User Manual - CoaguChek USA
Contents
1. mem cra Automatic quality control completed successfully Reports an error see Error messages error Room or meter temperature is outside the E acceptable range c Communication is taking place via the infrared interface 7 A Measurement chamber cover is open 55 Disposal of the Meter Test Strips Lancets and Batteries Any product coming in contact with blood is considered AN 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 disposed2. 20 Qut of Range Valilerin 24 Optional Testing Methods eissii 25 Using Capillary Tubes E Using Venous Blood disent Storing Test Results in Memory 30 Reviewing Stored Test Results ss 30 Erasing Stored Test Results s 32 Cleaning the Meter a 94 Cleaning the Exterior ascessi 34 Cleaning the Test Strip Guide 35 Advanced Features cree nee te nenen nn 37 Setting Advanced Features 38 The Meter s Display rrr rennen nnn 39 Error Messages ns ssssssseoneesesneessoneseesnensesnesceneesseneesconeessonsensoneenee Error Messages You May See After You Apply Blood Other Information cere ceenesnntnnns 48 Ordering Information for Health Care Professionals 48 Product EImit tiOris ieue es 48 Product SpecifIGatlOrs iseete tesi tteretatcctesrtcoeeetada 49 Support Services rtt s 50 ce ed 51 Disposal of the Meter Test Strips Lancets and Batteries 54 Wamani sinen desta Re 55 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 m Use by LOT Batch code Lot number IVD In vitro diagnostic medical device REF Catalog number m
3. press and hold down the M button KI 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 XM to confirm that you want to erase the entire memory Note To exit Erase mode without erasing the results press the ON OFF button instead The hourglass symbol flashes while the test results are being erased Then the counter is set to 0 and 3 dashes appear 33 34 Cleaning Disinfecting the Meter It is important to follow the procedures below to clean and disinfect the meter Failure to follow these procedures may cause malfunction of the meter Do not use sprays of any sort Ensure that swab or cloth is only damp not wet Cleaning Disinfecting the Exterior Use only the following items for cleaning disinfecting the CoaguChek XS meter housing for a contact time of gt 1 minute 70 isopropyl alcohol 10 Sodium hypochlorite solution 1 part bleach to 9 parts deionized water made fresh every 24 hours Note Do not use any other disinfectants cleaning solutions on the meter housing 1 Clean Disinfect the Exterior With the meter powered off F wipe the meter s exterior Ka e clean Do not let liquid accumulate near any opening Make sure that no liquid enters the
4. Laboratory Standards Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissue Approved Guideline NCCLS document M29 A 1997 Dispose of used items according to the disposal policy of your facility Preparing for a Test 1 Gather Items 2 Match Codes Gather the following items CoaguChek XS Meter Container of test strips Test strip code chip CoaguChek lancet Make sure the code number on the test strip container and the code chip match 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 3 Insert Code Chip Make sure the meter is powered off With the code number facing up insert the code chip into the code chip slot until it snaps into place Have the patient wash his or her hands in warm soapy water Or clean the fingertip with an alcohol wipe 4 Wash Hands Make sure the fingertip is Mii thoroughly dry eu A 20 Performing a Test 1 Get Ready pm PT Test l wa gts Bury E 2 Insert Strip Take a test strip out of the container Close the container tightly Do not open a container of test strips or touch a test strip With wet hands or wet gloves This may damage the test strips You have 10 minutes to use a test strip once you remove it from the container Slide the test
5. 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 power 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 powering 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 Installing or Replacing Batteries Have ready 4 AAA batteries With the meter powered off turn it over Press the latch gently inward and lift the cover Remove the old batteries if necessary 1 Open Battery Compartment Position the batteries according to the diagram inside the battery compartment Replace the cover Turn the meter back o
6. 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 When viewing results in memory results can be changed between INR and Seconds by pressing the Set button on the meter side This allows the user to toggle between seconds and INR Note All test results including their date and time 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 Memiaiy Press the M button KT The meter powers on if it is not already on and goes to Memory mode 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 di After you have viewed all the results in the memory 3 dashes appear 31 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 55 T 577 3 m Pv i 32 With the meter powered off
