Roche CoaguChek INRange Mode d'emploi

CoaguChek

®

INRange

User’s Manual

Manuel d’utilisation

2

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mechanical, for any purpose, without the express written permission of Roche Diagnostics. Roche

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changes necessary without notice as part of ongoing product development.

Please send questions or comments about this manual to your local Roche representative.

COAGUCHEK and SOFTCLIX are trademarks of Roche.

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certification marks of the Continua Health Alliance. CONTINUA is a registered trademark in some, but

not all countries this product is distributed.

The Bluetooth

®

word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any

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Revision History

Version Date Content

1.0 2016-03 New document

2.0 2018-03 Update, new Firmware version 01.04.xx; added information on

encryption key, updated target range setting section, updated sec-

tion about recommended cleaning/disinfection agents, minor edito-

rial revisions

CoaguChek INRange User’s Manual

3

What is new in publication version 2.0?

SW01.04.xx ...................................................................................................................................................................... 9

Handling changes ........................................................................................................................................................9

Editorial revisions ......................................................................................................................................................... 9

Introduction

Before you start ...........................................................................................................................................................................11

Intended use ................................................................................................................................................................11

PT time ............................................................................................................................................................................12

Self-testing ....................................................................................................................................................................12

The CoaguChek INRange System ........................................................................................................................................14

Test principle ................................................................................................................................................................16

Operating conditions .................................................................................................................................................18

Quality control .............................................................................................................................................................19

Important safety instructions and additional information ...........................................................................................20

The CoaguChek INRange Meter ..........................................................................................................................................22

Overview of the meter elements ...........................................................................................................................22

Batteries .........................................................................................................................................................................24

Starting Up

Inserting the batteries ...............................................................................................................................................28

Initially setting up the meter ...................................................................................................................................31

Code chip ......................................................................................................................................................................................36

Inserting the code chip ............................................................................................................................................37

4

CoaguChek INRange User’s Manual

4

Testing a Capillary Blood Sample

Important notes ...........................................................................................................................................................40

Getting a good capillary blood sample ..............................................................................................................42

Preparing to test .........................................................................................................................................................43

Performing a test ........................................................................................................................................................44

Notes concerning the results display .................................................................................................................55

Reviewing and Handling Data

Reviewing test results ...............................................................................................................................................................58

Displaying reports on the meter ...........................................................................................................................................60

Displaying a Trend report ........................................................................................................................................61

Displaying a Target report ......................................................................................................................................64

Transferring data ........................................................................................................................................................................66

Data transfer via USB ...............................................................................................................................................67

Data transfer via Bluetooth .....................................................................................................................................69

Displaying reports on a computer ........................................................................................................................................71

Security settings in the Internet browser ..........................................................................................................73

Virus scanner ...............................................................................................................................................................73

Reports overview ........................................................................................................................................................74

Time period ...................................................................................................................................................................75

Trend graph ..................................................................................................................................................................75

Target range display ..................................................................................................................................................76

Target graph .................................................................................................................................................................76

List of results ................................................................................................................................................................77

Printing reports ............................................................................................................................................................78

Using data in external applications .....................................................................................................................79

CoaguChek INRange User’s Manual

5

Reminders and Meter Settings

Setting up reminders .................................................................................................................................................................81

New reminder ..............................................................................................................................................................82

Editing or deleting a reminder ...............................................................................................................................86

Meter settings ..............................................................................................................................................................................87

Settings overview ........................................................................................................................................................88

Language .......................................................................................................................................................................90

Time & Date ..................................................................................................................................................................91

Units ................................................................................................................................................................................93

Result Format ...............................................................................................................................................................94

Set Targets ....................................................................................................................................................................95

Beeper Volume ............................................................................................................................................................98

Display Brightness .....................................................................................................................................................99

Button Click ............................................................................................................................................................... 100

Data Transfer ............................................................................................................................................................ 101

Cleaning and Disinfecting the Meter and the Lancing Device

Overview ..................................................................................................................................................................... 103

What is the difference between cleaning and disinfecting? ................................................................... 104

When to clean and disinfect the meter and the lancing device ............................................................ 104

