Thrombostat 1 User Manual V01 Aug 2015

Error Description... 16 Error Messages... 17 Cleaning...18 Maintenance...18 Specifications... 19 Dimensions... 19 Ambient Conditions... 19 Sample Volume... 19 Consumables... 19 Accessories... 19 Glossary...20

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General Safety Information All biological substances should be regarded as a potential source of infection! Wear gloves when handling blood, samples and objects contaminated by blood!

DANGER !

Strictly follow the existing regulations pertaining to the handling and manipulation of reagents for laboratory use and blood samples!

IMPORTANT!

This instrument may only be operated by trained specialists, who have been instructed and trained in procedures using In Vitro Diagnostics. They must be familiar with the operation manual, and able to work with the instructions, in order to use the whole effciency of the instrument.

IMPORTANT!

This product is an in vitro diagnostic medical device. It complies with the requirements of the in vitro diagnostic (IVD) Directive 98/79/CE and the requirements and limitations of the standards listed in the declaration of conformity supplied with it. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a residential, commercial or industrial environment. This equipment generates uses and can radiate radio frequency energy, and, if not installed in accordance with the instruction manual, may cause harmful interference to radio communications. We recommend that you observe the different warnings inscribed on the instrument itself and indicated in the documentation supplied.

CAUTION!

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

CAUTION!

Intervention in and modification of the product, not explicitly approved by the equipment manufacturer, may result in loss of functional capability. The costs for necessary repairs are to be borne by the user.

CAUTION!

If the equipment is used in a manor deviating from the specifications of the manufacturer, the protection can be impaired or be without function.

CAUTION!

The equipment manufacturer is not liable for any damage resulting from non-compliance of the specifications stated in these instructions, damage caused by handling of reagents and biological fluids, or other handling of the product which is not in line with these instructions.

CAUTION!

Data processing equipment connected to the instrument, such as personal computers or printers, must conform to the EN 60950 or UL 1950, respectively.

CAUTION!

This device has been designed and tested in accordance with CISPR 11 Class A. It may cause radio interference in a domestic environment. In this case, it may be necessary to take action to eliminate the interference.

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Warnings These instructions contain the information necessary for installation and operation of the Thrombostat. CAUTION!

It is recommended that the user conscientiously reads and understands these instructions to fully utilize the capabilities of the Thrombostat!

Meaning of the warnings used in these instructions: DANGER!

This information is for your own safety.

CAUTION!

Information for optimum Thrombostat use.

Read and follow this information before using the Thrombostat.

Graphic Symbols Explanation

Symbol

Direct current (DC)

Alternating current (AC) Direct or alternating current Ground terminal Protective isolation protection class II

ON (mains switch) OFF (mains switch)

CAUTION; observe documentation Warning of dangerously high voltage

Warning of a hot surface Warning of a biological hazard

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Graphic Symbols Symbol

Explanation Keep steel balls out of magnetic fields! (Speakers, CRT Monitors, etc.)

Please refer to the User Manual for additional information Returned goods and environmentally compliant disposal This instrument is classified as a Category 8 product according to ElektroG (medical products with the exception of implanted or infectious products). This instrument does not fall under the RoHS Directive. As required by WEEE 2002/96/EG and ElektroG, we mark our instruments according to the following symbol as designated by DIN EN 50419. This instrument is not allowed to be disposed in normal waste. Please pay attention to and follow your local provisions.

Unpacking the Thrombostat Check the packing for any signs of shipping damage. CAUTION! If packing or contents is damaged, put a claim in with the freight forwarder and notify the equipment manufacturer or your dealer. Open the packing and take out the accessories and the instrument. Check the contents for completeness. The following items are standard delivery for the Thrombostat: - 1 Mains Adapter - 1 Ball Dispenser - 500 Single Cuvettes - 500 Balls - 1 Dust Cover - 1 Instructions for Use Keep the original packing for possible later transport. CAUTION! Direct or indirect damage to the instrument, caused by shipping in an improper packing, is not covered by the equipment manufacturer's liability or warranty.

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Location Select a location where the instrument is not exposed to direct sunlight, excess heat, humidity, dust and 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 which allows unhindered access to the power outlet at any time. Do not use this device near sources of strong electromagnetic radiation, fields (e.g., unshielded, intentional powered RF sources), because these fields could interfere with proper operation. Evaluate the electromagnetic environment before you operate the system. CAUTION!

Do not install next to water fittings, baths, sinks, etc. Also do not place near centrifuges, washers, dishwashers, etc. Avoid close proximity to radiators or other sources of heat, etc.

Set-up Place the instrument on a sturdy, level surface and plug the AC adaptor into a power outlet. DANGER!

