Axis-Shield PoC

Thrombotrack Solo Instruction Manual Nov 2005

Instruction Manual

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File Name: Axis-Shield PoC - Thrombotrack Solo Instruction Manual Nov 2005 - 2005-11.pdf

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Thrombotrack™ Solo IVD

Instruction Manual

Manufacturer: Axis-Shield PoC AS Oslo, Norway 150905_Solo_Man_GB_Ed.2005-11

Thrombotrack™ Solo – Instruction Manual CONTENTS General information ...2 1 Intended use of Thrombotrack™ Solo...2 2 Installation and environmental conditions ...2 2.1 Package unit ...2 2.2 Unpacking of Thrombotrack™ Solo ...2 2.3 Placing of Thrombotrack™ Solo ...3 2.4 Turn on Thrombotrack™ Solo...3 2.5 Turn off Thrombotrack™ Solo ...4 3 Functional description of Thrombotrack™ Solo ...5 3.1 Symbols on Thrombotrack™ Solo ...5 3.2 Functional parts of Thrombotrack™ Solo ...5 3.3 Description of <START> and <RESET / INCUBATION> buttons ...6 3.3.1 In testing mode...6 3.3.2 Programming Normal Time and ISI ...7 3.3.3 Incubation timer ...8 3.4 The measuring system...9 3.5 Functionality of Thrombotrack™ Solo...10 4 Preparation prior to operation ...11 4.1 Connecting start pipette ...11 4.2 Loading the steel ball dispenser...11 5 Operating procedure...11 5.1 General...11 5.2 Starting up...11 5.3 General information during operation ...12 5.4 Operating procedure, Thrombotest™ ...13 5.4.1 Citrated whole blood method, 50 µL (“diluted method”)...13 5.4.2 Capillary blood method...13 5.4.3 Plasma method, 30 µL (“undiluted plasma”)...13 5.5 Operating procedure, Normotest™...14 5.5.1 Citrated whole blood method, 25 µL (“diluted method”)...14 5.5.2 Plasma method, 15 µL (“undiluted method”)...14 5.6 Operating procedure Nycotest® PT...15 5.7 Operating procedure Nycoplastin™ ...16 5.8 Operating procedure Cephotest™...17 6 User guidelines...17 6.1 Use of reagent ...17 6.2 Calibration and interpretation of results ...18 6.3 Quality Control ...18 6.4 Operational check of the Thrombotrack™ Solo ...18 7 Warnings and precautions...19 8 Trouble shooting ...20 8.1 Error description ...20 8.2 Error Messages...21 9 Cleaning ...22 10 Maintenance...22 11 Warranty declaration...22 12 Technical data ...23

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Thrombotrack™ Solo – Instruction Manual

General information This instruction manual contains information necessary for installation and operation of the Thrombotrack™ Solo. Chapter 7 specially covers warnings and precautions. In addition, and in connection with relevant chapters, important information with respect to security and optimum use of Thrombotrack™ Solo is described. The first indication of such information is: IMPORTANT!

The users must conscientiously read and understands these instructions to fully utilize the capabilities of the Thrombotrack™ Solo!

This instruction manual is valid for Thrombotrack™ Solo with software version later than V. 2.02.

1 Intended use of Thrombotrack™ Solo Thrombotrack™ Solo is a 1-channel, processor driven instrument for measurement of coagulation analysis. Coagulation is detected by the viscosity change, which occurs upon clot formation. This patented system enables analyses of all coagulation parameters using whole blood or plasma samples. For PT tests the instrument can calculate the INR value.

2 Installation and environmental conditions 2.1 Package unit The contents of the package unit for Thrombotrack™ Solo, material number 1114717 is: Thrombotrack™ Solo Cuvettes Steel balls Steel ball dispenser Mains adapter 230 V-12 V Dust cover Instrument Warranty Card

1 unit 1x500 units 1x500 units 1 unit 1 unit 1 unit 1 unit

2.2 Unpacking of Thrombotrack™ Solo Check the package for any signs of shipping damage. Open the package and take out the accessories and the instrument. Check the contents for completeness according to information in chapter 2.1 and sign the Instrument Warranty Card following package unit.

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Thrombotrack™ Solo – Instruction Manual IMPORTANT!

If package or contents is damaged, or anything is missing, contact your local distributor.

2.3 Placing of Thrombotrack™ Solo Select a location where the instrument is not exposed to direct sunlight, excess heat, humidity, dust or vibrations. To ensure that the measuring block's temperature control (37°C) can work properly, the room temperature should be between 17°C and 28°C. Place the instrument in a position that allows unhindered access to the power outlet at any time. IMPORTANT!

