must be placed on racks between tube positions 1 and 2, even if bar code labels on specimens are not used. For more information, refer to Chapter 2: Installation.

The Tube Rack Bar Code Label identifies each rack by number and is read by the Bar Code Reader. Each individual tube position has a unique bar code. The system tracks the rack number and tube position for each specimen placed in the rack.

The Sample Loader provides positive specimen identification with a Laser Bar Code Reader at Station 2. As each tube reaches Station 2, the tube rotates and the bar code reader turns on to read the bar code label on the tube. If no bar code label is present or the label is unreadable, the sample will be identified on the Data Station RUN screen and in the Data Log by the rack number and tube position (in the format RxTx).

The use of bar code labels is recommended for positive sample identification. Operation of the Sample Loader with non-bar-coded samples is allowed, but the operator must then pay careful attention to the rack number and tube position of each sample for correct identification.

CAUTION: Do NOT remove any non-bar-coded specimens from the racks until the specimen ID numbers are matched to the rack number and tube position and entered on the record.

CAUTION: If a fault occurs which requires or causes the Sample Loader to be reinitialized, the operator must remove the specimens that have been processed to avoid accidentally repeating a specimen. Whenever the Sample Loader reinitializes, the Tube Rack that was under the Tower when the Sample Loader stopped moves back to the starting position. Processing, therefore, starts again with the tube in position number one of that rack.

The operator must pay careful attention to the rack number and tube position of each sample being processed, particularly when not using bar code labels and when using the Work List. For a complete explanation of the Work List, see Chapter 5: Operating Instructions.


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Function SequenceThe following sequence is a basic description of the events that occur from the time that the Sample Loader power is turned ON through the complete processing cycle. During the cycle, the position of the Tube Racks is monitored by four reflective sensors in the corners of the Sample Loader tray. Another sensor detects the non-reflective black mark on the End Rack.

1. Each time the Sample Loader is switched ON, it completes an Initialization cycle.

2. When the Sample Loader is initialized and ready, the START key on the Sample Loader Keyboard flashes and the message AUTO SAMPLER READY appears in the Data Station Bulletin Line.

3. When the START key is pressed, the Sample Loader begins moving the right rear rack under the tower. As the rack advances, the sensor at the Pre-Mixing Station searches for a tube. When the sensor detects a tube, the rack advances it to the Mixing Station. The second tube in the rack is positioned at the Pre-Mixing Station.

4. The Mixing Head moves down until the height sensor senses the tube at the Mixing Station. Mixing begins at the same time that the bar code label is read. If no bar code label is present, the sample is identified by rack number and tube position or by a Work List entry. (For instructions on using the Work List, refer to Chapter 5: Operating Instructions.)

5. The first specimen is then mixed by counter-rotation for approximately 60 seconds. When approximately 30 seconds have elapsed, the second tube begins mixing. The total mixing time for each sample is approximately 60 seconds.

NOTE: Tubes must be able to spin freely while in the tube racks. Tubes with excessive numbers of labels or with label flaps sticking out will not spin properly and may cause the Sample Loader to stop. (Refer to Figure 12.3, Tube Labeling Requirements.) The Bulletin Line will display the following message: SAMPLING ERROR — INCOMPLETE ASPIRATION. The RUN screen will display the MIXING ERROR and SAMPLING ERROR messages.


Sample LoaderChapter 12 Operating Principles

The Sample Loader does not attempt to aspirate an improperly mixed sample. Therefore, the SAMPLING ERROR — INCOMPLETE ASPIRATION message is displayed along with the MIXING ERROR message, and results look like background counts. In addition, results from tubes that cannot spin properly (and therefore are not mixed) also look like background results.

If the tube cannot spin, the Sample Loader emits three beeps, the Mixing Head motor stops (to prevent damage to the motor), and the sample is not aspirated. The message MIXING ERROR is displayed and printed to the right of the MCH result, and the message SAMPLING ERROR is displayed and printed to the right of the MCHC result. An “M” appears in the column preceding the date in the Data Log and the QC Log.

6. Rack movement resumes, and the first tube is moved to the Vent/Aspiration Station. When the Vent/Aspiration Needle begins to move down, the Plunger moves forward to position the tube so the stopper is pierced near the center. The needle continues to move down and pierces the stopper to vent the tube. The needle moves down to the bottom of the tube and the Sample Loader signals the Analyzer to aspirate the sample. The sample is pulled into the Shear Valve by the Sample Aspiration Pump. The Analyzer then begins a normal count cycle.

NOTE: If the Sample Loader detects four consecutive metering faults or incomplete aspirations, the Sample Loader stops and the Bulletin Line message alternates between SAMPLING ERROR — INCOMPLETE ASPIRATION and AUTO SAMPLER CONSECUTIVE DATA FAULTS and AUTO SAMPLER BUSY. The message SAMPLING ERROR is displayed and printed to the right of the MCHC result. Troubleshoot metering faults appropriately for clogs and other likely causes.

7. While Tube #1 is being aspirated, the Bar Code Reader identifies Tube #2, either by reading the bar code label on the tube or by reading the rack number and tube position. Tube #2 is then mixed for 30 seconds.


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8. Tube #3 is sensed by the tube sensor and pre-mixed for approximately 30 seconds.

NOTE: Whenever there is an empty space in a rack, mixing timing returns to that of the first tube in the first rack. When an empty space is detected, the Sample Loader automatically advances the next tube directly to the mixing station and mixes it for approximately 60 seconds. This has only a minor effect on overall throughput but may become significant if there are numerous empty spaces.

9. After the sample is aspirated, the Vent/Aspiration Needle is retracted and washed. The plunger retracts when the needle has been fully withdrawn from the tube.

10. Steps 4–9 are repeated until all the tubes in the rack have been processed.

11. When the last tube in the rack is at the Mixing Station, the rack sensor senses that the rack has moved far enough to the left side of the Sample Loader Tower. The second rack is moved into position on the right side of the tower and the first tube is positioned at the Pre-Mixing Station.

12. These sequences are repeated until the End Rack sensor detects the End Rack. When all tubes in this rack are processed, the Sample Loader automatically stops and audible beeps alert the operator that processing is completed. The message SAMPLES COMPLETED is displayed in the Bulletin Line.

NOTE: If no End Rack is used, processing continues until the Sample Loader is manually stopped by pressing the PAUSE key, or until a fault occurs.



Routine Operating Procedures

Directions for routine operation with the Sample Loader are given in Chapter 5: Operating Instructions.

Operating Tips

1. All samples which have been sitting for an extended period of time must be properly mixed before they are placed in the Sample Loader racks.

2. Spaces must be left between tubes with rubber stoppers when they are placed in the Sample Loader rack. If the tubes are placed side by side, mixing errors will occur because the rubber stoppers will touch each other when the tubes spin.

3. If a tube has multiple labels on it, spin the tube by hand after it is put in a rack to be sure it will spin freely and mix properly.


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NOTES



Other Chapters to Reference

MaintenanceMaintenance procedures for the Sample Loader should be performed as directed in Chapter 9: Maintenance. These procedures consist of cleaning the Safety Cover, the Vent/Aspiration Needle, the Tray, and the Tube Racks. If the Vent/Aspiration Needle requires replacement, refer to Chapter 10: Troubleshooting, Subsection: Troubleshooting Guide.

Set UpFor detailed instructions on how to set up the Sample Loader, refer to Chapter 2: Installation.

TroubleshootingIf a Sample Loader fault, error, or other problem is detected, an alert message is displayed on the Bulletin Line of the screen. For a list of messages, descriptions of possible problems, and recommended actions, refer to Chapter 10: Troubleshooting.


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NOTES


Chapter 13 Veterinary PackageVeterinary Package

Introduction

The Veterinary Package software enables the CELL-DYN® 3700 System to analyze animal samples. When the Vet Package is selected, the instrument can be configured to process veterinary samples. The software stores instrument settings for up to 60 different types of animals in a configuration file unique to each animal type. A database in the Vet Package, called the Animal Catalog, contains manufacturer-developed settings for common species. Additional species may be added at the discretion of the user.

By pressing the appropriate soft keys, the operator can switch between species or return to the original instrument (human) settings.

In this chapter you will find the information needed to configure the system to run animal samples.

• Access the Vet Package from the Set Up Menu

• Add a new animal specie and enter normal ranges for that animal

• Run the animal samples and make changes to the gain settings for appropriate CBC and differential results

• Calculate and calibrate the MCV for each new animal

• Adjust the Baso Box

The following information regarding the use of the Veterinary Package is included in this chapter:

Principles of Operation


Operating Instructions (including a description of the soft keys)

Calibration

Quality Control

Adding New Animal Types (including instructions for configuring additional species)

Turning the Vet Package OFF


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Chapter 13 Veterinary Package


The Vet Package is designed to configure the instrument to process up to 60 different animal types. The configuration file for each animal type can be customized for the following:

Electronic set-points

Calibration factors (MCV and MPV)

Limits Sets

When a particular species is selected, the instrument will automatically choose the appropriate configuration file and adjust the instrument settings to the values contained in the file. This configuration is retained until another species is selected or the Vet Package is turned OFF. When the Vet Package is turned OFF, the instrument automatically returns to the original settings for human samples.

Adjustments to the instrument settings (for calibration or alignment) are always made in the human mode. Therefore, a special animal type called “Default” is maintained in the Animal Catalog (described in the next section) and in the Animal Type Set Up Table. The settings for the default animal are identical to the settings for humans and all animal settings are maintained relative to these settings. When the instrument is calibrated or any procedures are performed which alter the default animal (human) settings, the settings contained in all of the animal type files are automatically adjusted according to the altered default settings. Consequently, the animal configurations are always current and no adjustments are required.

The Animal CatalogThe Animal Catalog contains the pre-programmed configuration files for common species.

NOTE: All claims and specifications in this chapter are based on these pre-programmed animal types. No instrument performance claims can be provided for species configured by the user.

Files stored in the catalog, including the “Default” animal type, cannot be modified within or deleted from the catalog. However, these files can be reviewed or added to the Animal Type Set Up Table at any time, where they then can be edited.


9140320C — November 2000

Veterinary PackagePrinciples of Operation Chapter 13

The “Default” animal type stored in the catalog cannot be modified or deleted. It is a duplication of the original human settings, with their calibration and dilution factors, that were established for the Analyzer.

To run samples for the first time, a configuration file must be copied from the catalog to the Animal Type Set Up Table. This table is displayed on the ANIMAL TYPE SET UP screen. Once the file is stored in this table, it can be reviewed, modified, or deleted. Modifications to the file are stored in the Animal Type Set Up Table and do not alter the settings stored in the catalog. Consequently, a “Master File” is always maintained in the catalog for each species.

CAUTION: Do not modify the alignment and calibration factors for the default animal on the DIAGNOSTICS SET POINT ENTRY screen. Any changes to these settings would also modify the settings used for human sample testing and the Bulletin Line would display the following message to alert the operator: WARNING: Any change to the DEFAULT settings also affects the HUMAN settings. After the Vet Package is exited, the human settings would then reflect these modifications made while in the Vet Package.

Once the file is copied to the Animal Type Set Up Table, it may be accessed by pressing the [ANIMAL TYPE] key displayed on the RUN screen. When the key is pressed, the settings for that species are transferred to the Analyzer. (It takes approximately 10 seconds for the transfer to occur.) When the Status Box displays the READY message, samples may be processed. Samples from other species may be processed by again pressing the [ANIMAL TYPE] key and selecting the desired animal.




IntroductionInstrument performance specifications are included in Chapter 4: System Specifications. The Performance Characteristics included in this section illustrate instrument performance for the species indicated.

PrecisionPrecision results are derived from paired difference analysis of a minimum of 100 data pairs from normal animal samples. The results are stated as a coefficient of variation (CV).

* The PLT result was derived from a data set which includes samples exhibiting overlap between the RBC and PLT popula-tions. Platelet precision is improved if these samples are elimi-nated from precision determinations.

**Rat precision was calculated with n=31; pooled blood of four healthy rats.

Table 13.1: Precision

Parameter Result (CV)Dog Cat Rat ** Mouse1

WBC 3.8% 3.8% 2.4% 3.8%RBC 2.3% 2.3% 2.0% 2.5%HGB 1.5% 1.5% 1.5% 1.5%MCV 3.5% 3.0% 2.2% 2.8%PLT 8.5%* 11.3%* 4.2% 6.0%*


9140320C — November 2000

Veterinary PackagePerformance Characteristics Chapter 13

AccuracyAccuracy is expressed as a correlation coefficient based on a minimum of 50 pairs of samples. The data are correlated to a reference methodology. Dog and cat hemogram parameters are compared to a Coulter® S+IV and differential parameters are compared to a manual 100-cell differential. Rat and mouse hemogram parameters are compared to Contraves AL820® and differential parameters are compared to a manual 100-cell differential.

Table 13.2: Accuracy

Parameter Correlation CoefficientDog Cat Rat1 Mouse1

WBC > 0.96 > 0.92 > 0.99 > 0.99

RBC > 0.98 > 0.98 > 0.99 > 0.92

HGB > 0.95 > 0.96 > 0.99 > 0.98

MCV > 0.75 > 0.75 > 0.85 > 0.86

PLT > 0.91 > 0.77 > 0.94 > 0.97

% Neutrophils > 0.76 > 0.77 > 0.89 > 0.96

% Lymphocytes > 0.70 > 0.70 > 0.77 > 0.93

% Monocytes NA NA NA NA

% Eosinophils > 0.70 > 0.70 NA NA

% Basophils NA NA NA NA


Veterinary PackageChapter 13 Performance Characteristics

LinearityLinearity was evaluated by testing specimens with high values for the parameters indicated in the table. The highest values tested and correlated to a Coulter® S+IV or Contraves AL820® are listed in the following table.

NOTE: There are no preset limits for parameters that would generate out-of-range flags like those generated with the human settings. The maximum values that can be displayed for the hemogram parameters are:

WBC – 9999 K/µL

RBC – 9999 M/µL

HGB – 9999 g/dL

MCV – 9999 fL

PLT – 9999 K/µL

CarryoverCarryover is determined by running samples with high concentrations of WBCs, RBCs, HGB, and PLTs. Each sample is run in triplicate followed by three background cycles. The percent carryover is calculated using the following formula:

Table 13.3: Linearity

Parameter Highest Value TestedDog Cat Rat1 Mouse1

WBC 70.0 K/µL 43.0 K/µL 20.2 K/µL 19.4 K/µL

RBC 9.56 M/µL 9.98 M/µL 14.3 M/µL 11.1 M/µL

HGB 21.5 g/dL 16.0 g/dL 26.8 g/dL 20.9 K/µL

MCV 150 fL 150 fL NA NAPLT 950.0 K/µL 800 K/µL 1670 K/µL 1690 K/µL

Table 13.4: Carryover

Parameter CarryoverDog Cat Rat1 Mouse1

WBC < 1% < 1% < 1% < 1%

RBC < 1% < 1% < 1% < 1%

HGB < 1% < 1% < 1% < 1%

PLT < 3.5% < 3.5% < 3.5% < 3.5%

Background1 – Background3

Sample3 – Background3

% Carryover = x 100


9140320F — April 2007

Veterinary PackagePerformance Characteristics Chapter 13

FlaggingThe following Suspect Population Flags, and Suspect Parameter Flags are active in the Vet Package software:

WBC

DFLT (NLMEB)

NWBC

FWBC

NRBC

RRBC

PLTR

Descriptors:

WIC

WOC

The interpretive messages described in Chapter 3: Principles of Operation, Subsection: Operational Messages and Data Flagging are also active in the Vet Package.

Samples may be flagged by entering up to four sets of limits for each animal type. Limits may be normal range, panic values, etc. Values that fall outside these limits are displayed and printed as they are for human samples. When a result exceeds the maximum value that the system can display, >>>> (over-range) are displayed and printed in place of the result.



Operating Instructions

The operation of the Vet Package is discussed in the remaining sections of this chapter. There are four main sections:

Vet Package Keys

Routine Operation

Calibration

Adding New Animal Types

A description of the Vet Package set up procedures and how to access the various Vet Package functions is given in the first section. The Routine Operation section includes instructions for Sample Analysis and brief descriptions of the Work List and the Data Log. Calibration procedures are discussed in the Calibration section, and the steps required to add new species are described in the Adding New Animal Types section.

Figure 13.1: Operation Set Up Menu Screen

TURN ONVET PKG

TURN ONRETIC PKG

BAR CODESET UP

COMPUTERSET UP

RETURN



14:327573404


9140320C — November 2000

Veterinary PackageOperating Instructions Chapter 13

Vet Package KeysThe [TURN ON VET PKG] key is located on the OPERATION SET UP MENU screen (see the preceding figure), which is accessed from the SET UP MENU screen. When the [TURN ON VET PKG] key is pressed, the key label will change to [TURN VET PKG OFF] and the Vet Package software will be enabled. This key is used to enable or disable the Vet Package. When the Vet Package is ON, the Vet Package keys described on the following pages are accessible.

Procedure:Turn Vet Package ON

1. From the MAIN MENU screen, press the [SET UP] key followed by the [OPERATION SET UP MENU] key to display the OPERATION SET UP MENU screen.

2. From the OPERATION SET UP MENU screen, press the [TURN ON VET PKG] key to enable the Vet Package software.

NOTE: The key label changes to [TURN VET PKG OFF] when the Vet Package is selected.

3. Press the [RETURN] key followed by the [SET UP] key to return to the SET UP MENU screen.

The [ANIMAL SET UP] key is now displayed.

TURN ON

VET PKG

TURN VET

PKG OFF


Veterinary PackageChapter 13 Operating Instructions

Figure 13.2: Set Up Menu Screen

The [ANIMAL SET UP] key is displayed on the SET UP MENU screen (see the preceding figure) when the Vet Package is ON. When the [ANIMAL SET UP] key is pressed, the ANIMAL TYPE SET UP screen (see the following figure) and the following soft key labels are displayed:

ADD NEW ANIMALDELETE ANIMALVIEW ANIMALANIMAL LIMITSBROWSE CATALOGRETURN

DATE/TIME

ANIMALSET UP

REAGENTLOG

QC SET UPMENU

OPERATIONSET UP

UNITSSELECTION

CUSTOMIZEREPORT

MAIN

SET UP MENUReady


14:337573404

ANIMAL

SET UP


9140320C — November 2000


Figure 13.3: Animal Type Set Up Screen

The [ADD NEW ANIMAL] key is used to add a new animal type to the Animal Type Set Up Table. This key is discussed and directions for adding new animals are given in the Adding New Animal Types section of this chapter.

The [DELETE ANIMAL] key is used to delete the file indicated by the cursor position from the Animal Type Set Up Table. The following soft key labels are displayed when the [DELETE ANIMAL] key is pressed:


These keys are used to confirm or cancel the Delete Animal command.

Procedure: Delete Animal1. From the SET UP MENU screen, press the [ANIMAL SET UP] key

to display the ANIMAL TYPE SET UP screen.

2. Use the arrow keys on the keyboard to move the cursor to the animal that is to be deleted.


14:337573404

ADD NEWANIMAL

DELETEANIMAL

VIEWANIMAL

ANIMALLIMITS

BROWSECATALOG

RETURN

ANIMAL TYPE SET UPReady

CATDEFAULTDOGMOUSERAT

ADD NEW

ANIMAL

DELETE

ANIMAL



3. Press the [DELETE ANIMAL] key followed by the [CONFIRM DELETION] key. Verify that the selected animal is deleted from the list.

NOTE: The animal type to be deleted must not be the current animal type selected in the RUN screen. The default animal type cannot be deleted.

Figure 13.4: View Animal Type Set Up Screen

The [VIEW ANIMAL] key displays the configuration file for the animal type indicated by the cursor position on the ANIMAL TYPE SET UP screen. The VIEW ANIMAL TYPE SET UP screen is shown in the preceding figure.

Procedure: View Animal1. From the SET UP MENU screen, press the [ANIMAL SET UP] key

to display the ANIMAL TYPE SET UP screen.

2. Use the arrow keys on the keyboard to move the cursor to the animal that is to be viewed.

3. Press the [VIEW ANIMAL] key to display the VIEW ANIMAL TYPE SET UP screen for the selected animal.


14:377573404

PRINT RETURN

VIEW ANIMAL TYPE SET UPReady

WBCWBCWBCWBCRBCPLTWIC

WBCRBCPLTPLTWICWIC

DEFAULT SET UP

Current

0D10D90D90DEP

lohilohi

1408126714011465181721473307

36024023040956403000

HGBRBCWIC

MCVMPV

168029303000

0.9031.107

Gains:

Calibration FactorsTHRESH:

VIEW

ANIMAL


9140320C — November 2000


Figure 13.5: Animal Limit Set 1

The [ANIMAL LIMITS] key is used to enter upper and lower flagging limits for each animal in the Animal Type Set Up Table. Four different sets of limits may be entered for each animal type. The animal type is displayed on the upper left corner of each Limit Set. The following soft key labels are displayed (see the preceding figure) when the [ANIMAL LIMITS] key is pressed:

LIMIT SET 1*LIMIT SET 2LIMIT SET 3LIMIT SET 4PRINTRETURN

*The key label for the Limit Set displayed on the screen is not shown.


15:017573404

LIMITSET 2

LIMITSET 3

LIMITSET 4

PRINT RETURN

LIMIT SET 1Ready

WBCNEULYM

MONOEOS

BASORBCHGBHCTMCVMCH

MCHCRDW

PLTMPVPCT

PDW

Lower Limits Upper Limits6.73.60.70.10.10.0

5.5012.636.962.022.033.011.6

80.0.0

0.000.0


60.012.0

3.02.00.0

%N%L%M%E%B

18.312.5

6.01.71.80.1

8.2019.455.070.025.036.014.8560.99.99.9999.9


75.030.0

9.010.0

1.0

%N%L%M%E%B

Animal: DOG

ANIMAL

LIMITS



Whenever a parameter result exceeds an entered limit, the result is displayed in color on the screen to alert the operator. Results displayed in yellow are below the limit and results displayed in purple are above the limit. The flagged result is underlined on the graphics report and the blank ticket report. The flagged result is marked with an asterisk (*) on the pre-printed ticket report.

NOTE: To avoid data entry errors, limits can only be entered for the animal type that is currently displayed on the RUN screen.

Procedure: Animal Limits1. From the MAIN MENU screen, press the [RUN] key followed by

the [ANIMAL TYPE] key.

2. Use the arrow keys on the keyboard to move the cursor to the desired animal in the list displayed on the screen.

3. Press the [SELECT ANIMAL] key to set the instrument for the selected animal. The Status Box briefly displays the message Setting gains followed by the Ready message.

4. When the Ready message is displayed, press the [RETURN] key to return to the RUN screen.

5. Press the [MAIN] key followed by the [SET UP] key to return to the SET UP MENU screen.

6. From the SET UP MENU screen, press the [ANIMAL SET UP] key to display the ANIMAL TYPE SET UP screen.

7. Press the [ANIMAL LIMITS] key to display the ANIMAL LIMITS screen. A Limit Set is displayed on the screen. The set number (Limit Set 1, Limit Set 2, etc.) is displayed in the Status Box, and the animal type is displayed in the upper left corner of the screen. The other Limit Sets may be selected by pressing the appropriate soft key.

