Accu-Chek | INTEGRA | User`s manual | Accu-Chek INTEGRA User`s manual

ACCU-CHEK
®
Integra
BLOOD GLUCOSE MONITORING SYSTEM
0088
ACCU-CHEK, ACCU-CHEK INTEGRA and SOFTCLIX
are trademarks of Roche.
Complete
Instructions
for Use
Roche Diagnostics GmbH
D-68298 Mannheim, Germany
www.accu-chek.com
0 4524381001(03) 2007-05
Roche Diagnostics Australia Pty Ltd.
31 Victoria Avenue
Castle Hill, NSW 2154
Accu-Chek Enquiry Line: 1800 251 816
www.accu-chek.com
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 symbols, 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.
0088
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
Lancing device and lancets: These products fulfil the
requirements of Directive 93/42/EEC on medical devices.
Please read the instructions in this booklet carefully and completely before performing the first measurement. Should you have any questions,
call the Accu-Chek Enquiry Line on 1800 251 816.
AST cap: This product fulfils the requirements of Directive
93/42/EEC on medical devices.
Please read with special attention all text in this booklet that is preceded
by the following symbols:
Manufacturer
This symbol signifies a possible risk of injury or of damage to
your health.
Caution (refer to accompanying documents). Please refer to
the safety-related notes in the manual accompanying this
instrument.
This symbol indicates that your meter or lancing device is at
risk of being damaged.
For single use only
Sterilized using irradiation
Last update user information: November 2004
i
This symbol highlights important information.
1
Contents
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 Laboratory Standards: Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood,
Body Fluids, and Tissue. Approved Guideline, NCCLS document
M29-A, 1997).
2
Part 1 Accu-Chek Integra Blood Glucose Meter
User’s Manual
1
Introduction
1.1 Your blood glucose meter at a glance
1.2 Main features
1.3 About this manual
10
10
14
16
2
Initial steps before testing
2.1 Checking the contents
2.2 Checking that the correct unit is displayed
2.3 Inserting or replacing the batteries
2.4 Performing a full display test
2.5 Inserting or replacing the test strip drum
18
18
19
20
25
27
3
Basic settings
3.1 Turning the beep tone on or off
3.2 Setting the year
3.3 Changing the time/date format
3.4 Setting the time
3.5 Setting the date
36
38
40
42
44
46
4
Testing blood glucose
4.1 Plausible results
4.2 Implausible results
48
56
57
3
Contents
5
6
Using the Accu-Chek Integra meter as an electronic
notebook
5.1 Memory
5.2 Viewing test results
5.3 Highest value, lowest value, average
5.4 Downloading data to a PC or handheld computer
Contents
11
Introduction
11.1 Your lancing device at a glance
11.2 About the Accu-Chek Softclix lancing device
100
100
102
65
12
Using the Accu-Chek Softclix lancing device
12.1 Inserting or exchanging the lancet
12.2 Preparations for taking blood
12.3 Obtaining blood
12.4 Cleaning the Accu-Chek Softclix lancing device
103
103
105
106
107
Checking the Accu-Chek Integra meter
6.1 Quality control checking with Accu-Chek Integra
control solution
6.2 Performing a quality control check
65
66
7
Cleaning the Accu-Chek Integra meter
71
8
Measurement and storage conditions
8.1 Temperature range
8.2 Atmospheric humidity
8.3 Sources of interferences
75
75
77
77
9
Display messages and troubleshooting
9.1 Messages and symbols
9.2 Troubleshooting
78
79
84
10
Technical data
95
4
Part 2 Accu-Chek Softclix Lancing Device
Instructions for Use
58
58
59
60
62
5
Contents
Contents
Part 3 Accu-Chek Softclix AST Accessory
Instructions for Use
Part 4 Appendix
16
System components
122
13
Introduction
13.1 A new way to test
13.2 Important information for users
110
110
113
17
Guarantee
123
18
Patents
123
14
AST testing
14.1 Preparing for AST testing
14.2 Measuring blood glucose
116
116
119
19
Local customer support and service
19.1 Information and repair
19.2 Contact us
124
124
125
15
Cleaning the Accu-Chek Softclix lancing device
and the AST Cap
120
20
Alphabetical index
126
6
7
Part 1
ACCU-CHEK
Integra
BLOOD GLUCOSE METER
User’s Manual
8
®
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
10









Front edge of strip
that draws up blood

11
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
12
13
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.
14
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 thousandth of a millilitre). It waits until then before starting the measurement. 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 software.
We recommend that you use an Accu-Chek Softclix lancing device to
obtain capillary blood samples (see Part 2 of this booklet).
15
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 remember 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 instrument. Improper treatment can impair its function.
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.
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 intended 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 Chapter 3.3 “Changing the time/date format”).
16
17
2
Initial steps before testing
2.2
2.1
Checking the contents
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 instrument is coded. Ask your doctor if you do not know which is the right unit
for you. The setting cannot be changed.
Check that your Accu-Chek Integra Blood Glucose Monitoring Kit is complete. The package contents are listed on the box.
If anything is missing, please contact customer support (see Chapter 19
for details).
Checking that the correct unit is displayed
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.
18
19
2.3
Inserting or replacing batteries
 If the meter is on, turn it off.
 Remove any used batteries.
 Press lightly on the lid of the battery compartment
and slide it in the direction of the arrow (1).
 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.
 Open the battery compartment (2).


20
21
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.
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 sufficient voltage and will only allow you to perform a few measurements 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 perform 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 affect 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”).
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.
22
23
2.3
i
Inserting or replacing batteries
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.
AM
PM
mmol/L
MEMO CTRL
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.
24
25
2.4
2.5
Performing a full display test
 Release the MEMO button.
 Read the package insert that came with the test strip drums.
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.
mmol/L
MEMO CTRL
Standard display test
i
Inserting or replacing the test strip drum
 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.
MEMO
No results in memory
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
26
The meter automatically turns off if you keep the MEMO button
pressed for more than 90 seconds.
27
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
28
You can dispose of used drums with your regular
household waste.
29
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.
30
31
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
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.
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 controls 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.
32
33
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.
The drum symbol and “CTRL” flash in the display.
CTRL
After 90 days the date, the drum symbol and “CTRL”
flash in the display.
CTRL
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 attention 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.
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 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.
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.
34
35
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 notebook”) 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 repeatedly 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
36
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.
37
3.1
Turning the beep tone on or off
With the beep tone turned on, the meter beeps
 when it asks you to apply blood or control solution,
 when it starts to test, as confirmation that the test strip has
received a sufficient amount of blood or control solution,
 when the result is displayed
 each time it displays a message.
 Check the meter is off.
 Press the MEMO button to turn off the beep
tone. “OFF” appears in the display.
If you press the MEMO button again, “ON” reappears.
If you wish to set the year, leave the meter turned on and proceed to the
next section, 3.2.
 Press the SET button.
The meter turns on without advancing a test strip
from the drum.
If not, press the ON/OFF button to turn the meter off. The current settings will be saved automatically.

mmol/L
MEMO CTRL

The symbol for the beep tone flashes in the display
window, and “ON” appears.
38
39
3.2
Setting the year
If you have a new meter or you have just replaced the batteries, the date
will be set to 00.00.2000, and the time to 00:00 hours (24-hour format)
or 12:00 a.m. (12-hour format). The correct time and date are needed
to enable you to unambiguously identify your blood glucose test results,
perform statistical analysis and to transfer them from your meter’s
memory to a computer (see Chapter 5.4 “Downloading data to a PC or
handheld computer”).
 Check the meter is off.
 Press the SET button.
The meter turns on without advancing a test strip from the drum.
 Press the SET button repeatedly until the year
setting flashes at top right of the display. The
default value is 2000.
If you wish to define the time and date format, leave the meter turned
on and proceed to the next section, 3.3.
If not, press the ON/OFF button to turn the meter off. The current settings will be saved automatically.
i
The year is not displayed during testing or review of
blood glucose test results. It is still important, however, as
February 29 in a leap year will only be recognized if the year is
properly set. The current year setting is also needed to unambiguously identify your blood glucose test results if you transfer
them from your meter’s memory to a computer (see Chapter 5.4 “Downloading data to a PC or handheld computer”).

