Roche CoaguCheck Pro II Operator's Manual
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Roche CoaguCheck Pro II Operator's Manual

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Operator's Manual

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marisa mulvihill
February 24, 2025

when applying the blood test it keeps erroring with E405 . can you tell me how i can rectify this ?

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Summary of Contents for Roche CoaguCheck Pro II

  • Page 1 ® CoaguChek Pro II Operator’s Manual...
  • Page 2 Revision History Manual version Revision date Changes Version 1.0 2015-11 New document Version 2.0 2015-11 Revised safety information on barcode handling, minor changes...
  • Page 3 CoaguChek ® Pro II Operator’s Manual Version 2.0 0 7154879001 (02) 2015-11 EN...
  • 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 On the packaging and on the identification plate of the instrument you may encounter the following symbols, shown here with their meaning: Caution, consult accompanying documents. Refer to safety-related notes in the instructions for use accompanying this product. Temperature limitation (Store at) Use by Manufacturer Batch code/ Lot number...
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  • Page 7: Table Of Contents

    Introduction 1.1 Before you start............................11 Intended use ............................11 Important information regarding use ..................11 If you need help ..........................12 General note............................12 What can the system do for you? ....................12 Test principle ............................. 13 Contents of the pack ........................14 1.2 Important safety instructions and additional information............
  • Page 8 3.3 Options setup ............................58 Sort................................. 58 Beeper ..............................60 Auto Off..............................62 Connection............................63 QR Code............................... 64 Computer............................. 67 Printer ..............................68 Parameter Selection ........................69 3.4 ID Setup ............................... 70 System Administrator (Admin.)....................72 Operator ID ............................76 Patient ID ............................
  • Page 9 Sample material ..........................159 Storage conditions........................160 Transport conditions ........................160 10.2 Further Information ..........................161 Consumables / Accessories ..................... 161 Reagents and solutions ......................161 Product limitations........................161 Information about software licenses ..................162 Repairs .............................. 163 Contact Roche..........................163 Warranty...
  • Page 10 Appendix A.1 Operator and patient ID barcode masks..................165 A.2 Example of barcode symbologies .....................166 A.3 Supported characters in 2D barcodes ....................169 Appendix B.1 Supplement for Observed Test Sequence ..................171 Observed Test Sequence (OTS) ....................171 Using the OTS function....................... 172 Appendix C.1 Option: Wireless network (WLAN)....................175 Background .............................

  • Page 11: Introduction

    Introduction Before you start ® Intended use The CoaguChek Pro II system (consisting of the CoaguChek Pro II meter and the CoaguChek family of test strips) is used for the determination of PT and aPTT by healthcare professionals in a Point of Care environment. Important information regarding Read this operator's manual, as well as the package inserts for all relevant consumables, before using the...

  • Page 12: If You Need Help

    When error messages appear on the screen, refer to chapter 9, Troubleshooting. For all questions about the CoaguChek Pro II system that are not answered in this manual, contact your Roche Diagnostics representative. In order to expedite trouble- shooting, please have ready your CoaguChek Pro II meter, its serial number, this manual, and all related con- sumables when you call.

  • Page 13: Test Principle

    The CoaguChek Pro II meter has the ability to connect to a data management system (DMS) through the Handheld Base Unit from Roche Diagnostics (available separately) or via wireless communication (WLAN). The CoaguChek Pro II meter supports data exchange via the POCT1A standard.

  • Page 14: Contents Of The Pack

    Contents of the pack The CoaguChek Pro II pack contains the following items: CoaguChek Pro II meter ■ Universal Battery Pack ■ Power supply ■ Operator’s Manual (printed version, not shown ■ here) Manual CD ROM (contains PDF files of the Opera- ■...

  • Page 15: 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 Pro II 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 16 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 17: Safety Information

    Follow all health and safety regulations in force ■ locally. Avoidance of electrical shock, fire, and explosions Only use Roche Diagnostics original accessories ■ (cables, power supply units, battery packs, and spare WARNING parts). Third-party cables, power supply units, and battery packs can cause the battery pack to explode or the meter to become damaged.

  • Page 18: Disposal Of The System

    Handheld Base Unit (i.e., one connected to a power supply). Use only the specially designed battery pack provided by NOTICE Roche Diagnostics. Using any other type of battery may damage the system.
  • Page 19 Possible hazards posed by the battery pack Damaged or swollen battery packs can overheat, catch fire, or leak. Immediately cease use of CoaguChek Pro II WARNING meters with damaged or swollen battery packs and under no circumstances recharge them (do not place in the Handheld Base Unit).

  • Page 20: Electromagnetic Interference

    Observe the following general safety instructions for handling the battery pack: Disposal of used battery packs Do not dispose of the battery pack with normal domestic waste. Dispose of used battery packs in accordance with applicable local regulations and directives and your facility’s guidelines on the disposal of electronic waste equipment.

  • Page 21: Touchscreen

    Touchscreen NOTICE Use only your finger (even when wearing gloves) or ■ special pens designed for use with touchscreens to touch the screen elements. Using pointed or sharp- edged objects can damage the touchscreen. Avoid prolonged exposure to direct sunlight. Direct ■...

