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
4
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.

5
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

6
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

7
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

Introduction
11
English
Operating conditions
To ensure that your CoaguChek XS System functions properly, please
observe the following guidelines:
■Only use the meter at a room 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.
■If the meter is to remain unused for a longer period of time, keep it in
the carry-case supplied.
■Use the meter only up to a maximum altitude of 4300 metres.
Electromagnetic interference
Strong electromagnetic fields may interfere with the
proper operation of the meter. Do not use the meter near
strong electromagnetic fields.

Introduction
12
Quality control
The CoaguChek XS System has a number of inbuilt quality-control
functions such as:
■A check of the electronic components and functions every time the
meter is turned on.
■A check of the test strip temperature while a test is in progress.
■A check of the expiry date and lot information on the test strip.
■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.

Important Safety Instructions and Additional Information
13
English
Important Safety Instructions and
Additional Information
This section explains how safety-related messages and information
related to the proper handling of the system are presented in the
CoaguChek XS User’s Manual. Read these passages carefully.
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
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.
NOTICE Indicates a hazardous situation which, if not avoided,
may result in damage to the system.
■Important information that is not safety relevant is presented against
a colored background (without a symbol). Here you will find addi-
tional information on correct use of the meter or useful tips.
■Instructions that require you to actively do something also appear
on a blue background.

The CoaguChek XS Meter
14
The CoaguChek XS Meter
G
D
A
B
E
C
F
I
H
H

The CoaguChek XS Meter
15
English
The CoaguChek XS meter
ADisplay
Shows results, information,
symbols and results recalled
from memory.
BM (memory) button
Press this button to recall
results from memory and to
change the meter settings.
You also press this button
to confirm the code number
displayed before each test.
COn/Off button
Press this button to turn the
meter on or off.
DTest strip guide cover
Remove this cover to clean
the test strip guide.
ETest strip guide
Insert the test strip here.
FBattery compartment
cover
Covers the battery compart-
ment (4 1.5 V alkali-manga-
nese batteries type AAA).
GCode chip slot
Insert the code chip here.
HSet button
The Set button is located on
the left side of the meter.
Press this button to enter or
change the meter settings.
IInfrared window
You can transfer data stored
in memory via this infrared
interface.

The CoaguChek XS Meter
16
Batteries
To save power, the CoaguChek XS meter automatically turns itself off
after 3 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. The meter briefly indicates the battery
power level when it is turned on. The battery symbol is divided into four
segments which correspond to the battery power level.
Results are retained in memory together with the date and time even
when no batteries are inserted. All other settings are retained, too.
Think of the environment. Dispose of used batteries sensibly.
When replacing the batteries you must insert the new batteries within
one minute 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. Use only
alkali-manganese batteries type AAA.
The CoaguChek XS meter is shipped with high quality batteries. Since
quality varies among different battery brands, Roche recommends
replacing your used batteries with new batteries of a similar high quality
and not mixing different brands. Do not mix new and already used
batteries.
Please be aware that battery life may be affected by many factors, such
as battery quality, operating conditions (e.g. ambient temperature),
frequency of use, and test duration.
WARNING
Do not throw batteries onto a fire. They may explode!

Starting Up
17
English
Starting Up
Before using the meter for the first time, carry out the following steps:
1 Insert the batteries
2 Insert the code chip (you can also carry out this step immediately
before testing)
3 Set the current date and time
4 Select the coagulation unit in which the results are to be displayed

Starting Up
18
Inserting the batteries
1With the meter turned off,
turn it over.
2Gently press the tab on the
battery compartment cover
towards the centre of the
meter and lift off the cover.
3Insert the four batteries in
the battery compartment as
indicated. Pay attention to
the positions of “+” (top of
battery) and “–” (flat end).
Once you have inserted the
batteries, the meter turns
itself on after about
5 seconds.
Only use alkaline manganese
batteries (1.5 V, AAA). Think
of the environment. Dispose
of used batteries sensibly.

Starting Up
19
English
4Close the battery compart-
ment.
5Check that all of the display
symbols are displayed prop-
erly. Results may be misread
if a segment is missing.
Tip
If the display check when you
turn on the meter is too quick,
you can put it “on hold” by
pressing and holding down
the On/Off button the
next time you turn the meter
on.
For as long as you keep the
button pressed, the display
remains frozen.
code
pm
am
mem
error
set
%Q
Sec
INR
28:88 88 -- 8888
888
QC C
18:88

Starting Up
20
6On the next screen that
appears check that the date
and time are correctly set.
If these have not yet been set
or if they have been lost
(because the batteries were
removed from the meter for
more than one minute), your
CoaguChek XS meter now
automatically enters Set
Mode. After you have set the
date and time, the meter
enters Test Mode. If you wish
to enter any further settings,
turn to the chapter Setting up
the meter (Set Mode) starting
on page 26.
7Turn the meter off again
when the settings are
correctly entered.
11:23 11 -- 0412
set
00 -- 1231