Instructions For Use: Blood Glucose Meter

Blood Glucose Meter
Instructions for use
0088
0 5241430001(02) – 2008-05
ACCU-CHEK is a trademark of Roche.
Roche Diagnostics GmbH

68298 Mannheim, Germany
www.accu-chek.com
Explanation of symbols
On the packaging and on the type plate of the meter you may encounter the following symbols shown here
with their meanings:
Consult the instructions for use 0088 This product fulfils the requirements of
Directive 98/79/EC on in vitro diagnostic
Caution (refer to accompanying docu- medical devices.
ments). Please refer to safety-related
notes in the manual accompanying this This product fulfils the legal require-
instrument. ments of the People’s Republic of China
on the use of certain substances in
Store at electronic products.
The explanation of any other symbols can be found
Manufacturer in the instructions/inserts, accompanying compo-
nents within the packaging.
Catalogue number
Lot number
IVD For in vitro diagnostic use
Last update: 2008-05

2
Intended use
Intended use
The Accu‑Chek Active blood glucose meter Healthcare professionals must also read the
Meter for quantitative determination of blood glucose instructions in Chapter 10 “Testing blood
values in fresh capillary blood using Accu‑Chek glucose in more than one patient – Informa-
Active test strips. tion for healthcare professionals”.
Suitable for self-testing. Any object coming into contact with human
blood is a potential source of infection (see:
The meter may be used by patients who test their Clinical and Laboratory Standards Institute:
own blood glucose as well as by healthcare profes- Protection of Laboratory Workers from Occu-
sionals for monitoring patients’ blood glucose values. pationally Acquired Infections; Approved
Visually impaired persons must not use the meter. Guideline – Third Edition; CLSI document
M29-A3, 2005).
3
About these Instructions for use

Please read these Instructions for use carefully and remember that, in order to keep your meter in tip-top
completely before testing blood glucose for the first condition, you need to comply with all instructions
time. If you have any questions, please contact your given in addition to following the correct operating
customer support and service centre (see Chapter procedures. The meter is a precision instrument.
17). Improper handling can impair its operation.
These Instructions for use will help you get to know We recommend you start by studying the location of
your new meter step by step. They will provide you the key features of your meter (see Chapter 1.1).
with all the information you need to operate, trouble- Practise all of the operations described in these
shoot and care for your meter. It is important to Instructions for use, and also practise testing.
4
In these Instructions for use you will come across All instructions appear in a coloured frame as shown
three kinds of notes. Please read these very care- below:
fully.
1 Insert the test strip into the meter.
This symbol indicates a possible risk of
injury or of damage to your own health or
the health of others.
This symbol draws attention to actions that
could result in damage to your meter.
This symbol draws attention to important
i information.
5
In these Instructions for use you will see examples of Please note:
display screens. Elements that are surrounded by a All dates, times or results shown on the display
halo in these examples actually flash on the meter’s screens in these Instructions for use are intended
display. only as examples. They show results in units of
mg/dL (e.g. 128 mg/dL), dates in the day-month
format (e.g. 18- 5) and times in the 24-hour clock
(e.g. 15:27). Others can (and will) be shown on your
meter’s display screen. Your meter can, for example,
display results in mmol/L (e.g. 7.1 mmol/L), dates in
the month-day format (e.g. 5-18) and times in the
12-hour clock (e.g. 3:27pm).
6
Contents
Contents
1 Getting to know your meter 12
1.1 Your meter at a glance................................................................................................................... 12
1.2 The main features at a glance........................................................................................................ 14
2 Steps before testing 16
2.1 Checking the contents................................................................................................................... 16
2.2 Checking the unit of measurement for blood glucose..................................................................... 17
2.3 Removing the protective film from the battery................................................................................ 18
2.4 Performing a display check............................................................................................................ 19
3 Setting the time and date 21
3.1 Overview....................................................................................................................................... 22
3.2 Making settings............................................................................................................................. 24
4 Coding 28
7
Contents
5 Testing blood glucose 30

