ProTime - Accriva Diagnostics
Contents
1. Use the Q and U buttons to move the cursor and to enter the numeric ID The CONFIRM OID confirmation screen will follow the ENTER OID screen If YJ button is pressed the user will return to the previous screen otherwise if the Q button is pressed and PID is set to the ON position the program will proceed to the following ENTER PID screen Use the Q and O buttons to move the cursor and to enter the numeric ID 28 The CONFIRM PID confirmation screen will follow the ENTER PID screen After setting of both requested PID and or OID the WARMING screen will appear in the center of the display The test sequence continues as described previously in the Test Procedure section At the end of the test and in the database patient records will appear as one of the following If PID is ON and OID is OFF If PID is OFF and OID is OFF wl EE UE ee a I I I I I D I I DELELE LL A 0 LA ee sa aa o a aa o a aa o a oMa oM oaa e M E EE EE EE EE EE EE EE EE EE DE EE G hy HG i O00 OO Oe 0 0 0 ETET EETL sa aa s u aa o a aa o a aa Mo oa e M Ean EE EE EE EE EE EE EE EE EE EE EF pE Ped Fed AF act i bes Ti pea fk ag fe TE pea fF j r od od 29 Password The password option permits the professional to access portions of the ProTime program that are not accessible to patient self testers 30 SAFETY STANDARDS The ProTime instrument complies with the following safety standa2. DC Power Cord from AC DC Power Module Polarity VDC 15 0V 2 0A and A Input E Output Port for Data Transfer DATA paal Name and Address of Manufacturer PRINCIPLES OF OPERATION The ProTime Microcoagulation System measures the PT using fibrin clot formation and detection The ProTime cuvette is a self contained micro volume reaction cell constructed of precision molded plastic There are two user options within the ProTime Microcoagulation System the standard ProTime cuvette and the ProTime3 cuvette These cuvettes differ from each other in the amount of blood that needs to be collected and tested The standard ProTime cuvette has five micro channels which contain the dried reagents required to perform triplicate testing of the PT assay and two levels of controls The ProTime3 cuvette has three functional micro channels Two micro channels perform the controls and one micro channel performs the PT test The standard ProTime uses the Tenderlett Plus device for performing the fingerstick and it is designed to hold 65 uL of blood approximately 3 drops needed to fill all five micro channels The ProTime3 uses the Tenderlett Plus LV low volume device for performing the fingerstick and it collects 27 uL of blood approximately 1 large drop needed to fill the three micro channels of the ProTime3 cuvette The instrument draws the precise volume of blood into the micro channels of each cuvette which contain thromboplastin and other reagents A
3. file at ITC E233358 lie C US MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH STANDARD NO UL60601 1 CAN CSA C22 2 NO 601 1 58YB 31 Guidance and Manufacturer s Declaration Electromagnetic Emissions The ProTime Microcoagulation System is intended for use in the electromagnetic environment specified below The customer or the user of the ProTime Microcoagulation System should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions The ProTime Microcoagulation System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment CISPR 11 RF Emissions Class B The ProTime Microcoagulation System is suitable for use in all establishments including domestic establishments and those CISPR 11 directly connected to the public low voltage power supply Harmonic Emissions Class A network that supplies buildings used for domestic purposes IEC 61000 3 2 Voltage Fluctuations Complies Flicker Emissions IEC 61000 3 3 32 Guidance and Manufacturer s Declaration Electromagnetic Immunity The ProTime Microcoagulation System is intended for use in the electromagnetic environment specified below The customer or the user of the ProTime Microcoagulation Syste
4. is designed to run either on AC power supplied by the AC DC power module or on the rechargeable battery supplied within the unit Rechargeable Battery Facts e Batteries discharge naturally over time approximately 5 per month e Battery capacity the amount of charge the battery will hold is lower at low temperatures e Batteries charged to maximum capacity will generate heat if they continue to be charged e The ProTime instrument uses a rechargeable NiMH Nickel Metal Hydride type battery The maximum capacity of any rechargeable battery will gradually decrease over time To ensure maximum life of the rechargeable battery read and follow the information in the Care of the ProTime Battery for Maximum Life section Care of the ProTime Battery for Maximum Life A new instrument an instrument that is used infrequently or an instrument with a new replacement battery should be plugged in for at least 8 hours before use to ensure that the battery is completely charged The instrument screen will show CHARGING BATTERY when the AC DC power module is connected to the AC power cord and the ProTime instrument The screen will show CHARGE COMPLETE when the battery is fully charged The AC DC power module should be disconnected after the CHARGE COMPLETE message is seen The AC DC power module that has been supplied by ITC has been selected specifically for use with your ProTime Microcoagulation System Do not use any other AC DC power module When th
5. j Will Pee Nn Fee ppg Piel Pp pm g Fi bo m ees EE n Ee bhe ses hess f ses a ee Pir pu j tor wer he aes I i mk I oe el a obo IPP bat Pore pe ed ie ae i ton Ae fl oe Lor Each of these options will lead to sub menus within the selection The following buttons are used to navigate the menu e The button is used to move the highlight bar to select the option e The Q button is used to select the option that is highlighted Note The option to run external QC samples and store the results tagged as QC is accessed through RUN LQC selection This is not required to use the ProTime system For more information on this option refer to Appendix I Run Test To run the test select RUN TEST menu item The instrument does a SELF CHECK procedure which may take up to 60 seconds The following screen is displayed for this period of time The test sequence continues as described previously in the Test Procedure section When the test completes the result will appear as below Note X is used for illustrative purposes only in the following examples RUN LQC The need to run Liquid Quality Control LQC is a feature designed for use by professionals Instructions for use of the feature appear in Appendix I 16 SHOW RESULTS Press the Y button to move the highlight bar to the SHOW RESULTS line in the MAIN MENU Press the O button to view the SHOW RESULTS menu and observe the following scre
