Roche Diagnostics Limited
CoaguChek Coagulation Meters
CoaguChek INRange Users Manual Ver 2.0 March 2018
Users Manual
304 Pages
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2 © 2016-2018 Roche Diagnostics GmbH The contents of this document, including all graphics, are the property of Roche Diagnostics. 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. Roche Diagnostics has made every reasonable effort to ensure that all the information contained in this manual is correct at the time of printing. However, Roche Diagnostics reserves the right to make any changes necessary without notice as part of ongoing product development. Please send questions or comments about this manual to your local Roche representative. COAGUCHEK and SOFTCLIX are trademarks of Roche. CONTINUA, the CONTINUA Logos and CONTINUA CERTIFIED are trademarks, service marks, or certification marks of the Continua Health Alliance. CONTINUA is a registered trademark in some, but not all countries this product is distributed. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Roche is under license. Other trademarks and product names are the property of their respective owners. Revision History Version
Date
Content
1.0
2016-03
New document
2.0
2018-03
Update, new Firmware version 01.04.xx; added information on encryption key, updated target range setting section, updated section about recommended cleaning/disinfection agents, minor editorial revisions
3 What is new in publication version 2.0? SW01.04.xx ... 9 Handling changes ... 9 Editorial revisions ... 9
Introduction Before you start ...11 Intended use ...11 PT time ...12 Self-testing ...12 The CoaguChek INRange System ...14 Test principle ...16 Operating conditions ...18 Quality control ...19 Important safety instructions and additional information ...20 The CoaguChek INRange Meter ...22 Overview of the meter elements ...22 Batteries ...24
Starting Up Inserting the batteries ...28 Initially setting up the meter ...31 Code chip ...36 Inserting the code chip ...37
CoaguChek INRange User’s Manual
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4 Testing a Capillary Blood Sample Important notes ...40 Getting a good capillary blood sample ...42 Preparing to test ...43 Performing a test ...44 Notes concerning the results display ...55
Reviewing and Handling Data Reviewing test results ...58 Displaying reports on the meter ...60 Displaying a Trend report ...61 Displaying a Target report ...64 Transferring data ...66 Data transfer via USB ...67 Data transfer via Bluetooth ...69 Displaying reports on a computer ...71 Security settings in the Internet browser ...73 Virus scanner ...73 Reports overview ...74 Time period ...75 Trend graph ...75 Target range display ...76 Target graph ...76 List of results ...77 Printing reports ...78 Using data in external applications ...79
CoaguChek INRange User’s Manual
5 Reminders and Meter Settings Setting up reminders ...81 New reminder ...82 Editing or deleting a reminder ...86 Meter settings ...87 Settings overview ...88 Language ...90 Time & Date ...91 Units ...93 Result Format ...94 Set Targets ...95 Beeper Volume ...98 Display Brightness ...99 Button Click ... 100 Data Transfer ... 101
Cleaning and Disinfecting the Meter and the Lancing Device Overview ... 103 What is the difference between cleaning and disinfecting? ... 104 When to clean and disinfect the meter and the lancing device ... 104 Recommended cleaning/disinfection agents ... 105 Cleaning the meter housing ... 106 Cleaning the test strip guide ... 107 Cleaning and Disinfecting the Lancing Device ... 110 When to clean and disinfect the lancing device ... 110 What to clean and to disinfect ... 111 How to clean and disinfect the lancing device ... 111
CoaguChek INRange User’s Manual
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6 Other Functions and Troubleshooting Other functions ... 113 About (manufacturing information and data encryption key) ... 114 Clear Memory ... 115 Meter Log ... 117 Display Test ... 118 Firmware Update ... 119 Troubleshooting ... 121 Errors and unusual behavior without error messages ... 122
Symbols, Icons, Messages Symbols on packaging and meter ... 123 Icons on the display ... 125 Messages ... 127 Reminders ... 128 Information ... 130 Maintenance ... 131 Warnings ... 132 Error messages ... 133
CoaguChek INRange User’s Manual
7 General Product Information Ordering ... 135 Product limitations ... 135 Operating conditions and technical data ... 136 Sample material ... 137 Storage and transport conditions ... 137 Disposal of the CoaguChek INRange meter ... 138 For healthcare professionals ... 139 Disposal of used batteries ... 139 Repairs ... 139 Information service ... 140 Product Safety Information ... 141 Bluetooth Wireless Technology ... 141 Radio Frequency Communication ... 142 Electromagnetic Compatibility ... 143
Index
CoaguChek INRange User’s Manual
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CoaguChek INRange User’s Manual
9 What is new in publication version 2.0?
SW01.04.xx
CoaguChek INRange User’s Manual
•
Updated information on target range setup. See page 95.
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Updated information on encoded 2D encryption key. See page 114.
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Added 365 days scaling in the embedded reports screen.
What is new in publication version 2.0?
This section provides an overview of all major changes from User’s Manual version 1 to version 2. Deletions or minor corrections are not listed.
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10 Handling changes
What is new in publication version 2.0?
Editorial revisions
•
Updated information about allowed time without batteries. See page 25 and 28.
•
Changed description of blood application to the test strip. See page 49.
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Updated information about recommended cleaning and disinfection agents. See page 105.
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Updated image of test strip container.
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Minor editorial revisions.