Do not install next to water fittings, baths, sinks, etc. Do not install near centrifuges, washers, dishwashers, etc. Do not install near to radiators or other sources of heat, etc

Place the instrument on a sturdy, level surface. 2.4 Turn on Thrombotrack™ Solo Place the instrument on a sturdy, level surface and follow the instruction below. 1. “POWER” switch 2. “AC/DC” socket 3. “PIPETTE” socket

Figure 1 1. Set the switch (1) at the rear of the Thrombotrack™ Solo to position “0”. 2. Plug the cord of the AC adaptor into the socket (2). 3. Plug the cord of the start pipette into the socket (3) (Start pipette is optional). 4. Check that all cords and cables are properly connected.

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Thrombotrack™ Solo – Instruction Manual 5. Plug the AC adaptor into the mains socket outlet. 6. Turn on the Thrombotrack™ Solo with switch (1). IMPORTANT! The mains voltage must coincide with the technical specifications of the instrument. The mains circuit must have adequate fuse protection. The instrument must be connected to a properly grounded outlet only. If in doubt about mains voltage or the circuit in general, contact a qualified electrician. Do not connect other electrical appliances that may cause interference to the circuit. Do not set up the instrument near electrical appliances causing electric interference (appliances bearing no CE-label). Avoid connection to circuits to which other appliances having a high current draw (e.g. centrifuges) or which turn on and off frequently (e.g. refrigerator, water bath, etc.) are connected. Ensure that the power cord cannot be stepped on. All connections to the instrument should be made with the instrument turned OFF. 2.5

Turn off Thrombotrack™ Solo

1. Turn the Thrombotrack™ Solo off using the “POWER” switch (1). 2. Remove all used cuvettes and cover the instrument with the dust cover supplied.

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Thrombotrack™ Solo – Instruction Manual

3 Functional description of Thrombotrack™ Solo 3.1 Symbols on Thrombotrack™ Solo Two buttons as showed in the table below operate Thrombotrack™ Solo. Buttons

Synonymous with Reset

Symbols

Incubation

<START>

Start

3.2

Functional parts of Thrombotrack™ Solo

2 3 5 4

Figure 2 1. 2. 3. 4. 5.

Measuring position Heating positions Display <START> button <RESET / INCUBATION> button

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Thrombotrack™ Solo – Instruction Manual 3.3

Description of <START> and <RESET / INCUBATION> buttons

3.3.1 In testing mode Buttons <START>

Function Manual start (with standard pipette) Display of INR

Reset <RESET/INCUBATION> Incubation

Description This button activates countdown. Display counts down from 3 seconds. At 0, the measuring time starts. The sample (or start reagent) is added simultaneously When timer stops, the value is displayed in seconds first. By pressing <START>, the INR-value appears. If <START> is pressed once again, the second value will return on the display. The <RESET/INCUBATION> key resets the timer after measurement and 0.0 is displayed When the timer is set to 0.0, the incubation time in second intervals is counted by pressing <RESET/INCUBATION>. To differentiate this time from coagulation time, the decimal point flashes. Press <RESET>. The instrument is now ready for the next test. The incubation timer can be started if there is no measuring being done at the same time

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Thrombotrack™ Solo – Instruction Manual 3.3.2 Programming Normal Time and ISI 1. Press and hold the <RESET/INCUBATION> button and turn the Thrombotrack™ Solo ON with the “POWER” switch. The display shows “nt” (normal time). When the button is released the normal time is displayed, e.g. “10.0”. 2. Use the <RESET/INCUBATION> and/or <START> buttons to set the desired normal time. Pressing <RESET/INCUBATION> lowers the normal time while <START> increases it. When the normal time is set, it is automatically saved after 2 seconds. A beep and the message “SAVE” in the display indicate that it has been stored. 3. Turn the Thrombotrack™ Solo OFF with the “POWER” switch. 4. Press and hold the <START> button and turn the Thrombotrack™ Solo ON with the “POWER” switch. The display shows “ISI” (International Sensitvity Index), when the button is released the ISI value is displayed, e.g. “1.00”. 5. Use the <RESET/INCUBATION> (DOWN) and/or <START> (UP) buttons to set the ISI value. Once the ISI value is set, it will be automatically saved after 2 seconds. A beep and the message “SAVE” in the display indicate that it has been stored. 6. Turn the Thrombotrack™ Solo OFF with the “POWER” switch. 7. Turn the Thrombotrack™ Solo ON again with the “POWER” switch. The Thrombotrack™ Solo is now ready for use. Input - limits:

Normal time: 7 to 120 seconds ISI 0.5 up to 4

Ranges: INR – calculation:

From blank time (3.9 seconds) up to 300 seconds. For measuring times ≥ 300.0s “E2” is displayed A measuring time ≤ 50% of the programmed normal time is not calculated in INR Example: Normal time = 20.0s, measuring time = 9.9s. A calculation of the INR value is not possible.

