Operator’s Manual - Block · PDF fileTest Sequence Number ... through operation of the...

Operator’s Manual

132387 Rev. D, 2006-06

Analyzer®

132387 Rev. B, 2004-10

Operator’s Manual

Analyzer

132387 Rev. D, 2006-06

© 2003 Bayer HealthCare. All rights reserved.

Clinitek, Clinitek Status, Multistix, Multistix PRO, Combistix, Uristix,Labstix, Neostix, Clinitest and Chek-Stix are trademarks of Bayer.

Precept and Cidex are trademarks of Johnson & Johnson.

Theracide is a trademark of Lafayette Pharmaceuticals, Inc.

Amphyl is a trademark of Linden Corporation.

Kimwipes is a trademark of Kimberly-Clark.

US Pats 5,408,535; 5,477,326; 5,877,863; 6,239,445; D456,082;D489,816

Origin: UK

The information in this manual was correct at the time of printing.However, Bayer HealthCare continues to improve products and reservesthe right to change specifications, equipment, and maintenanceprocedures at any time without notice.

If this instrument is used in a manner differently than specifiedin this manual, the protection provided by the equipment maybe impaired.

Bayer Diagnostics Mfg (Sudbury) LtdSudbury, CO10 2XQ, UK

Bayer HealthCare LLCSubsidiary of Bayer CorporationTarrytown, NY 10591-5097 USA

iii132387 Rev. B, 2004-10

Table of Contents

A Brief Description ............................................................ vUnderstanding the Symbols and Display Icons .............. vii

1 Unpacking & Set Up ................................................. 1-1Unpacking .....................................................................1-1Set Up ...........................................................................1-2

Analyzer Set Up ...............................................1-2Plugging Analyzer In ........................................1-2Installing Batteries ............................................1-2Inserting Test Strip Table ..................................1-3Loading Test Table Insert .................................1-3Interfacing to a Computer .................................1-3Analyzer Software Upgrades ...........................1-4Loading the Printer Paper or Label Roll ...........1-5Warranty Registration .......................................1-6

Powering Up ..................................................................1-7Powering Down .............................................................1-8

2 Interacting with the Touch Screen .......................... 2-1Screens .........................................................................2-1Keyboards .....................................................................2-4

3 Start-Up Wizard ......................................................... 3-1

4 Testing ....................................................................... 4-1Quick Tests ....................................................................4-1

Urinalysis Strip Test ..........................................4-1Cassette Test ....................................................4-6

Full Tests ..................................................................... 4-11Urinalysis Strip Test ........................................ 4-11Cassette Test ..................................................4-19

iv 132387 Rev. D, 2006-06

5 Instrument Set Up ..................................................... 5-1Instrument Set Up .........................................................5-1Language Settings ........................................................5-2Password ......................................................................5-3Operator and Patient Information ..................................5-4Date and Time Settings ...............................................5-10Test Sequence Number ...............................................5-12Instrument Settings .....................................................5-13Restore Default Settings .............................................5-21Diagnostics ..................................................................5-22System Information .....................................................5-23

6 Recall Results ........................................................... 6-1Patient Results ..............................................................6-1Sending Data to a PC ...................................................6-3

7 Troubleshooting........................................................ 7-1List of Errors and Advisory Messages ...........................7-4Problem Checklist .........................................................7-8

8 Quality Control Testing ............................................ 8-1Information regarding CLIA Waiver ...............................8-2

9 Cleaning and Maintenance ...............................................9-1Cleaning ........................................................................9-1Changing Batteries ........................................................9-7

10 Appendices............................................................ 10-1Appendix A: Local Technical Support Providers andDistributors ..................................................................10-1Appendix B: Tables of Results ....................................10-4Appendix C: Specifications .......................................10-10Appendix D: Instrument Default Settings – English ..10-12Appendix E: System Overview & Principles ..............10-14Appendix F: CLIA Waiver Performance Characteristics 10-21Appendix G: Training & Educational Materials ..........10-23Appendix H: Safety Information ................................10-24

11 Index ..................................................................................... 11-1

v

A Brief Description

132387 Rev. D, 2006-06

What does the analyzer do?

Your Clinitek Status® analyzer isa portable instrument for readingBayer urinalysis strips and Clinitest®

immunoassay cassettes. No specialtraining is needed to use thisinstrument. Several different Bayerurinalysis strips (e.g., Multistix® 10SG) can be used with the analyzeras well as the Clinitest hCGPregnancy Test.

The analyzer can be set up to beas simple or sophisticated as youprefer. You may simply insert adipped urinalysis strip or a Clinitestcassette into the analyzer and theresult will be reported (this is calleda Quick Test).

Or, you have the option to enteran Operator ID, Patient Name andPatient ID. This added informationwill be reported along with the testresults (this is called a Full Test).

The touch screen displaysinstructions and prompts youthrough operation of the analyzer. Inaddition, you enter informationthrough the touch screen.

Do I have to calibrate?

You do not have to do anything tocalibrate. The instrument performsa system test each time it is turnedon. Then, each time a test is run,the instrument automatically

calibrates. The white calibration bar(on the test table) provides NISTtraceable calibration.

How does it work?

Testing starts (in the Quick Testmode) when either the Strip Testor Cassette Test is selected on themain menu screen.

Touching the Strip Test keyprompts you to adjust the test tableto accept a urinalysis strip. Thenyou touch the START key. Youhave 8 seconds to dip the test strip,blot the edge of the strip and placeit on the test strip table. The table ispartially pulled into the instrumentfor calibration and then pulledcompletely into the instrument toread the test strip.

Touching the Cassette Test keyprompts you to adjust the test tableto accept a cassette. Then youtouch the START key. You have8 seconds to draw the sample intoa pipette and dispense it into thesample well of the cassette. Theanalyzer automatically calibratesand then pulls the table completelyinto the instrument where thecassette is read.

In the Full Test mode for either aStrip Test or Cassette Test, youare prompted to enter an OperatorID, Patient Name and/or Patient IDprior to running a test.

A Brief Description

vi

A Brief Description

132387 Rev. D, 2006-06

How do I get results?

Results will be displayed on thetouch screen and printed (ifdesired). The results can also betransferred to a computer using a9-pin null modem serial cable andthe RS-232 serial port on the backof the instrument.

The analyzer stores results from200 patient tests. You are able torecall past patient test results onthe analyzer using the RecallResults function.

How is the analyzer powered?

The analyzer can be pluggedinto an electrical outlet for use onthe bench top, or it can be poweredby batteries and freely moved fromone testing site to another. Thebatteries fit into an opening on thebottom of the instrument.

What about this Operator’sManual?

The Operator’s Manual containsthe directions you need to unpack

the analyzer, use it for your dailyBayer urinalysis and Clinitestimmunoassay testing and keep it ingood working condition.

As you read through theOperator’s Manual, you will findthese symbols:

In the Operator’s Manual, you willnotice some text is in bold/italic orbold.

Bold/italic text identifies screen names.

NOTES: contain useful tipson using the analyzer. Notesappear in italicized type.

Bold text identifies a button(touch – sensitive area) on thescreen.

CAUTION: should befollowed carefully to ensure youranalyzer operates correctly andis not damaged. Cautionsappear in bold type.

vii

Understanding the Symbols and Display Icons

132387 Rev. D, 2006-06

Instrument and Labeling Symbols

This section describes the symbols that appear on the exterior of theClinitek Status instrument, the power supply provided with the instrument,the carton in which the instrument was delivered and the supplies of reagentstrips and cassettes which you will use with the instrument.

Indicates that the input supply is direct current

Identifies that the instrument is type B equipment, whichprovides a particular degree of protection against electric shock

Identifies that the instrument is class 1 type equipment, whichhas basic insulation and additional safety grounding precautions

Double insulated product or transformer may also identifyclass 2 equipment (power supply only)

Identifies that the instrument is listed by UnderwritersLaboratories as meeting U.S. and Canadian requirements forsafety

The CE mark identifies that the product complies with theapplicable directives of the European Union

Manufacturer

European authorized representative

Indicates a power on/off button

Caution, consult accompanying documents

In vitro diagnostic device

Consult instructions for use


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132387 Rev. D, 2006-06

Indicates a serial port

Temperature limitation (18 - 30 C)

Contents sufficient for (n) tests (100)

Use by YYYY-MM

Catalog number

Serial number

Batch code

Biohazard

Indicates that this equipment is classified as Waste Electricaland Electronic Equipment under the European WEEEDirective. It must be recycled or disposed of in accordancewith applicable local requirements.

Printed on recycled materials

Indicates compliance with RESY packaging standards

Keep this way up

Fragile, handle with care

100

18

30

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132387 Rev. D, 2006-06

VDE Testing and Certification Institute - Germany

Manufacturer’s mark (FRIWO) and manufacturing location(Hong Kong)

Manufacturer’s mark (FRIWO) and manufacturing location(Geratebau, Germany)

Encapsulated safety isolating transformer (short-circuit proof)

Positive Temperature Coefficient (PTC) - A thermistor deviceused to protect the transformer from short-circuits or overload.This is an auto reset device.

Thermal cut-out (TCO) – This safety device disconnects thesupply voltage to the transformer at a specific temperature.The operation temperature is stated below.

Ingress protection rating – protected against the entry of solidobjects >1 mm but no protection from liquids.

Keep dry

Keep away from sunlight and heat

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132387 Rev. B, 2004-10

Display Icons

The Bayer logo is shown in the top left of the display while some of thesystem diagnostic tests are being carried out after power-up. There areseven other icons which display in the same position to show the mode ofthe instrument. They also appear on the selection area for each function.The icons are:

Instrument Set UpThis is displayed when the instrument is being set up to suit theusers’ requirements.

Strip Test (e.g., Multistix 10SG)Shown when a test is being carried out using a reagent strip forurinalysis, and when results are displayed following a strip test.

Cassette Test (e.g., Clinitest hCG)Displayed when a cassette test is being carried out and whenresults are shown after a cassette test.

Results recallUsed to show that results are being recalled from theinstrument’s memory.

PrinterThis icon is displayed when results are being printed.

Data transfer to Personal ComputerShows that data, including results, is being transferred to a PC.

AlertUsed when an error is being displayed.

There are two icons which may appear in the title bar.

Battery powerThis has a maximum of four segments which show the levelof battery power. It will be shown in the top right corner of thetitle bar when the instrument is battery powered.

Paper-outAppears in the top of the title bar when the printer paper/label roll needs replacing.

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1 Unpacking & Set Up

132387 Rev. D, 2006-06

Clinitek Status® analyzer

Test table

Test table insert

Power Supply

Unpacking

2 Remove each of the wrappingsand check for the following items:

1 Carefully remove the contentsof the shipping carton. Check thecarton and instrument for visiblesigns of damage; if seen,immediately contact the carrier.

41

5

3

2

Appendix A, Local Technical SupportProviders and Distributors).

Paper Roll

Clinitek Status® Check Cassette (notshown)

Depending on the model you havereceived, there may also be a WarrantyRegistration Card, Unpacking/Setup Guide,and/or Quick Reference Guide included.

25

6

If you are using a reagent stripthat has 4 or fewer test pads,e.g., Uristix® 4, you must use a shorttest table insert. This has to be orderedseparately (for a list of suppliers seeAppendix A, Local Technical SupportProviders and Distributors).

Do not touch the whitecalibration bar.

If the power cord is not the styleyou need, contact your local Bayeroffice (for a list of contacts see

1

Do not remove the CheckCassette from its foil packaging. TheCheck Cassette should be availableif you need to call Bayer forassistance with an analyzer error.Store the cassette in the pocketlocated inside the back cover of yourOperator’s Manual.

Unpacking

3

4

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132387 Rev. D, 2006-06

The best temperature for usingthe instrument is between 22°C and26°C (72°F and 79°F). Do not placethe analyzer outside or nearwindows, ovens, hot plates, orradiators.

5

3

4

Set Up

Set Up

Analyzer Set Up

Place the instrument on a levelwork surface where thetemperature and humidity are fairlyconstant.

Plugging Analyzer In

Plug the appropriate end of thepower cord into the power inletsocket located on the rear of theClinitek Status analyzer. Plug theother end of the power cord into anAC electrical wall outlet.

