Roche Diagnostics MG10 Blood Coagulation Meter User Manual UserManual

Roche Diagnostics GmbH Blood Coagulation Meter UserManual

1. UserManual.pdf
2. UserManual_Safety.pdf

UserManual.pdf

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CoaguChek INRange
Coagulation Monitoring System
User’s Manual
© 2014 Roche Diagnostics GmbH
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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.
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Please send questions or comments about this manual to your local Roche representative.
ACCU-CHEK, COAGUCHEK and SOFTCLIX are trademarks of Roche.
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CONTINUA, the CONTINUA Logos and CONTINUA CERTIFIED are trademarks, service
marks, or certiication marks of the Continua Health Alliance. CONTINUA is a registered
trademark in some, but not all countries this product is distributed.
Revision History
Content
New document
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Date
2014-xx
Version
1.0
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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.
3
Introduction
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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
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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
CoaguChek INRange User’s Manual
4
Reviewing and Handling Data
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Reviewing test results .......................................................................................................................................... 56
Displaying reports on the meter ...................................................................................................................... 58
Displaying a Trend report..................................................................................................................... 59
Displaying a Target report ................................................................................................................... 62
Data transfer............................................................................................................................................................ 64
Data transfer via USB ............................................................................................................................ 65
Data transfer via Bluetooth ................................................................................................................. 67
Displaying reports on a computer .................................................................................................................. 69
Security settings in the Internet browser ....................................................................................... 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
CoaguChek INRange User’s Manual
5
Reminders and Meter Settings
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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
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Cleaning and Disinfecting the Meter and the Lancing Device
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Overview ...................................................................................................................................................101
What is the difference between cleaning and disinfecting? ................................................102
When should the meter and the lancing device be cleaned and disinfected? ............102
Recommended cleaning/disinfection agents.............................................................................103
Cleaning the meter housing .............................................................................................................104
Cleaning the test strip guide ............................................................................................................105
Cleaning and Disinfecting the Lancing Device .......................................................................................107
When to clean and disinfect the lancing device .......................................................................108
What to clean and to disinfect .........................................................................................................109
How to clean and disinfect the lancing device..........................................................................109
CoaguChek INRange User’s Manual
6
Other Functions and Troubleshooting
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Other functions ....................................................................................................................................................111
About (version and irmware) ..........................................................................................................112
Clear Memory .........................................................................................................................................113
Meter Log.................................................................................................................................................115
Display Test .............................................................................................................................................116
Firmware Update ...................................................................................................................................117
Troubleshooting....................................................................................................................................................119
Errors and unusual behavior without error messages ............................................................120
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Symbols, Icons, Messages
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Symbols on packaging and meter ................................................................................................................121
Icons on the display............................................................................................................................................123
Messages ...............................................................................................................................................................125
Reminders ................................................................................................................................................126
Information ..............................................................................................................................................127
Maintenance ...........................................................................................................................................128
Warnings ..................................................................................................................................................129
Error messages ......................................................................................................................................130
CoaguChek INRange User’s Manual
7
General Product Information
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Ordering ...................................................................................................................................................131
Product limitations ................................................................................................................................131
Operating conditions and technical data.....................................................................................132
Sample material .....................................................................................................................................133
Storage and transport conditions ...................................................................................................133
Disposal of the CoaguChek INRange meter...............................................................................133
For healthcare professionals ............................................................................................................134
Disposal of used batteries .................................................................................................................134
Repairs ......................................................................................................................................................134
Information service ...............................................................................................................................135
Product Safety Information ..............................................................................................................................136
Bluetooth Wireless Technology........................................................................................................136
Radio Frequency Communication...................................................................................................137
Electromagnetic Compatibility .........................................................................................................139
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Index
CoaguChek INRange User’s Manual
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CoaguChek INRange User’s Manual
9
Introduction
Before you start
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Intended use
It is not intended for use in the professional
setting.
CoaguChek INRange User’s Manual
Introduction
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The CoaguChek® INRange system
(CoaguChek INRange meter and CoaguChek
XS® PT test strips) measures blood-clotting
time (prothrombin time or “PT”) using
fresh capillary blood from the ingertip. The
CoaguChek INRange system is suitable for
self-testing by patients who are taking anticoagulation medications such as Coumadin®
or warfarin (vitamin K antagonist therapy).
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PT time
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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.
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Self-testing
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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
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If you self-test, you can adjust your medication dose yourself.
CoaguChek INRange User’s Manual
11
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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 qualiied
healthcare professional.
CoaguChek INRange User’s Manual
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.
Introduction
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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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The CoaguChek INRange System
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Introduction
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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 lot-speciic information about these test
strips, including calibration data that allow the
correct results to be calculated, 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
13
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If you have any questions about the
CoaguChek INRange meter, please contact
your local customer support and service center. You will ind contact details on page 135.
CoaguChek INRange User’s Manual
Introduction
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Please note: Before you use the meter for
the irst time (i.e. after you have irst 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.
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Test principle
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Introduction
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The CoaguChek XS PT 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 irst appears, this
signal is then converted by means of an algorithm into customary coagulation units (INR,
%Quick, seconds) and the result is displayed.
CoaguChek INRange User’s Manual
15
Contents of the pack
CoaguChek INRange meter
•
4 alkali-manganese batteries, 1.5 V,
type AAA
•
USB cable
•
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
CoaguChek INRange User’s Manual
Introduction
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•
16
Operating conditions
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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 it is
roughly horizontal.
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If the meter is to remain unused for a
longer period of time, keep it in the carrycase supplied.
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Use the meter only up to a maximum
altitude of 4300 metres.
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Introduction
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Electromagnetic interference
Strong electromagnetic ields may interfere
with the proper operation of the meter. Do not
use the meter near strong electromagnetic
ields.
CoaguChek INRange User’s Manual
17
Quality control
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The CoaguChek INRange System has a
number of inbuilt quality control functions
such as:
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A check of the electronic components and
functions every time the meter is turned on.
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A check of the test strip temperature while a
test is in progress.
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A check of the expiry date and lot information
on the test strip.
CoaguChek INRange User’s Manual
Introduction
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A quality control function is incorporated
into the test strip. Quality control and system
checks using control test solutions that you
may be familiar with from other systems are
no longer required.
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Important Safety Instructions and Additional Information
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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.
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WARNING
Indicates a hazardous situation which, if
not avoided, could result in death or serious
injury.
CAUTION
Indicates a hazardous situation which, if not
avoided, could result in minor or moderate
injury.
Introduction
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The safety alert symbol by itself (without a
signal word) is used to promote awareness
to hazards which are generic or to direct the
reader to related safety information
CoaguChek INRange User’s Manual
19
NOTICE
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Indicates a hazardous situation which, if not
avoided, may result in damage to the system.
CoaguChek INRange User’s Manual
Introduction
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Important information that is not safety
relevant is presented against a colored
background (without a symbol). Here you
will ind additional information on correct
use of the meter or useful tips.
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The CoaguChek INRange Meter
Overview of the meter elements
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Overview of the meter elements (front)
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A Display
Shows menus, results, messages and
results recalled from memory.
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B Back button
Exit the currently displayed menu.
C Arrow up/down button
Move or scroll up/down in a screen.
D Enter button (Power on)
Conirm the currently selected option or
perform a function. Also used to power the
meter on and off.
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F Test strip guide
Insert the test strip here.
Introduction
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E Test strip guide cover
Remove this cover to clean the test strip
guide.
CoaguChek INRange User’s Manual
21
Overview of the meter elements (back and
sides)
G Battery compartment cover
Covers the battery compartment (four
1.5 V alkali-manganese dioxide batteries
type AAA).
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CoaguChek INRange User’s Manual
Introduction
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USB port
For wired communication and data transfer to a computer.
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H Code chip slot
Insert the code chip here.
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Batteries
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To save power, the CoaguChek INRange
meter automatically turns itself off after 2
minutes unless a button has been pressed or
a new test strip has been inserted. When the
meter turns itself off, all results obtained up to
that point remain in memory.
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When the Main Menu screen is displayed,
the meter indicates the battery power level on
the top right of the display. The battery symbol
is divided into four segments which correspond to the battery power level. Replace batteries at latest when the lashing red battery
symbol or a corresponding message appears.
Main Menu
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Test
My Data
Reminders
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Settings
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17:03
17 Sep 2015
Sep
Introduction
Other
Please be aware that battery life may be
affected by many factors, such as battery
type, quality, operating conditions (e.g.
ambient temperature), frequency of use,
and test duration.
CoaguChek INRange User’s Manual
23
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Results together with the date and time, the
comments and the download information
are retained in the memory even when no
batteries are inserted. All other settings are
retained, too.
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Think of the environment. Dispose of used
batteries sensibly.
WARNING
CoaguChek INRange User’s Manual
Introduction
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Do not throw batteries onto a ire. They may
explode!
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CoaguChek INRange User’s Manual
25
Starting Up
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Before using the meter for the irst time, carry
out the following steps:
Insert the batteries
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Set the language
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Set the current date and time
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Select the coagulation unit in which the
results are to be displayed
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Insert the code chip (you can also carry
out this step immediately before testing)
CoaguChek INRange User’s Manual
Starting Up
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•
26
Inserting the batteries
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When replacing the batteries you must
insert the new batteries within 10 minutes
of removing the old ones, to keep the date
and time settings. If you take longer than
this, you must re-enter the date and time.
Only use alkaline-manganese dioxide
batteries 1.5 V type AAA.
With normal use the batteries will last for
approximately 60 tests.
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Think of the environment. Dispose of used
batteries sensibly.
Starting Up
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Roche recommends replacing used batteries only with new high quality batteries and
not mixing different brands. Do not mix new
and already used batteries.
CoaguChek INRange User’s Manual
27
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It is not recommended to use rechargeable batteries. In case you want to use
them anyway, use AAA (Micro) 1.2 V NiMH
HR6 batteries with a minimum capacity of
2500 mAh. Always use a battery charger
recommended by the manufacturer.
The number of tests that can be performed per battery charge is much lower
than with regular batteries.
Performing tests in a cold environment
may not be possible at all.
•
The remaining capacity may not be
displayed correctly. If the meter displays
a Battery Low message, performing
further tests may already be impossible. Replace the batteries as soon as
possible.
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CoaguChek INRange User’s Manual
Starting Up
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•
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When you use rechargeable batteries,
please observe the following:
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1 Turn the meter over.
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2 Gently press the tab on the battery
compartment cover towards the top of the
meter and lift off the cover.
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3 Insert the four batteries in the battery
compartment as indicated. Pay attention
to the positions of “+” (top of battery) and
“–” (lat end).
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Starting Up
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4 Re-attach the cover. Close the battery
compartment by pushing the cover down
until the tab snaps into place.