8. Use the arrow keys on the keyboard to move the cursor to the desired limit entry field and type the number.

9. Press the Enter key on the keyboard to save the entry and advance the cursor to the next entry position.

10. Repeat steps 8 and 9 until all desired entries have been made.

11. If desired, press the [PRINT] key to obtain a printout of the Limit Set.

NOTE: Retaining a hard copy of each Limit Set is recommended, as the screens do not display categories for the Limit Sets.


9140320C — November 2000


12. Press the appropriate soft key to select another Limit Set and repeat steps 8–11 to enter the desired limits.

13. Press the [RETURN] key to return to the ANIMAL TYPE SET UP screen.

14. Repeat this procedure to enter limits for a different species.

Figure 13.6: Animal Type Catalog Screen

The [BROWSE CATALOG] key is used to view the Animal Catalog. The Animal Catalog stores the files for up to 60 different animal types. Information for the animal types currently supported by existing data is stored in the catalog. To run samples from a specific animal, the file must be moved from the catalog to the Animal Type Set Up Table. When the [BROWSE CATALOG] key is pressed, the ANIMAL TYPE CATALOG screen and the following soft key labels are displayed (see the preceding figure):

VIEW SET UPEXPECTED RANGESADD TO SET UPRETURN


14:397573404

VIEWSET UP

EXPECTEDRANGES

ADD TOSET UP

RETURN

ANIMAL TYPE CATALOGReady


BROWSE

CATALOG



Figure 13.7: Catalog Contents, Animal Type Set Up Screen

When the [VIEW SET UP] key is pressed, the CATALOG CONTENTS, ANIMAL TYPE SET UP screen (see the preceding figure) for the animal type indicated by the cursor position and the following soft key labels are displayed:

PRINTRETURN

NOTE: The file cannot be modified from this screen, only displayed and printed.

The [PRINT] key is used to print a copy of the displayed settings.

The [RETURN] key is used to return to the ANIMAL TYPE CATALOG screen.


14:397573404

PRINT RETURN

CATALOG CONTENTSReady

WBCWBCWBCWBCRBCPLTWIC

WBCRBCPLTPLTWICWIC

CAT SET UP

Current

0D10D90D90DEP

lohilohi

1948139728662998338822583307

40024025740955203000

HGBRBCWIC

MCVMPV

168029303000

0.5191.127

Gains:

Calibration Factors

ANIMAL TYPE SET UP

THRESH:

VIEW

SET UP

PRINT

RETURN


9140320C — November 2000


Figure 13.8: Expected Ranges

The [EXPECTED RANGES] key is used to display the pre-programmed ranges for the animal type indicated by the cursor position. (See the preceding figure.)

NOTE: When a file is transferred from the Animal Catalog to the Animal Type Set Up Table, the expected ranges stored in the catalog become Limit Set 1.

The [ADD TO SET UP] key is used to move the configuration file indicated by the cursor position from the Animal Catalog to the Animal Type Set Up Table.

Procedure: Add to Set Up1. From the ANIMAL TYPE SET UP screen, press the [BROWSE

CATALOG] key to display the ANIMAL TYPE CATALOG screen.

2. Use the arrow keys on the keyboard to move the cursor to the desired animal type.


14:417573404

PRINT RETURN

EXPECTED RANGESReady

WBCNEULYM

MONOEOS

BASORBCHGBHCTMCVMCH

MCHCRDW

PLTMPVPCT

PDW

Lower Limits Upper Limits4.602.00.6000.000.000.004.0412.237.780.027.031.811.6142.0.000.000.00


37.010.00.000.000.00

%N%L%M%E%B

10.26.903.40.900.700.2006.1318.153.797.031.235.414.8424.100.9.99100.


80.050.012.07.002.50

%N%L%M%E%B

Animal: DEFAULT

EXPECTED

RANGES

ADD TO

SET UP



3. Press the [ADD TO SET UP] key to move the file to the Animal Type Set Up Table.

NOTE: If the selected file has already been moved to the Animal Type Set Up Table, the Bulletin Line will display the message: Animal type was added to set up already. The file with the same name must be deleted from the Animal Type Set Up Table before the selected file can be added.

4. Press the [RETURN] key to return to the ANIMAL TYPE SET UP screen. The added file is entered in the list and displayed in alphabetical order.

The [PRINT] key is used to print a list of the files contained in the Animal Catalog.

The [RETURN] key is used to return to the ANIMAL TYPE SET UP screen. The [RETURN] key on the ANIMAL TYPE SET UP screen is used to return to the SET UP MENU screen.

PRINT

RETURN


9140320C — November 2000


NOTES



Routine Operation

This section gives instructions for running veterinary samples. A brief discussion of the Data Station RUN screen is included to explain the different keys displayed when the Vet Package is ON.

Figure 13.9: Run Screen for Animals

Run ScreenThe RUN screen for animals differs slightly from the RUN screen for humans. The preceding figure shows the RUN screen for animals. On this screen, the <PATIENT> field is replaced by the <ANIMAL> field. The selected animal type is automatically displayed in this field.

The [SPECIMEN TYPE] key is replaced by the [ANIMAL TYPE] key. However, the [SPECIMEN TYPE] key is available from the ANIMAL TYPE SELECTION screen.

NOTE: Animal type and specimen type are two independent characteristics of the sample. For example, Dog QC, Cat Background, etc.

Next ID CAT/10533/03 AutoAnimal: CATSex(M/F):M DOB:01/09/92Dr FELINE, DVMParam: 1 Limits: 1

WBC 7.24 K/uLNEU 4.75 65.6 %NLYM 1.63 22.5 %L

MONO .566 7.82 %MEOS .168 2.33 %E

BASO .129 1.79 %B




CLEARAPERTURES

WORKLIST

ANIMALTYPE

CUSTOMIZEREPORT

CHANGESAMPLER

PRINTTICKET

PRINTREPORT

MAIN



09:447321702Report for CAT/10552/02

90

deg

SIZE

COMPLEXITY 10 deg

RBC PLT

WCT:4.33

RCT:6.26

Open SamplerWL:OFFXB RBC:1/OUT2 XB WBC


9140320C — November 2000

Veterinary PackageRoutine Operation Chapter 13

Selecting the Animal

Figure 13.10: Animal Type Selection Screen

When the [ANIMAL TYPE] key on the RUN screen is pressed, the ANIMAL TYPE SELECTION screen (see the preceding figure) and the following soft key labels are displayed:

SELECT ANIMALSPECIMEN TYPERETURN

Adjusting the SettingsThe [SELECT ANIMAL] key is used to adjust the instrument to the animal settings determined by the cursor position. When the key is pressed, the Status Box briefly displays the message Setting gains to indicate that the adjustments are in process. This message is immediately followed by the Ready message indicating the adjustments are complete.


14:437573404

SELECTANIMAL

SPECIMENTYPE

RETURN

ANIMAL TYPE SELECTIONReady


ANIMAL

TYPE

SELECT

ANIMAL


Veterinary PackageChapter 13 Routine Operation

Figure 13.11: Specimen Type Screen

Choosing the Specimen TypeWhen the [SPECIMEN TYPE] key is pressed, the SPECIMEN TYPE screen (see the preceding figure) and the following soft key labels are displayed:

PATIENTQC SPECIMENBACKGROUNDELECTRICL BACKGRNDLATEXRESISTANT RBCRETURN

The functions of these keys are discussed in Chapter 5: Operating Instructions.

PATIENT QCSPECIMEN

BACK-GROUND

ELECTRICLBACKGRND

LATEX RESISTANTRBC

RETURN

SPECIMEN TYPEReady


14:457573404

1.2.3.4.5.6.7.8.9.

10.

File Name

Press QC SPECIMEN key to select QC FILE at cursor position.

LOW 44 SLNORM 44 SLHIGH 44 SLLOW 45 OPENNORM 45 OPENHIGH 45 OPENLOW 44 HSLNORM 44 HSLHIGH 44 HSLPRECSL01/28

333333000

31

# Specimens

11.12.13.14.15.16.17.18.19.20.

File Name

PRECOP02/01PRECSL02/01PRECSL01/29LOW RD 13 OPNOR RD 13 OPHI RD 13 OPPRECOP01/27PRECSL01/27PRECOP01/29PRECOP01/28

31313171716931313431

# Specimens

SPECIMEN

TYPE


9140320C — November 2000


Figure 13.12: Dog Background Count

When the Vet Package is ON, the screens differ in that the selected animal type is always displayed in the upper left corner of each of the specimen type RUN screens. See the preceding figure for an example of a BACKGROUND screen for a dog.

Sample AnalysisVeterinary samples may be run in the Open Mode or the Closed Mode (SL or CS) on the CELL-DYN 3700 System. Once the animal type is selected, these samples are processed in the same manner as human samples. Daily Start Up Procedures and Quality Control checks should be performed before processing samples. For instructions for these procedures, refer to Chapter 5: Operating Instructions, Subsections: Daily Start Up Procedure, Daily Quality Control Procedures, and Sample Analysis.

Dec 01 1998Animal: DOGType BACKGROUNDParam Set: 1

WBC 0.12 K/uLNEU %NLYM %L

MONO %MEOS %E

BASO %B

RBC .001 M/uLHGB 009 g/dLHCT %MCV fLMCH pg

MCHC g/dLRDW %

PLT 0.00 K/uLMPV fL

RUNReady


Report for BACKGROUND

Open SamplerWL:OFF

CLEARAPERTURES

WORKLIST

ANIMALTYPE

CUSTOMIZEREPORT

CHANGESAMPLER

PRINTTICKET

COLORPRINT

MAIN

10:207574166

GRANLRTY

SIZE


RBC PLT

WCT:4.57

RCT:6.23


Veterinary PackageChapter 13 Routine Operation

Procedure: Selecting Animal Type/Specimen TypeNOTE: In the following procedure, [ANIMAL TYPE] refers to the species being sampled. [SPECIMEN TYPE] refers to the following selections available on the RUN screen:

Patient

QC Specimen

Background

Electrical Background

Latex

Resistant RBC (in the Open Mode only)

1. From the MAIN MENU screen, press the [RUN] key followed by the [ANIMAL TYPE] key.

2. Use the arrow keys on the keyboard to move the cursor to the desired animal and press the [SELECT ANIMAL] key.

The Status Box briefly displays the message Setting gains and returns to the Ready message.

3. When the Ready message is displayed, press the [SPECIMEN TYPE] key.

4. Press the soft key for the desired specimen type and then press the [RETURN] to display the RUN screen for the selected specimen type.

5. Run the sample in the selected mode of operation.

6. To run a different species, press the [ANIMAL TYPE] key.

7. Move the cursor to the desired animal and press the [SELECT ANIMAL] key.

8. Press the [RETURN] key to display the RUN screen for the selected animal type.

9. Run the sample in the selected mode of operation (Open or Closed).

10. Repeat this procedure to run samples from a different species.


9140320C — November 2000


Sample Analysis with the Work ListA Work List can be created for only one species at a time. Therefore, animal samples must be batched to use this feature (for example, all dog samples must be run together, all cat samples must be run together, etc.). Sample analysis with the Work List is identical to that described in Chapter 5: Operating Instructions.

Data LogAll veterinary samples are entered in the Data Log in the order in which they are processed. All samples run with the Vet Package ON are stored with the Data Log code V to indicate veterinary samples.



Calibration

With the Vet Package ON, calibration of the directly measured parameters is linked to the calibration factors set for human (“Default” animal type) samples. When the calibration factors for human (“Default” animal type) samples are changed, the calibration factors contained in the configuration files stored in the Animal Type Set Up Table are automatically updated.

Calibration factors for WBC, RBC, HGB, and PLT always remain identical to the factors for the default animal type. This is true for all species listed in the Animal Type Set Up Table.

CAUTION: The calibration factors for these parameters are always identical to those for human samples. Don’t modify the alignment and calibration factor settings for the default animal on the Animal Type Set Up Table. Any changes to these settings would also modify the settings used for human sample testing and the Bulletin Line would display the following message to alert the operator: WARNING: Any change to the DEFAULT settings also affects the HUMAN settings. After the Vet Package is exited, the human settings would then reflect these modifications made while in the Vet Package.

Calibration factors for MCV and MPV may differ from those for the default animal type. These calibration factors may also differ among the species. If a calibration factor is not entered in the configuration file for these parameters, the factors for the default animal type will be used. If calibration factors are entered for these parameters, they will be linked to the factors for the default animal type. Whenever the default factors are changed, these factors will be automatically updated.

When the calibration factors for MCV and MPV have been computed, they are entered manually from the ENTER CALIBRATION FACTOR screen (see the following figure) in the Calibration menu as directed on the following pages.


9140320C — November 2000

Veterinary PackageCalibration Chapter 13

Procedure: MCV or MPV CalibrationOnce the animal type is selected, directions for MCV or MPV calibration are identical to those given in Chapter 6: Calibration. For Open Mode calibration, use the Manual Calibration procedure for the Open Mode. For the Closed Mode (SL or CS), use the Manual Mode to Mode Calibration procedure.

Figure 13.13: Enter Calibration Factor Screen

Pre-Calibration ProceduresBe certain to complete the procedures outlined in the Pre-Calibration Procedures section of Chapter 6 before beginning the calibration procedure. Human blood should be used to verify specifications.

ENTER CALIBRATION FACTOR

RESTOREFACTORS

RETURN

ReadyDec 01 1998Operator IDSequence #

09:327321700

Animal: CAT Ready

Open Sampler

Parameter Factor

MCV 0.486

MPV 0.974


Veterinary PackageChapter 13 Calibration

Determining the Calibration Factors for MCV and MPV1. From the MAIN MENU screen, press the [RUN] key followed by

the [ANIMAL TYPE] key.




4. Use the arrow keys on the keyboard to move the cursor to an empty QC file. Name the file as directed in the appropriate manual calibration procedure and press the [QC SPECIMEN] key.

5. Press [RETURN] key to display the RUN screen for the selected QC file.

6. Run the samples as directed in the appropriate manual calibration procedure.

7. Compute the MCV and/or MPV calibration factors as follows:

If the RBC gains or set point entry was changed, a new MCV Calibration Factor must be calculated as follows:

If platelet gains or set point entry was changed, an new MPV Calibration Factor must be calculated as follows:

Entering the Calibration Factor1. From the MAIN MENU screen, press the [CALIBRATION] key.

The MCV and MPV calibration factors for the selected species and sampler mode are displayed on the screen.

2. If necessary, press the [OPEN SAMPLER] key or the [CLOSED SAMPLER] key to display the calibration factors for the other mode.

3. Press the [ENTER FACTOR] key to display the ENTER CALIBRATION FACTOR screen for the selected mode.

Default RBC GainsAnimal RBC Gains

x Current Default MCV Cal Factor =New MCV Factor

Default PLT GainsAnimal PLT Gains

x Current Default MPV Cal Factor =New MPV Factor


9140320C — November 2000

Veterinary PackageCalibration Chapter 13

4. Use the arrow keys on the keyboard to move the cursor to the appropriate factor and type in the new factor. Press the Enter key on the keyboard to save the entry and advance the cursor.

5. When the new factor(s) have been entered, press the [RETURN] key to display the CALIBRATION LOG screen.

6. Document the calibration as directed in the calibration procedure.

NOTE: It is important to include the name of the species in the Calibration Log, as it includes records for all calibrations.



Quality Control

Quality Control procedures are identical to those described in Chapters 5: Operating Instructions and Chapter 7: Quality Control.


9140320C — November 2000

Veterinary PackageQuality Control Chapter 13

NOTES


Veterinary PackageChapter 13 Adding New Animal Types

Adding New Animal Types

NOTE: The Animal Catalog contains pre-programmed configuration files for common species. All performance characteristics given in this chapter are based on these animal types. Additional species may be configured by the user, but no instrument performance claims can be provided.

Adding new species to the Animal Type Set Up Table is a multistep process, as follows:

• The first step is to create a new configuration file for the new species.

• The appropriate instrument settings are then computed for the file by running normal samples from the new species on the instrument. The position of each scattergram and histogram is compared to the scattergrams and histograms for normal human samples. (A diagram is included at the end of this section for use in comparing the population locations.) Adjustment factors are computed from these data for six electronic gain settings.

• The factors are then entered into the configuration file, which adjusts the Analyzer to the new settings.

• Samples are repeated to verify that the new settings are correct and the MCV and MPV are recalibrated if necessary.

• Finally, Baso Box adjustments are made if necessary and samples are repeated to verify changes.


9140320C — November 2000

Veterinary PackageAdding New Animal Types Chapter 13

Adding a New Configuration FileNOTE: Be sure the Vet Package is ON before creating a new configuration file.

Figure 13.14: Add New Animal Type Screen

NOTE: The name of the new species must be different from other animal names that are already in the Animal Type Set Up Table.

1. From the MAIN MENU screen, press [SET UP] key followed by the [ANIMAL SETUP] key.

2. Press the [ADD NEW ANIMAL] key to display the ADD NEW ANIMAL TYPE screen shown in the preceding figure.

3. Type in the name of the new species to be added.

The screen displays the following message: Do you wish to copy this animal from an existing animal?

If you do not wish to copy this animal from an existing animal, type N and press the Enter key on the keyboard to save the entry and advance the cursor. The default settings will be used to create the new configuration file.

ADD NEW ANIMAL TYPE

RETURN

ReadyDec 01 1998Operator IDSequence #

09:417321702

Ready

New Animal name: NEW ANIMAL NAME

Do you wish to copy this animal from an existing animal?



If you do wish to copy this animal from an existing animal, it must be a species that has similar cellular properties. Type Y and press the Enter key on the keyboard to save the entry and advance the cursor.

The screen displays the message: Animal name to copy from:

Type the exact name of the animal whose configuration file you wish to copy. Press the Enter key on the keyboard to save the entry.

4. Run the specimens from the new species.

Setting Up the File1. From the MAIN MENU screen, press [RUN] key followed by the

[ANIMAL TYPE] key.




4. Press the [PATIENT] key followed by the [RETURN] key to display the RUN screen for the selected specimen type.


9140320C — November 2000


Figure 13.15: Customized Display for Adding New Animals

Customizing the DisplayFollow the instructions given in Chapter 5: Operating Instructions for Customizing the Displayed Report. Customize the display as shown in the preceding figure. Select color printing on the CUSTOMIZE PRINTED REPORT Screen for the graphics printer.

Next ID ----------- AutoAnimal: HORSESex(M/F):-M DOB:--/--/--Dr ---------------------Param: 1 Limits: 1


MONO %MEOS %E

BASO %B


MCHC g/dLRDW %

PLT 0.00. K/uLMPV fL

CLEARAPERTURES

WORKLIST

ANIMALTYPE

CUSTOMIZEREPORT

CHANGESAMPLER

PRINTTICKET

COLORPRINT

MAIN



10:207574166


GRANLRTY

SIZE


RBC PLT

XB RBC: XB WBC: Open SamplerWL:OFF



Turning on the Gains TemplateFollow the instructions below for turning on the Gains template (refer to the following figure):

1. If necessary from the RUN screen, press [CHANGE SAMPLER] to select the Open Mode.

2. With the RUN screen displayed, press the F12 key followed by the F2 key on the keyboard. Boxes and crosses will be displayed in the scatterplot/histogram section as shown in the following figure. These tools will assist the user in computing the adjustment for the gain settings in the SET POINT ENTRY section.

NOTE: These tools will be displayed on the RUN screen, the DISPLAY SPECIMEN screen in the DATA LOG, and the FLAGGING DIAGNOSTICS screen. When turned ON, they are displayed on all Patient specimen screens, human as well as animal.

Figure 13.16: Gains Template

Next ID ----------- AutoAnimal: HORSESex(M/F):-M DOB:--/--/--Dr ---------------------Param: 1 Limits: 1


MONO %MEOS %E

BASO %B


MCHC g/dLRDW %

PLT 0.00. K/uLMPV fL

CLEARAPERTURES

WORKLIST

ANIMALTYPE

CUSTOMIZEREPORT

CHANGESAMPLER

PRINTTICKET

COLORPRINT

MAIN



10:207574166


GRANLRTY

SIZE


RBC PLT

XB RBC: XB WBC: Open SamplerWL:OFF


9140320C — November 2000


Preparing the Samples • Specimen recommendations: Obtain 3 to 5 mL of

appropriately anticoagulated blood from at least 3 to 5 healthy animals of the species to be set up.

• The specimens should be analyzed within six hours of collection.

• Use specimens from at least two different animals of the same species to ensure that the scatter populations are displayed in the same general location.

• Each specimen should have sufficient volume to be run four times each in the Open Mode. (Specimens are run in duplicate to compute the adjustment factors and then repeated to verify the adjustments.)

Running the Samples1. Run, in duplicate, a minimum of two normal samples from

the species.

2. Obtain a printout after each run. If necessary, refer to the directions given in Chapter 5: Operating Instructions to customize the graphics report and select color printing.

3. Save the printouts for use in the next section, Determining the Variance.



Determining the Variance

Example

Figure 13.17: Target Locations for the Neutrophil and Lymphocyte populations

The ideal position of the Neutrophil population is shown in Figure 13.17. Increasing or decreasing the WOC 0° gain setting moves the population up and down on the 0° axis. Decreasing or increasing the WOC 10° gain setting moves the population left and right on the 10° axis.

For example, if the Neutrophil population is located below the Target Box, increase the WOC 0° gain setting until the population is centered over the box. If the Neutrophil population is located above the Target Box, decrease the WOC 0° gain setting until the population is centered over the box. If the Neutrophil population is located to the left or right of the Target Box, increase or decrease the WOC 10° gain setting to move the population in the desired direction on the 10° axis.

NOTE: Remember that the Lymphocyte population will also move up and down on the 0° axis and left and right on the 10° axis when the gain settings are increased or decreased.

Neutrophil Population

Target Box

COMPLEXITY10 0

LymphocytePopulation

00

SIZE


9140320C — November 2000


Estimating the WOC 0° and 10° AdjustmentsWorksheets are included at the end of this section. Make copies as necessary.

To estimate the amount of gain adjustment that may be necessary to center the population, do the following:

1. Using the first printout, observe the orange Neutrophil population on the SIZE/COMPLEXITY (0°/10°) scatterplot. Compare the center of the Neutrophil population to the center of the template box. (See the preceding figure.) The population center should be located in the middle of the template box.

2. Using the marks on the 0° axis as a guide (each mark = 25% from the apex), estimate the percent needed to move the center of the population up or down on this axis to center it in the template box. Write this number in the appropriate column on the worksheet.

3. Using the marks on the 10° axis as a guide (each mark = 25% from the apex), estimate the percent needed to move the center of the population left or right on this axis to center it in the template box. Write this number in the appropriate column on the worksheet.

