Roche CoaguChek XS Pro Operator's Manual
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Roche CoaguChek XS Pro Operator's Manual

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CoaguChek
Operator's Manual
For meters shipped before January 2013
P O I N T
O F
C A R E
T E S T I N G
XS Pro
®

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  • Page 1 P O I N T C A R E T E S T I N G CoaguChek XS Pro ® Operator’s Manual For meters shipped before January 2013...
  • Page 2 Manual version Revision date Changes Version 1.0 2009-09 New document Version 2.0 2010-04 Update cleaning/disinfection, minor revisions Version 2.1 2016-08 Revised to add Rx only statement.
  • Page 3 The contents of this document, including all graphics and photographs, are the property of Roche. 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.
  • Page 4 Purchaser’ s sole and exclusive remedy, with respect to the CoaguChek XS Pro meter and parts thereof, shall be the repair and/or replacement of the meter or parts at the option of Roche Diagnostics.
  • Page 5 CoaguChek XS Pro ® Operator’s Manual Version 2.1 For meters shipped before January 2013 0 8103089001 (01) 2016-08 USA ©2010-2016 Roche Diagnostics. All rights reserved...
  • Page 6 The contents of this document, including all graphics, are the property of Roche Diagnostics. Information in this document is subject to change without notice. Roche Diagnostics shall not be liable for technical or editorial errors or omissions contained herein. 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.

  • Page 7: Table Of Contents

    Electromagnetic Interference ...................... 15 Touchscreen............................15 Operating conditions ........................16 Quality control ........................... 17 2 The CoaguChek XS Pro Meter Overview of the meter elements......................19 Buttons and icons overview ......................... 20 Power supply.............................. 23 3 Putting the Meter into Operation Inserting the batteries ..........................
  • Page 8 4 Meter Setup Note on presentation of screen elements in this manual..........27 Settings summary ........................... 28 Screen setup .............................. 32 Contrast..............................32 Result Units ............................33 Language Selection......................... 35 Setting the date..........................36 Setting the time..........................38 Setting the display options for date and time ............... 40 Options setup ............................
  • Page 9 Storage and transport conditions ................... 122 Further Information ..........................122 Ordering ............................122 Reagents and solutions ......................122 Product limitations........................122 Information about software licenses ..................123 Repairs .............................. 123 Contact Roche..........................123 12 Warranty 13 Appendix Contact Roche ............................125 Alphabetical Index...
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  • 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 Pro meter according to your needs before initial use. Refer to chapter 4, Meter Setup. Be sure to read the Safety information and additional information sec- tion in this chapter before operating the system.

  • Page 12: What Can The System Do For You

    What can the system do for you? The CoaguChek XS Pro system makes coagulation testing easy. You only need to insert the code chip, power the meter on, insert the test strip, and apply a small blood sample. The blood mixes with the reagents on the test strip, and the meter determines when the blood clots.

  • Page 13: Safety Information And Additional Information

    Safety information 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 Pro Operator’s Manual. Read these passages carefully. The safety alert symbol by itself (without a signal word) is used to pro-...

  • Page 14: Safety Information

    Only trained healthcare professionals may operate the CoaguChek XS Pro system. Operators must have received comprehensive instruction in the operation, quality control, and care of the CoaguChek XS Pro system. Protection against infection There is a potential risk of infection. Healthcare professionals using the...

  • Page 15: General Care

    Introduction General Care NOTICE Clean the meter only with the solutions recommended (see page 109). 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. Laser Scanner The built-in barcode scanner emits a laser beam when activated.

  • Page 16: Operating Conditions

    Introduction Operating conditions To ensure that the meter functions properly, please observe the following guidelines: Only use the meter at a room temperature between 15 °C and 32 °C (59 °F and 90 °F). ■ Only use the meter at a relative humidity between 10% and 85% (no condensation). ■...

  • Page 17: 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 Pro system. These controls are provided to assist with meeting regulatory compliance requirements as applicable to your facility.

  • Page 18: The Coaguchek Xs Pro Meter

    The CoaguChek XS Pro Meter The CoaguChek XS Pro Meter...

