Roche CoaguChek XS Plus Operator's Manual
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Roche CoaguChek XS Plus Operator's Manual

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P O I N T
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T E S T I N G
CoaguChek
XS Plus
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Operator's Manual

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Summary of Contents for Roche CoaguChek XS Plus

  • Page 1 P O I N T C A R E T E S T I N G CoaguChek XS Plus ® Operator’s Manual...
  • Page 3 CoaguChek XS Plus ® Operator’s Manual 0 5021464001 (05) 2012-05 USA...
  • Page 4 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 5 On the packaging and on the identification plate of the instrument you may encounter the following symbols, shown here with their meaning: Caution, consult accompanying documents. Refer to safety-related notes in the instructions for use accompanying this product. Temperature limitation (Store at) Use by Manufacturer Batch code/ Lot number...
  • Page 6 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 7: Table Of Contents

    Electromagnetic Interference ...................... 18 Touchscreen............................18 Operating conditions ........................19 Quality control ........................... 19 2 The CoaguChek XS Plus Meter Overview of the meter elements......................21 Buttons and icons overview ......................... 22 Power supply.............................. 24 3 Putting the Meter into Operation Inserting the batteries ..........................
  • Page 8 ID setup................................ 56 System Administrator (Admin.)....................58 Operator ID ............................64 Patient ID ............................65 QC Settings setup ............................ 68 QC Range ............................69 QC (quality control) Lockout......................72 Operator Lockout ..........................74 5 Testing a Blood Sample Important notes............................77 Getting a good capillary blood sample ..................
  • Page 9 Reagents and solutions ......................128 Product limitations........................128 Repairs .............................. 128 Information about software licenses ..................129 12 Warranty 13 Appendix Contact Roche ............................137 14 Supplement for Observed Test Sequence Observed Test Sequence (OTS) ..................... 139 Using the OTS function....................... 140 Index...
  • Page 10 This page intentionally left blank.

  • Page 11: Introduction

    Read this operator's manual, as well as the package inserts for all relevant consumables, before using the system for the first time. You must configure the CoaguChek XS Plus meter according to your needs before initial use. Refer to chapter 4 Meter Setup. Be sure to read the Important safety instructions and additional information section in this chapter before operating the system.

  • Page 12: If You Need Help

    When error messages appear on the screen, refer to chapter 10 Troubleshooting. For all questions about the CoaguChek XS Plus system that are not answered in this manual, contact your Roche representative or Roche Diagnostics Technical Service. In order to expedite troubleshooting, please have ready your CoaguChek XS Plus meter, its serial number, this man- ual, and all related consumables when you call.

  • Page 13: Test Principle

    Handheld Base Unit and of your DMS for technical details. 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.

  • Page 14: Important Safety Instructions And Additional Information

    Important safety instructions and additional information This section explains how safety-related messages and information related to the proper handling of the system are presented in the CoaguChek XS Plus Operator’s Manual. Read these passages carefully. The safety alert symbol alone (without a signal word) promotes aware- ness to hazards which are generic or directs the reader to related safety information.
  • Page 15 Introduction Illustrations in this manual show two different kinds of hands: Hand without glove Hand with glove A dashed arrow between screen illustrations indicates that some screens have been skipped in these illustrations.

  • Page 16: Safety Information

    There is a potential risk of infection. Healthcare professionals using the WARNING CoaguChek XS Plus system must be aware that any object coming into contact with human blood is a potential source of infection. Healthcare professionals must also be aware that any cross-contamination is a potential source of infection for patients.

  • Page 17: Disposal Of The System

    European Directive 2002/96/EC** This is not a require- ment for the U.S.A.; however, Roche is committed to recycling and sus- tainability. Comply with any laws or ordinances relating to the disposal of sharps and/or contaminated products.

  • Page 18: General Care

    Introduction General Care NOTICE Clean the meter only with the solutions recommended (see page 119). Using other solutions may result in incorrect operation and possible system failure. Do not let cleaning solution enter the instrument. Make sure that the meter is thoroughly dried after cleaning or disinfecting. Electromagnetic Interference Do not use the meter near strong electromagnetic fields, which could interfere with the proper operation of the meter.

  • Page 19: Operating Conditions

    A two-level, onboard 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 meeting regulatory compliance requirements...

  • Page 20: The Coaguchek Xs Plus Meter

    The CoaguChek XS Plus Meter The CoaguChek XS Plus Meter...

  • Page 21: Overview Of The Meter Elements

    The CoaguChek XS Plus Meter Overview of the meter elements Touchscreen Charging terminals Shows test results, information, icons, and Used for power supply and/or charging results recalled from memory. To select an the battery pack, when the meter is option, simply touch the button lightly.

