Roche CoaguChek XS Plus User manual

CoaguChek XS Plus
®
POINT OF CARE
TESTING
Operator’s Manual

On the packaging, on the type plate of the instrument and in the manual you may encounter the
following symbols, shown here with their meaning:
Use by
Lot number
For in vitro diagnostic use
This product fulfils the requirements 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

The CoaguChek XS Plus System
3
The CoaguChek XS Plus System
The CoaguChek XS Plus System is used for quantitative monitoring of coagulation values
(common terms: prothrombin time, PT, Quick value) with CoaguChek XS PT test strips.
Please note: This manual contains all the information you need to operate and care for the
CoaguChek XS Plus System. Please read this entire manual carefully before you use the monitor.
Last update: 2007-04

The CoaguChek XS Plus System
4

5
The CoaguChek XS Plus System 3
Introduction 7
The CoaguChek XS Plus System ................................................................................................. 7
Test principle ...................................................................................................................................... 8
Contents of the pack ....................................................................................................................... 8
Safety information ............................................................................................................................. 9
Operating conditions .................................................................................................................... 10
Quality control ................................................................................................................................. 11
About this manual 12
Manual format ................................................................................................................................. 12
The CoaguChek XS Plus monitor 14
Monitor elements overview ........................................................................................................ 15
Power supply ................................................................................................................................... 16
Operating the instrument 17
Inserting the batteries .................................................................................................................. 18
Monitor setup 20
Display field and icons ................................................................................................................. 21
Settings overview ........................................................................................................................... 24
Screen setup ..................................................................................................................................... 28
Contrast ............................................................................................................................................. 28
Units .................................................................................................................................................... 30
Language .......................................................................................................................................... 32
Setting the date .............................................................................................................................. 34
Setting the time .............................................................................................................................. 36
Setting the display formats for date and time ..................................................................... 38
Options setup .................................................................................................................................... 40
Sort ...................................................................................................................................................... 40
Beeper ................................................................................................................................................ 42
Auto Off ............................................................................................................................................. 45
Computer .......................................................................................................................................... 47
ID Setup ............................................................................................................................................. 49
Administrator ................................................................................................................................... 50
Operator ............................................................................................................................................ 56
Patient ................................................................................................................................................ 57
Block setup ........................................................................................................................................ 59
Operator block ................................................................................................................................ 60
QC (Quality Control) block ......................................................................................................... 63

6
Testing a capillary blood sample 65
Important notes ............................................................................................................................... 65
Getting a good capillary blood sample ................................................................................... 66
Getting a good test with venous whole blood ..................................................................... 67
Preparing to test .............................................................................................................................. 68
Code chip .......................................................................................................................................... 69
Inserting the code chip ................................................................................................................ 69
Switching on the monitor ............................................................................................................ 71
Performing a test ............................................................................................................................ 73
Quality control 83
Preparing to run a quality control check ............................................................................... 84
Performing a quality control check .......................................................................................... 86
Memory 93
Viewing test results ........................................................................................................................ 93
Display Patient Result memory .................................................................................................. 95
Display Quality Control memory ............................................................................................... 96
Data transfer ..................................................................................................................................... 96
Cleaning 97
Cleaning the plastic housing ...................................................................................................... 97
Cleaning the test strip guide ...................................................................................................... 98
Error messages 101
Error messages overview .......................................................................................................... 101
Error messages after turning the monitor on .................................................................... 104
Error messages when preparing to test .............................................................................. 105
Error messages during or after blood application .......................................................... 107
Other error messages ................................................................................................................ 109
Further information 113
Ordering .......................................................................................................................................... 113
Product limitations ...................................................................................................................... 113
Disposing of the instrument .................................................................................................... 113
Information about the software license .............................................................................. 113
Product specifications 121
Operating conditions and technical data ........................................................................... 121
Sample material ........................................................................................................................... 121
Storage and transport conditions .......................................................................................... 122
Information service ..................................................................................................................... 122
Repairs ............................................................................................................................................. 122
Warranty 123
Alphabetical Index 125

