CoaguChek XS PST User Manual
Contents
1. Testing a Blood Sample Tips for a Good Fingerstick For fingerstick blood testing increasing the blood flow in your finger will help you get a good drop of blood Before you stick your finger try the following techniques until you see that your fingertip has good color Warm your hand by holding it under your arm use a hand warmer and or wash your hand with warm water Hold your arm down by your side so that your hand is below your waist Massage your finger from its base If needed immediately after pricking gently squeeze your finger from the base to encourage blood to flow Important Notes About Blood Testing Always Operate the meter at temperatures between 59 F and 90 F 15 C and 32 C Refer to the test strip package insert for proper use and handling of test strips Keep the test strip guide and meter clean See Cleaning the Meter section in this manual for more information Never Store the meter in extreme temperatures below 59 F or above 90 F below 15 C or above 32 C Store the meter in damp or humid conditions greater than 85 humidity Remove or insert the code chip while the meter is performing a test Use a code chip from a box of test strips other than the one in use Touch or remove the test strip during a test Wait more than 15 seconds after sticking your fingertip before applying the blood Add more blood after the te2. Do not use the meter near a strong magnetic field such as a microwave oven as this may interfere with the meter s proper operation Note The CoaguChek XS Meter automatically shuts off after 3 minutes if no buttons have been pushed Getting Started Refer to the Getting Started guide to learn how to set up the meter and prepare for and run your first blood clotting time test Batteries The CoaguChek XS Meter uses 4 AAA batteries The recommended batteries alkaline manganese batteries should last for approximately 300 tests When you turn the meter on the display briefly shows the battery symbol The battery symbol is divided into 4 segments With new fresh batteries in the meter the battery symbol shows all 4 segments When only 1 segment appears replace the batteries When only 1 segment appears you can still access results stored in the meter s memory If you insert new batteries within 1 minute of removing the old batteries the date and time settings will remain in memory But if you do need to reset the date and time refer to the Meter Setup section in this manual The meter saves battery power by automatically turning off after 3 minutes unless you press a button or insert a test strip Even when the batteries are removed the test results are saved in memory m Installing or Replacing Batteries Have ready 4 AAA batteries 1 Open Battery Compartm With the meter turned off t
3. 47 48 Sample Material Sample type Capillary whole blood or non anticoagulated venous whole blood Sample size At least 8 uL Interference Refer to the test strip package insert Non Operating Storage and Transport Conditions Temperature range 13 F to 158 F 25 C to 70 C Relative humidity 10 to 85 without condensation Support Services Questions Please call the Roche Diagnostics Technical Service Center at 1 800 428 4674 if you have questions regarding the handling of your meter the reliability of your results or if you suspect the meter is defective Repairs Please note that repairs new settings or other modifications to the meter may only be performed by persons authorized by Roche Diagnostics Symbols The following table lists all of the display screen icons and their meaning Symbol Meaning Ld Test strip without sample application area LH Test strip with sample application area Apply sample User must wait until the meter has completed an action 24 hour time format 12 hour time format am Time between midnight and noon in 12 hour time format pm Time between noon and midnight in 12 hour time format Q Indicates the results are displayed as a Quick percentage value Sec Indicates the results are displayed in Seconds INR Indicates the results are displayed in INR units 49 Mean
4. After you have viewed all the results in the memory 3 dashes appear 29 Erasing Stored Test Results You can erase all of the test results that are stored in the meter s memory You cannot however erase individual test results To erase all stored results 1 Go to Erase mode With the meter turned off press and hold down the M button Q While you are holding down the M button press the ON OFF button and then hold down both buttons for at least 5 seconds 56 The meter displays mem Ne flashing and clr The yaw number of results in memory is shown in the a la top right corner of the display 30 2 Confirm Press the M button to confirm that you want to erase the entire memory The hourglass symbol flashes while the test results are being erased Then the counter is set to 0 and 3 dashes appear Note To exit Erase mode without erasing the results press the ON OFF button instead 31 Cleaning Disinfecting the Meter Please follow the procedures below to clean and disinfect the meter Failure to follow these procedures may cause malfunction of the meter Clean the meter only when contaminated with blood Do not use sprays of any sort Ensure that swab or cloth is only damp not wet Useful tip To prevent contamination apply blood via side dosing directly from fingertip 32 Cleaning Disinfecting the exterior Use 10 bleach s