  • Page 22: Buttons And Icons Overview

    The CoaguChek XS Plus Meter Buttons and icons overview The buttons and icons that appear during normal operation are shown here, along with their respective meanings. Error messages and the description of the icons linked to them are pro- vided in a separate chapter. See Troubleshooting starting on page 123.
  • Page 23 The CoaguChek XS Plus Meter Button/Icon Meaning Apply liquid control (QC) sample (the time left to apply sample is counted down in the display) 180 SEC Insert the test strip code chip Insert the QC code chip Automatic quality control completed successfully...

  • Page 24: Power Supply

    The power adapter also serves as a charger if you use it with the special rechargeable battery pack. To save power, the CoaguChek XS Plus meter has the option to automatically power itself off based on your setup selections, unless a button has been pressed or a new test strip has been inserted.
  • Page 25 The CoaguChek XS Plus Meter Main Menu 09:15 am During battery operation, the meter always displays the battery power level. Patient Test When replacing the batteries or the rechargeable battery pack, you must insert the new batteries or battery pack within ten...

  • Page 26: Putting The Meter Into Operation

    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 or to the optional Handheld Base Unit (HBU) and dock the meter.

  • Page 27: Inserting The Batteries

    Putting the Meter into Operation Inserting the batteries 1 With the meter powered off, press the battery compartment cover release tab and slide the cover off. 2 Insert the four batteries in the battery compartment as indicated. The batteries should last about 80 tests, depending on the type of battery used.

  • Page 28: Powering The Meter On And Off

    Putting the Meter into Operation 3 Slide the battery compartment back onto the meter and close it. The meter powers itself on after the batteries have been inserted. Powering the meter on and off 1 Place the meter on a level, vibration-free surface, or hold it in your hand so it is roughly horizontal.

  • Page 29: Checking The Software Version

    Putting the Meter into Operation Checking the software version Init After displaying the Roche logo, the meter briefly displays the Init (for “initialization” ) CoaguChek screen. Here you can check which software XS Plus version is currently running on your meter.
  • Page 30 Putting the Meter into Operation This page intentionally left blank.

  • Page 31: Meter Setup

    Meter Setup Meter Setup Note on presentation of screen elements in this manual Buttons are screen prompts that cause something to happen when touched. The names of all buttons are either shown as bold text or as the icon used on the button (e.g., for OK ).

  • Page 32: Settings Summary

    Meter Setup Settings summary The diagram below shows all of the setup areas that can be accessed on the meter. Setup Screen Result Language Contrast Confi rmation Selection Result Units Date / Time Options Sort Beeper Auto Off Connection ID Setup Admin.
  • Page 33 Meter Setup Group Subgroup Setting Values * Screen Contrast 0 – 10 (5 *) Result Units INR * INR/SEC INR/%Q Result Confirmation Enable Disable * Language Selection Dansk Deutsch English * Español Français Italiano Nederlands Norsk Português Suomi Svenska Date/Time Date 01/01/2012 * Time...
  • Page 34 Meter Setup Group Subgroup Setting Values * Options Sort Date/Time * Patient ID Patient Name Beeper Beeper Medium * High Key Click Off * Auto Off [minutes] 1 … (5*) … 10 Connection Off * Computer * Default settings are labeled with an asterisk (*).
  • Page 35 Meter Setup Group Subgroup Setting Values * ID Setup Admin. (Administrator) Blank (Off) * Operator (Operator List is optional) Active Inactive * Patient No * Optional Required QC Settings QC Range Default Range* Custom Range Display Target Value On/Off * Deviation from Target Value Percentage (%) Operator Lockout (only if the Operator...

  • Page 36: Screen Setup

    Meter Setup Screen setup The Screen setup area contains the options for changing the display. Contrast Use the Contrast menu to adjust the display to your ambient light conditions and make it easier to read. 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings.

  • Page 37: Result Units

    Meter Setup 4 Touch to change the contrast in a range from 0 to 10. ■ Contrast “0” makes the display very dark. Contrast 09:15 am ■ Contrast “10” makes the display very light. Contrast (0-10): 5 Touch to save this setting, or touch to exit this menu without saving any changes.
  • Page 38 Meter Setup The current unit of measure setting is high- lighted (white type on a blue background). You can select either: ■ ■ INR and seconds ■ INR and Quick value in % 4 Touch the button to select the unit of Units 09:15 am measure of choice.

  • Page 39: Result Confirmation

    Meter Setup Result Confirmation In some circumstances, it may be useful for operators to confirm the validity of their results. Use this setting to prompt operators to confirm the results of every test. 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings.

  • Page 40: Language Selection

    Meter Setup Language Selection Use this setting to select the language for all displays (that contain text). 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings. Patient Test 2 From the Setup Menu, touch Screen. Control Test 3 From the Screen menu, touch Language Selection.