6. on the screens 19 Changing the Hour The time is pre set to Eastern Standard Time EST For example the time is 1 25 PM Change the hour by pressing the Y button until the correct hour appears in the highlight bar In this example the correct hour is 10 AM To change the hour press the Y button until 10 AM appears in the highlight bar The PM changes to AM at midnight Once the correct hour appears press the button to set the hour The procedure will then advance to the MINUTES screen tou Ee mihl leat bd she IE siess ses I tt Changing the Minutes The hour on the top line has changed to the time just set and PM has changed to AM Change the minute by pressing the Y button until the correct minute appears Once the correct minute appears press the O button to set the minutes The procedure will then automatically advance to the DAY screen Changing the Day Only the day can be changed The month and year can be changed only in PROGRAM MODE Change the day by pressing the Y button until the correct day appears Once the correct day appears press the O button to set the day SETTING AND CHANGING NUMERICAL INFORMATION PID OID PASSWORD The use of patient and operator identification numbers is a feature designed for use by professionals Instructions for use of these features appear in Appendix II 20 SET BEEP If SET BEEP is selected the following screen appears Then press button to turn
7. that of a typical domestic commercial or hospital environment If the user of the ProTime Microcoagulation System requires continued operations during power mains interruptions it is recommended that the ProTime Microcoagulation System be powered from an uninterruptible power supply or battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical domestic commercial or hospital environment NOTE Ur is the AC mains voltage prior to application of the test level 33 This page intentionally left blank 34 INDEX attention label c 4112046c ex teasoasaneagcarasoageachecnneasnaates 4 Daie CATO oia wean oss 7 battery information 7 CMAN SUNG on AAN 7 blood coagulation systems s s s 2 blood collection 10 finger incision preparation 10 insert A cuvette occ ieecccccccccecessssecsseessteeeeseseeens 9 AULES SEAU A occcsaecccctencecusccenccscceanveucnescensasts 2 LVEF OU COM A oencassnasscsanssnnsenssnnsat SiR ies 2 TOG PE CORDS 55223 sso cacs 2532325222232522225252280 07 a 26 PAI MEN 43issse sae 16 OID entering and changing ceee 27 password entering and changing eee 30 performance characteristics ACCUTANE RANEA 22 COMPALISONS voice ire EEEE 23 patient self testing 23 PLCCSION siemens 22 Quality control 23 SEMIS IIVIVY a aai 23 PID entering and changing eee 27 preparation 35 CONICS RRE AAEE 8 KON LOG eer EEEE crer 25 safety feature
8. with OID off For LQC Normal with OID on For LQC Abnormal with OID off For LQC Abnormal with OID on 1 pa rt abe hm 26 APPENDIX Il USE OF PID AND OID NUMBERS The PID OID selection is indicated only by the location of the highlight text on the screen is unchanged e Use the U button to select PID OID options mn a a ERA rr E m eE Po Ped bed bes tect E e Selecting PID OID ON enables both a patient ID and operator ID to be entered e Selecting PID ON enables only a patient ID to be entered e Selecting OID ON enables only an operator ID to be entered e Selecting OFF disables both a patient ID and operator ID Note The selection is highlighted and remains the default until changed again by the user Entering and Changing Numerical Information PID OID Password By using a combination of the J and Q buttons and the triangular cursor on the display screen numeric information can be entered into the instrument for operator identification number OID patient identification number PID and PASSWORD fields When entering numeric information into a field pressing a button has the following actions e U CHANGE Pressing the Q button once will increment the digit in the current cursor position by one starting at 0 and going through 9 and back to 0 again e O OK Pressing the Q button briefly enters the digit displayed in the current cursor position and then moves the curso
9. ATA line e Press the O button to access the PRINT DATA or SEND DATA option and select THIS RESULT or ALL RESULTS option in the PRINT DATA or SEND DATA screen PRINT DATA SEND DATA THIS RESULT THIS RESULT ALL RESULTS ALL RESULTS AUTO SEND ON OFF AUTO SEHD GH OFF MAIN MENU MAIN MENU T MOLE J MOLE 0 0 ok Upon selecting THIS RESULT the last recorded test is sent from the instrument memory to a printer or to a computer If ALL RESULTS is selected all results up to 50 are printed sent from the instrument memory to a printer or to a computer If MAIN MENU selection is made the user is returned to the main menu Note Ifthe AUTO SEND feature is on results will be automatically sent if the PROCABLE is connected prior to the start of a test To use a laser printer the data must be first transferred to an IBM compatible personal computer and the results can be printed from that computer The following screen displays until the PRINT DATA or SEND DATA process is complete 18 SET UP GO to the MAIN MENU screen and choose the SET UP option by using the Y button to scroll and the O button to select SET UP The following screen appears i a L eh eg peee e p j EO Pepina PP o ka i Bassi BE ee aea E Esel horas e a T F Fera prore i s pu j E i iP E E y ses has F E oh E h ro I ie m Perr era T pm f i O O O O O O E ene bese E I she Bee ewe olla Bem pm pm pmp pp am pe j peme poss peos gomo om hemn
10. Bess Benon Bosna pm prr t pke bee p pp i PERPE PREE EEE BE Pe I f e m so FE oh BE A EOE ene ha hon rar T Lt ey E ee De ee ear bai F EGE Bale FOE EB bsee EB sna SET LANGUAGE Press the O button to select SET LANGUAGE The following options are displayed when SET LANGUAGE is selected Li i ol a ea PT CE i T ii aa E 7 ea T m m 4 j i Ft i Highlight the language selection and press the O button to set it Note English will be highlighted as the default language in a new instrument After changing the language the new language becomes the default The instrument will automatically turn off after changing the language selection SET TIME DAY Select SET TIME DAY from the SET UP menu The following screen is displayed TCT bal ee res i Ce a re i oh EE fan Cd Di q Pir ie bel bel oe Par t pii rk Pee i p a bE ET abs clos CE eee ses Eos E EE B bhe ha ial Libel m behed spm heh Fees pi FE itii nA anl sle I E ee Oe tort eg ae oo Pir ie Pear oe kel bell I pii th IPP om f ff fP FPiite shs sien CEE ie ee Tame hams rue et Len Ee ne ket bet e AU ODP QJ rer ie EEE tt oir Eo OB Sees h Bisse 0 ae es i wes Toe 12 HOUR MM DD will be highlighted as a default selection Highlight your TIME DAY preference and then press the O button Note In the case of a 24 HOUR selection AM PM acronyms will not appear