Recommended cleaning/disinfection agents ............................................................................................... 105

Cleaning the meter housing ................................................................................................................................ 106

Cleaning the test strip guide ............................................................................................................................... 107

Cleaning and Disinfecting the Lancing Device .......................................................................................................... 110

When to clean and disinfect the lancing device ......................................................................................... 110

What to clean and to disinfect ........................................................................................................................... 111

How to clean and disinfect the lancing device ............................................................................................ 111

6

CoaguChek INRange User’s Manual

6

Other Functions and Troubleshooting

Other functions ......................................................................................................................................................................... 113

About (manufacturing information and data encryption key) ............................................................... 114

Clear Memory ........................................................................................................................................................... 115

Meter Log ................................................................................................................................................................... 117

Display Test ............................................................................................................................................................... 118

Firmware Update ..................................................................................................................................................... 119

Troubleshooting ....................................................................................................................................................................... 121

Errors and unusual behavior without error messages .............................................................................. 122

Symbols, Icons, Messages

Symbols on packaging and meter .................................................................................................................................... 123

Icons on the display ................................................................................................................................................................ 125

Messages .................................................................................................................................................................................... 127

Reminders .................................................................................................................................................................. 128

Information ................................................................................................................................................................. 130

Maintenance ............................................................................................................................................................. 131

Warnings ..................................................................................................................................................................... 132

Error messages ......................................................................................................................................................... 133

CoaguChek INRange User’s Manual

7

General Product Information

Ordering ...................................................................................................................................................................... 135

Product limitations .................................................................................................................................................. 135

Operating conditions and technical data ....................................................................................................... 136

Sample material ....................................................................................................................................................... 137

Storage and transport conditions ...................................................................................................................... 137

Disposal of the CoaguChek INRange meter ................................................................................................. 138

For healthcare professionals ............................................................................................................................... 139

Disposal of used batteries .................................................................................................................................... 139

Repairs ......................................................................................................................................................................... 139

Information service ................................................................................................................................................. 140

Product Safety Information .................................................................................................................................................. 141

Bluetooth Wireless Technology .......................................................................................................................... 141

Radio Frequency Communication ..................................................................................................................... 142

Electromagnetic Compatibility ............................................................................................................................ 143

Index

8

CoaguChek INRange User’s Manual

8

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What is new in publication version 2.0?

CoaguChek INRange User’s Manual

9

What is new in publication version 2.0?

This section provides an overview of all major

changes from User’s Manual version 1 to version

2. Deletions or minor corrections are not listed.

SW01.04.xx • Updated information on target range setup.

See page 95.

• Updated information on encoded 2D encryp-

tion key

. See page 114.

• Added 365 days scaling in the embedded

repor

ts screen.

10

CoaguChek INRange User’s Manual

What is new in publication version 2.0?

10

Handling changes • Updated information about allowed time

without batteries. See page 25 and 28.

• Changed description of blood application to

the test strip. See page

49.

• Updated information about recommended

cleaning and disinfection agents

. See

page 105.

Editorial revisions • Updated image of test strip container.

• Minor editorial revisions.

Introduction

CoaguChek INRange User’s Manual

11

Introduction

Before you start

Intended use The CoaguChek

®

INRange system, consisting of

the CoaguChek INRange meter and the

CoaguChek XS

®

PT Test PST test strip, is

intended for the determination of prothrombin

time (PT) in fresh capillary blood. It is intended

for use by properly selected and appropriately

trained patients and their respective caregivers.

The prothrombin time (PT) test is a general

coagulation test to monitor Vitamin K Antagonist

therapy.

The CoaguChek INRange system is intended for

single patient self-testing only. It is not intended

for use in a professional setting.

12

CoaguChek INRange User’s Manual

Introduction

12

PT time A PT test is often called an INR test. The Inter-

national Normalized Ratio (INR) is a way of

standardizing the results of prothrombin time

tests because there are different test methods.

INR enables you and your doctor to understand

your coagulation results even when they come

from different labs using different test methods.

Prothrombin time can also be expressed as

%Quick or in seconds.

