Roche CoaguChek XS System Manuale utente

CoaguChek

®

XS

User’s Manual

Manuale per l’uso

ccxs_user_EN.book Seite 1 Montag, 11. Juli 2005 7:11 19

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

ccxs_user_EN.book Seite 8 Montag, 11. Juli 2005 7:11 19

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.

ccxs_user_EN.book Seite 12 Montag, 11. Juli 2005 7:11 19

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.

ccxs_user_EN.book Seite 13 Montag, 11. Juli 2005 7:11 19

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.

ccxs_user_EN.book Seite 14 Montag, 11. Juli 2005 7:11 19

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

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The CoaguChek XS monitor

17

English

The CoaguChek XS monitor

A Display

Shows results, information,

symbols and results recalled

from memory.

B M (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.

C On/Off button

Press this button to turn the

monitor on or off.

D Measurement chamber

cover

Remove this cover to clean

the test strip guide.

E Test strip guide

Insert the test strip here.

F Battery compartment

cover

Covers the battery compart-

ment (4 1.5 V alkali-manga-

nese batteries type AAA).

G Code chip slot

Insert the code chip here.

H Set button

Press this button to enter or

change the monitor settings.

I Infrared 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

ccxs_user_EN.book Seite 19 Montag, 11. Juli 2005 7:11 19

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.

ccxs_user_EN.book Seite 20 Montag, 11. Juli 2005 7:11 19

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