  • Page 19: Overview Of The Meter Elements

    The CoaguChek XS Pro Meter Overview of the meter elements Touchscreen Battery compartment cover Shows test results, information, icons, and Covers the battery compartment results recalled from memory. To select an (4 standard AA alkali-manganese option, simply touch the button lightly.

  • Page 20: Buttons And Icons Overview

    The CoaguChek XS Pro Meter Buttons and icons overview The buttons and icons that appear during normal operation are shown here, along with their respective meanings. Icon Meaning Go to Main Menu OK; save setting Cancel; discard setting Return (to previous menu)
  • Page 21 The CoaguChek XS Pro Meter Icon Meaning Insert the test strip code chip Insert the QC code chip Automatic quality control completed successfully Results are displayed as a Quick percentage value Results are displayed in seconds Results are displayed in INR units Result in the chosen unit of measure is above the measuring range.
  • Page 22 The CoaguChek XS Pro Meter Error messages and the description of the icons linked to them are provided in the Troubleshooting chapter of this manual. Icon Meaning Reports a warning message Reports an error (see: Troubleshooting) Reports a serious error (see: Troubleshooting)

  • Page 23: Power Supply

    The CoaguChek XS Pro Meter Power supply The CoaguChek XS Pro meter can operate with either the power adapter provided, batteries, or a special rechargeable battery pack (optional). The CoaguChek XS Pro meter uses four standard type AA alkaline batteries. You should insert the batteries or the optional rechargeable battery pack even when you use the power adapter.

  • Page 24: 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 Pro meter or to the optional Handheld Base Unit (HBU) and dock the meter.

  • Page 25: 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 26: 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 27: 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 28: 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 29 Meter Setup Group Subgroup Setting Values * Screen Contrast 0 – 10 (5 *) Result Units INR * INR/SEC INR/%Q Language Selection Dansk Deutsch English * Español Français Italiano Nederlands Norsk Português Svenska Date/Time Date 01/01/2005 * Time 12:00 am * Date formats DD.MM.YYYY (16.09.2009) MM/DD/YYYY (09/16/2009) *...
  • Page 30 Meter Setup Group Subgroup Setting Values * Options Sort Date/Time * Patient ID number Beeper Beeper Medium * High Key Click Off * Auto Off [minutes] 1 … (5*) … 10 Computer Active Inactive * * Default settings are labelled with an asterisk (*).
  • Page 31 Meter Setup Group Subgroup Setting Values * ID Setup Admin. (Administrator) Blank (Off) * Operator (Operator List is optional) Active Inactive * Patient No * Optional Required Lockouts Operator Lockout (only if the Operator Off * option is set to Active and an operator list Weekly is available) Monthly...

  • Page 32: 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 33: 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 34 Meter Setup The current unit of measure setting is high- lighted (white type on a black 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 35: 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. 3 From the Screen menu, touch Language Control Test Selection.

  • Page 36: 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 37 Meter Setup 4 From the Date/Time menu, touch Set 09:15 am Date/Time Date. Set Date 5 Touch to set the year, then 09:15 am Date Set Time the month, then the day. 2010 Year: 6 Touch to save this setting, or: Format Month: Touch...

  • Page 38: 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 39 Meter Setup 4 From the Date/Time menu, touch Set 09:15 am Date/Time Time. Set Date 5 Touch to set the hours, then 09:15 am Time Set Time the minutes. Hour: 6 Touch to save this setting, or: Format Minute: Touch to exit this menu without saving any changes.

  • Page 40: 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. 3 From the Screen menu, touch Date/Time.
  • Page 41 Meter Setup 4 From the Date/Time menu screen, touch 09:15 am Date/Time Format. Set Date Format 09:15 am The current settings are highlighted. You can Set Time DD.MM.YYYY Date: select one of the following display formats: Format MM/DD/YYYY Date: DD.MM.YYYY (Day.Month.Year), ■...

  • Page 42: 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 Pro meter. You can display stored results chronologically by date and time or by person, based on the Patient ID.
  • Page 43 Meter Setup The current setting is highlighted. You may 09:15 am Sort Sort By: select from the following sort options: By Date/Time Date / Time ■ By Patient ID Patient ID ■ 4 Touch the button to select the Sort by option of choice.