  • Page 41: Setting The Date

    Meter Setup Setting the date When you power 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 42 Meter Setup 4 From the Date/Time menu, touch Set Date/Time 09:15 am Date. Set Date 5 Touch to set the year, then Date 09:15 am Set Time the month, then the day. 2012 Year: Format 6 Touch to save this setting, or Month: touch to exit this menu without...

  • Page 43: Setting The Time

    Meter Setup Setting the time When you power on the meter for the first time (or after a long period without power), this 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 menu of choice.
  • Page 44 Meter Setup 4 From the Date/Time menu, touch Set Date/Time 09:15 am Time. Set Date Time 09:15 am 5 Touch to set the hours, then Set Time the minutes. Hour: Format 6 Touch to save this setting, or Minute: touch to exit this menu without saving any changes.

  • Page 45: Setting The Display Options For Date And Time

    Meter Setup Setting the display options for date and time Select your preferred format for the date and time display. 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings. Patient Test 2 From the Setup Menu, touch Screen. Control Test 3 From the Screen menu, touch Date/Time.
  • Page 46 Meter Setup 4 From the Date/Time menu screen, touch Date/Time 09:15 am Format. Set Date Format 09:15 am Set Time The current settings are highlighted. You can DD.MM.YYYY Date: select one of the following display formats: Format MM/DD/YYYY ■ Date: DD.MM.YYYY (Day.Month.Year), YYYY-MM-DD e.g., 30.09.2012 ■...

  • Page 47: Options Setup

    Sort refers to the order in which measured and stored results are displayed when you use the Review Results function of the CoaguChek XS Plus meter. You can display stored results chronologically by date and time or by person, based on the Patient ID. If you are working with a DMS and a patient list, you can also display the patient list and the stored results sorted by Patient Name.
  • Page 48 Meter Setup Sort 09:15 am The current setting is highlighted. You may Sort By: select from the following sort options: Date / Time ■ By Date/Time Patient ID ■ By Patient ID Patient Name ■ By Patient Name 4 Touch the button to select the Sort by option of choice.

  • Page 49: Beeper

    Meter Setup Beeper The CoaguChek XS Plus meter can display information visually and alert you to special circum- stances with a Beeper. When the Beeper is enabled, the meter beeps when: ■ it is switched on ■ it detects a test strip ■...
  • Page 50 Meter Setup 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings.. Patient Test 2 From the Setup Menu, touch Options. Control Test 3 From the Options menu, touch Beeper. Review Results Setup 04/19/2012 Setup Menu 09:15 am Screen...
  • Page 51 Meter Setup The current setting is highlighted. You may select from the following options: Beeper 09:15 am For the Beeper ■ ■ Medium High ■ Medium Key Click: ■ High For the Key Click 04/19/2012 ■ ■ 4 Touch the button with the desired setting for the Beeper, then touch the button with the setting of choice for the Key Click.

  • Page 52: Auto Off

    Meter Setup Auto Off You can set up your CoaguChek XS Plus meter so that it powers itself off automatically if it has not been used (no buttons touched or tests run) for a preselected time period. Use this feature to save power and extend the life of the batteries.
  • Page 53 Meter Setup You may select from the following options: ■ Off (meter never powers itself off) Auto Off 09:15 am Minutes: ■ Time until meter powers itself off: 1…10, 15, 20, 25, 30, 40, 50, 60 minutes 4 Touch to select the time of choice in minutes or to switch the feature off.

  • Page 54: Connection

    Meter Setup Connection In the Connection menu you can configure the data exchange with external devices. The meter can be connected to a computer. 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings. Patient Test 2 From the Setup Menu, touch Options.
  • Page 55 Meter Setup Computer The CoaguChek XS Plus meter can connect with a computer or host system running appropriate software (that is, a DMS must be installed). To use this connectivity feature, however, you need the optional Handheld Base Unit. The connection is established in two steps.

  • Page 56: Id Setup

    It is not necessary for Admin. identification to be activated to use the CoaguChek XS Plus meter. However, it might be desired or necessary, depending on the regulatory environment and the site of use.
  • Page 57 Meter Setup The buttons in the ID Setup menu show what the current settings are (this is just an example, the screen may look different on your meter): ■ The standard display of the Admin. ID Setup 09:15 am button means the function is available but Admin.

  • Page 58: System Administrator (Admin.)

