CoaguChek XS PT Test
Contents
1. 0 If the meter displays lt less than 0 8 or gt greater than 8 0 repeat the test If when you repeat the test you get the same display either lt 0 8 or gt 8 0 call your doctor Built in controls The CoaguChek XS System has built in quality control functions in the meter and test strips The meter automatically runs its own quality control test as part of every blood test so you never have to run quality control tests with liquid quality control solutions For more information about the built in quality control functions see the CoaguChek XS System User Manual for Self Testing Performance Characteristics Measuring range The CoaguChek XS PT System has a PT measuring range of 0 8 8 0 INR and 9 6 96 0 seconds Accuracy A study was conducted comparing test results obtained by trained users with those obtained by healthcare professionals when both were using the CoaguChek XS System The correlation was very good as indicated by the following statistics N 463 Slope 1 000 Intercept 0 0 and Correlation Coefficient 0 977 This study shows that trained users are able to obtain results that are as accurate as those obtained by healthcare professionals trained in the use of the CoaguChek XS System Results Comparison User vs Healthcare Professional N 463 PB y 1 000x 0 0 Slp Cl 1 000 1 030 Int Cl 0 05 0 Correlation 0 977 User INR Average Healthcare Professional INR The test results obtained by2. A total of 88 patients completed all four visits to the site The reasons for drop outs were as follows Reason for Drop Out of Subjects Felt it was too stressful Didn t have time Didn t want to use meter on his own Didn t think he could learn to use meter Was having knee surgery Study terminated prior to Visit 4 Unknown on wo Pp Disqualified due to target INR range outside of study protocol Precision A study was conducted and the precision of duplicates for capillary blood results was calculated for both trained users and healthcare professionals The following results were obtained User Professional Results Results N 214 249 Mean INR 2 57 2 52 SD 0 13 0 13 CV 5 13 5 36 This study shows that trained users are able to obtain results that are as precise as those obtained by healthcare professionals trained in the use of the CoaguChek XS System Symbols Roche Diagnostics uses the following symbols and signs for this product Catalogue number Batch code In vitro diagnostic medical device Manufacturer Contains sufficient for lt n gt tests Use by date Temperature limit Consult instructions for use Analyzers Instruments on which reagents can be used q B S lt 5 YSTEM GTIN Global Trade Item Number Additional information The CoaguChek XS System User Manual for Self Testing contains more information If you need technical help call the Roche Diagnostics Technic
3. and apply the blood drop within 15 seconds of sticking the fingertip CoaguChek XS 10 Record the result on the CoaguChek XS System Prothrombin Time Self Testing Log Book Call your doctor with the test result 11 Properly dispose of the used lancet and test strip 12 Power the meter OFF If you need to redo a test use a new lancet a new test strip and a different finger Limitations of procedure Information for you and your physician If you still get error 7 call your doctor immediately to arrange for testing using another method If the meter displays any other error message refer to the Error Messages section of the CoaguChek XS System User Manual for Self Testing 2 00 i 30 06 error The CoaguChek XS System for patient self testing should not be used for patients being treated with any direct thrombin inhibitors including Hirudin Lepirudin Bivalirudin and Argatroban The CoaguChek XS PT Test for patient self testing uses only fresh capillary blood from a fingerstick The blood drop must be a minimum of 8 uL in volume Low sample volume will Cause an error message Never add more blood to test strip after test has begun or perform another test using the same fingerstick When a patient is on intravenous infusion therapy do not collect fingerstick sample from arm receiving the infusion line Hematocrit ranges between 25 55 do not significantly affect results Testing ha