CoaguChek INRange User’s Manual
29
Initially setting up the meter
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When you power on the meter for the very
irst time, you will automatically be guided
through the Language, Time & Date,
and Units setup. If the meter automatically
powers off before you have completed the
settings (2 minutes after inserting the batteries), then:
to power the
1 Press the Enter button
meter on (again).
CoaguChek INRange User’s Manual
Starting Up
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The meter automatically displays the
Language screen. A green dot indicates
which language is currently active.
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2 Use the Arrow up/down buttons
to
select your preferred language. The newly
selected language is highlighted (blue).
Arrow symbols on top and/or bottom of
the screen indicate more entries above or
below the currently visible part of the list.
Language
English
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Deutsch
Français
Español
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3 Press the Enter button
to conirm the
selection, which is now marked by the
green dot.
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Nederlands
Save
again to save the
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Starting Up
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4 Press the Enter button
selected language.
CoaguChek INRange User’s Manual
31
The meter now displays the screen for setting
the time format.
Time & Date
5 Use the Arrow up/down buttons
to select the time format for the display
(24 hour or 12 hour am/pm). The newly
selected format is highlighted (blue).
12 hr Format
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24 hr Format
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6 Press the Enter button
to conirm the
selection, which is now marked by the
green dot.
Next
7 Press the Enter button
again to save
the setting. The screen for setting time and
date follows next.
Time & Date
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CoaguChek INRange User’s Manual
All test results are saved together with time
and date. Analyzing stored test results or
using reminders will only work with time
and date correctly set. Always check (and,
if necessary adjust) time and date after
replacing the batteries.
Next
Throughout this manual the 24h format is
used on example screens.
Starting Up
Next
2015 Sep
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17
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2015 Sep
13 : 45
01 : 45 PM
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Time & Date
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8 Use the Arrow up/down buttons
the current hour.
Time & Date
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13 : 45
2015 Sep
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10 Proceed with setting the remaining ields.
The Enter button
always conirms a setting (and highlights the subsequent ield,
if available), the Back button allows you
to jump back to the previous ield.
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2015 Sep
9 Press the Enter button
to conirm the
hour. The next input ield (minutes) will be
highlighted.
Time & Date
13 : 45
to set
17
Next
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Starting Up
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Next
CoaguChek INRange User’s Manual
33
Select the preferred coagulation unit (for
displaying a test result) as the last step of this
initial setup process. The currently active unit
is shown by a green dot.
Units
INR
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%Q
11 Use the Arrow up/down buttons
to select your preferred unit. The newly
selected unit is highlighted.
Sec
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Main Menu
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12 Press the Enter button
to conirm the
selection, which is now marked by the
green dot.
Test
My Data
Reminders
13 Press the Enter button
selected unit.
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Settings
17 Sep 2015
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17:03
CoaguChek INRange User’s Manual
again to save the
Other
Sep
The initial setup is now inished, the meter
displays the Main Menu. For a complete
overview of setup options (including those
which are not part of the initial setup) see
chapter Meter settings starting on page 85.
If you wish to power off the meter after setup:
14 Press and hold the Enter button
the meter powers off.
until
Starting Up
Save
34
Code chip
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The code chip provides the meter with important information which it needs to perform the
coagulation test. The chip contains information about the test method, the lot number
and the expiry date. The meter is ready to use
once the code chip has been inserted.
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Once the code chip information has been
read by the meter, it will be stored for future
use. You may remove the code chip then. Up
to 5 code chip data sets can simultaneously
be stored in the meter.
Protect the code chip from moisture and
equipment which produces magnetic ields,
e.g. loudspeakers, induction stove or other
electronic devices.
Starting Up
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If you use a new test strip lot and have not
inserted the corresponding code chip yet, you
must do so at latest after inserting the test
strip. Otherwise you cannot perform a test.
The meter displays the number of the code
chip belonging to the new test strip lot.
CoaguChek INRange User’s Manual
35
Inserting the code chip
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1 Remove the old code chip, if one is
inserted in the meter. Discard the old code
chip with your household waste.
CoaguChek INRange User’s Manual
Starting Up
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2 Slide the new code chip into the slot on
the side of the meter as shown until you
feel it snap into place.
36
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Starting Up
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EN
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CoaguChek INRange User’s Manual
37
Testing a Capillary Blood Sample
What you need
CoaguChek INRange meter
•
The code chip already inserted in the
meter (each test strip container has its
own code chip)
•
Test strips belonging to the code chip
mentioned above
•
Lancing device (e.g. CoaguChek XS
Softclix)
Lancet (e.g. CoaguChek Softclix Lancet)
•
Lint-free cloth or paper tissue
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CoaguChek INRange User’s Manual
Testing a Capillary Blood Sample
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EN
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•
38
Important notes
close the container immediately after
having removed a test strip.
•
operate the meter at an ambient temperature between 15 °C and 32 °C.
•
place the meter on a level, stable surface
(table) or hold it so it is roughly horizontal.
•
follow the information on correct handling
of test strips in the package insert.
FI
EN
TI
AL
•
keep the test strip guide and housing
clean. Refer to the chapter Cleaning and
Disinfecting the Meter and the Lancing
Device.
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•
Testing a Capillary Blood Sample
Always …
CoaguChek INRange User’s Manual
39
Never …
store the meter at extreme temperatures.
•
store the meter in damp or humid conditions without protection.
•
remove or insert the code chip while the
meter is performing a test.
•
touch or remove the test strip during a
test.
•
wait more than 15 seconds after lancing
the ingertip before applying the blood.
add more blood after the test has begun.
•
perform a test with a drop of blood from a
previous puncture.
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•
CoaguChek INRange User’s Manual
To avoid inaccurate results make sure you
follow the above recommendations.
Testing a Capillary Blood Sample
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EN
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AL
•
40
Getting a good capillary blood sample
To get a suitable drop of blood:
Wash your hands in warm water and dry
thoroughly.
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WARNING
AL
•
EN
Let your hand hang at your side before
lancing your inger.
•
Immediately after lancing, massage gently
along the side of your inger to obtain a
suficiently large blood drop without pressing or squeezing too hard.
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FI
•
Testing a Capillary Blood Sample
Residues of water on the skin can dilute the
drop of blood and so produce false results.
CoaguChek INRange User’s Manual
41
Preparing to test
1 Have the test strip container to hand.
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2 Make sure that the code chip belonging to these test strips is available or the
information has previously been stored in
the meter.
EN
3 Prepare the lancing device by inserting a
fresh lancet.
CoaguChek INRange User’s Manual
Testing a Capillary Blood Sample
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Do not lance your inger until asked to do so
further on in this description.
42
Performing a test
WARNING
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1 Wash your hands with soap and warm
water. Dry them thoroughly.
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Residues of water on the skin can dilute the
drop of blood and so produce false results.
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3 Power the meter on by pressing the Enter
button . Alternatively, you can insert a
test strip to power it on, which will put the
meter – after completing the startup – into
test mode directly.
Testing a Capillary Blood Sample
EN
2 Place the meter on a level, vibration-free
surface or hold it in your hand so it is
roughly horizontal.
CoaguChek INRange User’s Manual
43
4 Check the battery level during startup (or
in the Main Menu afterwards).
AL
If the meter displays a Battery Low message, you can still perform up to 3 tests.
Replace the batteries as soon as possible.
CoaguChek
®
EN
TI
5 Check that the date and time are correct.
Correct any wrong entries as described
from page 89 onwards.
17:03
17 Sep 2015
Test
My Data
AF
Reminders
Settings
Other
17:03
CoaguChek INRange User’s Manual
17 Sep 2015
Sep
6 After startup Test is preselected and
highlighted. Press the Enter button
to
start the test.
Testing a Capillary Blood Sample
-C
Main Menu
FI
If you have powered on the meter by inserting
a test strip, the meter will skip the following steps 6 to 9 and proceed to the steps
described on page 45.
44
The test strip symbol prompts you to insert a
test strip.
TI
NOTICE
AL
7 Remove a test strip from its container. Immediately after removing a test strip, close
the container again with the stopper.
9 Slide the test strip into the test strip guide
in the direction indicated by the arrows.
Slide the test strip in as far as it will go.
A beep tone indicates that the meter has
detected the test strip. (Unless you have
disabled the beeper in the Settings menu.)
AF
-C
FI
8 Hold the test strip so the lettering, the
arrows and the blood drop symbols are
facing upward.
Testing a Capillary Blood Sample
EN
Exposure to external inluences (e.g. humidity)
may deteriorate the test strips and may lead
to error messages.
CoaguChek INRange User’s Manual
45
The meter reads the strip information (provided by the barcode on the test strip) and
checks if it matches code chip information
already stored in the meter.
•
If you haven’t inserted the code chip yet
or in case of a mismatch, you will be
prompted to insert the correct code chip.
•
When the test strip check has been completed successfully, the meter indicates
that the test strip is warming up.
•
Once the warming-up process is complete,
the meter displays the symbols for test
strip and blood drop. These symbols tell
you that the meter is ready to perform the
test and is waiting for you to apply blood.
Test
-C
Test strip warming up...
AF
Test
Ready
Apply blood
30
seconds remaining...
CoaguChek INRange User’s Manual
At the same time a 180-second countdown
begins. You must apply the drop of blood
to the test strip within this time, otherwise
you will receive an error message.
Testing a Capillary Blood Sample
FI
330
TI
Test
Insert code chip...
EN
Reading strip...
AL
•
Test
46
10 Now lance the side of a ingertip with the
lancing device.
AL
We recommend obtaining the capillary
blood from the side of the ingertip as this
causes least pain.
EN
TI
11 Massage the lanced inger until a drop
of blood is formed. Do not press or
squeeze the inger.
FI
-C
AF
Testing a Capillary Blood Sample
12 Apply the irst drop of blood from the
inger to the test strip.
CoaguChek INRange User’s Manual
47
13 Apply the blood directly from the inger to
the semicircular, transparent sample application area of the test strip.
EN
TI
AL
Alternatively, you can touch the blood drop
against the side of the sample application
area (instead of applying it to the center from
above). The test strip draws up the blood by
capillary action.
AF
-C
Apply the blood drop to the test strip within
15 seconds of lancing the ingertip. Applying
blood after this period of time would falsify
the result, as the coagulation process would
already have begun.
CoaguChek INRange User’s Manual
Testing a Capillary Blood Sample
FI
During this process you must hold the blood
drop to the test strip until the next screen
indicates that the blood has been applied
successfully.
48
You hear a beep tone when you have applied enough blood (if you have activated
the beeper function). The blood drop symbol
disappears and the test starts.
Test
AL
Blood Applied
Do not add more blood. Do not touch the
test strip until the result is displayed.
TI
Automated quality check...
EN
The meter now performs an automatic quality
control check on the test strip. Following a
successful outcome of the quality control
check, the coagulation measurement starts.
The circular progress bar spins until the meter
has determined the result.