11. ELY and re tested at the lab INR LOW REPEAT TEST IF SAME CALL MD Repeat the test Check for adequate Level I or II control is too storage of cuvettes or sampling high or too low technique Confirm results with the ON BOARD QC OUT OF RANGE TRY AGAIN lab Repeat the test If it occurs again At least one channel did not patient should be referred to their clot physician IMMEDIATELY and re tested at the lab NO CLOT DETECTED REPEAT TEST IF SAME CALL MD Test again with new Tenderlett Plus TIME OUT Time ran out before starting and a fresh fingerstick You may reuse TRY AGAIN test the cuvette if no blood was in contact with the cuvette TEST INTERRUPTED Cuvette removed or operator TRY AGAIN interrupted test Review correct procedure Repeat test 14 Screen Display SAMPLE NOT SEEN TURN OFF TRY AGAIN SAMPLE TOO LARGE TURN OFF TRY AGAIN SAMPLE TOO SMALL TURN OFF TRY AGAIN SAMPLE ERROR TURN OFF TRY AGAIN CUVETTE EXPIRED BARCODE ERROR REMOVE CUVETTE TRY AGAIN BATTERY ERROR TURN OFF TRY AGAIN INSTRUMENT ERROR TURN OFF TRY AGAIN CHARGE ERROR TURN OFF TRY AGAIN TEMP ERROR TURN OFF TRY AGAIN PHOTO ERROR TURN OFF TRY AGAIN Source of Error Can be caused by small samples clots air bubbles or a seal problem in one or more channels Sample oversize Sample undersize Incorrect fluid movement Air bubble detected in one or more of the channels Expired cuvette In
12. ProTime C E Microcoagulation System For in vitro Diagnostic Use Operator s Manual for Patient Self Testers TABLE OF CONTENTS INTENDED USE ricisiepiorainar a aai EATE 2 SUMMARY AND EXPLANATION sssssssssnsssssernnrsesssrrrrrrsessrrrrrrees 2 SYSTEM FEATURE S sniaoaron eea a a a ae 3 IMPORTANT LABELS AND SYMBOLS aaiiieeeeennersesrrrrrrreenn 4 PRINCIPLES OF OPERATION rianan aaa AE S 4 SAFETY FEATURES AND QUALITY CONTROL ee 5 INSTRUMENT SPECIFICATIONS 0 000 eee ee cece etteeeeeeeeeeea ees 6 SERVICE AND MAINTENANCE 0 ceceeeeeeeeeeeeeeeeeeeeeeaeeeeeeeeees 7 PREPARING THE INSTRUMENT 00 ccc ee cece eee eeeeeeeeeeeeeeeaeeeees 8 TEST PROCEDURE sik ici scieceseat edict ees ah ee oat TROUBLESHOOTING sirina a a 14 MAIN MENU OPTIONS oi sciuseesaccncexcctiadeecices nevaxgetdocensexeeteadeecicanes 16 SET WP ioeo coateces cen acacaccuanes EN a AA 19 PERFORMANCE CHARACTERISTICS 0 ceeeeeeeteeeeeeeeeeeeees 22 TECHNICAL ASSISTANCE ceeee ni naaa 23 SUGGESTED READING cciecet ccc cancers a eee 24 ORDERING INFORMATION 0 ceeeee eee ee eee ee ee eeeeeeeeeeeeeaaaaeeeeeees 24 APPENDIX I RUN LOC icc tccicee eats ah 25 APPENDIX II USE OF PID AND OID NUMBERS 27 SAFETY STANDARDS renun ai 31 INDEX araon N E E 35 This manual is published by International Technidyne Corporation ITC for use with the ProTime Microcoagulation System and Tenderlett Plus fingerstick blood collection device Que
13. The I button is used to move through menu screens and to scroll through results 5 START SELECT Button The 0 button is pressed to turn ProTime on and off to start the test and to select menu items 6 Cuvette Entry Port The cuvette entry port accepts only ProTime and ProTime3 cuvettes 7 AC DC Power Module The AC DC power module is used to connect the ProTime instrument to the AC power cord to recharge the battery 8 Input DC Port Plug the DC power cord from the AC DC power module into this port when connecting the ProTime instrument to the AC DC power module 9 Output Data Port Use this port to download records in the ProTime memory IMPORTANT LABELS AND SYMBOLS Before using the ProTime Microcoagulation System it is essential that the contents of this Operator s Manual and any Instructions accompanying the ProTime Cuvettes and Tenderlett Plus incision devices are read and understood by the operator These materials make reference to various symbols that are explained below Start Select Menu Scroll Expiration Date of Cuvettes Serial Number of Device Lot Number of Cuvettes Tenderlett Plus ITC Catalogue Number of Device Do Not Reuse Single Use Only Upper and Lower Temperature Limitations For Storage or Use For in vitro Diagnostic Use Attention Read Accompanying Documentation or Instructions Consult Instructions for Use o He E OR RE a o Class II Protection Against Electrical Shock pj Input Port for
14. Time cuvette and the Tenderlett Plus LV low volume device is to be used with the ProTime3 cuvette The Tenderlett Plus device will collect approximately 65 uL of blood approximately 3 drops while the Tenderlett Plus LV device will collect approximately 27 uL of blood approximately 1 large drop Samples should be analyzed immediately after collection No additional sample preparation is required For venous samples collect venous whole blood into an anticoagulant free plastic syringe in place of fingerstick sampling steps 0 and 4 of the Test Procedure section Immediately dispense venous sample into the Tenderlett Plus collection cup filling the Tenderlett Plus collection cup Follow instructions from step 5 of the Test Procedure section Note Serum plasma or whole blood collected with any anticoagulants are NOT suitable samples PREPARING THE INSTRUMENT Unpacking and Inspection 1 Remove any protective packaging that may be present around the instrument 2 Examine the packaging material to be sure that the AC DC power module AC power cord see note below connecting cables or other components have been removed The materials that are provided are listed below Note Inspect each component for damage when unpacking If damage is observed contact your ProTime representative Materials Provided Article Quantity ProTime Microcoagulation Instrument 1 ProTime Microcoagulation System Information and Training CD 1 Cay AC DC power modul
15. and timing functions battery level and optical electrical and mechanical functions The instrument does not require further calibration Each ProTime cuvette has two integral reagent controls that ensure assay reliability and performance Both levels of control produce quantifiable clotting endpoints that are compared to pre set acceptance limits programmed in the instrument Other in process instrument QC features and the integral reagent controls function together to ensure correct sample size and collection technique correct test procedure instrument functionality and reagent integrity A fault message is displayed instead of PT results when any instrument or reagent quality criterion is not met When a fault message is displayed the user should review the product instructions and repeat the test Additional external control materials may be used to check instrument function reagent integrity and user technique Each institution should establish a quality assurance program for prothrombin time testing that complies with existing local state and federal regulations as applicable As with all diagnostic tests the ProTime Microcoagulation System test results should be scrutinized in light of a specific patient s condition and anticoagulant therapy Any results exhibiting inconsistency with the patient s clinical status should be repeated or supplemented with additional test data TECHNICAL ASSISTANCE For further information and technical as