    When you enter an Admin. password, this password will have to be entered from this point forward before any of the settings above can be changed. The Admin. password must also be entered before you can delete or change the Admin. password itself. If you forget the Admin. password, contact your Roche representative.
  • Page 59 Meter Setup If an Admin. password has not been set up yet: 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings. Patient Test 2 From the Setup Menu, touch ID Setup. Control Test 3 From the ID Setup menu , touch Admin.
  • Page 60 Meter Setup Admin. Admin. 4 Using the keypad displayed on the screen, 09:15 am 09:15 am ***| enter the Admin. password of choice. The password can consist of up to 20 characters. Pay close attention to the buttons you press, because the characters are not displayed on the screen.
  • Page 61 Meter Setup Repeat ID 9 Enter the Admin. password again (the 09:15 am ***| keypad is automatically displayed again on the screen) to confirm the first entry. 10 Touch to save this entry, (the Admin. password is now set), or Touch to exit this menu, the Admin.
  • Page 62 Meter Setup Changing an existing Admin. password: 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings. Patient Test 2 From the Setup Menu, touch ID Setup. Control Test 3 Using the keypad displayed on the screen, enter the valid Admin.
  • Page 63 Meter Setup Deactivating an existing Admin. pass- word: 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings. Patient Test 2 From the Setup Menu, touch ID Setup. Control Test 3 Using the keypad displayed on the screen, enter the valid Admin.

  • Page 64: Operator Id

    Meter Setup Operator ID If you want to create a list of Operator IDs from which you can select an operator, additional software (a data management system) and the Handheld Base Unit are required (for more details see Data handling, starting on page 115). In the default setting, the Operator login is not activated.

  • Page 65: Patient Id

    Meter Setup Patient ID If you want to create a list of Patient IDs from which you can select a patient for testing, addi- tional software (a data management system) and the Handheld Base Unit are required (see page 115). In the default setting, input of Patient IDs is set to No.
  • Page 66 Meter Setup Patient ID 09:15 am You may select from the following options: ■ No (tests will be assigned numbers automatically) Optional ■ Optional (automatic numbering or Required list/manual input) ■ Required (list/manual input) 04/19/2012 Touch the button with the setting of choice.
  • Page 67 Meter Setup 6 Select the form for input of the Patient ID. You may select from the following options: Patient ID 09:15 am ■ Alphanumeric Alphanumeric Enter any combination of letters and Numeric numbers, e.g., “J. DOE 3378” Min. Length: ■...

  • Page 68: Qc Settings Setup

    QC Range There are two options: ■ Default Range: The meter displays the QC Range provided by Roche in the code chip. ■ Custom Range: The option Custom Range lets the user define their own QC Range within the default range.

  • Page 69: Qc Range

    Meter Setup QC Range Liquid Quality control ranges can be customized to comply with local guidelines. The QC Range function enables you to narrow the default range. 1 From the Main Menu, touch Setup to Main Menu 09:15 am Setup Menu 09:15 am open the meter settings.
  • Page 70 Meter Setup If you selected Custom Range, the QC Range QC Range 09:15 am QC Range 09:15 am screen opens and offers you the following Display target value options: Default Range ■ Display target value (On/Off) Deviation from Custom Range target value ■...
  • Page 71 Meter Setup 6 Use the arrows to to set the allowed per- centage deviation from the target value. Use the arrows on the left to adjust the whole number before the decimal point. Use the arrows on the right to adjust the number after the decimal point.

  • Page 72: Qc (Quality Control) Lockout

    Meter Setup QC (quality control) Lockout The QC Lockout ensures that the optional quality control tests are run on a regular basis. This is independent of the operator, however. This option should be used if you work without oper- ator lists. It is also possible to mandate Operator Lockouts and QC Lockouts in parallel. In addi- tion to defining time intervals, QC Lockout can also be used to specify that a quality control test must be carried out when a new test strip lot is used (New Code).
  • Page 73 Meter Setup 4 Select the triggers, based on lot and/or QC Lockout 09:15 am New Code time, for requiring a quality control test. You may select from the following options: Daily ■ New Code Yes/No (applies every time a Weekly new test strip lot is used) Monthly The general intervals are:...

  • Page 74: Operator Lockout

    Optional liquid quality controls can be used to ensure that an operator is performing tests prop- erly on the CoaguChek XS Plus meter. The Operator Lockout function constrains an operator, who has been set up in the list, to perform these quality controls on a regular basis.
  • Page 75 Meter Setup 4 Select the interval of choice in which the Op. Lockout 09:15 am mandatory quality control tests must be performed. Weekly Monthly Every 3 Months You may select from the following options: Every 6 Months ■ No (deactivated) 04/19/2012 ■...
  • Page 76 Meter Setup 8 For every option except for No, you must Op. Lockout 09:15 am Number of Levels now indicate the number of levels in which the quality control must be per- One Level formed. Two Levels 9 Touch to save this setting, or touch to exit this menu without saving any changes.

  • Page 77: Testing A Blood Sample

    Testing a Blood Sample Testing a Blood Sample What you need: ■ CoaguChek XS Plus meter ■ CoaguChek XS PT Test Strips and matching code chip ■ When testing with capillary blood: – Single-use lancing device approved for professional use (e.g., the Accu-Chek Safe-T-Pro Plus lancing device or the CoaguChek Lancets) –...
  • Page 78 Testing a Blood Sample Never … ■ … store the meter at extreme temperatures (greater than 40 °C or 104 °F) while it is in regular use. ■ … store the meter in damp or humid conditions without protection. ■ …...

