Coaguchek INRange User manual

CoaguChek® INRange
User’s Manual
Manuel d’utilisation

© 2019 Roche Diagnostics GmbH
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Revision History
Version Date Content
1.0 2019-02New document, based on international CoaguChek INRange
manual 0 7408811001 (02) 2018-03 EN/FR.

3
Introduction
Before you start.....................................................................................................................................................................9
Intended use ...........................................................................................................................................................9
PT time ...................................................................................................................................................................10
Self-testing ...........................................................................................................................................................10
The CoaguChek INRange System ...............................................................................................................................12
Test principle .......................................................................................................................................................14
Operating conditions ........................................................................................................................................ 16
Quality control ..................................................................................................................................................... 17
Important Safety Instructions and Additional Information ................................................................................ 18
The CoaguChek INRange Meter .................................................................................................................................20
Overview of the meter elements ..................................................................................................................20
Batteries ................................................................................................................................................................ 22
Starting Up
Inserting the batteries ......................................................................................................................................26
Initially setting up the meter .......................................................................................................................... 29
Code chip .............................................................................................................................................................................34
Inserting the code chip ....................................................................................................................................35
Testing a Capillary Blood Sample
Important notes ..................................................................................................................................................38
Getting a good capillary blood sample ...................................................................................................... 40
Preparing to test ................................................................................................................................................. 41
Performing a test ................................................................................................................................................42
Notes concerning the results display .........................................................................................................53
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Reviewing and Handling Data
Reviewing test results ......................................................................................................................................................56
Displaying reports on the meter ..................................................................................................................................58
Displaying a Trend report ............................................................................................................................... 59
Displaying a Target report .............................................................................................................................. 62
Transferring data ............................................................................................................................................................... 64
Data transfer via USB .......................................................................................................................................65
Data transfer via Bluetooth ............................................................................................................................ 67
Displaying reports on a computer .............................................................................................................................. 69
Security settings in the Internet browser .................................................................................................. 71
Virus scanner.......................................................................................................................................................71
Reports overview ................................................................................................................................................72
Time period ..........................................................................................................................................................73
Trend graph .......................................................................................................................................................... 73
Target range display..........................................................................................................................................74
Target graph ......................................................................................................................................................... 74
List of results ....................................................................................................................................................... 75
Printing reports ................................................................................................................................................... 76
Using data in external applications ............................................................................................................. 77
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Reminders and Meter Settings
Setting up reminders .......................................................................................................................................................79
New reminder .....................................................................................................................................................80
Editing or deleting a reminder ......................................................................................................................84
Meter settings .................................................................................................................................................................... 85
Settings overview .............................................................................................................................................. 86
Language ..............................................................................................................................................................88
Time & Date .........................................................................................................................................................89
Units ........................................................................................................................................................................ 91
Result Format ......................................................................................................................................................92
Set Targets ............................................................................................................................................................93
Beeper Volume ....................................................................................................................................................96
Display Brightness .............................................................................................................................................97
Button Click ......................................................................................................................................................... 98
Data Transfer .......................................................................................................................................................99
Cleaning and Disinfecting the Meter
Overview ..............................................................................................................................................................101
What is the difference between cleaning and disinfecting? ...........................................................102
When to clean and disinfect the meter ..................................................................................................103
Recommended cleaning/disinfection agents .......................................................................................104
Cleaning the meter housing ........................................................................................................................105
Cleaning the test strip guide .......................................................................................................................107
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Other Functions and Troubleshooting
Other functions ................................................................................................................................................................111
About (manufacturing information and data encryption key) ........................................................112
Clear Memory ....................................................................................................................................................113
Meter Log ...........................................................................................................................................................115
Display Test ........................................................................................................................................................116
Firmware Update ..............................................................................................................................................117
Troubleshooting ...............................................................................................................................................................119
Errors and unusual behavior without error messages .......................................................................120
Symbols, Icons, Messages
Symbols on packaging and meter ............................................................................................................................121
Icons on the display .......................................................................................................................................................123
Messages ...........................................................................................................................................................................125
Reminders ...........................................................................................................................................................126
Information .........................................................................................................................................................128
Maintenance ......................................................................................................................................................129
Warnings .............................................................................................................................................................130
Error messages .................................................................................................................................................131
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General Product Information
Ordering ..............................................................................................................................................................133
Product limitations ...........................................................................................................................................133
Operating conditions and technical data ...............................................................................................134
Sample material ................................................................................................................................................135
Storage and transport conditions ..............................................................................................................135
Disposal of the CoaguChek INRange meter .........................................................................................136
For healthcare professionals .......................................................................................................................137
Disposal of used batteries ............................................................................................................................137
Repairs .................................................................................................................................................................137
Information service ..........................................................................................................................................138
Product Safety Information ..........................................................................................................................................139
Bluetooth Wireless Technology ..................................................................................................................139
Radio Frequency Communication .............................................................................................................140
Electromagnetic Compatibility ....................................................................................................................141
Index
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CoaguChek INRange User’s Manual

9
Introduction
Before you start
Intended use
The CoaguChek® INRange system, consist-
ing of the CoaguChek INRange meter and
the CoaguChek XS® PT Test PST test strip,
is intended for the determination of pro-
thrombin 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 Antago-
nist therapy.
The CoaguChek INRange system is intended
for single patient self-testing only. It is not
intended for use in a professional setting.
Introduction
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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.
Self-testing
If you self-test, you can adjust your medication
dose yourself. However, you need to discuss
your therapy model with your healthcare pro-
fessional rst. 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.
Introduction
CoaguChek INRange User’s Manual