INR – resolution:

2 decimals, max possible error 0.02 at INR > 0.5 < 10

Max measurement time for other tests:

From blank time (3.9 seconds) up to 999 seconds

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Thrombotrack™ Solo – Instruction Manual 3.3.3 Incubation timer The incubation timer can only be started when no analysis is running. Procedure for activating/deactivating incubation timer: 1. Press the <RESET/INCUBATION> button. The display changes from “0.0” to “0” and displays the elapsed time in seconds. To distinguish the incubation timer display from the coagulation time display the decimal point is flashes. 2. Press the <RESET/INCUBATION> button again and Thrombotrack™ Solo is ready for the next test.

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Thrombotrack™ Solo – Instruction Manual 3.4

The measuring system A magnet (1) is located beneath the cuvette (5), which causes the steel ball (2) to rotate. This enables the sample to be optimally and gently homogenised (4). A sensor (3) is used to monitor the rotation of the steel ball. As a result of clot formation, the viscosity changes and causes the ball either to stop or divert towards the middle of the cuvette. In both cases, the sensor signals the change and stops the measurement. The clot formation is reliably detected and without interference from turbid plasma.

Figure 3 When coagulation starts, the viscosity of the sample changes and affects the continuous motion of the ball. When a strong clot is formed, the steel ball will stop as shown in figure 4. When the clotting starts the viscosity of the sample changes, affecting the continuous motion of the ball. Clotting in the normal range will stop the ball (Fig. 2).

Figure 4 A weak clot will deflect the ball towards the center of the cuvette's base (figure 5). The sensor detects the changed course of the ball and stops the measurement.

Figure 5 In both cases the start of the clotting process is positively detected, irrespective of the sample's cloudiness.

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Thrombotrack™ Solo – Instruction Manual 3.5

Functionality of Thrombotrack™ Solo

Thrombotrack™ Solo determines the clotting time of citrated whole blood, citrated capillary blood, capillary blood and plasma, by using the measuring principle as described in chapter 3.4. The following tests can be performed with the Thrombotrack™ Solo: -

Prothrombin time

PTT / APTT

Activated partial thromboplastin time

Thrombin clotting time

FIB

Fibrinogen (Clauss method)

FAC

Coagulation factor activity

Thrombotrack™ Solo has the following functions: -

Automatic start when reagent is added with the start pipette

“Count-Down” start with standard pipette

Reaction process monitoring

Notification of critical events

Automatic checking

Display of the measuring time in seconds

Display of coagulation activity as INR

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Thrombotrack™ Solo – Instruction Manual

4 Preparation prior to operation The operating conditions and how to turn Thrombotrack™ Solo on are described in chapter 2.3 and 2.4. 4.1

Connecting start pipette

A start pipette for automatic start of measurement can be connected to the back of the instrument. 4.2

Loading the steel ball dispenser

Unscrew the steel ball dispenser tip.

Fill steel balls from the steel ball tube into the ball dispenser.

Screw the steel ball dispenser tip on again.

5 Operating procedure 5.1 General The operating procedures described in this chapter include the specific procedures for Thrombotest™, Normotest™, Nycotest® PT, Nycoplastin™ and Cephotest™. It is presupposed that reagent preparation is completed and correct. For PT tests the normal time and ISI are programmed as described in chapter 3.3.2. When working with the Thrombotrack™ Solo, always pay attention to methods and reagents described in the package inserts. Discrepancies can cause errors in measurements. Chapter 6, “User guidelines”, gives information related to the use of reagents, calibrators and controls. 5.2 Starting up Turn the instrument on by using the switch on the back of the instrument. Message “cold” appears. The “cold” message remains until the Thrombotrack™ Solo has reached the correct operating temperature. When working temperature is reached “0.0” appears. Instrument is now ready for use. Note: At a room temperature of approx. 23°C the heating-up time is approx. 10 - 15 minutes.

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Thrombotrack™ Solo – Instruction Manual 5.3 General information during operation Before starting the specific operating procedure, the following information should be considered: Cuvettes:

Single cuvettes are used

Dispensing steel balls:

When dispensing steel balls, by means of the steel ball dispenser, into each cuvette, the dispenser should be placed on the cuvette in such a manner that the steel ball is kept from ricocheting.