Test
FI
AF
Test
-C
Quality check complete
Measuring...
Testing a Capillary Blood Sample
Blood Applied
CoaguChek INRange User’s Manual
49
The result is displayed in the unit you chose
when setting up the meter. It is automatically
saved to memory.
Test
17:03
17 Sep 2015
2.8 INR
AL
When interpreting your result, please also
read the test strip package insert carefully.
EN
TI
If you wish, you can add up to six predeined
comments to a test result. Comments can
provide, for example, additional information
about the test conditions or your general state
of health.
Add Comment
AF
-C
FI
These comments can only be added immediately after the test result is displayed (before
the meter is powered off), later editing is not
possible.
CoaguChek INRange User’s Manual
Testing a Capillary Blood Sample
Main Menu
50
14 To add a comment, use the Arrow up/
down buttons
to highlight Add
Comment.
Test
17:03
17 Sep 2015
2.8 INR
to proceed to
AL
15 Press the Enter button
the comment list.
Add Comment
Main Menu
EN
TI
16 Use the Arrow up/down buttons
to
highlight the comment(s) you wish to
apply.
Text
17 Press the Enter button
to conirm the
currently highlighted comment. A green
checkmark
appears behind each selected comment.
Test
FI
Diet change
Illness
Medication change
Missed medication
18 Once you have selected the desired
comment(s), use the Arrow up/down buttons
to highlight Conirm.
19 Press the Enter button
the next step.
to proceed to
AF
Conirm
-C
Post-operation
Pre-operation
Testing a Capillary Blood Sample
Result: 2.8 INR
CoaguChek INRange User’s Manual
51
Text
20 The next screen displays a list of all previously selected comments. Check if the list
is correct, and use the Arrow up/down
buttons
to highlight Conirm.
Test
Result: 2.8 INR
Text
AL
Test
Medication change
21 Press the Enter button
to save the
selected comments with the test result and
exit this menu.
Result: 2.8 INR
Comments
Pre-operation
Post-operation
Illness
Missed medication
Medication change
EN
The result screen now shows the Comment
symbol . The test is completed.
Conirm
FI
Edit Comment
Test
17 Sep 2015
-C
17:03
Conirm
AF
2.8 INR
Edit Comment
Main Menu
CoaguChek INRange User’s Manual
Testing a Capillary Blood Sample
Illness
TI
Diet change
52
22 Remove the test strip from the test strip
guide.
until
AL
23 Press and hold the Enter button
the meter powers off.
TI
24 Discard the used test strip with your regular household waste.
EN
WARNING
FI
-C
AF
Testing a Capillary Blood Sample
Dispose of used lancets carefully (e.g. use a
sturdy sharps container with lid) so that the
needles cannot cause injury to yourself or to
others.
CoaguChek INRange User’s Manual
53
Notes concerning the results display
All values that lie within the set target
range are marked with a green bar.
•
If your results are displayed in INR and you
have activated the detailed result format
(as shown in the irst screen on the left),
values that are above the last measured
test result are lagged with an up arrow.
Results that are below the last measured
test result are lagged with a down arrow.
•
Values above or below the target range are
marked with a blue (above) or yellow (below) bar plus a corresponding text note.
17 Sep 2015
TI
2.8 INR
17:02
Test
17 Sep 2015
1.2 INR
-C
Result BELOW target range
Test
Add Comment
17:03
AF
Main Menu
FI
17:03
Main Menu
17 Sep 2015
>8.0 INR
Result ABOVE
measuring range
Add Comment
Main Menu
CoaguChek INRange User’s Manual
•
Values above or below the measuring
range of the meter are marked with a
> (above) or < (below) symbol plus a
corresponding text note.
For further information about setting the
result format or the target range, see Meter
settings starting on page 85.
Testing a Capillary Blood Sample
2.7 INR
EN
Add Comment
Previous:
7 Sep 2015
17:03
•
AL
Test
54
AL
The target range is the range that you
have agreed with your Healthcare Professional. Your test result should fall within the
target range.
EN
TI
The measuring range refers to the
measuring range of the system itself and is
deined by the technical limits of the meter
and test strip.
FI
-C
INR: 0.8–8.0
•
%Q: 120%–5%
•
Sec: 9.6–96
If results outside the measuring range are
displayed, refer to the section Test limitations and known interferences in the package insert supplied with the test strips, and
repeat the test.
AF
•
Testing a Capillary Blood Sample
The valid measuring ranges for CoaguChek
XS PT test strips are:
CoaguChek INRange User’s Manual
55
Reviewing and Handling Data
AL
The CoaguChek INRange meter lets you store,
review, and manage test results in several
ways:
Store and review up to 400 test results
including additional information and comments.
•
Display result reports as graphics or tables
directly on the meter.
•
Transfer data to a computer for immediate
evaluation, printout, and export (embedded reports).
CoaguChek INRange User’s Manual
•
Transfer data to a dedicated USB or
Bluetooth enabled device for medical
communication, e.g., to your physician or
healthcare provider (data transfer).
Reviewing and Handling Data
AF
-C
FI
EN
TI
•
56
Reviewing test results
1 Power the meter on by pressing the Enter
button . Wait until the Main Menu is
displayed.
AL
Main Menu
Test
2 Use the Arrow up/down buttons
select My Data.
TI
My Data
Reminders
3 Press the Enter button
Data menu.
EN
Settings
Other
My Data
to open the My
4 Select Review Results and press the
Enter button
to display the results list.
FI
17 Sep 2015
Review Sep
Results
All stored test results are displayed in a list
with the most recent at the top.
Trend
Data Transfer
Text
-C
Reports
Target
Review Results
AF
19 Jul 2015
Reviewing and Handling Data
17:03
to
2.5 INR
12 Jul 2015
2.6 INR
05 Jul 2015
2.8 INR
29 Jun 2015
2.4 INR
22 Jun 2015
2.9 INR
15 Jun 2015
2.9 INR
CoaguChek INRange User’s Manual
57
Text
5 Use the Arrow up/down buttons
scroll through the list.
Review Results
05 Jul 2015
2.8 INR
29 Jun 2015
2.4 INR
Review Results
22 Jun 2015 09:58
2.9 INR
The test result will be displayed, along with
the comments (entered at the time the test
was performed)
17 Sep 2015
EN
2.6 INR
2.9 INR
AF
-C
FI
Illness
Medication change
CoaguChek INRange User’s Manual
to return to the
7 Use the Back button
results list.
Reviewing and Handling Data
2.6 INR
TI
2.5 INR
12 Jul 2015
AL
6 Press the Enter button
to open the
details screen for a stored test result.
19 Jul 2015
15 Jun 2015
to
58
Displaying reports on the meter
AL
The CoaguChek INRange meter offers two
kinds of inbuilt reports, which can be displayed directly on the meter:
Trend:
a graphical or tabular report allowing a
linear, time-based analysis of stored test
results.
•
Target:
a graphical or tabular report allowing a
statistical analysis of stored test results.
FI
-C
AF
Reviewing and Handling Data
EN
TI
•
CoaguChek INRange User’s Manual
59
Displaying a Trend report
1 Power the meter on by pressing the Enter
button . Wait until the Main Menu is
displayed.
Main Menu
AL
Test
2 Use the Arrow up/down buttons
select My Data.
My Data
TI
Reminders
3 Press the Enter button
Data menu.
EN
Settings
Other
My Data
Reports
Target
Text
-C
Trend
90 Days
INR
AF
Average: 2.5 INR
CoaguChek INRange User’s Manual
Time
Table
Reviewing and Handling Data
Trend
Data Transfer
to open the My
4 Select Trend and press the Enter button
to display the report.
17 Sep 2015
Review Sep
Results
FI
17:03
to
60
Text
Trend
Trend
90 Days
90 Days
Average: 2.5 INR
All test results stored within a selected period
of time will be displayed in the chart as linear
values. Each test result (represented by the
symbol) is plotted along the time axis according to the time when the test was performed.
All test results are connected by a line. This
creates (angular) “curves” which, together
with the actual test result entry, allow you to
obtain a detailed analysis of individual results
and trends.
Time
AL
EN
TI
INR
INR
Average: 2.5 INR
Time
Table
Text
The green area behind the curve marks the
INR target range valid at that point in time (if
set, otherwise not displayed).
Table
2.5 INR
12 Jul 2015
2.6 INR
2.8 INR
-C
05 Jul 2015
29 Jun 2015
2.4 INR
22 Jun 2015
2.9 INR
AF
15 Jun 2015
5 Use the Arrow up/down buttons
to
select the time period you want to evaluate. Starting from your most recent test
result, you can choose a time period going
back 60, 90, 120, or 180 days.
19 Jul 2015
2.9 INR
Graph
6 Press the Enter button
to toggle between graphic and tabular display.
7 Press the Back button
Data menu.
return to the My
Reviewing and Handling Data
Trend
FI
Text
CoaguChek INRange User’s Manual
61
Text
Text
Trend
Trend
90 Days
60 Days
Test results above or below the measuring range are marked accordingly. If the
selected period of time contains no test
results, no graph will be displayed.
OK
Due to an incorrect time setting a test result
may be stored with a date in the future. The
example on the lower left shows a test performed after inadvertently setting the date to
the next year, and setting the date back to the
correct year afterwards.
AL
Average: 2.5 INR
These test results appear in red in the table
and are not displayed in the trend graph. As
there is no continuity between the test results
before and after this test, all previous results
(including this test) will not be displayed in
the trend curve.
EN
TI
INR
No data in range
Time
2.6 INR
05 Jul 2015
2.8 INR
29 Jun 2016
2.4 INR
22 Jun 2015
2.9 INR
2.9 INR
Graph
90 Days
Average: 2.5 INR
AF
15 Jun 2015
Trend
CoaguChek INRange User’s Manual
12 Jul 2015
Text
-C
2.5 INR
INR
19 Jul 2015
FI
Trend
Time
Table
Reviewing and Handling Data
Table
Text
62
Displaying a Target report
The Target report is only available if you have
set and enabled an INR target range (see “Set
Targets” on page 93).
Main Menu
AL
Test
1 Power the meter on by pressing the Enter
button . Wait until the Main Menu is
displayed.
My Data
TI
Reminders
EN
Settings
2 Use the Arrow up/down buttons
select My Data.
Other
My Data
3 Press the Enter button
Data menu.
17 Sep 2015
Review Sep
Results
Reports
4 Select Target and press the Enter button
to display the report.
Target
Text
-C
Target
90 Days
AF
Average: 2.5 INR
Above
Within
Reviewing and Handling Data
Trend
Data Transfer
to open the My
FI
17:03
to
Below
Table
CoaguChek INRange User’s Manual
63
Text
The percentage of values above, within and
below the set target range will be displayed
as a pie chart. The average (numerical) value
of the selected time period is also displayed.
If the selected period of time contains no test
results, no graph will be displayed.
