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

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Operator's Manual

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Summary of Contents for Roche CoaguChek XS Pro

  • Page 1 P O I N T C A R E T E S T I N G CoaguChek XS Pro ® Operator’s Manual...
  • Page 2 Revision History Manual version Revision date Changes Version 1.0 2009-09 New document, international launch with document 0 5548829001 (01) EN 2009-09. Version 2.0 2010-04 Update cleaning/disinfection, minor revisions Version 3.0 2010-10 Update to SW 03 Version 4.0 2013-01 Update to SW 03.01, new functions; creation of document 0 6950540001 (01) EN-CAN/ 0 6950566001 (01) FR-CAN with altered instructions on cleaning/disinfection for...
  • Page 3 CoaguChek XS Pro ® Operator’s Manual Version 5.0 0 6950540001 (02) 2015-12 EN-CAN...
  • Page 4 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 5: Table Of Contents

    Local Area Network: protection from unauthorized access ..........18 Wired network connection ......................19 Operating conditions ........................20 Quality control ........................... 20 The CoaguChek XS Pro Meter 2.1 Overview of the meter elements......................22 2.2 Buttons and icons overview ......................... 23 2.3 Power supply.............................. 25 Putting the Meter into Operation 3.1 Inserting the batteries ..........................
  • Page 6 4.4 ID setup................................ 54 System Administrator (Admin.)....................56 Operator ID ............................60 Patient ID ............................61 4.5 QC Settings setup ............................ 63 QC Range ............................64 QC (quality control) Lockout......................67 Operator Lockout ..........................69 STAT Test Configuration........................ 71 Testing a Blood Sample 5.1 Important notes............................
  • Page 7 Ordering ............................140 Reagents and solutions ......................140 Product limitations........................140 Information about software licenses ..................141 Repairs .............................. 141 Contact Roche..........................142 Warranty Appendix A.1 Working with barcodes.........................143 A.2 Operator and patient ID barcode masks..................144 A.3 Example of barcode symbologies .....................145 Appendix B.1 Supplement for Observed Test Sequence ..................147...
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  • Page 9: Introduction

    You must configure the CoaguChek XS Pro meter accord- ing to your needs before initial use. Refer to chapter 4, Meter Setup. Be sure to read the “Important safety instructions and additional information”...

  • Page 10: If You Need Help

    When error messages appear on the screen, refer to chapter 10, Troubleshooting. For all questions about the CoaguChek XS Pro system that are not answered in this manual, contact your Roche representative. In order to expedite troubleshooting,...

  • Page 11: Test Principle

    Optional liquid controls for the system are also available. The CoaguChek XS Pro meter has the ability to connect to a data management system (DMS) through the Hand- held Base Unit from Roche (available separately). The CoaguChek XS Pro meter supports data exchange via the POCT1A standard.

  • Page 12: 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 Pro Operator’s Manual. Read these passages carefully. The safety alert symbol alone (without a signal word) promotes awareness to hazards which are generic or directs the reader to related safety information.
  • Page 13 Introduction • 1 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 14: Safety Information

    Safety Information Operator qualification 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 and blood-borne pathogens WARNING...

  • Page 15: Disposal Of The System

    Do not short circuit the power supply unit, the hand- ■ held base unit contacts, or the battery pack. Do not drop the CoaguChek XS Pro meter, the power ■ supply unit, or the battery pack and protect these against shaking and vibrations.
  • Page 16 Damaged or swollen lithium-ion (Li-ion) battery packs WARNING can overheat, catch fire, or leak. Immediately cease use of CoaguChek XS Pro meters with damaged or swollen Li-ion battery packs. Under no circumstances recharge meters with damaged or swollen Li-ion battery packs by placing them in the handheld base unit or connecting them to the power adapter.

  • Page 17: General Care

    Introduction • 1 Disposal of used batteries Do not dispose of the batteries with normal domestic waste. Dispose of used batteries in an environmentally responsible manner and in accordance with applicable local regulations and directives. Contact your local council/local authority or the manufacturer of the used batteries for advice on correct disposal.

  • Page 18: Laser Scanner

    1 • Introduction Laser Scanner The built-in barcode scanner emits a laser beam when activated. The built-in barcode scanner is a Class 1 laser, according to EN 60825-1:2007. A barcode does not need to be present for the laser scanner to become active. Do not stare directly into the laser beam.

  • Page 19: Wired Network Connection

    Introduction • 1 Wired network connection If the Handheld Base Unit from Roche is used to connect this meter to a local area network, the Handheld Base Unit must be protected against unauthorized access by means of a strong password management. Observe...

  • Page 20: Operating Conditions

    Roche Diagnostics has available optional liquid quality controls for the CoaguChek XS Pro system. These con- trols are provided to assist with meeting regulatory com- pliance requirements as applicable to your facility.