  • Page 44: Beeper

    Meter Setup Beeper The CoaguChek XS Pro meter can display information visually and alert you to special circum- stances with a Beeper. When the Beeper is activated, the meter beeps when: it is switched on ■ it detects a test strip ■...
  • Page 45 Meter Setup 1 From the Main Menu, touch Setup to 09:15 am Main Menu open the meter settings.. Patient Test 2 From the Setup Menu, touch Options. 3 From the Options menu, touch Beeper. Control Test Review Results Setup 03/16/2010 Setup Menu 09:15 am Screen...
  • Page 46 Meter Setup The current setting is highlighted. You may select from the following options: Beeper 09:15 am For the Beeper ■ ■ Medium Medium ■ High Key Click: High ■ For the Key Click 03/16/2010 ■ ■ 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 47: Auto Off

    Meter Setup Auto Off You can set up your CoaguChek XS Pro meter so that it powers itself off automatically if it has not been used (no buttons pressed or tests run) for a preselected time period. Use this feature to save power and extend the life of the batteries.
  • Page 48 Meter Setup You may select from the following options: Off (meter never powers itself off) ■ Auto Off 09:15 am Time until meter powers itself off: Minutes: ■ 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 49: Computer

    Meter Setup Computer The CoaguChek XS Pro 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 50 Meter Setup 1 From the Main Menu, touch Setup to 09:15 am Main Menu open the meter settings. Patient Test 2 From the Setup Menu, touch Options. 3 From the Options menu, touch Control Test Computer. Review Results Setup 03/16/2010 Setup Menu 09:15 am Screen...

  • Page 51: Id Setup

    It is not necessary for Admin. identification to be activated to use the CoaguChek XS Pro meter. However, it might be desired or necessary, depending on the regulatory environment and the site of use.
  • Page 52 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 53: 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 54 Meter Setup If an Admin. password has not been set up yet: 1 From the Main Menu, touch Setup to 09:15 am Main Menu open the meter settings. Patient Test 2 From the Setup Menu, touch ID Setup. 3 From the ID Setup menu , touch Admin. Control Test Review Results Setup...
  • Page 55 Meter Setup 4 Using the keypad displayed on the screen, Admin. Admin. 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 56 Meter Setup 9 Enter the Admin. password again (the Repeat ID 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 57 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. 3 Using the keypad displayed on the screen, Control Test enter the valid Admin.
  • Page 58 Meter Setup Deactivating an existing Admin. pass- word: 1 From the Main Menu, touch Setup to 09:15 am Main Menu open the meter settings. Patient Test 2 From the Setup Menu, touch ID Setup. 3 Using the keypad displayed on the screen, Control Test enter the valid Admin.

  • Page 59: Operator

    Meter Setup Operator 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 105). In the default setting, the Operator login is not activated.

  • Page 60: Patient

    Meter Setup Patient 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 105). In the default setting, input of Patient IDs is set to No. This means each test is simply assigned a consecutive number.
  • Page 61 Meter Setup You may select from the following options: Patient ID 09:15 am No (tests will be assigned numbers ■ automatically) Optional Optional (automatic numbering or ■ list/scan/manual input) Required Required (list/scan/manual input) ■ 03/16/2010 Touch the button with the setting of choice.
  • Page 62 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 text and numbers, e.g., “J. DOE 3378” Numeric Numeric ■ numbers only, e.g., “3387” Max.

  • Page 63: Lockouts Setup

    Meter Setup Lockouts setup The Lockouts menu contains the option for liquid quality control that require the operator to per- form 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 from further use.

  • Page 64: Operator Lockout

    Optional liquid quality controls can be used to ensure that an operator is performing tests prop- erly on the CoaguChek XS Pro 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 65 Meter Setup 4 Select the interval of choice in which the 09:15 am Op. Lockout mandatory quality control tests must be performed. Weekly Monthly Every 3 Months You may select from the following options: Every 6 Months No (deactivated) ■ Weekly ■...
  • Page 66 Meter Setup 8 For every option except for No, you must Op. Lockout 09:15 am now indicate the number of levels in Number of Levels 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 67: 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 68 Meter Setup 4 Select the triggers, based on lot and/or 09:15 am QC Lockout time, for requiring a quality control test. New Code 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 69: Testing A Capillary Blood Sample

    Testing a Capillary Blood Sample Testing a Capillary Blood Sample What you need: CoaguChek XS Pro meter ■ CoaguChek XS PT Test Strips and matching code chip ■ Lancing device approved for professional use (e.g., the Accu-Chek Safe-T-Pro Plus ■...