 Press the MEMO button repeatedly to set the year.
The meter scrolls upwards through the year
values.
If you hold the MEMO button down, the meter fast-scrolls forward to
2032 and then begins again at 2000.
40
41
3.3
Changing the time/date format
You can choose between the 24-hour format (0:00 to 23:59), in which
case the date format is DD-MM (day followed by month), and the 12hour format (1 to 12 o’clock with a.m. or p.m.). In the latter case the
date format changes to MM-DD (month followed by day).
If you wish to set the time, leave the meter turned on and proceed to the
next section, 3.4.
If not, press the ON/OFF button to turn the meter off. The current
settings will be saved automatically.
 Check the meter is off.
 Press the SET button.
The meter turns on without advancing a test strip from the drum.
 Press the SET button repeatedly until “24h” is
displayed. 24-hour format is selected.
The time is set to 00:00.
i
If you do not set the time and date, these fields will be filled
with zeros during testing. Your blood glucose test results saved
in memory will be numbered consecutively. However, only test
results that are saved with the time and date will be included
in the statistics (see Chapter 5 “Using the Accu-Chek Integra
meter as an electronic notebook”).

 Press the MEMO button to select 12-hour format.
In the display you see “12h” and the time is set
to 12:00 a.m.
AM
If you press the MEMO button again, “24 h” reappears.
42
43
3.4
Setting the time
 Check the meter is off.
 Press the SET button.
The meter turns on without advancing a test strip from the drum.
 Press the SET button again.
The minute field flashes.
 Press the SET button repeatedly until the
hour field flashes.

 Press the MEMO button repeatedly to set the
minute.

 Press the MEMO button repeatedly to set
the hour.
If you hold the MEMO button down, the meter fast-scrolls forward to 59
and then begins again at 0.
24-hour format: If you hold the MEMO button down, the meter
fast-scrolls forward to 23 and then begins again at 0.
12-hour format: If you hold the MEMO button down, the meter
fast-scrolls forward to 12 p.m. and then to 12 a.m.
If you wish to set the date, leave the meter turned on and proceed to the
next section, 3.5.
If not, press the ON/OFF button to turn the meter off. The current
settings will be saved automatically.
i
44
At temperatures below –10°C the batteries do not have enough
power to keep the internal clock functioning. In this event the
clock must be reset.
45
3.5
Setting the date
 Check the meter is off.
 Press the SET button.
The meter turns on without advancing a test strip from the drum.
 Press the SET button repeatedly until the month
field flashes.
24-hour format: DD-MM
12-hour format: MM-DD
 Press the SET button again. The day field flashes.
24-hour format: DD-MM
12-hour format: MM-DD

 Press the MEMO button repeatedly to select the
correct day.

 Press the MEMO button repeatedly to select the
correct month.
If you hold the MEMO button down, the meter fast-scrolls forward to 31
and then begins again at 1.
If you hold the MEMO button down, the meter fast-scrolls forward to 12
and then begins again at 1.
46
 Press the ON/OFF button to turn the meter off.
The current settings will be saved automatically.
47
4
Testing blood glucose
The Accu-Chek Integra meter is intended for use by one person
only.
 Wash your hands thoroughly with warm water and soap and dry
them well.
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.
 Open the display cover.
 Press the ON/OFF button. The meter turns on.
Any object coming into contact with human blood is a potential
source of infection (see: National Committee for Clinical Laboratory Standards: Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood,
Body Fluids, and Tissue. Approved Guideline, NCCLS document
M29-A, 1997).
Keep the test strip away from skin unless you are touching it
against blood. Residues (e.g. of skin cream, food or drink) on
the skin can find their way onto the strip and may produce incorrect results. Incorrect results can cause the wrong therapeutic
decision to be taken and so produce adverse health effects.
Do not bend the test strip, or the following
error message will be displayed.
i
48
The meter turns off automatically after 5 minutes of non-use.
49
4
Testing blood glucose
 Wait until the flashing hand and blood drop symbol appear in
the display and the meter beeps (provided the beep tone is turned
on).
The following messages appear in turn on the display.


mmol/L
MEMO CTRL
Standard display test

mmol/L
A test strip is
being advanced
mmol/L
You may now
apply blood
The standard display test takes about 2 seconds.
 Check that all the segments making up the numerals are properly
displayed.
If a segment is missing, test results may be displayed inaccurately (e.g.
through a “9” being confused with a “3”). If this happens, call your local customer support and service centre.
You now have approximately 5 minutes in which to apply blood. After
this time the meter automatically turns off. This strip can no longer be
used. If this occurs, press the ON/OFF button to eject the test strip. Start
the blood glucose measurement again with a new test strip.
 Hold the meter so the test strip is pointing downwards at a slight
angle (see illustration).
Always hold the meter so the test strip is pointing downwards
when you are applying blood. If you hold it with the test strip
pointing upwards, blood may enter the meter and contaminate
it.
 Use the Accu-Chek Softclix lancing device to prick the side of a
fingertip. Gently squeeze the fingertip to develop a small drop of
blood (please turn to Part 2 and read the instructions for using the
Accu-Chek Softclix lancing device).
i
50
For testing with blood collected from alternative sites, such as
the forearm, or the base of the thumb, please turn to Part 3
and read the instructions for using the Accu-Chek Softclix AST
Accessory.
51
4
Testing blood glucose
 Touch the blood drop against the front edge of the test strip near
the black notch without delay.
The strip draws up the blood.
As soon as a sufficient amount of blood has been drawn up, the meter
beeps and the test commences automatically. 000 appears in the display at the start of the test.
If the test does not commence, you did not apply sufficient blood. You
can then apply more blood (see the package insert that came with the
test strip drum).
As measurement progresses, the three 000 disappear in turn from the
display.