5.1 Preparing to test blood glucose...................................................................................................... 30
5.2 Testing blood glucose..................................................................................................................... 31
Turning the meter on............................................................................................................... 31
Applying blood with the test strip in the meter......................................................................... 34
Applying blood with the test strip outside the meter................................................................. 36
Turning the meter off............................................................................................................... 39
Flagging test results................................................................................................................ 40
5.3 Checking the test result using the test strip control window........................................................... 43
5.4 Symbols seen before, during or after testing and what they mean.................................................. 45
5.5 Notes on blood glucose testing...................................................................................................... 46
5.6 Evaluating results.......................................................................................................................... 49
Measuring range..................................................................................................................... 50
Implausible results – possible sources of error........................................................................ 51
8
Contents
6 Using the meter as a diary 53

6.1 Memory......................................................................................................................................... 53
6.2 Retrieving results from the memory............................................................................................... 54
6.3 Retrieving averages....................................................................................................................... 58
6.4 Downloading test results................................................................................................................ 64
If downloading is unsuccessful................................................................................................ 69
7 Checking your meter 70
7.1 Preparing for a performance check................................................................................................ 71
7.2 Carrying out a performance check................................................................................................. 72
7.3 Possible sources of error during performance checks.................................................................... 79
8 Cleaning the meter 82
8.1 External parts................................................................................................................................. 83
8.2 Test strip guide and measuring window......................................................................................... 83
9
Contents
9 Changing the battery 87

10 Testing blood glucose in more than one patient – Information for healthcare professionals 91
10.1 Testing blood glucose..................................................................................................................... 93
10.2 Disinfecting the meter.................................................................................................................... 95
11 Measurement and storage conditions 96
11.1 Temperature.................................................................................................................................. 96
11.2 Atmospheric humidity.................................................................................................................... 98
11.3 Light conditions............................................................................................................................. 98
11.4 Sources of interference.................................................................................................................. 99
12 Symbols, problems and error messages 100
12.1 Symbols shown in the display...................................................................................................... 101
12.2 Problems..................................................................................................................................... 107
12.3 Error messages............................................................................................................................ 109
10
Contents
13 Technical data 116

14 Disposing of your meter 121
15 System components 122
16 Patents 123
17 Customer support and service 124
17.1 Information service and troubleshooting....................................................................................... 124
17.2 Addresses.................................................................................................................................... 124
18 Alphabetical index 127
11
Getting to know your meter
1 Getting to know your meter

1.1 Your meter at a glance
8 1 Display
2 S button (retrieving settings for time and date)
3 Measuring window cover
4 Measuring window (underneath the cover)
1 5 Test strip guide
7
6 M button (retrieving readings from the memory,
changing time / date)
6 2 7 Code chip
5 8 Infrared window
12
9 Code chip slot

10 Code chip (inserted)
14 11 Type plate
13 12 Battery compartment
12 9 13 Battery (type CR 2032)
10 14 Locking catch for opening the battery
compartment
11
13
1.2 The main features at a glance
Fast testing Flagging

results
The meter needs only approximately 5 seconds for You can flag results with different symbols, which
each test. indicate particular situations during the test.
Easy
testing Memory

For testing, you do not need to press a single The meter automatically saves up to 350 results
button. You insert a test strip into the meter, which with the time and date of the test and all other
switches it on, apply blood to the test strip, read information that is important for the test.
the value and then pull the test strip out of the Integrated data analysis
meter. From the stored test results your meter can calcu-
Blood
volume checking late your average values for the last 7, 14 or 30
To perform a test, the meter requires 1–2 µL blood days.
(1 µL (microlitre) = 1 thousandth of a millilitre). The
meter detects if the applied amount is not suf-
ficient.
14
Data
transfer
The meter has an infrared port enabling you to
download stored test results to a computer.
Applying
blood outside the meter
When the meter prompts you to apply blood, you
can remove the test strip from the meter, apply the
blood and insert it back into the meter.
15
Steps before testing
2 Steps before testing