Target
90 Days
AL
Average: 2.5 INR
Above
Within
TI
5 Use the Arrow up/down buttons
to
select the time period you want to evaluate. Starting from your most recent test
result, you can choose a time period going
back 60, 90, 120, or 180 days.
Text
Target
Average: 2.5 INR
16%
Within
60%
Below
24%
-C
Above
AF
CoaguChek INRange User’s Manual
FI
6 Press the Enter button
to toggle between graphic and tabular display.
90 Days
Graph
7 Press the Back button
My Data menu.
to return to the
Reviewing and Handling Data
Table
EN
Below
64
Data transfer
•
data backup
EN
further evaluation of stored test results in
suitable computer applications
FI
AF
-C
Neither USB nor Bluetooth
selected. Check Settings.
The preferred method (USB/Bluetooth) used
for data transfer has to be selected in the
meter settings, before transferring data for
the irst time. Otherwise a corresponding
message will be displayed.
Both methods will be described separately
on the following pages. For using a Bluetooth
connection, pairing has to be completed
during setup, before you can perform a data
transfer (see “Data Transfer” on page 99).
It is not possible to perform a test while the
meter is connected to the PC.
Reviewing and Handling Data
Data Transfer
Cancel
•
Text
TI
AL
The CoaguChek INRange meter is able to
communicate with a computer and/or other
devices either via USB or a wireless Bluetooth
connection. You can use this feature for the
following purposes:
CoaguChek INRange User’s Manual
65
Data transfer via USB
1 Power the meter on by pressing the Enter
button . Wait until the Main Menu is
displayed.
Main Menu
AL
Test
2 Use the Arrow up/down buttons
select My Data.
My Data
TI
Reminders
3 Press the Enter button
Data menu.
EN
Settings
Other
My Data
Reports
Target
Text
-C
Data Transfer
AF
Connect USB to
Meter & PC
CoaguChek INRange User’s Manual
Reviewing and Handling Data
The meter waits now for a connection to be
established.
Trend
Data Transfer
to open the My
4 Select Data Transfer and press the Enter
button
to start the data transfer mode.
17 Sep 2015
Review Sep
Results
FI
17:03
to
66
EN
TI
AL
For connecting the meter to a computer, you
will need a suitable USB cable (included in
the kit). Connect the micro USB type B plug
to the meter (the USB port is located on the
right-hand side of the meter) and the USB
type A plug to the computer. In order to
transfer data, always connect the cable to the
meter irst and then to the computer.
Data transfer must be actively triggered
by the computer application or device app
used for reading the stored data.
Text
FI
Data Transfer
To save battery power remove the USB
cable after transferring the test results to
the PC.
AF
-C
Data Transfer
Complete
When the connection has been established
and the download command was received,
the meter informs you about the progress.
Transferring data...
Data...
Reviewing and Handling Data
Data Transfer
CoaguChek INRange User’s Manual
67
Data transfer via Bluetooth
1 Power the meter on by pressing the Enter
button . Wait until the Main Menu is
displayed.
Main Menu
AL
Test
2 Use the Arrow up/down buttons
select My Data.
My Data
TI
Reminders
3 Press the Enter button
Data menu.
EN
Settings
Other
My Data
The meter waits now for a connection to the
paired device to be established.
Trend
Reports
Target
Text
-C
Data Transfer
AF
Activating Bluetooth
CoaguChek INRange User’s Manual
BT Smart
Information about compatible software for
data transfer with the CoaguChek INRange
meter can be found on
www.coaguchek.com/INRange.
Reviewing and Handling Data
4 Select Data Transfer and press the Enter
button
to start the data transfer mode.
17 Sep 2015
Review Sep
Results
Data Transfer
to open the My
FI
17:03
to
68
Text
When the connection has been established
and the download command was sent, the
meter informs you about the progress.
Data Transfer
Transferring data...
Depending on the software you are using
an information screen may appear after
completing the data transfer. It may contain,
e.g., information about available software
updates or a change of settings applied to
the meter.
TI
AL
Data...
Data Transfer
FI
Update
17. Sep 2015
INFORMATION
OK
AF
-C
Target range setting
changed.
SW update is available
Reviewing and Handling Data
EN
Data Transfer
Complete
CoaguChek INRange User’s Manual
69
Displaying reports on a computer
The reports displayed on the meter (see page
58 ff.) can also be displayed on a computer.
Opening these reports on an Internet browser
provides additional advantages like more
detailed information, the ability of printing,
and storing results to ile for further evaluation. You do not need an Internet connection,
all report data is stored on and retrieved from
the meter. Reports can only be used via an
USB connection. For displaying reports:
AL
Main Menu
Test
TI
My Data
Reminders
EN
My Data
Review Results
Trend
17
Sep 2015
1 Power the meter on by pressing the Enter
button . Wait until the Main Menu is
displayed.
FI
17:03
Target Sep
Data Transfer
Reports
-C
Text
Data Transfer
AF
Connect USB to
Meter & PC
CoaguChek INRange User’s Manual
2 Use the Arrow up/down buttons
select My Data.
3 Press the Enter button
Data menu.
to
to open the My
4 Select Reports and press the Enter button
Reviewing and Handling Data
Settings
Other
70
5 Connect the meter to the computer via
USB cable.
AL
The display shows “Connected” when the
connection has been established.
EN
TI
6 If this has not been done automatically,
open a window on your computer which
displays the contents of the meter (as a
removable disk drive).
7 Double click on START.HTM to open the
ile in your standard Internet browser.
Text
Reports
FI
8 After you have inished using the embedded reports, unplug the USB cable from
the meter and the computer.
-C
AF
When the meter is connected to a computer, it will not be powered via the USB
cable and will not power off automatically.
To save battery power always remove the
USB cable when the connection is no
longer in use.
Reviewing and Handling Data
Connected
CoaguChek INRange User’s Manual
71
Security settings in the Internet browser
The settings of your Internet Browser can
have an inluence on working with reports.
AF
-C
FI
In many cases, you can change the security
settings for using the Internet and working
with reports (e.g. at user login to the PC or by
deining user proiles in the browser).
CoaguChek INRange User’s Manual
If you choose the Internet browser security
settings appropriately (e.g. “Allow active
content to run iles on My Computer” or
similar), you can work with reports without
any restrictions.
Reviewing and Handling Data
EN
TI
AL
The reports use pages with so-called “active
content” (Java Script). This active content
can be suppressed by selecting appropriate security settings in the browser, causing
warnings to be issued or functionality to be
restricted. If this happens, check the relevant
Internet browser settings in order to ensure
smooth operation.
72
Reports overview
A report displayed in your Internet browser
contains the following elements:
-C
FI
B Report Content
The page body contains the Trend Graph,
the Target Graph, and a chronological list
of Results.
AF
Language, preferred units, and your personal
therapeutic range will displayed as set in the
meter. The target range is only available if
you have selected the unit INR in the meter
settings.
Reviewing and Handling Data
EN
TI
AL
A Report Header
Displays information about the meter (like
serial number, software version etc.), allows to set the Time Period for statistics
and the Target Range Display, and
contains buttons for printing and saving
the report to ile.
CoaguChek INRange User’s Manual
73
Time period
EN
TI
AL
Starting from your most recent test result, you
can choose a Time Period going back 60,
90, 120, or 180 days. This setting is applied to
both the Trend and Target graph.
Trend graph
CoaguChek INRange User’s Manual
Vertical lines on the Trend graph mark the
beginning of each week.
Reviewing and Handling Data
AF
-C
FI
All test results stored within a selected period
of time will be displayed in the chart as linear
values. Each test result (represented by the
symbol) is plotted along the time axis according to the time when the test was performed.
Test results above or below the measuring range are marked accordingly. All test
results are connected by a line in chronological order.
74
Target range display
AL
The green area behind the curve marks
the INR target range (if set, otherwise not
displayed). You may set the Target Range
Display to:
Constant: the current target range set in
the meter is applied to all results in the
selected time period.
•
Individual: the green bar shows the target
range valid at that point in time.
FI
The percentage of values above, within and
below the set target range will be displayed
as a pie chart. The average (numerical) value
and the total number of results in that range
are also displayed.
Below the Target graph you will ind further
statistical information calculated from all
values within the selected time period.
AF
-C
Target graph
Reviewing and Handling Data
EN
TI
•
CoaguChek INRange User’s Manual
75
List of results
AL
All test results are listed in chronological
order, with the latest result on top. The list
contains the following columns:
Date and Time
•
PT Coagulation (INR)
The result value is shown in INR. If the result is outside the measuring range, either
LOW or HIGH will be shown.
•
Target range (INR)
The target range valid at that point in time.
If the result is outside the target range
the cell is colored blue (above) or yellow
(below).
CoaguChek INRange User’s Manual
•
Comments
•
Data transfer
This indicator shows if a result has previously been transferred using the “Data
transfer” function of the meter. Viewing a
report on the computer as described here
is not a data transfer and thus does not
activate this indicator.
Reviewing and Handling Data
AF
-C
FI
EN
TI
•
76
Printing reports
All the reports displayed on the screen can
also be printed out at once.
EN
TI
AL
In order to achieve the best results, use the
print button
on the report header. Do
not use the integrated print function of the
browser.
1 Click the print button
header.
in the report
FI
AF
-C
3 Start the printing process.
Reviewing and Handling Data
2 Select the desired printer from the print
dialog box, and adjust print parameters
as needed, depending on the available
options.
CoaguChek INRange User’s Manual
77
Using data in external applications
TI
AL
For evaluating test results using other software, you can save the data as a *.csv ile.
The ile extension CSV stands for Comma
Separated Values. These iles can be used by
various applications, for example a text editor
or a spreadsheet application.
AF
-C
FI
1 Click the Save ile button
header.
CoaguChek INRange User’s Manual
in the report
2 Select the desired save options in the following dialog box.
Reviewing and Handling Data
EN
The *.csv ile always contains all the test results currently stored in your meter, including
test results that have already been transferred
during previous data transfers.
78
EN
TI
AL
The saved ile is handled by the system
like a download performed by the Internet
browser, the corresponding settings apply.
This will, for example, determine if the ile is
just stored or directly opened in an application. If saving the *.csv ile does not work
as expected check the relevant system and
browser settings.
Serial number of the meter
•
Date and time of data download to the
computer (for creating this *.csv ile)
•
Date, time, value and unit of each stored
test result
AF
-C
FI
•
Reviewing and Handling Data
The saved *.csv ile contains the following
information:
CoaguChek INRange User’s Manual
79
Reminders and Meter Settings
Setting up reminders
Test
•
Medication
AF
-C
FI
•
CoaguChek INRange User’s Manual
reminders
•
Appointment
•
Other
reminders
reminders
reminders
Each reminder can be scheduled as single
reminder, or as recurring reminder (daily, or in
1-4 week intervals).