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. If in doubt about mains voltage or the circuit in general, contact a qualified electrician.

CAUTION!

Do not connect other electrical appliances which may cause interference to the circuit. Do not set up the instrument near electrical appliances causing electric interference. 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 other persons can not step on or trip over the power cord.

All connections to the instrument should be made with the instrument turned OFF.

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Use Thrombostat Coagulometers are up-to-date, processor controlled semiautomatic measuring instruments for in - vitro - diagnostic blood coagulation analyses. The patented measuring system determines the clotting time of whole blood, citrated capillary blood or blood plasma by using the effect of a change in viscosity when the clotting starts. The system monitors the reaction progress during the analysis and indicates critical results to the user. The automatic detection of the Thrombostat eliminates the need for servicing and setting. A minimum sample volume of only 150 µl allows to use the economical micro volume method. Its compact design and simple handling make the Thrombostat a powerful coagulometer. The following clotting analyses can be performed with the Thrombostat : - PT

Prothrombin time

- PTT / APTT

Activated partial thromboplastin time

- TT

Thrombin clotting time

- FIB

Fibrinogen according to Clauß

- FAC

Factor definitions

Functions of the Thrombostat - Automatic start when reagent is added with the start pipette. - “Count-Down” start with commercially available pipette. - Reaction process monitoring. - Notification of critical events. - Automatic checking. - Display of the measuring time in seconds. - Calculation of the measuring time in INR - Calculation of the measuring time in RATIO

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The Measuring System A motor-driven magnet (1) beneath a cuvette (5) lets the steel ball (2) rotate in a circular path along the edge of the cuvette's base (Fig. 1). A sensor (3) monitors the continuous rotation of the steel ball. The movement of the ball causes gentle and optimal homogenizing of the sample (4). The clotting reaction within the sample, therefore, takes places in an absolutely synchronous manner.

Fig. 1

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).

Fig. 2

Clotting in the abnormal range will deflect the ball towards the center of the cuvette's base (Fig. 3). In both cases, the sensor detects the changed course of the ball and stops the measuring time. Thus the starting of the clotting is positively detected, irrespective of the sample's cloudiness.

Fig. 3

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Starting

1. “POWER” switch 2. “AC / DC” socket 3. “PIPETTE” socket Fig. 4

1

2

3

- Set the “POWER” switch (1) at the rear of the Thrombostat to position “0”. - Plug the cord of the AC adaptor into the “AC/DC” socket (2). - Plug the cord of the start pipette into the socket marked “PIPETTE” (3). (only with optional start pipette). - The other end of the cord is connected to the start pipette (only with optional start pipette). - Check that all cords and cables are properly connected. - Plug the AC adaptor into the mains socket outlet. - Turn the Thrombostat on using the “POWER” switch (1).

Switch the Thrombostat Off - Use the <POWER> switch (1) to switch off the Thrombostat - Remove any remaining cuvettes, and cover the Thrombostat with the dust cover supplied.

Discontinuing Use of the Thrombostat - Follow the points under “Starting” - in reverse order. - Remove all existing cuvettes and clean the equipment as described in section “Cleaning”. - Cover the equipment with the dust cover. - Place the equipment in the original package and add the power pack, ball dispenser and the manual

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The Thrombostat 1 2

3

5

4

Fig. 5

1. Measuring channel 2. Incubation positions 3. Display 4. <START> button 5. <RESET / INCUBATION> button

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Description Measuring channel (1) The cuvette with the patient sample or control plasma to be analysed is placed here. Incubation positions (2) Five positions are available for incubating plasmas or reagents. Display (3) The large display shows the measuring result, the incubation time lapsed and possible error messages. <START> button (4) With the <START> button, the analysis can be started when no start pipette is used. When the <START> button is pressed, the seconds from 3 to 0 are counted down 3..2..1..0 in the display (3); when reaching “0” a beep is sounded and the measuring time is automatically started. At the same time, the reagent is added with a commercially available pipette. When entering INR–parameters, the <START> button is assigned the function UP. <RESET / INCUBATION> button (5) Pressing the <RESET / INCUBATION> button will stop a running analysis at any time; the measuring channel is reset to the Ready state and the display (3) resets to “0.0”. Pressing <RESET / INCUBATION> again will start the incubation timer (see section Incubation Timer). When entering INR–parameters, the <RESET / INCUBATION> button is assigned the function DOWN. After turning the instrument ON, the display shows the program version “3.xx” for 0.5 seconds. By doing this, the Thrombostat indicates it is in the operating mode. If the measuring block has not yet reached its working temperature, the message “cold” flashes in the display. Once the temperature is reached, a beep is sounded, the message “cold” disappears and “0.0” is displayed. The analysis is started by the start pipette or by pressing the <START> button. The display counts at a rate of 0.1 seconds. After each analysis start, multiple parameters are acquired, by which the correct progression of the analysis is checked. Acquisition and processing the required parameters takes some time. For this reason, the minimum measuring time is 3.0 seconds. When the maximum measuring time of 999.9 seconds is exceeded, the analysis is stopped, a beep is sounded and the error message “E0” flashes in the display. Measured is the time from adding the start reagent until the occurrence of clotting. A flashing measuring result indicates an uncertain analysis progression. In this case the analysis should be performed again.

