C-2 Operators Manual V11.15

7/28/2019 C-2 Operators Manual V11.15

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Operation Manual

forHelena C-2Software: C11.15

For In-Vitro Diagnostic use

Instrumentation and reagents for human coagulation andhemostasisCopyright 2007, Helena BioSciences, U.K.

Revision 9Issue MAR-2008Document No: 38 422 11


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Operation Manual Helena BioSciences Europe

Helena C-2 - Software C11.15 Great Britain

2

Warning This manual is valid for firmware C11.15. The manual maydiffer slightly from the actual product as a result of productimprovements. Please read the Operation Manual in its entiretyprior to operate. In order to ensure a high level of performance,

all safety information must be followed.Copyright Copyright 2007 by Helena BioSciences

Neither the Operators Manual nor any part thereof may becopied, digitally processed or otherwise transferred withoutwritten permission from Helena BioSciences

Trademarks COATRON is a trademark of Helena BioSciences, Germany.Other product names used in this Operators Manual aretrademarks of the respective companies.

Software The software for Helena BioSciences products is the intellectualproperty of Helena BioSciences, which company retains all

rights to usage of the software. The purchaser of a Helena C-2acquires rights of use for this software.

Warranty Helena BioSciences guarantees that the instrument willdelivered in a fault free condition. Any damages resulted byaccidents, improper use, using not recommended material ornegligence of maintenance are excluded from warranty.Warranty will expire if not authorized persons perform anyservice on the instrument

Service Repairs to the instrument may only be carried out by trainedpersonnel, and replacement parts must comply with instrument

specifications. Please contact the local distributor of HelenaBioSciences if service is required.

Authorized for Distribution and Service :

Helena Biosciences EuropeQueensway SouthTeam Valley Trading EstateGateshead, Tyne & Wear NE11 0SDGreat Britain

Tel: + 44(0) 191 482 8440

Fax: + 44(0) 191 482 8442

General enquiries: [email protected]

Internet: http://www.helena-biosciences.com

Sub-Distributor:

Sub-Distributors stamp / address / label


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Firmware History Helena C-2

1.09 - First Release

1.10 - 6 dialogue languages introduced- Autosensitivity for clotting method- New Fib algorithm- Result Flag R & S introduced- OD & coag correction introduced

1.11 Chromogenic method introduced ( requires UV-LED optic upgrade)- New tests D-Dimer , Eccarin ECAH & ECAT

1.12 Minor changes and fixes

1.13 Tecam Smart interface implemented ( LIS connection)- Improved optic check for hi lipemic,bilirubin or other disturbance- Autostart sensitivity can be adjusted for every test individually- General improvements of measurements- D-Dimer can be adjust with time & od correction for any reagent

1.14c Profile can be set free Bugfix Tecam Interface & Print-Out Quick test change with keys up/down key- Results (s,%,INR,..) are scrolled- Result Flag B (Biphasic aPTT) introduced- Result Flag F (low fibrinogen) introduced- new test LA ( DRVVT) with automatic ratio calculation

- new test APCR with automatic ratio calculation- statistic counter for PT,aPTT,FIB,AT,DD and all introduced- bugfix for high bilirubin samples- Autostart sensitivity can be set now within SETUP TEST menu

1.15 D_Dimer adapted to new HELENA Blue D-dimer reagent 2008- Bugfix DD: For zero D-Dimer curves the former system could reboot sometimes


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TABLE OF CONTENTS

11..00 SAFETY INFORMATION _________________________________________ 7

22..00 GENERAL ____________________________________________________ 822..11.. Intended purpose____________________________________________ 9

22..22.. Installation_________________________________________________ 9

22..33.. Technical data _____________________________________________ 10

22..44.. CE marking________________________________________________ 11

33..00 INSTRUMENT COMPONENTS ____________________________________ 12

33..11.. Incubator Block ____________________________________________ 12

33..22.. Control panel ______________________________________________ 13

33..33.. Rear of equipment __________________________________________ 1433..44.. Autopipette (optional) _______________________________________ 14

33..55.. Thermal-Printer (optional)____________________________________ 14

33..66.. Barcode Scanner (optional) ___________________________________ 14

44..00 THEORY OF OPERATION _______________________________________ 15

44..11.. Clotting Assay (CLOT) _______________________________________ 16

44..22.. Derived Fibrinogen (CLOT + FIB)_______________________________ 17

44..33.. Chromogenic Assay (KINETIC)_________________________________ 17

44..44.. Chromogenic Ecarin Assay (100mOD) ___________________________ 1744..55.. Immunturbidimetric Assay (IMMUNO)___________________________ 18

55..00 OPERATING INSTRUCTIONS ____________________________________ 19

55..11.. Setup System ______________________________________________ 1955..11..11.. Language ____________________________________________________1955..11..22.. Fibrinogen Concentration Units____________________________________1955..11..33.. Temperature Control____________________________________________2055..11..44.. Signal _______________________________________________________2055..11..55.. Autostart_____________________________________________________2055..11..66.. Contrast of the LCD (Liquid Crystal Display) _________________________20

55..11..77.. Speed of the Mixer _____________________________________________2055..11..88.. Patient Identification____________________________________________21

55..22.. Setup Test ________________________________________________ 2355..22..11.. Setup Test____________________________________________________2355..22..22.. Units ________________________________________________________2455..22..33.. Standard Curve________________________________________________2455..22..44.. Correlation Factor (linearity index for calibration data) _________________2555..22..55.. Store Data____________________________________________________2555..22..66.. Print Test ____________________________________________________2555..22..77.. Autostart_____________________________________________________25

55..33.. Test Analysis ______________________________________________ 27

55..33..11.. Test Selection _________________________________________________2755..33..22.. Optic Activation & Entering Patient Identification Numbers ______________2855..33..33.. Duplicate testing_______________________________________________2955..33..44.. Starting the Analysis____________________________________________2955..33..55.. Display during measuring________________________________________30


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55..33..66.. Manual break of measurement ____________________________________3055..33..77.. Return to main menu ___________________________________________3055..33..88.. Unit Key Functions _____________________________________________3055..33..99.. Stopwatch Functions____________________________________________3055..33..1100.. Result Warning Messages ________________________________________31

55..44.. Hidden Functions ___________________________________________ 3355..44..11.. Set system to default ___________________________________________3355..44..22.. Change temperature adjustment __________________________________3455..44..33.. Set all test calibration points to zero _______________________________3455..44..44.. Set OD correction ______________________________________________3455..44..55.. Set COAG correction ____________________________________________35

66..00 SERVICE MENU ______________________________________________ 36

66..11.. System Analysis ____________________________________________ 36

66..22.. Optic-Values_______________________________________________ 37

66..33.. Print Sys-ID _______________________________________________ 37

77..00 TROUBLESHOOTING __________________________________________ 39

88..00 MAINTENANCE_______________________________________________ 43

88..11.. Recommended Maintenance___________________________________ 43

88..22.. Temperature Adjustment _____________________________________ 43

88..33.. Cleaning procedures_________________________________________ 43

99..00 APPLICATIONS ______________________________________________ 44

99..11.. Test Overview _____________________________________________ 44

99..22.. Prothrombin Time __________________________________________ 4599..33.. Derived Fibrinogen__________________________________________ 47

99..44.. Clauss Fibrinogen Assay______________________________________ 49

99..55.. Thrombin Time Assay________________________________________ 50

99..66.. APTT_____________________________________________________ 51

99..77.. PT-Based Factor Assays (II, V, VII & X)__________________________ 52

99..88.. APTT-Based Factor Assays (VIII, IX, XI & XII) ____________________ 53

1100..00 SPECIAL FUNCTIONS__________________________________________ 54

1100..11.. Software Upgrading _________________________________________ 54

1111..00 TECAM SMART THE LIMS SOLUTION ______________________________ 55

1111..11.. General___________________________________________________ 55

1111..22.. Interface Protocol __________________________________________ 56

1111..33.. Screenshots _______________________________________________ 59

1122..00 PRODUCT CATALOGUE_________________________________________ 61


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TABLE OF FIGURES

Figure 1- Incubator Block _____________________________________________12

Figure 2 - Control Panel_______________________________________________13Figure 3 - Rear of Equipment __________________________________________14Figure 4 - The detection principle _______________________________________15Figure 5 - The Turbidity Method ________________________________________16Figure 6 - The chromogenic method _____________________________________17Figure 7 - Latex agglutination __________________________________________18Figure 8 - Relationship of light absorbance and concentration of D-dimer ________18Figure 9 - Flow diagram for the "Setup" System" Submenu ___________________22Figure 10 - Flow Diagram for the "Setup Test" Submenu _____________________26Figure 11 - Flow Diagram of "ANALYSIS" Submenu _________________________32Figure 12 - Flow Diagram of "SERVICE" Submenu __________________________38Figure 13 LIMS communication _______________________________________56Figure 14 Tecam Smart Results _______________________________________59Figure 15 Tecam Smart statistics______________________________________59Figure 16 Tecam Smart DataBase followed by a report _____________________60

Symbols

Symbol Meaning Explanation

Advice Indicates important informationand tips.