Reminders and Meter Settings
EN
TI
AL
The CoaguChek INRange meter lets you set
up reminders, that work just like an alarm
clock telling you it’s time for an action.
Beyond the abilities of an alarm clock: these
reminders also tell you which action you have
scheduled at that point in time. You may set
up four different kinds of reminders:
80
New reminder
For setting up a new reminder:
Main Menu
1 Power the meter on by pressing the Enter
button . Wait until the Main Menu is
displayed.
AL
Test
My Data
Reminders
TI
2 Select Reminders and press the Enter
button
to open the corresponding
menu.
Other
EN
Settings
Text
Reminders
3 Select New and press the Enter button
to set up a new reminder.
17:03
Current Reminders
17 Sep 2015
FI
-C
The Reminders screen opens and displays
the options you can set:
Reminders
New
AF
Select reminder type
Once
•
Type (default:
•
Interval (default: once)
•
Time and date (default: current time on the
next day)
(Test))
13 : 45
Reminders and Meter Settings
Sep
2015 Sep
17
Next
CoaguChek INRange User’s Manual
81
4 Use the Arrow up/down buttons
to set
the desired type (test, medication, appointment, other).
Reminders
Select reminder type
Once
AL
5 Press the Enter button
to conirm the
selected type. The next reminder parameter (interval) will be highlighted.
6 Use the Arrow up/down buttons
to set
the desired interval (once, daily, every 7,
14, 21, or 28 days).
17 Reminders
EN
Select frequency
Next
7 Press the Enter button
to conirm the
selected interval. The next reminder parameter (hour) will be highlighted.
FI
7 Days
-C
Set time
Next
Reminders
Monday
13 : 45
7 Days
AF
13 : 45
Monday
CoaguChek INRange User’s Manual
Next
8 Set the remaining time/date parameters,
always using the Arrow up/down buttons
to set the parameters, and the Enter
button
to conirm and jump to the next
parameter.
Depending on the chosen interval, there
will be different time/date parameters to
set.
Reminders and Meter Settings
2015 Sep
TI
13 : 45
82
After entering and conirming the day, you
are prompted to set the audio signal for the
reminder.
Reminders
Set day of week
7 Days
AL
9 Select the desired Reminder Tones,
which may, for example, help you to
acoustically distinguish between reminder
types. Press the Enter button
to conirm
your selection. A green dot marks the
selected tone.
Reminder Tones
EN
Monday
TI
13 : 45
Next
Marimba
10 Press the Enter button
selection and proceed.
Timba
Doorbell
Save
High
-C
Reminder Volume
Medium
11 Select the desired Reminder Volume and
press the Enter button
to conirm your
selection. A green dot marks the selected
volume.
Bell
12 Press the Enter button
reminder.
to save the
AF
Low
Off
Reminders and Meter Settings
again to save the
FI
Ascending
Next
CoaguChek INRange User’s Manual
83
Text
The newly set reminder is now shown in the
list of reminders. You can now
Reminders
Current Reminders
•
set another New reminder
13:45, Thu 7 Days
•
Edit/Delete the existing reminder
•
exit the Reminders menu with the Back
button and return to the Main Menu.
EN
TI
AL
17:30, 17 Sep 2015
New
CoaguChek INRange User’s Manual
Reminders and Meter Settings
AF
-C
FI
Edit / Delete
84
Editing or deleting a reminder
Text
Reminders
For editing or deleting a reminder:
Text
Current Reminders
1 Select Edit/Delete and press the Enter
button
to proceed.
Edit Reminders
13:45, Thu 7 Days
AL
17:30, 17 Sep 2015
17:30, 17 Sep 2015
2 Select the desired reminder and press the
Enter button
to conirm your selection.
A green dot marks the selected reminder.
EN
TI
13:45, Thu 7 Days
3 Select Edit or Delete and press the Enter
button
to proceed.
New
Edit / Delete
Edit
The Edit/Delete button is only available
if there is at least one reminder listed. The
New button is only available if there are
less than four reminders listed.
AF
-C
FI
If you have selected to edit the reminder, proceed as described in section “New reminder”.
If you have selected to delete the reminder, it
will be deleted after conirmation.
Reminders and Meter Settings
Delete
CoaguChek INRange User’s Manual
85
Meter settings
EN
TI
AL
The initial meter setup has already been inished after powering on the meter for the irst
time. Use the following descriptions to set
up options that are not covered by the initial
setup (like, e.g., the target range) or to edit
settings already made.
1 Power the meter on by pressing the Enter
button . Wait until the Main Menu is
displayed.
FI
Main Menu
Settings
Language
Reminders
Time & Date
Settings
Units
Other
Result Format
AF
-C
My Data
Set Targets
17:03
17 Sep 2015
Beeper Volume
Sep
CoaguChek INRange User’s Manual
Test
2 Select Settings and press the Enter button
to open the corresponding menu.
Reminders and Meter Settings
Preceding to all of the following descriptions
(not repeated there) perform the following
steps:
86
Settings overview
Set Targets
TI
EN
•
•
On
Off
•
•
High value
Low value
60 days
90 days
120 days
180 days
AF
•
•
•
•
FI
Result Format
-C
• INR
• %Q
• Sec
• Simple
• Detailed
Time period
(statistics)
24-hour format (24h)
12-hour format (12h) with a.m./p.m.
Reminders and Meter Settings
Units
•
•
Time & Date
AL
Options
• English
• Deutsch
• Francais
• Espanol
• Nederlands
• Portugues
Time format
Setting
Language
CoaguChek INRange User’s Manual
87
CoaguChek INRange User’s Manual
TI
EN
Reminders and Meter Settings
AF
-C
Data Transfer
Button Click
FI
Display Brightness
AL
Options
• High
• Medium
• Low
• Off
• High
• Medium
• Low
• On
• Off
• None
• Bluetooth
• USB
Setting
Beeper Volume
88
Language
1 Select Language and press the Enter button
to open the corresponding menu.
Settings
A green dot indicates which language is currently active.
AL
Language
Time & Date
Units
TI
2 Use the Arrow up/down buttons
to
select your preferred language. The newly
selected language is highlighted (blue).
Arrow symbols on top and/or bottom of
the screen indicate more entries above or
below the currently visible part of the list.
EN
Result Format
Set Targets
Language
Beeper Volume
FI
English
3 Press the Enter button
to conirm the
selection, which is now marked by the
green dot.
Français
Español
4 Press the Enter button
selected language.
again to save the
5 In the following conirmation screen select
Conirm and press the Enter button
to
switch the meter to the selected language.
AF
Save
-C
Nederlands
Reminders and Meter Settings
Deutsch
CoaguChek INRange User’s Manual
89
Time & Date
1 Select Time & Date and press the Enter
button
to open the corresponding
menu.
Settings
AL
Language
2 Use the Arrow up/down buttons
to
select the time format for the display (24
hour or 12 hour am/pm).
Time & Date
Time & Date
TI
EN
Result Format
3 Press the Enter button
to conirm and
save the setting. The screen for setting
time and date follows next.
Set Targets12 hr Format
Beeper Volume
24 hr Format
Time & Date
Next
17
AF
Time & Date
Next
17
13 : 45
2015 Sep
Next
CoaguChek INRange User’s Manual
to set
-C
2015 Sep
13 : 45
FI
4 Use the Arrow up/down buttons
the current hour.
5 Press the Enter button
to conirm the
hour. The next input ield (minutes) will be
highlighted.
6 Proceed with setting the remaining ields.
The Enter button
always conirms a setting (and highlights the subsequent ield,
if available), the Back button allows you
to jump back to the previous ield.
Reminders and Meter Settings
Units
90
AL
In order to ensure a correct time and date
setting, the meter checks the date for plausibility. The meter will display a message in
the following cases:
the date you want to set is older than
the last stored measurement result
•
the date you want to set is six months
later than the last stored measurement
result
FI
-C
AF
Reminders and Meter Settings
EN
TI
•
CoaguChek INRange User’s Manual
91
Units
1 Select Units and press the Enter button
to open the corresponding menu.
Settings
Units
The currently active unit is shown with a
green dot on the right side.
Units
%Q
Result Format
Sec
2 Use the Arrow up/down buttons
to select your preferred unit. The newly
selected unit is highlighted (blue).
TI
INR
EN
Time & Date
AL
Language
Set Targets
Beeper Volume
FI
Save
AF
-C
4 Press the Enter button
selected unit.
CoaguChek INRange User’s Manual
again to save the
A target range can only be set and used if
the unit is set to INR.
Reminders and Meter Settings
3 Press the Enter button
to conirm the
selection, which is now marked by the
green dot.
92
Result Format
TI
AL
Choose Detailed if you want to see your current result in relation to your previous result
in the same screen. An up arrow indicates
that your current result is higher, and a down
arrow indicates that it is lower than your
previous result (see page 53).
1 Select Result Format and press the Enter
button
to open the corresponding
menu.
EN
Settings
Result Format
Detailed
Simple
Units
The currently active result format is shown
with a green dot on the right side.
FI
Time & Date
2 Use the Arrow up/down buttons
to
select your preferred result format. The
newly selected format is highlighted
(blue).
Result Format
Set Targets
-C
Beeper Volume
AF
Save
3 Press the Enter button
to conirm the
selection, which is now marked by the
green dot.
4 Press the Enter button
selected result format.
again to save the
Reminders and Meter Settings
Language
CoaguChek INRange User’s Manual
93
Set Targets
AL
A target range can only be set and used if
the unit is set to INR.
EN
TI
A target range (or therapeutical range)
deines the minimum and maximum values
which should be achieved during the therapy.
Reports and statistics can then include information about values within, above or below
this target range.
180 Days
Units
120 Days
Result Format
90 Days
Set Targets
60 Days
-C
AF
Beeper Volume
CoaguChek INRange User’s Manual
Time & Date
Time Period
FI
Set Targets
Language
Next
The currently selected time period, which will
be used as the default time period for reports
and statistics, is shown with a green dot on
the right side.
2 Select the desired time period.
3 Press the Enter button
to conirm the
selected time period, which is now marked
by the green dot.
4 Press the Enter button
to the next step.
again to proceed
Reminders and Meter Settings
1 Select Set Targets and press the Enter
button
to open the corresponding
menu.
Settings
94
The current activation status is shown with a
green dot on the right side.
Set Targets
On
A newly set or edited target range is only
valid for tests performed after this setting
was done, and will not affect test results
already stored in memory.
TI
AL
Off
EN
5 Use the Arrow up/down buttons
select On or Off.
Next
to
FI
again to proceed
AF
-C
7 Press the Enter button
to the next step.
Reminders and Meter Settings
6 Press the Enter button
to conirm the
selection, which is now marked by the
green dot.