The Incubation Timer The incubation timer can only be started if there is no analysis running and the measuring channel is in the Ready state. The incubation timer is started by pressing 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 flashes. Pressing the <RESET / INCUBATION> button again resets the Thrombostat into readiness for an analysis. An active incubation timer is stopped by pressing the <RESET / INCUBATION> button; the display returns to “0.0” and the measuring channel is ready for analyzing. If the display still shows a measuring time, press <RESET / INCUBATION> twice. CAUTION!

When an analysis is in progress the incubation timer cannot be started.

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Programming the INR Parameters The adjustment in INR (International Normalized Ratio) is especially used for PT analysis; it is calculated as described below. The normal time and the ISI value are stated in the reagent's enclosed instructions for use. Measuring time (s) = RATIO, RATIO ISI = INR Normal time (s) Example: Normal time = 30.0s ISI = 1.4 33.5s 30.0s

1,4

= 1.12

measuring time = 33.5s

=1.17

1. Press and hold the <RESET / INCUBATION> button and turn ON the Thrombostat with the “POWER” switch. Hold down the <RESET / INCUBATION> button, until “nt” (normal time) is shown, and then release the button, the normal time f. e. “10.0” will be present. 2. Use the <RESET / INCUBATION> button (to decrease the value ) or the <START> button (to increase the value) to set “nt” value. Once the “nt” value is set, it will be automatically saved after approximately 1 second. CAUTION! The normal time can be taken from the reagent*s instructions for use. 3. Turn OFF the Thrombostat with the “POWER” switch. 4. Press and hold the <RESET / INCUBATION> button and turn ON the Thrombostat with the “POWER” switch. Hold down the button, until “ISI” (International Sensitive Index) is shown, and then release the button, the ISI, f. e. “1.00” will be present. 5. Use the <RESET / INCUBATION> button (to decrease the value ) or the <START> button (to increase the value) to set ISI value. Once the ISI value is set, it will be automatically saved after approximately 1 second. CAUTION! The ISI value can be taken from the reagent's instructions for use. 6. Turn OFF the Thrombostat with the “POWER” switch. 7. Turn the Thrombostat ON again with the “POWER” switch. The Thrombostat is now ready for sample preparation.

Input ranges and calculation limits: Normal time ISI value

-

7.0 – 120.0s 0.50 – 4.00

If the result of the calculation is greater than “9999”, then “0L” is displayed.

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Setting of the beep 1. Press and hold the <START> button, and turn ON the Thrombostat with the “POWER” switch. Hold the button, until “BEEP” appears, then release the button, and the setting “ON” (default) is shown. With the keys <RESET / INCUBATION> or <START>, you can select the setting “ON” or “OFF”. The setting is stored automatically after approx. 1 second. A beep sounds and the displayed “SAVE” signal the storage of the setting. If the beep is set to “OFF”, this also is valid for the error messages. 2. Exit the setting; turn OFF the Thrombostat.

Setting the Count-Down-Start 1. Press and hold the <START> button, and turn ON the Thrombostat with the “POWER” switch. Hold the button, until “cd” (Count-Down) appears, then release the button, and the setting “ON” (default) is shown. With the keys <RESET / INCUBATION> or <START>, you can select the setting “ON” or “OFF”. The setting is stored, automatically after approx. 1 second. A beep sound and the displayed “SAVE”, signalised the storage of the setting. If CD is set to “OFF”, then the measurement starts immediately, by press the <START> button. 2. Exit the setting; turn OFF the Thrombostat.

Display of the Calculation Order After completing the measurement, you can query the different calculated values by pressing the <START> button. The default setting of the sequence, is “tI”. That means, that as first the time is automatically displayed, then, if you press the <START> button, the INR-Value is shown. Pressing the <START> - button again, the time value is shown, etc.

