I have 3 Roche Coaguchek XS Plus meters that were used in the past with no known operator ID’s and I can’t get to the admin screens to set up for use. how do I do a factory reset on the units so I can set them up for use again?

Summary of Contents for Roche CoaguChek XS Plus

Page 1 CoaguChek XS Plus ® System User Manual For meters shipped before January 2013 This is a CLIA waived system.
Page 2 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 written consent. Manual version Revision date Changes 05021464001 (01) June 2009 New document...
Page 3 (prothrombin time, PT, Quick value) with CoaguChek XS PT test strips. Please note: This manual contains the information you need to operate and care for the CoaguChek XS Plus System. Please read this entire manual carefully before you use the meter.
Page 5 CoaguChek XS Plus ® User Manual Version 3.1 For meters shipped before January 2013 0 8103062001 (01) 2016-08 USA...
Page 6 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.
Page 7 Consult instructions for use Global Trade Item Number Rx Only For prescription use only © 2007-2016, Roche Diagnostics. US Order Number: 0 8103062001 (01) 2016-08 USA Distribution in USA by: Roche Diagnostics, Indianapolis, IN This document is available electronically at www.coaguchek-usa.com.
Page 9: Table Of Contents
The CoaguChek XS Plus System The CoaguChek XS Plus System Introduction .......................... The CoaguChek XS Plus System ....................7 Test principle ............................8 Contents of the pack..........................8 Safety information ..........................9 Operating conditions ........................10 Quality control ............................11 About this manual ......................Manual format ............................12 The CoaguChek XS Plus meter ................
Page 10 Testing a capillary blood sample ..............Important notes ..........................53 Getting a good capillary blood sample ...................54 Getting a good test with venous whole blood ..............54 Preparing to test ..........................55 Test strip code chip .........................56 Inserting the code chip ........................56 Switching on the meter .........................58 Performing a test ..........................60 Optional Quality control ...................
Page 11: Introduction
The doctor will also determine how often the patient needs blood testing. The system includes the CoaguChek XS Plus meter and CoaguChek XS PT test strips. Optional liquid CoaguChek XS Plus PT Controls are also available. The meter guides you through the test step by step using the symbols and instructions on the display.
Page 12: Test Principle
Introduction Test principle The CoaguChek XS PT Test, used as directed with the CoaguChek XS Plus Meter, will provide an electrochemical measurement of prothrombin time following activation of blood coagulation with human recombinant thromboplastin. In simple terms, blood works with the chemicals in the test strip to make a small electric current in the test strip that measures blood-clotting time.
Page 13: Safety Information
Caution: There is a potential risk of infection. Medical staff and other persons using the CoaguChek XS Plus 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.
Page 14: Operating Conditions
Introduction Operating conditions To be sure that your CoaguChek XS Plus System functions properly, please observe the following guidelines: n Only use the meter at a room temperature between 59°F and 90°F (15°C and 32°C). n Only use the meter at a relative humidity between 10 and 85 percent.
Page 15: Quality Control
A two-level, on-board quality control test and patient result determination within a single test chamber. Roche Diagnostics has available optional liquid quality controls for the CoaguChek XS Plus System. These controls are provided to assist with regulatory compliance requirements as...
Page 16: About This Manual
About this manual About this manual Manual format The layout of this operator’s manual has been specially designed to help you locate the most important information quickly and easily. All instructions that require you to actively do something, as well as very important information, appear on a blue background.
Page 17 Example 2: This column contains an illustration of the This column contains information linked to display screen. the display screen. The main menu of the CoaguChek XS Plus Main Menu 09:15 am System contains buttons for the following functions: Patient Test...
Page 18: The Coaguchek Xs Plus Meter
The CoaguChek XS Plus meter The CoaguChek XS Plus meter...
Page 19: Meter Elements Overview
The CoaguChek XS Plus meter Meter elements overview Battery cover tab Touch screen Press tab to slide cover off. Shows results, information, symbols and results recalled from memory. To select Code chip slot with any of the screen prompts, touch the...