Pre-heating

In the operating procedures for Thrombotest™, Normotest™ and Nycotest® PT it is expected that the method specific reagent volume is heated up 37°C. For Nycoplastin™ and Cephotest™, a sufficient volume for running the required number of tests must be pre-heated. In order to reach the temperature of 37°C in the heating position, the volume of the reagent must not exceed 1.2 mL. The time required depends on the reagent temperature and may take 5 - 8 minutes.

Incubation timer

For activation of incubation timer, see chapter 3.3.3

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Thrombotrack™ Solo – Instruction Manual 5.4

Operating procedure, Thrombotest™

5.4.1 Citrated whole blood method, 50 µL (“diluted method”) Volumes: Sample volume: Reagent volume:

50 µL citrated whole blood 250 µL

Main steps A Pre- measurement

Procedure details I Place cuvettes in the pre-heating positions and add one ball to each with the ball dispenser II Pipette 250 µL of reagent into the cuvette and pre-heat for 5 min. III I

B Auto start

Manual start W/count down C Coagulation end point

D Reading INR

Frozen reagent must be preheated for 15 minutes Place cuvette for measurement in the measuring position Pipette 50 µL of sample into the cuvette with the start pipette Press <START>. The display counts down from 3 seconds. At 0, and signal tone, pipette 50 µL of sample into the cuvette with a standard pipette Upon clotting, the timer stops and the value in seconds is displayed Press <START>. INR-value is displayed Press <START> once again. The value in seconds is displayed

When <RESET/INCUBATION> is pressed, the instrument is ready for the next test. 5.4.2 Capillary blood method Volumes: Sample volume: 50 µL capillary blood Reagent volume: 250 µL The operating procedure is the same as for 5.4.1. 5.4.3 Plasma method, 30 µL (“undiluted plasma”) Volumes: Sample volume: Reagent volume:

30 µL undiluted plasma 250 µL

The operating procedure is the same as for 5.4.1with the exception of the sample volume (5.4.1, step B I or B II).

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Thrombotrack™ Solo – Instruction Manual 5.5

Operating procedure, Normotest™

5.5.1 Citrated whole blood method, 25 µL (“diluted method”) Volumes: Sample volume: 25 µL citrated whole blood Reagent volume: 250 µL Main steps A Pre- measurement

B Auto start Manual start W/count down C Coagulation end point D Reading INR

Procedure details I Place cuvettes in the pre-heating positions and add one ball to each with the ball dispenser II Pipette 250 µL of reagent into the cuvette and pre-heat for 5 min. III Place cuvette for measurement in the measuring position I Pipette 25 µL of sample into the cuvette with the start pipette II Press <START>. The display counts down from 3 seconds. At 0, and signal tone, pipette 25 µL of sample into the cuvette with a standard pipette I Upon clotting, the timer stops and the value in seconds is displayed I Press <START>. INR-value is displayed Press <START> once again. The value in seconds is displayed

When <RESET/INCUBATION> is pressed, the instrument is ready for the next test. 5.5.2 Plasma method, 15 µL (“undiluted method”) Volumes: Sample volume: 30 µL undiluted plasma Reagent volume 250 µL The procedure is the same as in 5.5.1, except for the sample volume (5.5.1, step B I or B II).

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Thrombotrack™ Solo – Instruction Manual 5.6 Operating procedure Nycotest® PT Volumes: Sample volume: 100 µL diluted plasma * Reagent volume: 200 µL * Plasma must be diluted 1+6 with Nycotest® PT Dilution Liquid Main steps A Pre- measurement

B Auto start Manual start W/count down C Coagulation end point D Reading INR

Procedure details I Place cuvettes in the pre-heating positions and add one ball to each with the ball dispenser II Pipette 200 µl reagent into the cuvette and pre-heat for 5 min. III Place cuvette for measurement in the measuring position I Pipette 100 µL of sample into the cuvette with the start pipette II Press <START>. The display counts down from 3 seconds. At 0, and signal tone, pipette 100 µL of sample into the cuvette with a standard pipette I Upon clotting, the timer stops and the value in seconds is displayed I Press <START>. INR-value is displayed Press <START> once again. The value in seconds is displayed

When <RESET/INCUBATION> is pressed, the instrument is ready for the next test.