Warning!

Risk of possible health damage orconsiderable damage toequipment if warning is notheeded.

Biohazard!Equipment can be potentiallyinfectious due to the samples andreagents used.

Danger!Potential risk to operatingpersonnel or equipment due toelectric shock.


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11..00 Safety information

Recommend materialsUse only origin disposables.Use only manufactorer approved material.

Avoid contactNever touch moving parts such as the measurement rotor orpipetting arm during device operation.

Do quality controlCarry out control measurement runs at regular intervals to ensurethat the Analyzer continues to function faultlessly.

Waste cuvettesThe cuvette blocks are intended as single-use items only.

Infectious MaterialAvoid direct contact with samples and sample residues in the usedcuvettes.

Infectious material such as cuvette waste and liquid waste must bedisposed in compliance with local regulations governing forinfectious materials.

Wear medical infection grade protective gloves for all cleaning andmaintenance work involving potential contact with infectious liquids

and use each pair of gloves once only.

Use a hand disinfectant product, e.g. Sterilium, to disinfect yourhands after completion of the work.Enviromental conditionAmbient temperature must be 18 25Chumidity must be below 80%avoid any vibrations or impacts to analyzerdo not use analyser if explosive or inflammable gas is around.

Elektrical SafetyMake sure the operating voltage setting is correct before connectingthe device to the power mains.Use only shockproof (grounded) electrical sockets.Use only shockproof extension leads in perfect condition. Defectiveleads must be replaced without delay.Never intentionally interrupt protective ground contacts.Never remove housing elements, protective covers or securedstructural elements, since so doing could expose parts carryingelectric current.Make sure surfaces such as the floor and workbench are not moistwhile work is being done on the device.


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22..00 General

The Helena C-2 is a manual 2 channel photo-optical instrument that offersclotting &chromogenic & immunturbidimetric testing capabilities. The Helena C-2 can be used for awide variety of coagulation and fibrinolysis tests such as:

Prothrombin Time (PT) Activated Prothrombin Time (aPTT) Thrombin Time (TT) Venom Time (VT) Fibrinogen (FIB) Factors (FII - FXII) Antithrombin (AT3) Heparin (HEP) Activated PC resistance (APCR) Lupus Anticoagulant (Screen,

Confirm)

Protein-C (PC) Protein-S (PS) D-Dimer (DD) von Willebrand Factor (VWF) Ecarin Chromogenic Assay Thrombin

(ECAT) Ecarin Chromogenic Assay Hirudin

(ECAH) Plasminogen (PLG) a2-Antiplasmin (A2AP)

FEATURES: Coagulation analyser for turbidimetric, chromogenic and immunturbidimetric

assays. Highly reliable, longlifing and nearly service free system Autosense optics to eliminate interferences like Bilirubin, Hemoglobin Approved clotting algorithm for all kind of samples and reagents. If there is a clot

- it will be detected. Biphasic aPTT waveform curve detection to DIC indication Low fibrinogen curve detection Fibrinogen concentration can be derived from a PT result additionally. For sure the

standard CLAUSS method is also available. Calculation in Activity %, INR, Ratio, g/L or mg/dL Every test is programmable up to 5 calibration points Correlation analyse of calibration curve 2 Stop-watch functions which can be used independently Multi-language software

(German, English, Spanish, French, Italian, Portuguese) Patient identification (No PID, manual input, autoseries, barcode) Test-Duplicate Modus Free Profile testing (PT,APTT, FIB) APC-R with automatic ratio calculation DRVVT with automatic ratio calculation Micro volume testing ( 60 - 75L) Reagent stirring with magnetic bars Routines for selftest (trouble-shooting) Routines for print outs (result, calibration, service, system) Optional autopipette for electronic triggered start Automatic Start triggered by adding reagent Optional data management and research software Optional printer Optional barcode scanner for patient identification Easy software update Interface for Laboratory Information & Management Systems (LIMS) CE marked Small dimension and weight - fits on every desktop


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22..11.. Intended purpose

The Helena C-2 is designed to carry out coagulometric tests such as PT, PTT, TT,fibrinogen, single factor tests, chromogenic and immunturbidimetric tests (for instance

Antithrombin-III, D-dimer etc.).

Use only citrate plasma for test analysis runs: Mix 9 parts venous blood with 1 part 3.2%(0.105M) sodium citrate and centrifuge the mixture at 1500g for approx. 10 minutes.Plasma must be used within 4h.

Do not use plasma with more than 25mg/dL Bilirubin concentrationDo not use plasma with more than 1000mg/L Hemoglobin concentration

The HELENA C-2 must be operated by a specialist, trained in clinical laboratory techniques.The operator needs also training and instruction in operation and must read and understoodthis Operators Manual.

22..22.. Installation

No special precautions are necessary when starting up the Helena C-2. However, thefollowing is recommended:

Place on a level surface in an area free from excessive temperature fluctuations Avoid vibration during measurement Protect the instrument from direct sunlight, moisture and dust Check that the voltage and frequency data on the identification plate on theinstrument agree with the local power rating before starting the instrument for

the first time

The instrument is connected to the power supply by the main cablesupplied. If obvious damage has occurred during shipping, do notuse. Contact your local distributor for replacement or repair.


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22..33.. Technical data

Instrument:Boards SMD (Small Mounted Devices) based

Microprocessor NEC V25Flash-EPROM 128 KByteRAM 128 KByteEEPROM 2 KByteAD-Converter 18 Bit (16 bit used)Optics 2 LEDs ultra bright, pulse modulation controlRS 232 9600 Bauds, 8 Data, 1 Stop, no parity

Power Supply:external,Input voltages 96 Vac to 243 Vac / 50 to 60 HzOutput voltages +5Vdc/3A; +15Vdc/2A; -15Vdc/0,5A

approvals TV, CSA, UL, CE, IEC950, IEC380

Keyboard:3x8 matrix, foil keyboard, with Test, Function and numerical keys

Display:4 lines x 20 characters Liquid Crystal Display

Incubation block:6x2 double-cuvette prewarming positions, 2 measuring and 3 reagent positions

Autopipette (optional):25 / 50 / 100 / 200 L volume with electronic triggered start


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22..44.. CE marking


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33..00 Instrument Components

33..11.. Incubator Block

The incubator block is made from aluminum, which ensures equal distribution of heat. Thetemperature of the incubator block is regulated to 36.5C - 37.5C

Figure 1- Incubator Block

Reagent containerposition (30mm)

stirred,different reagentadapter available

Measuring positionsright = Optic 2left = Optic 1

12 positions forprewarming orincubation

For Reagent tubes( 16 or 22.5 mm)


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33..22.. Control panel

ON / OFF switches on and off the unit

Temp. indicates Temperature is in theallowed range of 37C +/-0,2C

Optic 1 / 2 activate channel 1 and/or 2

Unit 1 / 2 convert result into otherdimensions

Timer 1 / 2 activate Timer function 1and/or 2

Cursor up Line up / Scroll down / selectsetup parameters

Menu Go back to Main Menu or next

entry

Cursor down Line down / Scroll down / selectsetup parameters

Numeric keys for input of calibration valuesand

Patient Identification orSelection of Submenu andSelection of Test No.

Enter confirm entry, jump to nextentry

Figure 2 - Control Panel


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33..33.. Rear of equipment

DC Pipette Printer Computer / Barcode Scanner AdapterInput (9600,8,1,N)

Figure 3 - Rear of Equipment

DC Input: For connector to Power Supply

Pipette: For connector to Autopipette (Cat.No. 19 029 00)

Printer: For connector to Thermal Printer (Cat.No. 80 535 00)

Computer For connector to PC (Firmware upgrading, TECMONI, LIMS) or connector tobarcode scanner

33..44.. Autopipette (optional)

Optional accessory tool for automatic test start. The pipette supports four different volumes(25, 50, 100 and 200 L)

33..55.. Thermal-Printer (optional)

Optional accessory tool for automatic print-out. When the Thermal printer is connected withprinter-port of the Helena C-2, following data will be printed automatically:

Result Print-Out Test Parameter Print-Out Service-Report Print-Out System-Identification Print-Out

33..66.. Barcode Scanner (optional)

Optional assessory tool for easy handling of patient identification. Upto 20 characters can beread.

Barcodes with more information will cut off at the maximum length. The barcode-scannermust support a serial interface, set to 9600 Baud, 8 Data, 1 Stop, No parity.

Warning: The barcode-scanner is powered with 5V over PIN9 of the RS232 Interface of the analyser. Do only usescanners with that feature.


