Accu-Chek Integra Manuale utente
0 4524381001(03) 2007-05
0088
BLOOD GLUCOSE MONITORING SYSTEM
Complete
Instructions
for Use
Farbe: PMS 583 – Prüfmittelnummer: 208
ACCU-CHEK
®
Integra
ACCU-CHEK, ACCU-CHEK INTEGRA and SOFTCLIX
are trademarks of Roche.
Roche Diagnostics Australia Pty Ltd.
31 Victoria Avenue
Castle Hill, NSW 2154
Accu-Chek Enquiry Line: 1800 251 816
www.accu-chek.com
Roche Diagnostics GmbH
D-68298 Mannheim, Germany
www.accu-chek.com
1
On packaging, on the type plate of the meter, on the lancing device itself
and in these instructions for use you may encounter the following sym-
bols, shown here with their meaning:
Please consult instructions for use
Catalogue number
IVD
For in vitro diagnostic use
Store at
Use by/Expiry date
Lot number
0088
Blood glucose meter and test strips: These products fulfil
the requirements of Directive 98/79/EC
on in vitro diagnostic medical devices.
Lancing device and lancets: These products fulfil the
requirements of Directive 93/42/EEC on medical devices.
0088
AST cap: This product fulfils the requirements of Directive
93/42/EEC on medical devices.
Manufacturer
Caution (refer to accompanying documents). Please refer to
the safety-related notes in the manual accompanying this
instrument.
For single use only
Sterilized using irradiation
Last update user information: November 2004
This booklet consists of four parts.
Part 1
Instructions for use (User’s Manual) for the Accu-Chek Integra blood
glucose meter.
Part 2
Instructions for use for the Accu-Chek Softclix lancing device.
Part 3
Instructions for use for the Accu-Chek Softclix AST cap, used to collect
blood from alternative sites (accessory for the Accu-Chek Softclix
lancing device).
Part 4
Appendix
Please read the instructions in this booklet carefully and completely be-
fore performing the first measurement. Should you have any questions,
call the Accu-Chek Enquiry Line on 1800 251 816.
Please read with special attention all text in this booklet that is preceded
by the following symbols:
This symbol signifies a possible risk of injury or of damage to
your health.
This symbol indicates that your meter or lancing device is at
risk of being damaged.
i
This symbol highlights important information.
Farbe: PMS 583 – Prüfmittelnummer: 208
2
Farbe: PMS 583 – Prüfmittelnummer: 208
3
The Accu-Chek Integra meter is intended for use by one person
only.
Use of the same Accu-Chek Integra meter by more than one
person or for performing blood glucose measurements in more
than one person poses an infection risk.
Any object coming into contact with human blood is a potential
source of infection (see: National Committee for Clinical Labora-
tory Standards: Protection of Laboratory Workers from Instru-
ment Biohazards and Infectious Disease Transmitted by Blood,
Body Fluids, and Tissue. Approved Guideline, NCCLS document
M29-A, 1997).
Contents
Part 1 Accu-Chek Integra Blood Glucose Meter
User’s Manual
1 Introduction 10
1.1 Your blood glucose meter at a glance 10
1.2 Main features 14
1.3 About this manual 16
2 Initial steps before testing 18
2.1 Checking the contents 18
2.2 Checking that the correct unit is displayed 19
2.3 Inserting or replacing the batteries 20
2.4 Performing a full display test 25
2.5 Inserting or replacing the test strip drum 27
3 Basic settings 36
3.1 Turning the beep tone on or off 38
3.2 Setting the year 40
3.3 Changing the time/date format 42
3.4 Setting the time 44
3.5 Setting the date 46
4 Testing blood glucose 48
4.1 Plausible results 56
4.2 Implausible results 57
4
Farbe: PMS 583 – Prüfmittelnummer: 208
5
Contents
5 Using the Accu-Chek Integra meter as an electronic
notebook 58
5.1 Memory 58
5.2 Viewing test results 59
5.3 Highest value, lowest value, average 60
5.4 Downloading data to a PC or handheld computer 62
6 Checking the Accu-Chek Integra meter 65
6.1 Quality control checking with Accu-Chek Integra
control solution 65
6.2 Performing a quality control check 66
7 Cleaning the Accu-Chek Integra meter 71
8 Measurement and storage conditions 75
8.1 Temperature range 75
8.2 Atmospheric humidity 77
8.3 Sources of interferences 77
9 Display messages and troubleshooting 78
9.1 Messages and symbols 79
9.2 Troubleshooting 84
10 Technical data 95
Contents
Part 2 Accu-Chek Softclix Lancing Device
Instructions for Use
11 Introduction 100
11.1 Your lancing device at a glance 100
11.2 About the Accu-Chek Softclix lancing device 102
12 Using the Accu-Chek Softclix lancing device 103
12.1 Inserting or exchanging the lancet 103
12.2 Preparations for taking blood 105
12.3 Obtaining blood 106
12.4 Cleaning the Accu-Chek Softclix lancing device 107
6
Farbe: PMS 583 – Prüfmittelnummer: 208
7
Contents
Part 3 Accu-Chek Softclix AST Accessory
Instructions for Use
13 Introduction 110
13.1 A new way to test 110
13.2 Important information for users 113
14 AST testing 116
14.1 Preparing for AST testing 116
14.2 Measuring blood glucose 119
15 Cleaning the Accu-Chek Softclix lancing device
and the AST Cap 120
Contents
Part 4 Appendix
16 System components 122
17 Guarantee 123
18 Patents 123
19 Local customer support and service 124
19.1 Information and repair 124
19.2 Contact us 125
20 Alphabetical index 126
8
Farbe: PMS 583 – Prüfmittelnummer: 208
Part 1
ACCU-CHEK
®
Integra
BLOOD GLUCOSE METER
User’s Manual
10
Farbe: PMS 583 – Prüfmittelnummer: 208
11
1 Introduction
1.1 Your blood glucose meter at a glance
SET button
Press this button to enter the Set menu
and change the settings.