Page 20: Power Supply
This ensures that you will not lose the date and time settings if the power goes out. To save power, the CoaguChek XS Plus meter has the option to automatically turn itself off based on your setup selections, unless a screen prompt has been pressed or a new test strip has been inserted.
Page 21: Operating The Instrument
3 Enter the settings of choice (language, unit of measure, user administration if applicable, etc.). * Instead of batteries, you can use a special rechargeable battery pack. If you choose this option, order the pack separately from Roche Diagnostics. To recharge, connect the power adapter to the CoaguChek XS Plus meter.
Page 22: Inserting The Batteries
2 Insert the four batteries in the battery compartment as indicated. (The CoaguChek XS Plus System uses AA batteries. The batteries should last about 60 tests, depending on the type of battery used.) 3 Slide the battery compartment back onto the meter and close it.
Page 23: Meter Setup
Meter setup Meter setup Please note: If you have not set the date and time (after turning the meter on for the first time or because the batteries were removed from the meter for more than 10 minutes), you cannot perform a test. In that case, turning on the meter takes you immediately to the Setup mode, where you must set the date and time.
Page 24: Display Field And Symbols
Meter setup Display field and symbols The screen prompts that appear during normal operation are shown here, along with their meaning. Error messages and the description of the symbols linked to them are provided in the chapter entitled Error messages. Symbol Meaning OK, Save setting...
Page 25 Meter setup Symbol Meaning Apply blood sample (the time left to apply sample is counted down in the display) 180 SEC Apply QC sample (the time left to apply sample is counted down in the display) 180 SEC Insert the code chip Automatic quality control completed successfully Results are displayed as a Quick percentage value.
Page 26 Meter setup Symbol 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.
Page 27: Settings Summary
Meter setup Settings summary The diagram below shows all of the SETUP areas that can be accessed on the meter. Setup Screen Contrast Units Language Date/Time Options Sort Beeper Auto Off Computer ID Setup Admin. Operator Patient Lockouts Operator Lockout QC Lockout...
Page 28 Meter setup Group Subgroup Setting Values * SCREEN CONTRAST 0 - 10 (5 *) RESULT UNITS INR * INR/SEC INR/%Q LANGUAGE Dansk Deutsch English * Español Français Italiano Nederlands Norsk Português Svenska DATE/TIME SET DATE 01/01/2005 * SET TIME 12:00 AM * Date formats Day.Month.Year (12.06.2006) Month/Day/Year (06/12/2006) *...
Page 29 Meter setup Group Subgroup Setting Values * OPTIONS SORT DATE/TIME * PATIENT ID NUMBER BEEPER BEEPER MEDIUM * HIGH KEY CLICK OFF * AUTO OFF [minutes] OFF * 1 … (5)* … 10 COMPUTER ACTIVE INACTIVE * * Settings that are in the meter when it leaves the factory are labeled with an asterisk (*).
Page 30 Meter setup Group Subgroup Setting Values * ID SETUP Admin. (Administrator) Blank (off) * OPERATOR (Operator list is optional) Blank (off) * PATIENT OPTIONAL * MANDATORY LOCKOUTS OPERATOR LOCKOUT (only if the Operator OFF * option is set to Action and an operator list WEEKLY is available) MONTHLY...
Page 31: Conventions Used In This Manual
Meter setup Conventions used in this manual This manual refers to all the various operations of the meter. When discussing a particular operation, a picture guide will appear at the top of the page. This guide shows how to navigate to this particular operation from the meter’s main menu. For example: This picture guide shows you how to get from the main menu to the date/time setup section.
Page 32: Screen Setup
Meter setup Screen setup The Screen setup area contains the options for changing the way the display looks. Contrast Use this setup option to make the screen display easier to see, depending on the lighting conditions where you are. Main Menu 09:15 am 1 From the main menu screen, touch Setup to call up the meter settings.
Page 33: Units
Meter setup Units Use this setting to select the unit(s) of measure to be displayed with the results. Main Menu 09:15 am 1 From the main menu screen, touch Patient Test Setup. 2 From the Setup menu screen, touch Control Test Screen.
Page 34: Language Selection
Meter setup Language Selection Use this setting to select the language for all displays (that contain text). Main Menu 09:15 am 1 Touch Setup in the main menu. Patient Test 2 From the Setup menu screen, touch Control Test Screen. Review Results 3 From the Screen menu screen, touch Setup...
Page 35 Meter setup Language 09:15 am 4 Touch to scroll to the Dansk language of choice on the screen. If Deutsch the arrow is just an outline , this English means the arrow is not active. On Español this screen, for example, there are no languages listed above “Dansk”.
Page 36: Setting The Date
