CoagVET Prothrombin Time analytical system 1. Quick Guide 5. Overview PT measurement ranges The Coag VET Prothrombin Time analytical system consists of an instrument and reagents developed for the InHouse measurement of Prothrombin Time (PT) values from citrated whole blood samples. The Coag VET coagulometer works by direct optical measurement of Prothrombin Time. 2. System elements 3. Coag VET Coagulometer o Mains adaptor with plug set. Sampling pipette, 20 l (pink) Reagent dispensing pipette, 200 l (blue) Coag VET PT test kit o Measuring cuvette, 25 cuvettes containing reagent 1 (R1 reagent) and a mixing ball (required for dissolution) o Reagent 2 (R2 reagent) 30x200 l, united in one reagent vial Pipette tips 6. Animal Range Interpretation Dog 7 – 11 s Normal range Cat 8 – 12 s Normal range Horse 10 – 14 s Normal range Turning on the Coag VET Coagulometer In order to operate the device from mains electricity, a country-specific connector plug must be fitted to the mains adaptor. Connect the mains adaptor to input F of the device, then plug the adaptor into the mains socket. Once the device is connected to mains electricity, switch it on using the On/Off Button D. To use the device without mains electricity, apply six (6) 1.5 V AA batteries in the battery well, as shown on the right: turn over the device, pull back the closing tab to open the battery well, open the battery well and remove the cover. Insert six 1.5 V AA batteries into the battery well checking that the polarities are correctly matched!! After supplying the device with battery power, switch it on with the On/Off Button D. The battery mode of the Coag VET device enables 1 hour of continuous operation. The Coag VET Coagulometer The Coag VET Coagulometer measures optical turbidity. It has a single detection site and operatates at a controlled temperature. The device can be used either connected to 230 V 50 Hz electric mains, with a mains adaptor, or independently of the electric mains with six 1.5 V AA batteries. The user’s primary communication interface is the colour touch screen. The device can be connected to IT equipment and suitable clinical laboratory data networks with USB A and USB B interfaces. With a built-in RFID reader the device checks the reagents before use and ensures the precise and userindependent entry of the calibration data needed for PT calculation. B. Sliding lid (locked) C. Touchscreen F. Mains adaptor connection 7. Tasks after turning on the device for the first time Set the date and time by accessing the Date/Time menu point to enable the RFID identification of the test kit, registration of the kit components and reading of the calibration data essential for determining the exact PT value. A. Detection site and cuvette hidden under the sliding lid E. RFID reader position 4. 8. Menu system of the device The menu system of the device can be accessed via the Menu button. The menu system has the following elements: Settings Button for accessing the functions needed for device settings Control Access button to the automatic internal operation tests of the Coag VET Coagulometer Memory Button for accessing and handling measurement data Animal Access button for selecting the type of animal to be tested Reagent Access button for test kit data display D. On/off button Approved sample type Venous blood: whole blood sample with Sodium citrate anticoagulant, collected according to the appropriate laboratory protocol in a closed blood sampling system. Menu Settings Animal Control Reagent Memory X 1 08/10/2011 37.0 o 9:17 CoagVET Prothrombin Time analytical system Quick Guide 2. Under the Settings menu point the following functions can be accessed : Language Communication language of the device. On selecting it, country-specific formats are automatically set Date/Time For setting system date and time Sound Turning the sound signals of the device on/off 3. The Control menu point provides information about the self testing of the device. For instructions on handling the memory, accessible from the Memory menu point, see chapter 3.8! Under the Animal menu point the following options are 08/10/2011 available: 37.0 o Test 9:17 Choosing Cont. I or Cont. II a respective control plasma level could be measured according the normal measuring protocol Dog Cont. I given in Chapter 10. Calibration data and valid ranges referring to the control levels are stored and managed in the RFID card of Cont. II Cat the test kit containing control plasmas. Measuring control plasma levels provides information about the Horse reliability of both the device and reagent. The control ranges does not provide information about the animal sample ranges. Start enter ID! Dog, 4. 