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44..00 THEORY OF OPERATION

The Helena C-2 is a highly sensitive 2-channel-photometer. A very bright LED-Opticensures accurate and precise results, even when iteric or lipemic samples are used. Thereceiver signal is detected and converted to an electrical current. During the actual test thesystem is searching for the best signal amplification, therefore it will support a wide rangeof different reagents (i.e. very turbid thromboplastins or very clear reagents). Additionallythe software is based on optical density (extinction), which absorbs outside light effects.

DETECTOR

Micro-ControllerPRINTERDISPLAY

LASER

PLASMA + REAGENT

CUVETTE

Figure 4 - The detection principle


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44..11.. Clotting Assay (CLOT)

The thrombin catalyzed conversion of fibrinogen to fibrin is the final reaction in thecoagulation cascade. Fibrin formation results in an increase in sample turbidity which is

detected by the photometer. Photometric detection is started manually by pressing theOptic key with simultaneous addition of the test reagent. Alternatively, the reaction isstarted by the addition of the test reagent using the Autopipette. The time between the startof the photometric detection, and the turning point of the reaction curve is the result. Theresult is displayed in seconds on the Liquid Crystal Display (and printed automatically to theoptional Thermal Printer.)

START OF TEST

(i.e. PT)

0

0.120 E

EXTINCTION

TURN-POINT

OF REACTION

FIBRINOGEN-

TRANSFORMATION

BEGIN OF

13.0s

END-POINT

OF REACTION

Biphasic Curve

Figure 5 - The Turbidity Method

The diagram is representative of a typical PT curve with normal control plasma and a curvewith biphasic reaction. Biphasic aPTT reaction are highly indicators of disseminatedintravascular coagulation (DIC)


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44..22.. Derived Fibrinogen (CLOT + FIB)

The derived fibrinogen is determined using the clotting method described in section above.The fibrinogen concentration in the sample is proportional to the change in optical density in

the cuvette, that accompanies the conversion of fibrinogen to fibrin at the end of thereaction. The result is expressed as E, which represents the optical densitiy at the end-point.

44..33.. Chromogenic Assay (KINETIC)

In this method, the end result is determined from the rate of optical density change. Testplasma is pre-incubated with an enzyme (i.e. - Thrombin for determination of AT-III) andresidual enzymatic activity is detected by the addition of a chromogenic substrate. The

concentration of the analyte in the test plasma is directly or indirectly proportional(depending on the reagent system) to the rate of substrate hydrolysis, and is reported asthe mean slope of optical density per minute (delta OD(E)/min).

result = slope of curve per minuteresult = (E2 - E1)/(t2 - t1) if t2 - t1 = 1 min

0

E1

t1

EXTINCTION

E2

1.000

t2 end oftest

time in sect3

100mOD

result = t3

Chromogenic Assay Chromogenic Ecarin Assay

Figure 6 - The chromogenic method

44..44.. Chromogenic Ecarin Assay (100mOD)

The measurement principle is similar to a regular chromogenic assays. But the result is thetime between start of test and when signal brake through 100mOD.


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44..55.. Immunturbidimetric Assay (IMMUNO)

Intensive light is able to penetrate turbid solutions, such as latex suspensions used for thedetermination of D-dimer concentration. Latex particles, designed specifically for automated

Dimex testing, are coated with a monoclonal antibody specific for D-dimer. If D-dimerantigen is present in the sample, an antigen-antibody reaction occurs, with a simultaneouslychange in light transmission. The concentration of D-dimer in the sample is directlyproportional to the rate of the antigen-antibody reaction. The result is reported as the meanslope of optical density per minute (OD (E)/min, E = Extinction, a unit of light-absorbance). The following diagram illustrates the measurement principle of the Dimex Jr.

Figure 7 - Latex agglutination

The D-dimer concentration is proportional to the rate of change in optical density. Theinstrument calculates the average slope of reaction, using the linear portion of the curveonly.

250 ng/mL

High Dose Effect

ABSORBTION

OFLIGHT

0

time [ s ] maximum time100 s

3000 ng/mL

1000 ng/mL

Figure 8 - Relationship of light absorbance and concentration of D-dimer

The kinetic algorithm for D-dimer testing is illustrated with three typical reactioncurves. At high doses the linear relationship between signal and concentration is notvalid. This is called High Dose Hook Effect.

SAMPLE +SAMPLELATEX

Ag - Ab OD D-DIMERANTIGEN

LEVEL


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55..00 Operating Instructions

This section provides general instructions necessary for the user to achieve maximal use andbenefit from the Helena C-2. Please refer to section 9.0 for specific test applications.

The On/Off switch is located on the rear panel of the instrument. For optimal results, donot operate until the temperature indicator light is on. It takes approximately 10-15minutes for the instrument to equilibrate to 37oC. The general sequence of operation for testanalysis is:1.) Enter the SETUP SYSTEM submenu to confirm/change system settings2.) Enter SETUP TEST to select test parameters and enter calibration data if desired; and3.) Enter the ANALYSIS submenu for sample testing.

From the Main Menu, the following options are available:

At each screen, selections are made using the Up/Down cursors. To proceed to the nextmenu item, press either the Menu or Enter key. If a mistake is made, press the Menukey until the main menu appears and start over.

To return the system to default values,Press simultaneously Optic 1+ . + Enter keys.

55..11.. Setup System

To enter this submenu, press #3 from the main menu. The default values for the systemparameters are:

LANGUAGE: ENGLISHFIBRINOGEN: mg/dLTEMP.CONTROL: ONSIGNAL: ON; VALUE 325AUTOSTART ONCONTRAST OF LCD: VALUE: 25

SPEED OF MIXER: VALUE: 215PAT.IDENT.: NO PAT.ID.

55..11..11.. Language

English, German, French, Italian, Spanish, PortugueseUse the cursor keys to select, press Enter or Menu to advance

55..11..22.. Fibrinogen Concentration Units

Use the cursor keys to select mg/dL or g/L, press Enter or Menu to advance

1. ANALYSIS

2. SETUP TEST3. SETUP SYSTEM4. SERVICE


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55..11..33.. Temperature Control

On/Off - use the cursor keys to select, press Enter or Menu to advance. For temperatureadjustment, refer to section 8.2 Temperature Adjustment

55..11..44.. Signal

ON/OFF (A beep at the start and end of testing)- use the cursor keys to select, pressEnter or Menu to advance.

Higher/lower - use the cursor keys to change and Enter to advance.

55..11..55.. Autostart

Change with cursor keys to change and continue with ENTER

ON Measurement starts with adding of reagent automatically.No need for use of the Autopipette or extra pressing of the relevant Optic channel

key.

Off regular mode for start with optional available Autopipette or manual startby pressing relevant Optic channel key

Activate optic channel just before adding of reagent.Movements of the cuvette can pre-start measurement Donot touch cuvette, if optic channel is active!

The sensitivity of the autostart can set for every testindividually within the menu SETUP TEST.

55..11..66.. Contrast of the LCD (Liquid Crystal Display)


55..11..77.. Speed of the Mixer



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55..11..88.. Patient Identification

Four choices are available:

No Patient ID Extra Input Autoseries Barcode

Use the cursor keys to select, press Enter or Menu to advance. If No Patient ID isselected, results will be printed out without a patient identification number. IfExtra Inputischosen, the user enters a patient identification number when running each test (in theAnalysis mode). The third option, Autoseries, allows the user to enter a starting patientidentification number here. Each sample run (in the Analysis mode) is then automaticallyincremented by one from the starting patient identification number entered by the user. IfBarcode is active, an alphanumeric Pat.Id. is entered by a barcode-scanner. No manuallyinput or correction is possible. The maximum length of the Pat.Id. in that mode is 20characters. Limited by the space on the LCD, only the first 10 characters will be displayed.


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3

M E N U

M E N U

O P T I C

1 . E N T E R

M E N U

M E N U

M E N U

M E N U

M E N U

M E N U E N T E R

M E N U

1 A N A L Y S IS

2 S E T U P T E S T

3 S E T U P S Y S T E M4 S E R V I C E

L A N G U A G E : ?

E N G L I S H

F IB R I N O G E N IN ?

m g /d l

T E M P E R A T U R E :

M A R K : 3 7 . 0 C

C U R R E N T : 3 4 .0 C

C O N T R O L : O N

S I G N A L :

O N

C O N T R A S T O F L C D :

V A L U E : 2 5

S P E E D O F M IX E R :

V A L U E : 2 1 5

P A T . ID E N T . : ?