7. meter 2 Dry the Exterior With a lint free tissue dry the meter Wipe away residual moisture and fluids after cleaning the housing Allow wiped areas to dry for at least 10 minutes before performing a test Cleaning Disinfecting the Test Strip Guide Use only 70 isopropyl alcohol or 10 bleach solution to clean the CoaguChek XS test strip guide Do not use any other cleaning disinfecting solutions on the test strip guide Use of other cleaning disinfecting solutions could result in damage to the meter 1 Open the Cover With the meter powered 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 2 Clean Disinfect the Test Hold the meter upright with Strip Guide the test strip guide facing down Clean the easily accessible areas with a cotton swab Ensure the swab is only damp not wet Apply cleaning agent for a contact time of 1 minute refer to the corresponding product labeling Wipe away residual moisture and fluids 35 36 Caution Do not insert any objects into the test strip guide Doing so could damage the electrical contacts behind the test strip guide 3 Allow to Dry 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 aga
8. 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 You can display all the letters numbers and symbols for a longer time to allow comparison To do this you will power the meter on and then hold down the ON OFF button The full display should appear as follows dB BB ww BB BB OB code error mem fe CN set t gem m A 2LILILI S mu um MD LULA is B Lac Cs 39 40 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 Roche Diagnostics Technical Service Center at 1 800 428 4674 24 hours a day 7 days a week Error Test Strip Solution A test strip was already Remove the test strip Then inserted when the meter was repeat the test with a new powered on If you did not CoaguChek XS PT test strip remove the test strip after the last test you will see this error This error could also occur if 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 UU 23040 error L1 m Error Meter Temperature The meter is too cold or too warm to measure correctly error id di Solution Pow
9. or nonanticoagulated venous whole blood Anticoagulation Medication Anticoagulation medications also known as blood thinners are prescribed to avoid unwanted clots Blood clotting time must be monitored to ensure that a patient s medication dosage is correct Blood clotting Time The rate at which blood clots is measured in units called INR It is very important for patients to stay within their target INR range If the INR is too low the risk of blood clots increases If the INR is too high the risk for internal bleeding increases Everyone s INR is different The patient s doctor determines the best INR range for the patient depending on why the patient is taking anticoagulants and how the patient reacts to them The doctor also determines how often the patient s blood should be tested The doctor needs to know the patient s blood clotting time in order to successfully treat the patient 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 meter and test strips work together to provide a safe and reliable system for testing blood clotting time 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 inse
10. the test strip E 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 il The result appears in about 1 minute 7 Record Result Record the result according to your facility s guidelines 8 Clean Up Place the used test strip and lancet in an approved container Power the meter off If the meter is dirty wipe it clean With a recommended cleaner 23 24 Out of Range Values The CoaguChek XS PT test strips provide test results if the INR value is 0 8 and 8 0 If the result falls outside of this range the meter displays lt less than 0 8 or gt greater than 8 0 If the meter indicates an out of range value refer to the test strip package insert and repeat the test In rare cases an error 7 message can occur in patients with long coagulation times gt 8 INR If this error message appears again when the test is repeated the result must be checked using another method lt FUL op ri LU INR LUI INR Optional Testing Methods Using Capillary Tubes You may use capillary tubes to collect the blood from a fingerstick and to dose the test strip Use only CoaguChek Capillary Tubes Bulbs REF 11621173001 Do not use glass capillary tubes or capillary tubes that contain anticoagulants The following steps are optional to the fingerstick blood sample
11. C Refer to the test strip package insert for proper use and handling of test strips Keep the test strip guide and meter clean You may occasionally need to clean them See the Cleaning the Meter section in this manual for more information Never 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 Open a container of test strips or touch a test strip with wet hands or wet gloves Touch or remove the test strip during a test Wait more than 15 seconds after sticking the fingertip before applying the blood Add more blood after the test 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 Follow appropriate infection control guidelines Use gloves Use a separate lancet for each person Dispose of used lancets and test strips in a stable container with a lid according to infection control guidelines Follow all other hygiene and safety procedures applicable Caution There is a potential risk of infection Medical staff and other persons using the CoaguChek XS Meter to perform tests on more than one patient must be aware that any object coming into contact with human blood is a potential source of infection See National Committee for Clinical
12. CoaguChek XS System User Manual This is a CLIA waived system 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 is a trademark of Roche DISPATCH is a registered trademark of Caltech Industries Inc All other trademarks are property of their respective owners 2011 2013 Roche Diagnostics US Order Number 04837991001 05 0913 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 by any means without prior