Installing Batteries (Optional)

Place the analyzer on its side andremove the battery cover bypressing down on the tab andpulling out. Place the 6 newAA-size batteries into the analyzer.Replace the battery cover and turnthe instrument back onto its base.

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Do not touch the whitecalibration bar.

Inserting Test Strip Table

Insert the test strip table into theanalyzer by holding it by the endopposite the white calibration barand with the white bar facing up.Push the test table into theanalyzer, pushing it in just overhalfway.

Loading Test Table Insert

The test table insert adapts for usewith a Bayer urinalysis strip orClinitest immunoassay cassette.One side is used for a strip test andthe other side is used for a cassettetest.

6

7

8

Set Up

Interfacing to a Computer

The instrument can send results toa computer via the serial portlocated on the back of the analyzer.This requires a 9-pin null modemserial cable that can be purchasedseparately at an electronics store orfrom your Bayer Representative(for a list of suppliers seeAppendix A, Local TechnicalSupport Providers andDistributors).

Do not push the test table fullyinto the analyzer as the test tablemay become jammed and preventthe use of the analyzer.

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132387 Rev. B, 2004-10

Analyzer Software Upgrades

From time to time Bayer HealthCarewill add new features and makeimprovements to theClinitek Status instrument software.

These software updates will beavailable on an electronic memorycard which is inserted into thesoftware update socket. Thissocket is located under the printercover and is on the left-hand side ofthe printer when you face the backof the instrument.

Updating the software is a simpleprocedure. Instructions for updatingthe software on your instrument willbe supplied with the memory card.

Analyzer Software Upgrades

9

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132387 Rev. B, 2004-10

Loading the Printer Paper orLabel Roll

1. Open the printer cover by pullingup on the tab.

2. Open the paper roll compartmentcover by pressing down on its taband pulling out.

3. Lift the paper holding arm intothe open, upright position.

4. Place the new paper roll into theprinter paper compartment with thepaper unrolling from underneathand toward the compartment wall.

5. Feed the paper up along walland through the printer. Once youhave approximately 4 inches (or10 cm) of paper through the printerthen feed the edge of the paperthrough the printer cover.

6. Push the paper holding armdown in to the closed position.

7. Close the printer and paper rollcovers by clicking them intoposition.

The analyzer is set up toautomatically print the results (toturn off the automatic print functionsee Section 5, Instrument Set Up).

paper holding arm

The analyzer uses ordinarythermal paper as provided, or labelstock (for ordering information seeAppendix A, Local TechnicalSupport Providers and Distributors).

Set Up

10

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132387 Rev. B, 2004-10

Warranty Registration

1. Lift the printer cover on theinstrument and the serial plate withthe instrument’s serial number willbe visible.

2. Write the serial number andinstallation date on the WarrantyRegistration Card. After theinstrument has been successfullyinstalled, complete the informationon the Warranty Registration Cardand return the card to your localBayer office (for a contact list seeAppendix A, Local TechnicalSupport Providers andDistributors).

11

Set Up

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132387 Rev. B, 2004-10

Press the on/off button locatedon the front of the instrument.

This is the first screen displayed.The analyzer will run an automaticsystem diagnostic test each time itis turned on.

If this is the first time you haveturned on the analyzer, you will beled through a Start-Up Wizard, aquick set-up procedure. If yourequire further instruction regardingthe Start-Up Wizard see Section 3,page 3-1.

Powering Up

Powering Up

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132387 Rev. D, 2006-06

Powering Down

Powering Down

1. Before turning the analyzer off,always ensure that there is no stripor cassette on the test table andthat the table and insert are clean.

2. Press the on/off button forat least 2 seconds. The test tablewill retract into the analyzer. If thereis no strip or cassette on the testtable, the door will close and theanalyzer will switch off.

If a strip or cassette is still on thetest table, the test table will bepushed out and the analyzer willturn off. The test table will remainout. In order to retract the test tableinto the analyzer, turn the analyzeron, and then off (without a strip orcassette on the test table).


2-1

2 Interacting with the Touch Screen

132387 Rev. B, 2004-10

The touch screen will guide youthrough the operation of theClinitek Status® analyzer. Thescreen will display messages,instructions and options to whichyou respond by touching theappropriate area on the screen.

The first main screen you see is theSelect screen. It displays the Bayerlogo, time and date, and indicatesthe instrument is ready to performany of the four actions or tasksshown.

Instrument Set UpRecall ResultsCassette TestStrip Test

Each screen that follows the Selectscreen has an icon, title bar andtouch-sensitive active areas.

In some cases, the screen will alsodisplay instructions, messages orerror messages.

The icon indicates the main sectionin which you are working (1 of the 4sections listed on the main Selectscreen).

Touch-Sensitive Area

Screens

Screens

Title BarIcon

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132387 Rev. D, 2006-06

How to Touch the ScreensThe screen needs to be touchedlightly in the touch-sensitive area toactivate a response.

Where to Touch the ScreensThere are three types of areas thatrespond to touching the screen.

• Round Buttons• Boxed Areas• Scroll Arrows

Round ButtonsThese buttons typically appear onscreens that require a selectionamong several items. The buttonwith a filled circle is the currentselection.

To change your selection, touch anunfilled circle. The newly selectedcircle (button) will now behighlighted. You then touch theNext button to move to the nextscreen.

If a touched area does notrespond as expected, slide yourfinger across the appropriateselection area.

Use of anything hard orpointed on the touch screenmay cause damage.

In order to proceed, you willalways touch the box with a right-pointed arrow labeled Next.

In order to go back, you willalways touch the box with a left-pointed arrow. These “back” optionboxes vary in title.

Round Buttons

Screens

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132387 Rev. B, 2004-10

Boxed AreasThese are areas on the screenenclosed in boxes. Simply touchany area within the box to activatethat function.

The boxed areas vary in size. Theboxes located on the main Selectscreen are examples of largerareas. Smaller box selectionsinclude boxes such as the“Previous” and “Next” boxes foundat the bottom of the screen.

Scroll ArrowsPress the up and down arrows onthe right side of the screen to scrollthrough the list of information onthe left side of the screen. Once theinformation on the left side of thescreen is highlighted, touch theSelect button to confirm yourselection and move to the nextscreen.

If there are double arrows on thescreen, these arrows (whentouched) will take you to the top orbottom of the page.

When an option can beselected it will be shown with athick black frame and will respondwhen touched. If an option is notavailable, it will be framed with athin black line and not respondwhen touched.

UnavailableOption

Boxed Area

Screens

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132387 Rev. B, 2004-10

Using the Alpha-NumericKeyboard

When the screen prompts you toenter information for Operator ID,Patient’s Name and/or PatientIdentification, a keyboard willappear on the screen.

Depending on how your analyzer isset up, either an alphabetic ornumeric keyboard will be displayedfirst. The first keyboard displayed isreferred to as “keyboard priority.”

To switch between the keyboards,touch the 123 button to get to thenumeric keyboard. Touch the ABCbutton to get to the alphabetickeyboard.

To type in a name, number, birthdate, etc., touch the appropriatebutton. Your selections will appearin the data entry box.

If you switch between keyboards,all values will be retained in thedata entry box on both keyboardscreens.

Keyboards

Data Entry BoxBack Space/Erase key

Confirmdataentries

Createsblankspace

Return topreviousscreen

If you require further instructionregarding how to change keyboardpriority see Section 5, Instrument SetUp.

Keyboards

Press to switch toalphabetic keyboard

Press to switch tonumeric keyboard

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132387 Rev. B, 2004-10

The maximum number ofcharacters allowed is 20. Anaudible tone will sound when youhave exceeded the maximumnumber of characters.

Once you have finished enteringthe information, touch Enter (fromeither keyboard screen).

Keyboards

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132387 Rev. B, 2004-10

3-1

3 Start-Up Wizard

132387 Rev. B, 2004-10

The first time your Clinitek Status®

analyzer is turned on (following anautomatic system diagnostic test), itwill take you through a quick set upprocedure. This procedure willallow you to select the basicfunctions of the analyzer so youcan use the analyzer with yourchoice of settings.

The Start-Up Wizard will allow youto select the following settings:

LanguageDate and timePreferred test sequence(e.g., Quick Test or Full

Test)Type of urinalysis stripResults format

Once you have selected yourchoices, the analyzer will display aConfirmation screen which allowsyou to check that your preferencesare correct.

If you require further instructionregarding how to change the settingssee Section 5, Instrument Set Up.

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3 Start-Up Wizard

132387 Rev. B, 2004-10

4 Testing

4-1132387 Rev. D, 2006-06

Quick Tests

Urinalysis Strip Test

Testing is started from the mainSelect screen.

Touch Strip Test to conduct aurinalysis strip test.

The next screen that appears isPrepare Test.

Make sure the test table insert hasthe reagent strip holder facingupward.

Also, have the test strip, urinesample and paper towel ready.

Touch the START button.

If you require more informationregarding use and storage of teststrips, please refer to the strip packageinsert.

If you would like the steps forurinalysis testing to be shown on thescreen then touch Help.

Quick Tests

BIOHAZARD Wear personal protectiveequipment. Use universal precautions.Refer to Appendix H for recommendedprecautions when working withbiohazardous materials.

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4 Testing

The next screen that appears isanother Prepare Test. This screenprompts you through the steps toprepare the test strip.

A timer displays how much timeyou have remaining to complete thesteps.

You have 8 seconds to completethe following four steps:

1 Dip the reagent strip into theurine sample, wetting all pads.Immediately remove the strip fromthe urine.

2 Drag the edge of the stripagainst the side of the samplecontainer as you remove it.

Quick Tests

4 Testing

4-3132387 Rev. D, 2006-06

Do not push or pull the testtable.

3 Blot by touching the edge of thestrip to the paper towel to removeexcess urine.

4 Place the reagent strip in thechannel of the table with the testpads facing up. Slide strip to end ofthe channel.

At the end of the 8 secondcountdown, the test table and stripwill automatically be pulled into theanalyzer.

Do not lay the pads on thepaper towel or cover the pads bythe paper towel.

The Clinitek Status® analyzerwill perform an automatic calibrationeach time a test is run.

Be sure not to move or bumpthe table while the instrument iscalibrating.

Quick Tests

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4 Testing

A timer will count down the timeremaining in analyzing the stripresults.

If the analyzer has been set up toautomatically print the results, thenthe Printing screen will bedisplayed until the print out hasbeen completed (otherwise theResults screen will appear).

The date, time and test sequencenumber will be printed along withthe test results. “Not Entered” willbe printed next to Color and Clarity.

If the results are positive, an

asterisk* will appear next to theresults (if “mark positive results” wasselected in Instrument Set Up).

Quick Tests

The Analyzing screen will bedisplayed when the calibration hasbeen completed and the analysis ofthe strip has begun.

4 Testing

4-5132387 Rev. B, 2004-10

The next screen displayed is theResults screen. The first page ofthe test results are displayed on thescreen and the test table and stripare automatically pushed out of theanalyzer.

To view the remaining test results,touch More on the screen.

If the analyzer has not been set upto automatically print the testresults, touch Print to have theresults printed.

The results will automatically besent to the connected PC if thisoption is set up in the analyzer.

From the test table, remove theused urinalysis strip and dispose ofit according to your standardlaboratory procedures. Wipe thetable insert, if necessary.

Report the results to a laboratorysupervisor or physician.

Touch Done to complete the testand return to main Select screen.

The results will be displayed onthe screen for 2 minutes. After thistime elapses, the display will return tomain Select menu.

Quick Tests

If you require further instructionregarding how to set up the analyzerso the results are printed or sent to acomputer automatically seeSection 5, Instrument Set Up.

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4 Testing

Cassette Test


Touch Cassette Test to conductthe test.

The next screen that appears isTest Type. Touch the ClinitesthCG cassette button.

The next screen that appears isPrepare Test screen.

If you would like the steps forcassette testing to be shown on thescreen then touch Help.

Bring the test cassette andpatient sample to roomtemperature 20°C to 30°C (68°F to86°F) prior to testing.