5. From the Reagent menu point, carry out the command shown, i.e. place the test kit box in the RFID reading area in order to access the data of the current test kit: Test kit type: Coag VET PT Reagent number: e.g. 87025 Lot number: e.g. 920622 Expiry date: e.g. yyyymmdd 6. The Coag VET data input system If required, a three-character per key virtual keyboard appears on the touchscreen of the Coag VET device. It can be used in a similar way to keypads, i.e. the desired character can be selected by pressing the appropriate button repeatedly. It is also possible to shift between keypads by pressing the selecting button in the top right corner. By touching the key containing the character you intend to enter, the desired character appears in the data input window at the top, in the position prompted with an underscore mark. Inputs step forward automatically. Entered character(s) may be deleted using the key in the middle of the command field of the touchscreen. After recording the desired data, the entire data input can be confirmed with the green button on the left of the command field. To exit the input window press the red x to the right of the command field. 10. 1. 7. Menu 8,00 – 11,00 Touch the .Start. button on the screen and, using the keyboard, enter the sample identifier (name, patient code, etc.) in the window! After entering the sample identifier, the name can be seen in 08/10/2011 the bottom orange field and a command is displayed. Below 37.0 o 9:17 the command the orange information text Read indicates the status of RFID reading. Put the reagent kit Place the box of the Test kit VI next to the device, close to next to the Coag Vet! the RFID icon on the side of the instrument at a distance no greater than 3 cm and keep it there for at least 15 seconds! Read… As soon as the device detects the presence of the test kit, it Dog, PT 8,00 – 11,00 reads its production data and calibration parameters. If the kit is within its shelf life, the device automatically advances to Stop the next measuring status. This is indicated by a short sound signal. The following message is displayed: 08/10/2011 37.0 o 9:17 Please enter a new cuvette! The Prothrombin Time measurement protocol Turn on the device by pressing the On/Off button! A message appears whilst the device reaches its operating temperature: PT Start X 9. Please wait until the device reaches the 37°C operating temperature! When this temperature is reached, the colour of the Block temperature indicator changes from red to green. Please check that the system date and time are both correct! If necessary, adjust the settings as described in chapter 8! From this point on the Coag VET device selects the settings, including “Dog” as the default animal. After turning on the device measurements will start in this status. For this reason, before starting a measurement please ensure that the animal displayed in the bottom orange field corresponds to the sample to be tested! Select the desired animal as described in chapter 8! 08/10/2011 The measuring process can be started once the command 37.0 o Menu 9:17 shown on the right is displayed, indicating that the system is ready to measure. Dog, 08/10/2011 25.0 o 9:17 Stop 8. PT 8,00 – 11,00 Fido 12/01 Pull the sliding lid towards the screen to make the detection site accessible! The circular orifice of the detection site can now be seen. 9. Remove a measuring cuvette from the test kit box. Check that the Lot number printed on the sealing aluminium foil of the cuvette is the same as the Lot number shown on the side of the box! If the Lot numbers are identical, press down the bulge on the sealing foil below the printed reagent data to release the mixing ball into the cuvette, 10. Next, remove the sealing aluminium foil from the cuvette! Warming up Please wait! Start 2 CoagVET Prothrombin Time analytical system Quick Guide 11. Please make sure that the mixing ball is at the bottom of the cuvette! If there is no ball in the cuvette*, the cuvette is defective and should not be used. Please use another cuvette as described in points 9 to 10 above! 12. Insert the measuring cuvette in the orifice of the detection site! Do not close the sliding lid! The device acknowledges insertion of the cuvette by emitting a short sound signal. 13. After the Coag VET device has detected insertion of the 08/10/2011 cuvette, the following message is displayed: 37.0 o 9:17 14. Place a new pipette tip on the teal blue Reagent dispenser pipette! 