4. Repeat steps 1 through 3 above for the second printout (and any additional printouts) obtained under Running Samples above.

5. On each of the printouts, locate the blue Lymphocyte population on the SIZE/COMPLEXITY scatterplot. Compare the center of the Lymphocyte population to the center of the cross. (You will not be able to directly shift the Lymphocyte population. It will move as the Neutrophil population is shifted.)

6. Average the estimated 0° adjustments. The resulting figure is the percent adjustment (variance) for the 0° axis. Write this number in the appropriate column on the worksheet.

7. Average the 10°estimated adjustments. The resulting figure is the percent of adjustment necessary for the 10° axis. Write this number in the appropriate column on the worksheet.

8. Enter the average variances in the appropriate boxes on the second chart on the worksheet.

9. For a description of the procedure for adjusting gain settings, refer to Entering New Gain Settings later this section.



Estimating the WOC 90° and 90° Depolarized AdjustmentsTo estimate the amount of gain adjustment that may be necessary to center the population, do the following:

NOTE: Retain the sign for the adjustment and the final variance.

1. Using the first printout, observe Neutrophil population on the GRANULARITY/LOBULARITY scatterplot. Compare the center of the Neutrophil population to the center of the cross. (See Figure 13.16.) The population center should be located on the center of the cross.

2. Using the marks on the 90°depolarized axis as a guide (each mark = 25% from the apex), estimate the percent needed to move the center of the population up or down (+ or -) on this axis to center it on the cross. Write this number in the appropriate column on the worksheet.

3. Using the marks on the 90°axis as a guide (each mark = 25% from the apex), estimate the percent needed to move the center of the population left or right (- or +) on this axis to center it on the cross. Write this number in the appropriate column on the worksheet.

4. Repeat steps 1 through 3 above for the second printout (and any additional printouts) obtained under Running Samples above.

5. Average the 90° depolarized estimated adjustments. The resulting figure is the percent adjustment (variance) for the 90° depolarized axis. Write this number in the appropriate column on the worksheet.

6. Average the 90° estimated adjustments. The resulting figure is the percent adjustment (variance) for the 90° axis. Write this number in the appropriate column column on the worksheet.

7. Enter the average variances in the appropriate boxes on Chart 2 on the worksheet.



9140320C — November 2000


RBC and PLT Histogram Adjustments To estimate the amount of gain adjustment that may be necessary to center the population, do the following:

NOTE: Retain the sign for the adjustment and the final variance.

1. Using the first printout, observe the peak of the RBC histogram in relation to the vertical center of the rectangle. (See Figure 13.16.) The RBC histogram peak should be centered on the vertical center of the rectangle.

2. Using the marks on the x-axis as a guide (each mark = 50 channels) determine the present channel and the desired channel. Use the following formula to estimate the percent needed to move the peak of the histogram left (-) or right (+) to center it in the rectangle.

Write this number in the appropriate column on the worksheet.

3. Repeat steps 1 and 2 above for the second printout (and any additional printouts) obtained under Running Samples above.

4. Average the RBC estimated adjustment. The resulting figure is the percent of adujstment (variance) necessary to center the RBC histogram. Write this number in the appropriate column on the worksheet.

5. Repeat steps 1 through 4 above for the PLT histogram.


X 100

Formula:Variance = Desired Channel - Present Channel

Present Channel



Computing the New Gain Settings1. Press the [MAIN] soft key followed by [DIAGNOSTICS] to

display the main DIAGNOSTICS menu.

2. Press the F12 key followed by the F1 key on the keyboard to display the SET POINT ENTRY screen. (See the following figure.)

NOTE: Be sure the appropriate animal type is displayed in the upper left corner of the screen.

3. Press the PRINT SCREEN key on the keyboard to obtain a copy of the current gain settings.

4. Record the current gain settings in the appropriate boxes on the second chart on the worksheet.

5. Compute the adjustment factors as follows:

NOTE: Be certain to retain the sign of the Adjustment Factor.

6. Compute the new settings as follows:

NOTE: If the Adjustment Factor has a negative sign, subtract it from the current setting.

Adjustment Factor = Current Setting X Average Variance

New Setting = Current Setting ± Adjustment Factor


9140320D — June 2003


Figure 13.18: Set Point Entry Screen

Entering the New SettingsCAUTION: Only change the settings for the six parameters to shift the population centers. Do not change any of the other settings on the SET POINT ENTRY screen.

1. For each parameter that needs adjustment, increase or decrease the gain setting with the adjustment factor to center the population.

2. Press [SET ANALYZER] to save the new settings.

NOTE: The analyzer must be in the Ready state to save changes.

3. Press the Print Screen key on the keyboard to obtain a printout of the new gain settings.


13:247323954

SETANALYZER

RETURN

SET POINT ENTRYReady

296 B 4

Current HGBRBCWIC

170032913000

Gains:

THRESH:

Animal: CAT

WOCWOCWOCWOCRBCPLTWIC

WOCRBCPLTPLTWICWIC

0D10D90D90DP

lohilohi

1769136930692825268440953765

32024039640954804095



Verifying the New SettingsNOTE: Retaining a hard copy of each animal gain settings and storing these settings on the Setup-disk is recommended. To save the gain settings on the Set-up disk, refer to the Post-Calibration Procedures Section in Chapter 6.

1. Press [MAIN] followed by [RUN] to return to the RUN screen.

2. Using a specimen from the second animal, run a minimum of 2 samples and observe the WBC population centers on the scatterplots and the RBC/PLT peaks on the histograms.

3. Check the MCVs and MPVs on the repeat runs. If necessary, calculate new factors as follows:

If the RBC gain or set point entry was changed, a new MCV Calibration Factor must be calculated as follows:

If the platelet gain or set point entry was changed, a new MPV Calibration Factor must be calculated as follows:

4. If all gain adjustments were successful, continue processing animal samples. If additional adjustments are necessary, repeat the appropriate procedure for identifying and correcting variances for WOC, RBC, or PLT as described above.

Default RBC Gain X Current Default MCV Cal Factor = New MCV FactorAnimal RBC Gain

Default PLT Gain X Current Default MPV Cal Factor = New MPV FactorAnimal PLT Gain


9140320C — November 2000


Baso Box SetupThe Baso Box setup is used to make an adjustment to the 0°/10° scatterplot when lymphs, monos, or noise is being included in the basophil count.

1. From the MAIN MENU screen, press [SET UP].2. From the SET UP menu, press [ANIMAL SET UP].3. Press F12 - F1 to access the Baso Box Settings.

These settings must be determined for each species (see the following figure):

1. Standard Deviation along Lymph/Neut Centerline to Baso Box. (If lymphs are being called basophils, increase #1 SD.)

2. Standard Deviation from Centerline to Baso Box Upper Line. (If monos are being called basophils, decrease #2 SD.)

3. Standard Deviation from Centerline to Baso Box Lower Line. (If noise is entering baso area, decrease #3 SD.)

4. Standard Deviation along Centerline to Noise Cut. (#1 and #4 should be moved the same number of SDs.)

Figure 13.19: Baso Box Set Up

Legend:N = NeutrophilL = LymphocyteM = MonocyteE = EosinophilBaso = Basophil

ME

L

N

Baso

3

4

1

2SIZE

COMPLEXITY



Adding New AnimalsWorksheet

Instrument: __________________________________ Date:______________________________________

Operator: ____________________________________ Animal:____________________________________

Chart 1: Variance Estimation

SampleID#

WOC 0° Estimated

Adjustment

WOC 10° Estimated

Adjustment

WOC 90°D Estimated

Adjustment

WOC 90° Estimated

Adjustment

RBCEstimated

Adjustment

PLTEstimated

Adjustment

Sum

N

AverageVariance


9140320C — November 2000


Adding New Animals Worksheet

Chart 2: Calculating New Settings

ParameterCurrentSetting x

AverageVariance =

AdjustmentFactor ±

CurrentSetting =

NewSetting

WOC 0D

WOC 10D

WOC 90D

WOC 90DP

RBC

PLT

Chart 3: Verification Run — Variance Confirmation

SampleID#

WOC0° Variance

WOC10° Variance

WOC90°D Variance

WOC90° Variance

RBCVariance

PLTVariance

Sum

N

AverageVariance

VarianceLimit ±5% ±5% ±5% ±5% ±5% ±5%


Veterinary PackageChapter 13 Vet Package Suggestions

Vet Package Suggestions

Some species require special consideration when preparing or running samples.

Avian and Reptile Species1. If only a small amount of specimen is available, dilute it with

diluent to obtain sufficient specimen for processing. (Remember to multiply the results by the dilution factor to obtain correct values.

2. Specimens for these species should not be drawn in EDTA, but in Sodium Citrate or Lithium Heparin. (Remember to multiply by the dilution factor if using Sodium Citrate.)

3. ALL bird and reptile specimens are to be run in Resistant RBC. If the RBCs continue to interfere with the WBC and Differential results, make a 1:4 dilution with Sheath reagent and run within 30 seconds. If Sheath is used to make the dilution, the RBC and Platelet parameters are not valid.

MiceSince only small amounts of specimen are available, make a dilution with diluent in order to have enough specimen for processing.

Multiply the results by the dilution factor to obtain correct values.

Goats, Sheeps, Llamas, and Other Mammals with Red Blood Counts over 10,000Since the linearity of impedance counts may be questionable for species with extremely high RBC counts, the RBC count may be underestimated unless a dilution is made. For example, a 1:2 dilution with diluent may yield more accurate RBC counts and RBC indices.

The results must be multiplied by the dilution factor.


9140320C — November 2000

Veterinary PackageVet Package Suggestions Chapter 13

Examples of Customer-Defined Default CodesThe Vet Package catalog has built-in codes for dog, cat, mouse, and rat. All other animals must be set up by starting with the default and then adapting the settings. The chart that follows lists some different examples of animal default settings that may be set by individual laboratories. Be sure to set default settings according to the needs of your own laboratory.

Animal 0 10 90 90D RBC PLT WIC MCV MPV WBC Threshold

African Grey 2.172414 1.569185 1.800365 0.748581 0.672043 1 1 1.294 1 499Baboon 1.087731 0.984767 1 1.17096 1.172267 1 1 1 1 360Beluga Whale 1.133031 1.049318 1 1 1 1 1 1.512 1 360Birds of Prey 1.33515 1.292976 1.519166 0.569043 0.509359 1 1 0.575 1.018 400Cat 1.542876 1.164875 2.044352 2.046253 1.8624 1.051621 1 0.434 1.018 400Cat 1.380197 1.078699 1.931829 2.045567 1.722136 1.037313 1 0.491 1.018 400Cat 1.380197 1.078699 1.931829 2.045567 2.019181 1.037313 1 0.575 1.018 400Cat 1.38006 1.101079 2.04504 2.046538 1.05126 1 0.575 1.018 400Cat 1.518741 1.22473 2.454656 2.249716 2.15 1.049957 1 0.465 0.952 400Catfish 1.236882 2.010795 2.433962 2.26958 1 1 1 1 1 360Chicken 1.723388 1.373896 1.52039 0.567537 0.758602 1 1 1.26 1 360Chick2 - 1.874063 1.373896 1.52039 0.567537 0.758065 1 1 1.26 1 299Chicken 2.307346 1.439647 1.800365 0.748581 1 1 1.488 1 360Cow 1.380607 1.102151 2.044352 2.046253 1.8624 1.051621 1 0.491 1.018 400Cow 1.380197 1.078699 1.931829 2.045567 2.122862 1.797191 1 1 1 360Cow 1.273613 0.939156 1.216677 0.99319 2.15 1.15682 1 0.465 0.864 400Cow 1.568966 1.206084 2.103469 1.983541 2.15 1.15682 1 0.465 0.864 400Cyno Monkey 1.137863 1.044803 1 1 1 1 1 0.704 0.772 320Deer 1.16042 1.128557 1.962264 2.249716 2.15 0.781929 1 0.465 1.279 400Dog 1.346183 1.095488 1.931829 2.404557 1.384137 1.779631 1.133841 0.97 1 360Dog 1.415292 1.159961 2.04504 2.26958 1.495161 1.646829 1.133846 0.669 0.607 320Dog 1 1.311844 1.274779 1.156421 2.213394 1.20808 1.646829 1.133846 0.669 0.607 320Dog 2 1.424288 1.324828 1.276932 2.213394 1.495161 1.646829 1.133846 0.669 0.607Dolphin 1 1 1 1.123153 1 1 1 not calc not calc 650Dolphin 0.991004 0.934249 1.240414 1.045403 1.036559 0.98914 1.008923 1 1 360Dolphin 1 0.991004 0.934249 1.240414 1.045403 1.036022 0.988705 1.008615 1 1 360Duck 1.813325 1.366487 1.418687 0.468384 0.973333 0.778584 1 0.97 1 360Elephant 2.284203 1.929696 1 1.368842 0.94816 1.043898 1 0.491 1.018 400Emu 1.461019 1.029441 1.52039 0.567537 0.757527 1 1 1.42 1 499Emu 1.461019 1.029441 1.52039 0.567537 0.756989 1 1 1.42 1 599Ferret 1.51096 1.520462 2.008337 2.045567 1.86366 1.037313 1 2.47 1 360Ferret 1.518741 1.22473 2.454656 2.096481 2.15 1.049957 1 0.465 0.952 400Fish 1.621271 2.276539 2.430295 2.269377 0.404313 1.417096 1 0.97 1 360Foal 1.446777 1.044161 2.454656 2.250851 2.15 1.433102 1 0.465 0.698 400Gentoo Penguin 1.437642 0.860441 1.616969 0.570197 0.478486 0.247147 1 not calc. not calc 360Goat 1.16042 1.128557 1.962264 2.249716 2.15 0.781929 1 0.465 1.279 400Goat 1.574213 1.274779 1.825928 2.096481 2.15 0.781929 1 0.465 1.279 400Goat 2 1.16042 1.128557 1.962264 1.829739 2.150538 0.000434 1 0.465 1.279 400Hamster 0.961741 0.945341 1 1 1 1 1 0.493 0.575 360Horse 1.51096 1.310598 2.008337 2.520936 2.122343 1.797191 1 0.97 1 360Horse 1.446777 1.044161 2.454656 2.250851 2.15 1.433102 1 0.465 0.698 400Horse 2 1.1994 1.177625 23454656 2.250851 2315 13433102 1 0.465 0.698 400Llama 1.37415 1.426023 1.137813 1.067734 2.122862 1.636962 0.992073 0.97 1 360Llama 1.49925 1.177625 1.673159 2.213394 2.201613 1.778019 0.861538 0.454 0.562 400Lizard 2.998501 2.943081 2.433962 1.135074 1 1 0.692308 1 1 360Macaw 2 2.172414 1.569185 2.433962 0.681044 0.537634 1.433102 0.384615 1.294 1 400Moray Eel 1.239607 2.010493 2.008337 2.023399 1 1 1 not calc not calc. 360Mouse 1.054749 0.896057 1 1 2.0256 1.706485 1 0.65 1 360


Veterinary PackageChapter 13 Vet Package Suggestions

Animal 0 10 90 90D RBC PLT WIC MCV MPV WBC Threshold

Ostrich 1.461019 1.029441 1.52039 0.567537 0.757527 1 1 1.42 1 499Ostrich 1.461019 1.029441 1.52039 0.567537 0.763441 1 1 1.55 1 360Ostrich 1.461019 1.029441 1.52039 0.567537 0.760215 1 1 1.55 1 360Ostrich 1.461019 1.029441 1.52039 0.567537 0.760215 1 1 1.42 1 360Pig 1.383905 1 1.477824 1.462529 2.184 1.194539 1 not calc not calc. 650Pig 1.415292 1.159961 2.04504 2.26958 1.770968 1.737619 1.133846 0.564 0.576 320Pig 1- 1.723388 1.668302 2.04504 2.26958 1.769892 1.737619 1.133846 0.564 0.575 320Pigeon 2.307346 1.439647 1.800365 0.748581 0.672043 1 1 1.488 1 360Prairie Chicken 1.874063 1.569185 1.52039 0.567537 0.757527 1 1 1.26 1 349Quail 1.51715 1.253584 1.418687 0.468384 1 1 1 not calc not calc 360Rabbit 1.154354 0.984767 1.301005 0.789813 1 1 1 0.616 0.62 360Rabbit 1.504913 1.373557 1.273664 1.163177 1.594609 1.797191 0.992073 not calc not calc 360Rabbit 1.43928 1.049068 1.455265 0.575482 1.378495 1.099913 1 0.726 0.909 360Rat 1.384565 1.164875 2.364873 2.34192 1.6 2.97619 1 1 1 360Rat 1.554723 1.139352 1.339014 2.270148 1.666667 1 1 0.6 0.72 360Rhesus 1.87335 0.983871 1.063868 1 1 1 1 1 1 360Sea Turtle 1.535982 1.519136 2.310408 2.26958 1 1 1 1 1 360Sheep-Goat 1.931784 1.544652 1.946439 0.681044 2.15 1.443962 1 1 1 360Snake 1.542729 1.668302 2.190505 2.433962 1 1 0.692308 1 1 240Squirrel Monkey 1 1 1 1 1 1 1

SPECIES 0 10 90 90D RBC PLT WIC MCV WBC RBC

CAL THRES THRESAfrican Grey 2.74 2.24 2.39 0.63 0.77 0.77 1.41 1.304 1.59 1.00Budgerigar 2.14 1.49 1.71 0.99 0.50 1.00 1.41 2.047 1.66 1.00Cockatoo 1.63 1.44 1.20 0.75 0.50 1.00 0.97 1.853 1.66 1.00Conure 1.81 1.44 1.80 0.75 0.67 0.97 0.94 1.364 1.66 1.00Great Horned Owl 2.56 1.79 2.73 1.26 0.75 1.00 0.97 1.374 0.83 1.00Gyrfalcon 1.63 1.44 1.20 0.75 0.50 1.00 0.97 1.364 1.66 1.00Macaw 1.81 1.44 1.80 0.75 0.67 0.97 0.97 1.364 1.66 1.00Meyer’s Parrot 2.19 1.49 1.71 0.75 0.50 1.00 0.94 20.47 1.66 1.00Owl 1.63 1.44 1.20 0.75 0.50 1.00 0.97 1.364 1.66 1.00Red Tailed Hawk 2.56 1.79 2.73 1.26 0.75 1.00 0.97 1.209 0.83 1.00Rhea 1.60 1.00 1.50 0.60 0.70 1.00 1.00 1.307 1.00 1.00Swainson’s Hawk 2.56 1.79 2.73 1.26 0.75 1.00 0.97 1.209 0.83 1.00


9140320D — June 2003

Veterinary PackageVet Package Suggestions Chapter 13

NOTES



Turning The Vet Package Off

When the Veterinary Package software is turned OFF, the instrument automatically returns to the original human settings and runs three background cycles to rinse the instrument.

Procedure: Turn Vet Package OFFNOTE: The instrument must be in the Open Mode in order to exit the Vet Package.

1. From the MAIN MENU screen, press [SET UP] followed by [OPERATION SET UP].

2. From the OPERATION SET UP MENU screen, press [TURN VET PKG OFF] to disable the veterinary software.

NOTE: The key label changes to [TURN ON VET PKG] when the Vet Package is deselected.

The instrument automatically returns to the original human settings and runs three background cycles. The Status Box displays the message RINSING THE ANALYZER and the Bulletin Line displays the message: Please wait while the analyzer is rinsed.

3. Verify that the background count is acceptable on the last cycle. If the background count is not acceptable, troubleshoot accordingly as directed in Chapter 10: Troubleshooting.

4. Quality Control samples should be run in the human mode before processing samples. Follow the instructions given in Chapter 5: Operating Instructions, Subsection: Daily Quality Control.


9140320C — November 2000

Veterinary PackageTurning The Vet Package Off Chapter 13

NOTES



References

1. Specifications for rats and mice were obtained from a study conducted between December 1993 and May 1994 by Dr. H. Lutz at the Facility of Veterinary Medicine, University Zurich, Zurich, Switzerland.


9140320C — November 2000

Veterinary PackageReferences Chapter 13

NOTES


Reticulocyte PackageChapter 14 Overview

Reticulocyte Package

Overview

The Reticulocyte Package software enables the operator of the CELL-DYN 3700 System to analyze a whole blood specimen for reticulocytes. The Reticulocyte specimen is prepared by using reticulocyte reagent to produce a diluted, stained sample. Reticulocyte specimens can be run as batches up to two hours after preparation, or they can be run on a STAT basis.

The Reticulocyte Package is enabled by pressing [TURN ON RETIC PKG] from the OPERATION SET UP MENU screen.

Each menu and function is modified when used in the Reticulocyte Package. Therefore, some of the soft keys that are displayed in the Standard Hematology Mode will be available from the different Reticulocyte screens, and some will not. A Reticulocyte Data Log and a Reticulocyte QC Log are available for samples and controls run within the Reticulocyte Package. Descriptions of all Reticulocyte soft keys are included in this chapter.

The prepared specimen run with the Reticulocyte Package on the CELL-DYN 3700 System will measure results as a reticulocyte percentage. The reticulocyte absolute number is automatically calculated when the RBC value is made available from the Standard Hematology Data Log or entered by the operator. The Immature Reticulocyte Fraction (IRF) is calculated from the Reticulocyte % and displayed below the Reticulocyte absolute number.

The CELL-DYN 3700 System can be returned to the Standard Hematology function by pressing [TURN OFF RETIC PKG] from the OPERATION SET UP MENU screen.

14-2 CELL-DYN 3700® System Operator’s Manual9140320C — November 2000

Reticulocyte PackageOverview Chapter 14

Chapter Contents

This chapter contains the following subsections:

• Principles of Operation

• Retic Menu Options

• Turning the Reticulocyte Package ON and OFF

• All Retic Menus Except the Retic Run Menu

• Routine Operation

• Retic Run Menu

• Reticulocyte Specimens

• Quality Control Guide

• Maintenance

• Troubleshooting




When procedures are depicted in flowcharts, shaded boxes and bold lines indicate which soft keys to press:

FlowchartsThe Reticulocyte Package master menu flowchart on the following page was designed to help guide the operator quickly and easily through the menu levels and soft key functions used in the Reticulocyte Package. A segment of this flowchart is included at the beginning of each submenu description to guide the operator through the levels and functions of each submenu and back again to the MAIN MENU. The master menu flowchart can be used as a pull-out guide.

MAIN MENUReady


RETIC DATA LOG

MAIN MENUReady

PATIENT REAGENTLOG

QC SETUP MENU

OPERATIONSET UP

SET UP RUN DATA LOG QUALITY

TURN ONVET PKG

TURN ONRETIC PKG

BAR CODESET UP

CONTROL

LIMITS

RETIC DATA LOG



NOTES



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NOTES


Reticulocyte PackageChapter 14 Principles of Operation


The Reticulocyte Package software is designed to configure the instrument to process stained, diluted specimens. When the Reticulocyte Package is turned ON, the instrument automatically selects the appropriate configuration file and adjusts the instrument settings to the values in this file. This configuration is retained until the Reticulocyte Package is turned OFF. The instrument then returns to the Standard Hematology settings.