  • Page 70: Getting A Good Capillary Blood Sample

    Testing a Capillary 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 71: Getting A Good Result From Venous Whole Blood

    Testing a Capillary Blood Sample Getting a good result from venous whole blood Alternatively to performing a test with capillary blood, you can also perform a test using venous whole blood. Note the following: Use a simple plastic syringe to remove the blood sample. Do not use anticoagulants ■...

  • Page 72: 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 73: Test Strip Code Chip

    The CoaguChek XS Pro meter stores the data from up to 60 code chips that have been inserted. Do not forget to use the test strip code chip that is supplied with each pack of test strips ■...
  • Page 74 Testing a Capillary 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 75: Powering On The Meter

    Testing a Capillary 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 and holding the button for approximately 1 second.
  • Page 76 Testing a Capillary Blood Sample If the function Operator ID is active: Without operator list: Operator 09:15 am 3 Touch Scan and hold the barcode approx. CoaguChek 10 cm (4 inches) from the built-in XS Pro scanner. The meter beeps once the barcode has been read successfully.
  • Page 77 Testing a Capillary Blood Sample With operator list: Operator 09:15 am 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 Scan 03/16/2010 5 Enter the (optional) password.

  • Page 78: Performing A Test

    Testing a Capillary Blood Sample Performing a test 1 Check the battery level. If there are no Main Menu 09:15 am bars left in the battery icon, you cannot perform any tests. Patient Test 2 Check that the date and time are correct. Control Test Correct any wrong entries as described in chapter 4, Meter Setup/Setting the date.
  • Page 79 Testing a Capillary 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), you are prompted to enter a Patient ID.
  • Page 80 Testing a Capillary Blood Sample With patient list 5 Touch Patient Test. 6 Touch to display the entry of 09:15 am Test Patient ID 09:15 am choice. Select the patient to be tested PID01 Smith, Henry from the list. PID02 Jones, Walther 7 If the patient is not in the list, touch New PID03...
  • Page 81 Testing a Capillary Blood Sample Alternatively, the Patient ID can also be entered via the built-in barcode scanner. Touch Scan and scan the patient barcode from a distance of approx. 10 cm (4 inches). The meter beeps once the barcode has been read successfully.
  • Page 82 Testing a Capillary Blood Sample 8 The test strip icon prompts you to insert a test strip. Remove a test strip from its con- tainer and close the container again with the stopper. Exposure to external influences (such as humidity) may deteriorate the test strips and may lead to error messages.
  • Page 83 Testing a Capillary Blood Sample The hourglass icon shows that the test strip is 09:15 am Test P-ID: PID01 warming up. When the warming-up process Smith, Henry Operator 1 is complete, a further beep (provided the Par: Code: 184 beeper is enabled) indicates that you can now apply blood.
  • Page 84 Testing a Capillary Blood Sample Use only a lancing device that is approved for use by healthcare profession- als, such as the Accu-Chek Safe-T-Pro or Safe-T-Pro Plus lancing devices, WARNING or the CoaguChek Lancets (professional-use lancets available only in the United States).
  • Page 85 Testing a Capillary Blood Sample When applied from above, the blood must cover the entire sample application area. You hear a beep tone when you have applied 09:15 am Test enough blood (provided the Beeper is P-ID: PID01 Smith, Henry Operator 1 enabled).
  • Page 86 Testing a Capillary Blood Sample The meter performs an automatic quality con- Test 09:15 am P-ID: PID01 trol test on the test strip before it displays the Smith, Henry 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 87: Adding Comments

    Testing a Capillary 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 88 Testing a Capillary 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 89: Quality Control

    ■ test chamber. Roche offers optional liquid quality controls for the CoaguChek XS Pro system. These controls are provided to assist with regulatory compliance requirements as applicable to your facility. To perform an optional liquid quality control test using control solutions, you need: CoaguChek XS Pro meter ■...