A U T O S E R I E S

1 0 0 0

A U T O S T A R T :

O N

C U R S O R U P / D O W N

S E L E C T :

L A N G U A G E

S E T U P S Y S T E MS E T U P S Y S T E M

+ +

E E P R O M r e s e t

S E L E C T W IT H :


IN P U T S T A R T V A L U E

O F A U T O S E R I E W I T H :

K E Y " 0 - 9 "

C O N F I R M W I T H :

" E N T E R " K E Y

C H A N G E W I T H :



" E N T E R " K E Y

S E L E C T W IT H :

" E N T E R " K E Y


T E M P : C U R S O R U P / D O W N + k e y "O P T I C 1 "

C O N T R O L : C U R S O R U P / D O W N




" E N T E R " K E Y




" E N T E R " K E Y




" E N T E R " K E Y

+

B I O S r e s e t




" E N T E R " K E Y

Figure 9 - Flow diagram for the "Setup" System" Submenu


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55..22.. Setup Test

The specific parameters for each test are entered in this menu. Once the initial data isentered and saved it is not necessary to go into this menu for routine testing. The submenu

of SETUP TEST is illustrated in Figure 6. To enter this submenu, press #2 from the mainmenu. The default values for SETUP TEST are:

METHOD: CLOTTING (or Clauss for FIB)UNITS: secondsCALIBRATION CURVE: Reset to zeroAUTOSTART: 800

55..22..11.. Setup Test

To select a test by enter the numeric code of the designated test. Alternatively, theUp/Down arrow keys can be used to scroll through the entire test menu. For example, key in#1 to select PT. Press Enter to confirm selection. The METHOD can also changed whenblinking.

Depending which test is active, following methods can be selected:

CLOT Clotting assays CLOT+FIB Fibrinogen will be derived from PT CLAUSS Fibrinogen according to CLAUSS KINETIC Chromogenic Assay 100mOD Chromogenic Ecarin Assays IMMUNO Immunturbidimetric Assays

TEST: PT

METHOD: CLOTAUTOSTART: 800


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55..22..22.. Units

Every result is displayed in seconds [s]. However, the user can also choose to display PT

results in % (% activity), R (ratio) and I (INR). Calibration data, the mean normal PT value,and/or the ISI of the thromboplastin reagent must be entered to obtain results in %, R andI. Refer to next section for information on calibration data entry. Use the Up/Down cursorkeys to select the desired units, Enter to confirm and Menu to advance.

The Helena C-2 reports results using the following units (which are test dependent):

E = Extinction (optical density) precision X.XXXs = seconds precision XXX.XR = ratio precision XX.XXI = INR precision XX.XX% = percent activity precision XXX.XXU = mg/L (except FIB: mg/dL or g/L) precision XXX.X

55..22..33.. Standard Curve

To obtain results in units of concentration (mg/dL, IU/mL...) or % activity, a calibrationcurve is needed. A minimum oftwo points is required, with a maximum of five. Calibrationdata is obtained by testing plasma [in duplicate (2) or quadruplicate (4)] in the Analysismode. An example of calibration data entry is shown below.

Example: A PT calibration curve with derived fibrinogen. Two different calibration curvesare required. The order of entry is not critical, the instrument will automatically sortcalibration points.

3-point Calibration Curve for PT 4-point Calibration Curve for Derived Fib.

100% = 12.2s 591 mg/dL = 0.413E50% = 18.0s 377 mg/dL = 0.246E25% = 27.2s 267 mg/dL = 0.140E0% = 0.0s 95 mg/dL = 0.042E

0% = 0.0s 0 mg/dL = 0.0E

A correct calibration curve is required to obtain results inunits of concentration or % activity. Those points remainingwith no data entry are not used in the calibration curvecalculation. For those tests that require a zero calibrationpoint a value greater than zero must be entered (i.e. 0,1 %and 0.1s). All calibration points can be reset to zero bysimultaneously pressing the 0 and Enter keys. A fullparameter reset will eliminate calibration data for all assays.

UNITS: PT(s-%-R-I): s-%-I- -NORMALVALUE: 12.2sISI-VALUE: 1,05


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26

Figure 10 - Flow Diagram for the "Setup Test" Submenu

1 ANAL YSI S

2 S E T U P T E S T

3 S E T U P S Y S T E M4 S E R V I C E

S E T U P T E S T : P T

2

M E N U

0-9U P 0-9D O W N

M E N U

T EST : PT

M E T H O D : C L O T T I N G

A U T O S T A R T : 8 0 0

UNI T S : PT

(s -%-R- I ) : s -%- I

N O R M A L V A L U E : 1 2 .0 s

ISI VAL UE : 1 .12

E N T E R

M E N U

S T A N D A R D C U R V E : P T

1 : 95 .0 % = 12 .5 s

2 : 30 .0 % = 27 .3 s

3 : 15 .0 % = 46 ,8 s

P T

S T O R E D A T A ?

Y E S N O

PRI NT T EST : PT

Y E S N O

M E N U

M E N U

E N T E R

E N T E R

M E N U

C U R S O R U P /D O W N

S E L E C T :

D E S I R E D U N I T S

E N T E R :

N O R M A L VA L U E

ISI VALUE (o n ly fo r I)


" E N TE R " K E Y

Only d isp layed i f % is se lec ted !


E N T E R :

C A L I B R A TI ON P OI N TS


" E N TE R " K E Y


S E L E C T :

Y E S o r N O


S E L E C T :

Y E S o r N O


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27

55..33.. Test Analysis

To enter the submenu Analysis, press #1 from the main menu.

55..33..11.. Test Selection

The first screen in the Analysis submenu will ask the user to make a test selection. Thiscan be done two ways: by scrolling through the test menu with the cursor Up/Down keys; orby entering a numeric test code (i.e. - 01 for PT test). The test selection is confirmed withthe Enter key.

TEST FOR ANALYSIS

...PT

PT: 00:00

PT: 00:00

Key

UP/DOWN

Keys

1 | 4 | 7

Key

3 | 6 | 9

Key

UP/DOWN

Keys

0-9

enter test code

or scroll

Optic1:

change PT/PTT/FIB

Optic2:

change PT/PTT/FIB

scroll test

OPTIC-1

OPTIC-2

Once a test is chosen, the system will prompt the user to remove any remaining cuvette,and insert a filter. Once Enter is pressed, the instrument performs a self-check. If anywarnings or errors are identified, a message will appear. The user is given the option toignore the error message or warnings by pressing the Enter key. However, all resultswill be printed with an error code and the results may be invalid. It is recommendedthat if an error occurs, the test should be interrupted. Return to the Main Menu and enterthe Service menu. Please refer to to section 6.0 for more specific instructions andinformation on error codes and warnings.

Within the analysis menu the actual test can switched if nomeasurement is ongoing.Change test optic-1 with Key 1 (PT), Key 4 (PTT), Key 7 (FIB)Change test optic-2 with Key 3 (PT), Key 6 (PTT), Key 9 (FIB)Change test optic-1+2 with Key UP , Key DOWN


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55..33..22.. Optic Activation & Entering Patient Identification Numbers

The optic can be activate in three different ways.

Single activation : Press optic key Enter / Change PID Press optic key again PID is confirmed and channel activeRepeat procedure for each desired optic channel

Multi activation with single PID Press key . (dot) All channels will activatedAll patient ID number will set logical if autoseries is active (PID = 100,101,102,103)

Multi activation with double PID Press key 0 All channels will activated in duplicate mode

If Autoseries was chosen in Setup System, press the Optic 1 key.

The patient identification number for channel one will be the number that was manuallyentered by the user. If this is not the correct patient identification number, the Up/Down

scroll keys can be used to increase or decrease this number. Press the Optic 1 key toconfirm and activate the channel. Press the Optic 2 key to continue. The patientidentification number will be automatically incremented by one for each subsequentchannel.

If Extra Input was chosen in Setup System, the patient identification number shownfor channel will be the last entered PID. Confirm or enter a new patient ID using thenumeric keyboard. Press the Optic key to confirm patient identification number andactivate the channel. Repeat for the remaining channels.

To enter the patient ID. with a Barcode scanner, press the "Optic 1" key ("Barcode" isdisplay), scan the barcode (the first 10 characters of the patient ID. are displayed).Continue with the next barcode.

IfNo Pat Id was selected in Setup Test, No PID will be seen for each channel.Press Optic 1 to confirm and activate channel. Repeat for remaining channels.

FIB: 100 00:00

FIB: 00:00

FIB: ACTIVE 00:00

FIB: 101 00:00


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55..33..33.. Duplicate testing

If duplicate testing is desired, enter the same patient identification twice. The mean resultwill automatically be printed along with the individual channel data.

If the duplicates differ more than 7.5% from the mean value, the mean resultwill be flagged with X!

If autoseries is selected a press on key 0 during optic activation, will activateall channels in duplicate mode

55..33..44.. Starting the Analysis

Place the required number of cuvettes in the cuvette pre-warming positions. To continuewith the PT example, pipette 50 L of sample to each cuvette well. Press the Timer 1button to start the stopwatch. Place the Thromboplastin reagent with magnetic stir bar inthe center large reagent pre-warming position.

Transfer the first cuvette with sample to the measurement position. Once patientidentification numbers have been entered, press the Optic keys again to activate thechannels.

When the timer has reached 2 minutes, pipet 100 uL of Thromboplastin reagent into thefirst cuvette position. If autostart is enable, the optic will start automatically.A beeping noisewill indicate the start of the reaction. Repeat for the remaining cuvettes. The reaction canalso be started either by pressing the optic key or by using the Autopipette, whichelectronically triggers the optic channel.

