Manual CXS PST 573
Contents
1. u 17 Tips for a Good Fingerstick sc 17 Important Notes About Blood Testing 18 AMO 18 NO 18 INFECTION CONTFOL sesessssesscsssssesssseescsssseesssseesssssseessssseeesen 19 Preparing for a TOSt sssssssssssssecsssessssssessssecsssesssseesssseesen 20 Performing a Ila 22 Very Low or Very High Test Results 27 SU 28 Storing Test Results in Memory ssscsssseecsssseecssssecssssees 28 Reviewing Stored Test ReSuItS sssssssssecssssecsssseecsen 28 Erasing Stored Test Results scsccecscassscsdasssssssssassesencccnssanstoiecnc 30 Cleaning the Meter ireenneee 32 Cleaning GER 32 Cleaning the Test Strip Guide iinnne 33 Error Messages ccssssccsssssssssssscssssssssssssecsssssessssseeesssseesen 35 Other Information rieeeeeennee 43 FIOCUGELRIMIANO AS 43 FIODUCCOPEGHGAlONS sai 43 SUPPONI sioni 44 SOY TOONS ara 45 Wani AN onian aiaa ana AREE 48 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 symbols or abbreviations E Use by Expiration date LOT Lot number IVD For in vitro diagnostic use CEs This product fulfills the requirements of Directive 98 79 EC on in vitro diagnostic medical devices REF Cat2. M button If the numbers are different make sure you are using the code chip that came with the test strips you are using An hourglass appears as the meter warms up which takes about thirty seconds When the meter is warmed up a flashing test strip appears and the meter begins a countdown You have 120 seconds to apply blood to the test strip 23 4 Collect the Blood ze press the tip of the lancet 5 Identify the Target Area he AU Le fi sa Pe tt 24 your fingertip Press the Massage your finger until 6 Apply the Blood Within 15 seconds of you see increased color in sticking your fingertip your fingertip apply the blood to the target area of the test strip from the side of the test strip 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 Keeping your hand down firmly against the side of release button Gently squeeze from the base of your finger to develop a hanging drop of blood The result appears Find the target area in about 1 minute on the test strip To prevent error messages the meter must be on a table free of vibrations 25 26 Record the result on the CoaguChek XS System Prothrombin Time Self Testing Log Book Call your doctor with the test result 7 Record Result Remove the lancet from the
3. lt E remove the old code chip and throw it away Make sure that the 3 digit code number on the new test strip ilui container matches the 9 3 digit code number on the new code chip 2 Match Code Numbers 3 Insert New Code Chip mme N Sp W w Slide the new code chip 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 v appears following the letters QC Then the meter continues to run the blood test If the quality control test fails the meter displays this error message See the Error Messages section in this manual for an explanation of this and other error messages and what to do when they occur 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 e Warm your hand by holding it under your arm use a hand warmer and or wash your hand with warm wat
4. lancet device Place the used test strip and lancet in a puncture proof container with a lid Turn the meter off 8 Clean Up 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 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 27 Memory Storing Test Results in Memory The CoaguChek XS Meter automatically stores up to 100 test results and their dates and times in its memory lf 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 R
5. measuring range Result in the chosen unit is below the measuring range Symbol LOCO mem Lec I error Meaning 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 Automatic quality control completed successfully Reports an error see Error messages Room or meter temperature is outside the acceptable range Communication is taking place via the infrared interface Measurement chamber cover is open 47 Warranty CoaguChek XS Meter Limited 1 Year Warranty The foregoing warranty shall not apply to a meter ROCHE DIAGNOSTICS warrants to the original which is damaged by accident or subject to alteration purchaser only that the meter shall be free from all misuse tampering and or abuse including the use of defects in material and workmanship for a period of Dispatch products Meters which show damage one year from the date of purchase or misuse will be handled in accordance with the l non warranty service policy of Roche Diagnostics Purchaser s sole and exclusive remedy with respect to y pni J the CoaguChek XS meter and parts thereof shall be the The warranty of the repaired replacement meter will repair and or replacement of the meter
6. or parts at the expire on the date of the original warranty expiration or option of Roche Diagnostics ninety 90 days after shipment of a replacement THE ABOVE WARRANTY IS EXCLUSIVE OF ALL III ENE Nr Pen SONDEL 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 49 50 Roche Diagnostics 9115 Hague Road Indianapolis IN 46256 www coaguchek com
7. 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 Ld LT d al ro pan nd pm AQ Sec INR Meaning Test strip without sample application area 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 Time between midnight and noon in 12 hour time format Time between noon and midnight in 12 hour time format Indicates the results are displayed as a Quick percentage value Indicates the results are displayed in Seconds Indicates the results are displayed in INR units 45 n D f code 46 Meaning Beep tone is turned on Beep tone is turned off 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 Displays the time in HH MM format Displays the date in DD MM YY MM DD YY or YY MM DD format The monitor is in Setup Mode Indicates the code number of the code chip inserted in the meter Result in the chosen unit is above the