16. ck whole blood samples were compared to INR values obtained using standard laboratory plasma PT methods with samples collected in 3 2 sodium citrate tubes The following accuracy data was obtained A Standard ProTime Cuvette vs Lab Plasma Sample Type Regression Equation r n Fingerstick Y 0 94x 0 38 0 95 229 Venous Y 0 91x 0 44 0 94 232 B ProTime 3 Cuvette vs Lab Plasma Sample Type Regression Equation r n Fingerstick y 1 05x 0 07 0 95 229 Venous y 0 97x 0 19 0 95 219 22 Clinical Performance Comparison A ProTime3 vs ProTime Linear regression containing clinical fingerstick results from three sites yielded a regression equation as below y 1 02x 014 r 0 94 n 229 B Patient Self Testing In a trial of patient self testing PST in the home vs professional testing in the clinical and reference lab equivalent ProTime results were obtained ProTime Professional vs Patient Self Testing y 94 0 13 r 0 92 n 421 ProTime Patient Self Testing vs Reference Lab y 77x 0 38 r 0 87 n 368 Sensitivity ProTime is sensitive to deficiencies in vitamin K dependent coagulation factors known to influence the PT test i e Factors II VII and X Hematocrit levels between 20 and 60 do not significantly affect test results Quality Control The ProTime instrument has been designed with multiple systems to ensure proper instrument function The instrument self check at startup checks temperature
17. e ITC Part No IR5226 1 ProTime Microcoagulation Operator s Manual 1 Note An AC power cord is provided in the United States and Canada only Materials Needed But Not Supplied e ProTime cuvettes e Tenderlett Plus incision device Optional Materials Article Personal Computer Interface Cable ITC No PROCABLE ITC Part No IR5313X Printer Label Maker ITC No LBLKIT Replacement Printer Label Maker Interface Cable ITC No LBLCABLE ITC Part No IR5314X Replacement Battery ITC No PROBATTERY Charging the Battery The battery of the instrument needs to be charged before the first use 1 Connect the AC DC power module to an electrical service outlet using the AC power cord 2 Connect the DC power cord from the AC DC power module into the DC port on the back of the instrument The instrument screen will show CHARGING BATTERY when the AC DC power module is connected to the AC power cord and the ProTime instrument The screen will show CHARGE COMPLETE when the battery is fully charged 3 Allow the battery to charge for at least eight hours TEST PROCEDURE 1 Turn on the ProTime Instrument Press the Q button to start ProTime performs a self check procedure that may take up to 60 seconds ProTime will prompt you through the test Watch the screen and follow the prompts EA a geld HOS 2 Inserta Cuvette Make sure the ProTime cuvette is brought to room temperature before use Wait for the prompt Insert th
18. e battery indicator on the screen shows less than 25 charge remaining please refer to the Charging the Battery section for instructions To maximize battery life allow your ProTime instrument to discharge completely before re charging Avoid charging the ProTime instrument for frequent short periods of time such as charging for a few minutes removing from the AC DC power module and then recharging again Avoid storing and charging the ProTime instrument at extreme temperatures Built in ProTime Battery Features The ProTime instrument will shut off after 5 minutes if left unattended in order to preserve the battery charge If the instrument shuts off automatically press the Q button to re start the instrument Before the start of each test the ProTime instrument checks the amount of battery charge If there is not enough charge in the battery to run a test the ProTime screen will display PLEASE CHARGE IT If this occurs follow the charging instructions located in the Charging the Battery section Whether or not the batteries are charged you may continue to run tests once the ProTime instrument is plugged into its AC DC power module Battery Replacement Refer to the instructions provided with the replacement battery The used battery should be disposed of in accordance with local regulations for NiMH batteries SPECIMEN COLLECTION Fingerstick whole blood is the recommended specimen The Tenderlett Plus device is to be used with the Pro
19. e cuvette into the slot with the printing face up and the bar code down metre H E a ses WA pp PE ges H 3 Prepare for Finger Incision While the cuvette is warming prepare the finger Wait for the prompt before incising the finger and collecting blood It is easier to collect blood if the hands are warm Follow these steps to ensure a good sample e Wash the hands in warm water or rub hands together to stimulate blood flow e Apply firm pressure to the palm and finger Massage the hand and push blood into the fingertips e Cleanse middle or ring finger and dry To prevent contamination do not touch the site after cleansing 4 Blood Collection When this screen appears it is time for the finger incision 4 i ale i ra oo ome poe sel CAUTION Blood collection must be finished within 2 10 minutes to prevent early clotting of the sample ProTime will keep time If the 2 10 minute interval has expired and the Q button has not been pressed during this interval a TIME OUT error message is displayed To run another test repeat procedure from Step 2 e Place the Tenderlett Plus device firmly against the side of the finger Place thumb on top of the device as shown and press the red trigger firmly using the other thumb e Wipe away the first trace of blood e Gently massage from the base of the finger to force blood to the tip so that a large drop of blood forms 10 e Touch t