13. 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 5 43 x 3 07 x 1 10 in 138 x 78 x 28 mm Weight 4 48 oz or 127 g without batteries 51 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 52 Symbols The following table lists all of the display screen icons and their meaning Symbol Meaning Ld Test strip without sample application area L Test strip with sample application area d 4 Apply sample User must wait until the meter has comple
14. NECTED 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 The foregoing warranty shall not apply to a meter which is damaged by accident or 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 Roche Diagnostic s non warranty service policy 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 57 Notes COAGUCHEK is a trademark of Roche Distribution in the USA by Roche Diagnostics 9115 Hague Road Indianapolis IN46256 Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany www poc roche com 0 4837991001 05 2013 09 USA
15. ange the month Press the 3 100 SET button Press the M button XM to change the day Press the SET button ego The time format flashes in the as upper left corner 3 Set Current Time Press the SET button Press the M button XM to change the hour Press the agen SET button Press the M button XM to change the minutes Press the SET button ZN dar 4 Power Off Power the meter off 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 powered off Ni lt J remove the old code chip and throw it away e 2 Match Codes Make sure that the three number code on the new test strip container matches the three number code on the new code chip Slide the new code chip into the code chip slot until it snaps into place 3 Insert New Code Chip Z E n Integrated Quality Controls The CoaguChek XS System has quality con
16. d the internal quality control check The test strip is unusable error 46 Solution Power 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 Measurement Error Measurement error caused by the blood sample error sy a E Solution Do not touch or remove the test strip when a test is in progress Be sure to apply the blood drop to the test strip within 15 seconds of sticking the fingertip In rare cases error 7 message can occur in patients with long coagulation times 8 INR If this error message appears again when the test is repeated the result must be checked using another method The CoaguChek XS PT test strip may be used for patients under a combination therapy of oral anticoagulants plus heparin injections Under no circumstances should heparinized capillary tubes be used for sample application If capillary tubes are used please use only the dedicated CoaguChek capillary tubes In rare cases patients with abnormal or unusally long clotting times may receive an ERROR 7 message 47 If you still receive this message when you repeat the test you must use an alternative test method to confirm the result Error Internal Error Solution An error occurred during the Power the meter off and internal diagnostic test remove the batteries Wait at lea
17. e Consult instructions for use Caution consult accompanying documents Refer to safety related notes in the manual accompanying this instrument gt Manufacturer E Temperature limitation Store at The system fulfills the Canadian and U S safety USTED 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 Video DVD Format The CoaguChek XS System Video is for new users of the CoaguChek XS System The video 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 The CoaguChek XS System The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy The CoaguChek XS System uses fresh capillary
18. er the meter off and allow it to stand for about 30 minutes at room temperature between 59 F and 90 F Error Battery The battery level is too low error iti Solution Replace the batteries See the Batteries section of this manual 41 Error Test Strip Guide Cover Solution The test strip guide cover is Close the test strip guide not properly closed COVer COD E3070 SZ yerror yi Error Code Chip Solution The code chip is missing Check to see if you have not properly inserted or the correct code chip damaged properly inserted in the meter ve ET For more information see eO te 3040 the Code Chip section of rcode error this manual p If the code chip is damaged call Roche Diagnostics Technical Service Center at 1 800 428 4674 42 Error Test Strip Expired Solution The test strip has expired Check the meter s date setting If it is not correct set Eds the correct date For more ul information see the Meter RK ut Setup section of this manual em p al X If the date is correct power 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 Error Test Strip Unusable Solution The test strip is unusable Power the meter off remove the test strip and then re insert it If the error message reappears discard A l i P the unusable tes