  • Page 22: Wired Network Connection

    Wired network connection If the Handheld Base Unit from Roche Diagnostics is used to connect this meter to a local area network, the Handheld Base Unit must be protected against unauthor- ized access by means of a strong password manage- ment.

  • Page 23: Wireless Connectivity

    Wireless connectivity If the meter is equipped with WLAN functionality: Wireless connectivity allows the meter to send data (test results, patient IDs, operator IDs, etc.) to the data man- agement system without the need to return the meter to the Handheld Base Unit. This feature must be configured by the system administrator.
  • Page 24 WLAN but also could be near or at the same frequency and cause interference. Roche Diagnostics supports industry wireless standards and recommends using products that have Wi-Fi certifica- tion. This certification tests products to the 802.11 industry standards for basic connectivity, security, authentication, Quality of Service (QoS), interoperability and reliability.
  • Page 25 Changes or modifications made to this equipment not expressly approved by Roche Diagnostics may void the FCC authorization to operate this equipment. This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada.
  • Page 26 The CoaguChek Pro II system complies with the emission and immunity requirements described in EN 61326-2-6. It has been designed and tested to CISPR 11 Class B. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.

  • Page 27: Operating Conditions

    An onboard quality control within every single test ■ strip. Roche Diagnostics offers liquid quality controls for the CoaguChek Pro II system. These controls are designed to assist you in meeting regulatory compliance require- ments at your facility.

  • Page 28: Overview Of The Meter Elements

    Overview of the meter elements...
  • Page 29 Touchscreen Battery compartment cover Shows test results, information, icons, Remove to insert the battery pack. and results recalled from memory. To Charging terminals select an option, simply touch the Used for power supply and/or charging button lightly. the battery pack when the meter is On/Off button docked in the (optional) Handheld Base Press this button to power the meter on...

  • Page 30: Buttons And Icons Overview

    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 31 Button/Icon Meaning Apply sample (the time left to apply sample is counted down in the display) Apply liquid control (QC) sample (the time left to apply sample is counted down in the display) 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...
  • Page 32 Button/Icon Meaning Room or meter temperature is outside the acceptable range The test strip guide cover is open Reports a status message (see: Chapter 9, Troubleshooting) Reports an error message or a warning (see: Chapter 9, Troubleshooting) Lockout, one or more parameters are locked The following icons may appear when using the meter in conjunction with a data management system (DMS).

  • Page 33: Power Supply

    Power supply The CoaguChek Pro II meter is operated with the rechargeable battery pack. Insert the battery pack even when using the power adapter. This ensures that you will not lose the date and time settings if the power goes out. The power adapter also serves as a charger for the battery pack.
  • Page 34 During battery operation, the meter always displays the 09:15 am Main Menu battery power level. When replacing the battery pack, insert the new Patient Test battery pack within 24 hours of removing the old one. Otherwise you may need to re-enter date and time. Control Test The meter retains results in memory even when no bat- tery pack is inserted.

  • Page 35: Putting The Meter Into Operation

    Putting the Meter into Operation Before using the meter for the first time, perform the fol- lowing steps: Install the battery pack Connect the power adapter to charge the battery pack Set the current date and time Enter your chosen settings (language, unit of measure, user administration if applicable, etc.)

  • Page 36: Installing Or Replacing The Battery Pack

    Installing or replacing the battery pack When shipped, the battery pack is not installed in the CoaguChek Pro II meter. Unused battery packs lose their charge over time and have to be recharged before they can be used. After installing a new battery pack, the meter should be charged for two hours before testing.

  • Page 37: Removing The Battery Pack

    Removing the battery pack If a battery pack is already installed, make sure that the meter is powered off. Place the meter face down on a level surface. Using a an appropriate starshaped screwdriver, e.g. ® Torx size T5, remove the four screws holding the battery compartment cover in place.

  • Page 38: Installing The Battery Pack

    Installing the battery pack Loosen the screws on the battery compartment cover until they are protruding about 4-5 mm (2/10 in). Hold the battery pack in your hand, with the wires and the plug pinched between your thumb and index finger. Plug the connector plug into the socket.
  • Page 39 Place the cover on the battery compartment. Make sure that – the plug connector wires do not get pinched between meter and cover – the protrusion on the battery compartment cover fits into the corresponding groove on the battery compartment rim Tighten all four screws until snug (do not over- tighten).
  • Page 40 After inserting a new battery pack, the meter powers on automatically. The Roche logo is displayed. If the meter does not ■ power on automatically, the battery pack may be empty. Connect the power adapter for a minimum of 30 minutes, then remove the plug and try to...

  • Page 41: Powering The Meter On And Off

    To power the meter off after use, press the button for approximately 1 second. 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 ®...
  • Page 42 This page intentionally left blank.

  • Page 43: Meter Setup

    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 44 Touch Setup to open the meter settings. 09:15 am Main Menu Select the relevant group of settings (see the Patient Test Settings summary following this section.). Control Test Review Results Setup Setup Menu 09:15 am 05/29/2015 Screen Options ID Setup QC Settings Diagnostics 05/29/2015...