20. en i r P i DATA HISTORY Press the O button to view the most recent result in the DATA HISTORY memory The instrument memory holds 50 results Pressing the Y button will scroll through individual results The results are stored in memory from the most recent to the oldest Press the O button to return to the MAIN MENU PATIENT RECORDS The result and ID information will be stored in the database as follows Note MM DD YYYY and HH MM are used for illustrative purposes only in the following examples of date and time screens PRINT DATA OR SEND DATA Press the T button to move the highlight bar to the SHOW RESULTS line on the MAIN MENU Then press the O button to view the SHOW RESULTS menu The instrument auto send feature allows transmitting of test results directly to a serial printer or to a computer by using the PROCABLE Contact ITC Customer Service to order the PROCABLE To use the AUTO SEND feature press the Y button at the PRINT DATA or SEND DATA display until AUTO SEND is highlighted Press the O button and depending on the current settings in the instrument one of the following displays will appear 17 Example Printing Data Press the NI button to set the feature to ON or OFF and then press the O button to save the setting e Highlight the SHOW RESULTS line in the MAIN MENU e Press the O button to view the SHOW RESULTS menu e Press the NU button to move the highlight bar to the PRINT DATA or SEND D
21. ent e g printers etc not identified in this manual either in the patient vicinity or that does not comply with either the equivalent safety requirements of this equipment or UL IEC 60601 1 or IEC 60601 1 2 may lead to a reduced level of safety with the resulting system Limitations e The ProTime instrument uses only fresh capillary or venous whole blood Plasma or serum cannot be used Glass tubes or syringes must not be used to collect venous samples Use only plastic syringes without anticoagulants to collect venous samples Poor fingerstick blood collection technique may affect results e In clinical trials no significant difference was observed between fingerstick and venous specimens run on ProTime During those trials ProTime measured patients with an INR range of 0 8 to 7 0 ProTime is programmed to calculate and report INR results as follows If the calculated INR is Then ProTime displays lt 0 6 INR LOW 0 6 0 79 INR lt 0 8 0 8 7 0 Result 7 1 9 9 Result followed by 10 0 12 0 INR gt 9 9 gt 12 0 INR HIGH e Results may be affected in patients receiving heparin or who have an abnormal response to heparin e Correlation of results reported by the ProTime instrument to laboratory results depends on the precision of the laboratory method and on the ISI value of the laboratory reagent and instrument system e Do not disturb instrument while test is in progress As with all diagnostic tests ProTime Micr
22. he large drop of blood to the collection cup Keep adding blood until the blood level fills the cup above the line e For Tenderlett Plus LV ensure the cup is filled completely Ensure the blood extends all the way to the bottom of the cup Add another drop if you are not sure that you have enough 5 Snap Tenderlett Plus to ProTime e Hold the device at an angle and place the front end of the device into the slot in the instrument e Press down to click the Tenderlett Plus in place You should hear a soft click Note Proper engagement of the Tenderlett Plus to the cuvette is critical to prevent a sample error 11 6 Start the Test e Press the Q button to start the test This signals ProTime to draw the sample into the cuvette e It takes only a few seconds for ProTime to draw the blood into the cuvette Watch the screen for the next prompt SAPIPL IMIS 7 Remove Tenderlett Plus Remove Tenderlett Plus immediately when prompted to do so CAUTION Failure to do so will result in an error message ProTime allows you six seconds FEMALE TENDER LETPERENS LERT e Donot press the O button after the Tenderlett Plus is removed from the ProTime instrument while you are testing your INR This will interrupt the test procedure and you will have to start over with a new blood sample 12 e The instrument then progresses to the test and displays the TESTING screen 8 Read the Result In a few minutes
23. icrocoagulation System is designed for measuring prothrombin time PT and International Normalized Ratio INR The reagents for a prothrombin time test are in the cuvette Whole blood clotting time is converted to INR and then the result is calculated for plasma equivalent PT seconds This test is done to check the status of the oral anticoagulation therapy What is INR The International Normalized Ratio INR was developed to help the doctor compare an individual s prothrombin time results from one lab to another An advantage of reporting an INR is to allow for normalization of comparisons from one lab or instrument to another The precision of the INR is improved when a reagent with a lower ISI is used Note ISI stands for International Sensitivity Index ProTime uses this number to calculate PT seconds from INR Blood Coagulation Test Methodology Traditional coagulation tests measure the time required for the formation of a fibrin clot following the addition of a coagulation activating reagent Laboratory assays typically use plasma recovered from anticoagulated citrated whole blood samples The clotting time is a measure of the functionality of the patient s hemostatic system Specific coagulation activating reagents are employed in various clotting tests to measure specific components of the hemostasis system Clotting times are prolonged in the case of either decreased procoagulant activity or increased anticoagulant activity S
24. le causes and solutions As with all diagnostic tests the ProTime Microcoagulation System test results should be scrutinized in light of a specific patient s condition and anticoagulant therapy Any results exhibiting inconsistency with the patient s clinical status should be repeated or supplemented with additional test data If you get a persistent error write down the error message and call ITC Technical Support at 1 732 548 5700 1 800 631 5945 or e mail us at techsupport itcmed com Please have the ProTime serial number and cuvette lot number ready when you contact ITC Technical Support Troubleshooting Guidelines e Become skilled at obtaining blood with the fingerstick technique This will help you avoid sample errors e Follow all of the directions on the screen for optimal operation e Do not try to hasten the test process by performing the fingerstick while the WARMING screen is displayed as blood may clot before it is drawn into the cuvette and an error may occur FOLLOW THE INSTRUCTIONS ON THE SCREEN Troubleshooting Guide Screen Display Source of Error Method of Control Repeat the test If it occurs again Patient s PT result is too patient should be referred to their high INR gt 12 0 physician IMMEDIATELY and re tested at the lab INR HIGH REPEAT TEST IF SAME CALL MD Repeat the test If it occurs again Patient s PT result is too low patient should be referred to their INR lt 0 6 physician IMMEDIAT