5. error Pa Sg L new fingerstick from a error different finger oe nai via UU _ Error Blood Application Solution Turn the meter off and remove the test strip Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger Error Test Strip Interference The test strip was touched or removed during the test error C S om 42 Solution Turn the meter off and remove the test strip Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger Do not touch or remove the test strip when a test is in progress NOTE For meters with serial number UP0910000 and lower 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 who are under treatment with warfarin in combination Error Quality Control Failure The test strip failed the internal quality control check The test strip is unusable error with antibiotics and or chemotherapeutics leading to extremely high coagulation times gt 10 INR lt 5 Quick In this case and if ERROR 6 is displayed repeatedly please contact your physican without delay Solution Turn the meter off and remove the test strip Repeat
6. 30 so error AN gas Error Code Chip The code chip is missing not properly inserted or damaged igor 2 3 code error AO Solution Close the test strip guide cover Solution Check to see if you have the correct code chip properly inserted into the meter For more information see the Code Chip section of this manual If the code chip is damaged call the Roche Diagnostics Technical Service Center at 1 800 428 4674 39 Error Test Strip Expired The test strip has expired Error Test Strip Unusable The test strip is unusable error NTA k 40 Solution Check the meter s date setting If it is not correct set the correct date For more information see the Meter Setup section of this manual If the date is correct turn the meter off and remove the code chip and the test strip Then use the code chip and a test strip from a new box of test strips Solution Turn the meter off remove the test strip and then re insert it If the error message reappears discard the unusable test strip and use a new one Solution Turn the meter off and remove the test strip Repeat the test using a new test strip and blood taken from a Error Time Exceeded You did not apply blood to the test strip within 180 seconds after the blood drop symbol appeared Error applying blood to the test strip Ng a
7. Take a test strip out of ae the container Close the container tightly H You have 10 minutes ngi pe to use a test strip once so you remove it from the A Rak container 2 Insert Strip Slide the test strip into p the test strip guide in the direction of the arrows until it stops W The meter turns on The code number of the inserted code chip flashes on the display 22 3 Match the Code Numbers Confirm that the number displayed matches the number on the test strip container then press the M button Ql If the numbers are different make sure you are using the code chip that came with the test strips you are using 2 An hourglass appears as the meter warms up which takes about 30 seconds W When the meter is warmed up a flashing test strip appears and the meter begins a countdown You have 180 seconds to apply blood to the test strip 23 4 Collect the Blood 5 Identify the Target Area ttt 24 ee Massage your finger until you see increased color in your fingertip Keeping your hand down press the tip of the lancet firmly against the side of your fingertip Press the release button Gently squeeze from the base of your finger to develop a hanging drop of blood Find the target area on the test strip To prevent error messages the meter must be on a table free of vibrations 6 Apply the Blood Within 15 seconds of sticking your fingerti
8. for important updates Keep the insert from your current lancet device package for future reference The CoaguChek XS System The CoaguChek XS System measures blood clotting time Prothrombin Time for people who are taking anticoagulation medications such as Coumadin or warfarin The CoaguChek XS System measures blood clotting time using blood from the fingertip Anticoagulation Medication Anticoagulation medications also known as blood thinners are prescribed to avoid unwanted clots Your blood clotting time must be monitored to ensure that your medication dosage is correct Blood clotting Time The rate at which blood clots is measured in units called INR It is very important that you stay within your target INR range If your INR is too low the risk of blood clots increases If your INR is too high the risk for internal bleeding increases Everyone s INR is different Your doctor determines the best INR range for you depending on why you are taking anticoagulants and how you react to them Your doctor also determines how often your blood should be tested Your doctor needs to know your blood clotting time in order to successfully treat you How the System Works The CoaguChek XS System includes a meter and CoaguChek XS PT test strips Each box of test strips has its own code chip that you insert into the meter The code chip contains important information about the test strips such as their expiration date and lot n