2.1 Checking the contents Check that the contents of the package are complete.
You will find a list with the contents on the box.
If anything is missing, please contact your customer
support and service centre (see Chapter 17).
16
2.2 Checking the unit of measurement for blood glucose
Blood glucose results can be displayed in two differ- You can find the unit of measurement that your meter
ent units (mg/dL or mmol/L). Two different versions of displays on the type plate on the back of your meter.
the same meter are therefore available. Please check If you do not know which is the right unit for you, ask
if your meter displays the unit you are accustomed to. your doctor.
The unit of measurement that your meter
displays cannot be changed. If the wrong unit
is printed on the type plate, please consult
your dealer or pharmacy. A wrong unit of
measurement could lead to test results being
misinterpreted.
Type plate
17
2.3 Removing the protective film from the battery
The meter is supplied with a battery inserted. The

battery contacts are covered with a protective film to
prevent the battery from becoming drained prema-
turely. Before using the meter, remove the protective
film. You will see the film projecting from the battery
compartment on the back of the meter.
1 Simply pull the film vertically out of the meter.

You do not need to open the battery compart-
ment to do this.
i For how to change the battery, see chapter 9.
18
2.4 Performing a display check
You can check if all of the display elements are

properly displayed, by carrying out a full display
check.
1 With the meter turned off, press the M and S
buttons at the same time until the meter is
switched on automatically (more than 3 sec-
onds).
Press at the same time

for more than 3 seconds
19
2 Compare the display of your meter with the

one shown here.
If any of the display elements are missing or the
unit shown for the blood glucose results is not the
correct one, please ask your dealer/pharmacy to
exchange the meter.
mg/dL meter mmol/L meter
3 Press any button to terminate the display
check and turn off the meter.
20
Setting the time and date
3 Setting the time and date

The time and date is not preset in new meters. You When you set the time and date for the first time, the
can still, perform blood glucose tests. In this case, factory defaults are displayed.
however, the meter displays the time 0:00 (0:00am) The settings are made in the following order (default
and the date 0- 0. This means that test results are in brackets):
saved without a time and date. Averages cannot be
calculated, and when downloaded to a computer, the 1. Time and date format (24-hour display with day-
statistical evaluation of test results is very restricted month date format)
or cannot be performed at all. 2. Time – hour, minute (0:00)
So that test results are saved with a time and date, 3. Year (year of manufacture)
you must set the time and date and, if required,
change the format in which they are displayed. 4. Date – month, day (month of manufacture, day 15)
If you do not wish to set the time and date, proceed

to Chapter 4 “Coding”.
21
3.1 Overview
Turning the meter on
Press the S button and hold it down (for more than 3

seconds) until the depicted display appears.
When set-up appears in the display, you can make

changes to the time and date.
Press for more than
3 seconds
Changing settings
Press the M button.
Holding down the M button increases the number

quickly.
For a detailed description of how to set the time and
date, see Chapter 3.2.
22
Time and date format Confirming the change and continuing with the
Time (hour, minute) next setting
Year Press the S button briefly.
Date (month, day)
Final display
Turning the meter off at any time
Press the M and S buttons briefly at the same time.
First confirm your last change with the S button,

since the change will otherwise be lost.
If you do not press any buttons, the meter turns off
automatically after approx. 30 seconds. In this case,
all changes are lost and the original settings remain
Press briefly at the unchanged.
same time
23
3.2 Making settings
Setting the time and date format You can choose between two formats:
24-hour format 35 time from 0:00 to 23:59, date
in the day-month format (DD-MM)
12-hour format 35 time from 12:00 to 11:59
followed by am or pm, date in the month-day
format (MM-DD)
When you change the time and date format, the time
and date are changed accordingly.
1 Press the M button briefly to switch from one

format to the other.
2 Press the S button to go to the time.
24
Setting the time The hours flash in the upper left corner of the
display.
1 Press the M button to set the hours.

2 Press the S button to go to the minutes.
The minutes flash in the display.
3 Press the M button to set the minutes.

4 Press the S button to go to the year.
25
Setting the year The year flashes in the upper right corner of the
display.
1 Press the M button to set the year.

2 Press the S button to go to the month.
Setting the date The month flashes in the upper right corner of the
display.
1 Press the M button to set the month.