25. m should assure that it is used in such an environment Immunity Test Electrostatic Discharge ESD IEC 61000 4 2 Electrical fast transient Burst IEC 61000 4 4 Surge IEC 6100 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 Test Level 6 kY contact 8 KV air 2 kV for power supply lines 1 KV for input output lines 1 KV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Up for 5 cycles 70 Ur 30 dip in Up for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Compliance Level 6 kV contact 8 KV air 2 kV for power supply lines 1 KV for input output lines 1 KV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Up for 5 cycles 70 Ur 30 dip in Up for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical domestic commercial or hospital environment Mains power quality should be that of a typical domestic commercial or hospital environment Mains power quality should be
26. n array of LEDs detects the motion of sample reagent mixtures as they move through a precision restriction in each channel The blood is pumped back and forth until a clot forms obstructing the channel and slowing the flow of blood The instrument detects the clot when the blood movement decreases below a predetermined rate SAFETY FEATURES AND QUALITY CONTROL Each ProTime and ProTime3 cuvette has two channels for performing the two levels of control which work simultaneous with the channel s used for testing the PT assay The built in safety features of the instrument and integral reagent controls work together to ensure that the instrument and reagent systems are working properly and that the test procedure was performed correctly Two levels of quality control are performed with each and every test Calibration The ProTime instrument and cuvettes are pre calibrated No additional calibration is required Reagents ProTime cuvettes are pre loaded with dried thromboplastin stabilizers and buffers The thromboplastin has a high sensitivity measured as an ISI near 1 0 Each cuvette performs the prothrombin time test and in addition has one channel for a Level I control and one channel for a Level II control The controls consist of purified plasma extracted coagulation factors and anticoagulants Operating Precautions e For in vitro Diagnostic Use e The ProTime instrument is designed for use only with ProTime cuvettes e The ProTime inst
27. ocoagulation System test results should be scrutinized in light of a specific patient s condition and anticoagulant therapy Any results exhibiting inconsistency with the patient s clinical status should be repeated or supplemented with additional test data Follow doctor s instructions if you have difficulty performing the test or receive a result outside of the prescribed therapeutic range Reagent Preparation and Storage e Bring the foil pouched cuvette to room temperature prior to use e ProTime cuvettes are ready to use No additional preparation is required e Store the foil pouched cuvettes in a refrigerator 2 C to 8 C 36 F to 46 F e An unopened cuvette pouch is stable when stored at 2 C to 8 C until the date printed on the pouch Unopened cuvette pouches may be stored at room temperature for 60 days Once the pouch has been opened the cuvette must be used within 16 hours Cuvette or Tenderlett Disposal The ProTime cuvette and Tenderlett Plus are for single use only and are not to be reused After use they contain human blood and should be disposed of in accordance with local regulations for human blood contaminated waste INSTRUMENT SPECIFICATIONS Size 2 77 b x 4 5 w x 8 75 D inches Weight 1 6 pounds Operating Temperature Room temperature 15 C to 30 C 59 F to 86 F PT Test Temperature 37 1 0 C Battery Type Nickel Metal Hydride NiMH Operating Time On Battery Approximately 2 hours constant run or 10 comple
28. r right to the next field position Pressing the Q button for 2 seconds or longer saves the complete numeric field EXAMPLE Entering a PID number With the PID feature enabled the following screen appears after a cuvette is inserted into the instrument To enter a PID the first position in the PID field starting from the left is indicated by a triangular cursor e Press the Y button until the desired digit is displayed e Press the O button briefly to enter the digit in that position of the field The cursor will automatically move to the next field position e Repeat these steps until the desired field length is entered e To save the entered PID value press and hold the O button for approximately 2 seconds until the second audio beep is heard Note These audio beeps will be heard regardless of BEEP setting ON OFF 27 After the cuvette is inserted the user has the option to set an operator ID OID and or a patient ID PID if the OID and or PID have been enabled in SET UP section of MAIN MENU The PID may contain up to twelve digits the OID can be a value with up to six digits Note In the different scenarios related to SET PID OID ON OFF settings some of the following four screens are not presented to the user For example none of these four screens will appear if both PID and OID are set to OFF value The default numerical PID and OID values are zero If OID is set to the ON position the following screen will appear
29. rd requirements and directives CSA 22 2 601 1 Medical Electrical Equipment General Requirements for Safety EN 60601 1 UL IEC 60601 1 Medical Electrical Equipment General Requirements for Safety Medical Electrical Equipment Part 1 2 General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests EN 60601 1 2 IEC 60601 1 2 Directives 89 336 EEC and as amended by 91 263 EEC 92 31 EEC 93 68 EEC and 98 13 EC 98 79 EC Equipment Classifications As Defined Per UL 60601 1 2003 IEC60601 1 2nd Edition e Protection against electrical shock Class II Internally Powered Equipment with no applied parts e Protection against ingress of liquids Ordinary no protection as defined by IEC 529 e Product cleaning and disinfection Only according to recommendations of the manufacturer s accompanying documentation e Mode of operation of equipment Continuous e Degree of safety of application in the presence of flammable anesthetic mixture with air oxygen or nitrous oxide Not Suitable NOTE As defined in the above standards the classification of Not Suitable DOES NOT MEAN that the instrument is not suitable for use in an Operating Room OR environment Rather it is intended to indicate that the instrument is not suitable for use in the direct presence of a flammable anesthetic mixture with air oxygen or nitrous oxide All relevant documentation is kept on