  • Page 21: The Coaguchek Xs Pro Meter

    The CoaguChek XS Pro Meter • 2 The CoaguChek XS Pro Meter...

  • Page 22: Overview Of The Meter Elements

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

  • Page 23: Buttons And Icons Overview

    The CoaguChek XS Pro Meter • 2 Buttons and icons overview The buttons and icons that appear during normal opera- tion are shown here, along with their respective mean- ings. Error messages and the description of the icons linked to them are provided in a separate chapter. See “Troubleshooting”...
  • Page 24 2 • The CoaguChek XS Pro 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 25: 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 Pro 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 26 2 • The CoaguChek XS Pro Meter During battery operation, the meter always displays the Main Menu 09:15 am battery power level. When replacing the batteries or the rechargeable Patient Test battery pack, you must insert the new batteries or bat- tery pack within ten (10) minutes of removing the old one(s) to retain the date and time settings.

  • Page 27: 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, con- nect the power adapter to the CoaguChek XS Pro meter or to the optional Handheld Base Unit (HBU) and dock the meter.

  • Page 28: Inserting The Batteries

    3 • Putting the Meter into Operation Inserting the batteries With the meter powered off, press the battery com- partment cover release tab and slide the cover off. 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 29: 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 Place the meter on a level, vibration-free surface, or hold it in your hand so it is roughly horizontal.

  • Page 30: Checking The Software Version

    3 • Putting the Meter into Operation Checking the software version After displaying the Roche logo, the meter briefly displays Init the Init (for “initialization”) screen. Here you can check which software version is currently running on your CoaguChek meter. (The Init screen shown here is for illustration pur- XS Pro poses only.

  • Page 31: Meter Setup

    Meter Setup • 4 Meter Setup Note on presentation of screen Buttons are screen prompts that cause something to elements in this manual 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 4 • Meter Setup Touch Setup to open the meter settings. Main Menu 09:15 am Select the group of settings of choice (see the Patient Test Settings summary following this section.). Control Test Review Results Setup Setup Menu 09:15 am 04/19/2012 Screen Options...

  • Page 33: Settings Summary

    Meter Setup • 4 Settings summary The diagram below shows all of the setup areas that can be accessed on the meter. Setup Screen Result Language Contrast Confirmation Selection Result Units Date / Time Options Sort Beeper Auto Off Connection ID Setup Admin.
  • Page 34 4 • Meter Setup Group Subgroup Setting Values * Contrast 0 – 10 (5 *) Screen 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...
  • Page 35 Meter Setup • 4 Group Subgroup Setting Values * Sort Date/Time * Options Patient ID Patient Name Beeper Beeper Medium * High Key Click Off * Auto Off [minutes] 1 … (5*) … 10 Connection Off * Computer Printer * Default settings are labeled with an asterisk (*).
  • Page 36 4 • Meter Setup Group Subgroup Setting Values * Admin. (Administrator) Blank (Off) * ID Setup Operator (Operator List is optional) Active Inactive * Patient No * Optional Required QC Range Default Range* QC Settings Custom Range Display Target Value On/Off * Deviation from Target Value Percentage (%)

  • Page 37: Screen Setup

    Meter Setup • 4 Screen setup The Screen setup area contains the options for changing the display. Contrast Use the Contrast menu to adjust the display to your ambi- ent light conditions and make it easier to read. Main Menu 09:15 am Setup Menu 09:15 am...

  • Page 38: Result Units

    4 • Meter Setup Result Units Use this setting to select the unit(s) of measure to be dis- played with the results. Main Menu Setup Menu Screen 09:15 am 09:15 am 09:15 am Screen Contrast Patient Test Result Units Options Result Confirmation Control Test ID Setup...

  • Page 39: Result Confirmation

    Meter Setup • 4 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. Main Menu 09:15 am Setup Menu 09:15 am Screen 09:15 am...

  • Page 40: Language Selection

    4 • Meter Setup Language Selection Use this setting to select the language for all displays (that contain text). Main Menu Setup Menu Screen 09:15 am 09:15 am 09:15 am Screen Contrast Patient Test Result Units Options Result Confirmation Control Test ID Setup Language Selection Review Results...

  • Page 41: Setting The Date

    Meter Setup • 4 Touch to display the language of choice Language 09:15 am on the screen. Dansk If the arrow is just an outline , you have reached Deutsch the end of the list in the repective direction. English Touch the button to select the language of choice.
  • Page 42 4 • Meter Setup Main Menu 09:15 am Setup Menu 09:15 am Screen 09:15 am Screen Contrast Patient Test Result Units Options Result Confirmation Control Test ID Setup Language Selection Review Results Date / Time Setup QC Settings 04/19/2012 04/19/2012 04/19/2012 From the Main Menu, touch Setup to open the meter settings.