CoaguChek INRange User’s Manual
11 Introduction Before you start Intended use
The CoaguChek® INRange system, consisting of the CoaguChek INRange meter and the CoaguChek XS® PT Test PST test strip, is intended for the determination of prothrombin time (PT) in fresh capillary blood. It is intended for use by properly selected and appropriately trained patients and their respective caregivers. The prothrombin time (PT) test is a general coagulation test to monitor Vitamin K Antagonist therapy.
Introduction
The CoaguChek INRange system is intended for single patient self-testing only. It is not intended for use in a professional setting.
CoaguChek INRange User’s Manual
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12 PT time
A PT test is often called an INR test. The International Normalized Ratio (INR) is a way of standardizing the results of prothrombin time tests because there are different test methods. INR enables you and your doctor to understand your coagulation results even when they come from different labs using different test methods. Prothrombin time can also be expressed as %Quick or in seconds.
Introduction
Self-testing
If you self-test, you can adjust your medication dose yourself. However, you need to discuss your therapy model with your healthcare professional first. Self-testing is not a substitute for regular visits to your doctor. Depending on the training you have received and the instructions from your healthcare professional, you might communicate your results to a healthcare professional or clinic to receive the appropriate dose adjustment. Or you may be able to adjust your medication independently according to a pre-determined dose-INR schedule developed for you by your doctor.
CoaguChek INRange User’s Manual
13 Self-monitoring and self-adjustment of oral anticoagulation therapy using coagulation values determined with the CoaguChek INRange system may only be undertaken after consultation with your doctor and comprehensive instruction by a qualified healthcare professional.
This manual contains all the information you need to operate and care for the CoaguChek INRange System. Please read this entire manual carefully before you use the meter.
CoaguChek INRange User’s Manual
Introduction
Your pharmacist/specialist supplier can provide you the training and/or put you in touch with associations or institutions offering training in coagulation self-monitoring. Please read the special notes on INR self-monitoring in the package insert accompanying the test strips.
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14 The CoaguChek INRange System
Introduction
The CoaguChek INRange System makes coagulation testing easy. The graphical user interface of the CoaguChek INRange meter guides you through the test step by step. The code chip accompanying the test strips contains strip lot-specific information and the expiry date for the test strips. You only need to insert the code chip, turn the meter on, insert the test strip, and apply a blood sample. The CoaguChek INRange meter measures your coagulation time and displays the result. After the test is completed, the meter automatically saves the result to memory.
CoaguChek INRange User’s Manual
15 If you have any questions about the CoaguChek INRange meter, please contact your local customer support and service center. You will find contact details on page 140.
Please note: Before you use the meter for the first time (i.e. after you have first inserted the batteries), you must set the date and time correctly to allow you to carry out measurements properly. Each time you replace the batteries, you need to check (and, if necessary, adjust) the date and time.
Introduction
Note on screenshots: The test results and software and hardware information shown in the screenshots in this manual are for illustration purposes only. The information displayed on your meter may differ.
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16 The CoaguChek XS PT Test PST test strip contains a lyophilized reagent (reagent in dried form). The reactive components of this reagent consist of thromboplastin and a peptide substrate. When a sample is applied, thromboplastin activates coagulation, which leads to the formation of thrombin. At the same time, the meter starts to measure the time. The enzyme thrombin cleaves the peptide substrate, generating an electrochemical signal. Depending on the time elapsed when it first appears, this signal is then converted by means of an algorithm into customary coagulation units (INR, %Quick, seconds) and the result is displayed.
Introduction
Test principle
CoaguChek INRange User’s Manual
17 Contents of the pack CoaguChek INRange meter
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4 alkaline batteries, 1.5 V, type AAA (LR03)1
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USB cable
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CoaguChek XS Softclix lancing device with instructions for use
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CoaguChek Softclix Lancet
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System carry case (not shown here)
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User’s Manual (this document)
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Quick Reference Guide (not shown here)
Introduction
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1 CoaguChek INRange User’s Manual
Also available as “alkaline-manganese dioxide batteries”
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Introduction
Operating conditions
To ensure that your CoaguChek INRange System functions properly, please observe the following guidelines: •
Only use the meter at a temperature between 15 °C and 32 °C.
•
Only use the meter at a relative humidity between 10% and 85%.
•
When testing, place the meter on a level, vibration-free surface or hold it so that it is roughly horizontal.
•
If the meter is to remain unused for a longer period of time, keep it in the carry-case supplied.
•
Use the meter only up to a maximum altitude of 4000 meters.
Electromagnetic interference Strong electromagnetic fields may interfere with the proper operation of the meter. Do not use the meter near strong electromagnetic fields.
CoaguChek INRange User’s Manual
19 Quality control
The CoaguChek INRange System has a number of inbuilt quality control functions such as: A check of the electronic components and functions every time the meter is turned on. A check of the test strip temperature while a test is in progress. A check of the expiry date and lot information on the test strip.
Introduction
A quality control function is incorporated into the test strip. Quality control tests and system checks using control test solutions (that you may be familiar with from other systems) are no longer required.
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20 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 INRange User’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. WARNING Indicates a hazardous situation which, if not avoided, could result in death or serious injury.
Introduction
CAUTION Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.
CoaguChek INRange User’s Manual
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NOTICE Indicates a hazardous situation which, if not avoided, may result in damage to the system.
Introduction
Important information that is not safety relevant is presented against a colored background (without a symbol). Here you will find additional information on correct use of the meter or useful tips.
CoaguChek INRange User’s Manual