Display window
ON/OFF button
Press this button only if you want
to test your blood glucose or to turn
the meter off.
Drum compartment release button
Drum compartment
Test strip drum
Test strip
Optical system
Optical system cover*
MEMO button
Press this button to view results
stored in the meter’s memory.
Display cover*
* available as replacement part
Front edge of strip
that draws up blood
12
Farbe: PMS 583 – Prüfmittelnummer: 208
13
1.1 Your blood glucose meter at a glance
Battery compartment cover*
Type plate
Infrared window
Battery compartment
Batteries: Type AAA, LR 03, AM 4, Micro
Test strip guide
Control window
(shows the number of strips remaining)
* available as replacement part
14
Farbe: PMS 583 – Prüfmittelnummer: 208
15
1.2 Main features
With your Accu-Chek Integra blood glucose meter you can test your
blood glucose simply and with confidence.
Test strip drum instead of individual test strips
You never need to touch a test strip. Simply insert a drum with 17 test
strips into the Accu-Chek Integra meter.
Easy to operate
Turn on the meter, apply blood, read the result, press the button to eject
the test strip.
Automatic coding
Every test strip drum has its own bar code. The Accu-Chek Integra blood
glucose meter is automatically coded when you insert a new drum,
a process which provides the meter with information on the specific
characteristics of the test strips.
Reliability
The Accu-Chek Integra blood glucose meter checks each test strip. If it
finds a defective strip, it lets you know before you apply blood.
Blood volume checking
The Accu-Chek Integra blood glucose meter can tell when you have
applied sufficient blood (approximately 1.5 µL (1 microlitre = 1 thou-
sandth of a millilitre). It waits until then before starting the measure-
ment. If the measurement does not start, you may apply more blood.
Easier way of dosing blood
Blood is drawn up into the test strip through capillary action. This means
that the collection of blood from alternative sites, such as the forearm,
the upper arm or the base of the thumb, is much easier.
Downloading data to a PC
The Accu-Chek Integra blood glucose meter has an infrared interface
which enables you to download results to a PC running suitable soft-
ware.
We recommend that you use an Accu-Chek Softclix lancing device to
obtain capillary blood samples (see Part 2 of this booklet).
16
Farbe: PMS 583 – Prüfmittelnummer: 208
17
1.3 About this manual
This manual will help you get to know your new Accu-Chek Integra
meter step by step. It will provide you with all the information you need
to operate, troubleshoot, and care for your meter. It is important to re-
member that, in order to keep your meter in tip-top condition, you need
to comply with all instructions given in addition to following the correct
operating procedures. The Accu-Chek Integra meter is a precision in-
strument. Improper treatment can impair its function.
Throughout this manual you will see examples of what the display looks
like. Elements that flash are shown surrounded by a halo.
Example:
mmol/L
You have turned on the meter to perform a blood glucose measurement.
The display shows a number of elements, some of which (the blood
drop and the hand symbol) are flashing.
The date, time and blood glucose results shown in the display are in-
tended only as examples. They will not be the same as those shown by
your Accu-Chek Integra meter. The blood glucose meter that is depicted
displays blood glucose results in mmol/L (see Chapter 2.2 “Checking
the blood glucose unit”) and has been set to 24-hour format (see Chap-
ter 3.3 “Changing the time/date format”).
We recommend that you start by familiarizing yourself with all of the
elements of your Accu-Chek Integra meter shown on pages 10 – 13
of these instructions. Practise all of the operations described in these
instructions, and also practise testing. That way you will always have a
dependable partner to accompany you through the day.
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