  • Page 45: Settings Summary

    Settings summary The diagram below shows all of the setup areas that can be accessed on the meter. Setup Screen Result Contrast Date / Time Confi rmation Language Result Units Selection Options Parameter Sort Auto Off Selection Beeper Connection ID Setup Admin.
  • Page 46 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 01/01/2015 * Time 12:00 am * Date formats...
  • Page 47 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 QR Code Off * Parameter Selection Enable Disable * Admin.
  • Page 48 Group Subgroup Setting Values * QC Range Default Range* QC Settings aPTT Custom Range Lockouts Operator Lockout Off * (only if the Operator Weekly option is set to Active Monthly and an operator list is Every 3 months available) Every 6 months Yearly Number of levels QC Lockout...

  • Page 49: Screen 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 ambi- ent light conditions and make it easier to read. 09:15 am 09:15 am 09:15 am Main Menu Setup Menu Screen...

  • Page 50: Result Units

    Result Units Use this setting to select the unit(s) in which the result is displayed. This setting only applies to PT test results. Regardless of the settings chosen for PT, aPTT is always displayed in seconds. 09:15 am 09:15 am 09:15 am Main Menu Setup Menu...

  • Page 51: Result Confirmation

    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. 09:15 am 09:15 am 09:15 am Main Menu Setup Menu Screen Screen Contrast...

  • Page 52: Language Selection

    Language Selection Use this setting to select the meter language. Main Menu 09:15 am Setup Menu 09:15 am Screen 09:15 am Screen Contrast Patient Test Result Units Options Control Test Result Confi rmation ID Setup Review Results Language Selection QC Settings Setup Date / Time Diagnostics...

  • Page 53: Setting The Date

    Touch to display the language of choice 09:15 am Language 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. Español Your selection is now highlighted.
  • Page 54 09:15 am 09:15 am 09:15 am Main Menu Setup Menu Screen Screen Contrast Patient Test Options Result Units Control Test ID Setup Result Confi rmation Review Results QC Settings Language Selection Setup Date / Time Diagnostics 05/29/2015 05/29/2015 05/29/2015 From the Main Menu, touch Setup to open the meter settings.

  • Page 55: Setting The Time

    Setting the time When you power on the meter for the first time (or after a long period without power), this Time 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 56: Setting The Display Options For Date And Time

    Setting the display options for Select your preferred format for the date and time display. date and time Main Menu 09:15 am Setup Menu 09:15 am Screen 09:15 am Contrast Screen Patient Test Result Units Options Control Test Result Confi rmation ID Setup Review Results Language Selection...
  • Page 57 Touch the button with the display format of choice 09:15 am Date/Time 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 58: Options Setup

    Options setup Sort Sort refers to the order in which measured and stored results are displayed when you use the Review Results function of the CoaguChek Pro II meter. You can display stored results chronologically by date and time or by per- son, based on the Patient ID.
  • Page 59 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 09:15 am Sort choice. Your selection is now highlighted. Sort By: Date / Time The sort option Patient Name is available only when...

  • Page 60: Beeper

    Beeper The CoaguChek Pro II meter can display information visu- ally and alert you to special circumstances with a Beeper. The meter always beeps when it is switched on. When the Beeper function is enabled the meter beeps once when: it detects a test strip ■...
  • Page 61 09:15 am 09:15 am 09:15 am Main Menu Setup Menu Options Screen Sort Patient Test Options Beeper Control Test ID Setup Auto Off Review Results QC Settings Connection Setup Parameter Selection Diagnostics 05/29/2015 05/29/2015 05/29/2015 From the Main Menu, touch Setup to open the meter settings..

  • Page 62: Auto Off

    Auto Off You can set up your CoaguChek Pro II 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 battery pack.

  • Page 63: Connection

    You may select from the following options: 09:15 am Auto Off 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 min- utes or to switch the feature off.

  • Page 64: Qr Code

    If you are a customer or a 3rd party IT provider, and you are interested to use this feature, contact your local Roche Diagnostics repre- sentative for additional information. Touch Plain Text, Coded Data or URL Transmission, depending on the intended use.
  • Page 65 If you have selected URL Transmission, the button will 09:15 am QR Code become active. Use this button to set the additional Show QR code: parameters. Plain Text Touch to open the URL Transmission menu. Coded Data Touch URL to enter the URL to which the test result data will be uploaded (note: the URL will be pro- URL Transmission vided by your specialized service provider).
  • Page 66 Touch Encryption Key to display the Encryption 09:15 am URL Transmission Key menu. The Encryption Key menu displays two types of informa- tion which are required in order to identify and decode the transmitted test result. This information is required by Encryption Key the IT system, to which the test result is transmitted via the defined URL.

  • Page 67: Computer

    Computer The CoaguChek Pro II 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 or the meter must be configured for wireless communica- tion.

  • Page 68: Printer

    Printer The CoaguChek Pro II meter can also connect directly to a printer. To use the printing feature you need an optional infrared printer. 09:15 am 09:15 am 09:15 am Main Menu Setup Menu Options Screen Sort Patient Test Options Beeper Control Test ID Setup...