Reticulocytes are defined by the Clinical and Laboratory Standards Institute (formerly NCCLS) as transitional red cells, between nucleated red cells and the so-called mature erythrocytes1. In contrast to mature RBCs, reticulocytes contain ribosomal RNA. This RNA can be seen with certain supravital, cationic dyes that simultaneously stain and precipitate the polyanion to form a network or reticulum. The CELL-DYN 3700 System reticulocyte method uses the thiazine dye New Methylene Blue N. The reticulocyte assay is performed in the WOC channel of the instrument. Sample preparation is performed manually by diluting 20 µL of blood into a tube of CELL-DYN Reticulocyte Reagent. At room temperature, staining of reticulum is complete within approximately 15 minutes. The stained sample is aspirated in the Open Mode. After the stained sample is aspirated, it is diluted approximately 50-fold with Sheath Reagent. Once diluted with Sheath, the RBCs sphere due to the influence of the nonionic detergent incorporated into the staining solution. Sphering is necessary to eliminate optical orientational noise that would otherwise be introduced into the scatter measurements. The usual lytic action of the Sheath is prevented by electrolytes contained in the staining solution and the lack of the usual incubation period used in this channel during WBC analysis. In addition, the high New Methylene Blue concentration in the staining reagent exerts a stabilizing effect on RBCs.

During data acquisition, 10 degree and 90 degree scatter are collected for up to 30,000 events. The 0 degree threshold is set high enough to exclude most platelets. Histogram data are used to differentiate reticulocytes, mature RBCs, platelet clumps, and nucleated cells. Reticulocytes have 10 degree scatter that are similar to the scatter for mature RBCs, but differ from them by exhibiting greater 90 degree scatter. Reticulocytes are reported in percent. The instrument will automatically calculate the Reticulocyte Absolute value if an RBC count is entered.

14-8 CELL-DYN 3700® System Operator’s Manual9140320F — April 2007

Reticulocyte PackagePrinciples of Operation Chapter 14

The RBC value may be obtained from the Standard Hematology Data Log, or it may be entered by the operator directly on the RETIC PATIENT SPECIMEN screen.

Immature reticulocytes contain more RNA and absorb more stain than mature reticulocytes; therefore, they exhibit greater 90 degree scatter. On the CELL-DYN 3700, immature reticulocytes are classified as the population of reticulocytes that exceed a predetermined scatter threshold. Consequently, it is possible to determine the Immature Reticulocyte Fraction (IRF) from the scatter measurements.

The IRF was initially designated as the Reticulocyte Maturation

Index (RMI), and defined by CLSI/NCCLS H44-A21 as a quantitative expression of the maturation state of the entire reticulocyte population in the peripheral blood. Since automated reticulocyte methods allow the enumeration of immature reticulocytes as a subfraction of the total reticulocyte population, the preferred nomenclature is Immature Reticulocyte Fraction (IRF). The immature reticulocytes are then reported as a fraction (or percent) of the reticulocytes.

The clinical utility2 of the IRF is widely recognized as follows:

• Monitor hemopoietic regeneration after bone marrow transplant, hemopoietic stem cell transplantation, or intensive chemotherapy

• Monitor bone marrow toxic insults from drugs (for example, AZT)

• Monitor erythropoietin therapy in renal failure, AIDS, infants, myelodysplastic syndromes, and blood donations

• Classify anemia

• Monitor efficacy of anemia therapy (Fe, B12, Folate)


Reticulocyte PackageChapter 14 Retic Menu Options

Retic Menu Options

This section discusses the operation of the Reticulocyte Package. It contains the following subsections:

• Turning the Reticulocyte Package ON and OFF

• Retic Main Menu

• Retic Set Up Menu

• Retic Data Log Menu

• Retic QC Log Menu

• Retic Diagnostics Menu

• Retic Special Protocols Menu

For information about the RETIC RUN menu, refer to Routine Operation, Retic Run Menu later in this chapter. For specific instructions about running Reticulocyte specimens, refer to Routine Operation, Reticulocyte Specimens later in this chapter.


Reticulocyte PackageRetic Menu Options Chapter 14

Turning the Reticulocyte Package ON and OFF

Turning ON the Reticulocyte PackageThe [TURN ON RETIC PKG] key is located on the OPERATION SET UP MENU screen (see the following figure), which is accessed from the SET UP screen. The Reticulocyte Package software is enabled when the [TURN ON RETIC PKG] key is pressed, and the soft key label changes to [TURN OFF RETIC PKG]. When the Reticulocyte Package is ON, the soft keys are displayed as described in this chapter.

Figure 14.1: Operation Set Up Menu Screen with Reticulocyte Package Disabled

TURN ONRETIC PKG

TURN OFFRETIC PKG

TURN ONVET PKG

BAR CODESET UP

COMPUTERSET UP

RETURN


Mar 22 1998Operator IDSequence #

16:10

123

TURN ONRETIC PKG

To turn on the RETIC PKG you must enter the operator ID and the

sy

instrument must be in Open mode. To turn on the VET PKG you mustexit the RETIC PKG.



Procedure: Turning ON the Reticulocyte Package1. From the MAIN MENU, press the [SET UP] key followed by the

[OPERATION SET UP] key to display the OPERATION SET UP MENU screen.

2. From the OPERATION SET UP MENU screen, press the [TURN ON RETIC PKG] key to enable the Reticulocyte Package.

NOTE: The key label changes to the [TURN OFF RETIC PKG] key when the Reticulocyte Package has been enabled.

3. Press the [RETURN] key to display the RETIC SET UP screen. Then press the [RETIC MAIN] key to display the RETIC MAIN menu screen.

The software to analyze reticulocytes is now enabled on the CELL-DYN 3700 System.

MAIN MENUReady

DATE/ UNITSSELECTION

CUSTOMIZEREPORT

PATIENTLIMITS SET UP

OPERATION MAINREAGENTLOG

QC SETUP MENU

SET UP DIAGNOSTICS SPECIALPROTOCOLS

RUN CALIBRA-DATA LOG QUALITY

TURN ONVET PKG

TURN ONRETIC PKG SET UP

COMPUTER RETURNBAR CODESET UP

RETICRETICUNITS

RETIC PTLIMITS SET UP

OPERATIONMAIN

RETIC QCSET UP

CONTROL TION

TIME

RETICDATA LOG



Turning OFF the Reticulocyte PackageThe [TURN OFF RETIC PKG] key is located on the RETIC OPERATION SET UP MENU screen (see the following figure), which is accessed from the RETIC SET UP screen. The Reticulocyte Package software is disabled when the [TURN OFF RETIC PKG] key is pressed, and the soft key label changes to [TURN ON RETIC PKG]. When the Reticulocyte Package is OFF, the soft keys are displayed as described in Chapter 5: Operating Instructions.

Figure 14.2: Operation Set Up Menu Screen with Reticulocyte Package Enabled

When the Reticulocyte Package is turned OFF, the instrument automatically runs three wash cycles before returning to the Standard Hematology Mode.

CAUTION: If the instrument has been idle for four hours, it enters the STANDBY state and automatically returns to the Standard Hematology mode without running a cleaning cycle. If this happens, perform an Auto-Clean cycle before using the instrument again.

TURN OFFRETIC PKG


BAR CODE RETURNCOMPUTERTURN OFFRETIC PKG SET UP SET UP

Mar 22 1998Operator IDRetic Seq#

14:10

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Procedure: Turning OFF The Reticulocyte Package1. From the RETIC MAIN menu screen, press the [RETIC SET UP]

key followed by the [OPERATION SET UP] key to display the OPERATION SET UP MENU screen.

2. From the OPERATION SET UP MENU screen, press the [TURN OFF RETIC PKG] key to disable the Reticulocyte Package. The instrument automatically rinses, runs three backgrounds, and returns to the Standard Hematology Software.

NOTE: The key label changes to [TURN ON RETIC PKG] when the Reticulocyte Package has been disabled.

3. Press the [RETURN] key to display the MAIN MENU.

The software to analyze reticulocytes is now disabled on the CELL-DYN 3700 System.

MAIN MENUReady

UNITS RETIC PT

LIMITS SET UPOPERATION

MAINRETIC QCSET UP

SET UP DIAGNOSTCRETIC SP

PROTOCOLSRUN DATA LOG

TURN OFFRETIC PKG SET UP

COMPUTER RETURNBAR CODESET UP

DATA LOGRETICRETIC RETIC RETIC

QC LOGRETIC

RETICRETIC

14-14 CELL-DYN 3700® System Operator’s Manual9140320E — September 2004


Retic Main Menu

Figure 14.3: Reticulocyte Main Menu Screen

The upper left-hand corner of the RETIC MAIN menu screen shows the current revision of the instrument system. The upper right-hand corner shows the current date and time, the current operator ID, and the Reticulocyte Sequence Number. The information in the upper right-hand corner is displayed on every screen during operation of the Reticulocyte Package.

The Status Box is displayed in the top center of the screen. This box appears on every screen to show the following information:

• Menu in use (such as RETIC MAIN)

• Analyzer status (such as Ready)

• Other applicable information (such as report or file identity and any existing fault conditions)

RETIC RETIC RETIC DATA LOG RETICSET UP RUN DATA LOG QC LOG DIAGNOSTC

RETIC SPPROTOCOLS

CD 3700SL RETIC MAIN Ready

Version 1.1Aug 16 2004Operator IDRetic Seq#

14:10

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RETIC



The cursor is positioned at the <OPERATOR ID> field when the RETIC MAIN menu screen is displayed. An operator ID of up to three alphanumeric characters can be entered. Press the Enter key on the keyboard to accept this operator ID. This operator ID will be displayed on all other Reticulocyte Package screens and printed on all reports.

The following soft key labels are displayed on the RETIC MAIN menu screen:

RETIC SET UPRETIC RUNRETIC DATA LOGDATA LOGRETIC QC LOGRETIC DIAGNOSTCRETIC SP PROTOCOLS

The RETIC RUN menu is described in Routine Operation later in this chapter.



Retic Set Up Menu

Figure 14.4: Reticulocyte Set Up Screen

RETIC SET UPReady

MEANS/LIMITS

RANGEENTRY

RETICQC LIMITS

RETICSET UP QC

COMPUTERSET UP

BAR CODESET UP

RETICRETICUNITS

RETIC PTLIMITS MAIN

RETIC QCSET UP SET UP

OPERATION

RETIC MAINReady

TURN OFFRETIC PKG

RETIC

RETIC SET UP Ready


14:10

OPERATIONSET UP

RETICUNITS

RETIC QCRETIC PTLIMITS SET UP

R123sy

MAIN



The following soft keys are displayed on the RETIC SET UP menu screen:

RETIC PT LIMITSRETIC QC SET UPOPERATION SET UPRETIC UNITSRETIC MAIN

These soft keys are described in this section as they appear from left to right on the screen.

Retic Patient Limits Soft KeyThe [RETIC PT LIMITS] key is used to display the RETIC PATIENT LIMITS screen (see the following figure). The following soft key labels are displayed on the RETIC PATIENT LIMITS screen:

LIMIT SET 1*LIMIT SET 2LIMIT SET 3LIMIT SET 4PRINTRETURN

*The soft key label for whichever limit set is displayed on the screen is not shown.

RETIC PTLIMITS



Figure 14.5: Reticulocyte Patient Limits Screen

The [RETIC PT LIMITS] key is used to enter upper and lower flagging limits for groups of patient samples. (For example, limits may be entered for adult males, adult females, neonates, etc.)

Four sets of limits may be entered. Whenever a result falls outside an entered limit, the result is displayed in color on the screen to alert the operator. Results displayed in yellow are below the limit and results displayed in purple are above the limit. The flagged result is underlined on the graphics report and in the Reticulocyte Data Log when printed. Patient results that exceed the linearity specifications will be suppressed and chevrons (>>>>) will be displayed and printed.

Procedure: Enter Retic Patient Limits1. From the RETIC SET UP screen, press the [RETIC PT LIMITS] key

to display the RETIC PATIENT LIMITS screen. A patient limit set is displayed on the screen. The other three limit sets (Limit Set 2, Limit Set 3, etc.) may be displayed by pressing the appropriate soft keys.

RETURNLIMITSET 2

RETIC PATIENT LIMITSReady

LIMITSET 3

PRINTLIMITSET 4

RETIC% 1.06 % 2.64 %

RETIC ABS 10 K/uL 140 K/uL

RBC 4.04 M/uL 6.13 M/uL

IRF 0.01 0.25

Lower Limits Upper Limits

LIMIT SET 1


14:10

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2. Use the arrow keys on the keyboard to move the cursor to the desired limit entry field and type the desired number. Press the Enter key on the keyboard to save the entry.

3. Repeat step 2 until all desired entries have been made.

4. If desired, press the [PRINT] key to obtain a printout of the Limit Set being displayed.

NOTE: Retaining a hard copy of each Limit Set is recommended, as the screens do not display names or categories for the Limit Sets.

5. Press the appropriate soft key to select another Limit Set and repeat steps 2– 4 to enter the desired limits.

6. Press the [RETURN] key to return to the RETIC SET UP menu.

Retic QC Set Up Soft Key

Figure 14.6: Reticulocyte QC Set Up Screen

1.2.3.4.5.6.

File Name

Press arrow key to select RETIC QC FILE at cursor position.

FILE 1FILE 2FILE 3FILE 4FILE 5FILE 6

000000

# Specimens

RETURNRETICQC LIMITS

RETIC SET UP QC

RETIC QC SET UP Ready


14:10

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The [RETIC QC SET UP] key is used to display the QC files and the RETIC QC SET UP screen (see the preceding figure). The following soft key labels are displayed on the RETIC QC SET UP screen:

RETIC QC LIMITSRETIC SET UP QCRETURN

This section discusses the procedures that are used to set up the Reticulocyte QC files. The keys are discussed in the order in which they are used to set up the QC files. Use the arrow keys on the keyboard to move the cursor to the desired QC file shown on the RETIC QC SET UP screen, then type in the desired alphanumeric file name. (Up to 12 characters may be entered.) Press the Enter key on the keyboard to save the entry and advance the cursor to the next QC file. Use the arrow keys to move the cursor back into the selected file. Then press the [RETIC QC LIMITS] key or the [RETIC SET UP QC] key to continue to set up the QC file.

Retic QC Limits Soft KeyThe [RETIC QC LIMITS] key is used to display the RETIC QC RANGE ENTRY screen or the RETIC QC MEANS/LIMITS screen, and the following soft key labels:

MEANS/LIMITS orRANGE ENTRY (This key label alternates between these two selections.)

PRINTRETURN

RETIC QCSET UP

RETIC QCLIMITS



Figure 14.7: Retic QC Range Entry Screen

RETURNMEANS /LIMITS

RETIC QC RANGE ENTRYReady

PRINT

Lower Limit Upper Limit


14:10

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RETIC % 4 6

IRF 0.47 0.77

For FIle 1



Figure 14.8: Retic QC Means/Limits Screen

QC Limits are entered by selecting the QC file from the RETIC QC SET UP screen (by moving the cursor to the desired QC file) and pressing the [RETIC QC LIMITS] key. The RETIC QC MEANS/LIMITS screen is now displayed.

Two types of QC limits are available:

Range Entry This option is used to enter the upper and lower flagging limits as absolute numbers.

Means and Limits This option is used to enter the mean value and a + range value that defines the upper and lower flagging limits.

RETIC QC MEANS/LIMITSReady

Means Limits (+/-)

RETURNRANGE PRINT


14:10

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ENTRY

For File 1

RETIC% 5 1

IRF 0.62 0.15



If Range Entry is selected by pressing the [RANGE ENTRY] key, the current upper and lower limits for the selected file are displayed as shown in Figure 14.7, Retic QC Range Entry Screen.

If Means/Limits Entry is selected by pressing the [MEANS/LIMITS] key, the current means and limits for the selected file are displayed as shown in Figure 14.8, Retic QC Means/Limits Screen.

Procedure: Range Entry1. Select a file from the RETIC QC SET UP screen by using the

arrow keys on the keyboard to move the cursor to the desired file.

2. Press the [RETIC QC LIMITS] key followed by the [RANGE ENTRY] key to display the RETIC QC RANGE ENTRY screen for the selected file.


4. Type the desired numbers and press the Enter key on the keyboard to save each entry.

5. If desired, press the [PRINT] key to obtain a printout of the entered values.

6. Press the [RETURN] key to save the entries and return to the RETIC QC SET UP screen.

NOTE: When entries are saved, the software checks to see if any entries would result in the upper limit being less than the lower limit. If this situation occurs, the limits are automatically reversed. The bulletin line displays the following message:

LIMITS WERE EXCHANGED TO MAKE UPPER > LOWER

Procedure: Means/Limits Entry1. Select a file from the RETIC QC SET UP screen by using the

arrow keys on the keyboard to move the cursor to the desired file.

2. Press the [RETIC QC LIMITS] key to display the RETIC QC MEANS/LIMITS entry screen for the selected file.


4. Type the desired means and limits values and press the Enter key on the keyboard to save each entry.

RANGEENTRY

MEANS/LIMITS



5. If desired, press the [PRINT] key to obtain a printout of the entered values.

6. Press the [RETURN] key to save the entries and return to the RETIC QC SET UP screen.



Retic Set Up QC Soft Key

The [TOGGLE ON/OFF] key is used to configure the QC file. The file can be used for commercial controls. The lot number and expiration date may be entered into the appropriate areas on the RETIC SET UP QC screen (see the following figure) and saved by pressing the Enter key on the keyboard. The following soft key labels are displayed on the RETIC SET UP QC screen:

TOGGLE ON/OFFPRINTRETURNThe Westgard Rule selections can be toggled ON or OFF using the [TOGGLE ON/OFF] key.

The Westgard Rules are discussed in detail in Chapter 7: Quality Control.

Figure 14.9: Retic Set Up QC Screen

RETIC

SET UP QC

TOGGLEON/OFF

Lot Number: _ _ _ _ _ _ _ Expiration Date (Month/Day/Year): _ _/_ _/_ _


ON RULE 1:

OFF RULE 2:

ON RULE 3:

OFF RULE 4:

ON RULE 5:

OFF RULE 6:

Value outside 3 SD.






RETIC SET UP QCReady

PRINTTOGGLE RETURNON/OFF


14:10

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For File 1



Procedure: QC File Set Up1. Select a file from the RETIC QC SET UP screen by using the


2. Press the [RETIC SET UP QC] key to display the RETIC SET UP QC screen.

3. Move the cursor to the <Lot Number> entry field. Enter the alphanumeric lot number with up to 9 characters. Press the Enter key on the keyboard to save the entry.

4. The cursor will move to the <Expiration Date> entry field. Use the same format indicated using one or two digits. Separate the digits with a slash (/) or a period(.). Press the Enter key on the keyboard to save the entry.

5. The cursor will advance to the <WESTGARD RULE SELECTION> entry fields. Use the arrow keys on the keyboard to position the cursor at the desired Westgard Rule. Press the [TOGGLE ON/OFF] key to enable or disable the rule and advance the cursor.

6. Repeat step 5 until all desired rule selections have been made.

7. If desired, press the [PRINT] key to obtain a printout of the entries.

8. Press the [RETURN] key to return to the RETIC QC SET UP screen.

9. These steps can be repeated for each QC file you need to set up.



Operation Set Up Soft Key

Figure 14.10: Operation Set Up Menu Screen with Reticulocyte Package Enabled

The [OPERATION SET UP] key on the RETIC SET UP menu is used to display the OPERATION SET UP MENU screen. The OPERATION SET UP MENU screen in the Reticulocyte Package displays the following soft keys:

TURN OFF RETIC PKGBAR CODE SET UPCOMPUTER SET UPRETURN

The [TURN OFF RETIC PKG] key is discussed earlier in this chapter (in Retic Menu Options, Turning the Reticulocyte Package ON and OFF). The [BAR CODE SET UP] and [COMPUTER SET UP] keys are described in Chapter 5: Operating Instructions.


BAR CODE RETURNCOMPUTERTURN OFFRETIC PKG SET UP SET UP


14:10

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OPERATION

SET UP



Retic Units Selection Soft Key

Figure 14.11: Reticulocyte Units Selection Screen

The [RETIC UNITS] key on the the RETIC SET UP screen is used to display the RETIC UNITS SELECTION screen (see the preceding figure). The RETIC UNITS SELECTION screen shows the report units for the indicated parameters. Units may be selected for each parameter individually, or a set of units may be selected by pressing the appropriate soft key. The following soft key labels are displayed on the RETIC UNITS SELECTION screen:

USA UNITSSI UNITSSI MOD UNITSSET 1 UNITSSET 2 UNITSSELECT UNITSRETURN

RETIC UNITS SELECTIONReady

USA RETURNSI SI MOD SET 1 SELECTUNITS UNITS UNITS UNITS UNITS

Parameters

RETIC %RETIC ABS

RBC

USA SI SI MOD

%K/uLM/uL

SET 1

%G/LT/L

%10e9/L10e12/L

%10e3/uL10e6/uL


14:10

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SET 2UNITS

SET 2

%10e4/uL10e4/uL

RETICUNITS



Procedure: Retic Units Selection1. From the RETIC SET UP menu, press the [RETIC UNITS] key.

2. Choose one of the following two options:

• To select a predefined set of units, press the appropriate soft key. The group of selected units is highlighted on the screen. If using this option, skip to step 6.

• For individual unit selection, use the arrow keys on the keyboard to move the cursor to the desired units.

3. Press the [SELECT UNITS] key to enter the selection. The chosen selection is highlighted on the display.

4. Use the arrow keys on the keyboard to move the cursor to the next unit to be selected.


6. If desired, press the Print Screen key on the keyboard to obtain a printout of the selected units.

7. Press the [RETURN] key to return to the RETIC SET UP menu.

Retic Run MenuFor a description of the RETIC RUN menu and the submenus that are accessed from it, refer to Routine Operation, Retic Run Menu within this chapter.



Retic Data Log Menu

The [RETIC DATA LOG] key on the RETIC MAIN menu screen is used to display the RETIC DATA LOG screen. The Reticulocyte Data Log stores all data (Reticulocyte percentage, RBC value, Reticulocyte Absolute Number, IRF, and Reticulocyte Flags) and all patient demographic information in a log format for each of the most current 2,000 Reticulocyte cycles run on the CELL-DYN 3700 System. The record information is stored chronologically by Reticulocyte Sequence Number. Each Reticulocyte Sequence Number will have an "R" prefix (R0 to R1999). This will distinguish the Reticulocyte Sequence Numbers from the Standard Hematology Data Log sequence numbers. Scatterplots and histograms are stored for all 2,000 records. The RBC value will be identified on the RETIC DISPLAY SPECIMEN screen to show whether it was obtained from the Standard Hematology Data Log or entered by the operator. This section discusses the RETIC DATA LOG screen first, then it discusses how to review data from the Reticulocyte Data Log.