CoaguChek INRange User’s Manual
95
If you have selected the option Off, the Set
Targets setup ends here. If you have selected
the option On, proceed as follows:
Set Targets
On
8 Select the value you wish to set and press
the Enter button
to proceed.
AL
Off
TI
9 Use the Arrow up/down buttons
the desired value.
11 Repeat the last steps to set the second
value as well.
6.0
AF
Conirm
CoaguChek INRange User’s Manual
12 Select Conirm and press the Enter button
to save the settings.
-C
High Value
Set Targets
INR
Save
Reminders and Meter Settings
1.0 INR
to save the set
6.0 INR
Low Value
10 Press the Enter button
value.
FI
Next
High Value
EN
Set Targets
to set
96
Beeper Volume
AL
If the beeper is activated, the meter always
beeps when an action is taken, for example a
test strip is inserted or suficient sample has
been applied.
EN
TI
The beeper volume can be set or deactivated.
However, in case of an error the meter will
always beep for safety reasons, even if you
have set the beeper function to Off. To set the
beeper volume:
High
Result Format
Medium
Set Targets
Low
Beeper Volume
Off
AF
Display Brightness
-C
Units
Time & Date
1 Select Beeper Volume and press the
Enter button
to open the corresponding
menu.
FI
Beeper Volume
Reminders and Meter Settings
Settings
Save
The currently set volume is shown with a
green dot on the right side.
2 Use the Arrow up/down buttons
select the desired volume.
to
3 Press the Enter button
to conirm the
selection, which is now marked by the
green dot.
4 Press the Enter button
selected volume.
again to save the
CoaguChek INRange User’s Manual
97
Display Brightness
Settings
1 Select Display Brightness and press the
Enter button
to open the corresponding
menu.
Text
Display Brightness
High
Set Targets
Medium
Beeper Volume
Low
The currently set display brightness is shown
with a green dot on the right side.
TI
Result Format
AL
Units
EN
2 Use the Arrow up/down buttons
to
select the desired display brightness. The
display will temporarily switch to the currently highlighted brightness.
Display Brightness
3 Press the Enter button
to conirm the
selection, which is now marked by the
green dot.
AF
-C
FI
Save
CoaguChek INRange User’s Manual
4 Press the Enter button
again to save the
selected display brightness.
To improve battery lifetime, choose a lower
display brightness setting.
Reminders and Meter Settings
Button Click
98
Button Click
The meter can be set to play a click sound,
whenever you press a button.
Settings
AL
To set the button click:
1 Select Button Click and press the Enter
button
to open the corresponding
menu.
TI
Text
Button Click
ON
Set Targets
OFF
The current status is shown with a green dot
on the right side.
Result Format
EN
Units
2 Use the Arrow up/down buttons
select On or Off.
FI
Beeper Volume
3 Press the Enter button
to conirm the
selection, which is now marked by the
green dot.
Button Click
to
4 Press the Enter button
selected status.
again to save the
AF
-C
Save
Reminders and Meter Settings
Display Brightness
CoaguChek INRange User’s Manual
99
Data Transfer
EN
TI
AL
The CoaguChek INRange meter is able to
communicate with a computer and/or other
devices either via USB or a wireless Bluetooth
connection. Using the Data Transfer option
(see chapter Data transfer starting on page
64) enables the transfer mode (USB or
Bluetooth) preselected here.
To set up data transfer:
1 Select Data Transfer and press the Enter
button
to open the corresponding
menu.
FI
Data Transfer
Set Targets
USB
-C
Bluetooth
Display Brightness
None
Beeper Volume
Button Click
AF
Data Transfer
CoaguChek INRange User’s Manual
The currently set transfer mode is shown with
a green dot on the right side.
Result Format
Save
2 Use the Arrow up/down buttons
select the desired transfer mode.
to
3 Press the Enter button
to conirm the
selection, which is now marked by the
green dot.
4 Press the Enter button
selected transfer mode.
again to save the
Reminders and Meter Settings
Settings
100
If you have selected None or USB, data
transfer setup ends here.
Paired device:
My Smartphone
Activating Bluetooth
Delete pairing and pair with
another device?
EN
Yes
FI
BTPairing
Smart
5 Enter the displayed code on the device you
want to pair the meter with.
Pairing Information:
987654
Text
Pairing in Text
Progress
After you have successfully done so, the
meter continues the pairing process.
6 Press the Enter button
to conirm and
inish the pairing process.
AF
Pairing
-C
Pairing
Pairing Complete
Reminders and Meter Settings
If the Bluetooth interface has been activated
for the irst time (or you have chosen to delete
the previously paired device), the meter displays the pairing information.
No
Text
If you have selected Bluetooth, you need to
perform a “device pairing”before data can be
transferred. If the device pairing has already
been done in the past, the meter displays
information about the paired device.
AL
Pairing
TI
Data Transfer
Text
My Smartphone
OK
CoaguChek INRange User’s Manual
101
NOTICE
AL
Overview
EN
TI
To avoid malfunction of the meter, follow the
procedures below to clean and disinfect the
meter and the lancing device.
Make sure the meter is turned off.
•
Do not use sprays of any sort.
•
Ensure that the cloth or cotton swab/bud
is only damp, not wet, to protect against
moisture entering the meter.
AF
-C
FI
•
CoaguChek INRange User’s Manual
To prevent soiling the meter, apply blood via
side-dosing directly from ingertip.
Cleaning and Disinfecting the Meter and the Lancing Device
Cleaning and Disinfecting the Meter and the Lancing Device
102
Cleaning is the removal of dirt from the meter
or lancing device.
EN
TI
AL
Disinfecting is the removal of most, but not
all, disease-causing and other types of microorganisms (bloodborne pathogens) from the
meter or lancing device.
Clean and disinfect the meter and/or the
lancing device to remove visible dirt or
other material on a regular basis.
AF
-C
FI
•
When should the meter and the lancing device be cleaned and disinfected?
•
Clean and disinfect the meter and/or the
lancing device always when there is blood
on it.
•
Clean and disinfect the meter and/or the
lancing device before allowing anyone else
to handle the meter and/or the lancing
device, for instance, if you have someone
assisting you. Do not allow anyone else to
use the lancing device.
Cleaning and Disinfecting the Meter and the Lancing Device
What is the difference between cleaning and disinfecting?
CoaguChek INRange User’s Manual
103
Gently wipe the meter’s surface with one of
these cleaning agents:
a soft cloth slightly dampened (not wet)
with a small amount of liquid soap diluted
in water
•
Rubbing alcohol (70% ethanol or isopropyl
alcohol)
•
Alcohol-based disinfectant (a mixture
of 1-propanol (400 mg/g), 2-propanol
(200 mg/g) and glutaraldehyde (1.0 mg/g))
FI
EN
TI
AL
•
AF
-C
•
CoaguChek INRange User’s Manual
Disposable wipes (containing quaternary
ammonium compounds up to 0.5 % (single
compound or mixture) in isopropyl alcohol
(isopropanol) up to 55 %))
Ask your healthcare professional or
pharmacist to recommend commercially
available wipes containing the acceptable
cleaning agents.
Cleaning and Disinfecting the Meter and the Lancing Device
Recommended cleaning/disinfection agents
104
Ensure that the blue test strip guide
cover remains tightly closed while cleaning the meter housing.
•
Do not let liquid accumulate near any
opening.
EN
TI
AL
•
NOTICE
AF
-C
FI
Ensure that no liquid enters the meter when
you clean the exterior. If moisture enters the
meter, it may cause malfunction of the instrument.
Cleaning and Disinfecting the Meter and the Lancing Device
Cleaning the meter housing
CoaguChek INRange User’s Manual
1 With the meter turned off, wipe the meter’s
exterior clean.
AL
2 With a fresh dry cloth or lint-free tissue,
wipe away residual moisture and luids
after cleaning the housing.
EN
TI
3 Allow wiped areas to dry for at least 10
minutes before performing a test.
Cleaning the test strip guide
AF
-C
FI
1 Remove the test strip guide cover to clean
it. (Use your thumbnail to open the cover
of the test strip guide by pressing its front
edge upward.) Move the cover safely away
from the meter.
CoaguChek INRange User’s Manual
2 Rinse the cover with warm water or wipe
it clean using the solutions recommended
above. Let the test strip guide cover dry for
at least 10 minutes before re-attaching it.
Cleaning and Disinfecting the Meter and the Lancing Device
105
3 Hold the meter upright with the test strip
guide facing down.
Clean the easily accessible white areas
with a moistened cotton swab/bud.
•
Ensure the swab/bud is only damp, not
wet. Wipe away residual moisture and
luids.
EN
TI
AL
•
NOTICE
Ensure that no liquid enters the meter. If
moisture enters the meter, it may cause
malfunction of the instrument.
•
Do not insert any objects in the test strip
guide. Doing so may damage the electrical
contacts behind the test strip guide.
AF
-C
FI
•
Damage to the instrument
Cleaning and Disinfecting the Meter and the Lancing Device
106
CoaguChek INRange User’s Manual
107
4 With the cover off, let the test strip guide
dry for at least 10 minutes.
FI
Cleaning and Disinfecting the Lancing Device
EN
TI
AL
5 After this time, re-attach the test strip
guide cover to the housing. Make sure that
the cover is properly closed. You will hear
it snap into place.
Do not throw away the lancing device cap
after each use. Use approved cleaning and
disinfecting products on it.
•
Remove the lancet before cleaning and
disinfecting the lancing device.
•
-C
AF
CoaguChek INRange User’s Manual
NOTICE
To clean and disinfect without damaging
the lancing device, follow these procedures
carefully.
Cleaning and Disinfecting the Meter and the Lancing Device
On completion of cleaning:
108
Clean the lancing device to remove visible
dirt or other material prior to disinfecting.
•
Clean and disinfect the lancing device
before allowing anyone else to handle the
lancing device, for instance, if you have
someone assisting you. Do not allow anyone else to use the lancing device.
AF
-C
FI
EN
TI
AL
•
Cleaning and Disinfecting the Meter and the Lancing Device
When to clean and disinfect the lancing device
CoaguChek INRange User’s Manual
109
The entire lancing device surface
•
The cap
AL
•
TI
How to clean and disinfect the lancing device
EN
1 Wash hands thoroughly with soap and
water.
AF
-C
FI
2 Wipe the entire surface of the lancing
device and the inside of the lancing device
cap with the approved cleaning and
disinfection product. Always use the same
product for both cleaning and disinfecting.
CoaguChek INRange User’s Manual
3 Dry the lancing device and cap with a soft
cloth or gauze. Make sure no solution is
seen in any opening.
4 For disinfecting the lancing device, repeat
step 2 using a new wipe or cloth. Follow
the instructions of the lancing device.
5 Wash hands thoroughly with soap and
water.
Cleaning and Disinfecting the Meter and the Lancing Device
What to clean and to disinfect
110
DO NOT get any moisture into the opening
around the button.