On completion of the test, the result appears in the
display together with the flashing test strip symbol.
The meter will save the result simultaneously.
52
53
4
Testing blood glucose
 Hold the meter upright over a waste bin.
 Press the ON/OFF button.
The meter turns off and the used test strip falls out.
i
If you do not turn off the meter, it turns off automatically after
about 60 seconds. The test strip then remains in the meter.
When you turn on a meter still containing a used test strip, this
is merely ejected and the meter automatically turns off again.
i
Always let the meter eject the test strip.
Never pull the test strip from the meter while
the test is running.
Measurement is then interrupted and the
following message is displayed:
Once a test strip has been ejected, never push
it back into the test strip chamber. This could
damage the meter.
If a test strip is pushed back into the test strip
chamber, the following message is displayed
when the meter is turned on:
The meter does not allow a test to be performed.
i
54
Please dispose of used test strips with your regular household
waste.
55
4.1
Plausible results
Your Accu-Chek Integra meter measures blood glucose within a defined
range (0.6-33.3 mmol/L).
Values below this range are displayed as:
Your blood glucose result is below 0.6 mmol/L.
Values above this range are displayed as:
Your blood glucose result is above 33.3 mmol/L.
These values are not used for statistical calculations (see Chapter 5.3
“Highest value, lowest value, average”).
If the test result agrees with the way you feel, follow your
doctor’s advice. If the way you feel does not agree with this
test result, please perform a quality control check with the
Accu-Chek Integra Control solution and a new test strip. Repeat
the blood glucose test. If you feel the new result is also implausible please consult your doctor.
56
4.2
Implausible results
If your meter repeatedly displays error messages, or if you have reason
to doubt the validity of a test result, please check the following points.
 Did you perform the test as directed (see Chapter 4 “Testing blood
glucose”)?
 Did you wait for the flashing hand symbol and blood drop symbol
to appear before applying blood?
 Did you wash your hands with warm water and soap to improve the
blood flow and to remove any residues, e.g. of food, drink or skin
cream? Did you dry your hands well?
 Did you just gently squeeze your fingertip to develop the drop of
blood?
 Did you apply blood to the test strip without delay after the blood
drop was formed?
 Did you perform the test within the correct temperature range
(+10 °C to +40 °C)?
 Did you use a test strip drum whose 90-day “use-by” period has
not expired (see Chapter 2.5 “Inserting or replacing the test strip
drum”)?
 Did you observe the proper storage conditions for the meter and
test strip drum (see Chapter 8 “Measurement and storage conditions” and the package insert that came with the test strip drum)?
If you have checked these points and still receive error messages or
doubt the validity of results, please contact Customer Support (see
Chapter 19 for details).
57
5
Using the Accu-Chek Integra meter as an
electronic notebook
5.2
5.1
Memory
 With the meter turned off, press the MEMO button.
The meter turns on without advancing a test strip
from the drum. The most recent test result and
“MEMO” are displayed.
Your Accu-Chek Integra meter has a 100-value memory for saving results together with time and date (provided the latter are correctly set).
You do not need to save a result specially, the meter does it all for you.
Once all the memory locations are full, the meter automatically overwrites the oldest entry. All results in memory are consecutively numbered from 1 (most recent) to a maximum of 100 (oldest).
In addition to results, your meter also stores all relevant additional
information and display messages. For example, results flagged as
control results (see Chapter 6.2 “Performing a quality control check”)
are always displayed together with “CTRL”. Results obtained at a temperature outside the permitted range are displayed together with a thermometer symbol ( ). Please refer to Chapter 9 “Display messages and
troubleshooting” for a complete list of display messages and symbols.
i
Viewing test results
mmol/L
MEMO
Only turn on the meter with the MEMO button when you would
like to review results held in memory.
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.
 Press the SET button to move towards the
“oldest” result stored.
mmol/L
MEMO
 Press the MEMO button to scroll forward to the
“most recent” result again.
You can hold down the buttons to scroll through your results more
quickly.
 Press the ON/OFF button to turn the meter off.
A test strip is not ejected.
i
If you did not set the time and date, your
results will be displayed with the number
of their memory location.
mmol/L
MEMO
58
59
5.3
Highest value, lowest value, average
Your meter can display the highest and lowest blood glucose results and
the average (or mean) of current test results. Statistics are based on the
test results stored for the last 7 days, as long as they were saved with
the date and time. If more than 100 tests were carried out during this
period, statistics will be based on the last 100.
 Press the MEMO button again.
The highest measured test result is displayed
together with the time and date.
 Press the MEMO button to enter memory.
The meter turns on without advancing a test strip
from the drum. The most recent test result and
“MEMO” are displayed.
 Press the MEMO button again.
The lowest measured test result is displayed
together with the time and date.
 Press the SET and MEMO buttons at the same
time.
The average of your current test results is displayed, identified by an “A”.
i
60
mmol/L
MEMO
mmol/L
mmol/L
MEMO
MEMO
 Press the ON/OFF button to turn the meter off.
A test strip is not ejected.
mmol/L
MEMO
When the average is being calculated, all results flagged as
control readings are ignored.
61
5.4
Downloading data to a PC or handheld computer
Your Accu-Chek Integra meter has an inbuilt infrared interface permitting cordless data downloading to a suitably equipped PC or handheld
computer. All results in memory are downloaded each time.
 Install the software according to the manufacturer’s instructions.
For data downloading you need a suitable PC program as well as the
Accu-Chek Infrared Cable.
Roche Diagnostics offers a variety of special software programs (e.g.
Accu-Chek Compass, Accu-Chek Pocket Compass and Accu-Chek Camit
Pro) to expand the memory functions in your Accu-Chek Integra meter.
Such programs enable you and your doctor to manage your data more
effectively and, through graph and table views, make it easier for you to
understand your self-testing data.
 Position the infrared cable less than 10 cm away, so the two infrared windows are pointing toward one another.
 Locate the infrared window on the Accu-Chek Integra meter.
Not all software programs are available in all countries. For further information please contact your local customer support and service centre.
i
Data can only be evaluated on a PC or handheld computer
as long as you have set the time and date (see Chapter 3.4
“Setting the time” and Chapter 3.5 “Setting the date”).
i
Your results remain in the meter’s memory following downloading to a PC or handheld computer.
62
63
5.4
Downloading data to a PC or handheld computer
 Press the SET button and MEMO button at the
same time.
The meter turns on without advancing a test strip
from the drum. Two arrows appear in the display.
The meter automatically downloads all stored blood
glucose test results to your computer. The two arrows
flash in the display during the download.
Once downloading has finished, the meter turns off automatically.
A message is displayed on the computer indicating that the data
transfer is complete. The computer turns the Accu-Chek Integra
meter off.
i
64
If data transfer did not occur or was incomplete, the two arrows
do not start to flash and the meter turns off automatically after
5 minutes. Please refer to Chapter 9 “Display messages and
troubleshooting”.
6
Checking the Accu-Chek Integra meter
6.1
Quality control checking with Accu-Chek Integra
control solution
To ensure your results are always dependable, you must periodically
check the performance of your Accu-Chek Integra meter.
Do this by running a quality control check using Accu-Chek Integra
Control solution (not supplied with the meter):
 when you open a new pack of test strip drums
 after you have replaced the batteries
 if your meter flashes “CTRL”, indicating that a quality control test is
required
 after you have cleaned your meter
 if your result does not agree with how you feel
Please contact your local customer support and service centre for details of where you can obtain Accu-Chek Integra Control solution (see
Chapter 19 for details).
65
6.2
Performing a quality control check
 Read the package insert that came with the control solutions.
 Press the ON/OFF button. The meter turns on.
You now have approximately 5 minutes in which to apply control solution. After this time the meter automatically turns off. This strip can no
longer be used. If this occurs, press the ON/OFF button to eject the test
strip. Start the quality control check again with a new test strip.
 Check during the standard display test that all the segments making
up the numerals are properly displayed.
 Take one bottle of control solution.
 Open the display cover.
If a segment is missing, test results may be displayed inaccurately
(e.g. through a “9” being confused with a “3”). If this happens, call your
local customer support and service centre.
 Open it and wipe the tip of the dropper with a clean paper towel in
order to remove dried-on residues.
 Wait until the flashing hand symbol and blood drop symbol appear
in the display and the meter beeps (provided the beep tone is
turned on).
 Gently squeeze the bottle until a small drop of solution is suspended
from the tip.
 Press the SET button. “CTRL” appears in the display.
i
If you press the SET button before the hand symbol and the
drop of blood appear in the display, “CTRL” will appear together
with these in the display.
i
If you pressed the SET button inadvertently, you can press it
again in order to remove the control test flag.
i
If “CTRL” flashes in the display because the meter asked you to
run a quality control check (e.g. because you inserted a partially
used test strip drum) and you press the SET button, “CTRL”
stops flashing.
66
 Point the dropper downwards at an angle.
 Touch the drop against the black notch at the front edge of the test
strip.
67
6.2
i
Performing a quality control check
The control solution you apply to the test strip must come
from a suspended drop. Do not apply control solution that has
trickled down the outside of the dropper, as this will possibly
generate results that are too high.
As soon as a sufficient amount of control solution has been drawn up,
the meter beeps and the test commences automatically. 000 appears
in the display at the start of the test and gradually disappears while the
test is running.
Always hold the meter so the test strip is pointing downwards
when you are applying control solution. If you hold it with the
test strip pointing upwards, control solution can enter the meter
and contaminate it.
On completion of the test, the result appears in the
display together with the flashing test strip symbol and
“CTRL”. The meter saved the result simultaneously
together with “CTRL”.
68
mmol/L
CTRL
 Refer to the table of expected values on the peel-off label of the test
strip drum container.
If the result is outside this range, run another quality control check.
If the result of the second test is outside the expected range as well,
please check the following points:
 Did you perform the quality control check as directed?
 Did you perform the test within the correct temperature range
(+10 °C to +40 °C)?
 Did you use a test strip drum whose 90-day “use-by” period has
not expired (see Chapter 2.5 “Inserting or replacing the test strip
drum”)?
 Did you observe the proper storage conditions for the meter, test
strip drum and control solution (see Chapter 8 “Measurement and
storage conditions” and the package inserts that came with the test
strip drum and control solution)?
 Did you use a control solution that is not beyond its expiry date (see
label on bottle)?
 Has the control solution been open for more than three months?
Once opened, control solutions are stable for three months. They
must not be used after this period.
 Did you use the correct quality control solution (Accu-Chek Integra
Control)?
69
6.2
Performing a quality control check
If you are unable to identify or eliminate the source of the problem
please contact Customer Support (see Chapter 19 for details).
 Hold the meter upright and press the ON/OFF button.
The used test strip falls out at the bottom.
i
Control readings (identified by “CTRL”) are not used in statistical calculations.
7
Cleaning the Accu-Chek Integra meter
The Accu-Chek Integra meter utilizes an optical measuring method that
relies heavily on all of its components being clean. Owing to the way the
test strip works, the meter does not normally come into direct contact
with blood or control solution. Regular cleaning is therefore largely unnecessary. In the rare event of it becoming soiled through improper use,
cleaning may become necessary (see error message “OFF” on page 92).
For cleaning use only cold water. Any other cleaning agents
may damage the meter or impair its measuring function.
Use a lightly moistened cloth or a lightly moistened cotton
swab. Do not spray anything onto the meter and do not immerse it in water. This may damage internal parts, so affecting
its operation.
If the outside of your meter or the display are dirty, wipe them with a
lightly moistened cloth.
70
71
7
Cleaning the Accu-Chek Integra meter
Clean the meter carefully, if
 the test strip guide has become visibly soiled,
 the message OFF is displayed (see page 92).
 Clean the small window covering the optical system, its surroundings and the test strip guide carefully with a lightly moistened cotton swab or a soft, lint-free cloth.
 Remove the cover from the measurement optics by slightly squeezing it from both sides (1) and lifting it off (2).