Change the Setting of the Calculation Order 1. Press and hold the <RESET / INCUBATION> button and turn ON the Thrombostat with the “POWER“ switch. Hold the button until “CO“ (Calculation Order) appears; then release the button, and the setting “tI“ (default) is shown. With the keys <RESET / INCUBATION> or <START>, you can select the setting. The setting is stored, automatically after approx. 1 second. A beep sound and the displayed “SAVE“, signalise the storage of the setting. You can choose from the following options

2. Exit the setting; turn OFF the Thrombostat.

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Preparation Loading the ball dispenser - Unscrew the ball dispenser's tip. - Fill balls from the magazine vessel into the ball dispenser. - Replace the ball dispenser's tip. Connect the start pipette (optional). Turn the Thrombostat ON with the <POWER> switch on the rear. - Program version “3.xx” is displayed for 0.5 seconds, then a beep is sounded and the message “cold” flashes in the display. This message is displayed until the working temperature of 37°C is reached. When the working temperature is reached, a beep is sounded and the display reads “0.0”. The Thrombostat is now ready for operation. Note: At a room temperature of approx. 23°C, the heating-up time is approx. 10 - 15 minutes. - Put cuvettes in the incubation positions and, with the ball dispenser, add one ball to each cuvette. Note: The ball dispenser should be placed on the cuvette so that no ball can jump back out of the cuvette. - Reconstitute reagent and control plasma as per manufacturer's instructions. CAUTION! Always follow the reagent manufacturer's instructions!

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Performing an Analysis (Example of a PT analysis)

1. Reconstitute the PT - reagent as per the reagent manufacturer's instructions. 2. Pipette the amount of reagent required for the analyses in a cuvette and heat up to 37°C in one of the incubation positions. Note: In order to reach the required temperature of 37°C the volume must not exceed 1.2 ml. The time required to come up to temperature depends on the reagent temperature and may take 5 - 8 minutes. 3. Set cuvettes into the remaining incubation positions. 4. Dispense one ball from the ball dispenser into each cuvette. 5. Fill patient plasma (100 µl) into a cuvette. 6. Start the incubation timer by pressing the <RESET / INCUBATION> button. 7. After 120s set the cuvette with plasma into the measuring channel. Note: A minimum incubation time of 120 seconds is recommended (see Reagent Use). 8. Take up PT reagent (200 µl) with a pipette or the start pipette. 9. Press <RESET / INCUBATION>, the incubation timer is stopped and the measuring channel automatically activated. The display reads “0.0”. 10. Start the analysis. -

using a start pipette: when adding the reagent the measuring time starts automatically.

-

using a commercially available pipette: The Count-Down-Start is ON: press the <START> button, the display changes to “3” and counts down the seconds “3..2..1..0”; on reaching “0” the analysis will start automatically. On “0” the reagent is pipetted into the cuvette. The Count-Down-Start is OFF: Push the <START> button at the same time reagent is added in the cuvette.

11. When clotting starts the measuring time is stopped and the time displayed in seconds in the display, e.g. “12.4”. Pressing the <START> button displays the INR value. Pressing the <START> button again displays the measuring time again. The result is then manually added to the relevant reference curve or evaluation. 12. Remove cuvette from the measuring channel and proceed with the next analysis, beginning with either item 7 or item 8. CAUTION! For information regarding measuring result evaluation or conversion refer to the instructions provided by the respective reagent manufacturer.

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Reagent Use The Thrombostat works with all commercially available reagents, control plasmas or calibration plasmas for In Vitro Diagnostica coagulation analysis. All information necessary for reagent preparation and use is provided by the reagent manufacturer in the instruction leaflet of the reagent used. The same applies to the respective control plasmas or calibration plasmas. Always follow this information, disregard may result in incorrect results. In case various ways of performing a test are described (e.g. for automated instruments), the instructions concerning manual performance of the test are decisive. An exception is the incubation time information. The information about the incubation time for manual performance refers to the use of a water bath. The efficiency of this incubation method is high and cannot be reached by an incubation block. A minimum incubation time of 120 seconds is therefore recommended.

Evaluation / Reference Curves In the display, the measuring result is displayed as a value in seconds, independent of the type of coagulation analysis (PT, APTT, FIB or others). Measured is the time from adding the start reagent until the occurrence of clotting. This time value is the basis for an evaluation. The processor processes every measuring result, independent of the type of analysis (e.g. PT) into a RATIOor INR-Value. If the RATIO- or INR-Value is not relevant for the analysis, simply ignore it. In the User Guides for the reagents, the manufacturer provides detailed information regarding evaluation, creation of reference curves, and handling of the measuring result.

Operational Check of the Thrombostat - Start an analysis without placing a cuvette in the measuring channel. After approximately 1 second “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 start an analysis. After a time longer than 3.0 seconds, pull the cuvette out of the measuring channel. The display stops and displays the corresponding “measuring result”, e.g. “10.6” seconds.

