Roche CoaguChek XS System User manual

CoaguChek®XS
User’s Manual
Manuel d’utilisation

2
On the packaging and on the type plate of the meter you may encounter
the following symbols and abbreviations shown here with their meaning:
Use by
Batch code/ Lot number
In vitro diagnostic medical device
This product fulfills 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 fulfills the Canadian and U.S. safety require-
ments (UL LISTED, in accordance with UL 61010A-1:02
and CAN/CSA-C22.2 No. 61010-1-04)
LOT
IVD

The CoaguChek XS System
3
English
The CoaguChek XS System
The CoaguChek XS System is used for quantitative monitoring of coagu-
lation values (common terms: thromboplastin time, PT, Quick value) with
CoaguChek XS PT test strips.
Self-monitoring and self-adjustment of oral coagulation therapy using
coagulation values determined with the aid of the CoaguChek XS System
may only be undertaken after consultation with your doctor and compre-
hensive instruction by a qualified healthcare professional. Your pharma-
cist / 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.
Last update user information: 2011-04
WARNING
The CoaguChek XS Softclix lancing device is intended
only for patient self-monitoring by a single person. It
must not be used to collect blood in a multi-patient
setting as it does not incorporate any features to
guard against cross-infection.
This manual contains all the information you need to operate and care
for the CoaguChek XS System. Please read this entire manual care-
fully before you use the meter.
Healthcare professionals: In addition, observe carefully the pre-
cautions and procedures applying to professional use provided in the
relevant sections of this manual.

The CoaguChek XS System
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Revision History
Manual version Revision date Changes
1.0 2009-09 New document
2.0 2010-03 Cleaning/disinfectionrecommendations
and presentation safety messages
revised. Screens updated.
3.0 2011-04 Change in lancing device. Memory: 300
test results with date and time. Screens
updated.

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English
The CoaguChek XS System 3
Introduction 9
The CoaguChek XS System ......................................................................... 9
Test principle ..................................................................................................... 10
Contents of the pack ..................................................................................... 10
Operating conditions .................................................................................... 11
Quality control .................................................................................................. 12
Important Safety Instructions and Additional Information 13
The CoaguChek XS Meter 14
The CoaguChek XS meter .......................................................................... 15
Batteries ............................................................................................................... 16
Starting Up 17
Inserting the batteries .................................................................................. 18
Code Chip 21
Inserting the code chip ................................................................................ 22
Meter Setup 24
Settings summary ........................................................................................... 25
Setting up the meter (Set Mode) ............................................................ 26
Setting the date format ................................................................................ 29
Setting the date ............................................................................................... 30
Setting the time format ................................................................................ 32
Setting the time ............................................................................................... 33
Selecting the unit ............................................................................................ 34
Setting the beep tone ................................................................................... 35
Setting the therapeutic range (INR) ...................................................... 36

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Testing a Capillary Blood Sample
41
Important notes ............................................................................................... 42
Getting a good capillary blood sample ............................................... 44
Preparing to test ............................................................................................. 45
Performing a test ............................................................................................ 46
Notes concerning the results display .................................................. 57
Testing by Healthcare Professionals 61
Getting a good capillary blood sample in a healthcare
setting
.................................................................................................................. 62
Disposal by healthcare professionals .................................................. 62
Memory 63
Viewing test results ....................................................................................... 63
Erasing memory .............................................................................................. 66
Cleaning and Disinfecting the Meter 69
Recommended cleaning/disinfecting solutions ............................. 70
Cleaning/disinfecting the exterior (meter housing) ..................... 71
Cleaning/disinfecting the test strip guide ......................................... 72
Error Messages 75
Error messages overview ........................................................................... 76
Error messages after turning the meter on ...................................... 78
Error messages when preparing to test ............................................ 80
Error messages after the code number was confirmed ............. 84
Error messages during or after blood application ........................ 86
Error message during infrared downloads ....................................... 94

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English
Display Information and Symbols 96
Further Information 99
Ordering .............................................................................................................. 99
Product limitations ......................................................................................... 99
Product Specifications 100
Operating conditions and technical data ........................................ 100
Sample material ............................................................................................ 101
Storage and transport conditions ........................................................ 101
Disposal of the CoaguChek XS meter ............................................... 102
Disposal of used batteries ....................................................................... 102
Information service ..................................................................................... 103
Repairs .............................................................................................................. 103
Guarantee 104
Alphabetical Index 105

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Introduction
9
English
Introduction
The CoaguChek XS System
The CoaguChek XS System (CoaguChek XS meter and CoaguChek XS PT
test strips) quantitatively determines prothrombin time (PT/Quick value/
INR) using capillary blood from a fingertip or untreated venous whole
blood. The CoaguChek XS System makes coagulation testing easy.
The CoaguChek XS meter guides you through the test step by step
using the symbols in the display.
The code chip accompanying the test
strips contains lot-specific 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. When the
CoaguChek XS meter is ready for a measurement, the result will be
displayed about 1 minute after application of the sample. After the
measurement, the meter automatically stores the result in memory.
If you have any questions about the CoaguChek XS meter, please contact
your local customer support and service centre. You will find contact
details on page 103.
Please note: Before you use the meter for the first time (i.e. after you
have first inserted the batteries), you must set the date and time correctly
to allow you to carry out measurements properly. Each time you replace
the batteries you need to check (and, if necessary adjust) the date and
time.

Introduction
10
Test principle
The CoaguChek XS PT test strip contains a lyophilized reagent (reagent
in dried form). The reactive components of this reagent consist of throm-
boplastin and a peptide substrate. When a sample is applied, thrombo-
plastin activates coagulation, which leads to the formation of thrombin.
At the same time the meter starts to measure the time. The enzyme
thrombin cleaves the peptide substrate, generating an electrochemical
signal. Depending on the time elapsed when it first appears, this signal
is then converted by means of an algorithm into customary coagulation
units (INR, %Quick, seconds) and the result is displayed.
Contents of the pack
■CoaguChek XS meter
■4 alkali-manganese batteries, 1.5 V, type AAA
■CoaguChek XS Softclix lancing device with instructions for use
■CoaguChek Softclix Lancet
■System carry-case
■User's Manual