Introduction
7
Introduction
The CoaguChek XS Plus System
The CoaguChek XS Plus System (the CoaguChek XS Plus monitor, CoaguChek XS PT control
solution 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 Plus System makes coagulation testing easy. The CoaguChek XS Plus monitor
guides you through the test step by step using the icons and instructions in the display. The code
chip accompanying the test strips contains lot-specific information about these test strips includ-
ing 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 Plus monitor is ready for a measurement, the result will
be displayed about 1 minute after application of the sample. After the measurement, the monitor
automatically stores the result in memory.
For professional use, the CoaguChek XS Plus System also includes user management with
security features, such as the QC (quality control) block.
If you have any questions about the CoaguChek XS Plus monitor, please contact your local
customer support and service centre. You will find contact details on page 122.
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 measu-
rements properly.
Each time you replace the batteries you need to check (and, if necessary adjust) the date
and time.

Introduction
8
Test principle
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 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 coag-
ulation units (INR, %Quick, seconds) and the result is displayed.
Contents of the pack
■ CoaguChek XS Plus monitor
■ Power supply unit
■ Operator’s manual in English
■ CD-ROM with Operator’s Manual in other languages

Introduction
9
Safety information
Operator qualification
Only trained medical personnel must operate the CoaguChek XS Plus System.
Operators must also have received comprehensive instruction in the use, quality
control and care of the CoaguChek XS Plus System.
Protection against infection
There is a potential risk of infection. Medical staff using the CoaguChek XS Plus
System to perform tests in more than one patient must be aware that any object
coming into contact with human blood is a potential source of infection.
■Use gloves.
■Use a separate lancet and lancing device for each person.
■Dispose of used lancets and test strips in a sturdy sharps container with lid.
■Follow all health and safety regulations applicable to your laboratory or
pratice.

Introduction
10
Operating conditions
To ensure that your CoaguChek XS Plus 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 operating the monitor using the power supply unit, use only mains voltage of 100 V
to 240 V (± 10%) , 50/60 Hz.
■ A touchscreen makes the monitor easier to operate. To use the touchscreen, simply use
your finger (even when wearing gloves) or special pens designed for use with handheld
devices. Pointed or sharp objects can damage the touchscreen.
■ When testing, place the monitor on a level, vibration-free surface or hold it so it is roughly
horizontal.
Electromagnetic interference
Strong electromagnetic fields may interfere with the proper operation of the
monitor. Do not use the monitor near strong electromagnetic fields.

Introduction
11
Quality control
The CoaguChek XS Plus 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 carried out by the code
chip.
■ 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.
Note: As an option, you still measure liquid controls if you prefer, or if required by your local
regulations. You have the option of defining the conditions in the meter for performing a quality
control test using liquid controls (e.g., when changing test strip lots or after certain intervals).
These quality controls must then be completed successfully before regular patient samples can
be measured. For settings with multiple operators, quality controls can also be set up on an
operator-specific basis.

About this manual
12
About this manual
Manual format
The layout of this Operator’s Manual has been specially designed to help you locate the most
important information quickly and easily.
Where illustrations are used, they always appear on the left side of the page with the accompany-
ing explanation on the right.
All instructions that require you to actively do something as well as very important information
appear on a blue background.
This symbol draws attention to the possible risk of injury or of damage to your health.
Example 1:
The left column contains an illustration of the
display screen.
The right column states what you should do at
this point.
1 Touch the
PATIENT TEST button.

About this manual
13
Example 2:
This column contains an illustration of the dis-
play screen.
This column contains information linked to the
display screen.
The main menu of the CoaguChek XS Plus
System contains buttons for the following
functions:
■PATIENT TEST for performing a test
■QC TEST for performing a quality
control test
■MEMORY to recall results from the
memory
■SETUP to edit settings
MAIN MENU
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MEMORY
SETUP
QC TEST
PATIENT TEST

The CoaguChek XS Plus monitor
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The CoaguChek XS Plus monitor
A
B
C
D E
G H
F
I
J

