Roche CoaguChek XS System User manual

CoaguChek®XS
User’s Manual
Manuale per l’uso
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On the packaging, on the type plate of the monitor and in the User’s
Manual you may encounter the following symbols and abbreviations
shown here with their meaning:
Use by/Expiry date
Lot number
For in vitro diagnostic use
This product fulfills the requirement of Directive 98/79/EC
on in vitro diagnostic medical devices.
Catalogue number
Please consult instructions for use
Caution (refer to accompanying documents). Please refer
to safety-related notes in the manual accompanying this
instrument.
Manufacturer
Store at
LOT
IVD
0088
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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.
Please note : This manual contains all the information you need to
operate and care for the CoaguChek XS System. Please read this entire
manual carefully
before you use the monitor.
Last update user information: June 2005
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The CoaguChek XS System
4
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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
About this manual 13
Manual format .................................................................................... 13
The CoaguChek XS monitor 16
Monitor guide ..................................................................................... 17
Batteries ................................................................................................ 18
Starting up 19
Inserting the batteries ..................................................................... 20
Code chip 23
Inserting the code chip ................................................................... 24
Monitor setup 26
Settings summary ............................................................................. 27
Setting up the monitor (Set Mode) ............................................ 28
Setting the date format ................................................................... 31
Setting the date ................................................................................. 32
Setting the time format ................................................................... 34
Setting the time ................................................................................. 35
Selecting the unit .............................................................................. 36
Setting the beep tone ...................................................................... 37
Setting the therapeutic range (INR) .......................................... 38
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6
Testing a capillary blood sample 43
Important notes ................................................................................. 44
Getting a good capillary blood sample .................................... 46
Testing by healthcare professionals .......................................... 47
Preparing to test ............................................................................... 48
Performing a test .............................................................................. 49
Disposal by healthcare professionals ....................................... 59
Notes concerning the display of results .................................. 60
Memory 63
Viewing test results ......................................................................... 63
Erasing memory ................................................................................ 66
Cleaning 69
Cleaning the plastic housing ....................................................... 69
Cleaning the test strip guide ........................................................ 70
Cleaning by healthcare professionals ...................................... 72
Error messages 73
Error messages overview ............................................................... 74
Error messages after turning the monitor on ........................ 76
Error messages when preparing to test ................................... 78
Error messages after the code number is confirmed ......... 82
Error messages during or after blood application ............... 84
Error message during infrared downloads ............................. 90
Display information and symbols 92
Further information 95
Ordering ............................................................................................... 95
Product limitations ........................................................................... 95
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7
English
Product specifications 96
Operating conditions and technical data ................................. 96
Sample material ................................................................................. 97
Storage and transport conditions ............................................... 97
Information service ........................................................................... 98
Repairs .................................................................................................. 98
Guarantee 99
Alphabetical index 100
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8
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Introduction
9
English
Introduction
The CoaguChek XS System
The CoaguChek XS System (CoaguChek XS monitor 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 monitor 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 monitor on, insert the test strip, and apply a blood sample. When the
CoaguChek XS monitor is ready for a measurement, the result will be
displayed about 1 minute after application of the sample. After the meas-
urement, the monitor automatically stores the result in memory.
If you have any questions about the CoaguChek XS monitor, please con-
tact your local customer support and service centre. You will find contact
details on page 98.
Please note: Before you use the monitor 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.
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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 thrombo-
plastin and a peptide substrate. When a sample is applied, thromboplas-
tin activates coagulation, which leads to the formation of thrombin. At the
same time the monitor 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 monitor
■ 4 alkali-manganese batteries, 1.5 V, type AAA
■ CoaguChek Softclix lancing device with instructions for use
■ CoaguChek Softclix Lancet XL
■ System carry-case
■ User's Manual
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Introduction
11
English
Operating conditions
To ensure that your CoaguChek XS System functions properly, please
observe the following guidelines:
■ Only use the monitor at a room temperature between 18°C and 32°C.
■ Only use the monitor at a relative humidity between 10% and 85%.
■ When testing, place the monitor on a level, vibration-free surface or
hold it so it is roughly horizontal.
■ If the monitor is to remain unused for a longer period of time, keep it
in the carry-case supplied.
■ Use the monitor only up to a maximum altitude of 4300 metres.
Electromagnetic interference
Strong electromagnetic fields may interfere with the proper
operation of the monitor. Do not use the monitor near strong
electromagnetic fields.
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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
monitor 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.
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About this manual
13
English
About this manual
Manual format
The layout of this User’s Manual has been specially designed to help you
locate the most important information quickly and easily. Where illustra-
tions are used, they always appear on the left side of the page with the
accompanying explanation text on the right.
All instructions that require you to actively do something as well as
especially important information appear on a blue background.
This symbol draws attention to the possible risk of sustaining
injury or of damaging your health.
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About this manual
14
Example:
This column contains an illustra-
tion.
This column states what you
should do at this point.
1 Press the On/Off button.
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About this manual
15
English
Example:
This column contains an illustra-
tion of the display screen.
This column contains information
linked to the display screen.
Each time you turn on the moni-
tor, it runs a full display check,
briefly showing all the symbols
that might be displayed.
To prevent reading errors, check
regularly that all segments of the
symbols are showing.
code
pm
am
mem
error
set
%Q
Sec
QC C
INR
28:88 88 -- 8888
888
18:88
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The CoaguChek XS monitor
16
The CoaguChek XS monitor
G
D
A
B
E
C
F
I
H
H
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The CoaguChek XS monitor
17
English
The CoaguChek XS monitor
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 monitor settings.
You also press this button to
confirm the code number dis-
played before each test.
COn/Off button
Press this button to turn the
monitor on or off.
DMeasurement chamber
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
Press this button to enter or
change the monitor settings.
IInfrared window
You can transfer data stored
in memory via this infrared
interface.
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The CoaguChek XS monitor
18
Batteries
To save power, the CoaguChek XS monitor automatically turns itself off
after 3 minutes unless a button has been pressed or a new test strip has
been inserted. When the monitor turns itself off, all results obtained up to
that point remain in memory. The monitor 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.
Do not throw batteries onto a fire. They may explode!
When replacing the batteries you must insert the new batteries within
one minute of removing the old ones, to keep the date and time set-
tings. If you take longer than this, you must re-enter the date and time.
Use only alkali-manganese batteries type AAA.
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Starting up
19
English
Starting up
Before using the monitor 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
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Starting up
20
Inserting the batteries
1 With the monitor turned off,
turn it over.
2 Gently press the tab on the
battery compartment cover
towards the centre of the
monitor and lift off the cover.
3 Insert the four batteries in the
battery compartment as indi-
cated. Pay attention to the
positions of “+” (top of bat-
tery) and “-” (flat end). Once
you have inserted the batter-
ies, the monitor 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.
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