  • Page 90: Preparing To Run A Liquid Quality Control Test

    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 91 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 92: Performing A Liquid Quality Control Test

    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 and holding the button for approximately 1 second.
  • Page 93 Quality Control 6 Touch Control Test. Main Menu 09:15 am QC Lockout Control Test Review Results Setup Logout 03/16/2010 7 The test strip icon prompts you to insert a 09:15 am QC Test test strip. Remove a test strip from its con- Operator 1 tainer and close the container again with the stopper.
  • Page 94 Quality Control If you are using a new test strip lot and have 09:15 am QC Test 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- tions.
  • Page 95 Quality Control 11 Select the level for this measurement. 09:15 am QC Test Code: 184 Par: Operator 1 Level 1 Level 2 03/16/2010 The hourglass icon shows that the test strip is QC Test 09:15 am Level: 1 warming up. When the warming-up process is Code: 184 Par: Operator 1...
  • Page 96 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 97 Quality Control You hear a beep when you have applied QC Test 09:15 am Level: 1 enough control solution (provided the beeper Code: 184 Par: Operator 1 is enabled). The dropper icon disappears and the test starts. 03/16/2010 The result of the liquid quality control test is QC Test 09:15 am Level: 1...
  • Page 98 Quality Control 14 If you want to add a comment, touch 09:15 am QC Comment Comm. Acceptable Control 15 Select the desired predefined comment(s) Asymptomatic from the pick list (if configured) or Cleaned Meter 16 Touch Custom to enter your own custom Doctor Notified comment.

  • Page 99: Review Results

    Review Results Review Results The CoaguChek XS Pro meter can save 1000 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 100 Operator and 200 Patient IDs is allowed.

  • Page 100: 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 and holding the button for approximately 1 second. To power the meter off after use, press the button for approximately 2 seconds.
  • Page 101 Review Results 4 Touch Review Results. Main Menu 09:15 am Patient Test Control Test Review Results Setup 03/16/2010 5 Select the type of results you want to view. Memory 09:15 am Display Patient Result memory ■ Display QC Result memory ■...

  • Page 102: Display Patient Result Memory

    Review Results Display patient result memory This memory area contains all test results for your patients, sorted chronologically or by Patient ID. The most recent results are at the top of the list. 1 Touch to scroll to the entry 09:15 am Memory of choice on the screen.

  • Page 103: Display Qc (Quality Control) Result Memory

    Review Results Display QC (quality control) result memory This memory area contains all 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 104 Review Results This page intentionally left blank.

  • Page 105: Extended Functionalities

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

  • Page 106: Operator Lists

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

  • Page 107: 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, entering the Patient ID using the on-screen keypad or, if available, of scanning the barcode with the Patient ID. The Patient ID, if entered on the DMS, comes with an additional identification entry.

  • Page 108: Barcode Scanner

    Extended Functionalities Barcode scanner Using a DMS, the barcode scanner may be configured to accept only selected barcode symbol- ogies (e.g., EAN-13 Barcodes are not allowed). Furthermore it is possible to define a barcode mask for Patient ID and Operator ID. With masks being defined, the meter checks a barcode after scanning and rejects it, if it does not match the mask.

  • Page 109: 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. Make sure the meter is powered off.

  • Page 110: Cleaning/Disinfecting The Exterior (Meter Housing)

    Cleaning and Disinfecting the Meter Cleaning/disinfecting the exterior (meter housing) Use the solutions recommended on page 109 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 111: Cleaning/Disinfecting The Test Strip Guide

    Cleaning and Disinfecting the Meter Cleaning/disinfecting the test strip guide Use the solutions recommended on page 109 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 112: Cleaning The Scanner Window

    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 ■...

  • Page 113: 10 Troubleshooting

    Troubleshooting 10 Troubleshooting The CoaguChek XS Pro meter continually checks its systems for unexpected and unwanted conditions. A troubleshooting table follows that will help you when the system is not performing as expected. Most concerns can be resolved quickly by referring to this table for help. Take the following steps when an unexpected condition arises: Find the displayed message or condition in the Troubleshooting Table.