  • Page 69: Parameter Selection

    Parameter Selection When performing a test, the meter can be set to display a screen that allows the operator to select the test parame- ter to be used. Otherwise the meter will determine the test parameter by reading the test strip (barcode) infor- mation from the inserted test strip.

  • Page 70: Id 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 71 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) – allow a unique Patient ID as optional, or –...

  • Page 72: System Administrator (Admin.)

    The Admin. ID must also be entered before you can delete or change the Admin. ID itself. If you forget the Admin. ID, contact your Roche Diagnostics representative. If an Admin. ID has not been set up yet:...
  • Page 73 Using the keypad displayed on the screen, enter the 09:15 am Admin. ***| Admin. ID of choice. The ID can consist of up to 20 characters. Pay close attention to the buttons you press, because the characters are not displayed on the screen. Aster- isks are displayed instead (as if entering a password on a computer).
  • Page 74 Changing an existing Admin. ID: Main Menu 09:15 am Setup Menu 09:15 am ID Setup 09:15 am 09:15 am Admin. ***| Screen Admin. Patient Test Options Operator Control Test ID Setup Patient Review Results QC Settings Setup Diagnostics 05/29/2015 05/29/2015 05/29/2015 From the Main Menu, touch Setup to open the meter settings.
  • Page 75 Deactivating an existing Admin. ID: Main Menu 09:15 am Setup Menu 09:15 am ID Setup 09:15 am 09:15 am Admin. ***| Screen Admin. Patient Test Options Operator Control Test ID Setup Patient Review Results QC Settings Setup Diagnostics 05/29/2015 05/29/2015 05/29/2015 From the Main Menu, touch Setup to open the meter settings.

  • Page 76: Operator Id

    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 139). In the default setting, the Operator login is not activated.

  • Page 77: Patient Id

    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 139). In the default setting, input of Patient IDs is set to No. This means each test is simply assigned a consecutive number.
  • Page 78 Select the form for input of the Patient ID. 09:15 am Patient ID You may select from the following options: Alphanumeric Numeric Alphanumeric ■ Min. Length: Enter any combination of letters and numbers, e.g., “J. DOE 3378” Max. Length: Numeric ■...

  • Page 79: Qc Settings Setup

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

  • Page 80: Qc Range

    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 individually for each test parameter. 09:15 am 09:15 am 09:15 am Main Menu Setup Menu QC Settings Screen QC Range...
  • Page 81 If you selected Default Range, touch to save ■ this setting, or touch to exit this menu without saving any changes. If you selected Custom Range, touch to pro- ■ ceed with corresponding settings, or touch exit this menu without saving any changes. The dis- play automatically returns to the previous screen.
  • Page 82 Touch On (the target value will be displayed with a 09:15 am QC Range 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 83: Qc (Quality Control) Lockout

    QC (quality control) Lockout 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. QC Lockout is disabled by default. For routine confirma- tion of system reliability it is recommended to enable this feature.
  • Page 84 You may select from the following options: 09:15 am QC Lockout New Code New Code Yes/No (applies every time a new test ■ strip lot is used) The general intervals are: Daily Weekly ■ Monthly Daily ■ Weekly ■ 05/29/2015 Monthly ■...
  • Page 85 09:15 am 09:15 am 09:15 am QC Lockout QC Lockout QC Lockout Number of strips (1-999): Number of Levels New Code Weekly One Level Monthly Two Levels No. of Hours No. of Strips 05/29/2015 05/29/2015 05/29/2015 Touch the button to select the interval of your choice.

  • Page 86: Operator Lockout

    Operator Lockout Optional liquid quality controls can be used to ensure that an operator is performing tests properly on the CoaguChek Pro II 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 87 09:15 am 09:15 am 09:15 am Op. Lockout Op. Lockout Op. Lockout Number of Levels Weekly Weekly Monthly One Level Monthly Every 3 Months Two Levels Every 3 Months Every 6 Months Every 6 Months Yearly 05/29/2015 05/29/2015 05/29/2015 Select the interval of choice in which the mandatory quality control tests must be performed.

  • Page 88: Stat Test Configuration

    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 STAT Tests (STAT = Short TurnAround Time). You can set the number of tests (up to nine) permitted beyond the lockout.
  • Page 89 09:15 am 09:15 am 09:15 am 09:15 am Main Menu Setup Menu QC Settings Lockouts QC Lockout Screen QC Range Patient Test Options Operator Lockout Lockouts Control Test ID Setup Scan QC Material STAT Test Confi g. Review Results QC Settings Setup Diagnostics 05/29/2015...

  • Page 90: Scan Qc Material

    Scan QC Material The barcode scanner of the CoaguChek Pro II meter can be used to scan barcodes from QC material vials. 09:15 am 09:15 am 09:15 am Main Menu Setup Menu QC Settings Screen QC Range Patient Test Options Lockouts Control Test ID Setup...