9. subject to alteration misuse tampering and or abuse including the use of Dispatch products Meters which show damage or misuse will be handled in accordance with the non warranty service policy of Roche Diagnostics The warranty of the repaired replacement meter will expire on the date of the original warranty expiration or ninety 90 days after shipment of a replacement system whichever period is longer 54 ACCU CHEK COAGUCHEK and SOFTCLIX are trademarks of Roche Manufactured for and distributed in the U S A by Roche Diagnostics 9115 Hague Road Indianapolis IN 46256 Roche Diagnostics GmbH Sandhofer Strasse 116 D 68305 Mannheim Germany www roche com www poc roche com 0 4999045001 04 2013 07 USA
10. the M button j to change the year Press the SET button Press the M button j to EEE change the month di Press the SET button Press the M button j to FIN change the day Press the SET button 3 Set Current Time Press the SET button Press the M button to change the hour Press the SET button Press the M button to change the minutes Press the SET button 4 Power Off Power the meter off D If in the future you need to change the date and time press the SET button to re enter Setup mode After you change the date and time just turn the meter off Other set up choices in the meter must be set or changed by your doctor The Meter s Display When you turn the meter on it briefly shows all the display s letters numbers and symbols Regularly check that all segments of each letter number and symbol appear Please compare your meter s display to the meter display shown here on this page O8 88 im se 88 85 88 mem 7 ON set symbols for a longer time to allow comparison To do his turn the meter c z i D I x ee ani then noid oun the SS ne utton g E Ta H The full display should appear as shown at left You can display all the letters numbers and Code Chip Each box of test strips comes with its own code chip The code chip provides the meter with information such as the lot number and expiration date of th
11. the test using a new test strip and blood taken from a new fingerstick from a different finger 43 44 Error Measurement Error Measurement error caused by the blood sample 2 00 e304 error l Solution 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 on the previous pages For example make sure the fingertip is thoroughly dry use the meter on a surface free of vibrations and apply the blood drop within 15 seconds of sticking the fingertip If you still get error 7 call your doctor immediately to arrange for testing using another method For meters with serial number UP0910000 and lower is the meter displaying ERROR 7 In rare cases patients with abnormal or unusally long clotting times may receive an ERROR 7 message If you still receive this message when you repeat the test you must use an alternative test method to confirm the result Contact your physician without delay 45 Error Internal Error An error occurred during the internal diagnostic test I i g Dalal uu we 2 3040 error A oO Error Internal Error 2 Hala uu Se a mu co ies e rro S E yi 46 Solution Turn the meter off and remove the batteries Wait at least 1 minute before re inserting the batteries into the
12. CoaguChek XS System for Self Testing The contents of this manual including all graphics and photographs are the property of Roche Diagnostics No part of this document may be reproduced or transmitted in any form or by any means electronic or mechanical for any purpose without the express written permission of Roche Diagnostics Roche Diagnostics has made every reasonable effort to ensure that all the information contained in this manual is correct at the time of printing However Roche Diagnostics reserves the right to make any changes necessary without notice as part of ongoing product development This training manual was created by the Roche Diagnostics Technical Publications department Direct questions or concerns regarding the contents of this document to Roche Diagnostics Technical Publications Department 9115 Hague Road P O Box 50457 Indianapolis IN 46250 0457 USA COAGUCHEK ACCU CHEK and SOFTCLIX are trademarks of Roche All other trade marks are the property of their respective owners 2007 2013 Roche Diagnostics US Order Number 04999045001 04 0713 Distribution in USA by Roche Diagnostics Indianapolis IN This document is available electronically at www poc roche com Revisions to this document are provided by Roche Diagnostics when necessary No part of this document may be reproduced in any form or consent Manual version Revision date by any means without prior written Chang