72
73
7
Cleaning the Accu-Chek Integra meter
Make sure that no liquid enters the meter itself and avoid
scratching the measurement optics, as this will impair the
measuring function.
 When all of the components are thoroughly dry, check that the
meter is clean (no lint or fluff remaining).
 Place the optics cover back in position from above. Press on the left
and right sides of the cover. The cover quietly clicks back into place.
 Perform a quality control check (see Chapter 6, “Checking the
Accu-Chek Integra meter”).
Please ensure that the optical system cover is firmly in place
before you test. Otherwise it may block the strip from moving
into test position or from being ejected.
If you use 70 % alcohol or a strongly diluted rinsing solution,
wipe these fluids off immediately after application. Do not use
cleaning agents that contain acetic acid (vinegar) or scouring
agents because they can damage the display and the measurement optics.
74
8
Measurement and storage conditions
When testing blood glucose, pay close attention to the following points.
They affect the dependability of your Accu-Chek Integra meter and the
accuracy of your results.
8.1
Temperature range
 Without batteries and test strip drum, the meter may be stored at
between -40 °C and +70 °C.
 With batteries but without the test strip drum, the meter may be
stored at between -10 °C and +50 °C.
At temperatures above +50 °C the batteries could leak and
damage the meter.
At temperatures below -10 °C the batteries do not have
enough power to keep the internal clock functioning.
 With batteries and test strip drum, the meter may be stored at
between +2 °C and +30 °C.
 For performing blood glucose tests the permitted range is from
+10 °C to +40 °C.
75
8.1
Temperature range
 A test can be performed at the limits of the permitted range
(between +5 °C and +10 °C or between +40 °C and +45 °C),
but the result should be interpreted with caution and should not be
used as a basis for making therapeutic decisions. A thermometer
symbol ( ) flashes in the display.
 Tests cannot be performed at temperatures outside the permitted
range (below +5 °C or above +45 °C).
The following message is displayed:
8.2
Keep the meter at below 85 % relative humidity.
Sudden changes in temperature cause condensation to form on
or within the meter. If this happens, do not turn the meter on.
Wait until it is thoroughly dry again. Make sure that it returns to
room temperature slowly. Never keep it in a room that is likely
to harbour condensation (e.g. a bathroom).
8.3
Do not use results obtained at the limits of the permitted temperature range as a basis for making therapeutic decisions.
Your blood glucose test results may be incorrect. Incorrect
results can cause the wrong therapeutic decision to be taken
and so produce adverse health effects.
Never try to speed up warming or cooling of your Accu-Chek
Integra meter artificially (e.g. by placing it on a radiator or in a
refrigerator). Doing so can damage your meter and cause it to
give incorrect results. Incorrect results can cause the wrong
therapeutic decision to be taken and so produce adverse health
effects.
76
Atmospheric humidity
Sources of interferences
Strong electromagnetic fields may interfere with the proper
operation of the meter. Do not use this meter close to sources
of strong electromagnetic radiation.
To avoid electrostatic discharge, do not use the meter in a very
dry environment, especially one in which synthetic materials
are present.
77
9
Display messages and troubleshooting
When you use your Accu-Chek Integra meter, various letters and symbols will appear on the display and also at times error messages. Some
of the routine display messages have already been explained. Following
is a complete list of display messages, what they mean, and what action
you should take in case you see an error message.
Please watch out for any messages displayed when you use the meter.
Every message provides you with important information. Therefore, if
you do not recognize a symbol or do not understand a message, please
refer immediately to this chapter for an explanation. Otherwise you run
the risk of misinterpreting your blood glucose results.
Please note:
Several messages may be displayed simultaneously. For example, in
this display the blood glucose result and time are not flashing while
date, test strip symbol, thermometer symbol, drum symbol and “CTRL”
are flashing.
9.1
Messages and symbols
When symbols and numbers are surrounded by a halo, it indicates that
they are flashing in the meter’s display.
This message/
symbol appears ...
and means:
This is a pre-programmed unit displayed with the
blood glucose result. (See Chapter 2.2)
mmol/L
The beep tone is turned on.
A test strip is being advanced or is still in the
meter.
You may apply blood or control solution to the
test strip now.
mmol/L
CTRL
This means that the temperature during testing was at the limits of the
permitted range, the 90-day use-by period for the test strip drum has
expired and the test strip is still in the meter.
78
79
9.1
Messages and symbols
This message/
symbol appears ...
and means:
This message/
symbol appears ...
The test is in progress.
and means:
You are requested to run a quality control test.
CTRL
This is/was a quality control test.
CTRL
The temperature during testing is at the limits of
the permitted range (between +5 °C and +10 °C
or between +40 °C and +45 °C).
MEMO indicates a value saved in memory.
Do not use the result as a basis for therapeutic
decisions.
MEMO
MEMO
80
 No results have been saved.
 The meter cannot calculate the average
value
 as memory only contains results that are
not considered in the calculation, e.g.
quality control results,
 as you have not entered the time and
date,
 as you have set the date to a time in
the past.
Turn the meter off. Let the meter slowly cool
down or warm up. Turn the meter on and repeat
the test. The optimum measuring temperature is
between +10 °C and +40 °C.
The result in memory was obtained outside the
permitted temperature range.
MEMO
Do not use the result as a basis for therapeutic
decisions.
81
9.1
Messages and symbols
This message/
symbol appears ...
and means:
The battery is running low. When this symbol
first appears, you can perform approximately
a further 50 tests. Continue testing until all the
test strips in the test strip drum have been used.
Then insert two new batteries (type AAA) and a
new test strip drum.
When the batteries are so weak that no more
tests can be performed, the battery symbol appears briefly for 3 seconds in the display. Then
the meter turns off. Insert two new batteries
(type AAA).
This message/
symbol appears ...
and means:
The blood glucose result is above the measuring
range (>33.3 mmol/L or 600 mg/dL).
If this test result agrees with the way you feel,
follow your doctor’s advice. If the way you feel
does not agree with this test result, please perform a quality control check with the Accu-Chek
Integra Control solution and a new test strip.
Repeat the blood glucose test. If you feel the new
result is also implausible, please contact your
doctor.
The blood glucose result is below the measuring
range (<0.6 mmol/L or 10 mg/dL).
If this test result agrees with the way you feel,
follow your doctor’s advice. If the way you feel
does not agree with this test result, please perform a quality control check with the Accu-Chek
Integra Control solution and a new test strip.
Repeat the blood glucose test. If you feel the new
result is also implausible, please contact your
doctor.
82
83
9.2
Troubleshooting
When symbols and numbers are surrounded by a halo, it indicates that
they are flashing in the meter’s display.
If this happens ...
The meter is turned
on, but the display
remains blank.
The display is defective.
Clock has stopped
or clock is slow after
the meter is turned
on.
The meter was exposed to temperatures below
-10 °C and the batteries are starting to freeze.
Turn the meter off. Let the meter slowly warm
up. With batteries always store the meter at
between -10 °C and +50 °C (with test strip drum
at between +2 °C and +30 °C).
Contact Customer Support (see Chapter 19 for
details).
and means:
The test strip drum in the meter is empty.
it means:
Meter will not turn on.  Batteries are empty.
Insert new batteries.
 Ambient temperature is too low.
Move somewhere warmer. Let the meter
slowly warm up.
 Meter is defective.
Contact Customer Support (see Chapter 19
for details).
84
This message/
symbol appears ...
Insert a new drum. If the message is still displayed, please contact Customer Support (see
Chapter 19 for details).
CTRL
 You inserted a test strip drum that has already been used.
 You opened the drum compartment.
 You changed the batteries without changing
the test strip drum at the same time.
You are requested to run a quality control
check. The meter cannot determine how long
the test strip drum has been outside the meter,
or whether it is still usable. If you are certain
that the 90-day “use-by” period has not been
exceeded, you may continue to use the drum.
Perform a quality control check. The result of the
quality control check will be stored in memory
along with the flashing drum symbol and “CTRL”.
The drum symbol will remain displayed until
a new drum is inserted. All test results will be
stored along with the flashing drum symbol. If
you do not perform a quality control check, the
flashing drum symbol and the flashing “CTRL”
will appear with every new test until a new drum
is inserted.
85
9.2
Troubleshooting
This message/
symbol appears ...
and means:
 You inserted a test strip drum that has
already been used.
 You opened the drum compartment.
 You changed the batteries without changing
the test strip drum at the same time.
You performed the requested quality control
check and flagged it as such.
The bar code information from the test strip
drum has been lost.
Turn the meter off. Open the drum compartment
and close it again. The meter then rotates the
drum and reads the bar code. The drum symbol
and “CTRL” then flash in the display. Perform a
quality control check. You can use all remaining test strips. The 90-day use-by period will no
longer be properly calculated for this drum. The
drum symbol continues to flash in the display
until a new drum is inserted.
86
This message/
symbol appears ...
and means:
 There is no test strip drum in the meter.
Turn the meter off. Insert a test strip drum.
 You inserted a test strip drum from a different blood glucose monitoring system.
Turn the meter off. Insert an Accu-Chek
Integra test strip drum.
 The bar code on the drum is damaged.
Turn the meter off.