2 Press the S button to go to the day.
26
The day flashes in the display.
3 Press the M button to set the day.

4 Press the S button, and you will see the final
display.
Final display
1 Check that time and date are correct.

2 Press any button to turn off the meter.
27
Coding
4 Coding
A code chip is used to give the meter information Each time you open a new pack of test strips,
about the properties of the test strips. This is why you must replace the old code chip from the
each pack of test strips contains a code chip. meter with the new one from the pack. Code
chips from other packs may contain informa-
tion that is incorrect for your new test strips,
and can therefore lead to incorrect test results.
Incorrect results can cause the wrong therapy
recommendation to be made and so lead to
serious adverse health effects.
28
Coding
1 Compare the code number on the chip with the

corresponding code number on the label of the
test strip container.
The three-digit number on the code chip (e.g. 689)

must match the three-digit number on the label.
Leave the meter turned off.
2 Gently slide the code chip into the slot on the

side of the meter.
You must feel the code chip lock into place.
29
Testing blood glucose
5 Testing blood glucose

Please also consult the directions given at the end of 1 Read the package insert which came with the
this Chapter in the section “Notes on blood glucose test strips.
testing”. 2 Wash your hands with warm water and soap,
and dry them well before you start to perform
the test.
5.1 Preparing to test blood glucose
You need the following items to carry out the test: This helps remove any residues from the skin (e.g.
from food, drinks or skin cream) which can disturb
your meter with the code chip inserted the test. This also stimulates blood flow and reduces
the pack of Accu‑Chek Active test strips that contamination of the puncture site.
belong to the code chip
3 Prepare your lancing device to collect blood.
a lancing device to collect blood
a lancet for the lancing device
30
5.2 Testing blood glucose
Turning the meter on 1 Take a test strip from the container and close the
container again immediately.
2 Hold the test strip so the arrows printed on it and

the orange square face upwards.
3 Without bending it, gently push the test strip into
the test strip guide in the direction of the arrows.
You should feel the test strip lock into place.
31
The meter turns on and first performs a default

display check (approx. 2 seconds).
4 Check that all the segments of the numeric

display (mg/dL meter) or (mmol/L
meter) are displayed.
mg/dL meter mmol/L meter If segments are missing, please contact your cus-
tomer support and service centre (see Chapter 17).
Following the display check, the code number is

displayed (689 is just an example).
32
5 Check that this code number is the same as the

code number on the label of the test strip con-
tainer.
If the numbers do not match, even though the code

chip in the meter is the one that belongs to the test
strip container, please contact your customer sup-
port and service centre.
Following the code number, the test strip symbol and

the flashing blood drop appear on the display. The
meter is now ready to perform a blood glucose test.
33
Applying blood with the test strip in the meter
When the test strip and the flashing blood drop

symbols are displayed, you have approx. 90 seconds
to apply blood to the test strip. After this the meter
turns itself off.
1 Prick the side of a fingertip with your lancing

device.
2 Encourage a drop of blood to form by gently
massaging your finger towards the fingertip.
3 Apply the drop of blood to the centre of the
orange field and then remove your finger from
the test strip.
34
The flashing hourglass symbol indicates that the

test is in progress.
The test is complete after approx. 5 seconds and the
result appears on the display. The meter automati-
cally saves the result.
Now you can

turn the meter off (see “Turning the meter off”),
or flag the result (see “Flagging test results”),
or go to the saved test results (see Chapter 6.1).
35
Applying blood with the test strip outside the meter
When the test strip and the flashing blood drop

symbols are displayed:
1 Remove the test strip from the meter.
The test strip and blood drop symbols flash in the

display. Now you have approx. 20 seconds to apply
blood to the test strip and to re-insert it into the
meter. If you do not re-insert the test strip within this
time, the meter displays the error message .
36
2 Prick the side of a fingertip with your lancing

device.
massaging your finger towards the fingertip.
4 Apply the drop of blood to the centre of the
orange field.
5 Push the test strip back into the test strip guide
in the direction of the arrows. You should feel the
test strip lock into place.
37
The test starts and the flashing hourglass symbol

indicates that the test is in progress.
The test is complete after approx. 10 seconds and
the result appears on the display. The meter auto-
matically saves the result.
Now you can

or flag the result (see “Flagging test results”),
38
Turning the meter off
1 Remove the test strip from the meter.
The meter turns itself off.