13. battery compartment Re set the date and time as described in the Meter Setup section of this manual Caution The date and time must be set correctly Repeat the test If you see the same error message again the meter has a defect Call the Roche Diagnostics Technical Service Center at 1 800 428 4674 Solution Because this error indicates possible damage to the heater plate contacts call the Roche Diagnostics Technical Service Center at 1 800 428 4674 to have the meter replaced Other Information Product Limitations Please read the information packaged with the test strips regarding up to date product specifications and limitations Product Specifications Operating Conditions Temperature 59 F to 90 F 15 C to 32 C Relative humidity Maximum altitude Less than 85 without condensation 14 000 feet 4300 m Placement Operate the meter on a level vibration free surface or hold it so it is roughly horizontal Measuring range Refer to the test strip package insert Memory 300 test results with date and time Interface Infrared interface LED IRED Class 1 Battery operation 4 AAA batteries Number of tests per set of batteries Up to 2 years or up to 300 tests depending on frequency of use Safety class Automatic power off After 3 minutes Dimensions Weight 5 43 x 3 07 x 1 10 in 138 x 78 x 28 mm 4 48 oz or 127 g without batteries
14. e test strip guide 35 36 3 Allow to Dry 4 Close the Cover lt With the cover off allow the test strip guide to dry for at least 10 minutes before re attaching the test strip guide cover and testing again Close the cover and make sure it snaps into place Error Messages You may see the following error messages while using the CoaguChek XS Meter If you see an error message first try to correct the problem using the solution described below If the problem persists call the Roche Diagnostics Technical Service Center at 1 800 428 4674 Error Test Strip Solution Possible causes Remove the test strip A test strip was already Then repeat the test with inserted when the meter amp New CoaguChek XS PT was turned on test strip The meter timed out after you inserted the test strip The test strip is unusable The test strip is not a CoaguChek XS PT test strip error Le LE eh 37 Error Meter Solution Temperature Turn the meter off and The meter is too cold or allow it to stand for about too warm to measure 30 minutes at room correctly temperature between 59 F and 90 F 15 C and 32 C error Error Battery Solution The battery level is too Replace the batteries low See the Batteries section of this manual error 38 Error Test Strip Guide Cover The test strip guide cover is not properly closed oo
15. e test strips Before each test make sure the correct code chip is in the meter Each time you open a new box of test strips replace the old code chip with the new one Protect the code chip from moisture and also from equipment that produces magnetic fields such as a microwave oven Inserting a New Code Chip Have the correct code chip ready 1 Remove Old Code Chip With the meter turned off SSE remove the old code chip and throw it away Make sure that the 3 digit code number on the new test strip container matches the 3 digit code number on the new code chip X gt 200 3 Insert New Code Chip Slide the new code chip RO into the code chip slot until it snaps into place Integrated Quality 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 controls When the quality control test runs the letters QC flash on the meter s display When the quality control test is finished a checkmark W appears following the letters QC Then the meter continues to run the blood test If the quality control test fails the error meter displays this error message See the Error Messages section in this manual for an explanation of this and other error messages and Sac what to do when they occur
16. erting a New Code Chil csccsscsssssssssssssesssssessssseess 15 Integrated Quality Controls scsceeeeeeseeeeteeeeeee 16 Testing a Blood Sample ceecccccccseesssssssesseeeeseeen 17 Tips for a Good FINGerstiCk sssssssssssssssssssssssssssssssssssssesse 17 Important Notes About Blood Testing 18 PU s e ere ad 18 Nev r ga ees 18 Infection Contoleerismesne 19 Preparing for a TesStancerncer 20 Perfonming a TeSt S 22 Very Low or Very High Test Results 27 PVN NOY soiree eect nnermerammamaaaienn 28 Storing Test Results in M MOTY cssssssssssssssssssesssssecsssseess 28 Reviewing Stored Test Results csceseeeeeeeee 28 Erasing Stored Test Results s s scseseeeeeeee 30 Cleaning the Meter ccccscsessssssssseeseeeetmenneseese 32 Cleaning the Exterior cits ichcxsscaicstcaciesinchcantvcicttachabelacncbetsinian 32 Cleaning the Test Strip Guiide ssssssssssssssessssssssssssees 33 Error NGSSAQGS cette eS 35 Other Information eessssssssssssssesssssesssssesssssessssseesees 43 Product LIMItatlOrS iziii 43 Product Specifications iisiiisieies 43 SUPPO SENICE S i sisir 44 Sy MUG Ss ennei 45 Disposal of the Meter Test Strips Lancets and BAWGNIES eenean E n ES 50 Warranty ansisansanonaniiaaa 51 About this Manual Symbols and Abbreviations The test strip insert the label on the back of the meter the User Manual and other packaging material may contain the following