If you inserted the first drum from a
pack, remove the drum from the meter
and return it to its container. Insert the
second drum from the package and
use all 17 test strips. When it is time to
replace the drum, insert the first drum
with the damaged bar code. When the
error message is displayed, press the
SET button. The meter uses the code
from the previous drum. The drum symbol and “CTRL” flash in the display, requesting you to perform a quality control
check. You can use all 17 test strips. The
drum symbol continues to flash in the
display until a new drum is inserted.
87
9.2
Troubleshooting
This message/
symbol appears ...
and means:


If you inserted the second or third drum
from a pack, press the SET button. The
meter uses the bar code from the first
drum. The error message “E-2” disappears. The drum symbol and “CTRL”
flash in the display, requesting you to
perform a quality control check. You can
use all 17 test strips. The drum symbol
continues to flash in the display until a
new drum is inserted.
If you inserted a drum from a singledrum pack, you can no longer use this
drum. Insert a new drum.
All test strip drums in the same package
have a bar code unique to that package. Do not try to code the meter using
drums from a different package. If the
test strips and bar code do not belong
together, inaccurate blood glucose results may be obtained. Check you are
using the correct drums by comparing
their lot codes. The lot code is printed on
the label of the test strip drum next to
the
symbol.
88
This message/
symbol appears ...
and means:
If the message is still displayed, please
contact Customer Support (for details
see Chapter 19).
CTRL
The 90-day “use-by” period has been exceeded.
The test strips in the drum are unusable.
Insert a new drum.
If you continue to use the drum, carry
out a quality control check. The test
results obtained under these conditions
may only be used for reference purposes
and must not be used for decisions regarding therapy. Date and drum symbol
continue to flash in the display until a
new drum is inserted.
 The 90-day “use-by” period has been exceeded. You performed the requested quality
control check and flagged it as such.
 When retrieving results: The test strips used
to obtain the stored result were unusable
(more than 90 days old).
The test results obtained under these
conditions may only be used for reference purposes and must not be used for
decisions regarding therapy.
89
9.2
Troubleshooting
This message/
symbol appears ...
and means:
This message/
symbol appears ...
and means:
A test error has occurred.
The test strip is stuck in the guide.
Turn the meter off and on again. Repeat the test.
Turn the meter off. Pull the strip out of the meter.
Open the drum compartment and remove the
drum. Reinsert the drum and close the drum
compartment. The drum symbol and “CTRL”
flash in the display when the meter is turned on.
Perform a quality control check. You can use all
remaining test strips. The 90-day use-by period
will no longer be properly calculated for this
drum. The drum symbol continues to flash in the
display until a new drum is inserted.
There was not enough blood or control solution
on the test strip.
Turn the meter off and on again. Repeat the test
with a larger drop of blood or control solution and
a new test strip.
 You forcibly removed the test strip during
testing.
Turn the meter off and on again. Repeat the
test with a new strip, this time ejecting it by
means of the ON/OFF button.
 You bent the test strip while applying blood
or control solution or during measurement.
Turn the meter off and on again. Repeat the
test with a new strip.
It is too warm or too cold for the test, i.e. warmer
than +45 °C or colder than +5 °C. No test result
is displayed or saved.
Turn the meter off. Let the meter and test strips
slowly cool down or warm up. Turn the meter
on and repeat the test. The optimum measuring
temperature is between +10 °C and +40 °C.
 The optical system cover may not be closed
properly.
Ensure that the optical system cover is firmly
in place.
90
91
9.2
Troubleshooting
This message/
symbol appears ...
and means:
 You applied the blood drop or control solution
drop too soon.
Turn the meter off and on again. Repeat the
test. Wait until the flashing hand symbol and
blood drop symbol appear in the display and
the meter beeps (provided the beep tone is
turned on) before applying blood or control
solution.
 The optical system is dirty.
Clean the optical system (see Chapter 7
“Cleaning the Accu-Chek Integra meter”)
and repeat the test.
 The meter was turned off and on again. The
strip is still in the meter.
Turn the meter off. Hold the meter upright
and let the strip drop out, or remove the strip
manually, even if it takes a small amount of
force.
 You forcibly removed the test strip during
testing.
This message/
symbol appears ...
and means:
 The test strip that has been advanced is
defective.
Hold the meter with the strip pointing downwards. Turn the meter off and let the strip
drop out. Turn the meter on again. Repeat
the test with a new test strip.
The two arrows do not start to flash. The meter
turns off after 5 minutes and the computer displays a download-related error message.
 An error occurred while data was being
downloaded.
Download the data again.
 A bright light source is too close to one of the
infrared windows.
Increase the distance to the light source and
re-start the data download.
Turn the meter off and on again. Repeat the
test with a new strip, this time ejecting it by
means of the ON/OFF button.
92
93
9.2
10
Troubleshooting
This message/
symbol appears ...
Technical data
Meter type
Accu-Chek Integra
Catalogue number/serial
number
See type plate on the back of the
meter.
Test principle
Determination of glucose in fresh
capillary blood by reflectance photometry. When using different specimen material please refer to the
package insert that came with the
Accu-Chek Integra test strip drums.
Measuring range
0.6–33.3 mmol/L (10–600 mg/dL)
Sample size
Approx. 1.5 µL (1 microlitre =
1 thousandth of a millilitre)
 A computer software error occurred.
Read the Manual for the download software.
Measuring time
Approx. 15 seconds (depending on
concentration)
 Electrostatic discharge
Turn the meter off and on again.
System operating conditions
+10 °C to +40 °C
Meter storage conditions
Without batteries and test strip
drum: -40 °C to +70 °C
and means:
 The meter and the infrared cable are too
far away from one another or not correctly
aligned.
Decrease the distance between the infrared
windows of the two devices to less than
10 cm.
Make sure the two infrared windows are
pointing towards one another. Re-start the
data download.
 Meter is defective.
Please contact Customer Support (see Chapter 19 for details).
With batteries but without test strip
drum: -10 °C to +50 °C
With batteries and test strip drum:
+2 °C to +30 °C
94
95
10
Technical data
Humidity
Less than 85 % relative humidity
Memory capacity
100 test results with time and date,
average, highest and lowest blood
glucose reading
Dimensions
103 x 52 x 31 mm
Weight
Approx. 120 g with batteries and
test strip drum
Display
Liquid Crystal Display (LCD) with
symbols
Automatic power-off
After 60 seconds / 5 minutes
depending on testing status
Power supply
2 batteries (type AAA, LR 03, AM 4
or Micro)
Battery life
at least 500 readings
Interface
Infrared interface
Safety class
III
LED/IRED