8. CoaguChek XS System _ User Manual for Self Testing Table of Contents About this MaNUal rieeene 1 Symbols and Abbreviations irrirereceeeeeee 1 User RESOUICES 0 cccccsccssssssssssssssssssesssssseesssssesssssseessssseessssees 2 RICE i 2 Geting Startet erre eer 2 RSF NANU rrara E der eereeeeseeceerncnies 2 Test Strip Package NSEIS cir 3 Lancet Device Package INSErtS cccscreeeeee 3 The CoaguChek XS SySteM 00e 4 Anticoagulation Medication irrrereneeene 4 bIOOA cIO MINO 4 HOW the System Works sssscsssssessssssscsssseesssssescsssseesssseessen 5 The CoaguChek XS Nel 6 Operating CONG EONS siers 7 Getting Started rieeee eee 8 TO Seam ineee and ee rips antiioteeae Batteries scenari cornea 8 covered by one or more of the following U S patents 6 662 439 7 073 246 Installing or Replacing DALLE Ne Sasa 9 A a aiaino Neler oo 10 Selling Mie Dateand TIM 11 TOCNE S DISO a 14 ACCU CHEK COAGUCHEK and SOFTCLIX are trademarks of Roche a ernia depone GOCE Gi incssieuacs ORE CARNRAR RCA A RAPACE 14 Inserting a NEW Code CID 15 2007 Roche Diagnostics All rights reserved 04999045001 0307 Integrated Quality Controls scssscssossscsssssoseessosersserese 16 Testing a Blood Sample
9. alog number i Please read instructions for use A Caution refer to accompanying documents Please refer to safety related notes in the manual accompanying this instrument Manufactured by A Store at 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 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 su
10. ch 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 number 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 rea
11. chip is damaged call the Roche Diagnostics Technical Service Center at 1 800 428 4674 37 Error Test Strip Expired The test strip has expired Error Test Strip Unusable The test strip is unusable 38 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 Inen 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 Error Time Exceeded You did not apply blood to the test strip within 120 seconds after the blood drop symbol appeared Error Blood Application Error applying blood to the test strip 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 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 39 Error Test Strip Interference The test strip was touched or removed during the test Error Quality Control Failure The test strip failed the internal quality control check The test strip i
12. dy 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 A a Ti F CoaguChek Xs B cece Somes al S CS sci UPaRaE 4a DM Operating Conditions To ensure that the CoaguChek XS Meter functions correctly follow these guidelines e Use the meter at room temperature between 65 F and 90 F 18 C and 32 C e Use the meter at a relative humidity of less than 85 without condensation e When testing keep the meter level If 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 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 lea
13. er e Hold your arm down by your side so that your hand is below your waist e 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 e Operate the meter at temperatures between 65 F and 90 F 18 C and 32 C e 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 65 F or above 90 F below 18 C or above 32 C Store the meter in damp or humid conditions greater than 85 humidity e 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 e Wait more than 15 seconds after sticking your fingertip before applying the blood Add more blood after the test has begun e Touch any buttons while a test is in progress e 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 20 Gath
14. er 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 e gt SEI to accept a setting 1 Go to Setup Mode If the meter is not already in Setup mode press the SET button The date format flashes in the upper right corner 2 Set Today s Date Press the SET button Press the M button to change the year Press the SET button Press the M button Wi to change the month Press the SET button Press the M button Wi to change the day Press the SET button Press the SET button Press the M button to change the hour Press the SET butt
15. er the following items e CoaguChek XS Meter e Container of test strips e 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 the code chip into the code chip slot until it snaps into place 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 notches for the cap to fit Select the penetration depth Press the plunger A yellow dot appears in the release button Wash your hands in warm soapy water Make sure your fingertip Is thoroughly dry Performing a Test 1 Get Ready Take a test strip out of the container Close the container tightly You have 10 minutes to use a test strip once you remove it from the container Slide the test strip into the test strip guide in the direction of the arrows until it stops W he meter turns on The code number of the inserted code chip flashes on the display 3 Match the Code Numbers Confirm that the number displayed matches the number on the test strip container then press the