In summary, press the optic key once for patient identification data entry, pressagain to activate the channel, and a third time to manually initiate the reaction.(Do not press a third time if using the Autopipette to start the reaction!)

If using the Autopipette,- always pipet from left to right (channel 1 - 2)!- Disable the autostart function in the SETUP SYSTEM

FIB: ACTIVE 01:30

FIB: ACTIVE 00:26


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55..33..55.. Display during measuring

Once started, a short beeping noise is followed by a blinking screen -------. After the testdeadtime the actual optical density will be displayed. Avoid contact with the cuvette whilethis message is shown. A beeping noise will sound when the reaction is complete and theresult will be displayed on the screen. If the thermal printer is attached, results willautomatically be printed.

channels are in measurement a result is found on channel 2, butit

wait until channel 1 is ready.Channel 1 is running in high sensitivity

The flag S indicates, that the analyzer had switched to the high sensitivityThe flag R indicates, that a result was found, but it need more investigation.

The instrument will display and results sorted. If the instrument finds a result on opticchannel x, it will not display as long as lower numbered channels are in measurement. Inthis case the actual optical density is flagged with R (result found).

55..33..66.. Manual break of measurement

To cancel the measurement, press both the Enter and Optic keys. This will stop thereaction. All optic channels must be inactive in order to return to the main menu.

55..33..77.. Return to main menu

Press key MENU. All optic channels must be inactive in order to return to the main menu.Stop any measurements (refer section above). If a optic channel is active, start and breakthe measurement.

55..33..88.. Unit Key Functions

Once the measurement is complete, results can be converted to units other than s, E,E/min, if this option had been selected in Test Setup. For each optic channel, press thecorresponding Unit key to convert.

55..33..99.. Stopwatch Functions

To start each stopwatch, press the Timer keys 1-4. To stop and reset, press the Timer keyagain.

PT: S 31 mOD 01:52

PT: R 188 mOD 01:13

PT: 29 mOD 01:48

PT: 185 mOD 01:09


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55..33..1100.. Result Warning Messages

Additionally to the result the instrument may inform the operator at critical samples byattaching

status characters or error messages

DISPLAY PRINTER MEANING .* * Out of calibration (i.e. *167 %)> | < > Out of scale (i.e. >999.9 mg/dL)++++ NO CLOT DETECTED No clot detected within 300 seconds- - - - NO CLOT DETECTED Clot detected before deadtime???.? COAGULATION ERROR Detected reaction was not valid for coagulationOPTIC LOW SIGNAL Light transmission was not enough.

S High sensitivity modeR result foundB Biphasic APTT found (maybe DIC disease)F Low fibrinogen found (maybe liver disease)

Read section troubleshooting for further details.


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1 A N A L Y S I S

2 S E T U P T E S T

3 S E T U P S Y S T E M

4 S E R V I C E

T E S T F O R A N A L Y S IS

P T

R E M O V E C U V E T T E

P R E S S A N Y K E Y

P T : 0 0 : 0 0

P T : 0 0 : 0 0

A NY

K E Y

1

W A R N IN G

T E M P E R A T U R E : 3 4 .0 C


E R R O R IN S Y S T E M

O P T I C 1 : 0 0 0 0 0 0 0 0

O P T I C 2 : 0 0 0 0 1 0 0 0


E N T E R

A N Y

K E Y

D O TO P T I C

1

O P T I C

1

M E N UA N Y

K E Y

O P T I C

1

U N IT

1

M E N U

T I M E R

1

T I M E R

1

0

P T : P I D 1 0 0 : 0 0

P T : 0 0 : 0 0

E N T E R

P T : A C T I V E / P ID 1 0 0 :0 0

P T : 0 0 : 0 0

O P T I C

1

P T : A C T I V E / P I D 1 0 0 : 0 0

P T : A C T I V E / P I D 2 0 0 : 0 0

P T : A C T I V E / P I D 1 0 0 : 0 0

P T : A C T I V E / P I D 1 0 0 : 0 0

O P T I C

1

O P T I C

1

P T : ------------- 0 0 : 0 1

P T : 0 0 : 0 0

P T : 2 2 1 m O D 0 0 : 2 2

P T : 0 0 : 0 0

P T : 1 2 . 5 s 0 0 : 0 0

9 8 . 5 % 1 . 0 2 I

P T : 0 0 : 0 0

P T : 1 2 . 5 s 0 0 : 0 0

3 1 1 U 0 . 1 8 6 E

P T : 0 0 : 0 0

A N A L Y S I S

P O S S I B L E K E Y S :

u p / d o w n ,

0 - 9 ,

S Y S T E M W I L L B E E X A M IN E D

I F O K

O R U S E

A U T O P I P E T T

M E A S U R E M E N T IS

R U N N I N G . A c t u a l o p t i ca l

d e n s i ty i s d i sp l a ye d

B R E A K

R E S U L T I S D I S P L A Y E D

A N D P R I N T E D

R E S U L T S I S C O N V E R T E D

I N M E D . D IM E N S I O N S .

T H E D I M E N S I O N S A R E

S E L E C T E D I N T H E S E T U P

T I M E R W I L L S T A R T

T I M E R W I L L R E S E T

M A I N M E N U

S E L E C T

if a n y w a rn in g s if a n y e r ro rs

O P T I C i s r e a d y

to s ta r t

Figure 11 - Flow Diagram of "ANALYSIS" Submenu


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33

55..44.. Hidden Functions

To protect the instrument from improper use, critical routines can be called by pressingspecial key combinations.

55..44..11.. Set system to default

Within the main menu press key OPTIC 1 and . and ENTER simultaneously.

1 ANALYSE

2 SETUP TEST

3 SETUP SYSTEM

4 SERVICE

1 INIT TEST...

2 INIT BIOS ...

3 INIT ALL ...

4 TEST ACTIVATION

press simultaneously

"OPTIC 1" + "." + "ENTER"

INIT TEST:

all tests will be correct initiate into the memory. This means in detail that allcalibration points will be reset to zero, the method to clotting, the dimensions toseconds.

The language is set to English The format of fibrinogen concentration is mg/dL

This routine is only recommend when a new software will beupdated on the instrumentINIT BIOS:

Integration-time of the receiver to 100 s Temperature Basis Value LCD-Contrast to 33 Speed of Mixer to 215 Frequency of beep to 325 The serial interface is configured to 9600 Baud, Stop 1,Data 8, Parity Off

This routine is only recommend when the System pcb (Main board)

will be exchanged. The procedure must be followed by atemperature adjustment (see section 5.4.2)!

INIT ALL: INIT TEST INIT BIOS

TEST ACTIVATION:

Allows to fade in/out tests. Use keys UP DOWNto change, ENTERto proceed andMENUto escape. Deactivated test can not be selected later in the operators menu.


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55..44..22.. Change temperature adjustment

When entering the position TEMPERATURE in the submenu SETUP SYSTEM the currenttemperature can be changed by pressing the keys OPTIC 1 and UP or DOWN

simultaneously.The temperature will be in- or decrement by 0.1C. When pressing the keys OPTIC 1 andUP or DOWN and 1 simultaneously, the temperature will be in- or decrement by 1C. Formore information refer to section 8.2 Temperature Adjustment..

55..44..33.. Set all test calibration points to zero

When entering the position STANDARD CURVE in the submenu SETUP TEST allcalibration points can be set to zero by pressing the keys 0 and ENTER simultaneously.

55..44..44.. Set OD correction

Change to TEST SETUP and select test, which you want to correct.When method is blinking, press key 1 and MENU simultaneously.

SETUP TEST: PT

METHOD: CLOT

OD CORRECTION:

+20%press simultaneously

"1" + "MENU"

The measured optical density of the instrument can be corrected by a factor for each test.Therefore it is possible to adapt other reagents.

OD-CORRECTION = 0 no effect (default):

OD-CORRECTION > 0 will cause: longer clotting times reduce sensitivity of method (more results as +++.+ s)

Positive OD-CORRECTION < 0 will cause: shorter clotting times

increase sensitivity of method, which can cause wrong results (short time results!!!!)

OD-CORRECTION = -100% will invert the signal by -1.

Improper setting can cause false result. Consult your localdistributor or Helena BioSciences before changing the OD correction


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55..44..55.. Set COAG correction

Change to TEST SETUP and select test, which you want to correct.

When method is blinking, press key 2 and MENU simultaneously.

SETUP TEST: PT

METHOD: CLOT

COAG CORRECTION:

+10%press simultaneously

"2" + "MENU"

With the Coag Correction the instrument can correct the result for better correlation to othersystems or reagents.

Example: On other instrument a plasma is measured with PT = 12,1 seconds, on theHelena C-2 the result is 11,0 seconds. To get equal results, the result have to be correctedby factor +10%).