  • Page 43: Setting The Time

    Meter Setup • 4 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: Setting The Display Options For Date And Time

    4 • Meter Setup Setting the display options for Select your preferred format for the date and time display. date and time Main Menu Setup Menu Screen 09:15 am 09:15 am 09:15 am Screen Contrast Patient Test Result Units Options Result Confirmation Control Test ID Setup...
  • Page 45 Meter Setup • 4 Touch the button with the display format of choice Date/Time 09:15 am for date and time. Your selection is now high- Set Date lighted. Set Time Touch to save this setting, or touch to exit this menu without saving any changes. The display Format automatically returns to the previous screen.

  • Page 46: 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 per- son, 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 47 Meter Setup • 4 The current setting is highlighted. You may select from the following sort options: By Date/Time ■ By Patient ID ■ By Patient Name ■ Touch the button to select the Sort by option of Sort 09:15 am Sort By: choice.

  • Page 48: Beeper

    4 • Meter Setup Beeper The CoaguChek XS Pro meter can display information visually and alert you to special circumstances with a Beeper. When the Beeper is enabled, the meter beeps when: it is switched on ■ it detects a test strip ■...
  • Page 49 Meter Setup • 4 Main Menu 09:15 am Setup Menu 09:15 am Options 09:15 am Screen Sort Patient Test Options Beeper Control Test Auto Off ID Setup Review Results Setup QC Settings Connection 04/19/2012 04/19/2012 04/19/2012 From the Main Menu, touch Setup to open the meter settings..

  • Page 50: Auto Off

    4 • 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 touched or tests run) for a preselected time period. Use this feature to save power and extend the life of the batteries.

  • Page 51: Connection

    Meter Setup • 4 You may select from the following options: Auto Off 09:15 am Minutes: Off (meter never powers itself off) ■ Time until meter powers itself off: ■ 1…10, 15, 20, 25, 30, 40, 50, 60 minutes Touch to select the time of choice in minutes or to switch the feature off.

  • Page 52: Computer

    4 • Meter Setup Computer The CoaguChek XS Pro meter can connect with a compu- ter 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 53: Printer

    Meter Setup • 4 Printer The CoaguChek XS Pro meter can also connect directly to a printer. To use the printing feature you need an optional infrared printer. Main Menu 09:15 am Setup Menu 09:15 am Options 09:15 am Screen...

  • Page 54: Id Setup

    4 • Meter Setup ID setup Use the ID Setup menu to enter settings for user man- agement and patient management. These settings are optional and set to Off/Inactive by default; the meter can be operated without these settings. There are three types of identification used with the meter: System Administrator: The Admin.
  • Page 55 Meter Setup • 4 Patient: The Patient ID is assigned to the person, ■ whose test results are recorded. You can either: – block input of a unique Patient ID (in this case, every test is simply numbered in consecutive order) –...

  • Page 56: System Administrator (Admin.)

    The Admin. pass- word must also be entered before you can delete or change the Admin. password itself. If you forget the Admin. password, contact your Roche representative. If an Admin. password has not been set up yet: Main Menu...
  • Page 57 Meter Setup • 4 Using the keypad displayed on the screen, enter the Admin. 09:15 am ***| Admin. password of choice. The password can con- sist of up to 20 characters. Pay close attention to the buttons you press, because the characters are not displayed on the screen.
  • Page 58 4 • Meter Setup Changing an existing Admin. password: Main Menu 09:15 am Setup Menu 09:15 am ID Setup 09:15 am Admin. 09:15 am ***| Screen Admin. Patient Test Options Operator Control Test ID Setup Patient Review Results Setup QC Settings 04/19/2012 04/19/2012 04/19/2012...
  • Page 59 Meter Setup • 4 Deactivating an existing Admin. password: Main Menu 09:15 am Setup Menu 09:15 am ID Setup 09:15 am Admin. 09:15 am ***| Screen Admin. Patient Test Options Operator Control Test ID Setup Patient Review Results Setup QC Settings 04/19/2012 04/19/2012 04/19/2012...

  • Page 60: Operator Id

    4 • 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 111).

  • Page 61: Patient Id

    Meter Setup • 4 Patient ID If you want to create a list of Patient IDs from which you can select a patient for testing, additional software (a data management system) and the Handheld Base Unit are required (see page 111). In the default setting, input of Patient IDs is set to No.
  • Page 62 4 • Meter Setup Select the form for input of the Patient ID. Patient ID 09:15 am Alphanumeric You may select from the following options: Numeric Alphanumeric ■ Min. Length: Enter any combination of letters and numbers, e.g., “J. DOE 3378” Max.