The CoaguChek XS Plus monitor
15
Monitor elements overview
ATouchscreen
Shows results, information, icons and
results recalled from memory. To view any
of them, simply touch the button on this
screen.
BOn/Off button
Press this button to turn the monitor on or
off.
CMeasurement chamber cover
Remove this cover to clean the test strip
guide.
DTest strip guide
Insert the test strip here.
EBattery compartment cover
Covers the battery compartment (4 1.5 V
alkali-manganese batteries type AA)
or a rechargeable battery pack (REF
04805640).
FTab for battery compartment cover
GCode chip slot
Insert the code chip here.
HConnection socket for power supply
unit
Here you can plug in the power supply
unit provided.
IInfrared interface
JCharging terminals

The CoaguChek XS Plus monitor
16
Power supply
The CoaguChek XS Plus monitor can be operated either with the power supply unit provided or
with four alkali-manganese batteries (type AA) or a special rechargeable battery pack (REF
04805640). It is advisable to insert the batteries or optional rechargeable battery pack (REF
04805640) even when you use the power supply unit. This ensures that you will not lose the date
and time settings (if power goes out or if the local power supply is shut off).
To save power, the CoaguChek XS Plus monitor automatically turns itself off after a period of time
that can be programmed 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 and the
settings are retained (refer to
Auto Off in the chapter entitled Options setup on page 45).
Results are retained in memory together with the date and time even when no batteries are
inserted. All other settings are retained as well.
Think of the environment. Dispose of used batteries according to your local regulations.
During battery operation, the meter always
displays the battery power level. The battery
icon is divided into four segments which
correspond to the battery power level.
When replacing the batteries you must insert
the new batteries within ten (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. Use only
alkali-manganese batteries type AA.
To make certain you do not lose your date and
time settings, connect the power supply unit
while you change the batteries.
Do not throw batteries onto a fire. They may explode!
MAIN MENU
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MEMORY
SETUP
QC TEST
PATIENT TEST

Operating the instrument
17
Operating the instrument
Before using the monitor for the first time, carry out the following steps:
1 Insert batteries* and/or connect the power supply unit
2 Set the current date and time
3 Enter the settings of choice (language, unit of measure, user administration if applicable,
etc.)
* Alternatively, a special rechargeable battery pack may be used. This should be ordered
separately from Roche Diagnostics. To recharge, connect the power supply unit to the
CoaguChek XS Plus instrument.

Operating the instrument
18
Inserting the batteries
1 With the monitor turned off, hold it so that
the tab on the battery compartment cover
points upward.
2 Gently press the tab on the battery com-
partment cover towards the centre of the
monitor and lift the cover to the side.
3 Slide the battery compartment cover
upward and remove it.

Operating the instrument
19
4 Insert the four batteries in the battery
compartment as indicated.
Pay attention to the positions of “+” (top of
battery) and “-” (flat end).
Use only alkali-manganese batteries (1.5
V, AA). Think of the environment. Dispose
of used batteries according to your local
regulations.
5 Close the battery compartment.
The monitor turns itself on after the batter-
ies have been inserted. If the settings for
date and time have not yet been set or if
they have been lost (because the batteries
were removed from the monitor for more
than ten minutes), your CoaguChek XS
Plus monitor now automatically enters
Setup mode. You must enter the date and
time, then the monitor automatically
moves on to the main menu.

Monitor setup
20
Monitor setup
Please note: If you have not set the date (after turning on for the first time or because the
batteries were removed from the monitor for more than ten minutes), you cannot perform a
test. In that case turning on the monitor takes you immediately to the Setup mode, where you
must set the date and time (see page 34 and following).
The monitor automatically moves to the main menu, where you can start a test or enter more
settings.
You can call up any displayed function by
touching the button for it with your finger (or
a special pen for this purpose).
If the monitor did not automatically enter the
Setup mode (e.g., after the batteries were
replaced), you can call up the Setup menu
from the main menu.
1 Touch the SETUP button to call up the
monitor settings.
2 Select the group of settings of choice (see
the summary starting on page 24).
The following buttons and icons are used in
the
Setup menus.
MAIN MENU
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MEMORY
SETUP
QC TEST
PATIENT TEST
SETUP
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ID SETUP
BLOCK
OPTIONS
SCREEN