Please refer to the Clinitest® hCGcassette test package insert for moreinformation regarding use and storageof test cassettes.

Quick Tests


4 Testing

4-7132387 Rev. D, 2006-06

Make sure the test table insert is inposition for a cassette test.

Remove the test cassette from thefoil package and place the cassetteon the test table.

Touch START button.

The next screen that appears isanother Prepare Test. This screenprompts you through the steps toprepare the cassette test.

A timer displays how much timeyou have remaining to complete thesteps.

Once you touch the STARTbutton you have 8 seconds todraw the urine sample into thepipette and add the urine sampleinto the well on the cassette.

Quick Tests

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4 Testing

You have 8 seconds to completethe following two steps:

1 Draw the urine sample to theline marked on the pipette(approximately 0.2 mL).

2 Add entire contents of thepipette into the sample well of thetest cassette.

At the end of the 8 secondcountdown, the test table andcassette will automatically be pulledinto the instrument.

Do not push or pull the testtable.

Quick Tests

4 Testing

4-9132387 Rev. D, 2006-06

The Clinitek Status analyzer willperform an automatic calibration eachtime a test is run.

Be sure not to move or bumpthe table while the instrument iscalibrating.

The Analyzing screen will bedisplayed when the calibration hasbeen completed and the analysis ofthe cassette has begun.

The Clinitest hCG test results areeither negative, positive or borderline.The analyzer takes approximately5 minutes to confirm a negativeresult. If the result is a clear positive,the analyzer will report it sooner. Ifthe result is borderline, then youshould retest, with a new sample, in48 to 72 hours. Please refer to theClinitest hCG cassette test packageinsert for complete instructions foruse.

Quick Tests

A timer will count down the timeremaining in analyzing the cassetteresults.

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4 Testing

If the analyzer has been set up toautomatically print the results, thePrinting screen will be displayeduntil the print out has beencompleted (otherwise the Resultsscreen will appear).

The date, time and test sequencenumber will be printed along withthe test results.

The next screen displayed is theResults screen. The test resultsare displayed on the screen andthe test table and cassette arepushed out of the analyzer.

The results will be printed automaticallyif this option is set up in theanalyzer. If not, touch Print to printthe results on the analyzer’s printer.

The results will automatically besent to the connected PC if thisoption is set up in the analyzer.

Remove the used cassette anddispose of it according to yourstandard laboratory procedures.

Report the results to a laboratorysupervisor or physician.

Touch Done to complete the testand return to main Select screen.

If the result is positive, anasterisk* will appear next to the result(if “mark positive results” wasselected in Instrument Set Up).

The result will be displayed onthe screen for 2 minutes. After thistime elapses, the display will return tomain Select menu.

Quick Tests

If you require further instructionregarding how to set up the analyzerso results are automatically printed orsent to a computer see Section 5,Instrument Set Up.

4 Testing

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Full Tests

Urinalysis Strip Test

A Full Strip Test allows you theoption to enter an Operator ID,Patient Name and/or Patient IDprior to inserting a strip.

The procedures to enter theOperator and Patient data arepresented in this section.

The strip testing process is identicalto a Quick Strip Test.


Touch Strip Test to conduct aBayer urinalysis strip test.

If you require further instructionregarding the procedures required forrunning a Bayer urinalysis strip testsee Section 4, Quick Tests.

Full Tests


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4 Testing

The next screen that appears isOperator ID.

There are two options underOperator ID: Last Operator orEnter New Operator ID.

Option 1: Last Operator If this option is enabled, the lastoperator that entered his/her ID willbe displayed on the screen in thelower right side of the box. If youare this operator, then touch theLast Operator button to proceed.

Option 2: Enter New Operator IDIn order to enter the information fora new operator, touch Enter NewOperator ID button. The nextscreen that is displayed is EnterOperator ID.

Use the keyboards to enterOperator ID using a maximum of13 characters. Touch Enter whenyou have finished entering the IDand to move to the next screen.

Full Tests

If you require further instructionregarding keyboard usage seeSection 2, Interacting with the TouchScreen.

4 Testing

4-13132387 Rev. B, 2004-10

The next screen displayed isPatient Information.

There are two options under PatientInformation: Recall Patient orEnter New Patient.

Option 1: Recall PatientIn order to look up previouspatients, touch Recall Patient.

If previous patient identification hasbeen entered, a list of up to 200patient results will appear on thescreen. Use the up and down arrowbuttons to scroll through the list ofpatients. The most recentlyperformed test will be shown at thetop. Once the patient is highlighted,touch Select button.

The next screen will be PrepareTest.

A total of 200 patient tests canbe stored in the analyzer. The testsare listed in chronological order.When the limit of 200 has beenreached, the oldest test will bedeleted from the analyzer. Deletedinformation cannot be retrieved fromthe analyzer.

Full Tests

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4 Testing

Option 2: Enter New PatientIn order to enter the information fora new patient, touch Enter NewPatient button. The next screendisplayed is Enter Patient Name.

Use the keyboards to enter PatientName using a maximum of 20characters. Touch Enter when youhave finished entering the patient’sname and to proceed to the nextscreen.


Full Tests

4 Testing

4-15132387 Rev. B, 2004-10


The next screen displayed isPatient Identification. Use thekeyboards to enter PatientIdentification using a maximum of13 characters. Touch Enter whenyou have finished entering thepatient’s ID and to proceed to thenext screen.

Full Tests

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4 Testing

The next screen that appears isPrepare Test.

While the strip is being analyzed, aSelect Appearance screen will bedisplayed. The urine sample mustbe visually observed and then theappropriate color and clarity mustbe selected.

If the urine sample is yellow andclear, touch the Yellow and Clearbutton.

If the urine sample is not yellowand clear, touch the Other buttonfor more choices.

If you touched the Other button,then select the appropriate color bytouching the circle button thatcorresponds to the correctdescription.

If you require further instructionregarding the procedures for runninga Bayer urinalysis strip test seeSection 4, Quick Tests.

Full Tests

4 Testing

4-17132387 Rev. B, 2004-10

Select the clarity by touching thecircle that corresponds to thecorrect description. Then touchNext.

There is a time indicator on theSelect Appearance screen that iscounting down the time remainingin the analysis of the strip.

After color and clarity have beenentered the next screen displayedwill either be:

Analyzing – if the strip is stillbeing analyzed

Results – if analyzing thestrip has been completed

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4 Testing

If the results are positive, anasterisk* will appear next to theresults (if “mark positive results” wasselected in Instrument Set Up).

The test results displayed on thescreen and the printout will includethe following information:

Patient Name, ID or bothType of strip usedTest dateTimeOperatorTest NumberColorClarityResults

Full Tests

4 Testing

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Cassette TestsCassette Test

A Full Cassette Test allows you theoption to enter an Operator ID,Patient Name and/or Patient IDprior to inserting a cassette.

The procedures to enter theOperator and Patient data arepresented in this section.

The cassette testing process isidentical to a Quick Cassette Test.

If you require further instructionregarding the procedures for runninga Bayer Clinitest immunoassay testsee Section 4, Quick Tests.


Touch Cassette Test to conduct anhCG pregnancy test.

The next screen that appears isOperator ID.

There are two options underOperator ID: Last Operator orEnter New Operator ID.

Full Tests


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4 Testing

The next screen displayed isPatient Information.

There are two options underPatient Information: Recall Patientor Enter New Patient.

Option 2: Enter New Operator IDIn order to enter the information fora new operator, touch Enter NewOperator ID button. The nextscreen that is displayed is EnterOperator ID.

Use the keyboards to enterOperator ID using a maximum of13 characters. Touch Enter whenyou have finished entering the IDand to move to the next screen.

Full Tests


Option 1: Last OperatorIf this option is enabled, the lastoperator that entered his/her ID willbe displayed on the screen in thelower right side of the box. If youare this operator, then touch theLast Operator button to proceed.

4 Testing

4-21132387 Rev. B, 2004-10

Option 1: Recall PatientIn order to look up previouspatients, touch Recall Patient.

If the previous patient identificationhas been entered, a list of up to200 patients will appear on thescreen. Use the up and down arrowbuttons to scroll through the list ofpatients. The most recentlyperformed test will be shown at thetop. Once the patient is highlighted,touch the Select button. The nextscreen will be Test Type.

A total of 200 patient tests canbe stored in the analyzer. The testsare listed in chronological order.When the limit of 200 has beenreached, the oldest test will bedeleted from the analyzer. Deletedinformation cannot be retrieved fromthe analyzer.

Full Tests

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4 Testing

Option 2: Enter New PatientIn order to enter the information fora new patient, touch the Enter NewPatient button. The next screendisplayed is Enter Patient Name.

Use the keyboards to enter PatientName using a maximum of 20characters. Touch Enter when youhave finished entering the patient’sname and to move to the nextscreen.

Full Tests


4 Testing

4-23132387 Rev. B, 2004-10

The next screen displayed is EnterPatient ID. Use the keyboards toenter Patient Identification using amaximum of 13 characters. TouchEnter when you have finishedentering the patient’s ID and areready to proceed to the nextscreen.

Full Tests


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4 Testing

The next screen that appears isTest Type.

The test results displayed on thescreen and the printout will includethe following information:

Patient Name, ID or bothType of Clinitest cassette testTest dateTimeOperatorTest NumberResult

If the result is positive, anasterisk* will appear next to the result(if “mark positive results” was selectedin Instrument Set Up).

Full Tests

If you require further instructionregarding the procedures for running aClinitest hCG cassette test seeSection 4, Quick Tests.

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5 Instrument Set Up

Your Clinitek Status® analyzerallows you to change settings tosuit your workplace requirements.

Touch Instrument Set Up in orderto initiate changing the settings.

If a password has been set, theEnter Password screen will bedisplayed. Enter the password intothe data entry box. The charactersyou enter will be displayed asasterisks.

Touch Enter to proceed to a list ofsettings.

SettingsUse the up and down arrows toscroll through the ChooseSettings screen.

Touch Select when you havehighlighted the setting you want tochange.

Touch Done to return to the mainSelect screen.

If no customizing is desired, theanalyzer will automatically beprogrammed with default settings (toview default settings please seeAppendix D: Instrument DefaultSettings).

Instrument Set Up

Instrument Set Up

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Use the up and down arrows toscroll through the list of languages.Touch Select when you havehighlighted the desired language.

Before changing the language analert screen will be displayedrequesting you to confirm yourdecision.

Touch No to continue with samelanguage and retain currentsettings. The display will return toChoose Settings.

Touch Yes to change the language.

Language Settings

Changing the language will…delete all results from thememory.change the instrumentsettings to the defaults forthe new language (defaultsettings are listed inAppendix D: InstrumentDefault Settings).

Language Settings

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5 Instrument Set Up

Password

When a password has been set,no changes can be made to theInstrument Set Up until thepassword has been entered.

Set PasswordEnter a password into the dataentry box using the alphabetic and/or numeric keyboards (maximum12 characters).

Touch Enter to confirm thepassword and return to ChooseSettings.

Touch Done to return to mainSelect screen.

Remove PasswordOnce a password has been enteredthe option will change from SetPassword to Remove Password.

Highlight the Remove Passwordoption and touch Select. Theoption displayed will change to SetPassword and a password will nolonger be needed to accessInstrument Set Up.

Touch Done to return to the SelectMenu.

Keep a record of the password tobe sure to have access to InstrumentSet Up when required.

Password

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Operator and PatientInformation

Selecting this option will allow youto choose display options for dataentry.

The Input Settings screen allowsyou to select 1 of 3 test sequences.

Quick TestA test without any operator orpatient information required. Thetest will be identified by asequential test number when theresults are displayed or printed.

Full TestThe operator will be prompted toenter the following data duringtesting:

Operator IdentificationPatient’s NamePatient IdentificationSample Appearance (Colorand Clarity) of urinesample, when testing witha urinalysis strip.

Custom Set UpThis allows you to customize thedata to be entered whenconducting a test.

Operator and Patient Information

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5 Instrument Set Up

On the Input Settings screen,touch a round button in the box ofthe preferred test sequence. Thentouch Next for test sequenceconfirmation.