30. rument will not perform a test if the cuvette is past its expiration date or which has been improperly stored e The ProTime instrument is designed to be used for testing in a stationary position DO NOT perform testing while carrying or holding the instrument e In order to charge the ProTime instrument the AC power cord should be plugged into an electrical service outlet and the AC DC power module while the DC power cord from the AC DC power module is plugged into the Input DC port in the back of the ProTime instrument e DONOT expose the ProTime instrument to extreme temperature above 35 C 95 F Such exposure could affect the performance of any type of electronic instrumentation e DONOT drop the ProTime instrument and do not use the results if the instrument is dropped during a test e DONOT attempt to open the ProTime instrument other than for battery replacement as there are no user serviceable parts e DONOT remove the AC DC power module from the ProTime instrument by pulling on the cord Patient specimens and used cuvettes are potentially infectious The cuvettes include materials that have been prepared from human plasma or serum that has been tested using US FDA recognized methods and found to be non reactive for HIV antibody and for hepatitis B surface antigen Handle with appropriate care and dispose off cuvettes and blood collection materials in accordance with standard methods of biohazard control The use of accessory equipm
31. s CALIDI ANON 11 commen nese 5 A ONS ys s2eccoccccccustenanatanenenananananenatananandians 5 PLCCAUUONS ooroo 5 reagent preparation cece 6 PEADES A ENEE 5 SO isu annieneicemecee eae 6 service and maintenance DAMICL Ye CALC AAN E E 7 Dallery ACIS onea seemed 7 instrument disposal 7 routine MAINTENANCE erreen 7 set up DCD EE S 21 UAE aaraa E 20 PANO AO e AAE E 19 L110 oe ee 19 SCE UP UCTS e aa NS 19 SHOW TESTS Hermanas 17 printing and sending cece 17 technical assistance 23 test methodology 5 2 ccacasasencaenancnnannateianmnannts 2 IRK EEE asec 13 roubles hoon acena 14 International Technidyne Corporation 8 Olsen Avenue Edison NJ 08820 USA tel 732 548 5700 fax 732 248 1928 Co www itcmed com a subsidiary of Thoratec Corporation IR5245 1 08
32. sistance contact ITC Technical Support at 1 732 548 5700 1 800 631 5945 or e mail us at techsupport itcmed com 23 SUGGESTED READING Adcock DM Kressin DC Marlar RA Effect of 3 2 vs 3 8 Sodium Citrate Concentration on Routine Coagulation Testing Am J Clin Pathol 1997 107 105 10 Brien WF Baskerville JC Taberner DA Crawford L Calculation vs Calibration Curve for INR Determination Results of an Interlaboratory Proficiency Scheme Am J Clin Pathol 1999 111 193 201 Eckman MH Levine HJ Pauker SG Effect of Laboratory Variation in the Prothrombin Time Ratio on the Results of Oral Anticoagulant Therapy N Engl J Med 1993 329 696 702 Fairweather RB Ansell J van den Besselaar AMHP Brandt JT Bussey HI Poller L et al College of American Pathologists Conference XXXI on Laboratory Monitoring of Anticoagulant Therapy Arch Pathol Lab Med 1998 122 768 81 Gosselin R Owings JT White RH Hutchinson R Branch J Mahackian K et al A Comparison of Point of Care Instruments Designed for Monitoring Oral Anticoagulation with Standard Laboratory Methods Thromb Haemost 2000 83 698 703 Hirsh J Antithrombotic Therapy in Deep Vein Thrombosis and Pulmonary Embolism Am Heart J 1992 123 1115 22 Hirsh J Poller L The International Normalized Ratio A Guide to Understanding and Correcting its Problems Arch Intern Med 1994 Feb 14 154 3 282 8 Hubbard AR Margetts SM Weller LJ Macnab J Barrowcliffe TW An International Collabora
33. stions or comments regarding the contents of this manual can be directed to the address at the back of this manual or to your ITC representative Please read the instructions before use Call your ITC representative for help 2000 2001 2002 2003 2004 2005 This document is the copyright of ITC and must not be copied or reproduced in any form without prior consent ITC reserves the right to make technical improvements to equipment and documentation without prior notice as part of a continuous program of product development INTENDED USE The ProTime Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood The product is intended for use in the management of patients treated with oral anticoagulants by a healthcare professional and for patient self testing at home Additional information for medical professionals to monitor patients is located at the end of this instruction manual Materials are available through ITC for professionals to train patient self testers using the ProTime Microcoagulation System ProTime instruments intended for patient self testing are available in the U S by prescription only These instruments include patient specific product instructions For in vitro Diagnostic Use SUMMARY AND EXPLANATION What Does The ProTime Microcoagulation System Do The ProTime M
34. strument cannot read barcode accurately Power supply battery error Instrument set up data log or communication error Power supply error Temperature not in range LED blocked or other photo system error 15 Method of Control Check for proper collection technique Verify cup is completely filled Use another cuvette Review directions and repeat the test Repeat test Exceed the fill line on the cup to ensure sample size Turn off and on again and repeat test with new cuvette and fresh fingerstick Check to make sure cuvettes have not expired The expiration date is located on the packaging and alongside the barcode on the cuvette Visually inspect barcode If scratched discard cuvette If dirty wipe clean If barcode is good review correct procedure and repeat test Repeat the test If it occurs again replace the battery If problem persists call ITC Technical Support Repeat the test If problem persists call ITC Technical Support Check the AC DC power module repeat the test If problem persists call ITC Technical Support Check for proper operating temperature Repeat the test If problem persists call ITC Technical Support Repeat the test If problem persists call ITC Technical Support MAIN MENU OPTIONS The options presented in the MAIN MENU are Pil ILI pie ay ese ceric E PPI bd p p j E a l F B Benen ome A mi ILI irr Peon Gb E Fell rd ie Hawes aas ama