Laser Class 1
96
Electromagnetic compatibility
This device meets the electromagnetic immunity requirements as per
ISO 15197 Annex A. The chosen
basis for the immunity tests was
basic standard IEC 61000-4-2. In
addition it meets the electromagnetic emissions requirements as
per EN 61326. Its electromagnetic
emission is thus low. Interference
from other electrically driven equipment is not to be anticipated.
Blood glucose concentrations may be measured in whole blood or
plasma. Although you always apply whole blood to the test strip, your
meter displays blood glucose results that relate either to whole blood
or plasma. To see whether your blood glucose meter displays results
relating to whole blood or to plasma, see the package insert that came
with your test strips. It also contains information on how the system
works, on the test principle and on reference methods.
97
Part 2
ACCU-CHEK
Softclix
Lancing Device
Instructions for Use
98
®
11
Introduction
A
B
11.1 Your lancing device at a glance
Cap
B
Comfort Dial (for depth selection)
Protective cap
E
Lancet
F
Lancet holder
G
Semi-circular cut-out
H
Ejector
I
Transparent release button
J
Priming button
through
0°
18
D
ed
G
H
I
®
Notch
E
F
ACCU-CHEK
C
D
t ur n
A
C
®
Softclix
J
100
101
11.2 About the Accu-Chek Softclix lancing device
12
Using the Accu-Chek Softclix lancing device
The Accu-Chek Softclix lancing device is an easy-to-use lancing device
that has been specially developed to allow virtually pain-free collection
of capillary blood from a fingertip or earlobe.
12.1 Inserting or exchanging the lancet
Pull off the cap.
The depth of lancet penetration can be precisely adjusted to suit individual skin requirements.
Use the Accu-Chek Softclix lancing device only with Accu-Chek Softclix
lancets, as using any other lancet may prevent or impair the proper
functioning of the lancing device.
The Accu-Chek Softclix lancing device is intended for selfmonitoring by a single person. It must not be used on more
than one person due to the risk of infection.
If there is already a lancet in the lancing
device, slide the ejector forwards to
remove it.
Insert a new lancet in the lancet holder.
and push it until it clicks.
Remove the protective cap from the
lancet with a twisting motion.
102
103
12.1 Inserting or exchanging the lancet
12.2 Preparations for taking blood
Press the cap on again until it clicks. Be
sure to align the notch on the cap with
the centre of the semi-circular cut-out
on the ejector.
The best place for obtaining capillary blood is from a fingertip or an
earlobe. We recommend using the side of a fingertip, as this registers
least pain.
To avoid infection, use a new lancet each time you take blood.
Using each lancet once only helps ensure virtually pain-free
blood sampling.
Carefully dispose of used lancets so they cannot cause injury.
Wash hands with warm water and soap and dry well. This helps ensure
proper hygiene and stimulates blood flow.
Selecting penetration depth with the Comfort Dial
Modern blood glucose meters can take readings using just a tiny drop of
blood. Usually, enough blood can be obtained with a low depth setting.
This significantly reduces the pain of pricking the skin, after-pain is
reduced or absent altogether, and tissue scarring is minimized.
The penetration depth is set by rotating
the Comfort Dial (cap).
If you are using the Accu-Chek Softclix
lancing device for the first time, set the
depth selection dial to 1.
104
105
12.3 Obtaining blood
First check that you have set the desired
penetration depth.
Press in the priming button until it clicks.
Be careful not to press the release button at the same time. The lancing device
is primed when a yellow dot appears in
the transparent release button.
Gently press the lancing device against
the fingertip or earlobe and press the
release button, taking care not to push
against the priming button or to impede
its free movement.
Gently massage the fingertip or earlobe to encourage a drop of blood to
form. If you do not obtain sufficient blood, try again with progressively
deeper settings.
Perform a blood glucose test as described in Chapter 4 “Testing blood
glucose”.
Do not prime the Accu-Chek Softclix lancing device until you
are ready to take blood.
Never expose the Accu-Chek Softclix lancing device to extreme
temperatures (e.g. in a hot car).
Subsequent treatment of the puncture site
Wipe the puncture site with a dry, clean paper towel and keep it clean.
12.4 Cleaning the Accu-Chek Softclix lancing device
Clean the Accu-Chek Softclix lancing device weekly using a cloth moistened with water or 70 % alcohol (available from your pharmacist).
In addition, thoroughly wipe the inside of the cap using a cotton bud
moistened with 70 % alcohol.
Allow the Accu-Chek Softclix lancing device time to dry thoroughly.
Never dip the Accu-Chek Softclix lancing device in water or
alcohol.
106
107
Part 3
ACCU-CHEK
Softclix AST
ACCESSORY
Clear plastic AST cap for
blood glucose determination
with Accu-Chek Integra on
alternative sites
Instructions for Use
108
®
13
Introduction
13.1 A new way to test
Traditionally, blood samples for blood glucose testing are taken from the
fingertip or from the earlobe. With the Accu-Chek Integra system, you
now also have the option of using capillary blood samples from other
sites, such as the base of the thumb, the forearm, the upper arm or the
calf. Testing with blood from these alternative sites is referred to as
Alternative Site Testing (AST).
Blood from the fingertip can be used for testing at any time. If
alternative sites are used, there are certain times which are not
suitable for testing. Before you take a sample from a site other
than the fingertip you should therefore read these instructions
so that you can decide which option is right for you. Please
consult your physician before using alternative sites for blood
glucose testing.
The Accu-Chek Softclix lancing device and Accu-Chek Softclix
AST Accessory are intended for self-monitoring by a single
person. They must not be used by more than one person due to
the risk of infection.
To avoid infection, use a new lancet each time you take blood.
Using each lancet once only helps ensure virtually pain-free
blood sampling.
In rare cases bruising may occur after sampling.
Use the AST cap exclusively for collecting blood from alternative
sites.
If you use this cap to collect blood from a fingertip, the lancet
penetrates too deep into the finger. Pricking the skin is then
very painful and can result in injury.
Please also follow the instructions for your Accu-Chek Integra
blood glucose meter and test strips and for the Accu-Chek
Softclix lancing device.
110
111
13.1 A new way to test
13.2 Important information for users
Alternative Sites for Testing
Before you perform a test with blood from an alternative site, you should
be aware of the following limitations:
Capillary blood from the fingertip responds more quickly to changes in
blood glucose levels than blood from alternative sites. Blood glucose
values measured in blood taken from these sites may therefore differ
from values measured in blood from the fingertip. This is because the
fingertips contain more blood vessels than other sites.
�
�
�
�
�
�
Because of the possibility of discrepant blood glucose readings, alternative site testing is not recommended:
 up to two hours following a meal when blood glucose values are
rising quickly
�
�
 after exercise