  • Page 79: Getting A Good Capillary Blood Sample

    Testing a Blood Sample Getting a good capillary blood sample To get a suitable drop of blood: ■ Warm the hand. Have the patient hold it under his or her arm or use a hand warmer. Wash hands with soap and warm water. Dry thoroughly. ■...

  • Page 80: Preparing To Test

    Testing a 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. Each pack of test strips contains a code chip. The number on the code chip and the number on the test strip container must match.

  • Page 81: Test Strip Code Chip

    The code chip is required, whenever a new test strip lot is used, so that the meter can read and store the lot information about that particular lot of test strips. The CoaguChek XS Plus meter stores the data from up to 60 code chips that have been inserted. ■...
  • Page 82 Testing a Blood Sample 2 Check 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 83: Powering On The Meter

    Testing a Blood Sample Powering on the meter 1 Place the meter on a level, vibration-free surface, or hold it in your hand so it is roughly horizontal. 2 Power the meter on by pressing the button for approximately 1 second. You can also power on the meter directly by inserting a test strip or connecting the power adapter.
  • Page 84 Testing a Blood Sample If the function Operator ID is active: Operator ID 09:15 am Without operator list: 3 You are now prompted to enter an Operator ID. ■ Enter the Operator ID using the keypad. Touch to move to the next screen.
  • Page 85 Testing a Blood Sample Operator 09:15 am With operator list: Alan Smithee 3 Wait until the operator list is displayed. Jane Brown 4 Select the operator of choice by touching Ann Casey the corresponding button. Joe Dalton 04/19/2012 Password 5 Enter the (optional) password. 09:15 am 6 After you enter the password, touch to log on.

  • Page 86: Performing A Test

    Testing a Blood Sample Performing a test 1 Check the battery level. Main Menu 09:15 am Patient Test ■ If the battery icon turns red (one bar left), there may not be enough power left for Control Test another test. Review Results ■...
  • Page 87 Testing a Blood Sample Without patient list 3 Touch Patient Test. 4 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/ Patient ID), you are prompted to enter a Patient ID.
  • Page 88 Testing a Blood Sample With patient list 5 Touch Patient Test. 6 Touch to display the entry of Test 09:15 am Patient ID 09:15 am PID01 choice. Select the patient to be tested Smith, Henry from the list. PID02 Jones, Walther 7 If the patient is not in the list, touch New PID03 Hamilton, Fran...
  • Page 89 Testing a Blood Sample 8 The test strip icon prompts you to insert a Test 09:15 am P-ID: PID01 test strip. Remove a test strip from its con- Müller, David Schulz tainer and close the container again with Par: the stopper. 04/19/2012 Exposure to external influences (such as humidity) may deteriorate the test strips and...
  • Page 90 Testing a Blood Sample Test 09:15 am The hourglass icon shows that the test strip is P-ID: PID01 Smith, Henry warming up. When the warming-up process Operator 1 Par: Code: 184 is complete, a further beep (provided the beeper is enabled) indicates that you can now apply blood.
  • Page 91 Testing a Blood Sample Use only a single-use lancing device that is approved for use by health- care professionals, such as the Accu-Chek Safe-T-Pro or Safe-T-Pro Plus WARNING lancing devices, or the CoaguChek Lancets (professional-use lancets available only in the United States). Follow the manufacturer’s instruc- tions.
  • Page 92 Testing a Blood Sample When applied from above, the blood must cover the entire sample application area. You hear a beep tone when you have applied Test 09:15 am P-ID: PID01 enough blood (provided the Beeper is Smith, Henry Operator 1 enabled).
  • Page 93 Testing a Blood Sample Test 09:15 am The meter performs an automatic quality con- P-ID: PID01 Smith, Henry trol test on the test strip before it displays the Operator 1 Par: Code: 184 test result. “QC” appears in the display. Following a successful outcome of the quality control test, a checkmark appears after “QC.”...

  • Page 94: Accepting Or Rejecting A Test Result

    Testing a Blood Sample Accepting or rejecting a test result Test 09:15 am If this function is enabled, you may choose to P-ID: PID01 Smith, Henry accept or reject a test result. When the result Operator 1 Par: Code: 184 is displayed, touch 04/19/2012 09:14 am ■...

  • Page 95: Adding Comments

    Testing a Blood Sample Adding comments You can add up to three comments to a test result. Comments can provide, for example, addi- tional information about the test conditions or the patient. A comment may be up to 20 charac- ters in length.
  • Page 96 Testing a Blood Sample After the test result is displayed, touch . You will be prompted to remove the Remove 09:15 am strip. 5 Remove the test strip from the meter. 6 Power the meter off. 7 Clean the meter if necessary (see Chapter 9, Cleaning and Disinfecting the Meter).