  • Page 63: 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 64: Qc Range

    4 • 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. Main Menu 09:15 am Setup Menu 09:15 am QC Settings 09:15 am Screen QC Range Patient Test...
  • Page 65 Meter Setup • 4 If you selected Custom Range, the QC Range screen QC Range 09:15 am opens and offers you the following options: Display target value (On/Off) Default Range ■ Custom Range Deviation from target value (percentage value). See ■...
  • Page 66 4 • Meter Setup Touch On (the target value will be displayed with a QC Range 09:15 am test result) or Off (the target value will not be dis- Display target value played). Your selection is now highlighted. Use the arrows to to set the allowed percentage Deviation from target value deviation from the target value.

  • Page 67: Qc (Quality Control) Lockout

    Meter Setup • 4 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 operator lists. It is also possible to mandate Operator Lockouts and QC Lockouts in parallel.
  • Page 68 4 • Meter Setup Select the triggers, based on lot and/or time, for QC Lockout 09:15 am requiring a quality control test. New Code You may select from the following options: Daily New Code Yes/No (applies every time a new test ■...

  • Page 69: Operator Lockout

    Optional liquid quality controls can be used to ensure that an operator is performing tests properly 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 70 4 • Meter Setup Select the interval of choice in which the mandatory Op. Lockout 09:15 am quality control tests must be performed. You may select from the following options: Weekly Monthly No (deactivated) ■ Every 3 Months Weekly ■ Every 6 Months Monthly ■...

  • Page 71: Stat Test Configuration

    Meter Setup • 4 STAT Test Configuration Quality control tests ensure consistent quality and accu- rate measurements. In emergency situations, however, it may be necessary to perform a test without delay. To override an active lockout , you can allow for STAT Tests (STAT = Short TurnAround Time).
  • Page 72 4 • Meter Setup Main Menu 09:15 am Setup Menu 09:15 am QC Settings 09:15 am Screen QC Range Patient Test Options QC Lockout Control Test Operator Lockout ID Setup Review Results Setup QC Settings STAT Test Config. 04/19/2012 04/19/2012 04/19/2012 From the Main Menu, touch Setup to open the meter settings.

  • Page 73: Testing A Blood Sample

    Testing a Blood Sample • 5 Testing a Blood Sample What you need: CoaguChek XS Pro meter ■ CoaguChek XS PT Test Strips and matching code ■ chip When testing with venous blood: ■ – Standard blood collection device (syringe) When testing with capillary blood: ■...
  • Page 74 5 • Testing a Blood Sample Protection against infection: When collecting samples always observe the general precautions and guidelines relating to blood sampling (see page 14). Dispose of all test strips used for patient testing in accordance with the disposal policy of your laboratory or practice (see page 14) Never …...

  • Page 75: Getting A Good Capillary Blood Sample

    Testing a Blood Sample • 5 Getting a good capillary blood To get a suitable drop of blood: sample 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.

  • Page 76: Getting A Good Result From Venous Whole Blood

    5 • Testing a Blood Sample Getting a good result from For sample collection use a standard blood collection venous whole blood device. Do not use anti-coagulants (e.g., EDTA, citrate, fluoride, oxalate, or heparin) to collect the blood sample. Venous blood samples may be collected from a venous line.

  • Page 77: Preparing To Test

    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 ■...

  • Page 78: Inserting The Code Chip

    5 • Testing a Blood Sample Inserting the code chip Remove the old code chip, if one is inserted in the meter. Check that the number on the code chip matches the number on the label of the test strip container. Slide the new code chip into the code chip slot (as shown) until you feel it snap into place.

  • Page 79: Powering On The Meter

    Testing a Blood Sample • 5 Powering on the meter Place the meter on a level, vibration-free surface, or hold it in your hand so it is roughly horizontal. 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 80 5 • Testing a Blood Sample If the function Operator ID is active: Without operator list: You are now prompted to enter an Operator ID Operator ID 09:15 am Scan Enter the Operator ID using the keypad. Touch ■ to move to the next screen. Alternatively, the Operator ID can also be entered ■...
  • Page 81 Testing a Blood Sample • 5 With operator list: Wait until the operator list is displayed. Operator 09:15 am Alan Smithee Select the operator of choice by touching the cor- responding button. Jane Brown Enter the (optional) password. Ann Casey Joe Dalton After you enter the password, touch to log on.