Meter setup Setting the date When you turn on the meter for the first time (or after a long period without power), the input field for the date automatically appears first. The date (and time) must be entered before the meter can be used further.
Page 37: Setting The Time
Meter setup Setting the time When you turn on the meter for the first time (or after a long period without power), the Setup menu appears automatically after you set the date. If at a later time a time adjustment is needed, go to the Setup menu, then select the input field of choice.
Page 38: Setting The Display Options For Date And Time
Meter setup Setting the display options for date and time You don’t have to select display options for date and time, even though you must enter the date and time. However, if you want to reset the time and date formats, first go to the Setup menu.
Page 39: Options Setup
Sort refers to the order in which measured and stored results are displayed when you use your CoaguChek XS Plus meter’s memory function. You can display stored results chronologically by date and time or by person, based on the patient ID.
Page 40: Beeper
Meter setup Beeper Note: Your CoaguChek XS Plus meter can display information visually and alert you to special circumstances with a beeper. When the beeper is activated, the meter beeps when: n it is switched on n it detects a test strip...
Page 41 Meter setup Main Menu 09:15 am 1 From the main menu screen, touch Setup. Patient Test 2 From the Setup menu screen, touch Control Test Options. Review Results Setup 3 From the Options menu screen, touch Beeper. Setup Menu 09:15 am 09/16/2009 Screen The current setting is shown with white type...
Page 42: Auto Off
Meter setup Auto off You can set up your CoaguChek XS Plus meter so that it turns itself off automatically if it has not been used (no buttons pressed or tests run) for a period of time you select. Use this feature to save power and extend the life of the batteries.
Page 43: Computer
Meter setup Computer Your CoaguChek XS Plus meter can connect with a computer via an infrared interface using optional base unit. Using a computer, you can set up operator or patient lists, for example, or you can transfer test results stored in the meter to a PC for further evaluation. Using this computer capability requires software.
Page 44: Id Setup
It is not necessary for Administrator identification to be activated to use the CoaguChek XS Plus meter. However, it can be desired or necessary, depending on the environment and site of use.
Page 45: System Administrator (Admin.)
Meter setup System Administrator (Admin.) In the default setting, the meter is not protected with an Admin. password, and all setup options are accessible to anyone. If you set up a Admin. password, the following setup areas are automatically reserved only for the Admin: n Screen: Units, Date/Time n Options: (connection to a) computer n ID Setup (the entire area)
Page 46 Meter setup Admin. Admin. 09:15 am 09:15 am 4 Using the keypad displayed on the ***| screen, enter the Admin. password of choice. The password should include up to 20 characters and/or symbols of choice. Pay close attention to the buttons you press, because the actual characters and/or symbols are not displayed on the screen.
Page 47 Meter setup Main Menu 09:15 am Changing an existing Admin. password: Patient Test Control Test 1 From the main menu screen, touch Review Results Setup. Setup 2 From the Setup menu screen, touch Setup Menu 09:15 am 09/16/2009 ID Setup. Screen 3 Using the keypad displayed on the Options...
Page 48 Meter setup Main Menu 09:15 am Deactivating an existing Admin. password: Patient Test Control Test 1 From the main menu screen, touch Review Results Setup. Setup 2 From the Setup menu screen, touch Setup Menu 09:15 am 09/16/2009 ID Setup. Screen 3 Using the keypad displayed on the Options...
Page 49: Operator
Meter setup Operator (only available with optional software) To specify operators, an operator list must be created on the PC and downloaded into the meter using software. In the default setting, the meter is not set up for use with Operator ID numbers.
Page 50: Patient
Meter setup Patient In the default setting, input of Patient ID is “optional.” This means a Patient ID can be entered for each test, but this isn’t required. If you don’t enter a Patient ID , the test is simply assigned a consecutive number (the same as when the Patient ID is deactivated).
Page 51 Meter setup Patient ID 09:15 am 6 Select the input format of the Patient ID Alphanumeric to be entered. Numeric You may select from the following options: n Alphanumeric (text and numbers, e.g., “J. Doe 3378”) Max. Length: n Numeric (numbers only, e.g., “3387”) n Max.
Page 52: Lockouts Setup