This can be done by entering COAG CORRECTION = 110 (Factor 1,10The measured optical density of the instrument can be corrected by a factor for each test.Therefore it is possible to adapt other reagents.

Negative OD-CORRECTION will cause: longer clotting times reduce sensitivity of method (more results as +++.+ s)

Positive OD-CORRECTION will cause: shorter clotting times increase sensitivity of method, which can cause wrong results (short time results!!!!)

An new calibration run must be followed after every change COAGcorrection


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66..00 Service Menu

66..11.. System Analysis

Press #1 from the Service submenu to enter. Perform a SYSTEM ANALYSIS to checkinstrument operational status. In SYSTEM ANALYSIS, the Helena C-2 check the optic,temperature, Memory values and Analog to Digital Conversion. The Error Level for eachchannel is determined and displayed if a system error or warning is identified.

An example of a SYSTEM ANALYSIS screen is:The number after CH1-2 is the error code: Refering to section 5.2. the LED light of channelis notworking correctly, while channel 2 is without troubles.

After the self-check is complete, a service report is automatically printed.

1 SYSTEM ANALYSIS

2 OPTIC VALUES3 PRINT SYS-ID

ERROR IN SYSTEMOPTIC 1: 00001000OPTIC 2: 00000000PRESS ANY KEY

SERVICE REPORT

HELENA HELENA C-2

SN: 1000SOFTWARE: 1.11TEMP.FACTOR: 15496CONTRAST: 25MIXER: 200TEMPERATURE: 37,0C

OPTIC 1 2 .

SIGNAL: 32753 32679(20000-35000)

NOISE: 153 166

(0-500)

SERVICE: 184 202(110-390)

SYSTEM-ANALYSIS

OPTIC1 = 00000000 OKOPTIC2 = 00000000 OK

STATISTIC

PT: 1000PTT:1000TT: 1000FIB: 1000AT: 1000

Serial numberSoftware revisionDigital target temperature valueLCD contract valueSpeed of reagent mixerCurrent temperature at reagent position

Current optic valuesAllowed range of values

Current noise values

Allowed range of values

Current service valuesAllowed range of values

ErrorcodeErrorcode

Counters for differenct tests

1000 PTs performed on instrument....


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Error Level

When the self-check is followed by an error message, a 8 BIT long number in binary codecan be seen. Each BIT is indicative of a specific error or warning:

temperature error ( range 36.0 - 38-0C )

not used

not used

optic error by signal ( range: 20000 - 35000 )

optic error by service ( range: 110 - 300)

system error by keyboard

optic error by noise ( range : 0 - 500)

system error by AD conversion

Example: The Error Level 00000001 indicates that the temperature is out of range.

Refer to the troubleshooting guide for information on corrective actions.

66..22.. Optic-Values

From the SERVICE submenu, remove cuvettes and press #2 to enter OPTIC VALUES.The values of signal, noise and service is displayed for each channel.

An example of a OPTIC VALUES screen is:

Recommended values: *SIGNAL : 20000 35000NOISE: 0 - 500SERVICE: 110 390

66..33.. Print Sys-ID

press #3 from the Service menu.

MAINBOARD: 955.000SYSTEM: 1000BIOS: 1.00FLASH: 2.00SOFTWARE: 11.15

CH1: 32432 (202)152

CH2: 32169 (213)168

SYSTEM IDENTIFICATION HELENA HELENA C-2

-------------------------------------------------------

MAINBOARD REVISION 955MAINBOARD INDEX 0MAINBOARD SER.NO.: 1000BIOS REVISION: 1BIOS INDEX: 0FLASH REVISION: 2FLASH INDEX: 0SOFTWARE REVISION: 11SOFTWARE INDEX: 15


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SYSTEM - ID

WILL BE

PRINTED

1 ANALYSIS

2 SETUP TEST

3 SETUP SYSTEM

4 SERVICE

SERVICE

1. SYSTEM-ANALYSIS

2. OPTIC VALUES

3. PRINT SYS-ID

2 1

ANY

KEY

4

MENU

RESULT

OF

SYSTEM-EXAMINATION

SERVICE-

REPORT WILL

BE PRINTEDANYKEY

ANY

KEY

ERROR-

LEVELS

WILL BE SET

REMOVE CUVETTE

PRESS ANY KEY

OPTIC CHECK

100 %

4

CH1: 32566 (216)

113

CH2: 32635 (200)

110

SERVICE

1. SYSTEM-ANALYSIS2. OPTIC VALUES

3. PRINT SYS-ID

SERVICE - MENU

MAIN - MENU

SYSTEM-EXAMINATION

Figure 12 - Flow Diagram of "SERVICE" Submenu


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77..00 Troubleshooting

TEMPERATURE ERROR

DESCRIPTION Temperature is not between 36.0 38C

PROBABLYCAUSE

1. temperature draft environment (window)2. electronic error3. temperature is not adjusted correctly

CORRECTIVEACTION

1. place instrument in a draft free environment without directsun lighting

2. allow instrument to heat up at least 15 min after temp.adjustment or boot-up

3. adjust temperature (refer sections 8.1 & 8.2)Contact technical services at local distributor if error persists.

OPTIC ERROR : SIGNAL

DESCRIPTION This error occurs if not enough light is flashing onto the receiver.The optical signal must be between 20000 - 35000

PROBABLYCAUSE

1. temp. out of range2. dirt in optics3. LEDs on optic block defective4. chip errors on boards

CORRECTIVEACTION

1. wait until instrument is temperatured to 37C2. clean optics (refer section 8.3)3. replace optic block4. Contact technical services at local distributor if error persists

OPTIC ERROR : NOISE

DESCRIPTION Noise is produced by IC chips and external light sources (sun, lab-lighting)The digital value of the noise must be below 500.

PROBABLYCAUSE

1. The instrument is lighted by intensive external light sources,such as sun or halogen beamer

2. electronic errorsCORRECTIVEACTION

1. Protect instrument against sun or UV light2. Contact technical services at local distributor if error persists

OPTIC ERROR : SERVICE

DESCRIPTION This error occurs if the required signal amplification is not between110 - 300

PROBABLYCAUSE

1. temp. out of range2. dirt in optics3. LEDs on optic block defective4. chip errors on boards

CORRECTIVEACTION

1. wait until instrument is temperatured to 37C2. clean optics (refer section 8.3)3. replace optic block4. Contact technical services at local distributor if error

persists


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OPTIC ERROR : AD-Conversion

DESCRIPTION The photo receiver convert light intensity to analog direct current.This currentIs converted to a digital signal. Every digital value has his ownsignature. If there is lost a value, the system error occurs.

PROBABLYCAUSE

1. CPU defect2. ADC defect

CORRECTIVEACTION

Contact technical services at local distributor

ANALYSIS ERROR : ++++

DESCRIPTION No clotting reaction is detected within 300sPROBABLYCAUSE

1. There is really no clot2. The fibrinogen concentration in the sample is below 50

mg/dL3. started channel and pipeted channel are not equal

CORRECTIVEACTION

1. confirm correct handling2. Determine clotting time with research software TECMONI

or observe the optical values on the display during screen.The time until a change in signal can be observed is theclotting time

3. change to recommended reagent provider

ANALYSIS ERROR : ----

DESCRIPTION Clotting reaction start and end before deadtime

PROBABLYCAUSE

1. PT based test clot before 7 sec2. PTT based tests clot before 15 sec

CORRECTIVEACTION

change to recommended reagent provider

ANALYSIS ERROR :????

DESCRIPTION The instrument detected a reaction, but was not able to verify as aclot reaction.PROBABLYCAUSE

1. air bubbles2. touching of cuvette3. clot reaction starts before deadtime

CORRECTIVEACTION

1. avoid air bubbles pipet against cuvette wall2. avoid touching the cuvette during measurement start3. change to recommended reagent provider

ANALYSIS ERROR : OPTIC

DESCRIPTION The received signal is below 400 digits

PROBABLYCAUSE

1. very turbid samples or reagents2. dirt in optics3. optic is defective


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CORRECTIVEACTION

1. clean optics2. check optic value (refer section 6.2)3. change to recommended reagent provider


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ANALYSIS ERROR : >, 350 mg/dL) fibrinogen

concentration. Record the Extinction(OD) values for all samples.

2. Enter the fibrinogen data for thecalibration curve, Extinction &fibrinogen values.

3. Check the calibration curve withcontrols.4. Note - If % PT andderived fibrinogen

values are required, two calibrationcurves must be entered.


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99..44.. Clauss Fibrinogen Assay

REAGENT PREPARATION

Reconstitute Thrombin reagent 100 NIHU/mL according to the package insert.

SYSTEM PREPARATION

1. Turn on instrument and wait for greenLED light to come on.

2. Turn on printer if connected.3. Connect optional Autopipette to

system.4. Check system setup if necessary.5. Check test setup if necessary and enter

new calibration curve data.6. Return to main menu and enterAnalysis by pressing #1. Select Fibwith the Up/Down arrow keys or enterthe numeric test code, #6. If anywarning or error message appears,refer to section 7.0.