19. in 4 Close the Cover Close the cover and make sure it snaps into place Advanced Features The CoaguChek XS Meter includes advanced features that you can set up as necessary They are Changing the unit of measurement Disabling the beep With the beep enabled the meter beeps when it detects a test strip when it is ready for you to apply a sample when it detects a sample when the result is displayed and when an error occurs 3 short beeps Setting a therapeutic range for INR only The following table shows the setting options and the default setting for each advanced feature Feature Setting Options Unit Q Sec INR Beep On Off Therapeutic range On for INR only Off Set range Lower range 1 5 3 5 in INR Upper range 2 5 4 5 Default Setting INR On Off 1 5 INR 2 5 INR 37 Setting Advanced Features You can access these settings by going to Setup mode To go to Setup mode press the SET button The date format flashing will appear Once you are in Setup mode you ll use these buttons M to change a setting to accept a setting and move on to the next setting Note When you go to Setup mode the date format date time format and time settings appear first Press the SET button to move past the date and time settings to get to the advanced settings 38 The Meter s Display When you power the meter on it briefly shows all the display s letters
20. infection control guidelines 27 Using Venous Blood You may use the CoaguChek XS Meter to test venous blood Blood may be collected directly using a butterfly or a needle and syringe Do not clean the syringe tip with alcohol or water prior to dosing the test strip Use only a plastic syringe free of anticoagulant Do not use glass The syringe needle should be 23 gauge or larger A 21 gauge or larger needle is recommended Note Refer to the Preparing for a Test and Performing a Test sections of this manual for fingerstick blood testing instructions 1 Collect the Venous Sample When the flashing test strip appears on the meter s display collect the venous blood sample Do not perform venipuncture until the flashing test strip is displayed 28 2 Dose the Test Strip Discard the first 4 drops of blood Then immediately place 1 hanging drop of blood directly onto the target area of the test strip Completely cover the target area Do not touch the test strip Do not introduce air bubbles move the meter or add more blood during testing 3 Record Result Record the result according to your facility s guidelines 4 Dispose of Blood After testing discard the Collection Items needle syringe or butterfly and used test strip according to infection control guidelines 29 30 Memory Storing Test Results in Memory The CoaguChek XS Meter automatically stores up to 300 test results and their
21. instructions in the Preparing for a Test and Performing a Test sections of this manual 1 Prepare the Capillary Tube Firmly insert the end of the capillary tube into the capillary bulb Completely insert the tube into the bulb to break the bulb diaphragm Do not push the capillary tube in so far that it extends beyond the top of the bulb 25 26 2 Fill the Capillary Tube 3 Dose the Test Strip When the flashing test strip appears on the meter s display stick the fingertip Then touch the capillary tube to the blood drop Keep the tube level and allow it to fill by capillary action Fill the tube only halfway Avoid getting air bubbles into the sample Do not touch the hole at the top of the bulb If blood gets into the bulb during sample collection discard the bulb and repeat the test with a new test strip and fingerstick Within 15 seconds of sticking the fingertip apply the blood to the test strip Put your finger over the hole at the end of the capillary tube Hold the capillary tube directly over the target area of the test strip Squeeze the bulb to dispense one hanging drop of blood Do not touch the test strip move the meter or add more blood during testing 4 Record Result Record the result according to your facility s guidelines 5 Dispose of Blood After testing discard the Collection Items capillary tube along with the used test strip and lancet according to
22. 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 disposal 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 1 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 one year 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 Roche Diagnostic s option 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 CON
23. rted in the meter you simply insert a test strip and apply a blood sample 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 m OO W Display M Memory Button ON OFF Button Test Strip Guide Cover Test Strip Guide F Battery Compartment Cover G Code Chip Slot H SET Button Data Port CoaguChek XS pue wd um ere ax Lo UP8202 140 AREA 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 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
24. st 1 minute before re inserting the batteries in the battery compartment error SS ri Pd Re set the date and time as m described in the Meter Setup rd lt s 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 48 Error Internal Error 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 49 Other Information Ordering Information for Health Care Professionals Please contact Roche Diagnostics Customer Service at 1 800 428 5076 REF Cat Number CoaguChek XS System 04837975001 includes carrying case CoaguChek XS PT Test 04625315160 2 x 24 tests CoaguChek Lancets 04348150001 Box of 200 Capillary Tubes Bulbs 11621173001 Product Limitations Please read the information packaged with the test strips regarding up to date product specifications and limitations 50 Product Specifications Operating Conditions Temperature 59 F to 90 F 15 C to 32 C Relative humidity less than 85 without condensation Maximum altitude Placement 14 000 feet 4300 m Operate the meter on a level vibration free surface or hold it so it is roughly horizontal Measuring range Refer to test strip package insert