Meter setup Lockouts setup Note: The Lockouts menu contains the options for liquid quality control that require the operator to perform a liquid quality control test at specified intervals. If the liquid quality control test is not performed correctly, or if the result is outside the target value range, the meter is locked out from further use.
Page 53: Operator Lockout
Meter setup Operator lockout (only available with optional software) To perform a test with the CoaguChek XS Plus meter, the individual steps must be performed properly. Optional liquid quality control can be performed on a regular basis to ensure proper performance of these steps.
Page 54 Meter setup Op. Lockout 09:15 am 5 Touch to display the option of choice on the screen. If the arrow is just Weekly an outline , this means the button is not active. Monthly 6 Touch the screen prompt to select the Every 3 Months interval of choice.
Page 55: Qc (Quality Control) Lockout
Meter setup QC (Quality control) lockout QC Lockout ensures that the optional liquid quality control tests are run at preset intervals such as NO, DAILY, WEEKLY, or MONTHLY for the meter to be used. This is independent of the operator, however. Use this option if you work without operator lists. It is also possible to mandate Operator (OP) Lockout and QC Lockout in parallel.
Page 56 Meter setup QC Lockout 09:15 am 5 Touch the screen prompt with your option Number of Levels of choice for changing the test strip lot. One Level 6 Touch the screen prompt to select the interval of choice. Your selection is now Two Levels displayed with a black background.
Page 57: Testing A Capillary Blood Sample
Testing a capillary blood sample Testing a capillary blood sample Gather what you need: n CoaguChek XS Plus meter n CoaguChek XS PT Test Strips and matching code chip n CoaguChek Lancet n CoaguChek Capillary tube/bulb (optional) Do not use glass capillary tubes or capillary tubes that contain anticoagulants.
Page 58: Getting A Good Capillary Blood Sample
Dispose of used lancets and test strips in a sturdy sharps container with lid. n Follow all health and safety regulations in force locally. Medical staff and other persons using the CoaguChek XS Plus 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.
Page 59: Preparing To Test
Testing a capillary blood sample Preparing to test 1 Have the test strip container at hand. 2 Make sure that the code chip supplied with these test strips is at hand.
Page 60: Test Strip Code Chip
Your CoaguChek XS Plus meter stores the data from up to 60 code chips that were inserted. n Don’t forget to use the test strip code chip that was supplied with each new test strip container before you perform the first test.
Page 61 Testing a capillary blood sample 2 Always make sure that the number on the code chip matches the number on the label of the test strip container. 3 Slide the new code chip into the code chip slot (as shown) until you feel it snap into place.
Page 62: Switching On The Meter
Testing a capillary blood sample Switching on the meter 1 Place the meter on a level, vibration- free surface, or hold it in your hand so it is roughly horizontal. Turn the meter on by pressing the On/Off button and holding until the meter turns on. Alternatively, you can insert a test strip or connect it to the power adapter to turn it on.
Page 63 Testing a capillary blood sample With operator list (only available with optional software) Operator 09:15 am 3 If an operator list exists, wait until this Alan Smithee list is displayed. Jane Brown 4 Select the operator of choice by Ann Casey touching the screen prompt for it.
Page 64: Performing A Test
Testing a capillary blood sample Performing a test Main Menu 09:15 am 8 Check the battery level. If there are no bars left in the battery symbol, you Patient Test cannot perform any more tests. Control Test 9 Check that the date and time are Review Results correct.
Page 65 Testing a capillary blood sample Without patient list 10 Touch Patient Test. 11 If the Patient ID option was chosen as Patient ID 09:15 am either optional or required when the meter was set up (see Meter Setup, ID Setup), you are prompted to enter a Patient ID.
Page 66 Testing the capillary blood sample With patient list (only available with optional software) 12 Touch Patient Test. 13 Select the patient to be tested from Patient ID Test 09:15 am 09:15 am the list that is displayed. Touch PID01 Smith, Henry to display the entry of your PID02 Jones, Walther...
Page 67 Testing a capillary blood sample 15 The test strip symbol prompts you to insert a test strip. Remove a test strip from its container and close the container again with the stopper. 16 Hold the test strip so the lettering “CoaguChek XS PT”...
Page 68 Testing a capillary blood sample The hourglass symbol shows that the test Test 09:15 am strip is warming up. When the warming- P-ID: PID01 Smith, Henry up process is complete, a further beep Operator 1 Par: Code: 184 tone (provided the beeper is turned on) indicates that you can now apply blood.