You can dispose of used test strips in your house-
hold waste.
If you do not remove the test strip and do not press
any buttons, the meter turns off automatically after
approx. 30 seconds.
39
Flagging test results
You can flag test results to describe certain events The General flag (asterisk symbol ): You can
connected to the result or particular characteristics of define the meaning of this flag yourself. For exam-
the result. You can only flag a test result while the ple, you can, use it for test results that you have
test strip is still in the meter and the result is being obtained from alternative sites or after physical
displayed. activities.
The Control flag (bottle symbol ) is intended for
You can choose from 4 flags: performance checks in which you apply control
The Before Meals flag (apple symbol ) is intend- solution to the test field instead of blood (see
ed for test results that you have measured before Chapter 7).
your meals.
The After Meals flag (apple core symbol ) is
intended for test results that you have measured
after your meals.
40
No flag While the test result is displayed:
1 Press the S button repeatedly until the desired

flag is displayed.
Control (bottle) Before meals (apple) The flags appear in the following order:
1. Before meals
2. After meals
3. General
Press briefly
4. Control
After meals
If you decide to not flag the test result, press the S
General (asterisk) (apple core) button repeatedly until no further symbol is dis-
played.
41
After choosing the desired flag, you can

In both cases, the test result is saved with the flag.
42
5.3 Checking the test result using the test strip control window
The test strip itself allows you to estimate the test

result and thus also to check the displayed result.
Before the test

There is a round coloured control window on the
back of the test strip.
1 Compare the colour of this window with the

coloured dots on the label of the test strip
container.
The colour of the control window must match the

colour of the top coloured dot (0 mg/dL, 0 mmol/L).
If the control window is a different colour, you must
no longer use the test strip.
43
After the test
The label on the test strip container shows blood If you find there is a noticeable disparity, repeat the
glucose values in mg/dL und mmol/L next to each test. If you cannot obtain a match, even after several
colour sample. tests, contact your customer support and service
centre.
1 Look for the value which is closest to your test
result. Only the test results displayed by the meter should be
used for therapeutic decisions. The colour compari-
Within 30–60 seconds after applying blood: son serves only as a plausibility check of the test
results.
2 Compare the colour of the control window on the
back of the test strip with the coloured dots on
the label of the test strip container.
44
5.4 Symbols seen before, during or after testing and what they mean
The following symbols can appear on the disply instead of a result: The result is lower than
before, during or after a test. For further information, 10 mg/dL (0.6 mmol/L).
please refer to Chapter 12.1. may indicate that your blood
glucose is very low (possibly a severe
hypoglycemia). Follow the relevant
instructions given by your doctor
immediately and repeat the test.
instead of a result: The result is higher than
600 mg/dL (33.3 mmol/L).
The test strips are past their
expiry date.
The battery is almost empty.
The temperature during the test was outside
the permitted range of +10 to +40 °C.
45
5.5 Notes on blood glucose testing
Incorrect results can cause the wrong therapy Use only test strips with an expiry date which has
recommendation to be made and so lead to not been exceeded. Test strips with an expiry date
serious adverse health effects. that has already passed can produce incorrect
results. If the expiry date has passed, the
Therefore, please follow the following instructions: symbol will be displayed in the test strip symbol.
Only use the Accu‑Chek Active meter with Check the expiry date on the label of the test strip
Accu‑Chek Active test strips that are approved by container. You will find it next to the symbol.
Roche Diagnostics GmbH. Other test strips deliver Also check that the current date is set in the meter
incorrect results. and that the inserted code chip belongs to the test
strip you are using.
If the code number on the display does not match
the code number on the test strip container, do not
perform blood glucose tests. Incorrect coding
produces incorrect results.
46
The test strips are sensitive to humidity and If you have not applied blood to the test strip in the
moisture. Only remove test strips from the con- available time and the meter has turned off:
tainer when your hands are completely dry. Close Remove the test strip and dispose of it. Start the
the test strip container again tightly with its origi- blood glucose test again with a new test strip.
nal cap immediately after removing a test strip. If you have removed the test strip from the meter
The cap of the test strip container contains a and the error message is displayed: You must
drying agent which protects the strips from mois- not use this test strip any more even if you have
ture. If moisture gets into to the test strip container not yet applied any blood. Start the blood glucose
through handling test strips with moist hands or if test again with a new test strip.
the container is left open, the drying agent loses its
effect. Unusable test strips may lead to incorrect
results.
47
You can touch the test field when you apply blood, Please also note the following points, as incorrect
but do not rub the drop of blood into the test field. results or error messages can otherwise occur:
Do not store used test strips in a container which Do not bend the test strip while inserting it into the
still contains unused test strips. This could make meter.
the unused test strips unusable. Unusable test Do not to bend or move the test strip before or
strips can lead to incorrect results. while applying blood, or while the test is per-
formed.
Do not apply blood to the test strip before the drop
symbol flashes in the display.
If or are not shown completely during the
default display check (e.g. ), results cannot be
displayed correctly. In this case, contact your
customer support and service centre.
48
5.6 Evaluating results
i Further information If the displayed test result reflects the way you
feel, continue as instructed by your doctor. If
If you missed the code number in the display after the displayed test result does not reflect the
you inserted the test strip, remove it from the way you feel, please perform a performance
meter and re-insert it. check with an Accu‑Chek Active control
If you want to apply blood to a test strip which is solution (see Chapter 7). Repeat the blood
glucose test afterwards. If the latest test result
not inserted into the meter: Do not remove the test
still does not reflect the way you feel, please
strip until the drop symbol flashes in the display. If
contact your doctor.
you remove the test strip before this time, the
meter turns itself off.
Do not change your treatment based on just
one result.
49
Measuring range
The meter measures blood glucose results in the