�
�





Hand below the little
finger
Hand below the thumb
Inside of the forearm
Upper arm
Outside of the forearm
Calf

 if you have a temperature or if a medical condition is limiting your
mobility, e.g. after breaking a leg or being confined to bed
Preferred
alternative
sites
 if you suspect that your blood glucose is extremely low
(hypoglycaemia)
 if you know that you sometimes do not notice when you are
hypoglycaemic
 during peak action time of basal insulin or fast-acting insulin analogues
 up to two hours after injecting a fast-acting insulin analogue
112
113
13.2 Important information for users
If you are considering AST for your glucose measurements, please
discuss this first with your healthcare professional.
Pre-test Checklist
If the displayed blood glucose result does not match how you
feel, you should do a fingertip test to check the result. If the
fingertip result still does not match how you feel, contact your
doctor.
Do not change your treatment decisions based on just one AST
result.
i
114
The success of collecting a suitably sized drop of blood from
alternative sites may differ from person to person and from
alternative site to alternative site.
115
14
AST testing
14.1 Preparing for AST testing
1. Remove the blue cap from the
Accu-Chek Softclix lancing device.
2. Insert a new Accu-Chek Softclix
lancet into the lancet holder and
push it in until it clicks. Remove the
protective cap from the lancet with a
twisting motion.
3. Now place the clear plastic AST
cap on the device and press until it
clicks. Set the penetration depth to
the highest setting (5.5). (For AST on
the base of the thumb a setting of
3-4 is often sufficient.)
To obtain a sufficiently large drop of
blood from alternative sites, lancing
must be deeper than on the finger.
However, these sites are usually less
sensitive to pain and most patients
don`t feel any pain at all.
Do not use the clear cap for
sampling from the fingertip!
4. Press in the priming button until it
clicks (the lancing device is primed
when a yellow dot appears in the
transparent release button).
116
117
14.1 Preparing for AST testing
5. Choose a fleshy area of the alternative site and wash it with warm,
soapy water or use an alcohol wipe.
Ensure that the skin is dry before
taking a blood sample.
As an example you can use the top side
of your forearm, approximately 5 cm below the elbow.
6. Firmly press the clear AST cap
against the selected site. Press the
release button and continue to apply
pressure to the site for a couple of
seconds. You can watch the drop of
blood form through the clear cap.
The blood drop should be approximately
this size: 
If the drop is smaller, release the pressure for a few seconds, keeping the device on the skin. Then re-apply pressure
until you get a sufficiently large drop of
blood.
118
14.2 Measuring blood glucose
1. Obtain a drop of blood as described
above.
2. Hold the meter so the test strip is
pointing downwards at a slight angle.
Touch the front edge of the test strip
against the blood without delay.
The strip draws up the blood. As soon
as the correct amount of blood has
been drawn up, the meter beeps and
the test commences automatically.
The meter recognizes if too little
blood has been applied and displays
an error message. 000 appears in
the display at the start of the test.
3. Dispose of the used lancets and test
strips safely.
4. Remove the clear AST cap from the
lancing device and replace it with the
original plastic cap.
119
15
Cleaning the Accu-Chek Softclix lancing device
and the AST Cap
Clean the lancing device weekly using a cloth moistened with soapy
water or 70 % alcohol (available in pharmacies).
In addition, thoroughly wipe the inside of the blue cap and the clear AST
cap using a cotton bud moistened with 70 % alcohol.
Allow the lancing device and the two caps to dry thoroughly before performing a new test.
Part 4
ACCU-CHEK
Integra
Notes:
 Do not prime the device until you are ready to take blood.
 Carefully dispose of used lancets to avoid injuries.
 Never expose the Accu-Chek Softclix lancing device to extreme
temperatures (e.g. in a hot car).
 Never dip the Accu-Chek Softclix lancing device in water or alcohol.
120
BLOOD GLUCOSE MONITORING SYSTEM
Appendix
®
16
System components
With your Accu-Chek Integra meter use only Accu-Chek Integra test strip
drums. The drums contain 17 test strips. Each drum comes individually
packaged in its own container.
The test strip drums are available from your pharmacist or Diabetes
Australia.
For quality control checking of your Accu-Chek Integra meter use only
Accu-Chek Integra Control solutions (see Chapter 6 “Checking the
Accu-Chek Integra meter”).
For virtually pain-free blood sampling we recommend the
Accu-Chek Softclix lancing device and Accu-Chek Softclix lancets.
These are available in various pack sizes:

25 Accu-Chek Softclix lancets REF 0 3307492001
17
Guarantee
The statutory guarantee provisions governing the sale of consumer
goods in the country of purchase shall prevail.
18
Patents
Accu-Chek Integra blood glucose meter
Patents:
US 5,463,467, US 5,720,924, US 5,863,800, US 6,707,554,
US 6,475,436
Patent Applications:
EP 0 622 119, EP 0 632 262, EP 1 022 565, EP 1 117 989,
EP 1 189 064, US patents pending
 100 Accu-Chek Softclix lancets REF 0 3307506001
 200 Accu-Chek Softclix lancets REF 0 3307484001
N.B. Not all pack sizes may be available in all countries.
 To order a new AST cap please contact your nearest
Roche Diagnostics office.
Accu-Chek Softclix lancing device
EP-B-0565970, EP 1 034 740, US Re 35803, US 4,924,879,
US 6,419,661
German Design Model: DE 49900488.4
Your purchase entitles you to use the Accu-Chek Softclix lancing device
exclusively with Accu-Chek Softclix lancets.
122
123
19
Local customer support and service
19.2 Contact us
19.1 Information and repair
Accu-Chek Enquiry Line: Freecall 1800 251 816
Information service
If you have any questions on how to use your Accu-Chek Integra meter
or Accu-Chek Softclix lancing device or the AST cap, if any of the results
you obtain seem implausible, or if you suspect the meter or lancing device have a fault, please contact customer support and service. See the
next chapter for details.
Roche Diagnostics Australia Pty Ltd.
31 Victoria Avenue
Castle Hill, NSW 2154
Repair service
Please note that any repair, adjustment or other change of the meter or
lancing device must only be performed properly by persons who have
been authorized by Roche Diagnostics. If you suspect that the meter
or lancing device have a fault, please start by contacting your Roche
Diagnostics customer support representative. Our staff will attempt to
identify and solve your problem over the phone.
Web: www.accu-chek.com
124
Telephone: (02) 9899 7999
Facsimile: (02) 9894 7831
125
20
Alphabetical index
A
Alternative sites .............................................................................. 112
Alternative site testing ................................................................ 109 ff.
AST cap ...................................................................... 117 ff., 120, 122
Average .................................................................................. 60, 86 ff.
B
Bar code ........................................................................... 14, 30, 80 ff.
Batteries
Inserting or replacing ........................................................... 20 ff.
Lifetime ............................................................................. 23, 96
Symbol .............................................................................. 23, 82
Types .......................................................................... 12, 21, 96
Beep tone, turning on or off ........................................................... 38 f.
Beep tone symbol ............................................................................. 79
Blood
Dosing the strip ................................................................... 51 ff.
Obtaining a drop .............................................. 50, 105 ff., 116 ff.
Too little applied ...................................................................... 53
Volume .............................................................................. 15, 95
Blood drop symbol ............................................................. 50 f., 66, 79
126
C
Checking the meter ...................................................................... 65 ff.
Cleaning
Meter .................................................................................. 71 ff.
Lancing device ...................................................................... 107
AST cap ................................................................................. 120
Cleaning solution ......................................................... 71, 74, 107, 120
Coding, test strip drum ............................................................... 14, 30
Computer, downloading results to a .............................................. 62 ff.
Control solution ..................................................................... 65 ff., 122
Control window, test strip drum ............................................ 12, 31, 35
Customer support ........................................................................ 124 f.
CTRL symbol ..................................................................... 65 f., 68, 81
D
Date, setting the date .................................................................... 46 f.
Display test ................................................................................. 25, 50
Display messages ......................................................................... 79 ff.
Disposal of
Batteries .................................................................................. 24
Lancets ................................................................................. 104
Test strip ................................................................................. 55
Test strip drum ........................................................................ 29
Downloading data ......................................................................... 62 ff.
Drum compartment ................................................................ 10, 27 ff.
Drum symbol .................................................................... 85 ff., 89, 91
127
20
Alphabetical index
E
L
Electromagnetic interference ............................................................ 77
Error messages ............................................................................ 84 ff.
Expiry date, test strips ...................................................................... 31
Lancet ................................................................. 100, 103 f., 106, 122
Lancing device ................................................................... 100 ff., 122
Lot code ........................................................................................... 88
Lowest result ................................................................................. 60 f.
F
Full display test ................................................................................. 25
G
Guarantee ....................................................................................... 123
H
Hand symbol ...................................................................... 50 f., 66, 79
Highest result ................................................................................ 60 f.
Humidity ........................................................................................... 77
I
Implausible results ............................................................................ 57
Infrared cable .......................................................................... 62 f., 94
Infrared window ................................................... 12, 15, 62 f., 93 f., 96
128
M
Measurement conditions ............................................................... 75 ff.
Measuring principle .......................................................................... 95
Measuring time ................................................................................. 95
Measuring range ......................................................................... 56, 95
MEMO button .................................................................................... 10
MEMO symbol ............................................................................... 80 f.
Memory ........................................................................................ 58 ff.
Meter
Checking the meter ............................................................. 65 ff.
Cleaning the meter ............................................................. 71 ff.
Description of ...................................................................... 10 ff.
Storing the meter ................................................................ 75 ff.
129
20
Alphabetical index
O
S
ON/OFF button .................................................................................. 10
Optical system .................................................................................. 10
Optical system, cleaning the optical system .................................. 71 ff.
Optical system, opening the optical system ....................................... 72
Sample size ................................................................................ 15, 95
Service ........................................................................................ 124 f.
SET button ........................................................................................ 10
SET menu ..................................................................................... 36 ff.
Settings
Beep tone ....................................................................... 36, 38 f.
Date ............................................................................... 36, 46 f.
Time ............................................................................... 36, 44 f.
Time/date format ............................................................ 36, 42 f.
Year ................................................................................ 36, 40 f.
Power-off time ..................................................... 26, 51, 55, 64, 67, 96
Power-off automatic ......................................................................... 96
Software ........................................................................................... 62
Storage conditions ........................................................................ 75 ff.
Symbols explained ........................................................................ 78 ff.
Symbols
Battery .............................................................................. 23, 82
Beep tone ................................................................................ 79
CTRL ........................................................................ 65 f., 68, 81
Drop ......................................................................... 50 f., 66, 79
Drum ....................................................................... 85 ff., 89, 91
Hand ........................................................................ 50 f., 66, 79
MEMO .................................................................................. 80 f.
Test strip ................................................................................. 79
Thermometer .......................................................................... 81
System components ....................................................................... 122
P
Performance checking, meter ....................................................... 65 ff.
Penetration depth ................................................................... 105, 117
Plausible results ............................................................................... 56
Q
Quality control check .................................................................... 66 ff.
R
Results ............................................................... 19, 24, 53, 56 f., 58 ff.
Results, downloading to a computer ............................................. 62 ff.
Results, viewing stored results .......................................................... 59
130
131
T
Technical data .............................................................................. 95 ff.
Temperature range .................................................................. 75 f., 95
Test strip drum, inserting or replacing ........................................... 27 ff.
Test strip
Ejection ................................................................................ 54 f.
Guide ....................................................................................... 12
Symbol .................................................................................... 79
Testing blood glucose ................................................................... 48 ff.
Testing conditions ................................................................... 75 ff., 95
Thermometer symbol ........................................................................ 81
Time, setting the time .................................................................... 44 f.
Time/date format, setting the format .............................................. 42 f.
Troubleshooting guide ................................................................... 84 ff.
Type plate ...................................................................................... 12 f.
U
Units (mmol/L and mg/dL) .................................................... 19, 25, 79
Use-by date, test strip drum ............................................... 34 f., 55, 89
V
Values, highest, lowest, average .................................................... 60 f.
Y
Year, setting the year ...................................................................... 40 f.
132
Download PDF