Touch Done on the Input Settingsscreen to return to the ChooseSettings screen.


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Custom SettingsTouch the round button in theCustom Set Up box to customizeselections for data entry. TouchNext.

The next 5 screens present choicesfor customizing your testing.

Choose settings by touching andhighlighting a round button for eachcategory.

Proceed through all 5 screens bytouching Next at the bottom ofeach screen.

Screen 1 of 5Operator ID – allows you tochoose whether Operator ID will berequired for running a test –Enabled (on) or Disabled (off).

Keypad priority – allows you toselect either the Numeric orAlphabetic keyboard to bepresented as the first keyboardduring data entry.


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5 Instrument Set Up

Screen 2 of 5Patient Name – allows you tochoose whether patient name willbe required for running a test –Enabled (on) or Disabled (off).

Patient ID – allows you to choosewhether Patient ID will be requiredfor running a test – Enabled (on) orDisabled (off).

Screen 3 of 5Choose which to show inResults list – allows you to choosewhether Patient Name or PatientID will be included in the list ofresults.

Last Operator’s ID displayed –allows you to choose whether a“Select Last Operator” option isavailable to the user when you areprompted to enter an Operator IDduring Strip or Cassette Testing –Enabled (on) or Disabled (off).


A total of 200 patient recordscan be stored in the analyzer. Whenthe limit of 200 has been reached,the oldest test will be deleted fromthe analyzer. Deleted informationcannot be retrieved from theanalyzer. If Patient’s Name andPatient ID are both disabled, asequential test number will be shownwith the test results.

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Screen 4 of 5Choose which to record during astrip test – allows you to selectwhich sample details you would liketo be recorded during a strip test –Color and Clarity, Color only,Clarity only or None (no sampleinformation).

Screen 5 of 5Custom Field – allows you toname the custom field in order tocustomize data entry.

To name the custom field, touch theEnter Custom Field box.

The next screen displayed is EnterCustom Field. Use the keyboardsto enter a custom field(e.g., Physician Name). TouchEnter to return to the CustomSettings screen.



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5 Instrument Set Up

Touch the round button next toEnabled (on) to highlight andactivate this custom setting.

Touch the round button next toDisabled (off) to deactivate thecustom setting.

Touch Previous to scroll backthrough custom setting screens toreview.

Touch Next to proceed to the InputSettings screen which will providea list of the selections made inCustom Set Up.

Touch Done to confirm and returnto the Choose Settings screen.


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132387 Rev. B, 2004-10

Date and Time Settings


The date and time are displayed onthe Select screen and are recordedwith test results.

The format of the date and time aredisplayed along with specific dateand time values.

If the date and time values areincorrect, use the up and downarrow buttons to adjust the dateand time to the correct values.Touch AM or PM if you are in the12-hour time format. Touch Set toconfirm your choices and move tothe next screen.

If the format is not correct for yourworkplace, for example, you preferDD-MM-YY to MM-DD-YY or24-hour clock to 12-hour clock,touch Choose Format.

The next screen displayed isChoose Format. Touch the roundbutton that corresponds to yourchoice of a date format and a timeformat. Touch Done to return toSet Date & Time.

If the date and time are in theformat which you need, selectDone.

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5 Instrument Set Up

The Set Date & Time display willshow the date and time in theformats selected. Select Set toconfirm your choices and return tothe Choose Settings screen.

The AM and PM selections willnot be available if the time is in the24-hour format.


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The test sequence numbers runfrom 0001 to 9999 and can bereset. The screen shows the nexttest number.

Touch the Reset to 0001 roundbutton if you would like to reset thenumbers to start at 0001 for thenext test.

Touch Done to confirm the reset orto leave the screen if you have notselected the option to reset thenumber. You will return to theChoose Settings screen.

Test Sequence Number

Test Sequence Number

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5 Instrument Set Up

This section has a series ofscreens which control the way inwhich the Clinitek Status analyzerdisplays information and operates.

There are 5 Instrument Settingitems.

Results FormatSystem SettingsDisplay ContrastConnectivitySelect Urinalysis Test

Use the up and down arrows tohighlight a setting item and touchSelect.

Results FormatThis allows you to select the formatin which you would like the resultsto be displayed and printed.

Choose FormatScreen 1 of 2Units Selection – allows you toselect the format in which youwould like results by touching theround button next to theappropriate type of format.

Instrument Settings

Instrument Settings

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Plus System – select Enabled(on) if you wish to have resultsshown in the Plus System. You willalso see in Appendix B that resultscan be recorded in the Plus System(which uses “+” symbols) insteadof clinical units such as mg/dL(mmol/L). In some languages thereis no difference between the normalsystem and the Plus System.

Screen 2 of 2Mark Positive Results – allowsyou to choose whether positiveresults should be marked with anasterisk (see Appendix B for resultsto be shown as positive).

Touch the round button next to Yesto mark and record positive results.These will be marked on thedisplay, on a printout and when thedata is transferred to a hostcomputer.

Touch No and positive results willnot be marked.

Touch Done to enter your choiceand return to Instrument Settings.

Instrument Settings

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5 Instrument Set Up

System SettingsThis allows selections regarding theprinter, power and sound.

System SettingsScreen 1 of 2Printer – allows you to select thepreferred printing option bytouching the round button.

Automatic – Results foreach test will be printedautomatically when the testis complete.

Manual – Test results willnot be printed automatically.They can be perinted bytouching the Print selectionarea on the Resultsscreen.

Off – Test results will notbe printed.

Power Save – allows you to enableand disable this feature. If theinstrument is powered from anelectrical outlet and is not used for5 minutes, you may choose to havethe test table retract and theinstrument power down. When it ispowered by batteries, Power Saveis always enabled and it will powerdown after 3 minutes of non-use.Touch the Enabled (on) to activateor Disabled (off) if the Power Savemode is not desired.

Instrument Settings

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132387 Rev. B, 2004-10

Screen 2 of 2Sound – allows you to adjust thesound by highlighting and selectinga level.

Sound on – The instrumentwill use a range of audibletones.

Sound off – No audibletones will be made by theinstrument.

Key clicks only – Audibleclicks will be heard whenthe user touches an activebutton or key.

Display ContrastThis allows the contrast of thedisplay to be increased ordecreased to suit the work area inwhich it is being operated. Use theup and down arrows to sample thecontrast settings and touch Selectto set and return to the InstrumentSettings screen.

Instrument Settings

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5 Instrument Set Up

ConnectivityThis allows you to chooseconnectivity settings.

Allow results to be sent to PCThis allows the instrument totransfer patient results to a hostcomputer. If this function is notrequired, touch Done to return toInstrument Settings screen.

Touch the Enabled (on) roundbutton to allow transfer of results toa computer. As each test iscompleted, the results willautomatically be sent to theconnected PC.

Touch the Disabled (off) roundbutton if you do not wish to transferresults to a computer.

Instrument Settings

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Store instrument serial numberin patient recordsTouch round button of either Yes orNo depending on whether youchoose to include the serial numberof your Clinitek Status analyzer aspart of the patient results sent tothe computer.

Touch Edit Connectivity Settingsand a series of 3 screens forConnectivity Settings will allowyou to edit the settings.

Connectivity SettingsScreen 1 of 3Baud rate – Touch a round buttonto select the correct Baud rate andNext to move to the next screen.

If you have enabled the uploadcapability, you will need to ensurethat the connectivity settings arecorrect for the data transfer.

Instrument Settings

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5 Instrument Set Up

Screen 2 of 3Parity rate – Touch a round buttonto select the correct Parity rate andNext to move to the next screen.

Screen 3 of 3Stop Bits – Touch a round buttonto select the number of Stop Bits.

Select Urinalysis TestThis displays a list of some of theBayer urinalysis strips which can beused with the Clinitek Statusanalyzer.

Instrument Settings

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Use the up and down arrows toscroll through the list until the typeof strip you want to use ishighlighted. Touch Select toconfirm and return to theInstrument Settings screen.

Touch Done repeatedly to return tothe main Select screen.

Do not use any reagent stripproduct other than what is shownon the display. Using the wrongReagent Strip will give youincorrect results.

Some strips do not appear onthe list (e.g., Clinitek® Microalbumin).The analyzer will automaticallyidentify them through the color IDband on the strip.

You do not need to select a typeof Clinitest® immunoassay cassettewithin Instrument Set Up.

Instrument Settings

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5 Instrument Set Up

This option lists the analyzer’soriginal settings.

Use the up and down arrows toview the default settings.

Touch Restore in order to returnthe analyzer to the settings listed.

Touch Yes to confirm your decisionor No to maintain the currentsettings of your analyzer. You willthen return to the Restore screen.Select Exit to return to ChooseSettings.

Restore Default Settings

When the original settings arerestored, all results and patientdata will be deleted from thememory.

Restore Default Settings

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Diagnostics

These diagnostics testsshould only be conducted wheninstructed by a Bayer CustomerService representative. Therepresentative will lead youthrough the test procedures (seeAppendix A for Local TechnicalSupport Providers andDistributors).

Diagnostics

This option lists 7 diagnostic testswhich can be conducted.

DisplayTouch ScreenPrinterTest TableLight SourceElectronicsCheck Cassette

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5 Instrument Set Up

System Information

System Information

If the printer paper roll needsreplacing, Print will be disabled andyou will be able to select Help toview instructions on replacing theprinter paper (if you require furtherinstruction see page 1-5, Loading thePrinter Paper or Label Roll).

This screen has information aboutyour analyzer.

Touch System Configuration toview details of the current systemconfiguration. This screen will showthe current settings for all the itemswhich can be changed within theInput Settings and InstrumentSettings screens. Scroll throughthe list using the up and downarrows to view the details and printthe information if required.

Select Done once to return toSystem Information screen and asecond time to return to ChooseSettings screen.

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5 Instrument Set Up

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This completes the settings andchoices within Instrument Set Up.Touch Done to return to the mainSelect screen.

System Information

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6 Recall Results

132387 Rev. B, 2004-10

In order to look up a patient’sresults, return to the main Selectscreen.

Touch Recall Results button.

The next screen displayed isSelect Test Results.

The test results are in chronologicalorder. The most recent test result isdisplayed at the top of the screenand is highlighted.

Use the up and down arrow keys toscroll through the list of patienttests and highlight the patient youwould like to recall.

To view details of a patient result,touch the Select button.

The results will automatically besent to the connected computer ifthis option is set up in the analyzer.

Patient Results

Patient Results

If you require further instructionregarding how to set up the analyzerso the results are automatically sentto a computer see Section 5,Instrument Set Up.

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6 Recall Results

132387 Rev. B, 2004-10

The first page of the patient’sresults is displayed on the screen.

If more than one page of resultsexists for the patient, then the Morebutton will be present on thescreen.

If you would like to print the results,touch the Print button. Anyinformation that was entered inregard to the patient will beincluded on the printout.

When you are finished viewing thepatient’s results, touch Done.

You will return to the Select TestResults screen. Press Exit toreturn to the main Select screen.

Patient Results

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132387 Rev. B, 2004-10

To send data to a computer; if acomputer has been connected to theanalyzer, all results can be sent to thecomputer by touching the Send alldata button.

Sending Data to a PC

Sending Data to a PC

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132387 Rev. B, 2004-10

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7 Troubleshooting

132387 Rev. B, 2004-10

General InformationYour Clinitek Status® analyzer willoperate properly if you follow thedirections for using and cleaningthe instrument.

Error MessagesError messages will be displayed tohelp you when the Clinitek Statusanalyzer detects something whichneeds your attention. The format ofthis advisory information dependsupon the importance of theproblem and the mode in which theinstrument is being used.

Errors which Disable theInstrumentIf the error is one which preventsthe instrument from being used, allselection areas on the screen willbe disabled. Taking the correctiveaction shown will remove the erroralert screen and allow you to usethe instrument.

Other ErrorsThere are certain errors which needto be corrected to enable testing ofsamples but do not prevent otherinstrument functions from beingused. You will need to carry out thecorrective action to enable testing.

Advisory MessagesErrors of less importance will bepresented via a message on themain Select screen when thisscreen is next displayed. When youhave taken corrective action, themessage will be removed from thedisplay. If more than one of thisclass of error occurs, clearing onemessage will enable the next to bedisplayed in order of importance toa user.