  • Page 97: Control Testing And Quality Control

    A two-level, onboard quality control test and patient result determination within a single test chamber. Roche offers 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 98: Preparing To Run A Liquid Quality Control Test

    Control Testing and Quality Control Preparing to run a 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. 1 Have the test strip container at hand.
  • Page 99 Control Testing and Quality Control 7 Apply gentle pressure to the reservoir to transfer the entire contents of the dropper to the bottle. Make sure that the dropper does not come into contact with the dried control plasma. 8 Close the bottle again. 9 Make sure the dropper is at hand for the next steps in the liquid quality control test.

  • Page 100: Performing A Liquid Quality Control Test

    Control Testing and Quality Control Performing a liquid quality control test 1 Place the meter on a level, vibration-free surface or hold it in your hand so it is roughly horizontal. 2 Power the meter on by pressing the button for approximately 1 second. You can also power on the meter directly by inserting a test strip or connecting the power adapter.
  • Page 101 Control Testing and Quality Control 4 Check the battery level. Main Menu 09:15 am Patient Test ■ If the battery icon turns red (one bar left), there may not be enough power left for Control Test another test. Review Results ■...
  • Page 102 Control Testing and Quality Control 7 The test strip icon prompts you to insert a QC Test 09:15 am test strip. Remove a test strip from its con- Par: Schulz tainer and close the container again with the stopper. 8 Hold the test strip so the lettering with the test name is facing upward.
  • Page 103 Control Testing and Quality Control QC Test 09:15 am If you are using a new test strip lot and have not inserted the test strip code chip yet, you Operator 1 must do so now. Otherwise you cannot per- form a quality control test. As with the test strips, a quality control code chip is also provided with the control solu- 04/19/2012...
  • Page 104 Control Testing and Quality Control 11 If performing more than one level, select QC Test 09:15 am the level for this measurement. Code: 184 Par: Operator 1 Level 1 Level 2 04/19/2012 QC Test 09:15 am The hourglass icon shows that the test strip is Level: 1 Code: 184 Par:...
  • Page 105 Control Testing and Quality Control 12 Using the dropper, draw up the dissolved contents of the bottle. 13 Apply a single drop of control solution directly from the dropper to the semicircu- lar, transparent sample application area on top of the test strip. Do not add more control solution.
  • Page 106 Control Testing and Quality Control QC Test 09:15 am You hear a beep when you have applied Level: 1 Code: 184 Par: enough control solution (provided the beeper Operator 1 is enabled). The dropper icon disappears and the test starts. 04/19/2012 QC Test 09:15 am...
  • Page 107 Control Testing and Quality Control 14 If you want to add a comment, touch QC Comment 09:15 am Acceptable Control 15 Select the desired predefined comment(s) Cleaned Meter from the pick list (if configured) or Doctor Notified 16 Touch Custom to enter your own custom comment.
  • Page 108 Control Testing and Quality Control This page intentionally left blank.

  • Page 109: Review Results

    Review Results Review Results The CoaguChek XS Plus meter can save 2000 patient test results as well as 500 liquid quality control tests to memory, together with respective time and date. In addition, up to 60 code chip records (contents of test strip code chips and control solution code chips) are stored. If you are using operator and/or patient lists, a maximum of 5000 Operator and 4000 Patient IDs is allowed.

  • Page 110: Viewing Test Results

    Review Results Viewing test results 1 Place the meter on a level, vibration-free surface, or hold it in your hand so it is roughly horizontal. 2 Power the meter on by pressing the button for approximately 1 second. To power the meter off after use, press the button for approximately 1 second.
  • Page 111 Review Results 4 Touch Review Results. Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2012 5 Select the type of results you want to view. Memory 09:15 am ■ Display Patient Result memory ■ Display QC Result memory Patient Result QC Result 04/19/2012...

  • Page 112: Display Patient Result Memory

    Review Results Display patient result memory This memory area contains all test results for your patients, sorted according to the setting you chose for the option Sort (see page 47). If the Sort option is set to Date/Time, the most recent results are at the top of the list.

  • Page 113: Display Qc (Quality Control) Result Memory

    Review Results Display QC (quality control) result memory This memory area contains all liquid quality control tests that were run, sorted chronolog- ically. The most recent results are at the top of the list. 1 Touch to scroll to the entry 09:15 am of choice on the screen.
  • Page 114 Review Results This page intentionally left blank.

  • Page 115: Extended Functionalities

    When used in conjunction with the Handheld Base Unit from Roche (available separately), the CoaguChek XS Plus meter can conveniently connect to a data management system (DMS). The main advantages of such a connection between meter and DMS may include: ■...