The current date, time, and operator ID and the last Reticulocyte Sequence Number that was used are displayed in the upper right-hand corner of the RETIC DATA LOG screen.

RETICEDITID

TRANSMITDATA

PRINTDATA LOG

FINDSPECIMEN MAINDISPLAY SPECIMEN

RETIC DATA LOG SEARCHReady

PREVIOUSSPECIMEN

RETURNNEXTSPECIMEN

PRINTREPORT

EDITSPECIMEN SPECIMEN

TRANSMIT

RETIC DATA LOGReady

RETIC MAINReady

RETIC

DATA LOG



Figure 14.12: Reticulocyte Data Log Screen

NOTE: Press the F12 key followed by the F1 key on the keyboard to toggle between this Retic Data Log screen and the Data Log screen.

RETIC DATA LOGReady

EDIT RETICDISPLAY FIND TRANSMIT PRINTID SPECIMEN SPECIMEN DATA DATA LOG


14:10

R300123

0.684.402.101.76

13.400.96

34176

7448

41840

5.014.003.502.693.124.15

0.210.590.360.100.680.17

RTC% RABS RBC IRF

RTC% RABS RBC IRF

O 09/29/00 08:10 987O 09/29/00 08:30 964O 10/02/00 09:05 657O 10/02/00 09:27 864O 10/03/00 08:38 987O 10/03/00 09:07 964

MAIN

R284R285R286R287R288R289

Seq Specimen ID123456234567345678456789567890678901

Seq Specimen ID

COUNT

COUNT

Date Time Op

Date Time Op



Retic Data Log CodesThe following letters are displayed on the RETIC DATA LOG screen in the column immediately preceding the date. (See the preceding figure.)

O Sample was run in the Open Mode.

K Flow Error or Fragile RBCs.

NOTE: Reticulocyte results are not suppressed for Fragile RBCs but are suppressed for Flow Errors.

The RETIC DATA LOG screen contains the following soft keys:

EDIT ID (This key label is displayed only when the cursor is positioned next to a patient record.)

DISPLAY SPECIMENFIND SPECIMENTRANSMIT DATAPRINT DATA LOGRETIC MAIN

Edit ID Soft KeyThe [EDIT ID] key on the RETIC DATA LOG screen is used to edit only the Specimen ID. When the [EDIT ID] key is pressed, the cursor moves into the <SPECIMEN ID> field and all soft key labels are blank. Each edit is saved by pressing the Enter key on the keyboard.

NOTE: The [EDIT ID] key is displayed only when the cursor is positioned next to a Reticulocyte Patient Record. It is not displayed for Reticulocyte Background or Reticulocyte QC records.

When using the Edit Specimen ID feature in the Data Log, set up a laboratory procedure to verify any Specimen ID that has been manually edited in the Data Log by showing the content of the Specimen ID before and after editing.

Such verification could be:

Printouts of the Data Log summary reports that show the edited ID. These printouts should be signed, dated and saved to ensure tracking of any changes to specimen identification within your laboratory.

OR

Re-running any specimen unintentionally identified with a Rack and Tube Number, via Open or Closed Mode, to confirm that the correct Specimen ID is applied.

EDIT

ID



The current date, time, and operator ID and the last Reticulocyte Sequence Number that was used are displayed in the upper right-hand corner.

Display Specimen Soft Key

Figure 14.13: Reticulocyte Display Specimen Screen

The [DISPLAY SPECIMEN] key is used to display the results for the record indicated by the cursor position. The following soft keys are displayed on the RETIC DISPLAY SPECIMEN screen:

PREVIOUS SPECIMEN (This key label is not displayed when the first specimen in the RETIC DATA LOG is on the screen.)

NEXT SPECIMEN (This key label is not displayed when the last specimen in the RETIC DATA LOG is on the screen.)

EDIT SPECIMENTRANSMIT SPECIMENPRINT REPORT or

COLOR PRINT (This key alternates between these two selections depending on whether the Color print option is turned ON.)

RETURN

RETIC DISPLAY SPECIMENReady

RETURNTRANSMITSPECIMEN

May 04 1998Operator IDSequence #

13:50

1125SH

PREVIOUSSPECIMEN

EDITSPECIMEN

COLORPRINT

Spec ID AA12345Patient:Sex(M/F): DOBDr.LIMITS: 1

RETIC% 0.91 %RBC 4.00 M/uLRETIC ABS 36.00K/uLIRF 0.10

RBC value entered byOperator ID: SH

DISPLAY

SPECIMEN



Previous Specimen Soft KeyThe [PREVIOUS SPECIMEN] key is used to display the results for the Reticulocyte Sequence Number preceding the one currently displayed without returning to the main RETIC DATA LOG screen.

Next Specimen Soft KeyThe [NEXT SPECIMEN] key is used to display the results for the Reticulocyte Sequence Number following the one currently displayed without returning to the RETIC DATA LOG screen.

Edit Specimen Soft KeyThe [EDIT SPECIMEN] key is used to edit patient demographic information for the selected record. It may also be used to edit and display the results with a Parameter Set or Patient Limit Set different from the one currently displayed. The following soft key labels are displayed when the [EDIT SPECIMEN] key is pressed:

CONFIRMCANCEL

These keys are used to [CONFIRM] or [CANCEL] the edits. The bulletin line displays the message PRESS CONFIRM TO SAVE CHANGES OR CANCEL TO CANCEL CHANGES. When the [CONFIRM] key is pressed, the edited record is displayed.

Transmit Specimen Soft KeyThe [TRANSMIT SPECIMEN] key is used to transmit the displayed report to a Laboratory Information System or on-line computer.

Print Report/Color Print Soft KeyThe [PRINT REPORT] key is used to print a graphics report for the displayed report.

NOTE: The ticket printer is not supported in the Reticulocyte mode.

The [COLOR PRINT] key will be displayed if the Color Print option is turned on in the Standard Hematology Mode.

Return Soft KeyThe [RETURN] key is used to return to the RETIC DATA LOG screen.

PREVIOUSSPECIMEN

NEXT

SPECIMEN

EDIT

SPECIMEN

TRANSMITSPECIMEN

PRINT

REPORT

COLORPRINT

RETURN



Find Specimen Soft Key

Figure 14.14: Reticulocyte Data Log Search Screen

The [FIND SPECIMEN] key is used to locate a particular record by entering the Reticulocyte Sequence Number, the Reticulocyte Specimen ID, or the patient’s name for the desired record. When the [FIND SPECIMEN] key is pressed, the RETIC DATA LOG SEARCH screen is displayed. (See the preceding figure.) The Reticulocyte Specimen ID, the Reticulocyte Sequence Number, or the patient’s name may be entered in the appropriate area. The cursor will be flashing in the Reticulocyte Specimen ID area, but it can be moved to the other areas by using the arrow keys on the keyboard. If the requested reticulocyte record is available, the page of the RETIC DATA LOG that contains that record will be displayed on the screen. The cursor will be flashing next to the Reticulocyte Sequence Number that was requested. The reticulocyte record can be displayed by pressing the [DISPLAY SPECIMEN] key. If the record is not found in the Reticulocyte Data Log, the bulletin line displays the message NO ENTRY FOUND.

NOTE: If the patient name is used, the name must be typed exactly as it was originally entered.

Seq # : RSpec ID :Name :

FIND

SPECIMEN

RETIC DATA LOG SEARCHReady


14:10

R326jmb

0.684.402.101.76

13.400.96

34176

7448

41840

5.014.003.502.693.124.15

0.210.590.360.100.680.17

RTC% RABS RBC IRF

RTC% RABS RBC IRF

O 09/29/00 08:10 987O 09/29/00 08:30 964O 10/02/00 09:05 657O 10/02/00 09:27 864O 10/03/00 08:38 987O 10/03/00 09:07 964

R284R285R286R287R288R289

Seq Specimen ID123456234567345678456789567890678901

Seq Specimen ID

COUNT

COUNT

Date Time Op

Date Time Op



Transmit Data Soft KeyWhen the [TRANSMIT DATA] key is pressed, the screen prompts the operator to enter the starting and ending Reticulocyte Sequence Numbers (from the lowest to the highest) for the desired transmission. Records may be transmitted to a Laboratory Information System or on-line computer singly or in batches as designated by the Reticulocyte Sequence Number(s).

Print Data Log Soft KeyThe [PRINT DATA LOG] key is used to print the Reticulocyte Data Log. When the [PRINT DATA LOG] key is pressed, the screen prompts the operator to enter the starting and ending Reticulocyte Sequence Numbers (from the lowest to the highest) for the desired printout. (See the following figure.)

Figure 14.15: Reticulocyte Data Log Screen Showing the Starting Reticulocyte Sequence Number Field

TRANSMIT

DATA

PRINT

DATA LOG

RETIC DATA LOGReady

Starting Sequence # : R _ _ _ _ _ 883Mar 22 1998Operator IDRetic Seq#

20:44

R23

0.684.402.101.76

13.400.96

34176

7448

41840

5.014.003.502.693.124.15

0.210.590.360.100.680.17

RTC% RABS RBC IRF

RTC% RABS RBC IRF

O 09/29/00 08:10 987O 09/29/00 08:30 964O 10/02/00 09:05 657O 10/02/00 09:27 864O 10/03/00 08:38 987O 10/03/00 09:07 964

R16R17R18R19R20R21

Seq Specimen ID123456234567345678456789567890678901

Seq Specimen ID

COUNT

COUNT

Date Time Op

Date Time Op



Data Review from the Retic Data Log

Scrolling Through the Retic Data LogThe Page Up and Page Down keys on the keyboard can be used to scroll rapidly through the records stored in the Reticulocyte Data Log. Press the Page Up key to scroll backward and press the Page Down key to scroll forward.

Displaying a RecordA copy of the RETIC RUN RESULT screen can be displayed for the most current 2,000 records in the Reticulocyte Data Log. A record is displayed by positioning the cursor at the record you desire in the Reticulocyte Data Log listing and pressing the [DISPLAY SPECIMEN] key. The Status Box indicates RETIC DISPLAY SPECIMEN on results displayed (or printed) from the Reticulocyte Data Log record. (See following figure.)

Figure 14.16: Reticulocyte Display Specimen Screen

RETIC DISPLAY SPECIMENReady

RETURNTRANSMITSPECIMEN

May 04 1998Operator IDSequence #

13:50

1125SH

PREVIOUSSPECIMEN

EDITSPECIMEN

COLORPRINT

Spec ID AA12345Patient:Sex(M/F): DOBDr.LIMITS: 1

RETIC% 0.91 %RBC 4.00 M/uLRETIC ABS 36 K/uLIRF 0.09

RBC value entered byOperator ID: SH



Procedure: Displaying a Record1. From the RETIC MAIN menu screen press the [RETIC DATA LOG]

key.

2. If the desired record is not displayed on the screen, press the [FIND SPECIMEN] key to display the RETIC DATA LOG SEARCH screen.

3. To start the search, type the Reticulocyte Specimen ID, the Reticulocyte Sequence Number, or the patient name, then press the Enter key on the keyboard.

NOTE: If the patient name is used, the name must be typed exactly as it was originally entered.

NOTE: If necessary, you may press the Escape key (ESC) or the Enter key on the keyboard to exit from the search function and return to the RETIC DATA LOG screen.

4. If the requested record is available, the screen displays the page of the Reticulocyte Data Log with the cursor flashing at the Reticulocyte Sequence Number of the record.

5. Press the [DISPLAY SPECIMEN] key to display the RETIC DISPLAY SPECIMEN screen for the selected record.

6. Press the [PRINT REPORT] key (or the [COLOR PRINT] key if it is displayed) to obtain a printout.

7. The [PREVIOUS SPECIMEN] or [NEXT SPECIMEN] key may now be used to display records listed in the Reticulocyte Data Log that are next to the one currently displayed.



Retic QC Log Menu

Figure 14.17: Reticulocyte QC Log Screen

RETIC QC LOGReady

RETICVIEWQC LOG

RETICQC LIMITS MAIN

RETICSET UP QC

RETURNPURGEQC LOGS

PRINTQC LOG

LEVEY-JENNINGS

MOVESPECIMEN

REJECTSPECIMEN

DELETESPECIMEN

PRINT RETURN

ACCEPTSPECIMEN

RETIC MAINReady

1.2.3.4.5.6.

File Name

Press arrow key to select RETIC QC FILE at cursor position.

FILE 1 FILE 2 FILE 3 FILE 4 FILE 5 FILE 6

000000

# Specimens

RETICVIEWQC LOG

RETIC QC LIMITS

RETIC QC LOG Ready

RETICSET UP QC


14:54

R4lym

MAIN



The [RETIC QC LOG] key on the RETIC MAIN menu screen is used to display the RETIC QC LOG screen. The Reticulocyte Package on the CELL-DYN 3700 System offers six QC Logs with statistical and graphical analysis of the data. The statistical analysis includes the mean, standard deviation, and coefficient of variation. The results in each QC Log can be displayed as a Levey-Jennings chart. Westgard Rules can be applied to each QC Log. The rule options can be used independently or in combination, at the operator’s discretion.

NOTE: The [RETIC QC LIMITS] key and the [RETIC SET UP QC] key are used to set up the QC files.

The following soft keys are displayed on the RETIC QC LOG screen:

VIEW QC LOG (Move the cursor with the arrow keys on the keyboard to the QC file desired, then press this soft key.)

RETIC QC LIMITSRETIC SET UP QC RETIC MAIN

RETIC

QC LOG



View QC Log Soft Key

Figure 14.18: View Reticulocyte QC Log Screen

The [VIEW QC LOG] key is used to display the QC Log indicated by the position of the cursor. Each QC Log display includes the following information (see the preceding figure):

1. The lot number and expiration date are displayed in the upper left corner. The file name, the number of runs currently in the file, and the file capacity are also in the upper left corner. (For example, 35/120 indicates that the file contains 35 runs out of a possible 120.) The page number of the display and the total number of pages in the file are also displayed in the upper left corner.

2. The current date, time, and operator ID and the last Reticulocyte Sequence Number to be used are all displayed in the upper right-hand corner.

3. The remainder of the screen displays the file information and the data. The Upper and Lower Limits and Target Mean entered are displayed immediately above each parameter name. The Reticulocyte Sequence Number for each result is displayed to the left of the data. The date, time, and operator ID when the reticulocyte sample was run are displayed to the right of the data.

VIEW RETIC QC LOGReady

PURGE RETURNLEVEY- REJECT DELETE PRINTMOVE

Lot Number : 0123ABCD4Exp. Date: 09/24/00LEVEL I: 2/120Page 1 of 1

QC LOG JENNINGS SPECIMEN SPECIMEN SPECIMEN QC LOG

Oct 11 2000Operator IDRetic Seq#

08:01

R44902

2.240.641.44

RTC%1.381.42

RTC%2

1.400.03

2.1

0.770.470.62IRF

0.600.61

IRF2

0.610.01

1.1

Upper Limits:Lower Limits:Target Mean:SeqR31R32

N:FILE MEANStd Dev:CV%

DATE TIME OpO09/21/0013:45 902O09/21/0013:48 902

Auto-Sampler Pause

VIEW

QC LOG



4. The following QC Log codes are displayed in the column immediately preceding the date. These codes are the same as those used in the Reticulocyte Data Log.

O Sample was run in the Open Mode.

K Flow Error or Fragile RBCs.

NOTE: Reticulocyte results are not suppressed for Fragile RBCs but are suppressed for Flow Errors.

5. The statistics are displayed below the data as follows:

N: The number of runs used in the calculation.

FILE MEAN:The mean value for the number of runs used in the calculation.

Std Dev: The standard deviation for the number of runs used in the calculation.

CV%: The coefficient of variation, in percent, for the number of runs used in the calculation.

The following soft keys are displayed on the VIEW RETIC QC LOG screen:

PURGE QC LOGLEVEY-JENNINGSREJECT SPECIMEN or

ACCEPT SPECIMEN (This key label alternates between these two selections when the soft key is pressed.)

DELETE SPECIMENMOVE SPECIMENPRINT QC LOGRETURN

These soft keys are discussed in the order in which they appear on the screen from left to right.



Purge QC Log Soft KeyThe [PURGE QC LOG] key is used to delete the contents of a designated file in the QC Log. When the [PURGE QC LOG] key is pressed, the following soft key labels are displayed:

CONFIRM PURGECANCEL PURGE

These soft keys are used to confirm or cancel the [PURGE QC LOG] command. When the [CONFIRM PURGE] key is pressed, all the results are deleted from the designated file (the data are no longer displayed nor stored in the file). When the [CANCEL PURGE] key is pressed, the results are not deleted.

PURGEQC LOG



Levey-Jennings Soft Key

Figure 14.19: The Reticulocyte Levey-Jennings Screen

The [LEVEY-JENNINGS] key is used to display the Levey-Jennings graphs of the data in the QC Log. (See the preceding figure.) Up to 30 data points can be displayed on the screen at one time. If there are more than 30 data points in the QC Log, the [PREVIOUS 10] and [NEXT 10] keys can be used to scroll through the graphs. The following soft key labels are displayed when the [LEVEY-JENNINGS] key is pressed:

PREVIOUS 10 (This key is not displayed when the first 10 data points are displayed.)

NEXT 10 (This key is not displayed when the last 10 data points are displayed.)

PRINTRETURN

The [PRINT] key is used to print the Levey-Jennings graphs.

PRINT RETURN

RETIC LEVEY-JENNINGSReady

QC file: RETIC FILE 1Seq num: R328 to R339

RETIC %: - - - - - -

1.35

.850 .350


16:58

R341jmb

PREVIOUS NEXT10 10

WESTGARD RULE WARNINGS

IRF: - - - - - -

0.77

0.62 0.47

LEVEY-

JENNINGS

PRINT



The [RETURN] key is used to return to the VIEW RETIC QC LOG screen.

Figure 14.20: View Reticulocyte QC Log Screen with Rejected Results

Reject Specimen/Accept Specimen Soft KeyThe [REJECT SPECIMEN] key is used to exclude the results for the specimen indicated by the cursor position. When the soft key is pressed, the key label changes to [ACCEPT SPECIMEN], an “R” is displayed in the column immediately left of the results, and the statistics are recalculated excluding those results. (See the preceding figure.) The data are still displayed and stored in the file, but they are excluded from the statistical calculations.

When the [ACCEPT SPECIMEN] key is pressed, the “R” is deleted and the statistics are recalculated including those results.

RETURN

VIEW RETIC QC LOGReady

PURGE RETURNLEVEY- REJECT DELETE PRINTMOVE

Lot Number : 0123ABCD4Exp. Date: 09/24/00LEVEL I: 2/120Page 1 of 1

QC LOG JENNINGS SPECIMEN SPECIMEN SPECIMEN QC LOG

Oct 11 2000Operator IDRetic Seq#

08:01

R44902

2.240.641.44

RTC%1.381.42

RTC21.400.032.1

0.770.470.62IRF

0.600.61

IRF20.610.011.1

Upper Limits:Lower Limits:Target Mean:SeqR31R32

N:FILE MEANStd Dev:CV%:

DATE TIME OpO 09/21/00 13:45 902O 09/21/00 13:48 902

Auto-Sampler Pause

REJECT

SPECIMEN

ACCEPT

SPECIMEN



Delete Specimen Soft KeyThe [DELETE SPECIMEN] key is used to delete the results for the specimen indicated by the cursor position. When the [DELETE SPECIMEN] key is pressed, the following soft key labels are displayed:


These soft keys are used to confirm or cancel the Delete Specimen command. When the [CONFIRM DELETION] key is pressed, the results are deleted from the file (the data are no longer displayed nor stored in the file) and the statistics are recalculated excluding those results.

Move Specimen Soft KeyThe [MOVE SPECIMEN] key is used to move the QC result indicated by the cursor position to another QC file. When the [MOVE SPECIMEN] key is pressed, the RETIC QC LOG screen is displayed, allowing the desired file to be selected. When the [MOVE TO FILE] key is pressed, the result is moved to the indicated file.

Procedure: Move Specimen Soft Key1. From the RETIC QC LOG screen, use the arrow keys on the

keyboard to move the cursor to the file containing the result to be moved.

2. Press the [VIEW QC LOG] key.

3. Use the arrow keys on the keyboard to position the cursor at the result that is to be moved.

4. Press the [MOVE SPECIMEN] key to again display the RETIC QC LOG menu.

5. Use the arrow keys on the keyboard to move the cursor to the file in which the results are to be placed.

6. Press the [MOVE TO FILE] key to move the results to the designated file.

NOTE: The results are moved to the end of the list of data that is currently in the file.

7. The VIEW RETIC QC LOG screen for the original file is displayed showing that results have been moved.

DELETE

SPECIMEN

MOVE

SPECIMEN



Print QC Log Soft KeyThe [PRINT QC LOG] key is used to print the entire QC Log.

Return Soft KeyThe [RETURN] key is used to return to the RETIC QC LOG screen.

Retic Diagnostics Menu

PRINT

QC LOG

RETURN

RETIC DIAGNOSTICSReady

RETICFAULTREPORT

INITIAL-IZATION

RAW DATASUMMARY MAIN

CLEARFAULT

PRINT RETURNRETICCNT GRAPH

RETICCNT RATE

RETIC CNTRATE SUMM

RETIC MAINReady

PRINT RETURN



Figure 14.21: Reticulocyte Diagnostics Screen

The [RETIC DIAGNOSTC] key is used to display the RETIC DIAGNOSTICS screen. The soft keys displayed on this screen enable the operator or service representative to obtain information and execute programs that assist in troubleshooting and in identifying the corrective action needed. The RETIC DIAGNOSTICS screen displays a subset of the soft keys displayed on the main DIAGNOSTICS menu. The following soft keys are displayed on the RETIC DIAGNOSTICS screen:

FAULT REPORTRETIC CNT RATE SUMMCLEAR FAULTRAW DATA SUMMARYINITIALIZATIONRETIC MAIN

These soft keys are discussed in the order in which they appear on the screen from left to right.

RETIC DIAGNOSTICSReady

FAULT RETICRETIC CNT CLEAR RAW DATA INITIAL-REPORT RATE SUMM FAULT SUMMARY


14:10

R4lym

MAINIZATION

RETIC

DIAGNOSTC



Fault Report Soft KeyWhen the [FAULT REPORT] key is pressed, information regarding any pending fault is displayed on the screen. The screen displays the words OPERATOR CORRECTABLE FAULT REPORT: or FATAL FAULT REPORT and any additional information available. If there is no fault, the screen displays the words NO FAULT PENDING. Operator-correctable faults (for example, Waste Full, Diluent Empty) can be cleared after the corrective action has been taken by pressing the [CLEAR FAULT] key. After corrective action has been taken for a Fatal Fault, the system must be reinitialized.