•
To avoid damaging the lancing device and
stop it from working properly make sure
you follow the above recommendations.
AF
-C
FI
EN
TI
AL
•
Cleaning and Disinfecting the Meter and the Lancing Device
NOTICE
CoaguChek INRange User’s Manual
111
Other Functions and Troubleshooting
Other functions
TI
AL
The Other menu of the meter contains functions relevant for service and troubleshooting
purposes:
Version information and irmware update
•
Clear memory (deleting data and settings)
•
Meter log
•
Display test
-C
Test
About
Reminders
Clear Memory
Settings
Meter Log
AF
My Data
Other
Display Test
Firmware Update
17 Sep 2015
17:03
Sep
CoaguChek INRange User’s Manual
Text
Other
Preceding to all of the following descriptions
(not repeated there) perform the following
steps:
Main Menu
1 Power the meter on by pressing the Enter
button . Wait until the Main Menu is
displayed.
2 Select Other and press the Enter button
to open the corresponding menu.
Other Functions and Troubleshooting
FI
EN
•
112
About (version and irmware)
TI
AL
In case of technical problems the irmware
version is an important information for the
Roche customer support . Sometimes problems can be solved by applying a irmware
update. The About screen provides such
information.
Text
1 Select About and press the Enter button
to open the corresponding menu.
EN
Other
Text
The serial number, irmware version, hardware
information and production date is displayed.
Clear Memory
Meter Log
Model Serial Number
Display Test
00.07.00
ZenithFumu1
AF
-C
Firmware
Hardware
to exit this
Firmware Update
2 Press the Back button
screen.
0000000225
FI
About
Other Functions and Troubleshooting
About
CoaguChek INRange User’s Manual
113
Clear Memory
NOTICE
AF
-C
FI
The following data will be cleared:
CoaguChek INRange User’s Manual
•
Test results
•
Error log
•
Stored code chips
•
Reminders
The setup will be reset to the default settings. The meter turns off. When the meter
is turned on again, you will irst need to
perform an initial setup (see page 29).
Other Functions and Troubleshooting
EN
TI
AL
Potential loss of data
The Clear Memory function deletes all data
(stored test results) and settings from the
meter. If you want your data preserved, make
sure you have uploaded them to a computer
(using the data transfer function) before
clearing the memory.
114
Text
For clearing the memory:
Other
1 Select Clear Memory and press the Enter
button
to proceed.
About
Clear Memory
AL
Display Test
2 Select YES and press the Enter button
to proceed.
Text
Clear Memory
TI
Meter Log
3 Select YES again and press the Enter button
to clear all data from memory.
EN
Firmware Update
FI
Delete all Results and
Settings?
Text
No
Are you sure?
Clear Memory
Yes
AF
-C
Delete all Results and
Settings?
No
Yes
Other Functions and Troubleshooting
Clear Memory
CoaguChek INRange User’s Manual
115
Meter Log
Text
The Meter Log is another helpful source
of information when contacting Roche
Diagnostics customer support. The meter
stores a list of all warnings, maintenance and
error messages.
Other
AL
About
Text
1 Select Meter Log and press the Enter
button
to proceed.
Meter Log
Firmware Update
2 Select the event you want to know details
about and press the Enter button
to
proceed.
19 Jul 2015 [M-22]
12 Jul 2015 [M-41]
Test Strip Expired
[M-22]
-C
03 Jun 2015 [M-31]
AF
Test strip has expired. Use
a valid test strip.
CoaguChek INRange User’s Manual
OK
3 When done, close the detail screen with
OK.
26 Jun 2015 [M-31]
Maintenance
01 Jul 2015 [M-42]
FI
01 Jul 2015 [M-23]
Other Functions and Troubleshooting
Display Test
EN
Meter Log
TI
Clear Memory
116
Display Test
Text
Other
The Display Test lets you check the meter’s
screen for proper functioning. In case you
suspect the screen (or parts of it) to be defective, perform this display test.
Display Test
Clear Memory
AL
About
Display test. Go through
the four colored screens
with OK.
1 Select Display Test and press the Enter
button
to proceed.
TI
Meter Log
EN
Display Test
2 Read the information screen and press the
Enter button
to proceed.
3 Step through the following screens
by pressing the Enter button , while
inspecting each one for defective pixels or
other defects.
If all screens appeared lawlessly, your display
is functioning properly.
AF
-C
FI
OK
Other Functions and Troubleshooting
Firmware Update
CoaguChek INRange User’s Manual
117
Firmware Update
Text
Other
AL
Performing a irmware update requires
an update ile (provided by Roche) to
be available on your computer. You may
have downloaded this ile from the Roche
website.
About
Connect USB to
Meter & PC
1 Select Firmware Update and press
the Enter button
to start the update
process.
Firmware Update
EN
Firmware Update
Display Test
TI
Text
Meter Log
AF
-C
FI
2 Connect the meter to the computer via
USB cable.
CoaguChek INRange User’s Manual
The meter will now be mounted on the computer as an external drive (like an USB stick).
Other Functions and Troubleshooting
Clear Memory
118
Text
Text
Firmware Update
3 On the computer, open a window showing
the content of this drive.
Firmware Update
Loading Update
AL
4 Copy (or save) the required update ile to
this drive.
For Firmware Update copy
ile to INRange-Drive
EN
TI
The meter automatically recognizes the presence of an update ile and starts performing
the irmware update. Several screens inform
you about the progress during installation.
When the update has been completed successfully, the CoaguChek logo is displayed.
Unplug the USB cable from the meter and the
computer.
Firmware Update
AF
-C
FI
Preparing Update,
do not interrupt!
®
CoaguChek
Other Functions and Troubleshooting
Text
CoaguChek INRange User’s Manual
119
Troubleshooting
AL
The CoaguChek INRange meter continually
checks its systems for unexpected and unwanted conditions.
AF
-C
FI
Take the action suggested on screen to
resolve the problem. If the problem (and the
corresponding message) disappears, you may
continue using the meter as desired. If the
problem persists, contact Roche Diagnostics
(see page 135).
CoaguChek INRange User’s Manual
For troubleshooting problems which are not
indicated by a message see the following
pages.
Other Functions and Troubleshooting
EN
TI
Depending on the circumstances, a message
may appear on the display of the meter (see
chapter Messages starting on page 125).
These messages are marked with an icon
and are accompanied by a description and (if
necessary) a possible solution.
120
Errors and unusual behavior without error messages
Possible solution
Insert new batteries. Always replace all 4
batteries at the same time.
Refer to the package insert for the test
strips.
Check the settings for Beeper Volume
(page 96) and Button Click (page 98)
TI
AL
Display/symptom
Meter does not power on, display remains
dark
Meter displays an unexpected result
EN
Meter does not make sounds
FI
-C
AF
Other Functions and Troubleshooting
…?
CoaguChek INRange User’s Manual
121
Symbols, Icons, Messages
Symbols on packaging and meter
FI
This product fulills the requirements of the European Directive 98/79/EC on
in vitro diagnostic medical devices.
Catalogue number
Consult instructions for use
Caution, consult accompanying documents. Refer to safety-related notes in the
manual accompanying this instrument.
Manufacturer
Temperature limitation (Store at)
The system fulills the Canadian and U.S. safety requirements (UL LISTED, in
accordance with UL 61010A-1:02 and CAN/CSA-C22.2 No. 61010-1-04)
CoaguChek INRange User’s Manual
Symbols, Icons, Messages
In vitro diagnostic medical device
-C
Batch code/ Lot number
AF
Meaning
Use by
Symbol
EN
TI
AL
On the packaging and on the type plate of
the meter you may encounter the following
symbols and abbreviations shown here with
their meaning:
122
On the meter buttons the following symbols
are used:
Meaning
Back button, used to exit the
currently displayed menu or go
back one step.
Arrow up/down button, used to
select elements, scroll up/down
in a screen, or change numerical values.
Enter button, used to conirm
the currently selected option or
perform a function. Also used to
power the meter on and off.
-C
AF
Symbols, Icons, Messages
FI
EN
TI
AL
Symbol
CoaguChek INRange User’s Manual
123
Icons on the display
Symbol
Data icon, shown in main menu
CoaguChek INRange User’s Manual
EN
Appointment icon, shown in
reminders
Comment icon, shown with
stored test results
Upload icon, shown with stored
test results after data transfer
Radio button, shows the status
of a selectable option (off/on) in
meter setup screens
Warning message
Error message
Symbols, Icons, Messages
AF
-C
Bluetooth logo, shown when
starting a wireless data transfer
and in data transfer setup
USB symbol, shown when starting a wired data transfer and in
data transfer setup
Test icon, shown in main menu
and reminders
Control icon, shown with control
test results
Reminder icon, shown in main
menu
Meaning
Medication icon, shown in
reminders
TI
Meaning
Indicator for battery capacity
(full, almost empty, empty),
shown in main menu
FI
Symbol
AL
On the meter display the following icons may
appear.
124
Symbol
Meaning
Maintenance message
AL
Meaning
Settings icon, shown in main
menu, and selected option (e.g.
comment list)
Other icon, shown in main menu
and reminders
TI
Information message
-C
AF
Symbols, Icons, Messages
FI
EN
Symbol
CoaguChek INRange User’s Manual
125
Messages
AL
There are several kinds of messages which
can appear on the meter:
Reminders
•
Information
•
Maintenance
•
Warnings
•
Error messages
EN
TI
•
CoaguChek INRange User’s Manual
Symbols, Icons, Messages
AF
-C
FI
The following section explains what you can
do when such a message appears.
126
Reminders
Reminders are a useful tool to schedule tests
and other events. When a reminder becomes
active, it automatically powers on the meter
(if necessary), plays the corresponding sound
and displays the reminder message (test,
medication, appointment or other). You have
two options:
Medication Reminder
17:30, 17 Sep 2015
•
Snooze
Select Conirm, and press the Enter button
to conirm that you will perform the
required action right now. The reminder
will disappear and not come back. Or:
FI
Conirm
EN
TI
AL
Reminder
AF
-C
Select Snooze, and press the Enter button
to postpone the reminder message.
Symbols, Icons, Messages
•
CoaguChek INRange User’s Manual
127
Information
An information message informs you about
what is happening in the meter or a problem
that exists or may come up which requires
you to do something soon. You can continue
to use the meter.
INFORMATION
AL
Batteries Low [I-01]
TI
Batteries are getting low.
Replace batteries soon.
EN
1 Read the whole information message.
2 Press the Enter button
message.
to conirm the
3 Proceed with the current task.
CoaguChek INRange User’s Manual
Symbols, Icons, Messages
AF
-C
FI
OK
128
Maintenance
•
You may not be able to perform a test
because the code chip and the test strip
lot don’t match.
•
The meter may detect a problem when
performing a software self-check.
TI
The batteries are empty.