  • Page 116: Operator Lists

    Extended Functionalities Operator lists After powering the meter on, an Operator login may be configured. There are two possible con- figurations for an Operator login: ■ Operator is activated, but there is no list available: The Operator can log in via the onscreen keypad. The use of the meter is not restricted to a predefined Operator group, so Operator IDs are entered via the onscreen keypad and stored with test results for informational purposes only.

  • Page 117: Patient Lists

    Extended Functionalities Patient lists When starting a Patient Test, there will be the option of either selecting a Patient ID from a patient list or entering the Patient ID using the onscreen keypad. The Patient ID, if entered on the DMS, comes with an additional identification entry.

  • Page 118: Stored Test Results And Comments

    Extended Functionalities Stored test results and comments When performing a test, the test result will be stored along with additional information, including the Patient ID, Operator ID, the kind of test performed, and optional Comments. The meter comes with a default set of Comments that can be assigned to each test result. If you are working with a DMS, these comments can be replaced by the comments in the DMS.

  • Page 119: Cleaning And Disinfecting The Meter

    Cleaning and Disinfecting the Meter Cleaning and Disinfecting the Meter ■ Observe the disinfection guidelines of your institution. ■ Use gloves. NOTICE Follow the procedures below to clean/disinfect the meter. Failure to follow these procedures may cause malfunction of the meter. ■...

  • Page 120: Cleaning/Disinfecting The Exterior (Meter Housing)

    Cleaning and Disinfecting the Meter Cleaning/disinfecting the exterior (meter housing) Use the solutions recommended on page 119 for cleaning/disinfecting the meter exterior. Apply the solutions for a contact time of > 1 minute (refer to the corresponding product labeling). Ensure that the blue test strip guide cover remains tightly closed while cleaning the meter housing.

  • Page 121: Cleaning/Disinfecting The Test Strip Guide

    Cleaning and Disinfecting the Meter Cleaning/disinfecting the test strip guide Use the solutions recommended on page 119 for cleaning/disinfecting the test strip guide. Apply the solutions for a contact time of > 1 minute (refer to the corresponding product labeling) using lint-free cotton swabs/buds.
  • Page 122 Cleaning and Disinfecting the Meter NOTICE Damage to the instrument ■ Ensure that no liquid enters the meter. If moisture enters the meter, it may cause malfunction of the instrument. ■ Do not insert any objects in the test strip guide. Doing so may damage the electrical contacts behind the test strip guide.

  • Page 123: 10 Troubleshooting

    Take the action suggested on screen to resolve the problem. If the error disappears, you may continue using the meter as desired. If the problem persists, contact Roche (see page 137). The two different message types are illustrated below:...

  • Page 124: Additional Information On Error 406

    Troubleshooting E-406: Sample Error Error message Sample Error E-406 Touch to exit this message. Perform the suggested step(s) to solve the problem. Unsuitable sample composition. Check your procedure and repeat the test with a fresh sample. Check medication regimen of patient. Additional information on Error 406 Power the meter off and remove the test strip.

  • Page 125: Errors And Unusual Behavior Without Error Messages

    Troubleshooting Errors and unusual behavior without error messages Some conditions may arise that have no associated error or status message. Message Description No message or unusual behavior ■ Wait 10 seconds and try powering on the unit again. Meter display does not ■...
  • Page 126 Troubleshooting This page intentionally left blank.

  • Page 127: 11 General Product Specifications

    Infrared interface, LED/IRED Class 1 Battery operation 4 x 1.5 V batteries type AA or special rechargeable battery pack for the CoaguChek XS Plus meter Power connection Power supply adapter: Input: 100-240 V / 50-60 Hz / 400 mA Output: 7.5 V DC / 1.7 A Number of tests Approx.

  • Page 128: Storage And Transport Conditions

    Handheld Base Unit and Operator’s 04805658160 Manual Reagents and solutions Supplies are available through Roche Diagnostics. Contact your local Roche representative. Product limitations Please read the information in the package insert supplied with the test strips for detailed product data and limitations.

  • Page 129: Information About Software Licenses

    This product incorporates software that is under lcense from General Public License (GPL). The source code of this software can be requested on a standard data exchange medium from the manufacturer at the following address: Roche Diagnostics GmbH Sandhofer Str. 116 68305 Mannheim, Germany The GPL licensing conditions are printed below (in English only for legal reasons): GPL, Version 2, June 1991.
  • Page 130 General Product Specifications Finally, any free program is threatened constantly by software patents. We wish to avoid the danger that redistributors of a free program will individually obtain patent licenses, in effect making the program proprietary. To prevent this, we have made it clear that any patent must be licensed for everyone’s free use or not licensed at all.
  • Page 131 General Product Specifications These requirements apply to the modified work as a whole. If identifiable sections of that work are not derived from the Program, and can be reasonably considered independent and separate works in themselves, then this License, and its terms, do not apply to those sections when you distribute them as separate works.
  • Page 132 General Product Specifications 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 distrib- uting 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 Pro- gram or works based on it.
  • Page 133 General Product Specifications Each version is given a distinguishing version number. If the Program specifies a version number of this License which applies to it and “any later version”, you have the option of following the terms and conditions either of that version or of any later version published by the Free Software Foundation.
  • Page 134 General Product Specifications This program is distributed in the hope that it will be useful, but WITHOUT ANY WARRANTY; without even the implied warranty of MERCHANTABILITY or FITNESS FOR A PARTICULAR PUR- POSE. See the GNU General Public License for more details. You should have received a copy of the GNU General Public License along with this program;...
  • Page 135 General Product Specifications Neither the name of the University nor the names of its contributors may be used to endorse or promote products derived from this software without specific prior written permission. THIS SOFTWARE IS PROVIDED BY THE REGENTS AND CONTRIBUTORS “AS IS” AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WAR- RANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DIS- CLAIMED.