4. lance a different finger for the test v a a Y Sagn E o 3 z gt 7a 3 2 amp E 9 gt gt e ld la 8 Apply 1 drop of blood to the side of the test strip It s important to hold the blood drop to the test strip until you hear a beep 9 You ll see the hourglass when the blood test begins Then pull your finger away from the test strip Remember to apply only one drop of blood don t add more Do not touch or remove the test strip when a test is in progress The result appears in about 1 minute Error messages Is the meter displaying ERROR 6 Sporadically occurring ERROR 6 are generally due to an activation of the system fail safe mechanisms that are designed to prevent the release of wrong measurement results However in rare cases ERROR 6 may be received by patients under clinical conditions leading to extremely high coagulation times gt 10 INR lt 5 Quick e g treatment with warfarin vitamin K antagonists in combination with antibiotics and or chemotherapeutics If ERROR 6 is displayed repeatedly please contact your physician without delay If you see error 7 this means the meter was unable to detect a clot Repeat the test Be sure to carefully follow the steps in the CoaguChek XS System User Manual for Self Testing For example make sure the fingertip is thoroughly dry use the meter on a surface free of vibrations
5. trained users were also compared to results obtained using a laboratory based reference method Results are shown in the following plot 05990491001 2015 05 V4 0 Results Comparison User vs Laboratory Result N 297 PB y 1 154x 0 2 Sip Cl 1 111 1 198 Int Cl 0 3 0 2 Correlation 0 934 User INR 0 1 2 3 4 5 6 7 8 9 10 Laboratory INR Study user demographics A clinical study was conducted by Roche Diagnostics consisting of four visits to the clinical site Informed consent and randomization occurred at Visit 1 Testing began at Visit 2 Ninety one patients completed at least one visit after Visit 1 The following table outlines the demographic information for the trained users who completed at least one visit after Visit 1 Demographic Number Percent Total number of users 91 100 Caregivers 4 4 4 Males 51 56 Females 40 44 Age range years 32 89 N A Mean age years 64 N A Age 65 69 years 16 17 6 Age 70 74 years 13 14 3 Age 75 years and up 16 17 6 Education level eighth grade or less through advanced college degree wee Median education level Some college N A On warfarin 3 12 months 19 20 9 On warfarin 1 2 years 22 24 2 On warfarin 3 5 years 23 25 3 On warfarin gt 5 years 27 29 7 Atrial fibrillation 38 41 8 Valve replacement 25 27 5 Stroke stroke prevention 7 7 1 DVT 5 5 5 Other heart conditions 6 6 6 Other clotting disorders 10 11 There were 107 patients enrolled
6. Ta uf i CoaguChek XS PT Test 04625374160 3 6 CoaguChek XS PERSONAL USE Purpose The CoaguChek XS PT test strips are part of the CoaguChek XS System The CoaguChek XS System measures blood clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin The CoaguChek XS System uses blood from a fingerstick The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor Users should be stabilized on anticoagulation medications such as Coumadin or warfarin prior to self testing with the CoaguChek XS System Caution These test strips are for use outside the body only Do not eat the test strips For prescription use only Before you start testing If you are new to the CoaguChek XS System watch the CoaguChek XS System Patient Training DVD and read the CoaguChek XS System Getting Started Guide and the CoaguChek XS System User Manual for Self Testing before you start testing Storing the test strips Store the test strips in their original container with the cap tightly closed You can store test strips at room temperature or in the refrigerator 2 30 C or 36 86 F When stored properly the test strios can be used until the expiration date printed on the test strip container Throw the test strips away if they are past the expiration date Handling the test strips When you are ready to test remove 1 test
7. al Service Center at 1 800 428 4674 24 hours a day 7 days a week 365 days a year LIMITED WARRANTY Roche Diagnostics warrants that this product will meet the specifications stated in the labeling when used in accordance with such labeling and will be free from defects in material and workmanship until the expiration date printed on the label THIS LIMITED WARRANTY IS IN LIEU OF ANY OTHER WARRANTY EXPRESS OR IMPLIED INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE FOR INCIDENTAL INDIRECT SPECIAL OR CONSEQUENTIAL DAMAGES ACCU CHEK COAGUCHEK and SOFTCLIX are trademarks of Roche All other product names and trademarks are the property of their respective owners Additions deletions or changes are indicated by a change bar in the margin 2015 Roche Diagnostics cai Roche Diagnostics GmbH Sandhofer Strasse 116 D 68305 Mannheim www roche com Distribution in USA by Roche Diagnostics Indianapolis IN US Customer Technical Support 1 800 428 4674 www coaguchek usa com 05990491001 2015 05 V4 0