17. es Version 2 0 November 2009 New document Version 3 0 March 2011 Revised to update meter images add disposal information and update product specifications section Version 4 0 July 2013 Revised ERROR 6 and ERROR 7 verbiage Table of Contents About this Manual i ceccccccccesessstesceseeeeeeeeseeeeeeeeeeeeneee 1 Symbols and Abbreviations ccsssscsssssscsssseessseseeseeeeesseseeeseee 1 User Resources cscceacircscransaemitaeedian 2 Training DVD seresa 2 GETING Started assins iia 2 User Manualin 2 Test Strip Package Inserts n u ssusosssv1esuos11uoo1tnorr1uo1nrtnon 10 3 Lancet Device Package INSEItS ssssssssssssssssessseeeeeeee 3 The CoaguChek XS System s 11s11s11s1ss11s1rsrrs1ss1 4 Anticoagulation Medication scccssssssssssssseeesseseessee 4 Blood clotting Tie eeessssssssseccccccccessssssssttseeeeeesesesesseeeesssaee 4 How the System Works qu sssssssssssssssssssseetssssetssssettstetteteee 5 The CoaguChek XS Meter esssssssssssssssssssssssssssssssssssssssssssssses 6 Operating Conditions ccccscsssssssssssssssssssssssssssssssssssssssssssssseees 7 Getting StANTEG access enertre ome eeccneemnaneees 8 Batterie Sie ee eee 8 Installing or Replacing Batteries ssc 9 Meter SEU reisiin 10 Setting the Date and Time esssssssssssscsssssssssssessssssesssseees 11 The Meters Display izes ccc tinction das 14 Code IAI esse ciaacciasstinitstn tain nE 14 Ins
18. ing Beep tone is turned on Beep tone is turned off Bon Result is above the chosen therapeutic range only with INR as unit Result is below the chosen therapeutic range only with INR as unit Results in the chosen unit Error numbers Memory contains no results or no further results 0 00 Displays the time in HH MM format goo Displays the date in DD MM YY MM DD YY or YY MM DD format The monitor is in Setup Mode set Indicates the code number of the code chip code inserted in the meter Result in the chosen unit is above the gt measuring range lt Result in the chosen unit is below the measuring range 50 Symbol Meaning mem Battery status When the batteries still have their full charge all segments are lit Individual segments disappear one by one as the batteries become weaker When there is no segment remaining you can no longer perform a test You can however still access the meter s memory The meter is in Memory Mode L ocv fi Automatic quality control completed successfully error Reports an error see Error messages Room or meter temperature is outside the acceptable range i Communication is taking place via the infrared interface ZN Measurement chamber cover is open 51 52 Disposal of the Meter Test Strips Lancets and Batteries A Any product coming in contact with blood
19. is considered contaminated potentially infectious During normal testing the meter may come in contact with blood Lancing devices may also be considered sharps Disposal of sharps is regulated by law in many jurisdictions The European Union has a requirement for improving waste management practices for certain electronic equipment but meters fall outside the scope of the European Directive 2002 96 EC This is not a requirement for the United States however Roche is committed to recycling and sustainability Please consider the following points when disposing of your used testing materials Comply with any laws or ordinances relating to the disposal of sharps and or contaminated products Contact your local health department or other appropriate authorities for proper handling and disposal of used meters used test strips used lancets and used batteries Consider recycling of the meters and batteries at an appropriate facility Be aware the meter is potentially hazardous electronics scrap e scrap and should be disposed of accordingly The batteries are potentially hazardous also and should be disposed of accordingly Decontaminate the meter before recycling or disposing Wipe the outside of the meter with dilution of bleach solution one part bleach to nine parts water Users in professional environments i e healthcare professionals should follow the existing policies and procedures governing the proper handling and di
