Roche CoaguChek XS System Bedienungsanleitung

CoaguChek®XS

System

User Manual

for Self-Testing

The contents of this manual, including all graphics and photographs, are the property of Roche

Diagnostics. No part of this document may be reproduced or transmitted in any form or by any

means, electronic or mechanical, for any purpose, without the express written permission of

Roche Diagnostics.

Roche Diagnostics has made every reasonable effort to ensure that all the information

contained in this manual is correct at the time of printing. However, Roche Diagnostics

reserves the right to make any changes necessary without notice as part of ongoing product

development.

This training manual was created by the Roche Diagnostics Technical Publications department.

Direct questions or concerns regarding the contents of this document to:

Roche Diagnostics

Technical Publications Department

9115 Hague Road

P.O. Box 50457

Indianapolis, IN 46250-0457

USA

Aspects of the CoaguChek XS System (meter and test strips) and its use are covered by one

or more of the following U.S. patents: 6,662,439; 7,073,246; 7,386,937; 7,407,811; 6,881,378;

6,207,000; 7,429,865; 6,645,368; 7,049,131; 7,084,251; 5,625,036. Additional U.S. patents

pending.

COAGUCHEK, ACCU-CHEK and SOFTCLIX are trademarks of Roche. All other trademarks

are the property of their respective owners.

US Order Number: 0 4999045001 (02) 2009-11 USA

Distribution in USA by: Roche Diagnostics, Indianapolis, IN

This document is available electronically at www.poc.roche.com.

Revisions to this document are provided by Roche Diagnostics when necessary. No part of this

document may be reproduced in any form or by any means without prior written consent.

Manual version Revision date Changes

Version 2.0 November 2009 New document

About this Manual ..................................................................... 1

Symbols and Abbreviations ....................................................1

User Resources ........................................................................... 2

Training DVD ................................................................................2

Getting Started.............................................................................2

User Manual .................................................................................2

Test Strip Package Inserts.......................................................3

Lancet Device Package Inserts .............................................3

The CoaguChek XS System.................................................. 4

Anticoagulation Medication....................................................4

Blood-clotting Time....................................................................4

How the System Works ............................................................5

The CoaguChek XS Meter.......................................................6

Operating Conditions ................................................................7

Getting Started............................................................................. 8

Batteries..........................................................................................8

Installing (or Replacing) Batteries........................................9

Meter Setup ............................................................................... 10

Setting the Date and Time ................................................... 11

The Meter’s Display ................................................................ 14

Code Chip ................................................................................... 14

Inserting a New Code Chip.................................................. 15

Integrated Quality Controls.................................................. 16

Table of Contents

Testing a Blood Sample........................................................17

Tips for a Good Fingerstick.................................................. 17

Important Notes About Blood Testing............................. 18

Always ...................................................................................... 18

Never ........................................................................................ 18

Infection Control................................................................... 19

Preparing for a Test ................................................................ 20

Performing a Test..................................................................... 22

Very Low or Very High Test Results................................. 27

Memory..........................................................................................28

Storing Test Results in Memory......................................... 28

Reviewing Stored Test Results ........................................... 28

Erasing Stored Test Results ................................................. 30

Cleaning/Disinfecting the Meter.....................................32

Cleaning/Disinfecting the Exterior .................................... 33

Cleaning/Disinfecting the Test Strip Guide ................... 34

Error Messages..........................................................................37

Other Information.....................................................................45

Product Limitations ................................................................. 45

Product Specifications ........................................................... 45

Support/Services ...................................................................... 46

Symbols........................................................................................ 47

Warranty ........................................................................................50

Symbols and Abbreviations

The test strip insert, the label on the back of the meter,

the User Manual, and other packaging material may

contain the following symbols or abbreviations:

Use by

Batch code/Lot number

In vitro diagnostic medical device

This product fulfills the requirements of

the European Directive 98/79/EC for in vitro

diagnostic medical devices

Catalog 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)

About this Manual

0123

Several resources are available to help you use and

maintain the CoaguChek XS System.

Training DVD

The CoaguChek XS System DVD is for new users of

the CoaguChek XS System. This program will help you

get comfortable with the CoaguChek XS Meter and the

testing procedure.

Getting Started

The Getting Started guide shows you how to perform

your first coagulation test on the CoaguChek XS Meter.

User Manual

This CoaguChek XS System User Manual is a

comprehensive guide to the meter and test strips.

It is designed to provide answers to your questions

about the meter’s operation and use. Read this entire

manual carefully, and refer to it as necessary.

User Resources

Test Strip Package Inserts

Be sure to read the test strip package insert for

important updates and keep the insert from your

current test strip package for future reference.

Lancet Device Package Inserts

Be sure to read the lancet device package insert to

learn how to use the lancet device and for important

updates. Keep the insert from your current lancet

device package for future reference.

The CoaguChek XS System measures blood-clotting

time (Prothrombin Time) for people who are taking

anticoagulation medications such as Coumadin®or

warfarin. The CoaguChek XS System measures blood-

clotting time using blood from the fingertip.

Anticoagulation Medication

Anticoagulation medications, also known as blood

thinners, are prescribed to avoid unwanted clots. Your

blood-clotting time must be monitored to ensure that

your medication dosage is correct.

Blood-clotting Time

The rate at which blood clots is measured in units

called INR. It is very important that you stay within

your target INR range. If your INR is too low, the risk of

blood clots increases. If your INR is too high, the risk

for internal bleeding increases.

Everyone’s INR is different. Your doctor determines

the best INR range for you, depending on why you are

taking anticoagulants and how you react to them. Your

doctor also determines how often your blood should be

tested. Your doctor needs to know your blood-clotting

time in order to successfully treat you.

The CoaguChek XS System

Andere Handbücher für CoaguChek XS System

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