  • Page 136: 12 Warranty

    Purchaser’s sole and exclusive remedy, with respect to the CoaguChek XS Plus meter and parts thereof, shall be the repair and/or replacement of the meter or parts at the option of Roche Diagnostics.

  • Page 137: 13 Appendix

    Appendix 13 Appendix Contact Roche For all questions about the CoaguChek XS Plus system that are not answered in this manual, contact your Roche representative or call Technical Service 24/7/365 at 1-800-428-4674 or visit us online at www.poc.roche.com...
  • Page 138 Appendix This page intentionally left blank.

  • Page 139: 14 Supplement For Observed Test Sequence

    Supplement for Observed Test Sequence 14 Supplement for Observed Test Sequence Observed Test Sequence (OTS) Observed Test Sequence options can only be configured using a DMS. The availability of electronic configuration options will thus vary according to the data management software utilized by your institution.

  • Page 140: Using The Ots Function

    Supplement for Observed Test Sequence Using the OTS function A request for an Observed Test Sequence comes from the DMS. The presence of the icon on the Patient Test button indicates a pending OTS request. Observer: Main Menu 09:15 am 1 Touch Patient Test.
  • Page 141 Supplement for Observed Test Sequence Operator: Pat. Test - OTS 09:15 am Remove 09:15 am 1 Touch Patient Test. OTS enabled Perform the patient test as usual. Once the Observer Login test is completed, the observer has to com- Patient Test plete the next steps.
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  • Page 143: Index

    Index Index Adapter (power supply)............................24 Admin. password..............................58–63 Applying a blood sample............................91 Auto Off ..................................52 Batteries Inserting..................................27 Types..................................25 Beeper ................................49, 89, 102 Blood sample (testing)............................77–96 Capillary blood sample (testing) ........................77–96 Cleaning................................119–122 Meter housing..............................120 Test strip guide ..............................121 Coagulation process ..............................91 Code chip................................
  • Page 144 Index Display Icons................................. 22–23 Display format ................................45 Disposal ............................17, 25, 79, 96, 107 Error messages................................123 Fingertip..................................91 Icons Drop..................................90 Dropper................................104 Hourglass ..............................90, 104 Identification plate ..............................5 Overview ................................. 22–23 Packaging.................................5 ID Setup .................................. 56–67 Overview ................................56 Infrared interface...............................21, 115 Keypad....................................
  • Page 145 Index Memory Button................................... 111 Patient Result..............................112 Quality Control ..............................113 Meter Overview .................................20 Observed Test Sequence (OTS).........................139–141 Operating conditions ............................19, 127 Operator Lockout ...................................74 Logout ..................................85 Password ................................85 Operator ID..................................64 Operator list................................. 85, 116 Options..................................47–55 Ordering..................................128 Overview Meter elements..............................20 Setup................................
  • Page 146 Index Relative humidity ...............................19, 127 Reset button................................. 21 Result confirmation ............................39, 94 Review Results ..............................109–118 Data transfer ..............................115 Roche (Addresses) ..............................137 Safety Protection against infection ........................... 16 User qualification ............................... 16 Screen..................................36–46 Setup Admin. password............................58–63 Auto Off..................................
  • Page 147 Index Target value...................................71 Temperature range............................ 19, 77, 127 Test principle ................................13 Test result (patient test)............................93 Test result (quality control) ..........................106 Test strip Icon................................. 89, 102 Inserting................................ 89, 102 Test strip guide cover ............................. 121 Thromboplastin ................................13 Time....................................43 Troubleshooting................................ 123 Unit (test result)................................93 Units (of measure)..............................37 Voltage ....................................19...
  • Page 148 Index This page intentionally left blank.
  • Page 149 Notes Notes...
  • Page 150 Notes Notes...
  • Page 152 ACCU-CHEK, COAGUCHEK and SAFE-T-PRO are trademarks of Roche. Manufactured for and distributed in the U.S.A. by: Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.roche.com www.coaguchek.com www.poc.roche.com...

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