Results AlertIf an error occurs during testing andthe test cannot continue because ofthe error, this will be presented viathe Results Alert screen. This willprovide details of the error andshow that the test has beencancelled. The test table will beextended so that the urinalysis stripor Clinitest® cassette can beremoved.

To correct an error, see the List ofErrors and Advisory Messages locatedat the end of this section.

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Battery Power Icon

The battery icon indicates thepower level of the battery. Powercan be reduced while testingcontinues, with an advisorymessage displayed on the mainSelect screen. If battery level fallstoo low to power the analyzer, allselection areas on the display willbe disabled until the batteries arereplaced (if you require detailedinstructions regarding how tochange the batteries see Section 9,Cleaning and Maintenance).

Paper-out Icon

A paper-out icon appears in the topof the title bar when the printerpaper/label roll needs replacing.An advisory message will bedisplayed on the main Selectscreen. Replace with new paper orlabel roll as instructed in Section 1,Loading the Printer Paper or LabelRoll.

Dashes in DisplaysDashes are displayed in theResults screens and on printoutswhen no text has been entered fora field enabled in Instrument SetUp.

Dashes may appear next to Colorand Clarity on test result printouts.This occurs when the instrument ispowered by batteries. Color andClarity are selected in theInstrument Set Up, but noselections have been recorded onthe Select Appearance screensbefore time-out.

The time-out on these screens isdesigned to ensure that battery lifeis preserved. The Color and Claritydescription may be added to theprintout in writing if needed.

Irregular or Slow Movement ofTest TableIf movement of the test table isirregular or slow, this may becaused by:

a) heavy buildup of dried urine onthe test table. Clean the test tableand insert as described inSection 9, Periodic Cleaning of TestTable.

b) low battery power. Replace thebatteries as described in Section 9,Cleaning and Maintenance.

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Calling for AssistanceIf your Clinitek Status analyzer isdisplaying corrective actions for adetected problem, please carry outthe displayed instructions beforecalling for assistance. If this doesnot correct the problem or noinstructions are displayed, contactyour local technical supportprovider (for contact informationplease see Appendix A, LocalTechnical Support Providers andDistributors).

If you are calling for assistance witha displayed error, please have thefollowing items ready (this willassist your Bayer CustomerService and Support Center to dealwith your inquiry as quickly aspossible).

a) Error numberb) Clinitek Status Check

Cassette which wassupplied with yourinstrument.

c) Completed ProblemChecklist (found at the endof this section).

Do not remove the checkcassette from its packagingunless instructed to do so. Ifthe check cassette isrequired, instructions for itsuse will be given by your localtechnical support provider.

For customer support, pleasecontact your local technical supportprovider or distributor (for contactinformation please see Appendix A,Local Technical Support Providersand Distributors).

WarrantyYour Clinitek Status analyzer has aone-year warranty period. Thiswarranty is designed to protect youfrom the cost associated withrepairing systems that exhibitmalfunctions due to defects inmaterials and/or workmanshipduring the warranty period.

The warranty period commencesfrom the date that the instrument isreceived at your location. Use theWarranty Registration Cardprovided with the instrument toregister your warranty.

To obtain assistance during thewarranty period, please contactyour local technical supportprovider or distributor.

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132387 Rev. B, 2004-10

Error Code Description Action

E01 Replace the batteries: a) To view instructionson the display, touch the Error Report selectionarea, or b) To use the instructions in thismanual, see page 9-7, Changing Batteries.

Low battery power

1. Switch the instrument off by pressing theon/off button for 2 seconds. 2. Switch theinstrument on again by pressing the on/offbutton. 3. Repeat the test.

Loss of test results

E11 1. Make sure that the test table is in place.Move the test table in or out of the instrumentslightly to reposition the test table. 2. If theerror remains, with the instrument poweredon, unplug the power cord from rear ofinstrument and plug back in. Turn instrumenton by pressing the gray power button. 3. If theerror remains with the test table in place,contact your local Bayer Customer Serviceand Support Centre (contact information isgiven in Appendix A).

Failure of test table

E23 Replace the batteries: a) To view instructionson the display, touch the Error Reportselection area, or b) To use the instructions inthis manual, see page 1-2, Installing Batteriesand/or page 9-7, Changing Batteries. If thebattery level becomes too low to power theinstrument, Error Code E01 will be displayed.

Low battery power

E24 Replace the printer paper a) See instructionson the inside of the printer paper compartmentcover, or b) To view instructions on the display,touch the Error Report selection area, or c) Touse the instructions in this manual, see page1-4, Loading the Printer Paper or Label Roll.

No printer paper

E25,E64 orE65

Clean the calibration strip. If the error remainsafter cleaning, contact your local BayerCustomer Service and Support Center(contact information is given in Appendix A).

Failure of automaticcalibration

E27 1. Switch the instrument off by pressing theon/off button for 2 seconds. 2. Switch theinstrument on again by pressing the on/offbutton.

Set Up failure

Lists of Errors and Advisory Messages

List of Errors and Advisory Messages

E10 or E48

Clinitek Status Analyzer:

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7 Troubleshooting

132387 Rev. B, 2004-10


E28 Lift the printer cover and push the paperholding arm back into position (see page 1-5,Loading the Printer Paper or Label Roll forlocation of paper holding arm).

Printer error

E50 Ensure that the strip type selected inInstrument Set Up is being used (see 5-19and 5-20, Select Urinalysis Test). If the correcttype of strip is being used, check theinstrument operation by running another testusing: a) a yellow and clear sample, orb) Chek-Stix® (see page 8-1, Quality ControlTesting).

Incorrect strip type

E52 Repeat the test using a Bayer cassette.Invalid barcode

E53 Repeat the test using the Cassette Testroutine (see page 4-6 or 4-19).

Strip Testselected butcassette detected

E54 Repeat the test using the Strip Test routine(see page 4-1 or 4-11).

Cassette Testselected but stripdetected

E56 Repeat the test using the correct test table(see page 4-1).

Incorrect size testtable

E57 Repeat the test ensuring that the strip orcassette is positioned on the test table (seepage 4-1 or 4-6 for strip or cassette testing).

Missing strip orcassette

E58 Repeat the test ensuring that the strip iscorrectly positioned on the test table (seepage 4-3). If error remains and you are testinga urine dip strip, examine the test table insertto insure that the small, white line located nearthe tip of the strip (on strip side of insert) ispresent and not damaged. If this line isdamaged or missing contact your local BayerCustomer Service and Support Center(contact information is given in Appendix A).

Misplaced strip

E59 Repeat the test ensuring that the strip iscorrectly positioned on the test table (seepage 4-3).

Inverted strippositioned on thetest table


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Tilted strip

E61 Repeat the test ensuring that the strip has beenin contact with the sample (see page 4-2).

Dry strip


Failure to find endof strip

E67 orE68

A sample flow issue with the cassette test mayhave been detected. One or more of the testindicator lines may be missing or indiscerniblefrom the background, or not enough samplewas applied to the cassette. Repeat the testensuring the pipette is correctly filled and thecorrect volume of sample is dispensed into thewell of the cassette (see page 4-8).

Insufficient sample

E02 Contact your local Bayer Customer Serviceand Support Center (contact information isgiven in Appendix A).

Failure ofcalibration data


Failure of LED


Failure of clock


Light Ingress


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132387 Rev. B, 2004-10


E03, E04,E05, E06,E07, E08,E21, E22,E90, E91,E92 or E93

Contact your local Bayer Customer Serviceand Support Center (contact information isgiven in Appendix A).

Failure ofcomputer software


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132387 Rev. A, 2003-07

Serial Number ___________________________

Installation Date___________________________

1. Have you reviewed the error messages on pages7-4 to 7-7?

2. Please record any error messages that have beendisplayed:________________________________________________________________________________________________________________________________________________________________________________________________

3. Does the test table move out to the “load” positionwhen the analyzer is first turned on?

4. If Question #3 is NO –Is the power cord plugged into a liveelectrical outlet, into the transformer, andthen into the analyzer?If using batteries, are they fully charged andcorrectly placed in the analyzer?

5. Does the display show the Select screen or theResults screen as expected?

6. Does the test table move into and out of theanalyzer?

7. Does a quality control solution give the expectedresult?

YES NO

Problem Checklist

Problem ChecklistClinitek Status Analyzer:

7-9

7 Troubleshooting

132387 Rev. A, 2003-07

8. Is the name of the Bayer urinalysis strip or Clinitest immunoassay cassette shown on the display the same as the product being used?

9. Does the display or printout show the correct test names and expected results?

10. Is the white calibration bar on the test table dirty, scratched, or damaged?

11. Additional problem observations, please describe: ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

YES NO

Problem Checklist

7-10

7 Troubleshooting

132387 Rev. B, 2004-10

8-1

8 Quality Control Testing

132387 Rev. D, 2006-06

The Clinitek Status system is CLIAwaived only when used with Bayerbranded urinalysis reagent strips.

For CLIA waived settings, werecommend that a quality controltest be performed with each newreagent bottle opened.

Quality Control for UrinalysisStrip Testing

Test negative and positive controlswhenever a new bottle of reagentstrips is first opened.

Water should NOT be used as anegative control. Contact yourBayer Healthcare representative foradditional information onperforming QC testing.

Quality Control for CassetteTesting

It is recommended that qualitycontrol specimens be used witheach new reagent box opened.

Refer to the quality controlproduct insert for expected values foreach analyte.

hCG – Please refer to theClinitek®

hCG cassette test packageinsert for the appropriate qualitycontrol material.


8-2


132387 Rev. D, 2006-06

Information regarding CLIA Waiver

The Clinitek Status system is CLIAwaived for all Bayer brandedurinalysis reagent strips. Cassettetesting is currently categorized asmoderate complexity.

Failure to adhere to the instructionsfor use, including instructions forlimitations or intended use, and forperforming QC testing, isconsidered off-label use, resultingin the test being categorized ashigh complexity and subject to allCLIA regulations.

Expected Waiver Performance

Summary tables of the results fromthe waiver studies and physicianoffice studies are included inSection 10, Appendix F of thisoperator’s manual.

9-1

9 Cleaning and Maintenance

132387 Rev. D, 2006-06

The test table insert and the testtable should be kept clean if theanalyzer is to operate properly.

Routine Cleaning of Test TableInsert

1 Remove insert and thoroughlyclean.

2 Rinse both sides of the tableinsert under running water.

3 Dry and replace insert.

Periodic Cleaning of Test Tablewhen Required

1 Remove the test table bypulling it slowly out of theanalyzer. Lift the test tableinsert from the test table, drainthe drip tray if necessary.

2 Wet a cotton-tipped stick withwater and carefully clean testtable (except for whitecalibration bar).

Do not autoclave the test tableor test table insert.

Cleaning

Cleaning


9-2


132387 Rev. D, 2006-06

3 Dry the test table thoroughly(except for the white calibrationbar) with a soft cloth or lint-freetissue.

4 Reinsert the test table into theanalyzer by holding the table atthe end opposite the whitecalibration bar, with the whitecalibration bar facing upwards.Push the test table firmly butslowly, just over halfway intothe analyzer.

5 Replace the test table insert.

Cleaning

Care should be taken not toscratch the white calibration bar.Instructions for cleaning the whitecalibration bar are given later in thissection.


9-3


132387 Rev. D, 2006-06

Disinfecting the Test Table andInsert

1 Prepare one of the followingsolutions in a tall, narrowcontainer (e.g., empty Multistix®

bottle) to a depth of about4 inches (10 cm):

• Precept, Cidex,Theracide and Amphylsolutions - prepareaccording to productdirections.

• Household Bleach (5%sodium hypochlorite) – thiscan be used either fullstrength or dilute with waterto as much as 1:20(i.e., mix 5 mL bleach with95 mL water for a total of100 mL).

• Isopropyl Alcohol (70% to85%) - this can be used fullstrength.

2 Place the insert and/or testtable into the solution, makingsure the white calibration bar onthe test table remains abovethe liquid level.