  • Page 91: Diagnostics

    Diagnostics Under Diagnostics, you will find information about the system, such as software version, number of data records stored, and configuration details. The diagnostics screens shown here are for illustration purposes only. The Infor- mation shown on your meter may differ. 09:15 am 09:15 am 09:15 am...
  • Page 92 General 09:15 am Software 09:15 am Hardware 09:15 am Memory Usage 09:15 am Meter name: Build: 04.00.00 Patient Tests: CoaguChek Pro II in use/max. (no.): 1300/2000 Boot: 00.16.31 Home location: Control Tests: Kernel: 00.21.30 Serial no.: U76001234 Mannheim in use/max. (no.): 350/500 Last synchronization: Rootfs:...

  • Page 93: Testing A Blood Sample

    Testing a Blood Sample What you need: CoaguChek Pro II meter ■ CoaguChek PT and/or aPTT Test Strips with ■ matching code chip When testing with venous blood: ■ – Standard blood collection device (syringe) When testing with capillary blood: ■...
  • Page 94 Protection against infection: When collecting samples always observe the general precautions and guidelines relating to blood sampling (see page 17). Dispose of all test strips used for patient testing in accordance with the disposal policy of your laboratory or practice (see page 17) Never …...

  • Page 95: Getting A Good Capillary Blood Sample

    Getting a good capillary blood sample Prepare the selected blood collection site and obtain blood from the patient per facility policy. If no facility policy exists for obtaining capillary blood, follow these recommendations: Warm the hand. Have the patient hold it under his ■...

  • Page 96: Getting A Good Result From Venous Whole Blood

    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 97: Preparing To Test

    Preparing to test Have the test strip container at hand. Make sure that the code chip supplied with these test strips is at hand. Each box of test strips (PT, aPTT) contains a code chip. The parameter, the number on the code chip and the number on the test strip container must match.

  • Page 98: Inserting The Code Chip

    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 99: Powering On The Meter

    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 You can also power on the meter directly by inserting a test strip or connecting the power adapter.
  • Page 100 If the function Operator ID is active: Without operator list: You are now prompted to enter an Operator ID 09:15 am Operator ID Scan Enter the Operator ID using the keypad. Touch ■ to move to the next screen. Alternatively, the Operator ID can also be entered ■...
  • Page 101 With operator list: Wait until the operator list is displayed. Operator 09:15 am Select the operator of choice by touching the Alan Smithee corresponding button or touch Scan to scan an Jane Brown operator barcode. Ann Casey Joe Dalton Note: Scanned operator IDs must also be on the list. Otherwise the login attempt will fail and an error mes- sage will be displayed.

  • Page 102: Performing A Test

    Performing a test Check the battery level. 09:15 am Main Menu 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 103 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 104 With patient list 09:15 am 09:15 am Patient ID Test PID01 Smith, Henry PID02 Jones, Walther PID03 Hamilton, Fran PID04 Miller, Ted PID05 Reed, William Scan Scan 05/29/2015 Touch Patient Test. Touch to display the entry of choice. Select the patient to be tested from the list. If the patient is not in the list, touch New to create a new entry.
  • Page 105 Alternatively, the Patient ID can also be entered using the built-in barcode scanner . Touch Scan and scan the patient barcode from a distance of approx. 10-20 cm (4-8 inches), according to the barcode size. The meter beeps once the barcode has been read suc- cessfully.
  • Page 106 If the Parameter Selection option is enabled in the meter settings, you are now prompted to select the parameter to be tested. The testing procedure for both parameters is similar. For illustration purposes testing with PT test strips is shown as an example. Test 09:15 am aPTT...
  • Page 107 If you use a new test strip lot and have not inserted the 09:15 am Test 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 108: Applying Blood From The Fingertip

    Applying blood from the fingertip 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 WARNING CoaguChek Lancets (professional-use lancets available only in the United States). Follow the manufacturer’s instructions.

  • Page 109: Applying Blood With A Syringe

    Applying blood with a syringe Discard the first four drops of blood collected (within the first 10 seconds). Then immediately apply one drop of blood (at least 8 μL, but not more than 20 μL) directly onto the target area of the test strip. Ensure that no air bubbles are introduced into the sample.
  • Page 110 You hear a beep tone when you have applied enough 09:15 am Test blood (provided the Beeper is enabled). The blood drop P-ID: PID01 Smith, Henry Operator 1 symbol disappears and the test starts. Par: Code: Do not add more blood. To avoid error messages do not touch the test strip until the result is displayed.
  • Page 111 If a “C” is displayed along with the result: Test 09:15 am This may occur if the hematocrit value is very low or due P-ID: PID05 Müller, David Schulz to erroneous blood collection (e.g., wet hands). Repeat Par: Code: 05/29/2015 09:14 am the test.

  • Page 112: Accepting Or Rejecting A Test Result

    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 ■ 09:15 am Test P-ID: PID01 Accept ■ Smith, Henry Operator 1 Par: Code: If you reject a result, you must enter a comment with an...

  • Page 113: Adding Comments

    Adding comments You can add up to three comments to a test result. Com- Test 09:15 am ments can provide, for example, additional information P-ID: PID01 Smith, Henry Operator 1 about the test conditions or the patient. A comment may Par: Code: 05/29/2015 09:14 am...