TEST PROCEDURE

All quality control and patient samplesare diluted 1:10 in Imidazole BufferedSaline (IBS) for testing. If the

clotting times fall outside of the linearcurve, prepare and test 1:5 or 1:20dilutions as needed.

1. Pipette 50 L of diluted sample tocuvette.

2. Prewarm sample for 5 min, or the timeindicated in reagent package insert.Press the TIMER 1 key to start stop-watch 1.

3. Transfer cuvette to measuring position.4. While incubating, press OPTIC 1. If

selected, enter PAT-ID with numerickeys or Up/Down keys. Confirm bypressing OPTIC 1 again. Themessage ACTIVE is displayed andchannel 1 is ready to start the reaction.Repeat for the remaining channels.

5. Add 25 L 100 NIH U/mL Thrombinreagentand simultaneously press the

OPTIC 1 key. The test willautomatically start if using theAutopipette. (CAUTION: When the testprocedure is running, pressing the

OPTIC 1 and the Enter keys willinterrupt the test).

6. The instrument will read for 300 secs.If no clot is detected, the display will

read +++ and No Clot Detected willprint.

7. The result is displayed in seconds, and boththis result and the fibrinogen concentrationare automatically printed. press thecorresponding Unit key for fibrinogenconcentration if a printer is not attached.

8. For samples diluted 1:10, this is thefinal result. For other dilutions, theresult must be corrected. For example,if the sample was diluted 1:5, dividethe result by 2; if the sample was

diluted 1:20 or 1:40, multiply the resultby 2 or 4, respectively.

ASSAY CALIBRATION

1. Prepare standards using NormalCoagulation Reference Plasma. Asuggestedstandard curve is shown inthe following chart:

Dilution

Preparation

1:5 200 L plasma + 800 LIBS

1:10 100 L plasma + 900 LIBS

1:20 50 L plasma + 950 LIBS

1:35 100 L plasma + 3.4 mLIBS

2. Mix the standards and assay each inquadruplicate.

3. Enter the calibration data in the SetupTest submenu. For example: the

assigned fibrinogen value for the plasmaused to prepare the standard curve is250 mg/dL. The 1:10 dilutioncorresponds to 100% activity, thereforeit is equal to 250 mg/dL. The 1:5dilution is twice as concentrated, it isequal to 500 mg/dL. (The 1:20 dilution= 125 mg/dL and the 1:35 = 71.4mg/dL.)

4. Verify the calibration curve withdifferent Control Plasmas Level I,II,III.


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99..55.. Thrombin Time Assay

REAGENT PREPARATION

Reconstitute Thrombin Reagent10NIH/vial according to the packageinsert. (use europe procedure withconcentration of 5NIH/ml)

SYSTEM PREPARATION

1. Turn on instrument and wait forgreen LED light to come on.


system.

4. Check system setup if necessary5. Check test setup if necessary. Selectmethod clotting+fibrinogen, enter newcalibration curve data.

6. Return to main menu and enterAnalysis by pressing #1. Select PTwith the Up/Down arrow keys or enterthe numeric test code, #1. If anywarning or error message appears,refer to section 7.0.

TEST PROCEDURE

Clotting Method:

1. Pipette 50 L of undiluted plasmato cuvette.

2. Prewarm sample for 3 min, or thetime indicated in reagent packageinsert. Press the TIMER 1 key tostart stop-watch 1.

3. Transfer cuvette to measuringposition.

4. While incubating, press OPTIC 1. Ifselected, enter PAT-ID with numeric

keys or Up/Down keys. Confirm bypressing OPTIC 1 again. Themessage ACTIVE is displayed andchannel 1 is ready to start thereaction. Repeat for the remainingchannels.

5. Add 50 L Thrombin Time Reagentand simultaneously press the OPTIC1 key. The test will automaticallystart if using the Autopipette.(CAUTION: When the test procedure isrunning, pressing the OPTIC 1 andthe Enter keys will interrupt thetest).

6. The instrument will read for 300 secs.

If no clot is detected, the display willread +++ and No Clot Detectedwill print.

7. The result is displayed in seconds andis automatically printed.


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99..66.. APTT

REAGENT PREPARATION

Refer to package insert for APTT andCaCL2 reagents.

SYSTEM PREPARATION



system.4. Check system setup if necessary5. Check test setup if necessary. Select

method clotting+fibrinogen, enter newcalibration curve data.6. Return to main menu and enter

Analysis by pressing #1. Select PTwith the Up/Down arrow keys or enterthe numeric test code, #1. If anywarning or error message appears,refer to section 7.0.

TEST PROCEDURE

Clotting Method:

1. Pipette 25 L plasma to cuvette.2. Prewarm plasma for 2 min, or the time

indicated in reagent package insert.

Press the TIMER 1 key to start stop-watch 1.

3. Place CaCl2 in large central reagentposition.

4. Add 25 uLof the APTT reagent.Incubate for 3 or 5 minutes (refer topackage insert).


selected, enter PAT-ID with numerickeys or Up/Down keys. Confirm bypressing OPTIC 1 again. Themessage ACTIVE is displayed andchannel 1 is ready to start the reaction.

Repeat for the remaining channels.7. Add 25 L prewarmed CaCl2reagentand simultaneously press the

OPTIC 1 key. The test willautomatically start if using theAutopipette. (CAUTION: When the testprocedure is running, pressing the

OPTIC 1 and the Enter keys willinterrupt the test).

8. The instrument will read for 300 secs.If no clot is detected, the display willread ***.

9. The result is displayed in seconds. To

obtain results in R, press the Unit 1key.


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99..77.. PT-Based Factor Assays (II, V, VII & X)

REAGENT PREPARATION

Reconstitute Factor Deficient Plasma andThromboplastin reagent according to packageinsert.

SYSTEM PREPARATION

1. Turn on instrument and wait for green LEDlight to come on.

2. Turn on printer if connected.3. Connect optional Autopipette to system.4. Check system setup if necessary5. Check test setup if necessary. Select

method clotting+fibrinogen, enter newcalibration curve data.

6. Return to main menu and enter Analysisby pressing #1. Select PT with theUp/Down arrow keys or enter the numerictest code, #1. If any warning or errormessage appears, refer to section 7.0.

TEST PROCEDURE

All quality control and patient samples arediluted 1:10 in Imidazole Buffered Saline(IBS) for testing. If the clotting times falloutside of the linear curve, prepare andtest 1:5 or 1:20 dilutions as needed. It is

recommended to test 2 dilutions (1:10 &1:20) for each sample. Refer to thereagent package insert for moreinformation.

Clotting Method

1. Place Thromboplastin reagent with stir barin large central reagent position.

2. Pipette 25 L of diluted plasma and 25ul of deficient plasma to each cuvette.Refer to chart for sample preparation.

3. Incubate for 2 min, or the time indicated inreagent package insert. Press the TIMER

1 key to start stop-watch 1.4. Transfer cuvette to measuring position.5. While incubating, press OPTIC 1. If

selected, enter PAT-ID with numeric keys orUp/Down keys. Confirm by pressing OPTIC1 again. The message ACTIVE isdisplayed and channel 1 is ready to startthe reaction. Repeat for the remainingchannels.

6. Add 50 L prewarmed Thromboplastin

reagentand simultaneously press theOPTIC 1 key. The test will automaticallystart if using the Autopipette. (CAUTION:When the test procedure is running,pressing the OPTIC 1 and the Enter keyswill interrupt the test). Repeat forremaining channels.

7. The instrument will read for 300 secs. If noclot is detected, the display will read +++and No Clot Detected will print.

8. The result is displayed in seconds. Pressthe corresponding Unit key for conversionof results if a printer is not attached.

9. For patient and control samples diluted

1:10, this is the final result. If otherdilutions are tested, the calculated valueshould be multiplied by the appropriatedilution correction factor. (i.e., samplesdiluted 1:20, multiply result by 2; for 1:40dilutions, multiply by 4, etc.)

ASSAY CALIBRATIONFor calibration curves, a minimum of twovalues is required, with a maximum of 5. It ishighly recommended that more than twocalibration points be used.

1. Make dilutions of Normal CoagulationReference Plasma in Imidazole BufferedSaline (IBS). A suggestedstandard curve isshown below.

2. Assay standards in quadruplicate asdescribed.

3. Enter calibration data (% activity andseconds) in Setup Test. Check calibrationcurve with different controls.

Sample Dilution Preparation

100%Standard

1:10 100 uL referenceplasma + 900 uL IBS

50%Standard

1:20 50 uL of referenceplasma + 950 uL IBS

25%Standard


12.5%Standard

1:80 500 uL of 25%standard + 500 uL IBS

Patient orControl

1:10 100 uL sample + 900uL IBS


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99..88.. APTT-Based Factor Assays (VIII, IX, XI & XII)

REAGENT PREPARATION

Reconstitute Factor Deficient Plasma andAPTT reagents according to package insert.