3 Soak the table and insert for aminimum of 2 minutes andmaximum of 10 minutes. Do notsoak longer than 10 minutes.

4 Rinse the test table and insertthoroughly with water.

5 Dry with a soft cloth andreplace test table and tableinsert in the analyzer (asdescribed on the previouspage). Rinse away all bleach

residue, as remaining bleachwill affect several of the reagentpad chemistries.

Any solutions other than thoselisted above may damage the testtable and insert.

Be sure the solution does notcome in contact with the whitecalibration bar. Do not cover thecontainer while the test table issoaking.

Cleaning

9-4


132387 Rev. D, 2006-06

Cleaning

To enable your Clinitek Status®

analyzer to perform as intendedand provide reliable test results, itis recommended that youperiodically check the whitecalibration bar on the test table.

In normal use, the white calibrationbar should not become dirty ordiscolored.

Cleaning the White Calibration Bar

1 Remove the insert from the testtable.

2 Remove the test table by pullingit slowly out of the analyzer.

3 Check the white calibration baron the test table for dirt ordiscoloration.

WhiteCalibration Bar


9-5


132387 Rev. D, 2006-06

Care should be taken not toscratch the white calibration bar.Solvents of any kind must not beused to clean the bar.

Cleaning

4 If the white calibration bar isclean and unmarked, replacethe table into the analyzer byholding the table at the endopposite the white calibrationbar, with the white calibrationbar facing upwards. Push thetest table firmly but slowly, justover half way into the analyzer.

5 Replace the test table insert.

6 If the white calibration bar isdirty or discolored, gently wipeand clean it with a new cotton-tipped stick or lint-free clothwetted with distilled water.

7 Allow the calibration bar to airdry and then inspect the surfacefor dust, foreign material,scratches or scuffs. If thecalibration bar cannot becleaned or is still marked, obtaina new test table.

8 Reinsert the test table asdescribed earlier in point 4.


9-6


132387 Rev. D, 2006-06

Always keep the outside of theClinitek Status analyzer clean andfree of dust.

1 Turn the analyzer off bypressing the on/off button for2 seconds.

2 Wipe the outside (including thedisplay) with a damp (not wet)cloth and a mild detergent.

Do not use any type ofsolvent, oil, grease, silicone spray,or lubrication on the analyzer.

Do not spray the glass cleanerdirectly onto the screen. Do not uselaboratory wipes, such as Kimwipes,since they may scratch the screen.

Care should be taken to avoidliquid from entering the printercompartment.

The display may be disinfectedusing the same solutions as for the testtable (see earlier in this section). Wipethe solution on and allow to remain for10 minutes. Wipe clean using a cleancloth dampened with water, then dry.

Cleaning


9-7


132387 Rev. D, 2006-06

Battery-Powered OperationThe Clinitek Status analyzer isdesigned to let you carry out themaximum number of tests(approximately 100) from a set ofbatteries. To achieve this, thePower Save feature is alwaysactivated when the instrument ispowered by batteries.

If the instrument is not used in3 minutes when battery-powered, itwill automatically power down.

A battery power icon will be shownin the top right corner of the title barwhen the analyzer is beingpowered by batteries. The numberof segments displayed representsthe amount of power remaining inthe batteries.

When power is reduced but testingcan continue, an advisory messagewill be displayed on the mainSelect screen.

If you do not change the batteriesand the level becomes too low topower the analyzer, the error willbecome critical and all selectionareas on the screen will be disableduntil the batteries are replaced.

Changing Batteries

Changing Batteries

9-8


132387 Rev. B, 2004-10

Remove the test table from theanalyzer. Next, place the analyzeron its side and remove the batterycover by pressing down on the taband pulling out. Remove currentbatteries. Place 6 new AA-sizebatteries into the analyzer. Replacethe battery cover and turn theinstrument back onto its base.

Changing Batteries

10-1

10 Appendices

132387 Rev. D, 2006-06

Bayer S.A.División DiagnósticosRicardo Gutiérrez 3652B1605EHD Munro – Buenos AiresArgentina+54 (0) 11-4762-7000

Bayer Australia LimitedABN 22 000 138 714Diagnostics Division2 Keith Campbell CourtScoresby Victoria 3179Australia+61 (0) 3-9212-8444

Appendix A: Local Technical Support Providers and Distributors


Bayer Austria GesmbHGeschäftsbereich DiagnostikaLerchenfelder Gürtel 9-11A-1164 Wien, Austria+43 (0) 1-711-46-2424

Bayer s.a.-n.v.Division DiagnosticsAvenue Louise 143 Louizalaan1050 Bruxelles-Brussel,Belgium+32 (0) 2-535-66-81

Bayer S.A.Produtos DiagnósticosRua Domingos Jorge 110004779-900 – São Paulo – SPBrazil+55-11-5694-5166

Bayer Inc.77 Belfield RoadToronto, OntarioCanada M9W 1G6416-248-0771

Bayer s.r.o.Oddělení DiagnostikaZastoupení pro Českoua Slovenskou republikuLitvínovská 609/3CZ-190 21 Praha 9Česká republika+420 266101442

Bayer S.A.División DiagnósticaA.A. 80387Av. De las Américas No 57-52Santafé de Bogotá, D.C. – Colombia+571 (09) 423-4199

Legal InformationTo contact the legal representativefor Bayer within the Europeancommunity, contact the BayerAuthorized Representative. Toorder supplies or replacementparts, or to obtain service, contactyour local technical supportprovider.

Bayer Authorized RepresentativeBayer Diagnostics Mfg (Sudbury) LtdSudbury, CO10 2XQ, UK

Bayer Diagnostics Mfg (Sudbury) LtdSudbury, CO10 2XQ, UK

Bayer HealthCare LLCSubsidiary of Bayer CorporationTarrytown, NY 10591-5097 USA

10-2

10 Appendices

132387 Rev. D, 2006-06


Bayer HealthCare - DiagnosticsNørgaardsvej 32DK-2800 Kgs. Lyngby, Denmark+45-45-23-50-00

Bayer OYSuomalaistentie 7FIN 02270 Espoo, Finland+358-9-887-887

Bayer Diagnostics49-51, Quai de Dion Bouton92815 Puteaux Cedex, France+33 (0) 1-49-06-56-00

Bayer Vital GmbHDiagnostikaSiemensstraße 3D-35463 Fernwald, Germany+49 (0) 641 4003-0

Bayer Hellas AG18-22 Sorou str.GR-151 25 MarousiAthens, Greece+30 (0) 210 6187 500

Bayer HealthCare Co. Ltd.20/F Gee Chang Hong Centre65 Wong Chuk Hang RoadHong Kong+852-28147337

Bayer Hungária Kft.Alkotás PointH-1123 Budapest, HungaryAlkotás u. 50+36 (06) 1 4874 100

Bayer Diagnostics India Limited589, SayajipuraAjwa RoadBaroda – 390 019Gujarat, India+91 (0) 26-5562720

Bayer S.p.A.

Divisione DiagnosticiVia Grosio 10/420151 Milano, Italia+39-2-3978-1

Bayer Medical Ltd.Marunouchi Kitaguchi Building1-6-5, MarunouchiChiyoda-kuTokyo, Japan+81 (0) 3-3266-7302

Bayer Diagnostics Korea LimitedKye Myung Bldg. 4FMyungil-Don, 48-7Kangdong-KuSeoul 134070Korea+82 (0) 2-428-5987

Bayer (Malaysia) Sdn. Bhd11th FloorWisma DamansaraJalan Semantan50490 Kuala LumpurMalaysia+603 (0) 62093088

Bayer de México, S.A. de C.V.División DiagnósticosAvenida Coyocacán No. 1553Colonia del ValleCódigo Postal 03100Delegación Benito JuarezMéxico, D.F.Centro de Atención Telefónica (CAT)+52 55 57 28 33 12+52 55 57 28 33 06

Bayer B.V.Health CareDivision DiagnosticsEnergieweg 13641 RT MijdrechtThe Netherlands+31 (0) 297-280666

10-3

10 Appendices

132387 Rev. D, 2006-06


Bayer New Zealand LtdDiagnostics Business Group3 Argus PlaceGlenfieldAuckland, New Zealand+64 9-441-8549

Bayer ASDrammensvn. 147 BNO-0277 Oslo, Norway+47 24 11 18 00

Bayer Sp. Z o.o.Al. Jerozolimskie 15802-326 Warszawa, Polska+48 (0) 22-572-3500

Bayer Diagnostics Europe Ltd(sucursal em Portugal)Rua Quinta do Pinheiro, 52795-653 Carnaxide, Portugal+351-21-416-4227

Bayer Puerto Rico Inc.Diagnostics DivisionVictoria Industrial ParkBuilding 1Carolina, Puerto Rico787-752-8989

Bayer (South East Asia) Pte Ltd.No. 9 Benoi SectorSingapore 629844+65 6261 3389

Bayer (Pty) Ltd.Healthcare Division27 Wrench RoadIsando 1600, South Africa+27 (0) 11-921-5048

Química Farmacéutica Bayer, S.A.División Diagnósticosc/ Pau Claris, 19608037 Barcelona, España+34-93 4956500

Bayer ABDrakegatan 1S-402 24 Göteborg, Sweden+46-31-83-98-00

Bayer (Schweiz) AGGB DSGrubenstrasse 6CH-8045 ZürichSwitzerland+41 (0) 1-465-81-11

Bayer plcDiagnostics DivisionBayer HouseStrawberry HillNewbury, RG14 1JAUnited Kingdom+44 (0) 1635-563000

Bayer HealthCare LLCSubsidiary of Bayer Corporation511 Benedict AvenueTarrytown, NY 10591-5097 USA914-631-8000

10-4

10 Appendices

132387 Rev. B, 2004-10

Table 1 English – Conv.Units – Conventional

Reagent Strip Tests

Appendix B: Tables of Results


Reported Results Test Abbreviation Units

Normal System Plus System Negative 500 Negative 2+

100 >=1000 Trace 3+

Glucose

GLU mg/dL

250 1+

Negative Moderate Negative 2+ Bilirubin BIL

Small Large 1+ 3+

Negative 40 Negative 2+

Trace 80 Trace 3+

Ketone

KET mg/dL

15 >=160 1+ 4+

<=1.005 1.020

1.010 1.025

Specific Gravity SG

1.015 >=1.030

No Difference

Negative Small Negative 1+

Trace-lysed Moderate Trace-lysed 2+

Occult Blood

BLO

Trace-intact Large Trace-intact 3+

5.0 6.5 8.0

5.5 7.0 8.5

pH

pH

6.0 7.5 >=9.0

No Difference


PRO mg/dL 15 300 Low 3+

Protein

Multistix PROá

30 1+


PRO mg/dL Trace >=300 Trace 3+

Protein All other urinalysis strips 30 1+

0.2 4.0

1.0 >=8.0

Urobilinogen

URO E.U./dL

2.0

No Difference

Nitrite NIT Negative Positive No Difference

Negative Moderate Negative 2+

Trace Large Trace 3+

Leukocytes

LEU

Small 1+

10 80 Albumin ALB mg/L

30 150 No Difference

10 200

50 300

Creatinine

CRE mg/dL 100

No Difference

<30 Normal >300 High Abnormal

Albumin: Creatinine *

A:C mg/g 30 – 300 Abnormal

No Difference

10-5

10 Appendices

132387 Rev. B, 2004-10

Cassette Test

The results shown in shaded areas will be marked as positives, if “markpositive results” is selected in Instrument Set Up. They will be marked byasterisks when displayed, when printed and when the data is transferredto a host computer.

* Positive Albumin:Creatinine ratios are not marked when usingClinitek® Microalbumin reagent strip.



Normal System Plus System Normal Dilute

300 Abnormal

Normal >500 Abnormal

Protein: Creatinine Multistix PRO

P:C mg/g

150 Abnormal

No Difference

Reported Results Test Abbreviation

Normal System Plus System hCG Negative hCG Positive Human Chorionic

Gonadotropin hCG hCG Borderline

Repeat in 48-72 hours

No Difference

10-6

10 Appendices

132387 Rev. A, 2003-07

Table 2 English – S.I.Units – International (S.I.)