  • Page 82: Performing A Test

    5 • Testing a Blood Sample Performing a test Check the battery level. Main Menu 09:15 am If the battery icon turns red (one bar left), there may ■ Patient Test not be enough power left for another test. If there are no bars left in the battery icon, you cannot ■...
  • Page 83 Testing a Blood Sample • 5 Without patient list Touch Patient Test. If the Patient ID option was chosen as either Optional or Required when the meter was set up (see “Meter Setup”/“Patient ID”), you are prompted to enter a Patient ID If Required, enter the Patient ID, then touch ■...
  • Page 84 5 • Testing a Blood Sample With patient list Patient ID Test 09:15 am 09:15 am PID01 Smith, Henry PID02 Jones, Walther PID03 Hamilton, Fran PID04 Miller, Ted PID05 Reed, William Scan Scan 04/19/2012 Touch Patient Test. Touch to display the entry of choice. Select the patient to be tested from the list.
  • Page 85 Testing a Blood Sample • 5 Note: Extended data handling functionality is depend- ent on the capabilities of the particular Data Manage- ment System (DMS) being used and may vary. For more details see “Data handling”, starting on page 111. Alternatively, the Patient ID can also be entered using the built-in barcode scanner .
  • Page 86 5 • Testing a Blood Sample Test 09:15 am P-ID: PID01 Müller, David Schulz Par: 04/19/2012 The test strip icon prompts you to insert a test strip. Remove a test strip from its container 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 mes- sages.
  • Page 87 Testing a Blood Sample • 5 If you use a new test strip lot and have not inserted the Test 09:15 am code chip yet, you must do so now. Otherwise you cannot P-ID: PID01 Smith, Henry Operator 1 perform a test. The meter displays the number of the Par: code chip belonging to the new test strip lot.
  • Page 88 5 • Testing a Blood Sample Use only a lancing device that is approved for use by healthcare professionals, such as the Accu-Chek Safe-T- Pro or Safe-T-Pro Plus lancing devices, or the Coag- WARNING uChek Lancets (professional-use lancets available only in the United States).
  • Page 89 Testing a Blood Sample • 5 When applied from above, the blood must cover the entire sample application area. You hear a beep tone when you have applied enough Test 09:15 am blood (provided the Beeper is enabled). The blood drop P-ID: PID01 Smith, Henry Operator 1...
  • Page 90 5 • Testing a Blood Sample The meter performs an automatic quality control test on Test 09:15 am P-ID: PID01 the test strip before it displays the test result. “QC” Smith, Henry Operator 1 appears in the display. Par: Code: 184 Following a successful outcome of the quality control test, Test 09:15 am...

  • Page 91: Accepting Or Rejecting A Test Result

    Testing a Blood Sample • 5 Accepting or rejecting a test If this function is enabled, you may choose to accept or result reject a test result. When the result is displayed, touch Reject or ■ Test 09:15 am P-ID: PID01 Accept ■...

  • Page 92: Adding Comments

    5 • Testing a Blood Sample Adding comments You can add up to three comments to a test result. Com- Test 09:15 am P-ID: PID01 ments can provide, for example, additional information Smith, Henry Operator 1 about the test conditions or the patient. A comment may Par: Code: 184 04/19/2012 09:14 am...
  • Page 93 Testing a Blood Sample • 5 After the test result is displayed, touch . You will Remove 09:15 am be prompted to remove the strip. Remove the test strip from the meter. Power the meter off. Clean the meter if necessary (see Chapter 9, Main- tenance and Care).

  • Page 94: Stat Tests

    5 • Testing a Blood Sample STAT tests STAT tests are a limited number of tests that can be per- formed in emergency situations, see page 71. If the meter is configured to perform STAT tests, you have the option of performing a test by choosing STAT even though a QC Lockout is in place.

  • Page 95: Control Testing And Quality Control

    Control Testing and Quality Control • 6 Control Testing and Quality Control The CoaguChek XS Pro meter has a number of built-in quality control functions. A check of the electronic components and func- ■ tions every time the meter is powered on.

  • Page 96: Preparing To Run A Liquid Quality Control Test

    6 • 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.
  • Page 97 Control Testing and Quality Control • 6 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. Close the bottle again. Make sure the dropper is at hand for the next steps in the liquid quality control test.