Retic Count Rate Summary Soft Key

Figure 14.22: Reticulocyte Count Rate Summary Screen (Tabular Format)

FAULT

REPORT

RETIC PRINT RETURN

RETIC COUNT RATE SUMMARYReady

CNT GRAPH


17:30

R291jmb

WOC: TOTAL COUNT: 72861TIME: 0.53 1.06 1.59 2.11 2.65 3.18 3.71 4.24COUNT: 4672 9567 14692 19755 25078 30225 35779 40902RATE: 8899.05 9235.85 9669.81 9643.81 9949.53 9620.56 10479.24 9666.04TIME: 4.77 5.30 5.80 6.33 6.85 7.35 7.50COUNT: 46231 51353 56354 61591 66695 71487 72861RATE: 10054.71 9756.20 9902.97 9975.24 9721.90 9584.00 9159.99



When the [RETIC CNT RATE SUMM] key is pressed, the following soft key labels are displayed:

RETIC CNT GRAPHPRINTRETURN

The data displayed on the screen are the kinetic data for the Reticulocyte specimen from the last run, displayed in a tabular format. (See the preceding figure.) The total count, data acquisition intervals, and rate per second are displayed.

When the [RETIC CNT GRAPH] key is pressed, the rate per second data are displayed as a graph. (See the following figure.) The kinetic data and graph information are useful when troubleshooting problems with the reticulocyte parameter. A printout of the Reticulocyte Count Rate Summary may be obtained by pressing the [PRINT] key when the desired format is displayed on the screen.

Figure 14.23: Reticulocyte Count Rate Summary Screen (Graphic Format)

RETIC CNT

RATE SUMM

RETIC CNT

GRAPH

RETIC

CNT RATE

RETIC COUNT RATE SUMMARYReady

RETIC RETURNPRINTCNT RATE

10479.2

0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5RETIC CNT GRAPH


17:30

R291jmb

9169.3

7859.4

6549.5

5239.6

3929.7

2691.8

1309.9



Clear Fault Soft KeyWhen the [CLEAR FAULT] key is pressed, the Analyzer returns to the READY state if the corrective action that was taken has resolved the problem. If the corrective action did not correct the problem, the fault status does not change.

NOTE: Only operator-correctable faults can be cleared with the [CLEAR FAULT] key.

Raw Data Summary Soft Key

Figure 14.24: Reticulocyte Raw Data Summary Screen

When the [RAW DATA SUMMARY] key is pressed, information pertaining to the last cycle run in the Reticulocyte Package is displayed.

CLEARFAULT

RETIC RAW DATA SUMMARYReady

RETURN

List Mode WOC: 30000


17:37

R293jmb

PRINT

Raw Count WOC: 62039

RAW DATASUMMARY



Initialization Soft KeyWhen the [INITIALIZATION] key is pressed, the system is reinitialized. The system exits the Reticulocyte Package and returns to the Standard Hematology mode.

Print Soft KeyWhen the [PRINT] key is pressed, a Diagnostics Report is printed. This report contains information pertinent to the data displayed on the screen at the time the key is pressed. If no data are displayed on the screen, the printed report contains the current fault status.

Retic Main Soft KeyThe [RETIC MAIN] key is used to return to the RETIC MAIN menu screen. The [RETIC MAIN] key appears on each primary RETIC DIAGNOSTICS screen and works the same way on each screen.

Retic Special Protocols Menu

The [RETIC SP PROTOCOLS] key is used to display the RETIC SPECIAL PROTOCOLS menu. The following soft key labels are displayed on the RETIC SPECIAL PROTOCOLS menu:

FLUSH SHEATHEMPTY WOC orFILL WOC (This key label alternates

between these two selections.)

INITIAL-IZATION

PRINT

RETICMAIN

RETIC SPECIAL PROTOCOLSReady

RETICFLUSHSHEATH

DISABLEANALYZER

CLEANSHEAR VLV MAIN

EMPTYWOC

FILLWOC

RESTORESHEAR VLV

ENABLEANALYZER

RETIC MAINReady

RETIC SP

PROTOCOLS



CLEAN SHEAR VLV orRESTORE SHEAR VLV (This key label alternates


DISABLE ANALYZER orENABLE ANALYZER (This key label alternates


RETIC MAIN

A brief description of the function of each soft key follows. Instructions for the detailed use of each function are given in the appropriate maintenance procedure in Chapter 9: Maintenance.

Figure 14.25: Reticulocyte Special Protocols Screen

RETIC SPECIAL PROTOCOLSReady

FLUSH RETICEMPTY CLEAN DISABLESHEATH WOC SHEAR VLV ANALYZER


14:10

R4lyn

MAIN



Flush Sheath Soft KeyThe [FLUSH SHEATH] key is used to flush the WOC Flow Cell with Sheath Reagent.

Empty WOC/Fill WOC Soft KeyThe [EMPTY WOC] key is used to drain the reagent from the WOC flow cell. When the flow cell is empty, the soft key label changes to [FILL WOC].

When the [FILL WOC] key is pressed, the flow cell is refilled with reagent. When the flow cell is filled, the soft key label changes back to [EMPTY WOC].

Clean Shear Valve/Restore Shear Valve Soft KeyThe [CLEAN SHEAR VLV] key is used to prepare the shear valve for cleaning. When the soft key is pressed, the syringes will partially empty, which flushes the reagents out of the shear valve and the associated tubings. The shear valve then rotates into the position necessary for its removal. When the rotation is complete, the soft key label changes to [RESTORE SHEAR VLV].

When the [RESTORE SHEAR VLV] key is pressed, the syringes refill the shear valve and the associated tubings and the shear valve rotates back to its operational position. When the rotation is complete, the soft key label changes back to [CLEAN SHEAR VLV].

Disable Analyzer/Enable Analyzer Soft KeyThe [DISABLE ANALYZER] key is used to prevent the Analyzer from cycling while certain maintenance procedures are performed. When the Analyzer is disabled, the soft key label changes to [ENABLE ANALYZER].

When the [ENABLE ANALYZER] key is pressed, the Analyzer is returned to the operational state and the soft key label changes back to [DISABLE ANALYZER].

Retic Main Soft KeyThe [RETIC MAIN] key is used to return to the RETIC MAIN menu screen.

FLUSH

SHEATH

EMPTYWOC

FILLWOC

CLEAN

SHEAR VLV

RESTORE

SHEAR VLV

DISABLE

ANALYZER

ENABLE

ANALYZER

RETICMAIN


Reticulocyte PackageChapter 14 Routine Operation

Routine Operation

OverviewThis section contains information and procedures that are recommended for the routine operation of the Reticulocyte Package for the CELL-DYN 3700 System. This section contains the following subsections:

• Retic Run Menu Flowchart

• Retic Run Menu

• Reticulocyte Specimens

• Specimen Requirements

• Running Specimens

• Background

• Quality Control

• Patient

• Interfering Substances

• Specimen Preparation

For instructions on turning the Reticulocyte Package ON and OFF, refer to Retic Menu Options, Turning Reticulocyte Package On and OFF within this chapter.


Reticulocyte PackageRoutine Operation Chapter 14

Retic Run Menu Flowchart

RETIC PATIENT SPECIMENReady

RETIC RUNReady

RETICPATIENTSPECIMEN MAIN

QCSPECIMEN

BACK-GROUND

RETIC RUN RESULTReady



ENTER DATA

RETIC MAINReady



Retic Run Menu

Figure 14.26: Reticulocyte Run Screen

The [RETIC RUN] key on the RETIC MAIN menu screen is used to display the RETIC RUN screen. (See the preceding figure.) This screen allows the operator to decide which type of Reticulocyte specimen will be analyzed. The upper right-hand corner of the screen contains the current time and date, the operator ID, and the next Reticulocyte Sequence Number.

The following soft keys are displayed on the RETIC RUN screen:

CLEAR FAULT (This key label appears whenever a system fault occurs.)

PATIENT SPECIMENQC SPECIMENBACKGROUNDRETIC MAIN

These soft keys will be discussed as they appear on the RETIC RUN screen from left to right.

PATIENT QC BACK- RETIC

RETIC RUNReady

1.2.3.4.5.6.

File Name

Press QC SPECIMEN softkey to select QC FILE at cursor position.

FILE 1FILE 2FILE 3FILE 4FILE 5FILE 6

000000

# Specimens

SPECIMEN SPECIMEN GROUND


14:10

R4lyn

MAIN

RETICRUN



Clear Fault Soft KeyThe [CLEAR FAULT] key is displayed on the RETIC RUN screen whenever a system fault occurs (for example, Diluent Empty). This key is used after corrective action has been taken, to clear the fault message and return the Analyzer to the Ready state.

NOTE: A message describing the fault is displayed on the bulletin line. A list of fault conditions and corrective action is given in Chapter 10: Troubleshooting.

Patient Specimen Soft KeyThe [PATIENT SPECIMEN] key on the RETIC RUN screen is used to display the first RETIC PATIENT SPECIMEN screen. (See the following figure.) The patient specimen ID (up to 12 alphanumeric characters) is entered here. Type the information and press the Enter key on the keyboard to confirm the entry. The Standard Hematology Data Log will then be searched for the entered specimen ID.

NOTE: If the patient name is used for the specimen ID, the name must be typed exactly as it was originally entered in the Standard Hematology Data Log.

NOTE: Specimen IDs must match exactly and are case sensitive.

Figure 14.27: The First Reticulocyte Patient Specimen Screen

CLEARFAULT

PATIENT

SPECIMEN


CANCEL

ENTER SPECIMEN ID: 123456 Press ENTER to confirm.


15:02

R4lyn



If the specimen ID is found, the second RETIC PATIENT SPECIMEN screen is displayed. (See the following figure.) This screen displays the patient demographic information and the most recent RBC value found in the Standard Hematology Data Log.

NOTE: To ensure optimal flagging, perform the CBC run within 8 hours prior to the Retic run on the same analyzer using the same specimen.

This screen also displays the following question:

Use demographics and RBC value?-(Y/N).

• If a Y is entered, the RETIC RUN RESULT screen will display the patient demographic information and RBC value.

NOTE: If no RBC value is displayed (if there is a blank space following RBC), the RBC value was suppressed due to an RBC metering fault. Type "N" to display a manual RBC entry screen.

• If an N is entered, the RETIC RUN RESULT screen will be displayed without the patient demographic information or the RBC value.

If an entry error is made in the second RETIC PATIENT SPECIMEN screen, the operator may press the [CANCEL] key to return to the first RETIC PATIENT SPECIMEN screen.

Figure 14.28: The Second Reticulocyte Patient Specimen Screen (Displayed When the Specimen ID is Found)


CANCEL

PATIENT ID : C01804

PATIENT ID : C01804 found in HEMATOLOGY DATA LOG at Sequence # 592

Patient: _ _ _ _ _ _ _ _ _ _ _ _ _ _

Sex (M/F): _ _ DOB: 00/00/00

Dr. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

RBC 5.48 M/uL

Use demographics and RBC value? - (Y/N)


15:02

R4lyn



If the ID located is from a specimen run more than 8 hours ago, the third RETIC PATIENT SPECIMEN screen is displayed. (See the following figure.)

Figure 14.29: The Third Reticulocyte Patient Specimen Screen (Displayed When the Specimen ID Found is More Than Eight Hours Old)


CANCEL

ENTER SPECIMEN ID: 365127 Press ENTER to confirm.


15:02

R4lyn

SPECIMEN ID: 365127 was found in HEMATOLOGY DATA LOG but specimen data are more than 8 hours old . . .

Enter RBC value - - - - - - - M/uL. Press ENTER to confirm.



If the Specimen ID is not found in the Standard Hematology Data Log, the fourth RETIC PATIENT SPECIMEN screen is displayed. (See the following figure.) This screen displays a place for the operator to enter the RBC value. If an entry error is made in the fourth RETIC PATIENT SPECIMEN screen, the operator may press the [CANCEL] key to return to the first RETIC PATIENT SPECIMEN screen. If the operator presses the Enter key to confirm the RBC value, the RETIC RUN RESULT screen is displayed.

Figure 14.30: The Fourth Reticulocyte Patient Specimen Screen (Displayed When the Specimen ID Is Not Found)


CANCEL

PATIENT ID : 123456

PATIENT ID : 123456 was NOT found in HEMATOLOGY DATA LOG

Enter RBC value - - - - - - M/uL. Press ENTER to confirm.


15:03

R4lyn



Retic Run Result Screen

Figure 14.31: The Reticulocyte Run Result Screen for a Patient Specimen

Upper Left CornerThe numbers in the upper left-hand corner of the RETIC RUN RESULT screen (shown in the preceding figure) correspond with the following numbered data entry fields:

1. <Specimen ID> This data entry field automatically displays the specimen ID (up to 12 characters), which was previously entered on the RETIC PATIENT SPECIMEN screen.

2. <Patient> This data entry field automatically displays the patient’s name if it was found in the Standard Hematology Data Log when the patient specimen ID was entered into the first RETIC PATIENT SPECIMEN screen. If the information was not found in the Standard Hematology Data Log, the patient name can be entered here (up to 16 characters).

NOTE: If an entry error is made in the second RETIC PATIENT SPECIMEN screen, the operator may press the [CANCEL] key to return to the first RETIC PATIENT SPECIMEN screen.


May 04 1998Operator IDReticSeq#

11:44

R4SH

NEXTRETIC

COLORPRINT

1 Spec ID AA123452 Patient:3 Sex(M/F):- DOB:--/--/--4 Dr.--------------------5 Limits: 1

RETIC% 0.91 % RBC 4.00 M/uL RETIC ABS 36 K/uL IRF 0.10

RBC value entered by: Operator ID: SH



3. <Sex (M/F):/DOB> This data entry field automatically displays the sex and birth date of the patient if it was found in the Standard Hematology Data Log. If the information was not found in the Standard Hematology Data Log, the sex and birth date of the patient can be entered here.

4. <Dr.> This data entry field automatically displays the name of the patient’s doctor if it was found in the Standard Hematology Data Log. If the information was not found in the Standard Hematology Data Log, the name of the patient’s doctor can be entered here (up to 22 characters).

5. <Limits> This data entry field automatically displays the number of the Limit Set that will be applied to the sample results.

NOTE: The Limit Set applied to the reticulocyte sample may be changed after the specimen has been run. Refer to the description for the [EDIT SPECIMEN] key given in Reticulocyte Menu Options, Reticulocyte Data Log Menu, Display Specimen Soft Key within this chapter.

These demographics can be entered or changed before the Reticulocyte specimen is processed, or while the EDIT SPECIMEN screen in the Reticulocyte Data Log is displayed.



Top CenterThe Status Box is displayed in the top center of the RETIC RUN RESULT screen. This box appears on every screen to show the following information:·

• The menu in use (such as RETIC RUN RESULT).

• The status of the Analyzer (such as Ready, Not ready, and FAULT messages).

• Status and instructive messages. During the Reticulocyte Run cycle these are:

AspiratingRemove SpecimenDispensingRinsingProcessing DataReady

Upper Right CornerThe upper right-hand corner of the RETIC RUN RESULT screen displays the following information:

• The current date and time.

• The operator ID (which identifies the current operator).

• The Reticulocyte Sequence Number. ("R _ _ _ _ ," which automatically increments as reticulocyte samples are run.)

CenterThe center section of the RETIC RUN RESULT screen displays the results. The list of the parameters and results is displayed on the left side. The information on RBC value entry is also displayed on the left side. The scatterplot and the histograms are displayed on the right. The red blood cells are shown in red, the reticulocytes are shown in blue, the nucleated cells are shown in white (black on the color printout), the immature Reticulocytes are shown in cyan (light blue), and coincidence passage events are shown in green and the noise is shown in yellow. Any alert messages will appear in the lower left-hand corner of the screen.

The following soft key labels are displayed on the RETIC RUN RESULT screen:

NEXT RETIC (This soft key label appears when the Reticulocyte specimen run has been completed.)

PRINT REPORTRETURN (This key is used to return to the RETIC

RUN screen.)



QC Specimen Soft Key

Figure 14.32: Reticulocyte Run Result Screen for a QC Specimen

When the [QC SPECIMEN] key on the RETIC RUN screen is pressed, the QC file where the cursor is positioned is opened and the RETIC RUN RESULT screen for QC specimens is displayed. (See the preceding figure.) Results from the QC run option are stored in the selected reticulocyte QC file and in the Reticulocyte Data Log.

IRF

QC

SPECIMEN



Background Soft Key

Figure 14.33: Reticulocyte Run Result Screen for a Background Specimen

When the [BACKGROUND] key on the RETIC RUN screen is pressed, the RETIC RUN RESULT screen for background counts is displayed. (See the preceding figure.) Results from this run option are identified by the designation BACKGROUND on the RETIC RUN RESULT screen and in the Retic Data Log.

Retic Main Soft KeyWhen the [RETIC MAIN] key is pressed, the RETIC MAIN menu screen is displayed.

BACK-

GROUND

RETICMAIN



Reticulocyte Specimens

OverviewThis subsection discusses routine operation of the Reticulocyte Package. Guidelines and procedures are provided for running background counts, quality control, and patient specimens. The Reticulocyte Package is only available for use in the Open Sampler Mode.

For background counts, a tube of reticulocyte reagent is run without an aliquot of whole blood, to check for particulate material in the reagent and system.

Control material should be properly warmed and mixed according to the manufacturer’s recommendations. Patient reticulocyte controls should be handled according to the laboratory’s protocol. Quality control checks (which verify Reticulocyte Package performance) should be performed on each shift that reticulocyte samples are run.

Each reticulocyte sample is run by starting from the RETIC RUN screen. The operator selects the type of Reticulocyte specimen to be run (Patient, QC, or Background) and proceeds through the screen(s) displayed for that specimen type. When the reticulocyte sample is completed, the [NEXT RETIC] key is displayed. When the [NEXT RETIC] key is pressed, the operator can then select the specimen type for the next specimen. Specific instructions for each specimen type are given in this section of this chapter.

CAUTION: When using the reticulocyte reagent, avoid contact with skin and clothing. This reagent contains New Methylene Blue, which will stain skin, clothing, and many other surfaces.

WARNING: Potential Biohazard. Consider all clinical specimens and controls that contain human blood or serum as potentially infectious. Use established, good laboratory working practices when handling these specimens. Wear appropriate personal protective equipment and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule or other equivalent biosafety procedures.



Specimen Requirements• Do not run hemolyzed specimens, as they may result in

inaccurate reticulocyte values.

• Specimens may be run up to 8 hours after collection time without refrigeration.

NOTE: Studies have shown that reticulocytes continue to mature at room temperature. Increased flagging can occur when using specimens more than 8 hours old.

• If a specimen is more than 8 hours old and the CBC was processed on the CELL-DYN 3700 System more than 8 hours ago, obtain the RBC value from the Standard Hematology Data Log before entering the Reticulocyte Package. The Reticulocyte Package will select RBC values only for specimens processed within the last 8 hours.

• To ensure optimal flagging, perform the CBC run within 8 hours prior to the Retic run on the same analyzer using the same specimen.


• It is recommended that the RBC value used to determine the reticulocyte absolute number be selected from the results for the same specimen that will be used for the reticulocyte count.

Interfering SubstancesThe CELL-DYN 3700 Reticulocyte method is a nucleic acid staining method. Therefore, other substances that contain nucleic acids could potentially be enumerated by the instrument as reticulocytes. If these interfering substances are present in sufficient numbers, they may interfere with the dynamic thresholds used to obtain the CELL-DYN 3700 reticulocyte count. Consequently, these specimens should be flagged by the instrument. Refer to Troubleshooting, Instrument Alert Conditions within this chapter for a complete description of the Reticulocyte flags.

The information in the following table, based on CLSI/NCCLS

Document H44-A21 indicates substances that are known or potential interferents. The CELL-DYN 3700 Reticulocyte procedure is designed to minimize some common interferents, including high WBC counts and NRBCs.



Table 14.1: Potential Interfering Substances

Running SpecimensThis section contains information and procedures recommended for routine operation of the Reticulocyte Package. Proper start-up procedures should be performed prior to processing patient specimens. These include the background counts and daily quality control checks described in the following sections.

Background CountsThe reticulocyte background count must be included in the daily start-up procedures to check for particulate matter in the reticulocyte reagent and the CELL-DYN 3700 System. The background count is determined from the total counts that occur in the reticulocyte scatter area on the 10°/90° scatterplot.

Procedure: Background Count1. Select a tube from the current lot of reticulocyte reagent that

will be used for the day's testing.

2. Label the tube "Retic Background" and record the current date on the tube.

NOTE: One tube may be used to check daily background counts for a one-week period, provided the reagent is not contaminated.

3. Turn the Reticulocyte Package ON as directed in Retic Menu Options, Turning the Reticulocyte Package ON and OFF within this chapter.

4. From the RETIC MAIN menu screen, press the [RETIC RUN] key followed by the [BACKGROUND] key.

Cellular Elements Cellular Inclusions Miscellaneous

Massive platelet clumps

Basophilic stippling

Leukocyte fragments

Nucleated erythrocytes >200 NRBC/100 WBC

Howell-Jolly bodies

Heinz bodies

Pappenheimer bodies

Parasites (malaria, babesia)

Abnormal red cells

Paraproteins

Cold agglutinins

Platelet/erythrocyte coincidence

Hemolysis



5. Be sure that the word READY is illuminated on the Analyzer Status Indicator Panel and the word Ready is displayed in the Status Box on the RETIC RUN RESULT screen.

6. Open the tube labeled "Retic Background" and immerse the Open Sample Aspiration Probe in the reagent.

7. Press the Touch Plate located behind the probe to start the cycle. The word BUSY will be illuminated in yellow on the Analyzer Status Indicator Panel. The Status Box on the RETIC RUN RESULT screen will display messages indicating the various stages of the cycle.


9. When the cycle is complete, the Wash Block moves back to the top of the probe and the Ready message is displayed in the Status Box.

NOTE: No message is illuminated on the Analyzer Status Indicator Panel until the [NEXT RETIC] key is pressed and the operator has selected the specimen type for the next specimen to be processed.

10. The screen displays the background count results as Background Count Found in Retic Area.

11. Verify that the background count is within the acceptable limit of less than 100 counts.

NOTE: Results that are outside the acceptable range are displayed in purple.

12. If the background count is unacceptable, repeat it. If the repeated count is still unacceptable, follow the directions for troubleshooting background count problems given in the Troubleshooting section of this chapter.



Quality ControlQuality control checks should be performed daily according to the laboratory’s protocol. Control material should be properly warmed and prepared according to the manufacturer’s recommendations. Patient controls should be handled according to the laboratory’s protocol. For customizing the QC files, see Chapter 5: Operating Instructions, Subsection: Set Up Instructions, QC Set Up Menu.

Procedure: Quality Control1. Warm the control material according to the manufacturer’s

recommendations.

2. Use reticulocyte reagent and verify the expiration date. Store the stock reagent in the dark at room temperature.

3. Label one tube of reticulocyte reagent for each level of control material.

4. Pipette 20 µL of the control material into each labeled tube of reticulocyte reagent.

5. Incubate the prepared control specimens on the rotator or in a rack, after fully inverting the stained specimens 5 times. Incubation is performed according to the Reagent Package Insert.

6. Verify that the Reticulocyte Package is turned ON. For instructions on turning ON the Reticulocyte Package, refer to Retic Menu Options, Turning the Reticulocyte Package ON and OFF within this chapter.