Reagent Strip Tests



Normal System Plus System Negative 28 Negative 2+

5.5 >=55 Trace 3+

Glucose

GLU mmol/L

14 1+

Negative Moderate Negative 2+ Bilirubin BIL

Small Large 1+ 3+

Negative 3.9 Negative 2+

Trace 7.8 Trace 3+

Ketone

KET mmol/L

1.5 >=15.6 1+ 4+

<=1.005 1.020

1.010 1.025

Specific Gravity SG

1.015 >=1.030

No Difference

Negative Ca 25 Negative 1+

Trace-lysed Ca 80 Trace-lysed 2+

Occult Blood

BLD Ery/µL

Trace-intact Ca 200 Trace-intact 3+

5.0 6.5 8.0

5.5 7.0 8.5

pH

pH

6.0 7.5 >=9.0

No Difference


0.15 3.0 Low 3+

Protein Multistix PRO PRO g/L

0.3 1+


Trace >=3.0 Trace 3+

Protein All other reagent strips

PRO g/L

0.3 1+

3.2 66

16 >+131

Urobilinogen

UBG mmol/L

33

No Difference


Negative Ca 125 Negative 2+

Ca 15 Ca 500 Trace 3+

Leukocytes

LEU Leu/µL

Ca 70 1+



0.9 17.7

4.4 26.5

Creatinine

CRE mmol/L

8.8

No Difference

<3.4 Normal

>33.9 High Abnormal


A:C mg/mmol 3.4 – 33.9 Abnormal

No Difference

10-7

10 Appendices

132387 Rev. B, 2004-10

Cassette Test


* Positive Albumin:Creatinine ratios are not marked when usingClinitek Microalbumin reagent strip.



Normal System Plus System Normal Dilute 33.9

Abnormal

Normal >56.6 Abnormal

17.0 Abnormal

Protein: Creatinine Multistix PRO P:C mg/mmol

33.9 Abnormal

No Difference

Reported Results Test Abbreviation

Normal System Plus System hCG Negative hCG Positive Human Chorionic

Gonadotropin hCG

hCG Borderline Repeat in 48-72 hours

No Difference

10-8

10 Appendices

132387 Rev. A, 2003-07

Table 3 English – NordicUnits – Nordic Plus System

Reagent Strip Tests



Normal System Plus System Negative 3+ Negative 2+

1+ 4+ Trace 3+

Glucose

GLU

2+ 1+

Negative 2+ Bilirubin BIL

1+ 3+

No Difference

Negative 3+ Negative 2+

1+ 4+ Trace 3+

Ketone

KET

2+ 5+ 1+ 4+

<=1.005 1.020

1.010 1.025

Specific Gravity SG

1.015 >=1.030

No Difference

Negative 1+

+/- 2+

Occult Blood

BLD

+/- Intact 3+

No Difference

5.0 6.5 8.0

5.5 7.0 8.5

pH

pH

6.0 7.5 >=9.0

No Difference

Negative 2+

Low 3+

Protein Multistix PRO

PRO

1+

No Difference


+/- 3+ Trace 3+

Protein All other reagent strips

PRO

1+ 1+

3.2 66

16 >=131

Urobilinogen

URO µmol/L

33

No Difference



1+ 4+ Trace 3+

Leukocytes

LEU

2+ 1+



0.9 17.7

4.4 26.5

Creatinine

CRE mmol/L

8.8

No Difference

<3.4 Normal

>33.9 High Abnormal


A:C mg/mmol 3.4 – 33.9 Abnormal

No Difference

Normal Dilute 33.9 Abnormal

Normal >56.6 Abnormal

Protein: Creatinine Multistix PRO P:C mg/mmol

17.0 Abnormal

No Difference

10-9

10 Appendices

132387 Rev. B, 2004-10

Cassette Test


* Positive Albumin:Creatinine ratios are not marked when usingClinitek Microalbumin reagent strip.


Reported ResultsTest AbbreviationNormal System Plus SystemhCG Negative hCG PositiveHuman Chorionic

Gonadotropin hCGhCG BorderlineRepeat in 48-72hours

No Difference

10-10

10 Appendices

132387 Rev. D, 2006-06

Power Required110V AC ± 20%, 45 - 65 Hz(US only)220V AC ± 20%, 45 - 65 Hz(Europe only)240V AC ± 20%, 45 - 65 Hz (UKonly)100V - 240V AC ± 20%, 45 - 65 Hz(with in-line lead)

Battery Powered OperationSize 6 AA non-rechargeablealkaline batteries

DimensionsDepth - 272 mm (10.7 inches)Width - 171 mm (6.7 inches)Height - 158 mm (6.2 inches)

WeightClinitek Status® instrument only(unpacked, without batteries orpower supply) – 1.66 kg (3.65 lb)

Ambient Operating TemperatureRange18°C to 30°C (64°F to 86°F)

Ambient Operating HumidityRange18% to 80% Relative Humidity(non-condensing)

Appendix C: Specifications

Optimum Operating TemperatureRange22°C to 26°C (72°F to 79°F)

Optimum Operating HumidityRange35% to 55% Relative Humidity(non-condensing)Optimum ranges insure that thereagent results are optimized forperformance. At temperaturesunder 22°C (72°F), urobilinogenand leukocyte results may bedecreased, and at temperaturesabove 26°C (79°F), increased.

Altitude: 2000 m (6562 ft)

Installation Category: II

Pollution Degree: 2

Instrument Memory200 Patient test results200 Patient details (Patient’s Nameand/or Patient Identification)

Safety StandardsThe Clinitek Status analyzer isclassed as a Class A computingdevice in accordance with Part 15of FCC Rules.


10-11

10 Appendices

132387 Rev. D, 2006-06

The instrument complies with theprotection requirements ofEN 60601-1-2,EN 50082-1 January 1992,EN 50081-1 January 1992,and the safety specifications ofEN 61010-1.

NOTE: This equipment has beentested and found to comply with thelimits for a Class A digital device,pursuant to Part 15 of the FCCRules. These limits are designed toprovide reasonable protectionagainst harmfulinterference when the equipment isoperated in a commercialenvironment. The equipmentgenerates, uses, and can radiateradio frequency energy and, if notinstalled and used in accordancewith the instruction manual, maycause harmful interference to radiocommunications. Operation of thisequipment in a residential area islikely to cause harmful interferencein which case the user will berequired to correct the interferenceat his own expense.

The instrument is listed by theUnderwriters’ Laboratories (UL) andthe Canadian StandardsAssociation (CSA) as certified andcomplies with the safety standardsspecified in UL 3101 andCSA-C22, No. 1010.1.


The instrument is certified asmeeting the EMC requirements andsafety specifications of the In VitroDiagnostic Directive(98/79/EC).

10-12

10 Appendices

132387 Rev. B, 2004-10

PasswordPassword protection not set

Input SettingsQuick Test

Operator IDDisabled

Keyboard PriorityAlphabetic

Entry of Patient’s NameDisabled

Entry of Patient IDDisabled

Include Patient’s Name or ID inResultsPatient’s Name

Last Operator IDDisabled

Sample AppearanceDisabled

Custom Data EntryDisabled

Date FormatMM-DD-YYYY

Appendix D: Instrument Default Settings – English

Time Format12 hour

Results FormatUnits SelectionConventional

Plus SystemDisabled

Mark Positive ResultsDisabled

System SettingsPrinterAutomatic

Power SaveDisabled

SoundOn

Contrast Setting0 (zero)

ConnectivityAllow Results to be Sent tocomputerEnabled

Instrument Serial Number inPatient RecordsDisabled


10-13

10 Appendices

132387 Rev. A, 2003-07

Baud Rate115200

ParityNone

Stop Bits1 (one)

Urinalysis Test SelectedMultistix® 10 SG


10-14

10 Appendices

132387 Rev. B, 2004-10

Appendix E: System Overview & Principles

Intended Use of AnalyzerThe Clinitek Status® analyzer is forin vitro diagnostic use in:

• the semi-quantitativedetection of albumin,bilirubin, blood (occult),creatinine, glucose, ketone(acetoacetic acid),leukocytes, nitrite, pH,protein, specific gravity andurobilinogen in urinesamples. The testsreported depend on thetype of Bayer urinalysisstrip used.

• the semi-quantitativecalculation of albumin-to-creatinine and protein-to-creatinine ratios in urinesamples, when certainstrips are used.

• the detection of humanChorionic Gonadotropin(hCG) in urine samples,when Clinitest® hCGCassette Tests are used.

Description of Optical SystemThe optical system consists of sixlight emitting diodes, a light guide,a mirror, a lens and a detector.

Light from the LEDs travels alongthe light guide and is reflected offthe calibration bar, strip or cassetteonto the mirror. It is then directedthrough an aperture on the lens,from where it is focused onto thedetector. The light intensitydetected is converted into electricalimpulses, which are processed bythe instrument’s microprocessorand converted into clinicallymeaningful results.

When carrying out analysis on aurinalysis strip, the test tablepositions strip pads in the “readarea”. The light reflected at specificwavelengths (470 nm, 525 nm,565 nm, 625 nm, 660 nm and845 nm) from the test pad isdependent upon the degree of colorchange in the pad and is directlyrelated to the concentration of theparticular constituent in the urine.The analyzer’s optical systemimages the entire strip (i.e., allreagent pads at once).

When using a Clinitest immunoassaycassette, the detector will scan the“read area” for the test, referenceand control lines that form afterurine has been applied. Thereference and control lines will


10-15

10 Appendices

132387 Rev. A, 2003-07

always form whereas the test linewill only form if hCG is present inthe sample.

Description of Internal ChecksWhen the analyzer is first turnedon, the instrument performs aseries of electronic, signal andmemory checks, as well asensuring there is sufficient batteryvoltage to operate the instrument (ifpowered by batteries).

Each time a urinalysis strip is read,the instrument positions the tablecorrectly and checks the electronicsand signals. It then takes referencereadings off the white calibrationbar on the test table. The readingsare taken at all six wavelengths andare then used to calculate thesample readings.

The table and test strip are pulledinto the instrument after the correctplacement of the test strip isconfirmed. The table then movescompletely into the instrumentclosing the shutter. All test pads areread simultaneously at all sixwavelengths. The test andreference readings are then used todetermine presence and/or amountof each constituent in the urinesample.

Each time a cassette is read, theinstrument positions the tablecorrectly and checks the electronicsand signals. It then takes referencereadings of the white calibration baron the test table. The readings aretaken at two wavelengths (525 nmand 845 nm) and are then used tocalculate the sample readings.

The table and cassette are pulledinto the instrument where thepresence of the cassette isconfirmed. The table then pullscompletely into the instrumentclosing the shutter and thecassette “read area” is scanned attwo wavelengths. The test andreferences readings are then usedto determine presence or absenceof hCG the urine sample.

Differences between the HumanEye and Instrumental OpticsThere are inherent differencesbetween the colors that areperceived by the human eye andthat are detected by any instrumentoptical system. The human eye iscapable of detecting minutedifferences in shade and very smallareas of color; whereas instrumentoptical systems are less sensitiveto such small changes. Conversely,


10-16

10 Appendices

132387 Rev. A, 2003-07

instrument optics are capable ofdetecting certain colors that aremasked by or blended with othercolors to the human eye.

For this reason, exact agreementbetween visual results andinstrument results might not befound. However, agreement isgenerally within one visual colorblock or reported level and is equalto or better than the agreementbetween two visual readers.


10-17

10 Appendices

132387 Rev. A, 2003-07


10-18

10 Appendices

132387 Rev. B, 2004-10


10-19

10 Appendices

132387 Rev. B, 2004-10


10-20

10 Appendices

132387 Rev. B, 2004-10


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10 Appendices

132387 Rev. D, 2006-06

Appendix F: CLIA Waiver Performance Characteristics

The Clinitek Status received CLIA waiver status (42 CFR 493) for theentire urinalysis menu in 2005. Clinitek Microalbumin required a separateCLIA Waiver submission for use on the Clinitek Status. All additional testsusing new urinalysis chemistries or new immunoassay analytes willrequire Clinitek Status system CLIA Waiver approval.