  • Page 114: Displaying The Test Result As Qr Code

    Displaying the test result as QR code The QR code icon only appears if the QR code dis- play function is activated (see page 64 and following). Otherwise it is not displayed. Touch to display the result as QR code. 09:15 am Test P-ID:...

  • Page 115: Stat Tests

    STAT tests STAT tests are a limited number of tests that can be per- formed in emergency situations, see page 88. 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.
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  • Page 117: Control And Proficiency Testing

    An onboard quality control within every single test ■ strip. Roche Diagnostics offers liquid quality controls for the CoaguChek Pro II system. These controls are designed to assist you in meeting regulatory compliance require- ments at your facility.

  • Page 118: Preparing To Perform A Liquid Quality Control Test

    Preparing to perform 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 119 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 120: Performing A Liquid Quality Control Test

    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 You can also power on the meter directly by inserting a test strip or connecting the power adapter.
  • Page 121 09:15 am 09:15 am 09:15 am 09:15 am Main Menu QC Test QC Test QC Test Par: Schulz Patient Test Control Test aPTT Control Test Profi ciency Test Review Results Setup 05/29/2015 05/29/2015 05/29/2015 05/29/2015 Touch Control Test. In the QC Test menu, touch Control Test again. Touch the button to select the parameter you want to use.
  • Page 122 QC Test 09:15 am QC Test 09:15 am Operator 1 New Code QC 070 QC 060 QC 050 QC 048 Scan 05/29/2015 05/29/2015 If you are using a new test strip lot and have not inserted the test strip code chip yet, you must do so now. Other- wise you cannot perform a quality control test.
  • Page 123 If you are using a new control solution, remove the strip 09:15 am QC Test code chip from the meter and insert the code chip that Code: Par: Operator 1 came with the control solution instead. If the code chips get mixed up, check the letter on the code chips to tell them apart.
  • Page 124 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 125 You hear a beep when you have applied enough control 09:15 am QC Test solution (provided the beeper is enabled). The dropper Level: Code: Par: Operator 1 icon disappears and the test starts. The result of the liquid quality control test is displayed. It is automatically saved to memory.
  • Page 126 If you want to add a comment, touch 09:15 am QC Comment Select the desired predefined comment(s) from the Acceptable Cntrl. pick list (if configured) or Cleaned Meter Touch Custom to enter your own custom com- Doctor Notifi ed ment. Use the keypad (as with login) to enter your New Control Lot comment.

  • Page 127: Proficiency Testing

    Proficiency testing Observe the applicable regulations and directives of the responsible regulatory agencies when performing profi- ciency tests. Proficiency tests are performed on samples whose values are unknown to the operator performing the test. These samples are provided by an external source, and the results should be forwarded to the appropriate source after completing the test.

  • Page 128: Preparing To Perform A Proficiency Test

    Preparing to perform a proficiency test You prepare for a proficiency test in the same way you would prepare to perform a test with a capillary blood sample. The only difference is the use of the proficiency sample supplied instead of blood from a patient. To perform a proficiency test you need the following: The information of at least one code chip for test ■...

  • Page 129: Performing A Proficiency Test

    Performing a proficiency 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 You can also power the meter on directly by inserting a test strip or connecting the power adapter.
  • Page 130 09:15 am 09:15 am 09:15 am Main Menu QC Test Profi ciency Patient Test Control Test Control Test Profi ciency Test Review Results Setup 05/29/2015 05/29/2015 05/29/2015 Touch Control Test. Touch Proficiency Test. For proficiency testing, the test parameter information is read from the test strip.
  • Page 131 09:15 am 09:15 am 09:15 am Sample ID Profi ciency Profi ciency 202| Code: Par: aPTT Code: Par: aPTT 1:35 Min. Scan 05/29/2015 05/29/2015 Enter or scan the sample ID. The hourglass icon shows that the test strip is warming up.
  • Page 132 09:15 am 09:15 am Profi ciency Profi ciency Code: Par: aPTT Code: Par: aPTT 06/03/2015 11:30 am 51.6 Profi ciency 05/29/2015 05/29/2015 Apply a single drop of the sample directly from the dropper to the semicircular, transparent sample application area on top of the test strip. Do not add more of the sample.

  • Page 133: Review Results (Memory)

    Review Results (Memory) The CoaguChek Pro II 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 120 code chip records (contents of 60 test strip code chips and 60 control solution code chips) are stored.

  • Page 134: Viewing Test 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 Wait until the main menu is displayed. Main Menu 09:15 am Patient Test Control Test Review Results Setup...
  • Page 135 09:15 am 09:15 am 09:15 am Main Menu Memory Memory All results Patient Test Patient Result Control Test aPTT QC Result Review Results Setup 05/29/2015 05/29/2015 05/29/2015 Touch Review Results. Select the type of results you want to view. Display Patient Result memory ■...

  • Page 136: Display Patient Result Memory

    Display patient result memory This memory area contains all patient test results. They are sorted according to the order you defined for the option Sort (see page 58). If the Sort option is set to Date/ Time they are filtered by means of the test parameter you previously selected, the most recent results are at the top of the list.