8. s confirmed that PT INR test results are not affected by Bilirubin up to 30 mg dL Lipemic samples containing up to 500 mg dL of triglycerides Hemolysis up to 1000 mg dL Clopidogrel Plavix up to 20 mg dL Fondaparinux Arixtra up to 5 mg L Heparin concentrations up to 0 8 U mL Low molecular weight heparins LMWH up to 2 IU anti factor Xa activity mL The presence of anti phospholipid antibodies APAs such as Lupus antibodies LA can potentially lead to prolonged clotting times i e elevated INR values If you have or suspect that you have APAs contact your doctor Differences in reagents instruments and pre analytical variables can affect prothrombin time results These factors should be considered when comparing results from different test methods Results obtained with the CoaguChek XS System for patient self testing may not consistently correlate with clinical laboratory results particularly for certain types of laboratory reagents Your doctor can provide additional information regarding results comparison In rare cases patients with long clotting times gt 8 INR may receive an 0 1 2 3 4 5 6 7 8 9 10 error 7 message on the meter display If this error message appears again after repeating the test call your doctor immediately to arrange for testing using another method Very low or very high test results The CoaguChek XS PT test strips provide test results if the INR value is 0 8 to 8
9. sage your finger from its base If needed immediately after lancing gently squeeze your finger from its base to encourage blood flow Step 3 Performing the test 1 Wash your hands with warm soapy water Dry completely 2 Remove 1 test strip from the container and immediately close the container Make sure it seals tightly Do not open a container of test strips or touch a test strip with wet hands This may damage the test strips 3 Insert a test strip as far as you can into the meter The meter powers ON 4 Confirm that the number displayed matches the number on the test strip container then press M If the numbers are different make sure you are using the code chip that came with the test strips you are using If they still do not match call the Roche Diagnostics Technical Service Center at 1 800 428 4674 24 hours a day 7 days a week 365 days a year CoaguChek XS 0S0 120606 coge 5 An hourglass appears as the meter warms up which takes up to 30 seconds 6 When the meter is warmed up a flashing test strip and blood drop symbol appear and the meter begins a countdown You have 180 seconds to apply blood to the test strip 7 Use the lancet device to perform a fingerstick Set the penetration depth to 5 See the CoaguChek XS System User Manual for Self Testing for more information After sticking your finger you have 15 seconds to apply blood to the test strip If it takes longer to form a good drop of blood
10. strip from the container and immediately close the container Make sure it seals tightly You must use the test strip within 10 minutes of removing it from the container Otherwise you may get an error message and you will have to repeat the test Step 1 Getting ready to test Gather supplies CoaguChek XS Meter Container of CoaguChek XS PT Test strips 04625374160 Test strip code chip ACCU CHEK Softclix lancet device and lancet CoaguChek PT Test Place the meter on a flat surface like a table or countertop or hold it roughly horizontal so that it will not vibrate or move during testing Vibrations or other movement can result in an error message If you are using test strips from a new unopened box you will need to change the test strip code chip The 3 number code on the test strip container must match the 3 number code on the code chip To install the code chip follow instructions in the Code Chip section of the CoaguChek XS System User Manual for Self Testing oo gt 200 Exp Lor 20147 Step 2 Getting a good drop of blood Increasing the blood flow in your finger will help you get a good drop of blood Before you lance your finger try the following techniques until you see that your fingertip has good color Warm your hand by holding it under your arm using a hand warmer and or washing your hand with warm water Hold your arm down to the side so that your hand is below your waist Mas
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