  • Page 98: Performing A Liquid Quality Control Test

    6 • Control Testing and Quality Control Performing a liquid quality control test Place the meter on a level, vibration-free surface or hold it in your hand so it is roughly horizontal. Power the meter on by pressing the button for approximately 1 second.
  • Page 99 Control Testing and Quality Control • 6 Touch Control Test. Main Menu 09:15 am The test strip icon prompts you to insert a test strip. Patient Test Remove a test strip from its container and close the container again with the stopper. Control Test Hold the test strip so the lettering with the test Review Results...
  • Page 100 6 • Control Testing and Quality Control If you are using a new test strip lot and have not inserted QC Test 09:15 am the test strip code chip yet, you must do so now. Other- Operator 1 wise you cannot perform a quality control test. As with the test strips, a quality control code chip is also provided with the control solutions.
  • Page 101 Control Testing and Quality Control • 6 If performing more than one level, select the level QC Test 09:15 am for this measurement. Code: 184 Par: Operator 1 The hourglass icon shows that the test strip is warming up. When the warming-up process is complete, a further Level 1 beep (provided the beeper is enabled) indicates that you Level 2...
  • Page 102 6 • Control Testing and Quality Control Using the dropper, draw up the dissolved contents of the bottle. Apply a single drop of control solution directly from the dropper to the semicircular, transparent sample application area on top of the test strip. Do not add more control solution.
  • Page 103 Control Testing and Quality Control • 6 You hear a beep when you have applied enough control QC Test 09:15 am solution (provided the beeper is enabled). The dropper Level: 1 Code: 184 Par: Operator 1 icon disappears and the test starts. The result of the liquid quality control test is displayed.
  • Page 104 6 • Control Testing and Quality Control If you want to add a comment, touch QC Comment 09:15 am Acceptable Control Select the desired predefined comment(s) from the pick list (if configured) or Cleaned Meter Touch Custom to enter your own custom com- Doctor Notified ment.

  • Page 105: Review Results

    Review Results • 7 Review Results The CoaguChek XS Pro meter can save 2000 patient test results as well as 500 liquid quality control tests to mem- ory, 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.

  • Page 106: Viewing Test Results

    7 • Review Results Viewing test results Place the meter on a level, vibration-free surface, or hold it in your hand so it is roughly horizontal. 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 107 Review Results • 7 Main Menu 09:15 am Memory 09:15 am Patient Test Patient Result Control Test QC Result Review Results Setup 04/19/2012 04/19/2012 Touch Review Results. Select the type of results you want to view. Display Patient Result memory ■...

  • Page 108: Display Patient Result Memory

    7 • 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 46). If the Sort option is set to Date/ Time, the most recent results are at the top of the list.

  • Page 109: Display Qc (Quality Control) Result Memory

    Review Results • 7 Display QC (quality control) This memory area contains all liquid quality control tests result memory that were run, sorted chronologically. The most recent results are at the top of the list. 09:15 am Memory 09:15 am Level: 1 04/18/2012 11:31 am Code: 184...
  • Page 110 7 • Review Results This page intentionally left blank.

  • Page 111: Extended Functionalities

    System (DMS) being used and may vary. 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 connec-...
  • Page 112 8 • Extended Functionalities Through the DMS the system administrator (such as the POC coordinator) may specify what settings are to be applied to a set of meters within a site or unit (e.g., hospi- tals or wards). All meters assigned to a specific site and/ or unit would consequently share the same settings.

  • Page 113: Computer (Setup Option)

    Extended Functionalities • 8 Computer (Setup option) For initial connection to a DMS, the ability to communi- cate within a network has to be set up as follows: In the Setup menu, the Connection option must be ■ set to Computer (see page 51). The Handheld Base Unit must be configured cor- ■...

  • Page 114: Operator Lists

    8 • Extended Functionalities Operator lists After powering the meter on, an Operator login may be configured. There are three possible configurations for an Operator login: Operator list is activated, but there are no operators ■ available: The Operator can either log in via the onscreen keypad or a barcode scan.

  • Page 115: Patient Lists

    Extended Functionalities • 8 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 onscreen keypad or, if available, of scanning the barcode with the Patient ID. The Patient ID, if entered on the DMS, comes with an additional iden- tification entry.

  • Page 116: Patient List Validation

    8 • Extended Functionalities The Patient ID is set to “hidden” (only possible with ■ a data management system), and there is a list available: When you start the test, the screen is blank and Scan is displayed. – You may now scan a Patient ID using the barcode scanner.

  • Page 117: Configuring Operator And Patient Ids

    Extended Functionalities • 8 Configuring operator and When creating operator and patient IDs, apply the follow- patient IDs ing rules: Patient IDs can consist of up to 20 alphanumeric ■ characters, with specified minimum and maximum lengths. Operator IDs can consist of up to 20 alphanumeric ■...
  • Page 118 8 • Extended Functionalities The default preset comments in the meter are: INR result comments QC result comments Asymptomatic Acceptable Control ■ ■ Cleaned Meter Cleaned Meter ■ ■ Doctor Notified Doctor Notified ■ ■ Sick New Control Lot ■ ■...

  • Page 119: Maintenance And Care

    Maintenance and Care • 9 Maintenance and Care Conditions for storage and shipping Storage Store the system and test strips in the same envi- ■ ronment in which they are used. Do not store the meter in direct sunlight or under ■...