Quality Control Quality control is made by using special control plasmas or calibration plasmas. In their instructions of the respective reagent the reagent manufacturers name the control or calibration plasmas required for performing a quality control. All information for preparation and use of the control or calibration plasmas is given by the manufacturer in the instructions for the plasma used. Always follow this information, disregard may result in incorrect results.

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The Micro Method The term Micro Method stands for a reduction in sample volume. Here, two factors should be noticed: 1. The minimum measuring volume must not fall short of the Thrombostat minimum measuring volume of 150µl. 2. The volumes of plasma, reagent and, where appropriate, start reagent (calcium chloride) stated in the manufacturer's instructions for performing a test need to be reduced by the same percentage. Example: PT

Plasma Reagent Start reagent Sample Volume

Normal method

Micro method

100µl

50µl

APTT Normal method

Micro method

40µl

100µl

50µl

50µl

40µl

110µl 150µl

80µl 120µl

40µl 40µl 120µl

not allowed, sample volume too small

50µl 50µl 150µl allowed

70µl 60µl 180µl

allowed allowed not allowed, incorrect volume ratio

100µl 100µl 300µl allowed

not allowed, incorrect volume ratio

not allowed, sample volume too small

200µl 300µl

100µl 150µl

40µl

Note: To obtain the best possible accuracy the Fibrinogen determination should always be performed with the normal volume.

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Error Description Symptom

Likely Cause

Explanation / Remedy

Pipetting too vehement Sample preparation. Volume error.

This may cause bubbling, which disturbs the running of the ball and thus the measuring. In this case the sample preparation should be checked.

A ball may be present in the measuring channel.

If a ball was dispensed by mistake directly into the measuring channel and a cuvette is set into the measuring channel afterwards, the system is unable to work properly as the cuvette position is too high. Remove the ball from the measuring channel using pointed tweezers. Discard the ball removed from the measuring channel as it has become magnetized.

Measuring does not stop

Sample preparation.. Volume error.

The system does not detect any clotting. In this case the sample preparation should be checked. With Fibrinogen too much dilution of the plasma may also be the cause.

Display indicates “hot”

The temperature of the measuring block is too high.

One reason may be exposure to direct sunlight or installation close to a heater/radiator, which provides additional heating of the measuring block. In this case the location should be changed. Another reason may be too high a room temperature (> 30°C).

Display indicates “cold”

The temperature of the measuring block is too low.

The instrument is exposed to a cold draft or placed near an opened window. The instrument should be relocated.

Early stop or poor consistency

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Error Messages

Error Message

Likely Cause

Explanation

Measuring result flashes.

The automatic ball monitoring To be on the safe side, the analysis should be performed again. signals an extremely small blood clot or fault in the ball movement.

“cold”

Measuring block too hot.

“hot”

Measuring block too cold.

The warning limits are at ±1°C. The messages are cancelled again at ±0.6°C (hysteresis 0.4°C).

“OL”

RATION or INR value too high.

Check the measuring time, and ISI and nt parameters.

“E0”

Maximum measuring time exceeded

Press <RESET / INCUBATION>, prepare and repeat the analysis. In case of Fibrinogen, too high diluted plasma, may also be the reason.

“E3”

Ball failure during the calibration phase.

Ball problem, magnetic balls, cuvette not in position, sensor too weak.

"E4"

Voltage (sensor), unstable

Possibly a hardware problem, call the Service department

"E5"

Signal-amplitude not sufficient Ball problem, magnetic balls, cuvette not in position, sensor too weak.

"E6"

Offset too large

Possibly a hardware problem, call the Service department

"E7"

Pulse width too large

Ball problem, two balls inside, magnetic balls

"E8"

Pulse width too small

Ball problem, magnetic balls, cuvette not in position, sensor too weak.

“E10”

Memory error, User Parameter “nt” and “ISI”

A double memory error has occurred, check user data and correct it.

"E20"

Memory error, System, NTC, Turns, dc, etc

The system must be checked and adjusted.

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Cleaning To clean the Thrombostat, use an absorbent paper towel moistened with an alcoholic solution or wiping disinfectant of a pH-value between 7.4 and 9.0. Any other detergents having a higher pH-value may cause damage to the housing, measuring block or other components. CAUTION! Do not use cleaners containing salmiac or chlorine, as normally their pHvalue is higher than 9.0!

Maintenance The Thrombostat and its measuring system are maintenance-free. The system does not require calibration. Changes in the system (e.g. aging of the sensor) are automatically compensated.

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