15. With the Reagent dispenser pipette measure 200 l from Please add the R2 reagent vial in the Test kit box as described below! Press the operation button of the teal blue Reagent reagent! dispenser pipette as far as possible! While pressing down the button insert the narrow Dog, PT 8,00 – 11,00 end of the pipette tip into the R2 reagent vial, Stop below the liquid surface! Be very careful and make Fido 12/01 sure that the reagent does not become contaminated! While keeping the end of the pipette tip below the liquid surface, slowly release the operation button completely! Make sure that there are no bubbles in the aspirated reagent! 16. Keep the pipette vertically above the cuvette and press the pipette operation button rapidly to empty the liquid into the cuvette, making sure that no reagent is spilled! The Coag VET device detects that the reagent has been added and emits a short sound signal. If the device does not detect that the reagent has been added, incubation may be started by pressing the 18. Place a new pipette tip on the pink Sampling pipette! 19. Aspirate a blood sample from the blood collecting tube as described below: before aspirating the blood sample make sure that the contents of the tube are homogenised by using a gentle end over end movement, remove the cap from the tube, press down the operating button of the pink Sampling II pipette as far as possible, while keeping the button pressed down place the narrow end of the pipette tip below the surface of the blood, slowly release the operation button completely! Make sure that there are no bubbles in the aspirated blood sample! 20. Move the pipette vertically above the cuvette, insert the tip at the bottom of the cuvette and press the operation button to empty the sample into the cuvette! Keeping the operation button in the pressed position, remove the tip from the cuvette. The Coag VET device detects that the sample has been added and emits a short sound signal. If the device does not detect that the reagent has been added, measurement may be started by pressing the button marked with the pipetting icon which appears in the top left corner of the screen. 21. In accordance with the displayed command, start the test by 08/10/2011 37.0 o sliding back the lid in the position furthest from the screen 9:17 within thirty seconds (4.1.3, figure 16)! The Coag VET device warns that this action is required, after ten seconds, by 30 s for closing the emitting accelerating sound signals. sliding lid ! The measuring process may be discontinued any time by pressing the STOP button. The data of the test halted in this way are not stored. button marked with the pipetting icon which appears in the top left corner of the screen. 17. The process of dissolving the R1 reagent and setting the 08/10/2011 cuvette temperature to operating level starts automatically, 37.0 o 9:17 when the following text is displayed. The status of dissolving-incubation process is shown as a time bar: If despite all care a cuvette without a mixing ball is inserted in the detection site, the Coag VET device will now detect this, discontinue the test and display a message on the screen: If there is no ball in the cuvette*, do not start measuring with the defective cuvette but use another cuvette as described above! When the cuvette reaches the temperature required for the test, the following message is displayed, followed by a short sound signal: Sampling may now begin in accordance with the established test routine at any time after starting incubation. Pipette the sample into the dissolved reagent, if at all possible within two minutes after the message requesting dispensing has been displayed! Activation of the cellular and enzymatic components of the drawn blood sample starts at the moment of sampling. In order to avoid measuring errors, transfer the sample from the pipette into the reaction mixture in the cuvette within 30 seconds. Information about normal progress of the test is displayed: 08/10/2011 37.0 o 9:17 Dog, Stop PT 08/10/2011 37.0 o 9:17 Stop 15 s mixing 8,00 – 11,00 Dog, Fido 12/01 Stop 08/10/2011 37.0 o 9:17 Stop PT 8,00 – 11,00 Measuring 89 8,00 – 11,00 Dog, Fido 12/01 After the test has finished, read the displayed PT value, expressed in seconds, and record it in the patient log! The device emits a sound signal to indicate that the test has finished. Please add sample! Dog, PT Stop PT: Dog, Stop Fido 12/01 3 8,00 – 11,00 Fido 12/01 1 minute incubation Dog, PT PT 8,00 – 11,00 Fido 12/01 08/10/2011 37.0 o 9:17 8.5 sec PT 8,00 – 11,00 Fido 12/01 CoagVET Prothrombin Time analytical system Quick Guide After selecting the desired datasheets and the actions to be performed, an instruction to perform the operation may be issued by pressing the green Accept command button. 