Accu-Chek Integra User manual

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.
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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

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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

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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

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Part 1
ACCU-CHEK
®
Integra
BLOOD GLUCOSE METER
User’s Manual

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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












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






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

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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).

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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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2 Initial steps before testing
2.1 Checking the contents
Check that your Accu-Chek Integra Blood Glucose Monitoring Kit is com-
plete. The package contents are listed on the box.
If anything is missing, please contact customer support (see Chapter 19
for details).
2.2 Checking that the correct unit is displayed
Blood glucose results can be displayed in two different units (mmol/L
or mg/dL). Consequently, Roche sells two different versions of the same
meter. Check that your meter displays the unit you are accustomed to.
On the back of your meter you will find the unit for which your instru-
ment is coded. Ask your doctor if you do not know which is the right unit
for you. The setting cannot be changed.
If the wrong unit is printed on the type plate, please consult the
retail outlet where the meter was purchased. Using the wrong
units can cause you to misinterpret the test result.

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2.3 Inserting or replacing batteries
 If the meter is on, turn it off.
 Press lightly on the lid of the battery compartment
and slide it in the direction of the arrow (1).
 Open the battery compartment (2).
 Remove any used batteries.
 Insert two batteries (type AAA, LR 03, AM 4 or Micro). Make sure
that the minus (-) pole of the battery is next to the minus contact in
the battery compartment.



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2.3 Inserting or replacing batteries
 Fold the lid of the battery compartment down and slide it closed
again.
There will be an audible CLICK as it closes.
After you have inserted the batteries, the meter turns on and the motor
inside runs for about 10 seconds.
A meter already containing a test strip drum then automatically turns
off.
A meter that does not yet contain a test strip drum
emits a beep and displays the following message for
about 10 seconds:
This means that you have not yet inserted a test strip drum. The meter
then automatically turns off.
i
A new set of batteries provides enough power to carry out a
minimum of 500 blood glucose tests.
i
Do not use rechargeable batteries. They do not provide suffi-
cient voltage and will only allow you to perform a few measure-
ments before they need recharging.
i
When the battery symbol appears in the display for the first
time, it indicates that the battery is running low. You can per-
form about a further 50 tests. We recommend, however, that
you replace the batteries as soon as possible (see the following
information). By then the battery will have been considerably
drained, and changeable conditions (cold surroundings) can af-
fect its performance even further.
i
To keep things simple, we recommend you use up the current
drum of strips before replacing the batteries. Otherwise, it may
take the meter a long time to advance the first test strip from
the next drum, and the “use-by” date warning may also be lost
(see Chapter 2.5 “Inserting or replacing the test strip drum”).

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2.3 Inserting or replacing batteries
i
When you replace the batteries, your stored results are retained
in memory. However, you will need to re-enter the time and
date. If you fail to do so, any blood glucose test results you
obtain from this point forward will be displayed and saved
without time and date. In this case, the test results saved in
memory will be numbered consecutively so you can still see the
order in which you took the readings.
Never throw batteries into a fire. This is dangerous because
they may explode.
i
Remove the batteries if your Accu-Chek Integra meter is to
remain unused for some time.
i
Think of the environment. Dispose of used batteries sensibly.
2.4 Performing a full display test
To check that all of the display elements are functioning correctly, you
should carry out a full display test.
 If the meter is on, turn it off.
 Press and hold down the MEMO button.
The meter turns on. “On” appears briefly in the display. While you hold
down the MEMO button, all of the display elements are visible. Compare
the display screen of your meter with the one shown below.
MEMO button Full display test
If any of the display elements are missing or the unit shown for the
blood glucose results is not the correct one, please contact Customer
Support (see Chapter 19 for details) to exchange the meter.
CTRL
MEMO
mmol/L
AM
PM

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2.4 Performing a full display test
 Release the MEMO button.
The standard display test screen that is shown each time the meter
is turned on appears briefly. When it disappears, the meter is in
memory. If no results have yet been saved, three bars are displayed.
Standard display test No results in memory
i
You can perform a full display test whenever you wish. If there
are already results saved in memory, when you release the
MEMO button the most recently saved result is displayed.
 Press the ON/OFF button to turn the meter off.
i
The meter automatically turns off if you keep the MEMO button
pressed for more than 90 seconds.
2.5 Inserting or replacing the test strip drum
 Read the package insert that came with the test strip drums.
 If the meter is on, turn it off.
 Wait for the motor to stop before you open the meter.
Only open the meter when it is turned off and the motor is not
running. Opening the drum compartment when the meter is
turned on may result in damage to the meter.
CTRL
MEMO
mmol/L
MEMO

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2.5 Inserting or replacing the test strip drum
 Slide the release button on the right side of the meter in the
direction indicated by the arrow. The drum compartment opens.
 To exchange the drum, first tip the meter upright.
The old drum drops out.
i
You can dispose of used drums with your regular
household waste.