Almost always, you can ix the problem by
following the instruction in the maintenance
message. You can insert new batteries or start
the test again with a new test strip and the
correct code chip. Or the meter often ixes a
software problem itself when you power it off
and on again.
-C
AF
Symbols, Icons, Messages
FI
OK
•
EN
Test strip has expired. Use
a valid test strip.
Test Strip Expired
[M-22]
AL
A maintenance message requires your immediate attention. The meter may stop working
temporarily. Some examples:
Maintenance
1 Read the whole maintenance message
and the suggested action.
2 Press the Enter button
message.
to conirm the
3 Take the action suggested in the message.
CoaguChek INRange User’s Manual
129
Warnings
A warning message draws your attention to
a hazardous situation that could be a risk to
your health if not corrected. The CoaguChek
INRange meter will rarely display a warning
message. However, if you do receive a warning message, pay close attention to it.
Warning
AL
Sample Error [W-45]
TI
Unusual sample. Repeat
test with fresh sample. If
error persists, contact your
healthcare professional
without delay.
EN
1 Read the whole warning message and the
suggested action.
2 Press the Enter button
message.
to conirm the
FI
OK
CoaguChek INRange User’s Manual
Symbols, Icons, Messages
AF
-C
3 Take the action suggested in the message.
130
Error messages
An error message appears if the meter has
a problem that needs your attention and you
might not be able to solve. The meter stops
working.
Error
AL
Meter Lifetime End
[E-33]
Maximum number of tests
has been reached.
Contact your healthcare
professional or Roche
Diagnostics.
TI
1 Read the error message.
EN
2 Take the action suggested in the message.
If the error persists, please contact your local
Roche Diagnostics customer support (see
page 135).
-C
AF
Symbols, Icons, Messages
FI
Cancel
CoaguChek INRange User’s Manual
131
General Product Information
Ordering
AL
Please contact your pharmacist or specialist
supplier.
REF/Catalog Number
REF 0 4625358
REF 0 4625315
REF 0 3506509
…
AF
-C
Product limitations
CoaguChek INRange User’s Manual
Please read the information in the package
insert supplied with the test strips for detailed
product data and limitations.
General Product Information
FI
EN
TI
Item
CoaguChek XS PT Test, 24 test strips
CoaguChek XS PT Test, 2 x 24 test strips
CoaguChek Softclix Lancet, 50 lancets
…
132
Operating conditions and technical data
TI
EN
Measuring range
FI
Memory
Interfaces
-C
AF
Safety class
Automatic power-off
Dimensions
Weight
Battery operation
General Product Information
+15 °C to +32 °C
10 to 85% (no condensation)
4.300 m
Place the meter on a level, vibration-free
surface or hold it so it is roughly horizontal.
%Q: 120% – 5%
SEC: 9.6 – 96
INR: 0.8 – 8.0
400 test results with date and time
USB type B
Bluetooth
4 x 1.5 V batteries (alkali-manganese) type
AAA
III
After 2 minutes
approx. 145 x 75 x 30 mm
135 g (without batteries)
AL
Temperature range
Relative humidity
Maximum altitude
Position
CoaguChek INRange User’s Manual
133
Sample material
AL
For information regarding sample type, sample size and interferences refer to the respective
test strip package insert.
TI
Storage and transport conditions
–?? °C to +?? °C
10 to 85% (no condensation)
EN
Temperature range
Relative humidity
Disposal of the CoaguChek INRange meter
CoaguChek INRange User’s Manual
The meter falls outside the scope of the
European Directive 2002/96/EC (Directive on
waste electrical and electronic equipment
(WEEE)).
General Product Information
AF
-C
FI
During measurements the meter itself may
come into contact with blood. Used meters
therefore carry a risk of infection. Please dispose of your used meter – after removing the
batteries and cleaning the meter – according
to the regulations applicable in your country.
For information about correct disposal please
contact your local council.
134
For healthcare professionals
AL
Dispose of the meter in line with your facility’s procedures for dealing with potentially
biohazardous waste.
Disposal of used batteries
EN
TI
Do not dispose of the batteries with normal
domestic waste.
Please note that repairs and other modiications to the meter may only be performed by
persons authorized by Roche Diagnostics.
AF
-C
Repairs
General Product Information
FI
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.
CoaguChek INRange User’s Manual
135
Information service
CoaguChek INRange User’s Manual
FI
EN
TI
Canada
Roche Diagnostics
201 Boulevard Armand-Frappier
Laval, Québec H7V 4A2
Coagulation Info-Line
Telephone 1-877-426-2482
United Kingdom
Roche Diagnostics Ltd.
Charles Avenue
Burgess Hill, RH15 9RY
CoaguChek Careline
0808 100 7666
General Product Information
AF
-C
Australia
Roche Diagnostics Australia Pty Ltd.
ABN 29 003 001 205
31 Victoria Avenue
Castle Hill, NSW, 2154
Telephone 02-9860 2222 or 1800 645 619
New Zealand
Roche Diagnostics N.Z. Ltd.
15 Rakino Way
Mt. Wellington
Auckland 1060
Telephone 09-2764157
AL
If you have any further questions, please contact your local customer support and service
center.
136
Product Safety Information
Bluetooth Wireless Technology
TI
AL
The meter can utilize Bluetooth wireless
technology to communicate and transfer
information to other devices (e.g., computer or
smartphone).
-C
AF
General Product Information
FI
EN
Bluetooth wireless technology is a form of
radio frequency (RF) technology that operates
in the unlicensed industrial, scientiic, and
medical band at 2.4 to 2.485 GHz. The meter
can only communicate with the devices it is
paired with; therefore, other Bluetooth wireless technology devices cannot access your
personal information on the meter.
CoaguChek INRange User’s Manual
137
Radio Frequency Communication
AL
The device complies with the United States
Federal Communications Commission (FCC)
standards.
EN
TI
The device complies with FCC Part 15 Rules.
Operation of the device is subject to the
following two conditions: (1) this device may
not cause harmful interference, and (2) this
device must accept any interference received,
including interference that may cause undesired operation.
CoaguChek INRange User’s Manual
General Product Information
AF
-C
FI
Compliance with these guidelines means that
under normal, daily circumstances the device
should not affect the operation of other devices. In addition, the device should operate
normally in the presence of other devices.
138
TI
AL
The compliance mark indicates that the product complies with the applicable standard
and establishes a traceable link between the
equipment and the manufacturer, importer
or their agent responsible for compliance
and for placing it on the Australian and New
Zealand market.
The device has been tested and found to
comply with the limits for a Class B digital
device. The device generates, uses, and can
radiate radio frequency energy.
AF
-C
Changes or modiications to the device not
expressly approved by Roche could void the
user’s authority to operate the device.
General Product Information
FI
EN
In the event there is interference from another
device, it is recommended that you increase
distance between meter and that device. You
may also turn off the interfering device. In
addition, you may turn off Bluetooth wireless
technology on the meter.
CoaguChek INRange User’s Manual
139
Electromagnetic Compatibility
CoaguChek INRange User’s Manual
General Product Information
AF
-C
FI
EN
TI
AL
This meter meets the electromagnetic
immunity requirements as per ISO 15197
Annex A. The chosen basis for electrostatic
discharge immunity testing was basic standard IEC 61000-4-2. In addition, it meets the
electromagnetic emissions requirements as
per EN 61326. Its electromagnetic emission is
thus low. Interference from other electrically
driven equipment is not to be expected.
140
-C
AF
General Product Information
FI
EN
TI
AL
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CoaguChek INRange User’s Manual
141
Index
Altitude .......................................................... 16
AL
TI
EN
FI
Electromagnetic interference ............... 16
-C
Battery
compartment cover ..................... 21
insertion ................................... 26–27
low ..................................................... 43
power level ..................................... 22
type ............................................ 21, 26
Bluetooth
pairing ............................................ 100
Button
back .................................................. 20
click................................................... 98
enter.................................................. 20
up/down .......................................... 20
Data transfer ........................................ 64–68
Bluetooth ................................. 67–68
setup ................................................. 99
USB ............................................ 65–66
Display ........................................................... 20
brightness ....................................... 97
test................................................... 116
AF
Cleaning ............................................ 101–110
Code chip
insertion ................................... 34–36
slot ..................................................... 21
CoaguChek INRange User’s Manual
Firmware ........................................... 112, 117
Humidity........................................................ 16
Icons ................................................... 123–124
Information Service................................. 135
142
Quality control ............................................ 17
AL
TI
EN
FI
off....................................................... 33
on ....................................................... 29
Power
AF
Operating conditions ............................... 16
Other (functions) ........................... 111–116
Reminder .................................................... 126
edit/delete ...................................... 84
new.................................................... 80
setting up ................................. 79–84
Reports ................................................... 58–62
embedded ............................... 69–78
exporting to *.csv ......................... 77
list ...................................................... 75
printing ............................................ 76
targets ................................ 62–63, 74
trends ................................. 59–60, 73
Result ............................................................. 49
comment ........................... 50–51, 57
display ....................................... 49, 53
format ............................................... 92
review ........................................ 56–57
-C
Measuring range ....................................... 54
Memory
clearing .......................................... 114
Messages
error ................................................ 130
information ................................... 127
reminder ........................................ 126
warnings........................................ 129
Meter
cleaning ............................... 101–110
overview ................................... 20–21
powering off................................... 33
powering off (automatically) ... 22
powering on ................................... 29
settings .................................. 85–100
Meter log .................................................... 115
CoaguChek INRange User’s Manual
143
AF
Temperature ......................................... 16, 38
Test........................................................... 37–54
blood sample ................... 40, 46–48
performing...................................... 42
preparing ........................................ 41
result display .......................... 49, 53
Test strip
insertion .......................................... 44
Test strip guide ........................................... 20
CoaguChek INRange User’s Manual
port .................................................... 21
FI
EN
TI
AL
USB
-C
Setup .................................................... 85–100
beeper volume .............................. 96
button click .................................... 98
data transfer ........................ 99–100
display brightness........................ 97
initial .......................................... 29–31
language ......................................... 88
result format .................................. 92
set targets ................................ 93–94
settings overview .................. 86–87
time and date ......................... 31, 89
unit ............................................. 33, 91
Symbols
battery .............................................. 22
on packaging and meter 121–122
on the display .................... 123–124
144
AF
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FI
EN
TI
AL
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CoaguChek INRange User’s Manual
D
AF
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FI
EN
TI
AL
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AL
TI
EN
FI
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
www.roche.com
www.coaguchek.com
0 XXXXXXXXXX (01) 2014-XX EN
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AF
ACCU-CHEK, COAGUCHEK and
SOFTCLIX are trademarks of Roche.
0123

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Roche Diagnostics MG10 Blood Coagulation Meter User Manual UserManual

Roche Diagnostics GmbH Blood Coagulation Meter UserManual

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UserManual.pdf

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