20. olution 1 part bleach and 9 parts water or 70 isopropyl alcohol rubbing alcohol to clean and disinfect the meter housing the exterior of the meter Ensure that the blue test strip guide cover remains tightly closed while cleaning the housing Clean Disinfect the Exterior i 2 Dry the Exterior A With the meter turned off wipe the meter s exterior clean Do not let liquid accumulate near any opening Make sure that no liquid enters the meter With a lint free tissue wipe away residual moisture and fluids after cleaning the housing Allow wiped areas to dry for at least 10 minutes before IO a test 33 Cleaning Disinfecting the Test Strip Guide Use 10 bleach solution 1 part bleach and 9 parts water or 70 isopropyl alcohol rubbing alcohol to clean the test strip guide With the meter turned off use your thumbnail to open the cover of the test strip guide by pressing its front edge upward 1 Open the Cover 34 2 Clean Disinfect the Test Sirip Guide P Hold the meter upright with the test strip guide facing down Clean the easily accessible areas with a cotton swab Be sure the swab is only damp not soaking wet to ensure excess fluid does not enter the meter Wipe away residual moisture and fluids Caution Do not insert any objects into the test strip guide Doing so could damage the electrical contacts behind th
21. ou see error 7 this means the meter was unable to detect a clot Repeat the test Be sure to carefully follow the steps on the previous pages For example make sure the fingertip is thoroughly dry use the meter on a surface free of vibrations and apply the blood drop within 15 seconds of sticking eni e300 the fingertip If you still get error 7 call your doctor immediately to arrange for testing using another method 27 28 Memory Storing Test Results in Memory The CoaguChek XS Meter automatically stores up to 300 test results and their dates and times in its memory If the memory is full when you perform a test the oldest result is automatically deleted The most recent result is always saved Note All test results remain in memory even when the meter is without batteries Reviewing Stored Test Results You can review stored test results even when the meter s battery power is low To review results in memory 1 Access the Memory Press the M button Y The meter turns on if it is not already on and goes to Memory mode 2 View Most Recent The most recent test Result result appears The letters mem indicate that you are viewing a result in memory The time and date of the test also appear If there are no results in memory a O appears in the display s top right corner 3 View Earlier Results To view earlier results press the M button j again
22. p apply the blood to the target area of the test strip from the side of the test strip W Hold the blood drop to the test strip until you hear a beep The flashing blood drop symbol disappears Do not add more blood to the test strip Do not touch the test strip W The result appears in about 1 minute 25 26 7 Record Result Record the result on the CoaguChek XS System Prothrombin Time Self Testing Log Book Call your doctor and or the service provider that provides your test strips and the handling of your test results Log Book My CoaguChek XS Meter Serial il Number Dare Tne ets 100 am ta 8 Clean Up Remove the lancet from the lancet device Place the used test strip and lancet in a puncture proof container with a lid Turn the meter off If the meter is dirty wipe it clean with a lint free tissue and an approved cleaning solution See Cleaning the Meter section of this manual Very Low or Very High Test Results The CoaguChek XS PT test strips provide test results if the INR value is between 0 8 and 8 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 result either lt 0 8 or gt 8 0 call the Roche Diagnostics Technical Service Center at 1 800 428 4674 lt MD on gt 0M Ah Ale If y
23. sposal of potentially infectious waste e scrap and batteries 29 CFR 1910 1030 Bloodborne pathogens Directive 2002 96 EC Directive on waste electrical and electronic equipment WEEE Warranty CoaguChek XS Meter Limited 2 Year Warranty ROCHE DIAGNOSTICS warrants to the original purchaser only that the meter shall be free from all defects in material and workmanship for a period of two years from the date of purchase Purchaser s sole and exclusive remedy with respect to the CoaguChek XS meter and parts thereof shall be the repair and or replacement of the meter or parts at the option of Roche Diagnostics THE ABOVE WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES AND ROCHE DIAGNOSTICS MAKES NO OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE TO THE PURCHASER OR ANY OTHER PERSON FOR ANY INCIDENTAL CONSEQUENTIAL INDIRECT SPECIAL OR PUNITIVE DAMAGES ARISING FROM OR IN ANY WAY CONNECTED WITH THE PURCHASE OR USE OF THE METER NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IF ANY IS IMPLIED FROM THE SALE OF THE COAGUCHEK XS METER NO WARRANTY EXPRESS OR IMPLIED IF ANY SHALL EXTEND FOR A LONGER DURATION THAN THE DURATION OF THE EXPRESS WARRANTY STATED ABOVE 53 Warranty The foregoing warranty shall not apply to a meter which is damaged by accident or