7. From the RETIC MAIN menu screen press the [RETIC RUN] key.

8. From the RETIC RUN screen, move the cursor to the desired QC file and press the [QC SPECIMEN] key. The RETIC RUN RESULT screen for QC specimens is displayed. The control file information is located in the upper left-hand corner of the screen.

9. Open the well-mixed, prepared control specimen tube and immerse the Open Sample Aspiration Probe in the sample.

10. Press the Touch Plate located behind the probe to start the cycle. The word BUSY on the Analyzer Status Indicator Panel will be illuminated in yellow. The Status Box on the RETIC RUN RESULT screen will display messages to indicate the various stages of the cycle.

11. Remove the tube when the beep sounds. The Wash Block moves down the probe and cleans it.

14-72 CELL-DYN 3700® System Operator’s Manual9140320D — June 2003


12. When the cycle is completed, the Wash Block moves up the probe.

NOTE: The word Ready appears in the Status Box. No message is illuminated on the Analyzer Status Indicator Panel until the [NEXT RETIC] key is pressed on the RETIC RUN RESULT screen and the operator has selected the specimen type for the next specimen to be processed from the RETIC RUN screen.

13. Repeat steps 8 through 12 for all prepared control specimens.

14. Verify that the control results are acceptable.

NOTE: Out-of-range results are displayed in color. Data invalidating alerts, such as Fragile RBCs, are not valid when running commercial controls.

15. If the results are unacceptable, repeat the run. If the results are still unacceptable, run the other levels of the control material. If the results are still unacceptable, prepare another stained dilution of that level of the control material. If the results on all levels are unacceptable, troubleshoot accordingly. See Chapter 10: Troubleshooting.


Patient SpecimensCAUTION: When using the reticulocyte reagent, avoid contact with skin and clothing. This reagent contains New Methylene Blue, which will stain skin, clothing, and many other surfaces.

WARNING: Potential Biohazard. Consider all clinical specimens and controls that contain human blood or serum as potentially infectious. Use established, good laboratory working practices when handling these specimens. Wear appropriate personal protective equipment and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule or other equivalent biosafety procedures.



Specimen Preparation1. The Reticulocyte Package is available for use only in the

Open Sampler Mode.

2. Use reticulocyte reagent and verify the expiration date. Store the stock reagent in the dark at room temperature.

3. Label a tube of reticulocyte reagent for each patient.

4. Verify that the whole blood specimen is warmed to room temperature and well mixed prior to sampling.

5. Pipette 20 µL of the whole blood specimen into each labeled tube of reticulocyte reagent.

6. Incubate the stained Reticulocyte specimens on the rotator or in a rack, after fully inverting the stained specimens 5 times. Incubation is performed according to Reagent Package Insert.

NOTE: The timing stated in the Reagent Package Insert allows Reticulocyte specimens to be processed for either STAT requests or grouped and run in batches.

Running Patient SamplesNOTE: To ensure optimal flagging, perform the CBC run within 8 hours prior to the Retic run on the same analyzer using the same specimen.


1. Press the [RETIC RUN] key to display the RETIC RUN menu. Press the [PATIENT SPECIMEN] key to display the RETIC PATIENT SPECIMEN screen.

2. From the RETIC PATIENT SPECIMEN screen enter the Patient ID and press the Enter key on the keyboard to start the search process. The Standard Hematology Data Log for the last 8 hours will be searched for this Patient ID.

3. If the Patient ID is found, the second RETIC PATIENT SPECIMEN screen is displayed. All the available patient demographic information, and the RBC value, are shown on the screen. Proceed to step 4.

If the Patient ID is found but is more than 8 hours old, the third RETIC PATIENT SPECIMEN screen is displayed and the operator may enter an RBC value in this screen. Skip to step 5.

14-74 CELL-DYN 3700® System Operator’s Manual9140320D — June 2003


If the Patient ID is not found, the fourth RETIC PATIENT SPECIMEN screen is displayed and the operator may enter an RBC value in this screen. Skip to step 5.

NOTE: If an RBC value is entered manually, the Retic run will have incomplete flagging analysis for Excessive RBC Loss (ERL) and Excessive Nucleated Count (ENC).

4. Press Y on the keyboard to save this demographic information.

NOTE: If the Enter key was pressed in error, or if the patient demographic information is incorrect, press the [CANCEL] key to return to the first RETIC RUN screen, press the [PATIENT SPECIMEN] key, then reenter the Patient ID. If the Patient ID is found, skip to step 6. If not, proceed to step 5 after entering the RBC value.

5. Press the Enter key on the keyboard to confirm and accept this information.

6. The RETIC RUN RESULT screen is now displayed. The area in the upper left-hand corner displays the patient demographic information.

NOTE: The patient demographic data can be added or edited on this screen before the specimen is run, or from the EDIT SPECIMEN screen in the Reticulocyte Data Log after the reticulocyte run is complete.

7. The prepared dilution(s) of the patient reticulocyte sample(s) can be run after the control and background count results have met the laboratory’s criteria.

8. Open the well-mixed, prepared patient reticulocyte sample tube and immerse the Open Sample Aspiration Probe in the sample.

9. Press the Touch Plate located behind the probe to start the cycle. The word Busy on the Analyzer Status Indicator Panel will be illuminated in yellow. The Status Box on the RETIC RUN RESULT screen will display messages to indicate the various stages of the cycle.

10. Remove the sample tube when the beep sounds. The Wash Block moves down the probe and cleans it.

11. When the rinse cycle is complete, the Wash Block moves up the probe. The [NEXT RETIC] key is now displayed, and the Touch Plate is no longer active. The results of the reticulocyte run are displayed on the screen.



12. If automatic report printing has been specified, a report is printed according to the options selected in the SET UP MENU. If automatic report printing has not been specified, a report may be printed by pressing the [PRINT REPORT] key. Repeat this procedure for each subsequent reticulocyte sample.

NOTE: To obtain a color printout, the color printing option on the CUSTOMIZE PRINTED REPORT screen must be turned ON before entering the Reticulocyte Package.

13. Reticulocyte patient sample results can also be printed from the RETIC DISPLAY SPECIMEN screen, available from the RETIC DATA LOG screen.



NOTES


Reticulocyte PackageChapter 14 Quality Control Guide

Quality Control Guide

The CELL-DYN 3700 System offers several quality control options to monitor and validate instrument performance while running the Reticulocyte Package. The options are:

• 6 QC Files Statistical and graphical analysis of the data in each file to calculate the mean, standard deviation, and coefficient of variation

• Westgard Rules A multi-rule system applied to the data in each of the QC files

Each of these options is discussed in detail in Chapter 7: Quality Control.

All QC data should be reviewed according to your laboratory’s protocol.

Control MaterialAbbott Diagnostics recommends using the CELL-DYN control material for performing quality control checks on the CELL-DYN 3700 System. These controls should be run:

• After daily start-up procedures are completed.

• After a reagent lot number change.

• After a service call or component replacement.

• After calibrating the Standard Hematology Mode.

• In accordance with the laboratory’s quality control protocol.

• According to regulatory requirements.

NOTE: Data invalidating alerts, such as Fragile RBCs, are not valid when running commercial controls.


Reticulocyte PackageQuality Control Guide Chapter 14

Mixing and HandlingCAUTION: When using the reticulocyte reagent, avoid contact with skin and clothing. This reagent contains New Methylene Blue, which will stain skin, clothing, and many other surfaces.

Reagent• Use Reticulocyte Reagent prepared only by Abbott

Diagnostics. Verify the expiration date.

• Store the Reticulocyte Reagent in the dark at room temperature.

• Use one Reticulocyte Reagent tube for each CELL-DYN control or patient specimen.

Quality Control SpecimensAlways mix and handle commercial control material according to the directions given in the package insert. Pay particular attention to the following:

• Store the controls in the refrigerator at 2°– 8° C. Store in a suitable location in the refrigerator, away from the door if it is opened frequently.

• Carefully warm the controls prior to mixing, according to the directions given in the package insert. Proper mixing is essential for accurate results.

• Mix the control vials gently by hand to thoroughly resuspend the control material. Do not use automatic mixers to resuspend the control material.

• Check the open-vial stability dating given on the package insert and do not use the products longer than is recommended or results may be compromised.


Reticulocyte PackageChapter 14 Troubleshooting

Troubleshooting

OverviewThis section provides instructions for identifying, troubleshooting, and correcting instrument alerts and conditions in the Reticulocyte Package. All instrument conditions which adversely affect the Standard Hematology Mode of the CELL-DYN 3700 System will also apply to the Reticulocyte Package. These instrument conditions may be found in Chapter 10: Troubleshooting.

This section is divided into the following subsections:

• Operational Messages and Data Flagging

• Dispersional Data Alerts

• Instrument Alert Conditions

• Alert Messages with Suppressed Reticulocyte Results

• Data Invalidating Alerts

• High Background Counts

NOTE: For a list of interfering substances, refer to Routine Operation, Reticulocyte Specimens, Interfering Substances within this chapter.

Operational Messages and Data Flagging

Dispersional Data AlertsThe result of each run (patient, control, or background) is reviewed within the appropriate limits as entered by the operator or taken from the instrument’s preset limits. If a result for a parameter exceeds these limits, they are flagged on the screen and on the report. Dispersional Data Alerts are displayed or printed as follows:

Data Station Screen Display:• Result(s) below lower limits shown in yellow

• Result(s) above upper limits shown in purple

Linearity Exceeded: Result displayed as >>>>Reticulocyte QC Log: Result(s) outside limits underlined when

printedReticulocyte Data Log: Result(s) outside limits underlined when

printedGraphics Report: Result(s) outside limits underlined


Reticulocyte PackageTroubleshooting Chapter 14

Instrument Alert ConditionsInstrument Alert Conditions are messages displayed when the instrument detects an inappropriate condition during specimen processing. When necessary, data is suppressed. When these messages occur, follow the instructions given, and take the appropriate corrective action. When the problem is corrected, repeat the specimen.

Instrument Alert Messages with Suppressed Reticulocyte ResultsSuppression of Reticulocyte results occurs when the sample run data acquisition process exceeds normal parameters. When the Reticulocyte results are suppressed, one of the following three alerts will be displayed in the lower left-hand quadrant of the Data Station screen in the Reticulocyte Package and on the graphics printout under the heading ALERTS.

Alert Probable Cause Corrective Action

Flow Error

Note: Alert occurs when the average count rate rapidly increases during the Reticulocyte count cycle.

• Air bubble

• Hardware malfunction

1. Run a background count to cycle air through the system.

2. Rerun the Reticulocyte specimen.

3. If alert still occurs, refer to Chapter 10: Troubleshooting, Subsection: Trouble-shooting Flow Errors.

Too Few Events

Note: Alert occurs when fewer than 3000 events are counted during the Reticulocyte count cycle.

• Inadequate whole blood sample mixing- Improper pipet-

ting- Blood not stained

• Cold Agglutinin

1. Prepare another dilution verifying proper specimen preparation as dis-cussed in Routine Operation, Reticulo-cyte Specimens, Running Specimens, Patient, Specimen Preparation within this chapter.

2. Verify Reticulocyte results by an alter-nate method.

>>>> (Chevrons) • The Reticulocyte percentage exceeds the reportable linear range.

1. Verify Reticulocyte results by an alter-nate method.


Reticulocyte PackageChapter 14 Troubleshooting

Data Invalidating AlertsThe Reticulocyte results are not suppressed for the Data Invalidating Alerts. The alert message appears in the lower left-hand quadrant of the Data Station screen and on the graphics printout under the heading ALERTS.

Alert Probable Cause Corrective Action

Fragile RBC’s

NOTE: Alert occurs when the average count rate rap-idly decreases during the Reticulocyte count cycle.

• Air bubble

• Staining a fragile RBC specimen too long in the reticulocyte reagent

• Fragile RBCs

1. Run a background count to cycle air through the system. Rerun the Reticulo-cyte specimen.

2. Prepare another dilution verifying proper specimen preparation as discussed in Routine Operation, Reticulocyte Speci-mens, Running Specimens, Patient, Specimen Preparation within this chap-ter. Run the dilution after adequate incu-bation as indicated in the Reagent Package Insert.

3. Verify Reticulocyte results by an alternate method.

Excessive RBC Loss (ERL)

CAUTION: The (ERL) alert is functional only when CBC results have been run on the same analyzer.

• Specimen staining time too long in the reticulocyte reagent

• Rapid degeneration of RBCs.

• High concentration of platelets, platelet aggregates, or other interfering substances.

•• Microcytic RBCs•• Improper instrument

settings

1. Prepare another dilution verifying proper specimen preparation as discussed in Routine Operation, Reticulocyte Speci-mens, Running Specimens, Patient, Spec-imen Preparation within this chapter, and run after adequate incubation as indicated in the Reagent Package Insert.

2. Rerun the specimen.3. If the flag persists, verify the reticulocyte

results by an alternative method.

Excessive Nucleated Cells (ENC)

CAUTION: The (ENC) alert is functional only when CBC results have been run on the same analyzer.

• Too much blood added to reagent tube.

• High concentration of WBCs and/or NRBCs.

1. Prepare another dilution using 20lL of blood.

2. Rerun the specimen. If this alert persists, verify Reticulocyte results by an alter-nate method.


Reticulocyte PackageTroubleshooting Chapter 14

High Background CountsNOTE: The background count should be less than 100 counts.

1. If the background count is high, repeat the run.

2. If the results are still unacceptable, open a new tube of reticulocyte reagent and repeat the background count.

3. If the background count is still unacceptable, run a tube from a new lot of reticulocyte reagent if available.

4. If the results are still unacceptable, while in the Reticulocyte Background mode, press the Touch Plate to cycle air through the system.

5. If the results are still unacceptable, exit the Reticulocyte Package and perform a background check in the Standard Hematology mode.

6. If the background in the Standard Hematology mode is unacceptable, see Chapter 10: Troubleshooting, Subsection: Troubleshooting High Background Counts.

NOTE: Reticulocyte counts can not be processed until the reticulocyte background count is acceptable.


Reticulocyte PackageChapter 14 References

References

1. Clinical and Laboratory Standards Institute/NCCLS. Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline – Second Edition. CLSI/NCCLS document H44-A2 (ISBN 1-56238-527-5) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2004.

2. Davis, BH. Immature Reticulocyte Fraction (IRF): by any name a useful clinical parameter of erythropoietic activity. Laboratory Hematology 2:2-8, 1996.

3. Clinical and Laboratory Standards Institute/NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Second Edition. CLSI/NCCLS document EP9-A2 (ISBN 1-56238-472-4) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2002.

4. Clinical and Laboratory Standards Institute/NCCLS. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI/NCCLS document EP6-A (ISBN 1-56238-498-8) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2003.

5. International Committee for Standardization in Haematology (ICSH). The Assignment of Values to Fresh Blood Used for Calibrating Automated Cell Counters. Clinical and Laboratory Hematology 1988; 10:203-212.

6. Clinical Applications of Flow Cytometry. ASCP National Meeting. Spring 1990.

7. Shapiro Howard. Practical Flow Cytometry. New York: LISS. 1985.


Reticulocyte PackageReferences Chapter 14

NOTES

CELL-DYN® 3700 System Operator’s Manual Bibliography-19140320F — April 2007

Bibliography

American Society of Clinical Pathologists (ASCP). Clinical Applications of Flow Cytometry. ASCP National Meeting. Spring 1990.

Bull BS, Hay KL. Are Red Blood Cell Indexes International? Archives of Pathology and Laboratory Medicine; 109:604–606; 1985.

Bull BS, Jones AR, Gibson M, Twedt D. A Method for the Independent Assessment of the Accuracy of Hematology Whole Blood Calibrators. American Journal of Clinical Pathology; 98:623-29; 1992.

Bull BS, Korpman RA. Intralaboratory Quality Control Using Patients’ Data. Quoted in Cavill I, ed, Quality Control Edinburgh: Churchill Livingstone; pp. 121–150, 1982.

Cembrowski GS, Carey RN. Laboratory Quality Management. Chicago: ASCP Press, p. 189, 1989.

Cembrowski GS, et al. Use of a Multirule Control Chart for the Quality Control of PT and APTT Analyses. Laboratory Medicine. pp. 418– 421; June 1989.

Chanarin I, ed. Laboratory Hematology: An Account of Laboratory Techniques. New York: Churchill Livingstone, pp. 3-7, 1989.

International Committee for Standardization in Haematology (ICSH). The Assignment of Values to Fresh Blood Used for Calibrating Automated Cell Counters. Clinical and Laboratory Hematology; 10:203-212; 1988.

International Committee for Standardization in Haematology (ICSH). Protocol for Evaluation of Automated Blood Cell Counters. Clinical and Laboratory Hematology; 6:69-84; 1984.

Clinical and Laboratory Standards Institute/NCCLS. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard – Fifth Edition. CLSI/NCCLS document H3-A5 (ISBN 1-56238-515-1) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2003.

Bibliography-2 CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

Bibliography

Clinical and Laboratory Standards Institute/NCCLS. Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard – Fifth Edition. CLSI/NCCLS document H4-A5 (ISBN 1-56238-538-0) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2004.

Clinical and Laboratory Standards Institute/NCCLS. Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard – Third Edition. CLSI/NCCLS document H7-A3 (ISBN 1-56238-413-9) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2000.

Clinical and Laboratory Standards Institute. Reference Leukocyte Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard. CLSI/NCCLS document H20-A (ISBN 1-56238-131-8) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 1992.

Clinical and Laboratory Standards Institute/NCCLS. Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline – Second Edition. CLSI/NCCLS document H44-A2 (ISBN 1-56238-527-5) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2004.

Clinical and Laboratory Standards Institute/NCCLS. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI/NCCLS document EP6-A (ISBN 1-56238-498-8) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2003.

Clinical and Laboratory Standards Institute/NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Second Edition. CLSI/NCCLS document EP9-A2 (ISBN 1-56238-472-4) 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2002.

Shapiro Howard. Practical Flow Cytometry. New York: LISS. 1985.

Westgard JO et al. A Multi-Rule Shewhart Chart for Quality Control in Clinical Chemistry. Clinical Chemistry, 27:3:493–501, 1981.

CELL-DYN® 3700 System Operator’s Manual Appendix A-19140320D — June 2003

Appendix A Bar Codes

Overview

This section gives a brief overview of what bar coding is, how bar code labels are used for data entry and the different types of bar codes that may be used with the CELL-DYN® 3700 System.

Bar coding is an automated method of gathering alphanumeric information and transmitting it to a computer. Because it eliminates typing and associated errors, bar coding offers speed, increased accuracy and efficiency. The following are the major elements in a bar coding system:

• The computer, and its software, which interpret and store bar code data. For the CELL-DYN 3700 System, this is accomplished by the Data Station and its software.

• The scanning device, which “decodes” the information on the bar code labels. (The Sample Loader of a CELL-DYN 3700SL System has an integrated reader.)

• The bar code labels, which supply the specimen identification codes.

Bar Coding FunctionThe bar code label contains the actual identifying data for specimens in the form of a series of black bars and contrasting white spaces, which represent numbers and letters. The arrangement of the code follows one of several sets of rules for bar code languages, called symbologies. To decode the data in the label, a scanning device is used to pass a small spot of light over the bars and spaces and “read” them.

Since dark bars reflect little light back into the scanning device, while white space reflects a lot of light, a light detector inside the scanner can translate the differences in reflection into electrical signals. The signals are then converted into the sets of ones and zeros (the binary system used by computers) that stand for numbers and letters.

Appendix A-2 CELL-DYN® 3700 System Operator’s Manual

9140320D — June 2003

Bar CodesOverview Appendix A

Understanding the Label CodeIn all bar code symbologies, the code consists of elements (single bars or white spaces) and characters (groups of elements that stand for numbers or letters). In Code 39, a commonly used symbology, each code character contains nine elements, at least three of which must be wide. Wide elements (whether they are bars or spaces) in this symbology have a binary value of 1. Narrow elements have a binary value of 0.

Most contemporary bar code systems have several features in common. These include the following:

• The quiet zone, an area immediately before and after the bar code symbol, which enables the scanner to read the code properly.

• Start and stop characters, which indicate the beginning and end of the bar code symbol. They allow the label to be scanned from either right to left or left to right, ensuring that code information is transmitted correctly.

• Intercharacter gaps, which act as “spaces” between each character in the bar code symbol. Code 39 contains these gaps. However, there are other codes, including Interleaved 2 of 5, that do not use them.

• The interpretation line, an area at the bottom of the bar code label where human-readable information can be placed. This may or may not be the same data as in the label code.

• The check digit, an extra numeric character in the bar code that permits the scanning device to mathematically determine whether it read the code correctly. This keeps the error rate as low as one for every billion characters scanned.


Bar CodesAppendix A Overview

Bar Code Types and CharacteristicsThe CELL-DYN 3700 Sample Loader reads three types of bar codes:

• Code 39

Also referred to as code 3 of 9, Code 39 encodes 43 data characters: 0–9, A–Z, six symbols and spaces. Each character is represented by nine elements, three of which are wide and six of which are narrow.

• Interleaved 2 of 5

Interleaved 2 of 5 encodes the 10 numeric digits 0–9. The name is derived from the method used to encode two characters that are paired together. Bars represent the first character, and the interleaved spaces represent the second character. Each character has two wide elements and three narrow elements, for a total of five elements.

• Codabar

Codabar uses four bars and three spaces to represent the ten numeric digits 0–9 and certain special characters. The code is characterized by four unique start/stop codes and variable intercharacter spacing.

NOTE: When the check digit is on, only the letter A can be used as a stop/start character.

• Code 128

Code 128 has 106 different printed characters. Each character has three bars and three spaces comprising 11 modules. Each printed character can have one of three different meanings, depending on which of three different character sets is used. Three different start characters tell the reader which of the character sets is initially being used, and three shift codes permit changing the character set inside a symbol.


9140320D — June 2003

Bar CodesOverview Appendix A

NOTES



Specifications

Bar Code Label FormatsThe Sample Loader Bar Code Reader can read Code 39, Interleaved 2 of 5, Codabar and Code 128 formats interchangeably, provided the check digit option is disabled. Code size, collection tube length, and cap style limit the number of digits to the following maximum numbers:

• Code 39 — 9 digits

• Interleaved 2 of 5 — 10 or 12 digits only

• Codabar — 10 digits

• The maximum number of digits includes any check digits within the code. For example, if one check digit is used in Code 39, then there are 8 digits left for the rest of the code.

• Code 128 — 11 digits

Bar Code Check Digit FormatsBar code check digits are used whenever the Sample Loader is to read a specific type of bar code. (To enable or disable check digits, refer to Chapter 5: Operating Instructions, Subsection: Bar Code ON/Bar Code OFF Soft Key.) Check digit specifications are:

Code 39: The modulus 43 sum of all the character values in a given message.

Interleaved 2 of 5: The check digit is the complement of the weighted sum of the digits modulo 10. To weight the digits, multiply every other digit by 3, starting with the first.