  • Page 120: Shipping

    9 • Maintenance and Care Shipping Observe the following safety information when shipping the meter and battery pack. Failure to do so may result in injury to persons or damage to the meter or battery pack. If the meter is shipped or transported over long dis- ■...

  • Page 121: Cleaning And Disinfecting The Meter

    Maintenance and Care • 9 Cleaning and Disinfecting the Meter Observe the disinfection guidelines of your ■ institution. Protective gloves should always be worn when ■ cleaning and disinfecting the device. Follow the procedures below to clean/disinfect the NOTICE meter. Failure to follow these procedures may cause malfunction of the meter.

  • Page 122: When Should The Meter Be Cleaned And Disinfected

    9 • Maintenance and Care When should the meter be The meter should be cleaned whenever visibly ■ cleaned and disinfected soiled. The exterior of the meter and the test strip guide ■ should be cleaned and disinfected before being used on another patient.

  • Page 123: Approved Cleaning And Disinfecting Products

    Use only products containing the approved active ingre- dients. Do not use any other cleaning or disinfecting solutions as this could result in damage to the system components. For technical assistance or questions on cleaning and disinfecting, please contact Roche Care Center at 1-877-273-3433.

  • Page 124: Cleaning/Disinfecting The Exterior (Meter Housing)

    The test strip guide and test strip guide cover ■ If you notice any signs of deterioration after cleaning or disinfecting your meter, stop using it and contact Roche Care Center at 1-877-273-3433 for assistance. Ensure that the blue test strip guide cover remains tightly closed while cleaning or disinfecting the exterior housing.
  • Page 125 Maintenance and Care • 9 Clean the exterior With the meter powered off, wipe the meter’s exterior ® clean with a fresh Sani-Cloth Plus Germicidal Cloth. Remove any excess moisture from the the cloth before using it. Do not let liquid accumulate near any opening. Carefully wipe around the cover of the test strip guide and other openings.
  • Page 126 9 • Maintenance and Care Disinfect the exterior ® Take a fresh Sani-Cloth Plus Germicidal Cloth from the container. Remove excess moisture from the cloth. With the meter powered off, wipe the meter’s exterior again. Do not let liquid accumulate near any opening. Carefully wipe around the cover of the test strip guide and other openings.

  • Page 127: Cleaning/Disinfecting The Test Strip Guide

    Maintenance and Care • 9 Cleaning/disinfecting the test strip guide When to clean and disinfect the The test strip guide should be cleaned and ■ test strip guide disinfected whenever the housing is cleaned and disinfected (see above). Damage to the instrument NOTICE Use only products containing the approved active ingre- dients (see page 123).
  • Page 128 9 • Maintenance and Care Disinfect the test strip guide cover ® Take a fresh Sani-Cloth Plus Germicidal Cloth from the container. Remove excess moisture from the cloth. Disinfect the test strip guide cover by wiping with the germicidal cloth. To properly disinfect, let the test strip guide cover sit wet for a contact time of at least 2 minutes, or as instructed by the manufacturer in the product...
  • Page 129 Maintenance and Care • 9 Dry the interior test strip guide After the required contact time, carefully dry the test strip guide with a dry lint-free cloth. Let the inside of the test strip guide dry for at least 10 minutes before re-attaching the test strip guide cover and testing again.

  • Page 130: Maintenance Cleaning Of The Interior Test Strip Guide And Battery Compartment In Case Of Residue Build-Up

    9 • Maintenance and Care Maintenance cleaning of the interior test strip guide and battery compartment in case of residue build-up ® When to clean the test strip Over time, the Sani-Cloth Plus Cloths may leave a build- guide and battery compartment up of residue in the test strip guide and battery compartment.
  • Page 131 Maintenance and Care • 9 Clean the inner side of the cover with a cotton swab and water. If necessary rinse the cover under tap water. Clean the interior test strip guide Hold the meter upright with the test strip guide facing down.

  • Page 132: How To Perform Maintenance Cleaning Of The Battery Compartment

    9 • Maintenance and Care How to perform maintenance With the meter powered off, press the battery com- cleaning of the battery partment cover release tab and slide the cover off.. compartment You can either leave the batteries inserted in the battery compartment cover or remove them when performing the following maintenance cleaning steps.

  • Page 133: Cleaning The Scanner Window

    Maintenance and Care • 9 Damage through moisture entering the instrument NOTICE Ensure that no liquid enters the meter. If moisture enters the meter, it may cause malfunction of the instrument. If you have removed them, reinsert the batteries into the battery compartment cover. Slide the bat- tery compartment cover back onto the meter and close the battery compartment.
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  • Page 135: Troubleshooting

    Troubleshooting • 10 10 Troubleshooting The CoaguChek XS Pro meter continually checks its sys- tems for unexpected and unwanted conditions. These may arise for technical reasons (defective components or consumables, environmental factors) or due to handling and procedure errors. Depending on the circumstances, a message may appear on the display of the meter.