  • Page 137: Display Qc (Quality Control) Result Memory

    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 09:15 am Memory Level: 05/28/2015 11:31 am Code: Par: QC 999 Pass...
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  • Page 139: Extended Functionalities

    Data Manage- ment System (DMS) being used and may vary. When used in conjunction with the Handheld Base Unit from Roche Diagnostics (available separately), the CoaguChek Pro II meter can conveniently connect to a data management system (DMS). The main advantages...
  • Page 140 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 141: Computer (Setup Option)

    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 63). The Handheld Base Unit must be configured cor- ■...

  • Page 142: Operator Lists

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

  • Page 143: Patient Lists

    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 144: Patient List Validation

    The Patient ID is set to Optional or Required, and ■ there is a list available: The list of Patient IDs is always shown when start- ing a measurement. You may now: – select a patient from the list; – scan a Patient ID using the barcode scanner; –...

  • Page 145: Configuring Operator And Patient Ids

    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 146 The default preset comments in the meter are: Patient result comments QC result comments Asymptomatic Acceptable Control ■ ■ Cleaned Meter Cleaned Meter ■ ■ Doctor Notified Doctor Notified ■ ■ Sick New Control Lot ■ ■ Travel New Lot Number ■...

  • Page 147: Maintenance And Care

    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 ■ extreme temperature conditions. Observe the limits for temperature and humidity ■...

  • Page 148: Shipping

    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 149: Cleaning And Disinfecting The Meter

    Cleaning and disinfecting the meter Difference between cleaning Cleaning is the physical removal of organic soiling (e.g., and disinfecting dirt, or other foreign material) from the meter surface. Disinfecting is the removal of most, but not all, disease- causing and other types of microorganisms (blood-borne pathogens) from the meter.
  • Page 150 Observe the disinfection guidelines of your ■ institution. Use gloves. ■ Follow the instructions given below to clean and disinfect the meter. Failure to follow these instructions may cause malfunction of the meter. Instrument damage due to moisture NOTICE Ensure that no liquid enters the meter. If moisture enters the meter, it may cause malfunction of the instrument.

  • Page 151: Recommended Cleaning/Disinfecting Agents

    Recommended cleaning/disinfecting agents Use only the following solutions for cleaning/disinfecting the meter (housing and test strip guide). A soft cloth slightly dampened (not wet) with a ■ small amount of liquid soap diluted in water Rubbing alcohol (70% ethanol or isopropyl alcohol) ■...

  • Page 152: Cleaning/Disinfecting The Exterior (Meter Housing)

    Cleaning/disinfecting the exterior (meter housing) Use the solutions recommended on page 151 for clean- ing/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 153: Cleaning/Disinfecting The Test Strip Guide

    Cleaning/disinfecting the test strip guide Use the solutions recommended on page 151 for clean- ing/disinfecting the test strip guide. Apply the solutions for a contact time of > 1 minute (refer to the correspond- ing product labeling) using lint-free cotton swabs/buds. With the meter powered off, remove the test strip guide cover to clean it.

  • Page 154: Cleaning The Scanner Window

    Damage to the instrument NOTICE Ensure that no liquid enters the meter when clean- ■ ing the test strip guide. If moisture enters the meter, it may cause malfunction of the instrument. Do not insert any objects in the test strip guide. ■...

  • Page 155: Troubleshooting

    Take the action suggested on screen to resolve the prob- lem. If the error disappears, you may continue using the meter as desired. If the problem persists, contact Roche Diagnostics (see page 163). The two different message types are illustrated below:...

  • Page 156: Additional Information On Error E-406

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

  • Page 157: Errors And Unusual Behavior Without Error Messages

    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 meter ■...

  • Page 158: Meter Reset

    The meter powers off and on again. ■ The Roche logo is displayed. ■ If the Roche logo does not appear within 60 sec- CoaguChek ® onds, place the meter in the Handheld Base Unit for a minimum of 15 minutes to recharge the battery.

  • Page 159: 10 General Product Specifications

    10 General Product Specifications 10.1 Technical data Temperature range +12 °C to +32 °C (54 °F to 90 °F) Relative humidity 10 to 85% (no condensation) Maximum altitude 4300 m (14,000 feet) Position Place the meter on a level, vibration-free surface or hold it so it is roughly horizontal.

  • Page 160: Storage Conditions

    Storage conditions Temperature range –25 °C to +70 °C (-13 °F to +158 °F) Meter (without battery pack) Temperature range –10 °C to +35 °C (+14 °F to +95 °F) Meter (with battery pack)* Relative humidity 10 to 85 % (no condensation) * At temperatures above +70 °C/158 °F the battery pack could leak and damage the meter.

  • Page 161: 10.2 Further Information

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

  • Page 162: 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 163: Repairs

    Roche Diagnostics. Contact Roche For all questions about the CoaguChek Pro II system that are not answered in this manual, contact your Roche Diagnostics representative. If you do not already have contact details: Visit our website at www.roche.com. Select “Roche ■...