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2.5 Inserting or replacing the test strip drum
 Insert the new test strip drum.
 Close the drum compartment.
The meter automatically moves the drum to the
correct position and reads the code on the drum.
A dot appears in the small control window on the reverse side of the
meter. This dot indicates that you have just inserted a drum. When you
perform a blood glucose test, the meter counts the number of test strips
that have been used and displays the number of strips remaining.
Use only test strips that are within the expiry date. Expired test
strips can produce incorrect results. Incorrect results can cause
the wrong therapeutic decision to be taken and so produce
adverse health effects. The expiry date is printed next to the
symbol on the container.

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2.5 Inserting or replacing the test strip drum
Use only new test strip drums on which the aluminium foil
(the “silver ends”) is intact on both sides. Your blood glucose
test results may be incorrect if damaged drums are used in
the meter. Incorrect results can cause the wrong therapeutic
decision to be taken and so produce adverse health effects.
i
Handle the test strip drums with extreme care! Only remove a
test strip drum from its container when you intend to use it.
The container protects the aluminium foil on the drum from
damage.
i
When performing a quality control test, you need the list of
expected values given on the peel-off label attached to the test
strip drum container (see Chapter 6 “Checking the Accu-Chek
Integra meter”). You may, for instance, wish to stick the peel-off
label in your notebook or diary. When conducting quality con-
trols always check that the peel-off label with the concentration
table belongs to the test strips that are currently in the meter.
i
Use only Accu-Chek Integra test strip drums. Other test strips
cannot be used to perform measurements.
If you insert a different test strip drum, the
following message will be displayed:
When all the strips have been used, the dot reappears in the control
window.
 Insert a new test strip drum.
If you do not insert a new test strip drum, the
following message will be displayed the next time
you turn on the meter:
“End” and the drum symbol flash in the display,
indicating that the drum is empty.

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2.5 Inserting or replacing the test strip drum
When you insert a new drum the number of days the drum has been in
the meter is counted automatically. Each drum must be used up within a
90-day use-by period.
After 90 days the date, the drum symbol and “CTRL”
flash in the display.
The drum has been in the meter for 90 days. You are asked to perform
a quality control test in order to check the test strips. Carry out a quality
control check (see Chapter 6 “Checking the Accu-Chek Integra meter”).
If the measurement produces the correct results, you may continue to
use the test strips. If the results are incorrect, you need to insert a new
drum.
Following the quality control check, “CTRL” disappears from the display.
The drum symbol and the date continue to flash in order to draw atten-
tion to the fact that the drum has been in use for more than 90 days.
The meter is unable to calculate the 90-day use-by period if you
 remove a partly used drum from the meter and then insert it again,
 change the batteries and leave a partly used drum in the meter.
The meter has no way of telling when the drum was first inserted or
how long the partly used drum has already been in the meter.
The drum symbol and “CTRL” flash in the display.
You are asked to perform a quality control test in order to check the test
strips. Carry out a quality control check (see Chapter 6 “Checking the
Accu-Chek Integra meter”). If the measurement produces the correct
results, you may continue to use the test strips. If the results are incor-
rect, you need to insert a new drum. Following the quality control check,
“CTRL” disappears from the display. The drum symbol continues to flash
in order to draw attention to the fact that the meter cannot calculate the
use-by period.
i
If you insert a partly used drum in the meter, a dot appears in
the control window on its reverse side. When you then next turn
on the meter, it rotates the drum until it finds the first chamber
containing a test strip. The lower the number of test strips in
the drum, the longer the process takes. The control window
allows you to see the drum being rotated from one chamber to
the next.
CTRL
CTRL

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3 Basic settings
You may now move to the SET menu to turn the beep tone on or off, to
set the year, time and date, and to define the time and date format.
When you turn on your Accu-Chek Integra meter for the first time, it has
the following settings (which you can change):
 Beep tone: on
 Year: 2000
 Display format for the time and the date:
24 h (with the accompanying date format day-month/DD-MM)
 Time: 00:00
 Date: 0-0
If you do not set the time and date, a series of zeros will be displayed in
place of time and date when you take a reading.
In that case, statistical evaluations (in the electronic notebook, see
Chapter 5 “Using the Accu-Chek Integra meter as an electronic note-
book”) cannot be performed as they can only use data stored together
with the time and date. To distinguish readings internally (in memory),
they are numbered consecutively.
The procedure for changing the settings is as follows:
 Press the SET button to call up the SET menu.
The field currently flashing in the menu may now be changed.
 Press the MEMO button to change the current setting.
Numerals such as the year, time and date can be incremented to a
certain value, then the count-up starts again from the beginning.
In the case of settings where you have two options, e.g. the beep
tone setting and the time/date format, pressing the MEMO button
presents each option in turn.
 Press the SET button to save the chosen setting and move on to the
next setting.
 You can change any setting you wish. Press the SET button repeat-
edly until the setting you wish to change is displayed flashing. A test
strip is not advanced.
 You can close the set menu at any time by pressing the ON/OFF
button. All settings you have entered are saved and the meter turns
off.
i
Only turn on the meter with the SET button when you intend to
change the settings.
If you turn on the meter with the ON/OFF button and there is a
drum in the meter, a test strip will be advanced.