  • Page 136: Additional Information On Error E-406

    10 • 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.

  • Page 137: Errors And Unusual Behavior Without Error Messages

    Troubleshooting • 10 Errors and unusual behavior Some conditions may arise that have no associated error without error messages or status message. Message Description No message or unusual behavior Meter display does not power on Wait 10 seconds and try powering on the unit again. ■...
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  • Page 139: 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 / 350-150 mA Output: 7.5 V DC / 1.7 A...

  • Page 140: Storage And Transport Conditions

    CoaguChek XS PT Test 2 x 24 test strips CoaguChek XS PT Controls Optional liquid controls for the International edition CoaguChek XS Pro / XS Plus systems (not available in the CoaguChek XS Pro PT Controls Optional liquid controls for the US edition...

  • Page 141: Information About Software Licenses

    The source code of this soft- ware 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 General Public License (GPL) licensing conditions are available (in English only for legal reasons) as a PDF file (file name “License.txt.PDF”) on the CD supplied with...

  • Page 142: Contact Roche

    12 • Warranty Contact Roche For all technical questions about the CoaguChek XS Pro system that are not answered in this manual, contact your Roche Diagnostics representative, or contact us at: Roche Care Center Telephone (region of Montréal): (450) 686-7050...

  • Page 143: A Appendix

    Appendix • A Appendix Working with barcodes Risk of barcode read errors If a barcode is read incorrectly, this may lead to patient misidentification and therefore to inappropriate therapy WARNING decisions. To minimize the risk of barcode read errors, the facility must ensure that the barcode used is of adequate size and print quality.

  • Page 144: A.2 Operator And Patient Id Barcode Masks

    A • Appendix Operator and patient ID barcode masks Barcode mask character Definition A-Z, 0-9 If not preceded by the Caret (“^”), the scan data character must be the same as the mask character. This character is not saved as part of the ID. If the characters are not the same, the scan data is not a valid ID.

  • Page 145: A.3 Example Of Barcode Symbologies

    Appendix • A Example of barcode symbologies When creating patient or operator barcodes, always adhere to the applicable international IEC/ISO standards for the respective barcode symbology. In particular, ensure that barcode size and print quality (as defined in ISO/IEC 15421) are adequate. Inadequate print size and/ or quality may lead to erroneous decoding.
  • Page 146 A • Appendix Codabar Code 39 Code 93 Code 128 EAN 13 Interleaved 2/5...

  • Page 147: B Appendix

    Appendix • B Appendix Supplement for Observed Test Sequence Observed Test Sequence (OTS) The Observed Test Sequence (OTS) function allows an observer (supervisor) to assess and record an operator’s performance (e.g., for recertification purposes). The observer monitors an operator during a test to check that the test is being performed according to the recom- mended procedures.

  • Page 148: Using The Ots Function

    B • Appendix 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. Main Menu 09:15 am Pat. Test - OTS 09:15 am Observer 09:15 am...
  • Page 149 Appendix • B Pat. Test - OTS 09:15 am Remove 09:15 am Observer Login Observer 09:15 am OTS passed: I-010 Pass Fail OTS enabled Observer ALAN SMITHEE, Measurement Result OK? please log in to proceed. Otherwise the OTS test will Observer Login Reject Accept...
  • Page 150 B • Appendix This page intentionally left blank.

  • Page 151: Index

    Index Display Adapter (power supply) ........25 Icons ............. 23–24 Admin. password ..........56–59 Display format ............44 Applying a blood sample ........88 Disposal ........15, 26, 76, 93, 104 Auto Off ..............50 Error messages ............. 135 Barcode ...............80, 85 Masks ............... 144 Symbologies ........... 146 Fingertip ..............88 Barcode scanner .............22 Batteries...
  • Page 152 Memory Button ............... 107 Relative humidity ...........20, 139 Patient Result ..........108 Reset button ............. 22 Quality Control ..........109 Result confirmation ........39, 91 Meter Review Results ..........105–118 Overview .............21 Data transfer ..........111 Observed Test Sequence (OTS) ....147–149 Safety Operating conditions ........
  • Page 153 Target value ..............66 Temperature range ........ 20, 73, 139 Test principle ............11 Test result (patient test) ........90 Test result (quality control) ......103 Test strip Icon ...............86, 99 Inserting ............86, 99 Test strip guide cover ......... 127 Thromboplastin ............11 Time ................43 Troubleshooting ...........
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  • Page 156 ACCU-CHEK, COAGUCHEK and SAFE-T-PRO are trademarks of Roche. Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.roche.com www.coaguchek.com www.poc.roche.com...

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