Clinitek Multistix Expected Waiver Performance

At 3 sites, 75 untrained users with no laboratory experience, testedrandomized samples using Bayer Multistix reagent strips and 35Clinitek Status urinalysis analyzers. The CLIA waiver study demonstratedthat the performance of the Clinitek Status analyzer is acceptable in thehands of non-technical users when only a Quick Reference Guide is usedto learn and to perform tests.

The performance of the Bayer Multistix reagent strips with theClinitek Status analyzer, in the hands of LAY-users, met the primaryperformance criteria that 90% of the results should be within +/- one levelof the expected result.

TABLE 1 Percent Agreement of Clinitek Status Results to Target Levels(Bayer Masked Samples) tor LAY-users

AnalyteExact Agreement (%) ± One (1) Level (%)

LAY-user LAY-user

96.6 98.8

66.8 97.8Creatinine87.6 99.5Glucose

92.7 99.9Ketone92.8 99.9Leukocyte100 100Nitrite87.8 99.5pH

90.9 100Protein58.4 96.7Specific Gravity

Blood (occult)

10-22

10 Appendices

132387 Rev. D, 2006-06

The following analyte test results were derived from a Physician OfficeLaboratory (POL) study conducted at 3 POL sites and 1 clinical laboratorysite. The performance of the Clinitek Status analyzer and Multistix reagentfor these analytes met the primary performance criteria that 90% of theresults should be within +/- one level of the expected result.

TABLE 2 Percent Agreement of Clinitek Status Results to Target Levels(Bayer Masked Samples) in POL/clinical laboratory settings

Clinitek Microalbumin Expected Waiver Performance

To evaluate the expected performance of the Bayer Clinitek Microalbuminurinalysis product used on the Clinitek Status Analyzer in a CLIA-waivedsetting, a lay user field study was performed at three non-laboratory studysites. The 72 participants represented diverse demographics, had noprevious laboratory experience, and received no training for the study.Participants were provided with six (6) masked samples consisting of tworeplicate samples at each of three albumin concentrations: negative(0 mg/L), weak positive (35.6 mg/L), and strong positive (179 mg/L). Thelay user results were compared to results using a comparator quantitativemethod. A summary of the performance is shown below.

Lay User Results: 431

Lay Users: 72

The overall accuracy rates for microalbumin were:

*One result was omitted due to an error by the study monitor.

Statistical analysis (Fisher’s Exact Test) demonstrated that the observeddifferences between the three study sites were not significant.

Appendix F: CLIA Waiver Performance Characteristics

AnalyteExact Agreement (%) ± One (1) Level (%)

POL-user POL-user

96.7 100

92.6 99.5Urobilinogen

Bilirubin

Negative 100% (144/144) with 95% CI: (97.5% - 100.0%)

99.3% (142/143)* with 95% CI: (96.2% - 100.0%)

Strong Positive

Weak Positive

100% (144/144) with 95% CI: (97.5% - 100.0%)

10-23

10 Appendices

132387 Rev. D, 2006-06

Chek-Stix® Positive and Negative control strips areavailable for use in your training program for routine urinestrip testing (for supply information see Appendix A, LocalTechnical Support Providers and Distributors). Follow thepackage insert for instruction on preparation and testing.

Appendix G: Training & Educational Materials

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10 Appendices

132387 Rev. D, 2006-06

Appendix H: Safety Information

Protecting Yourself fromBiohazards

This information summarizes theestablished guidelines for handlinglaboratory biohazards. Thissummary is based on theguidelines developed by theCenters for Disease Control, theClinical and Laboratory StandardsInstitute, and the OccupationalSafety and Health Administration.

Use this summary for generalinformation only. It is not intendedto replace or supplement yourlaboratory or hospital biohazardcontrol procedures.

By definition, a biohazardouscondition is a situation involvinginfectious agents biological innature, such as the hepatitis Bvirus, the human immunodeficiencyvirus, and the tuberculosisbacterium. These infectious agentsmay be present in human bloodand blood products and in otherbody fluids.

The following are the major sourcesof contamination when handlingpotentially infectious agents:

needlesticks

hand-to-mouth contact

hand-to-eye contact

direct contact with superficialcuts, open wounds, andother skin conditions thatmay permit absorption intosubcutaneous skin layers

splashes or aerosol contactwith skin and eyes

To prevent accidentalcontamination in a clinicallaboratory, strictly adhere to thefollowing procedures:

Wear gloves while servicingparts of the system that havecontact with body fluids suchas serum, plasma, urine, orwhole blood.

Wash your hands beforegoing from a contaminatedarea to a noncontaminatedarea, or when you remove orchange gloves.

Perform procedures carefullyto minimize aerosolformation.

Wear facial protection whensplatter or aerosol formationare possible.

Wear personal protectiveequipment such as safetyglasses, gloves, lab coats oraprons when working withpossible biohazardcontaminants.

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10 Appendices

132387 Rev. D, 2006-06

Keep your hands away fromyour face.

Cover all superficial cuts andwounds before starting anywork.

Dispose of contaminatedmaterials according to yourlaboratory’s biohazardcontrol procedures.

Keep your work areadisinfected.

Disinfect tools and otheritems that have been nearany part of the systemsample path or waste areawith 10% v/v bleach.

Do not eat, drink, smoke, orapply cosmetics or contactlenses while in thelaboratory.

Do not mouth pipet anyliquid, including water.

Do not place tools or anyother items in your mouth.

Do not use the biohazardsink for personal cleaningsuch as rinsing coffee cupsor washing hands.

Do not recap, purposely bend, cut,break, remove from disposablesyringes, or otherwise manipulateneedles by hand. Needlestickinjuries may result.

References

1. Centers for Disease Control.Update: Universal precautions forprevention of transmission ofhuman immunodeficiency virus,hepatitis B virus and otherbloodborne pathogens inhealthcare settings. 1988. MMWR,37:377-382, 387, 388.

2. Clinical and LaboratoryStandards Institute (formerlyNCCLS). Protection of LaboratoryWorkers from OccupationallyAcquired Infections; ApprovedGuideline - Third Edition. Wayne,PA: Clinical and LaboratoryStandards Institute; 2005. CLSIDocument M29-A3. [ISBN 1-56238-567-4].

3. Federal Occupational Safetyand Health Administration.Bloodborne Pathogens Standard.29 CFR 1910. 1030.

Appendix H: Safety Information

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10 Appendices

132387 Rev. D, 2006-06

11 Index

11-1132387 Rev. C, 2005-09

A

Agreement with visual, 10-15Analyzing screen

strip test, 4-4cassette tests, 4-9

Analyzer intended use, 10-1Analyzer software upgrades, 1-4Auto shut down, 9-7

B

Batterieserror messages, 7-5installing/changing the batteries,

1-2, 9-7troubleshooting, 7-1

Battery powered operation, 5-15,9-7

Baud rate setting, 5-18Boxed areas, 2-2

C

Cablinginterfacing to a computer, 1-3

Calibration, 4-3, 4-9error messages, 7-4, 7-6

CassetteClinitek Status® Check cassette,

1-1full test, 4-19 to 4-24immunoassay cassette, 4-7, 4-8preparing a cassette, 4-7quick test, 4-6 to 4-10testing error messages, 7-4 to

7-7

Cleaningdisinfect the test table and insert,

9-3exterior cleaning, 9-6periodic cleaning, 9-1routine cleaning, 9-1white calibr-ation bar, 9-4

CLIA waiver, 8-1, 8-2, 10-21Clock error message, 7-6Color and Clarity, 5-8Connectivity, 5-17 to 5-19Custom

field entry, 5-6information, 5-6set up, 5-6 to 5-9

D

Date and timesettings, 5-10, 5-11

Defaultrestore default settings, 5-21settings, 10-12

Diagnostic tests, 5-22Display

contrast, 5-16icons, vii - xtime outs, 4-5, 4-10

E

Electrical outlet, 5-15Error(s)

calling for assistance with anerror, 7-3

dashes in display, 7-2error codes, 7-4 to 7-7messages, 7-1problem checklist, 7-8results alert, 7-1

11 Index

11-2 132387 Rev. B, 2004-10

F

Full testcassette test, 4-19 to 4-24set up, 5-4strip test, 4-11 to 4-18

G

General information, 7-1HHelp

cassette test, 4-6strip test, 4-1

H

I

Iconsbattery power icon, 7-2display icons, vii - xpaper-out icon, 7-2

Instrumentdiagnostics, 5-22error messages, 7-4 to 7-7settings, 5-13 to 5-20

Interfacing to a computer, 1-3connectivity, 5-17, 5-18sending results, 5-17

Internal checks, 10-15, 10-16

J

K

Keyboardsalphabetic, 2-4numeric, 2-4, 2-5set keyboard priority, 5-6

L

Languageselect language, 5-2

M

Mark positive results, 5-14

N

O

Operatorlast operator identification, 4-12, 4-19new operator identification, 4-12, 4-19set up of identification, 5-6

Optical system, 10-14 to 10-16

P

Parity setting, 5-19Password

remove password, 5-3set password, 5-3

Patiententer new patient identification,

4-14, 4-15, 4-22, 4-23information, 4-13, 4-22, 4-23patient identification set up, 5-7recall identification, 4-13, 4-21

Plus system, 5-14Positive results marked, 5-14

11 Index

11-3132387 Rev. B, 2004-10

Powerinlet socket, 1-2on/off button, 1-7, 1-8plugging analyzer in, 1-2save, 5-15supply, 1-1, 1-2

Power saveelectrical outlet, 5-15batteries, 5-15

Powering down, 1-8Powering up, 1-7Printer

error messages, 7-5loading the printer paper or label

roll, 1-5paper holding arm, 1-5paper-out, 7-2setting printing to automatic

manual, 5-15Printout of results

full cassette test, 4-24full strip test, 4-18quick cassette test, 4-10quick strip test, 4-4

Problem checklist, 7-8 to 7-9

Q

Quality controlcassette testing, 8-1urinalysis strip testing, 8-1

Quick testcassette test, 4-6 to 4-10set up, 5-5strip test, 4-1 to 4-5

R

Reagentselect strip product, 5-20

Resultsamount of time results displayed

on screen, 4-5, 4-10choose results format, 5-13 to

5-14error messages, 7-4 to 7-7full cassette test, 4-24full strip test, 4-17 to 4-18mark positive results, 5-14number stored, 4-13plus system, 5-14print recalled results, 6-2quick cassette test, 4-10quick strip test, 4-5recalling, 6-1sending results data to a PC, 6-3

Round buttons, 2-2

S

Scroll arrows, 2-3Sequence number

reset, 5-12Serial number of instrument

locating serial plate, 1-6recording serial number, 1-6storing serial number in patient

records, 5-18Serial port, 1-3Sound settings, 5-16Specifications of instrument, 10-10Start-up wizard, 3-1Stop bits setting, 5-19

11 Index

11-4 132387 Rev. B, 2004-10

Stripblot strip, 4-3changing strip type, 5-19dip strip, 4-2full strip test, 4-11 to 4-18holding channel, 4-3preparing a urine strip, 4-2quick strip test, 4-1 to 4-5select strip type, 5-20testing error messages, 7-4 to

7-7Supplies, ordering from Bayer,

10-1 to 10-3Symbols, vii - xSystem

configuration, 5-23information, 5-23settings, 5-15 to 5-16

T

Test tableirregular movement, 7-2

Testingfull cassette test, 4-19 to 4-24full strip test, 4-11 to 4-18help, 4-1, 4-6prepare strip test, 4-1quick cassette test, 4-6 to 4-10quick strip test, 4-1 to 4-5sequence number, 5-12

Touch screenalpha-numeric keypad, 2-4, 2-5how and where to touch, 2-2,

2-3layout, 2-1

Troubleshooting, 7-1 to 7-9

U

Unitsconventional units, 5-13nordic units, 5-13SI units, 5-13

Unpacking, 1-1Urinalysis test selection, 5-19, 5-20Urine sample

clarity, 4-17color, 4-16settings, 5-8visual appearance, 4-16, 4-17, 10-15

V

W

Warranty, 7-3registration card, 1-5

X

Y

Z

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