22. Press the STOP button! 23. In accordance with the message Remove old cuvette! displayed on the screen, remove the cuvette from the device and dispose of it together with the pipette tips and the disposable tools used for drawing the blood sample, in accordance with the general and local rules of waste disposal! 24. Further tests may be carried out with the remaining content of the test kit. On checking the expiry date the device will warn if an out of date kit is offered. Please then follow the instructions in points 4-28! 25. If you do not intend to perform another test, close the sliding lid and turn off the device by pressing the On/Off button D! * Please notify the manufacturer immediately! 11. 12. Data storage and data management system The measurement data stored by the device may also be searched and sorted according to the date and time of the test. The memory functions can be accessed after pressing the Menu button then the Memory access button of the menu system. 08/10/2011 After pressing the Memory button the datasheet of the last test is 37.0 o Memory 9:17 displayed. 2/2 The datasheet contains the following information: Date of measurement: Serial number of the stored data 12/10/2011 08:03 Time of the test Lot code: 910622 Sample identifier NAME: FIDO 12/01 The result and the type of animal tested PT: Ordering and maintenance service information Order item Coag VET Coagulometer Coag VET PT 8.5 Dog X ◄ ► It is also possible to navigate between the datasheets without using the search functions using the step buttons ► instead. The Search function access button among the step buttons allows specific searches among the datasheets. From the Memory menu point, by pressing the Search function access button the following search functions can be reached: Date Search according to the date and time of the test. Filter Search according to the sample identifier. Action Instruction relating to handling the selected datasheet(s). Memory 08/10/2011 37.0 o 9:17 Date All Filter All Action X Cleaning and sterilising the Coag VET Coagulometer In order for the device to function reliably and provide accurate results it is essential to operate and clean it according to the manufacturer’s recommendations. Failure to do so may result in inaccurate test results, failure of the device and possible loss of guarantee. The following cleaning / disinfecting solutions are recommended for use: 10% Sodium hypochlorite (Hypo) solution (9 parts tap water + 1 part Sodium hypochlorite), or 70% ethanol or isopropyl-alcohol Turn off the device and unplug the mains cable before cleaning it! If there is any liquid or blood on the cover of the device, wipe it off first with a dry lint-free cloth or cellulose swabs (observing the rules of hygiene and waste disposal) and then perform the cleaning/sterilisation! To sterilise it, wipe all of the cover of the device using a lint-free cloth impregnated with a cleaning/sterilising agent. Wipe also the area around the detection site (below the sliding lid) and allow it to dry! Leave the lid open during this time! Make sure that the cloth is only slightly wet and that no cleaning liquid can leak into the device or the detection site through the joints! Any cleaning fluid entering the detection site may result in device failure! Show Catalogue number g-CoagVET 87025 Name Address Internet Manufacturer Diagon Ltd 1047 Budapest Baross u. 52. www.diagon.com Distributor: Diagon Ltd 1047 Budapest Baross u. 52. www.diagon.com Maintenance service Diagon Ltd 1047 Budapest Baross u. 52. www.diagon.com Telecommunication Telephone Fax e-mail Telephone Fax e-mail Telephone Fax e-mail (+36 1) 369 6500/144 (+36 1) 369 6301 diagon@diagon.com (+36 1) 369 6500/144 (+36 1) 369 6301 diagon@diagon.com (+36 1) 369 6500/122 (+36 1) 369 6301 service@diagon.com Guarantee The distributor provides a product guarantee which is in accordance with the applicable laws valid in the distributor’s country. From the Action menu point the following data processing instructions can be issued: Show The selected datasheets are displayed on the screen.It is then possible to navigate among the datasheets as described above. Send The selected datasheets may be copied onto a computer with the help of the Hyperterminal function of the Windows Operating via an USB cable connection established through the USB B port. The virtual communication connection should be selected on the receiving side. Save The selected datasheets may be saved to an external USB storage device via the USB A port. Delete The selected datasheets are deleted from the memory. 4