Page 69 Testing a capillary blood sample 18 Now lance the side of a fingertip with the lancing device. We recommend obtaining the capillary blood from the side of the fingertip, as this causes the least pain. Massage the lanced finger until a drop of blood is formed.
Page 70 Testing the capillary blood sample Alternatively... n …you can touch the blood drop against the side of the sample application area. The test strip draws up the blood by capillary action. During this process, you must hold the blood drop to the test strip until the flashing blood drop icon has disappeared and the meter beeps (provided the beeper is turned on).
Page 71 Testing a capillary blood sample The meter performs an automatic quality Test 09:15 am control test on the test strip before it P-ID: PID01 Smith, Henry Operator 1 displays the test result. “QC” appears in Par: Code: 184 the display. Following a successful outcome of the quality control test, a check mark appears after “QC”.
Page 72 Testing a capillary blood sample In this display, you can scroll through additional results or return to the main menu. Menu symbol: Return to main menu. Individual symbol: Scroll through older values stored for this patient. (This feature is active only if older values are present.) Remove 09:15 am...
Page 73: Optional Quality Control
A two-level, on-board quality control test and patient result determination within a single test chamber. Roche Diagnostics has available optional liquid quality controls for the CoaguChek XS Plus System. These controls are provided to assist with regulatory compliance requirements as applicable to your facility.
Page 74: Preparing To Run An Optional Liquid Quality Control Test
Quality control Preparing to run an optional liquid quality control test Prepare for a liquid quality control test in the same way you would prepare to perform a test with a capillary blood sample. The only difference is the use of control solution instead of blood.
Page 75 Quality control 7 Close the container again. 8 Make sure the dropper is at hand for the next steps in the liquid quality control test. 9 Swirl the bottle using a circular motion to completely dissolve all of the control plasma inside.
Page 76: Performing An Optional Liquid Quality Control Test
Quality control Performing an optional liquid quality control test 10 Place the meter on a level, vibration- free surface, or hold it in your hand so it is roughly horizontal. Turn the meter on by pressing the ON/OFF button 11 Alternatively, you can insert a test strip or connect the meter to the power adapter to turn it on.
Page 77 Quality control Main Menu 09:15 am 15 Touch Control Test. QC Lockout Control Test Review Results Setup Logout 09/16/2009 16 The test strip symbol prompts you QC Test 09:15 am to insert a test strip. Remove a test strip from its container and close the Operator 1 container again with the stopper.
Page 78 Quality control If you are using a new test strip lot and QC Test 09:15 am have not inserted the test strip code chip yet, you must do so now. As with the test Operator 1 strips, a quality control code chip is also provided with the liquid quality controls.
Page 79 Quality control QC Test 09:15 am 20 Select the level for this measurement. Code: 184 Par: Operator 1 Level 1 Level 2 09/16/2009 The hourglass symbol shows that the test QC Test 09:15 am Level: 1 strip is warming up. When the warming- Code: 184 Par: Operator 1...
Page 80 Quality control 21 Using the dropper, draw up the dissolved contents of the vial. 22 Apply a single drop of control solution directly from the dropper to the semicircular, transparent sample application area of the test strip. Do not add more control.
Page 81 Quality control You hear a beep tone when you have QC Test 09:15 am Level: 1 applied enough control solution (provided Code: 184 Par: Operator 1 the beeper is turned on). The dropper symbol disappears and the test starts. 09/16/2009 QC Test 09:15 am The result of the liquid quality control test...
Page 82 Quality control If a liquid quality control test fails, an up QC Test 09:15 am Level: 1 arrow (too high) or down arrow (too low) Code: 184 Par: Operator 1 is displayed and flashes. 09/16/2009 09:15 am 0.9 INR (1.0 - 1.4 INR) Comm.
Page 83: Review Results
Review Results Review Results The CoaguChek XS Plus meter can save 1000 patient test results as well as 500 liquid quality control tests to memory, together with respective time and date. If the memory is full when you perform a test, the oldest result is automatically deleted. The most recent result is always saved.
Page 84 Review Results Memory 09:15 am 4 Select the function you want to perform in the memory. Patient Result You may select from the following QC Result options: n Patient Result memory n QC Result memory 09/16/2009 The following symbols for general use are located in the views described below: Menu symbol: Return to main menu...
Page 85: Display Patient Result Memory