  • Page 114: Error Messages After Powering On The Meter

    Troubleshooting Error messages after powering on the meter Error Description/Solution Error: Ambient tempera- The meter is too cold or too warm to measure correctly. ture Solution Error Power the meter off (unplug the power adapter) and allow it to stand for about 30 minutes at room temperature (+15 °C to +32 °C or 59 °F to 90 °F).

  • Page 115: Error Messages When Preparing To Test

    Troubleshooting Error messages when preparing to test Error Description/Solution Error: Cover The test strip guide cover was opened during a test, the test is cancelled. Solution Error Close the test strip guide cover and repeat the test. Error: Test strip The test strip is unusable or the test strip is not a CoaguChek XS PT Test strip, or the test strip was removed while the test was in prog- ress.

  • Page 116: Error Messages During Or After Blood Application

    Troubleshooting Error messages during or after blood application Error Description/Solution Error: Time for applica- The maximum allowed time of 180 seconds for applying blood has tion exceeded been exceeded. Solution Error Power the meter off, remove the test strip and start a new test using the same test strip.
  • Page 117 Troubleshooting Error Description/Solution Error: Measurement Measurement error resulting from the blood sample. Solution Error Power the meter off and remove the test strip. Repeat the measure- ment using a new test strip and blood taken from a new puncture site at the tip of another finger. Do not touch or remove the test strip when a test is in progress.

  • Page 118: Other Error Messages

    Repeat the test. If the error message persists or re-appears in the future, the meter is defective. This error indicates possible damage to the heater plate contacts. Contact your Roche representative. Error: Memory test The memory contains faulty data.
  • Page 119 Troubleshooting Error Description/Solution Error: Data transfer There was an error during data transfer to the data management system. Solution Error Check network connections (consult your administrator). ■ Remove the meter from the Handheld Base Unit, clean the infra- ■ red (IR) window, and then reinsert into the Handheld Base Unit. Error: Quality Control The control solution is beyond its expiration date.
  • Page 120 Troubleshooting This page intentionally left blank.

  • Page 121: 11 General Product Specifications

    Laser Class 1, according to EN 60825-1:2007 Battery operation 4 x 1.5 V batteries type AA or special rechargeable battery pack for the CoaguChek XS Pro meter or 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...

  • Page 122: Storage And Transport Conditions

    Handheld Base Unit and Operator’s 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 prod- uct data and limitations.

  • Page 123: Information About Software Licenses

    Roche. Contact Roche For all questions about the CoaguChek XS Pro system that are not answered in this manual, contact your Roche representative. If you do not already have contact details, a list of Roche Diagnostics offices is provided in the appendix or visit our website at www.Roche.com. Select “Roche Worldwide”...

  • Page 124: 12 Warranty

    Warranty 12 Warranty The statutory guarantee provisions on rights in consumer goods sales in the country of purchase shall apply.