  • Page 164: 11 Warranty

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

  • Page 165: A Appendix

    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 166: A.2 Example Of Barcode Symbologies

    Example of barcode symbologies If a barcode is read incorrectly, this may lead to patient misidentification and therefore to inappropriate therapy decisions. 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 15416 and 15415) are adequate.
  • Page 167 Avoidance of incorrect EAN 13 and Interleaved 2/5 barcode readings EAN 13 and Interleaved 2/5 barcodes, although widely WARNING used, are not recommended for patient/operator bar- codes. If an EAN 13 or Interleaved 2/5 barcode is read incorrectly, this may lead to patient misidentification and therefore to inappropriate therapy decisions.
  • Page 168 Codabar Code 39 Code 93 Code 128 EAN 13 Interleaved 2/5 PDF417 QR Code DataMatrix...

  • Page 169: A.3 Supported Characters In 2D Barcodes

    Supported characters in 2D barcodes The 2D barcode scanner is able to read characters from the following unicode ranges: Basic Latin (0021-007E) ■ Latin-1 Supplement (00A1-00FF) ■ Latin Extended-A (0100-017F) ■ The 2D barcode scanner does not support Asian characters.
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  • Page 171: B Appendix

    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 172: Using The Ots Function

    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. 09:15 am 09:15 am 09:15 am 09:15 am Main Menu Pat.
  • Page 173 09:15 am 09:15 am Observer Login 09:15 am Pat. Test - OTS Remove Observer OTS passed: I-010 Pass Fail OTS enabled Observer ALAN SMITHEE, Measurement Result OK? please log in to proceed. Observer Login Reject Accept Otherwise the OTS test will not be complete.
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  • Page 175: C Appendix

    Appendix Option: Wireless network (WLAN) Preliminary note This appendix has been developed to explain the wireless communication principles of the CoaguChek Pro II system and to help your facility’s information technol- ogy/management team(s) in effectively deploying the CoaguChek Pro II system on your wireless network. Whether your meter has wireless capability or not depends on the system configuration that you purchased.

  • Page 176: Background

    Background The CoaguChek Pro II meter can only be configured through a data management system to communicate wirelessly. The data management system (DMS) is also used to set-up and configure the meter to connect to one hospital specific Wireless Local Area Network (WLAN WLANs use electromagnetic waves in the 2.4 GHz frequency range to wirelessly transmit data .

  • Page 177: Technical Implementation

    Technical implementation Prior to connecting any wireless device to a wireless net- work, it is recommended that a WLAN site survey be per- formed. The goal of a WLAN site survey is to ensure that Access Points will provide enough coverage and per- formance to support any new radio frequency (RF) appli- cation or device.
  • Page 178 The current RF system consists of an antenna and a WLAN system-on-chip (SoC) along with other compo- nents. The WLAN system-on-chip is the core of the WLAN system. The RF system used in the CoaguChek Pro II meter specifically adheres to the following specifi- cations: Its WLAN system-on-chip supports IEEE 802.11b ■...

  • Page 179: Rf Specific Functionalities And Effective Performance Claims

    RF specific functionalities and The CoaguChek Pro II system offers the option of wireless effective performance claims network connectivity (WLAN/Wi-Fi). This module can only be configured by a data manage- ment system (DMS), which activates the meter’s wireless communication and data transfer capabilities. Wireless connectivity can help to ensure that updates to informa- tion in the DMS are sent immediately to all networked meters.
  • Page 180 The CoaguChek Pro II meter is capable of transfer- ■ ring to a suitable DMS, via WLAN, a data set of up to 1000 result records, 100 strip and control lot records, and 500 operator ID records in less than 15 minutes, when operated in a typical WLAN environ- ment (correct WLAN administration, typical popu- lation of other clients present, any of the supported...
  • Page 181 A typical range for direct connection between the CoaguChek Pro II meter and the access point (air, direct view, low disturbances) is up to 15 to 20 meters (49 to 66 feet). The actual range depends on the positioning of the access point’s antennas and other topological properties of the space between WLAN device and AP.
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  • Page 183: Index

    Index Display Accessories ............161 Format ..............56 Adapter (power supply) ........33 Icons ............. 30–31 Admin. ID ............72–75 Disposal ......18, 34, 96, 114, 126, 132 Applying a blood sample ........108 Auto Off ..............62 Error messages ............. 155 Barcode ..........100, 105, 122 Masks ...............
  • Page 184 Measuring range ..........159 Quality Control Memory Lockout .............83, 102 Button ............... 135 Memory ............137 Patient Result ..........136 Preparing ............118 Quality Control ..........137 Result ............125, 132 Meter Overview .............28 Reset ..............158 Relative humidity ...........27, 159 Reset .................
  • Page 185 STAT test Configure ............88 Perform ............115 Storage ..............147 Switching on the meter ........99 Symbols Error messages ..........155 System Administrator ........72–75 Target value ..............82 Temperature range ........ 27, 93, 159 Test principle ............13 Test result (patient test) ........110 Test result (quality control) .....125, 132 Test strip Icon ..........
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  • Page 188 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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