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Thrombotrack™ Solo – Instruction Manual 5.7

Operating procedure Nycoplastin™

Volumes: Sample volume: Reagent volume:

100 µL undiluted plasma 200 µL

Main steps A Pre- measurement

B Auto start Manual start W/count down C Coagulation end point D Reading INR

Procedure details I Place a cuvette in one of the pre-heating positions and heat up sufficient amount of reagent up to 37°C II Place cuvettes in the other pre-heating positions and add one ball to each by the steel ball dispenser III Pipette 100 µl of plasma into the cuvette and incubate for 60 sec. III When incubation of plasma is completed, move the cuvette to the measuring position I Pipette 200 µL of pre-heated reagent into the cuvette with the start pipette II Press <START>. The display counts down from 3 seconds. At 0, and signal tone, pipette 200 µL of preheated reagent into the cuvette with a standard pipette I Upon clotting, the timer stops and the second value is displayed I Press <START>. INR-value is displayed Press <START> once again. The value in seconds is displayed

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Thrombotrack™ Solo – Instruction Manual 5.8

Operating procedure Cephotest™

Volumes: Sample volume: Cephotest reagent: CaCl2, 20 mM:

100 µL undiluted plasma 100 µL 100 µL

Main steps A Pre-measurement

B Auto start Manual start W/count down C Coagulation end point

Procedure details I Place a cuvette in one of the pre-heating positions and heat up sufficient amount of CaCl2 to 37°C II Place cuvettes in the pre-heating positions and add one ball to each with the ball dispenser III Pipette 100 µL of plasma into a cuvette in the preheating position IV Pipette 100 µL of Cephotest™ reagent into the cuvette with 100 µL plasma and incubate for 6 min. V When incubation of plasma and reagent is completed, move the cuvette to the measuring position I Pipette 100 µl CaCl2 into the cuvette with the start pipette I Press <START>. The display counts down from 3 seconds. At 0, and signal tone, pipette 100 µL of preheated CaCl2 into the cuvette with a standard pipette I Upon clotting, the timer stops and the value in seconds is displayed

6 User guidelines 6.1

Use of reagent

The package inserts for reagents from Axis-Shield PoC provide all information necessary for reagent preparation and use. The same applies to the respective controls and calibrators. Always follow this information; improper use may result in incorrect results. Where several options of performance are described (e.g. for automated instruments), the instructions concerning manual performance of the test prevail. When using smaller volumes than those stated in the package inserts, it is important to reduce all pipetting volumes by same percentage. Make sure that the total sample volume is not less than 150 µl.

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Thrombotrack™ Solo – Instruction Manual 6.2 Calibration and interpretation of results The measured time is the time from adding the sample (or start reagent) until the occurrence of coagulation. This time value is the basis for an evaluation. PT kits from Axis-Shield PoC contain inserts with reagent and batch specific calibration data (Correlation tables). If there is any uncertainty regarding use of calibration data on the Thrombotrack™ Solo, contact your local distributor. The package insert from Axis-Shield PoC provides information on how to interpret results obtained. The description of how to enter normal time and ISI on the Thrombotrack™ Solo is given in chapter 3.3.2. 6.3 Quality Control To control the instrument, reagent and test method, special control plasmas are used. In the package inserts from Axis-Shield PoC, the recommended controls are listed. The package inserts for the controls give all information for preparation and use of the control plasmas. Always follow this information; improper use may result in incorrect results. The control kits also included data-key with recommended values. Control plasmas available from Axis-Shield PoC are: Control plasmas Control Plasma Normal Control Plasma AK Control Plasma Abnormal Control Plasma Heparin

Thrombotest Normotest

Nycotest PT

Nycoplastin

Cephotest

R R

R means recommended values stated in the data-keys. 6.4

Operational check of the Thrombotrack™ Solo

Start an analysis without placing a cuvette in the measuring channel. After 3.8 seconds “E5” will appear in the display, meaning the instrument has not detected a cuvette in the measuring channel.

Dispense a ball into a cuvette and fill it with at least 150µL distilled water or buffer. Place a cuvette in the measuring channel and press <START>. After a time longer than 3.8

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Thrombotrack™ Solo – Instruction Manual seconds, pull the cuvette out of the measuring channel. The counting stops and displays the corresponding “measuring result”, e.g. “10.6” seconds.

7 Warnings and precautions •

All biological substances should be regarded as a potential source of infection

•

Wear gloves when handling blood, blood samples and objects contaminated by blood

•

Follow the existing regulations pertaining to the handling and manipulation of reagents for laboratory use and blood samples

•

Only Trained laboratory personnel shall operate this instrument.

•

Thrombotrack™ Solo generates and uses high-frequency energy and may radiate such energy if the product is not installed and operated as detailed in these instructions.

•

Follow all warnings and notes affixed to the instrument or mentioned in the instructions.

•

Intervention in and modification of the product, not explicitly approved by the equipment manufacturer, may render it inoperative.

•

The equipment manufacturer is not liable for any damage resulting from disregard of the specifications stated in these instructions, damage caused by handling of reagents and biological fluids or other action with the product not in conformity with these instructions.

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