25. strip into the test strip guide in the direction of the arrows until it stops il The meter powers on The code number of the inserted code chip flashes on the display 3 Match the Code 4 Collect the Blood Confirm that the number displayed matches the number on the test strip container then press XM If the numbers are different make sure you are using the code chip that came with the test strips you are using Z An hourglass appears as the meter warms up which takes about thirty 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 Twist the protective cap off the CoaguChek lancet Massage the finger until you see increased color in the fingertip Keeping the hand down press the tip of the lancet firmly against the side of the fingertip Press the blue trigger button Gently squeeze from the base of the finger to develop a hanging drop of blood 22 5 Identify the Target Area Find the target area on the test strip You can dose the target area by bringing the patient s finger to the top of the test strip or by bringing the meter to the patient s finger so that the side of the test strip touches the blood drop 6 Apply the Blood Within 15 seconds of sticking the fingertip apply the blood to the target area of the test strip either from the top or side of
26. t strip and am use a new one error S 43 Error Messages You May See After You Apply Blood Solution Error Time Exceeded You did not apply blood to the test strip within 180 seconds after the blood drop symbol appeared error t Te Iu 1 em Ex i Error Blood Application Error applying blood to the test strip error wame w l TA 44 Power the meter off and remove the test strip Repeat the test using the same test strip and blood taken from a new fingerstick from a different finger Solution Power 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 KY o Solution Power 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 In rare cases ERROR 6 may indicate extremely high coagulation times 10 INR 596 Quick If ERROR 6 is displayed repeatedly the result must be checked using another method 45 Error Quality Control Failure The test strip faile
27. ted an action eh 24 hour time format ich 12 hour time format Time between midnight and noon am in 12 hour time format m Time between noon and midnight p in 12 hour time format Mel Indicates the results are displayed as a 9 Quick percentage value Indicates the results are displayed in Sec PT Seconds Indicates the results are displayed in INR units 53 Meaning Beep tone is enabled Beep tone is disabled 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 BE BB Displays the time in HH MM format BE BHBB Displays the date in DD MM YY MM DD YY or YY MM DD format The monitor is in Setup Mode set d 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 54 Symbol Meaning T 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
28. trol functions integrated into the meter and test strips so you never have to run quality control tests with liquid quality controls The meter automatically runs its own quality control test as part of every blood test When the quality control test runs the letters QC flash on the meter s display When the quality control test completes 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 the following 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 error Testing a Blood Sample Tips for a Good Fingerstick For fingerstick blood testing increasing the blood flow in the finger will help you get a good drop of blood Before you prick the finger try the following techniques until you see that the fingertip has good color Warm the hand by having the patient hold it under his or her armpit use a hand warmer and or wash the hand with warm water Have the patient hold his or her arm down to the side so that the hand is below the waist Massage the finger from its base If needed immediately after pricking gently squeeze the 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
29. ver 3 Power Off Power 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 In addition the meter has certain advanced features that you can set up if you plan to use them See the Advanced Features section in this manual to learn more about the advanced features and how to set them up 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 M to change a setting gt 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 23 HB upper right corner u qx 2 Set Today s Date Press the SET button Press the M button XM to change the year Press the SET button Press the M button I to o0 ch
30. written consent Manual version Version 3 0 Revision date November 2009 Changes New document Version 4 0 March 2011 Revised to update meter pictures remove patent information add disposal information and update product specifications section Version 5 0 September 2013 Revised ERROR 6 verbiage Table of Contents About this Manual nre nnnnt nnnm tenta nen Symbols and Abbreviations iD OQ Getting Started User Manual Test Strip Package Inserts 2 The CoaguChek XS System 3 Anticoagulation Medication a 3 Blood clotting Time trt 3 How the System Works retten 4 The CoaguChek XS Meter ttn 5 Operating Conditions nnns 6 Getting Started ressent rtnnnnnnia 7 sh 7 Installing or Replacing Batteries 8 Marg e 9 Setting the Date and Time 9 Code Chip a 4 12 Inserting a New Code Chip wn 12 Integrated Quality Controls 14 Testing a Blood Sample 15 Tips for a Good Fingerstick lt 15 Important Notes about Blood Testing 16 Always tenen 16 Never 16 Infection Control se 17 Preparing for a Test 2 18 Performing a Test
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