Review Results Display Patient Result memory Memory 09:15 am This memory area contains all test results PID01 09/15/2009 11:31 am for your patients, sorted chronologically PID01 09/14/2009 10:10 am or by Patient ID. The most recent results PID01 09/13/2009 10:07 am are at the top of the list.
Page 86: Display Qc (Quality Control) Memory
Review Results Display QC (Quality Control) memory This memory area contains all liquid Memory 09:15 am quality control tests that were run, sorted PID01 09/15/2009 11:31 am chronologically. The most recent results PID01 09/14/2009 10:10 am are at the top of the list. PID01 09/13/2009 10:07 am PID01...
Page 87: Cleaning/Disinfecting
Do not use sprays of any sort. n Ensure that swab or cloth is only damp, not wet. Cleaning/Disinfecting the Exterior n Use only the following items for cleaning/disinfecting the CoaguChek XS Plus meter housing for a contact time of >1 minute: - 70% isopropyl alcohol...
Page 88: Cleaning/Disinfecting The Test Strip Guide
Cleaning Cleaning/Disinfecting the Test Strip Guide n Use only 70% isopropyl alcohol or 10% bleach solution to clean/disinfect the CoaguChek Plus test strip guide. n 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...
Page 89 Cleaning 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 make sure it snaps into place.
Page 90: Error Messages
Your first step upon receiving an error message should be to try the solution suggested for that error. If the problem persists, please call Roche Diagnostics Technical Service Center at 1-800-428-4674, 24 hours a day, 7 days a week, 365 days a year.
Page 91 Error messages Error message Brief description (always prefaced by Error) Test strip guide cover open Error Code chip error Error Test strip beyond expiration date Error Test strip unusable Error Allowed time for blood application exceeded Error Blood application error Error Measurement error Error...
Page 92 Error messages Error message Brief description (always prefaced by Error) Quality control: Test strip unusable or quality control Error for new lot missing Measurement error Error Diagnostic testing error Error Diagnostic testing error Error Internal memory error (patient) Error Patient Internal memory error (QC) Error Internal memory error (setup)
Page 93 Error messages Error message Brief description (always prefaced by Error) Data transfer error Error Control solution beyond expiration date Error Memory (almost) full Error Date/time inconsistent Error DD:MM:YY ID error Error...
Page 94: Troubleshooting Error Messages After Turning The Meter On
Error messages Troubleshooting error messages after turning the meter on Error Description/Solution A test strip was already inserted when the meter was turned Error: Test strip on with the ON/OFF button. Solution Error Remove the test strip. The error message disappears. The meter is ready. Error: Ambient The meter is too cold or too warm to measure correctly.
Page 95: Troubleshooting Error Messages When Preparing To Test
Error messages Troubleshooting error messages when preparing to test Error Description/Solution The test strip guide cover is not properly closed. Error: Cover Solution Error Close the test strip guide cover. The error message disappears. The meter is ready. Error: Test strip The test strip is unusable or the test strip is not a CoaguChek XS PT test strip.
Page 96: Troubleshooting Error Messages During Or After Blood Application
Error messages Troubleshooting error messages during or after blood application Error Description/Solution The maximum allowed time of 180 seconds for applying blood Error: Time for application exceeded has been exceeded. Solution Error Turn the meter off, remove the test strip and start a new test using the same test strip and blood taken from a new fingerstick from a different finger.
Page 97 Error messages Error Description/Solution This message appears if quality control lockout was set up for Error: Quality Control NEW CODE lockout. A quality control test must be carried out when a new test strip lot is used. The quality control for new lot is missing. Solution Error Perform a quality control test with the new test strip lot.
Page 98: Troubleshooting Other Error Messages
Center at 1-800-428-4674 to have the meter replaced The memory contains faulty data. Error: Memory test (patient) Solution Error The meter has a fault. Please call Roche Diagnostics Technical Service Center at 1-800-428-4674. Patient The memory contains faulty data. Error: Memory test (QC) Solution Error The meter has a fault.
Page 99 Error Description/Solution The memory contains faulty data. Error: Memory test (setup) Solution Error The meter has a fault. Please call Roche Diagnostics Technical Service Center at 1-800-428-4674. Data was transferred incorrectly. Error: Data transfer Solution Error Repeat the last action.
Page 100 Error messages Error Description/Solution Date/time is inconsistent Error: Date/time setting Solution Error Check date/time. DD:MM:YY Error: Password The entered operator or supervisor password is wrong. Solution Error Enter the correct password.
