Roche CoaguChek XS System Bedienungsanleitung

CoaguChek®XS

User’s Manual

Manuel d’utilisation

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

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

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.

English

The CoaguChek XS System

Introduction

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

The CoaguChek XS Meter

The CoaguChek XS meter

.......................................................................... 15

Batteries

............................................................................................................... 16

Starting Up

Inserting the batteries

.................................................................................. 18

Code Chip

Inserting the code chip

................................................................................ 22

Meter Setup

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

Testing a Capillary Blood Sample

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

Getting a good capillary blood sample in a healthcare

setting

.................................................................................................................. 62

Disposal by healthcare professionals

.................................................. 62

Memory

Viewing test results

....................................................................................... 63

Erasing memory

.............................................................................................. 66

Cleaning and Disinfecting the Meter

Recommended cleaning/disinfecting solutions

............................. 70

Cleaning/disinfecting the exterior (meter housing)

..................... 71

Cleaning/disinfecting the test strip guide

......................................... 72

Error Messages

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

English

Display Information and Symbols

Further Information

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

This page intentionally left blank.

Introduction

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

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

Andere Handbücher für CoaguChek XS System

Inhaltsverzeichnis

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