  • Page 125: 13 Appendix

    Contact Roche Productos Roche S.A.Q.e I. Argentina RPD Decentral Solutions Rawson 3150 B1610BAL Ricardo Rojas Buenos Aires Roche Diagnostics Australia Pty Ltd. Australia ABN 29 003 001 205 31 Victoria Ave Castle Hill, NSW, 2154 Telephone 02-9899 7999 Roche Diagnostics GmbH...
  • Page 126 Tel.: 00385 1 4628 360 Productos Roche, S.A. Cuba Calle 96, No. 540, Esquina 7ma. Playa, C. La Habana + (537) 204 7515 Roche s.r.o., Divize diagnostiky, Near Patient Testing Czech Republic Karlovo náměstí 17 120 00 Praha 2 Tel.: 220 382 500 www.roche-diagnostics.cz...
  • Page 127 France 2 avenue du Vercors - BP 59 38242 MEYLAN CEDEX Assistance technique: Tél. : 04 76 76 31 00 Roche Diagnostics Deutschland GmbH Germany CoaguChek Kundenservice Sandhofer Straße 116 68305 Mannheim Telefon: 0180/2 00 01 64* Montag bis Freitag: 08.00 bis 18.00 Fax: 06 21/7 59-44 63 E-mail: mannheim.monitoring@roche.com...
  • Page 128 Appendix Roche Diagnostics India Pvt Ltd India Plot no 114 , Road no 15 , M.I.D.C Andheri ( E ) Mumbai – 400093 Tel: +91 022 6697 4900 Web: www.roche-diagnostics.co.in PT. Roche Indonesia Indonesia Diagnostics Division Artha Graha Building 21st floor Sudirman Central Business District –...
  • Page 129 Appendix Productos Roche, S.A. DE C.V. Mexico Vía I. Fabela Nte. 1536-B, C.P . 50030 Toluca Oficinas: Av. Santa Fe No. 485. - 4o Piso 05349 Del. Cuajimalpa, México DFP Roche Diagnostics Netherlands Nederland BV Transistorstraat 41 1322 CK Almere Telefoon: 0800 - 2882882 (gratis) Roche Diagnostics N.Z.
  • Page 130 Официальный дистрибьютор «Ф, Хоффманн-Ля Рош Лтд.» (Швейцария) Тел.: +7 (495) 258-27-77 Факс: +7 (495) 258-27-71 www.roche.ru Roche Diagnostics Asia Pacific Pte Ltd Singapore 298 Tiong Bahru Road #11-01/06 Central Plaza Singapore 168730 Tel: +65-62727500 Roche farmacevtska družba, d. o. o.
  • Page 131 Tel.: +598 (2) 6137888 Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 Roche Diagnostics Technical Service Center 1-800-428-4674 www.usdiagnostics.roche.com www.coaguchek-usa.com www.roche.com Productos Roche, S.A Venezuela RIF J-00044058-1 División Diagnostics Av. Diego Cisneros, Edf. Roche, piso 1 Urb. Los Ruices Caracas...
  • Page 132 Appendix This page intentionally left blank.

  • Page 133: Alphabetical Index

    Alphabetical Index Alphabetical Index Admin. password ............................... 53–58 Applying a blood sample ............................84 Auto Off ..................................47 Barcode ..................................76, 81 Barcode scanner ................................19 Batteries Inserting .................................25 Types ..................................23 Beeper ................................44, 82, 93 Blood sample (testing) ............................. 69–88 Capillary blood sample (testing) ........................69–88 Cleaning ................................109–112 Meter housing ..............................
  • Page 134 Alphabetical Index Data transfer ................................105 Date ....................................36 Disinfection ..............................109–112 Display Icons ................................20–21 Display format ................................40 Disposal ............................14, 23, 71, 88, 98 Error messages .............................. 113–119 Fingertip ..................................84 Icons Drop ..................................83 Dropper ................................. 95 Error ................................
  • Page 135 Alphabetical Index Mains voltage ..............................16, 121 Measurement Performing ..............................78–88 Preparing ................................72 Measuring range .............................. 86, 121 Memory Button .................................. 101 Patient Result ..............................102 Quality Control ..............................103 Meter Overview ................................18 Operating conditions ............................16, 121 Operator Lockout ..................................64 Logout ..................................77 Password ................................77 Operator ID ..................................59...
  • Page 136 Result ..................................97 Relative humidity ..............................16, 121 Reset button ................................19 Review Results ..............................99–108 Data transfer ..............................105 Roche (Address) ............................125–131 Safety Protection against infection .......................... 14 User qualification .............................. 14 Scan (button) ............................... 76, 81 Screen ..................................32–41 Setup Admin.
  • Page 137 Alphabetical Index Temperature range ........................... 16, 69, 121 Test principle ................................12 Test result (patient test) ............................86 Test result (quality control) ............................97 Test strip Icon ..................................82, 93 Inserting ................................82, 93 Test strip guide cover ............................111 Thromboplastin ................................12 Time ....................................38 Troubleshooting .............................113–119 Unit (test result) .................................86 Units (of measure) ..............................33 Voltage ...................................16...
  • Page 138 Notes Notes...
  • Page 140 ACCU-CHEK, COAGUCHEK and SAFE-T-PRO are trademarks 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...

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