Self-testing If you self-test, you can adjust your medication

dose yourself. However, you need to discuss your

therapy model with your healthcare professional

first. Self-testing is not a substitute for regular

visits to your doctor.

Depending on the training you have received

and the instructions from your healthcare pro-

fessional, you might communicate your results to

a healthcare professional or clinic to receive the

appropriate dose adjustment. Or you may be

able to adjust your medication independently

according to a pre-determined dose-INR

schedule developed for you by your doctor.

Introduction

CoaguChek INRange User’s Manual

13

Your pharmacist/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.

Self-monitoring and self-adjustment of oral

anticoagulation therapy using coagulation

values determined with the CoaguChek

INRange system may only be undertaken after

consultation with your doctor and comprehen-

sive instruction by a qualified healthcare

professional.

This manual contains all the information you

need to operate and care for the CoaguChek

INRange System. Please read this entire

manual carefully before you use the meter.

14

CoaguChek INRange User’s Manual

Introduction

14

The CoaguChek INRange System

The CoaguChek INRange System makes

coagulation testing easy. The graphical user

interface of the CoaguChek INRange meter

guides you through the test step by step. The

code chip accompanying the test strips contains

strip lot-specific information 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. The CoaguChek

INRange meter measures your coagulation time

and displays the result. After the test is com-

pleted, the meter automatically saves the result

to memory.

Introduction

CoaguChek INRange User’s Manual

15

If you have any questions about the CoaguChek

INRange meter, please contact your local cus-

tomer support and service center. You will find

contact details on page 140.

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 cor-

rectly 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.

Note on screenshots:

The test results and software and hardware

information shown in the screenshots in this

manual are for illustration purposes only. The

information displayed on your meter may differ.

16

CoaguChek INRange User’s Manual

Introduction

16

Test principle The CoaguChek XS PT Test PST test strip con-

tains a lyophilized reagent (reagent in dried

form). The reactive components of this reagent

consist of thromboplastin and a peptide sub-

strate. When a sample is applied, thromboplastin

activates coagulation, which leads to the forma-

tion 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 cus-

tomary coagulation units (INR, %Quick, seconds)

and the result is displayed.

Introduction

CoaguChek INRange User’s Manual

17

Contents of the pack

• CoaguChek INRange meter

• 4 alkaline batteries, 1.5 V, type AAA (LR03)

1

• USB cable

• CoaguChek XS Softclix lancing device with

instructions for use

• CoaguChek Softclix Lancet

• System carry case (not shown here)

• User’s Manual (this document)

• Quick Reference Guide (not shown here)

1 Also available as “alkaline-manganese dioxide batteries”

18

CoaguChek INRange User’s Manual

Introduction

18

Operating conditions To ensure that your CoaguChek INRange System

functions properly, please observe the following

guidelines:

• Only use the meter at a temperature between

15 °C and 32 °C

.

• Only use the meter at a relative humidity

betw

een 10% and 85%.

• When testing, place the meter on a level,

vibra

tion-free surface or hold it so that it is

roughly horizontal.

• If the meter is to remain unused for a longer

period of time, keep it in the carr

y-case

supplied.

• Use the meter only up to a maximum altitude

of 4000 meters

.

Electromagnetic interference

Strong electromagnetic fields may interfere with

the proper operation of the meter. Do not use the

meter near strong electromagnetic fields.

Introduction

CoaguChek INRange User’s Manual

19

Quality control The CoaguChek INRange System has a number

of inbuilt quality control functions such as:

A check of the electronic components and func-

tions every time the meter 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 tests and system

checks using control test solutions (that you may

be familiar with from other systems) are no

longer required.

20

CoaguChek INRange User’s Manual

Introduction

20

Important safety instructions and additional information

This section explains how safety-related mes-

sages and information related to the proper

handling of the system are presented in the

CoaguChek INRange User’s Manual. Read these

passages carefully.

The safety alert symbol alone (without a signal

word) promotes awareness to hazards which are

generic or directs the reader to related safety

information.

WARNING

Indicates a hazardous situation which, if not

avoided, could result in death or serious injury.

CAUTION

Indicates a hazardous situation which, if not

avoided, could result in minor or moderate injury.

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