24. st has begun Touch any buttons while a test is in progress Perform a test with a drop of blood from a previous fingerstick Infection Control The ACCU CHEK Softclix lancet device is intended for use by a single person and is not suitable for use where testing different persons with the same device may lead to infections Preparing for a Test 1 Gather Items CoaguChek PT Test 20 bs gt 2001 Eon Gather the following items CoaguChek XS Meter Container of test strips Test strip code chip ACCU CHEK Softclix lancet device and lancet Each box of test strips comes with a matching code chip Every time you open a new box of test strips you must replace the code chip Make sure the 3 digit code number on the test strip container and the code chip match 3 Insert Code Chip Make sure the meter is turned off With the code number facing up insert a the code chip into the code chip slot until it snaps into place 4 Prepare Lancet Device Pull off the cap of the lancet device Insert a new lancet Twist off the lancet s protective cap Put the cap back on the lancet device Line up the S notches for the cap to A fit Select the penetration depth Press the plunger A yellow dot appears in the release button 5 Wash Hands Wash your hands in warm soapy water Make sure your fingertip 4 is thoroughly dry Performing a Test 1 Get Ready
25. symbols or abbreviations z LOT Use by Batch code Lot number In vitro diagnostic medical device Catalog number Consult instructions for use Caution consult accompanying documents Refer to safety related notes in the manual accompanying this instrument Manufacturer Temperature limitation Store at The system fulfills the Canadian and U S safet requirements UL LISTED in accordance with UL 61010A 1 02 and CAN CSA C22 2 No 61010 1 04 User Resources Several resources are available to help you use and maintain the CoaguChek XS System Training DVD The CoaguChek XS System DVD is for new users of the CoaguChek XS System This program will help you get comfortable with the CoaguChek XS Meter and the testing procedure Getting Started The Getting Started guide shows you how to perform your first coagulation test on the CoaguChek XS Meter User Manual This CoaguChek XS System User Manual is a comprehensive guide to the meter and test strips It is designed to provide answers to your questions about the meter s operation and use Read this entire manual carefully and refer to it as necessary Test Strip Package Inserts Be sure to read the test strip package insert for important updates and keep the insert from your current test strip package for future reference Lancet Device Package Inserts Be sure to read the lancet device package insert to learn how to use the lancet device and
26. umber The CoaguChek XS System makes measuring blood clotting time easy The display on the meter guides you through the testing process With the code chip inserted in the meter you simply insert a test strip and apply a blood sample when the meter is ready The meter displays the result in about a minute The meter automatically stores the result in memory so that you can easily recall results The CoaguChek XS PT test strip contains various ingredients When a blood drop is applied the meter starts the test and the blood mixes with the ingredients on the test strip When the meter determines that the blood has clotted it stops the measurement and calculates the result The CoaguChek XS Meter A Display F Battery Compartment B M Memory Button Cover C ON OFF Button G Code Chip Slot D Test Strip Guide Cover H SET Button E Test Strip Guide Data Port CoaguChek XS e e hi F CoaguChek XS tad Soy ae BG avin e y n J H Operating Conditions To ensure that the CoaguChek XS Meter functions correctly follow these guidelines Use the meter at room temperature between 59 F and 90 F 15 C and 32 C Use the meter at a relative humidity of less than 85 without condensation When testing keep the meter level f you store the meter for a period of time remove the batteries Do not use the meter at an altitude higher than 14 000 feet 4 300 meters
27. urn it over Press the latch gently inward and lift the cover Remove the old batteries if necessary Position the batteries according to the diagram inside the battery compartment Replace the cover Turn the meter back over Whenever you put batteries in the meter it automatically goes to Setup mode 3 Turn Off Turn the meter off Meter Setup The CoaguChek XS Meter is preset with the U S date format month day year and U S time format 12 hour as opposed to 24 hour Before you use the meter for the first time or if there is no battery power for more than 1 minute you ll have to set the current date and time Setting the Date and Time The date and time settings are important Each time you run a test the meter compares its date with the test strip s expiration date If the test strips are expired the meter displays an error message and prevents you from running a test Whenever you put batteries in the meter it automatically goes to Setup mode where you set the date and time You can also go to Setup mode at any time by pressing the SET button To set the date and time you ll use these buttons to change a setting SET to accept a setting 1 Go to Setup Mode If the meter is not already in Setup mode press the SET button AZ 12 3 40 The date format flashes Bi in the upper right corner 2 Set Today s Date Press the SET button Press
Download Pdf Manuals
Related Search