SYSTEM PREPARATION


2. Turn on printer if connected.3. Connect optional Autopipette to system.4. Check system setup if necessary5. Check test setup if necessary. Select

method clotting+fibrinogen, enter newcalibration curve data.

6. Return to main menu and enter Analysis

by pressing #1. Select PT with theUp/Down arrow keys or enter the numerictest code, #1. If any warning or errormessage appears, refer to section 7.0..

TEST PROCEDURE

All quality control and patient samplesare diluted 1:10 in Imidazole BufferedSaline (IBS) for testing. If the clottingtimes fall outside of the linear curve,prepare and test 1:5 or 1:20 dilutions asneeded. It is recommended to test 2

dilutions (1:10 & 1:20) for each sample.Refer to the reagent package insert formore information.

Clotting Method

1. Place CaCl2 in large central reagentposition.

2. Pipette 25 L of diluted plasma and25 L of deficient plasma to eachcuvette. Refer to chart for samplepreparation.

3. Incubate for 2 min, or the time indicatedin reagent package insert.

4. Add 25 L of APTT reagent. Refer topackage insert for appropriate activationtimes. Press the TIMER 1 key to startstopwatch 1.


selected, enter PAT-ID with numeric keysor Up/Down keys. Confirm by pressingOPTIC 1 again. The message ACTIVE

is displayed and channel 1 is ready to startthe reaction. Repeat for the remaining

channels.7. Add 25 L prewarmed CaCl2 andsimultaneously press the OPTIC 1 key.The test will automatically start if usingthe Autopipette. (CAUTION: When the testprocedure is running, pressing the OPTIC1 and the Enter keys will interrupt thetest). Repeat for remaining channels.

8. The instrument will read for 300 secs. Ifno clot is detected, the display will read+++ and No Clot Detected will print.

9. The result is displayed in seconds. Pressthe corresponding Unit key forconversion of results if a printer is not

attached.10. For patient and control samples diluted

1:10, this is the final result. If otherdilutions are tested, the calculated valueshould be multiplied by the appropriatedilution correction factor. (i.e., samplesdiluted 1:20, multiply result by 2; for 1:40dilutions, multiply by 4, etc.)

ASSAY CALIBRATION

For calibration curves, a minimum of twovalues is required, with a maximum of 5. It

is highly recommended that more thantwo calibration points be used.1. Make dilutions of Normal Coagulation

Reference Plasma in Imidazole BufferedSaline (IBS). A suggestedstandard curveis shown below.

2. Assay standards in quadruplicate asdescribed.

3. Enter calibration data (% activity andseconds) in Setup Test. Checkcalibration curve with different controls.

Sample Dilution Preparation

100%Standard

1:10 100 uL referenceplasma + 900 uL IBS

50%Standard


25%Standard


12.5%Standard

1:80 500 uL of 25%standard + 500 uL IBS

Patient orControl

1:10 100 uL sample + 900uL IBS


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- MS DOS update ( for Windows 2000 / XP)

- open data explorer and extract all files maybe to drive C , folder HELENA- goto MS Windows START/RUN and enter cmd -> DOS command window

will open- change to directory with command cd c:\Helena- enter command dir -> all files including upgrade.bat should be listed- enter command upgrade.bat -> a dialog should open.- Follow dialog. Update will start and when finished the instrument will reboot.

1111..00 TECAM SMART the LIMS solution

1111..11.. General

TECAM SMART is user friendly software with LIMS functionality (Laboratory InformationManagement. It allows sampling all instrument results and managing it in a databaseapplication. The trial version allows only saving 5 results each start but has no other limits.With a purchased license it can be switch to a registered version.

Requirements: Pentium III , 128MB Ram Microsoft Windows 2000 or XP

DataBase: Microsoft Access Jet Engine 4.0 Max. 2GB ( 200.000 results )

Supported instruments: Helena Helena C-2 V1.13 or higher

Key features: Account Management: operator can loggin as Administrator or user in order to

control and manage the database with different access rights DataBase Management: operator can create, backup, import or export database Reaction Curve: can be displayed in fix or autoscale mode Patient DataBase: PID can be linked to patient names Filter functions: Every record field can be filtered (e.g. last 30 days all PT)

Report Generator: Day report , patient report , or last x days report can createdjust by filter the fields Statistical analysis: includes mean, SD,CV for filtered data Online Update: software be updated by internet


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1111..22.. Interface Protocol

Protocol: TECAM = HELENA Instrument MonitoringInstruments: Helena C-2 V1.13b or higher

Interface: 9600 Baud , no parity , 8 bit . 1 stop bitTransmission: result data = yes

Reaction curve data = yes

ASCII command characters:STX start of transmission asc(2)ETX end of transmission asc(3)TAB vertical tabulator asc(9)LF line feed asc(10)CR carriage return asc(13)DLE idle asc(16)

Overview of records and principle:

Figure13LIMScommuni

cation

The resultrecord isalwaystransmitted from theCoatron.

The curve record transmission must be activated from PC with a request record.

Coatron

Curve Start Record

Curve Request Record

Result Record

Curve Record

Curve Undo Record

PC

C-2


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The curve request record:

Function: enables curve transmission !

Definition:

The curve undo record:

Function: disables curve transmission !Definition:

The curve start record

Function: Indicates that a new measurement had been started.The transmission need to be enabled by the Curve Request Record.

Definition:

Fields: Delimiter: asc(9) = tabulator Record header ; STX=asc(2) optic cannel 1-4 (channel 1 = 0) Record end; LF=asc(10) , ETX=asc(3)

The curve record

Function: Send actual optical density every second

The transmission need to be enabled by the Curve Request Record.

Definition:

Fields: Delimiter: asc(9) = tabulator Record header ; STX=asc(2) optic cannel 1-4 (channel 1 = 0) milli optical density Record end; LF=asc(10) , ETX=asc(3)

Example: Signal = 0,999 E in channel 1-->


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The result record

Function: send after every result

Definition:

Fields: Delimiter: asc(9) = tabulator Record header ; STX=asc(2) optic cannel 1-4 (channel 1 = 0) system identifier ystem error , hexadecimal ddmmyy or 000000 if not used Result flags : + , - , * , > Result or patient ID number name of test (PT,APTT,)

12.5 000 100.0 1.00 1.00 300. mg/dL , ng/mL , Record end; LF=asc(10) , ETX=asc(3)

Examples:

Test PT with 12.5s 1.02INR 98.5% PID=1000 ERR=0 Kanal=1

Test FIB with 10.0s 200 mg/dL PID=1000 ERR=0 Kanal=1

Test AT3with 0.651E 78% PID=1000 ERR=0 Kanal=1 ( chromogen)


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1111..33.. Screenshots

Figure 14 Tecam Smart Results

Figure 15 Tecam Smart statistics


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Figure 16 Tecam Smart DataBase followed by a report


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1122..00PRODUCT CATALOGUE

Helena C-2 (with Standard Package)Cat. Number: 80 700 11

including:1 pc Power supply1 pc Power cord25 pcs Double cuvettes (2 wells/each)5 pcs Reagent container1 pc Stirring magnet1 pc Reagent adaptor (22.5mm)1 Pc Printer cable1 Pc Dust cover1 pc Operation manual1 Pc Warranty card

1 Pc Installation report1 Pc Service report

Consumables and Accessories

Cat.No. Description Content Qty

19 000 02 Double-cuvette (2 pos/ea) 250 1 Pac19 029 00 4-stage-Autopipette 25/50/100/200 l 1 1 Pc19 030 01 Reagent adaptor i=22,5mm 1 1 Pc19 030 02 Reagent adaptor i=22,8mm 1 1 Pc

19 030 03 Reagent adaptor i=24,2mm 1 1 Pc19 030 04 Reagent adaptor i=27,8mm 1 1 Pc19 030 05 Reagent adaptor i=25,2mm 1 1 Pc19 030 06 Reagent adaptor i=18,0mm 1 1 Pc19 070 00 CCD- Barcodescanner 1 1 Pc

20 038 00 Micropipette 15l 1 1 Pc20 038 01 Micropipette 25l 1 1 Pc20 038 02 Micropipette 50l 1 1 Pc20 038 03 Micropipette 150l 1 1 Pc

80 050 06 Stirring magnets 4 1 Pac80 050 09E Power cord Europe 1 1 Pc80 050 09U Power cord US 1 1 Pc80 525 00 Reagent container 22,5mm 100 1 Pac80 530 00 Reagent tubes 16mm 100 1 Pac80 535 00 Thermal printer (EU) 1 1 Pc80 920 07 Pipette tips 25/50/100/200 l 1.000 1 Pac80 920 12 Thermal paper for printer 5 1 Pac80 920 14 Printer cable for printer, long 1 1 Pc80 997 00 TECAM Smart Software 1 1 Set

Date post:	03-Apr-2018
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C-2 Operators Manual V11.15

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