Codabar: The check digit is the 16-(sum of character values modulo 16).

Code 128: The check digit is included and always on.

NOTE: If a specific check digit option is selected and enabled, the Sample Loader will read only bar codes in that specific format. If there is more than one format to be read, it is recommended that the check digit option be disabled.


9140320D — June 2003

Bar CodesSpecifications Appendix A

Bar Code Label SpecificationsBar code labels (shown in the following figure) must be printed on good quality label stock and must meet the following specifications:

• 0.25 inch minimum quiet zone on each end

• 0.01 inch (10 mils) minimum narrow bar width

• 2:1 to 3:1 wide to narrow bar ratio

• 0.5 inch minimum bar length

• 2 inch maximum label length

• 1.25 inch maximum label width

• Maximum possible contrast between bars and background label

Figure A.1: Bar Code Label Specifications

MinimumQuiet Zone0.25 inches

Maximum Label Length2.0 inches

Minimum Bar Length0.5 inches

Maximum Label Width1.25 inches

CELL-DYN® 3700 System Operator’s Manual Appendix A-79140320E — September 2004

Bar CodesAppendix A Specifications

CELL-DYN Bar Code LabelsCELL-DYN 4-digit Code 39 bar code labels are available for the Sample Loader. These labels may be used for positive specimen identification when laboratory-generated bar code labels are unavailable.

CELL-DYN Q LabelsSpecial bar code labels are available to identify QC specimens. These “Q” labels (numbers Q1–Q20) automatically select QC files 1 to 20, and therefore should be used to process only QC specimens.



Bar CodesSpecifications Appendix A

Bar Code Label PlacementThe following two guidelines should be observed when placing bar code labels on specimen tubes:

• All labels should be placed on the tubes securely and without flaps sticking out. (See the following figure.) Excessive numbers of labels may prevent tubes from mixing properly.

• The bar code label should be placed on the tube just below the stopper with the bars perpendicular to the length of the tube so that the entire bar code can be viewed through the slot in the rack as the tube rotates. Be sure that at least 0.10 inch (about 1/8 inch) of space is left between the bottom of the rack slot and the bar code symbol, as well as between the bottom of the tube cap and the bar code symbol, to satisfy the “quiet zone” requirement. See the following figure for proper placement.

NOTE: The bar code reader searches for a readable code when it reads a bar code label. It then performs multiple reads to verify that the code has been read correctly. If a second bar code label from a different patient is applied to the tube, it may be ignored by the bar code reader. Consequently, the possibility for misidentification exists. Good laboratory practice mandates that each specimen is labeled with information traceable to one patient only. Therefore, it is recommended that only one bar code label is used on each tube for correct specimen identification.

Figure A.2: Tube Labeling Requirements

Properly Labeled Tubes

Improperly Labeled Tubes

Top SurfaceShould Be Dry

16.5 mm

Width Limit forMultiple Labels

Diameter

ClearTape

Bar CodeLabel

ExposedBottom

HighCollar

Tail

Flap

EdgesPeeledLoose



Acknowledgment

The authors wish to acknowledge Computype, Inc. of St. Paul, Minnesota for providing their booklet “Bar Coding and Productivity” to assist in the writing of this chapter.


9140320D — June 2003

Bar CodesAcknowledgment Appendix A

NOTES

CELL-DYN® 3700 System Operator’s Manual Appendix B-19140320E — September 2004

Appendix B Parts List

Overview

This section lists the part numbers of components, accessories, controls, reagents, and consumables associated with the CELL-DYN 3700 System for user convenience when placing orders.

To place an order for these products or obtain technical assistance for your CELL-DYN System, contact Abbott Diagnostics Customer Service at 1-877-4ABBOTT (1-877-422-2688).

CELL-DYN 3700 AccessoriesList numbers are unique identifiers used when ordering products. List numbers and quantities provided in this Operator’s Manual are intended for guidance only and are subject to change. US Customers, contact Abbott Diagnostics Customer Service at 1-877-4ABBOTT (1-877-422-2688) for the most current information regarding list numbers. Customers outside the US, contact your local Customer Service Representative.

Table B.1 CELL-DYN 3700 Accessories Kit (List Number 06H88-01)

Part/ListNumber Quantity Description

02H33-01 1 CD 3700 Interface Specification

*1403216 1 Keyboard Cover

20005-01 1 6ft Interface Cable

21704-01 1 Waste Sensor Dummy Plug

*2400502 1 Cord Power, 125V

*3001008 1 Computer Printer Paper 8-1/2" X 11"

*5100165 2 Fuse, 8 Amp T (Slo-Blo)

*5100201 2 Fuse Fast, 1.6 Amp

*5406754 1 Allen Wrench, Hex, Short “L” 7

54305-01 1 Aperture Brush

*5100164 2 Fuse, 4 Amp T (Slo-Blo)

70048-01 1 Allen Wrench

91482-01 1 Reagent Line Kit

* Available only to Abbott Personnel.

Appendix B-2 CELL-DYN® 3700 System Operator’s Manual


Parts ListOverview Appendix B

91484-01 2 Peristaltic Pump Tubing- Small

91485-01 1 Peristaltic Pump Tubing- Medium

9212230 1 Sample Aspiration Tubing (Sample Loader)

92532-01 1 Serial Loop Back Device

03H99-01 1 CD 3700 SL Needle

03H96-01 1 Solenoid Ring Pull

95519-01 1 Data Station Cable

03H98-02 1 Waste Bottle Cable

Table B.2 CELL-DYN 3700 Sample Loader Accessories Kit

List Number Quantity Name Comments

04H91-04 1 set Sample Loader Racks Set of 11 Sample Loader racks pre-labeled with tube position numbers and rack number label

Table B.1 CELL-DYN 3700 Accessories Kit (List Number 06H88-01) (Continued)

Part/ListNumber Quantity Description

CELL-DYN® 3700 System Operator’s Manual Appendix B-39140320D — June 2003

Parts ListAppendix B Overview

CELL-DYN 3700 Optional AccessoriesTable B.3 CELL-DYN 3700 Optional Accessories

Part/ListNumber Quantity Name Description

25860-01 1 Bar Code Label Dispenser Dispenser for Bar Code Label rolls

99650-01 1 Bar Code Tube ID Labels, 1 roll Tube ID Bar Code Labels (1000 labels per roll)

99652-01 1 QC Bar Code Labels QC Bar Code Labels (Numeral 1-20), in Code 39 (without check digit)

04H34-01 1 Syringe, 10 mL For dispensing Diluent reagent

28561-01 1 Syringe, 2.5 mL For dispensing WIC/HGB Lyse reagent

28560-01 1 Syringe, 500 µL For injecting diluted sample into optical flow cell

03H99-01 1 Needle, Vent/Aspiration For venting/aspirating samples in Closed Mode

06H89-01 1 Operator’s Manual English Version

03H76-01 1 CELL-DYN 3700 Shear Valve Center Section

Ceramic Center Section for CELL-DYN 3700 Blood Shear Valve

99644-01 1 Enzymatic Cleaner

99624-01 Pre-Printed Tickets

Appendix B-4 CELL-DYN® 3700 System Operator’s Manual

9140320F — April 2007

Parts ListOverview Appendix B

Table B.4 CELL-DYN 3700 Calibrators and Controls

List Number Quantity Name Description

99120-01 1 CELL-DYN® 22 CALIBRATOR 2 x 2.5 mL tubes

08H57-01 1 CELL-DYN HemCal® Calibrator 2 x 3.0 mL vials

93111-01 1 CELL-DYN 22® Tri-Level Control 12 x 2.5 mL tubes

99106-01 1 CELL-DYN® 22 Tri-Level Control, half pack 6 x 2.5 mL tubes

99103-01 1 CELL-DYN® 22 Normal Level Control 6 x 2.5 mL tubes

01H91-01 1 CELL-DYN® 22 Control Assay Disk Diskette

08H58-01 1 CELL-DYN® 29 Plus Control (with Retic) 12 x 3.0 mL vials

08H58-02 1 CELL-DYN® 29 Plus Control (with Retic), half pack 6 x 3.0 mL vials

08H64-01 1 CELL-DYN® 29 Plus Control (with Retic), Assay Disk Diskette

08H62-01 1 CELL-DYN® Retic Plus Control 10 x 3.0 mL vials

Table B.5 CELL-DYN 3700 Reagents

List Number Quantity Name Single Container Size QTY/ Case

99231-01 1 Diluent Reagent 20 L cubitainer 1/case

99311-01 1 Sheath Reagent 9.6 L cubitainer 1/case

03H62-01 1 CN free HGB/WIC Lyse Reagent

3.8 L cubitainer 1/case

99431-01 1 HGB/WIC Lyse Reagent 3.8 L cubitaner 1/case

99321-01 1 Detergent Reagent 20 L cubitainer

03H40-01 1 Reticulocyte Reagent 5.0 mL tubes, each tube containing 3.7 mL of reagent

Kit of 100

CELL-DYN® 3700 System Operator’s Manual Appendix C-19140320E — September 2004

Appendix C

Appendix C

This table provides a detailed list of interfering substances. Note that some of the substances listed may not interfere with CELL-DYN 3700 results. Refer to the list of interfering substances provided in this manual in Section 3: Principles of Operation, Subsection: Operational Messages and Data Flagging and in Section 5: Operating Instructions, Subsection: Sample Collection and Handling, for the substances that commonly interfere with CELL-DYN 3700 results.

Source:

• Cornbleet J. Spurious Results from Automated Hematology Cell Counters. Laboratory Medicine 1983; 14:509-514.

Parameter Causes of Spurious Increase Causes of Spurious Decrease

White Cell Count (WBC) Cryoglobulin, cryofibrinogenHeparinMonoclonal proteinsNucleated red cellsPlatelets clumpingUnlysed red cells

ClottingSmudge cellsUremia plus immunosuppressants

Red Cell Count (RBC) Cryoglobulin, cryofibrinogenGiant plateletsElevated white cell count (> 30,000/μL)

Cold agglutininsClotted specimen (microclot)Hemolysis (in vitro)Polycythemia (increased RBC coincidence)Microcytic red cells

Hemoglobin (HGB) Carboxyhemoglobin (> 10%)Cryoglobulin, cryofibrinogenHemolysis (in vivo)Elevated white cell count (>30,000/μLHyperbilirubinemia, severe LipemiaAbnormal plasma proteins

Clotted specimen (microclot)

Hematocrit(Packed Cell Volume − Manual Method)

HyponatremiaPlasma trapping

Excess EDTAHemolysis (in vitro)Hypernatremia

Mean Cell Volume AutoagglutinationHigh white cell count (>50,000/μL)HyperglycemiaReduced red cell deformabilitySwollen red cells

Cryoglobulin, cryofibrinogenGiant plateletsHemolysis (in vitro)Microcytic red cells

Mean Cell Hemoglobin High white cell count (> 50,000/μL)Spuriously high hemoglobinSpuriously low red cell count

Spuriously low hemoglobinSpuriously high red cell count

Mean Cell Hemoglobin Concentration AutoagglutinationClottingHemolysis (in vivo and in vitro)Spuriously high hemoglobinSpuriously low hematocrit

High white cell count (> 50,000/μL)Spuriously low hemoglobinSpuriously high red cell count

Platelets (PLT) Cryoglobulin, cryofibrinogenHemolysis (in vivo and in vitro)Microcytic red cellsRed cell inclusionsWhite cell fragments

ClottingGiant plateletsHeparinPlatelet clumpingPlatelet satellitosis

Appendix C-2 CELL-DYN® 3700 System Operator’s Manual


Appendix C

NOTES

CELL-DYN® 3700 Operator’s Manual Index - 19140320F — April 2007

Index

Numerics10-mL Reagent Syringe 9-37

AAbbott Instrument Warranty iiiAccessing the Maintenance Log 9-8Accessing the Shear Valve 9-9Accuracy 13-6Acknowledgment A-9Adding a New Configuration File 13-34Adding New Animal Types 13-33Analyzer Air Filters 9-32Analyzer Flow Panel Components Diagram 9-2Analyzer 1-6Aperture Plates 9-39As Required 9-37Auto-Cal Calibration Criteria Worksheet 6-45,

6-57Auto-Cal Methodology 6-34Auto-Cal Mode to Mode Calibration 6-71Auto-Cal Overview 6-33Auto-Cal Sample Capacity 6-34Auto-Cal Using Calibrator 6-37Auto-Cal Using Whole Blood 6-47Auto-Calibrate Soft Key 6-19Auto-Clean 9-19

BBar Code Check Digit Formats A-5Bar Code Label Formats A-5Bar Code Label Placement 12-3, A-8,Bar Code Label Specifications A-6Bar Code Labels 12-3Bar Code Reader Window 9-46Bar Code Specifications 4-7Bar Code Types and Characteristics A-3Bar Coding Function A-1Baso Box Setup 13-46Bibliography Bibliography-1

CCalibrating All Parameters 6-43, 6-54, 6-80Calibrating Individual Parameters 6-44, 6-55,

6-81Calibrating the Closed Mode 6-90Calibrating the Open Mode 6-65Calibration Backup 6-95Calibration Factor Calculation 6-40, 6-50, 6-77,

6-90Calibration Factor Calculations 6-62Calibration Guidelines 6-27Calibration Log Soft Key 6-18Calibration Materials 6-3Calibration Menu 6-13Calibration Menu Flowchart 6-13Calibration Methods 6-3Calibration Procedural Summary 6-11Calibration Requirements for Auto-Cal 6-35Calibration Screen 6-14Calibration 13-27Calibrator 1-27Carryover 13-7Cell Populations and Flagging 3-45CELL-DYN 3700 Accessories B-1CELL-DYN 3700CS System Specifications 4-3,

4-9CELL-DYN Bar Code Labels 12-3, A-7CELL-DYN Controls 7-27CELL-DYN Q Labels 12-3, A-7Chemical Hazards 8-4Closed Mode Calibration Confirmation 6-72Closed Sampler Aspiration Needle 9-22Closed Sampler Tube Retainer Adjustment (CS

System Only) 9-51Coincidence Passage Correction 3-27Collecting the Calibration Data 6-38, 6-48, 6-75Combined Specifications for the SL and

CS Systems 4-13Completing Manual Calibration 6-66Completing Mode to Mode Calibration 6-82,

6-91Completing Open Mode Calibration 6-44

Index - 2 CELL-DYN® 3700 Operator’s Manual

9140320F — April 2007

Completing Whole Blood Open Mode Calibration 6-55

Control Material 14-77Controls and Calibrator 1-27Controls 1-27Conventions Used in this Chapter 6-11Conventions Used in This Manual xiv, 5-5Customer Support iCustomize Report Soft Key 5-51Customizing the Display 13-36

DDaily Maintenance Procedures 9-19Data Log Menu 5-122Data Log Set Up Procedures 5-135Data Review from the Data Log 5-140Data Review from the Retic Data Log 14-37Data Station Program Overview 5-2Data Station 1-19Date/Time Soft Key 5-14Decontamination Procedures 9-4Determining Reference Values 6-73Determining the Calibration Factors for MCV

and MPV 13-29Determining the Closed Mode Mean 6-86Determining the Open Mode Mean 6-61, 6-85Determining the Variance 13-39Determining Which Parameters Need

Calibration 6-41, 6-52, 6-63, 6-78, 6-88Diagnostics Menu Flowchart 10-4Diagnostics Menu 10-3Disabling/Enabling the Analyzer 9-9Draining the Reagent Reservoirs 9-7

EElectrical Hazards 8-5Electrical Impedance Measurements 3-27Emptying the Transducers 9-6Enter Factor Soft Key 6-16Entering the Calibration Factor 13-29Entering the Reference Values 6-37, 6-48, 6-74Examples of Customer-Defined Default Codes

13-50Extended Auto Clean 9-28, 9-35

FFlagging Diagnostics Screen 3-57Flagging Summary 3-49Flagging 13-8Flushing the “Y” Fitting — Open and Closed

Modes 9-47Foreword iFunction Sequence 12-12Functional Description 12-9

GGeneral 8-3Graphics Printing 11-3Guidelines 6-60

HHandling and Disposing of Biohazardous

Materials 8-4Hazard Information and Precautions 8-3Hemoglobin Analysis 3-6, 3-35Hemoglobin Flow Cell Manual Cleaning 9-43Hemoglobin Measurement Process 3-35HGB Parameters 3-36High Background Counts 14-82

IInitial Preparation 2-3Installation 2-7Instrument Disclaimer iiInstrument Fault and Status Messages 3-37Instrument Installation 2-13Instrument Labeling viiiInstrument Logbook 5-1Instrument Rinsed 3-7Instrument Start Up 5-92Intended Use i, 1-3Interpretive Messages 3-58Interval Set Up Procedure 9-15Introduction to WBC Flagging 3-41Introduction 10-1, 3-37, 13-1, 13-5Inventory 2-3


LLaser Hazards 8-6Linearity 13-7List of Messages and Fault Conditions 10-66List of Symptoms 10-38Loading Blank (Continuous-Feed) Tickets 11-8Loading Individual Tickets 11-7

MMain Module 12-5Main Soft Key 6-16Maintenance 11-11, 12-17Maintenance Log Set Up 9-13Manual Calibration Overview 6-59Manual Calibration Procedure — Open Mode

6-61Manual Calibration Worksheet 6-68Manual Mode to Mode Calibration (CS or SL)

6-85Manual Mode to Mode Calibration Worksheet

6-93Manual Mode to Mode Calibration 6-72Measurement Specifications 4-13Menu Flowcharts 5-6Messages and Fault Conditions 10-68Mixing and Handling 14-78Mode To Mode Auto-Cal Calibration (Closed

Sampler Only) 6-73Mode to Mode Auto-Cal Calibration Criteria

Worksheet 6-83Mode To Mode Calibration Overview 6-71Mode to Mode Calibration Preparation 6-72Monthly Maintenance Procedures 9-29

OOpen and Closed Modes 6-2Open Sampler/Closed Sampler Soft Key 6-15Operating Instructions 13-9Operating Principles 12-9Operating Tips 12-15Operation Set Up Soft Key 5-43Operational Messages and Data Flagging 3-37,

14-79Operational Specifications 4-6, 4-11Optional Calibration Confirmation 6-82, 6-91Other Chapters to Reference 12-17

PPackage Inspection 2-3Parameter Flagging Messages 3-38Patent Statement iiPatient Limits Soft Key 5-16Percent Difference Calculation 6-87Performance Characteristics 4-20, 13-5Performance Specifications 4-15Physical and Mechanical Hazards 8-6Physical Specifications 4-3, 4-9Pictorial Disclaimer iiPlatelet Flagging 3-34PLT Measurement Process 3-32PLT Parameters 3-33Post-Calibration Procedures 6-95Power Requirements 2-5Power Specifications 4-4, 4-10Pre-Calibration Procedures Checklist 6-29Pre-Calibration Procedures 6-27, 13-28Precision 13-5Preparation for Inactivity or Shipping 9-52Preparing for Manual Calibration 6-61Preparing for Manual Mode to Mode Calibration

6-85Preparing the Samples 13-38Preventive Maintenance Schedule 9-2Principles of Operation 13-3, 14-7Print Soft Key 6-15Printer Installation 2-7Printer 1-23Procedure: MCV or MPV Calibration 13-28Proprietary Statement ii

QQC Set Up Menu Soft Key 5-21Quality Control Guide 7-15, 14-77Quality Control Menu Flowchart 7-2Quality Control Menu 7-3Quality Control 6-95, 13-31


9140320F — April 2007

RRBC Flagging 3-31RBC Parameters 3-30RBC/PLT Analysis 3-6, 3-27RBC/PLT Measurement Process 3-29Reagent Log Soft Key 5-19Reagent Syringes 9-29Reagent System 1-23References 3-61, 4-25, 5-143, 6-99, 7-29, 8-11,

13-55, 14-83Related Symbols xiiiRelocation 2-17Repackaging for Shipment 9-54Replaceable Components 10-32RER 3-28Results Displayed 3-7Retic Data Log Menu 14-30Retic Main Menu 14-14Retic Menu Options 14-9Retic QC Log Menu 14-39Retic Run Menu 14-57Retic Run Menu Flowchart 14-56Retic Set Up Menu 14-16Retic Special Protocols Menu 14-52Reticulocyte Analysis 3-6Reticulocyte Reagent System 1-26Reticulocyte Specimens 14-67Reticulocytes 3-32Revision Log xviiiRevision Status xviiRoutine Operating Procedures 12-15Routine Operation 5-67, 13-21, 14-55Run Menu 5-68Run Screen Soft Keys 5-74Run Screen 13-21Running Controls 7-15Running the Samples 13-38

SSafety Agency Approvals ivSafety xviSample Analysis Cycle Overview 3-5Sample Analysis Using the CS Model 5-99Sample Analysis Using the SL Model 5-92Sample Analysis Using the Work List 5-114Sample Analysis 5-89Sample Aspiration Peristaltic Pump Tubing 9-26

Sample Aspiration 3-3Sample Collection and Handling 5-87Sample Loader Aspiration Needle 9-21Sample Loader Components 12-5Sample Loader Set Up 2-10Sample Loader Tray, Racks, and Safety Cover

9-27Sample Loader 1-23Selecting the Animal 13-22Self-Test Printouts 11-4Set Up Instructions 5-13Set Up 12-17Shear Valve 9-23Space Requirements 2-4Special Procedures 9-51Special Protocols Menu 9-5Special Protocols Screen #2 9-10Specifications A-5Starting Auto-Cal 6-37, 6-47, 6-74Suspect Parameter Flags 3-50Suspect Population Flags 3-53Symbols vSymptom Identification and Resolution 10-39System Components 1-5

TThe Animal Catalog 13-3Ticket Printing 11-5Tower Unit 12-7Trademark Statements ivTroubleshooting Guide 10-27Troubleshooting Procedures 10-29Troubleshooting 11-13, 12-17, 14-79Turning on the Gains Template 13-37Turning the Reticulocyte Package ON and OFF

14-10Turning The Vet Package Off 13-53

UUnclogging the Open Sample Aspiration Probe

9-45Understanding the Label Code A-2Units Selection Soft Key 5-49Update Maintenance Log Procedure 9-16Using The Data Log 5-121Using The Work List 5-103


VVet Package Keys 13-10Vet Package Suggestions 13-49View QC Log Soft Key 7-8Volumetric Metering 3-28

WWarning Conventions 8-1Waste Requirements 2-5WBC Analysis 3-5, 3-9WBC Descriptors 3-49WBC Differential Analysis 3-19WBC Flagging 3-26

WBC Parameters 3-25Weekly Maintenance Procedures 9-23Westgard Rules 7-17When to Calibrate 6-1WIC Measurement 3-10WIC/WOC Interaction 3-9WOC Analysis 3-13WOC Transfer Peristaltic Pump Tubing 9-33

XX-B Analysis 7-20X-B File Soft Key 7-4


9140320F — April 2007

NOTES

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Cell-Dyn 3700 - Operations Manual

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