Page 101: Further Information
Further information Further information Ordering Please contact Roche Diagnostics Customer Service at 1-800-428-5076. CoaguChek XS PT Test, 2 x 24 test strips REF 04625315160 CoaguChek XS Pro PT Controls REF 04625382160 Rechargeable battery pack REF 04805640001 CoaguChek XS PT Optional Base Unit...
Page 102 Further information Preamble The licenses for most software are designed to take away your freedom to share and change it. By contrast, the GNU General Public License is intended to guarantee your freedom to share and change free software—to make sure the software is free for all its users. This General Public License applies to most of the Free Software Foundation’s software and to any other program whose authors commit to using it.
Page 103 Further information translated into another language. (Hereinafter, translation is included without limitation in the term “modification”.) Each licensee is addressed as “you”. Activities other than copying, distribution and modification are not covered by this License; they are outside its scope. The act of running the Program is not restricted, and the output from the Program is covered only if its contents constitute a work based on the Program (independent of having been made by running the Program).
Page 104 Further information this section to claim rights or contest your rights to work written entirely by you; rather, the intent is to exercise the right to control the distribution of derivative or collective works based on the Program. In addition, mere aggregation of another work not based on the Program with the Program (or with a work based on the Program) on a volume of a storage or distribution medium does not bring the other work under the scope of this License.
Page 105 Further information 5. You are not required to accept this License, since you have not signed it. However, nothing else grants you permission to modify or distribute the Program or its derivative works. These actions are prohibited by law if you do not accept this License. Therefore, by modifying or distributing the Program (or any work based on the Program), you indicate your acceptance of this License to do so, and all its terms and conditions for copying, distributing or modifying the Program or works based on it.
Page 106 Further information 9. The Free Software Foundation may publish revised and/or new versions of the General Public License from time to time. Such new versions will be similar in spirit to the present version, but may differ in detail to address new problems or concerns. Each version is given a distinguishing version number.
Page 107 Further information How to Apply These Terms to Your New Programs If you develop a new program, and you want it to be of the greatest possible use to the public, the best way to achieve this is to make it free software which everyone can redistribute and change under these terms. To do so, attach the following notices to the program.
Page 108 Further information This software was developed by the Computer Systems Engineering group at Lawrence Berkeley Laboratory under DARPA contract BG 91-66 and contributed to Berkeley. All advertising materials mentioning features or use of this software must display the following acknowledgement: This product includes software developed by the University of California, Lawrence Berkeley Laboratory.
Page 109: Product Specifications
Infrared interface, LED/IRED Class 1 (CoaguChek IR key) Battery operation The CoaguChek XS Plus System uses four AA batteries. The batteries should last about 60 tests, depending on the type of battery used. A special rechargeable battery pack for the CoaguChek XS Plus instrument is also available.
Page 110: Sample Material
10% to 85% (no condensation) Support/Services Please call 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, if you suspect the meter is defective or if you have other questions.
Page 111: Warranty
Warranty CoaguChek XS Plus 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.
Page 112 COAGUCHEK is a trademark of Roche. Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany Made in Germany Manufactured for and distributed in the U.S.A. by: Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 Rx Only www.roche.com www.coaguchek-usa.com www.usdiagnostics.roche.com...

Roche CoaguChek XS Plus User Manual

Introduction

About this Manual

The Coaguchek XS Plus Meter

Operating the Instrument

Meter Setup

Testing a Capillary Blood Sample

Optional Quality Control

Review Results

Cleaning/Disinfecting

Error Messages

Further Information

Product Specifications

Warranty

Quick Links

Troubleshooting

Need help?

Questions and answers

Related Manuals for Roche CoaguChek XS Plus

Summary of Contents for Roche CoaguChek XS Plus

Table of Contents