35. te test cycles per charge Tests may also be run while ProTime is plugged in to AC DC power module Anticipated Battery Life 500 charges 100 240 VAC Power Input 100 240 volts AC 47 63 Hz Supply Charger Output 15 volts DC 2 0 A SERVICE AND MAINTENANCE Routine Maintenance and Cleaning DO NOT immerse the ProTime instrument or allow fluid to enter the cuvette housing Inspect and clean the outside of the cuvette slot as required Remove residual dried blood or other foreign matter on the outside of the instrument using gauze dampened with a 10 dilution of household bleach in water or with gauze dampened with isopropyl alcohol or other disinfectant DO NOT use other solvents or strong cleaning solutions as they may damage the plastic components of the instrument Servicing the ProTime Instrument Other than replacement of the rechargeable battery as described in this manual the ProTime instrument is not user serviceable Should service be required please contact Technical Support at 1 732 548 5700 1 800 631 5945 or e mail us at techsupport itcmed com If you are advised to return the instrument to ITC for service or repair prior to shipping please clean the instrument as described above Instrument Disposal If instrument disposal is required follow local regulations for the disposal of electronic devices For battery disposal see the Battery Replacement section Battery Information The ProTime Microcoagulation System
36. the beep sound ON Note Regardless of BEEP setting the beep will sound under the following conditions power on power off and following a key hold 21 PERFORMANCE CHARACTERISTICS The ProTime instrument has been tested extensively by doctors nurses and patients Eighty four people ages 7 to 81 participated in the first home use trial The trial was conducted to see how well ProTime results compare to the lab Comparisons of this type are described by correlation values and a correlation value near 1 0 means the comparison is good The home tests compared to tests run at the clinic using ProTime with venous samples 421 samples had a correlation of 0 92 The home test results compared to a reference laboratory results 368 samples had a correlation of 0 87 These correlation values mean that home testing is comparable to lab testing Precision Precision testing was conducted with two levels of standard control plasma substrate preparations Level I and Level ID A Standard ProTime Cuvette Control Precision n Mean SD Level I Within day 17 0 9 0 06 Day to day 5 days 4 day 1 0 0 08 Within day 19 3 2 0 19 Level II Day to day 5 days 4 day 5 2 0 12 B ProTime3 Cuvette Control Precision n mean SD Level Within day 18 0 9 0 07 Day to day 5 days 4 day 0 9 0 12 Within day 20 4 0 0 19 Level II Day to day 5 days 4 day 4 2 0 22 Accuracy INR results generated by the ProTime and ProTime3 cuvettes using venous and fingersti
37. the result is ready e Press the Q button to turn off e Press the J button to go to the MAIN MENU if you want to run another test review the data in memory print results transfer results to a computer or perform set up functions Notes e The result remains displayed for 5 minutes or until the Q button or the XY button is pressed e If the cuvette has not been removed and the instrument is left unattended for 5 minutes the instrument will display the following messages before shutting down and powering OFF What Does the Result Mean The result indicates the clotting activity of blood When ProTime is used as a self testing instrument the healthcare provider may program ProTime with the upper and lower limits that are right for the patient In this case ProTime will display OTR if results are outside of the therapeutic range The OTR will not display if results are within the limits If no limits are set ProTime will display only the result Note If OTR Out of Therapeutic Range appears after the INR result the result is out of the therapeutic range TR limits that have been preset by the physician 13 TROUBLESHOOTING Most often a fault message indicates a problem with blood collection or a mistake in the test procedure If an error message appears read the instructions again and repeat the test with a new cuvette The ProTime Troubleshooting Guide below gives the messages for the most common errors with possib
38. tive Study on the INR Calibration of Freeze Dried Reference Plasmas Br J Haematol 1999 Mar 104 3 455 60 Levine M HJ Landefeld Raskob G Hemorrhagic Complications of Anticoagulant Treatment CHEST 1992 102 352s 63s Technical Assistance For further information and technical assistance call ITC Technical Support at 1 732 548 5700 1 800 631 5945 or e mail us at techsupport itcmed com ORDERING INFORMATION For further information on ordering and supplies contact your ProTime distributor 24 For LQC Normal with OID off For LQC Abnormal with OID off T pi ce EEE m ale hn The instrument performs a SELF CHECK procedure which may take up to 60 seconds Refer to the Liquid NOTE The result and ID information will be stored in the database as a LQC record QC package insert for instructions The testing proceeds as described above except that no prompt for PID will be shown for a QC test whether PID is ON or OFF APPENDIX I RUN LQC NOR ABN NORMAL ABNORMAL For LQC Normal with OID on For LQC Abnormal with OID on When RUN LQC is selected from the MAIN MENU the following screen is displayed and the user can select NOR ABN selection When the test completes the result will be displayed as follows depending on OID ON OFF and LQC re 5 am Bed 25 LQC RECORDS The LQC record will be displayed as follows depending upon the OID ON OFF selections and the LQC NOR ABN selections For LQC Normal
39. ummary of the Blood Coagulation System The events leading to the formation of a fibrin clot are simplified in coagulation theory into two coagulation pathways the intrinsic and the extrinsic pathways There are twelve clotting factors or proteins involved in this cascade scheme numbered I through XIII excluding VI The prothrombin time test measures the extrinsic coagulation pathway and is sensitive to coagulation Factors VII X V II and Fibrinogen I With the exception of Factor V vitamin K is a required co factor for biosynthesis of these factors in the liver The prothrombin time PT test uses thromboplastin as the active reagent to initiate the extrinsic pathway The prothrombin time test will be prolonged in patients with liver disease or vitamin K deficiency The test is widely used to monitor oral anticoagulant therapy which suppresses the synthesis of vitamin K dependent clotting factors SYSTEM FEATURES 1 Tenderlett 2 ProTime Cuvette ie Display Panel MENU SCROLL Button 5 START SELECT Button 6 Cuvette Entry Port 7 AC DC Power Module 8 Input DC Port 9 Output Data Port 1 Tenderlett Plus Tenderlett Plus LV The finger incision and blood collection device used with ProTime and ProTime cuvettes 2 ProTime ProTime 3 Cuvette The cuvette performs the PT test 3 Display Panel The display panel prompts you through the test procedure displays results and error messages 4 MENU SCROLL Button
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