16. et to 0 and 3 dashes appear Note To exit Erase mode without erasing the results press the ON OFF button instead 31 Cleaning the Meter It is important to keep the meter clean Clean the meter whenever it looks dirty or if you prefer a regular schedule clean the meter each time you open a new box of test strips Use only the following products to clean the meter 10 bleach solution 1 part bleach and 9 parts water e 70 isopropyl alcohol solution lint free tissues cotton swabs Caution Do not spray any cleaning solution on the meter Never use a spray of any type Cleaning the Exterior 1 Clean the Exterior With the meter turned off wipe the meter s exterior clean 2 Dry the Exterior With a lint free tissue dry the meter Cleaning the Test Strip Guide 1 Open the Cover 2 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 Move the cover safely away from the meter Then rinse the cover with water or wipe it clean Clean the easily accessible areas with a cotton swab Caution Do not insert any objects into the test strip guide Doing so could damage the electrical contacts behind the test strip guide 33 3 Allow to Dry With the cover off allow the test strip guide to dry for about 10 minutes 4 Close the Cover Close the cover and 7 O 4 ma
17. eviewing 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 Wi The meter turns on if it is not already on and goes to Memory mode 28 2 View Most Recent Result 3 View Earlier Results The most recent test 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 0 appears in the display s top right corner To view earlier results press the M button again After you have viewed all the results in the memory 3 dashes appear 29 30 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 Mi While you are holding down the M button press the ON OFF button and then hold down both buttons for at least 5 seconds The meter displays mem flashing and clr The number of results in memory is shown in the top right corner of the display 2 Confirm Press the M button Mi 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 s
18. ke sure it snaps into es place 34 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 oA i Then repeat the test with Aid La a new CoaguChek XS PT meter was turned on test strip The meter timed out after you inserted the test strip e The test strip is unusable e The test strip is not a CoaguChek XS PT test strip 35 Error Meter Temperature The meter is too cold or too warm to measure correctly error mr a Error Battery The battery level is too low error 36 Solution Turn the meter off and allow it to stand for about 30 minutes at room temperature between 65 F and 90 F 18 C and 32 C Solution Replace the batteries See the Batteries section of this manual Error Test Strip Guide Cover The test strip guide cover is not properly closed Error Code Chip The code chip is missing not properly inserted or damaged 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
19. ll the Roche Diagnostics Technical Service Center at 1 800 428 4674 Other Information Product Limitations Please read the information packaged with the test strips regarding up to date product specifications and limitations Operating Conditions Temperature Relative humidity Maximum altitude Placement Measuring range Memory Interface Battery operation Number of tests per set of batteries Safety class Automatic power off Dimensions Weight Product Specifications 65 F to 90 F 418 C to 32 C Less than 85 without condensation 14 000 feet 4300 m Operate the meter on a level vibration free surface or hold it so it is roughly horizontal Refer to the test strip package insert 100 test results with date and time Infrared interface LED IRED Class 1 4 AAA batteries Approx 60 tests Ill After 3 minutes 5 43 x 3 07 x 1 10 in 138 x 78 x 28 mm 4 48 oz or 127 g without batteries 43 44 Sample Material Sample type Capillary whole blood or non anticoagulated venous whole blood Sample size At least 10 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
20. on Press the M button to change the minutes Press the SET button 3 Set Current Time 4 Turn Off Turn the meter off 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 displays 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 30 po og ae E You can display all d the letters numbers and TH Gan SN ot set symbols for a longer time to allow comparison To do his h US utton The full display should appear as shown at left 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 the 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
21. rn 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 60 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 Wp inuunp Installing or Replacing Batteries Have ready 4 AAA batteries 1 Open Battery With the meter turned off Compartment turn it over Press the o latch gently inward and lift the cover Remove the old batteries if necessary 2 Insert New Batteries 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 met
22. s unusable 40 Solution Error Measurement Turn the meter off and Error remove the test strip Measurement error Repeat the test using a caused by the blood new test strip and blood sample taken from a new fingerstick from a 3 90 6 different finger error Do not touch or remove the test strip when a test is in progress 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 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 4 42 Error Internal Error An error occurred during the internal diagnostic test iCD i t error Pp Solution Turn the meter off and remove the batteries Wait at least 1 minute before re inserting the batteries into the 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 Ca
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