range from 10 to 600 mg/dL (0.6–33.3 mmol/L).
If the result is lower than 10 mg/dL (0.6 mmol/L),

is displayed instead of a result.
may indicate that your blood glucose is
very low (possibly a severe hypoglycemia).
Follow your doctor’s instructions immediately
and repeat the test.
If the result is higher than 600 mg/dL (33.3 mmol/L),

is displayed instead of a result. Repeat the test.
50
Implausible results – possible sources of error
If your meter repeatedly displays implausible results

Did you take the test strip from the container
or error messages, please check the following points. yes
to which the code chip in the meter belongs?
If your responses to the questions listed below are
Did you perform the test according to the
different from those given, make the respective yes
instructions for use?
corrections when you perform the next test. If you
have taken all of these points into account and still Did you wash your hands with warm water
obtain implausible results or error messages, contact and soap? Did you dry your hands thorough- yes
your customer support and service centre. ly?
Did you massage your finger only gently in
yes
the direction of the fingertip?
Did you use a used test strip? no
51
Did you bend the test strip while inserting it Is the test strip guide and measuring window
no yes
into the meter? clean?
Did you wait for the drop symbol to flash in Did you measure within the correct tempera-
yes yes
the display before applying blood? ture range (10–40 °C)?
Did you apply the drop of blood immediately Did you observe the storage conditions for
yes
after it formed? the meter and test strips (see Chapter 11
yes
Did you bend or move the test strip before or and the package insert that came with the
no test strips)?
during the test?
Are the test strips past their expiry date Did you take the sources of error into ac-
(check next to the symbol on the test count that are referred to in the package yes
no insert that came with the test strips?
strip container label and also the symbol
on your meter’s display)?
If your meter has been dropped, it can also lead to
implausible results or error messages. In this case
also contact your customer support and service
centre.
52
Using the meter as a diary
6 Using the meter as a diary

6.1 Memory In addition to the results, the time and the date, your
meter also saves other information that is important
Your meter can save up to 350 test results with their for the test. This includes all symbols which are
time and date. You do not need to do anything to save displayed with the result (except the battery symbol)
the results. The meter automatically saves all test and the flags with which you marked the results.
results.
If all the memory locations are occupied, the oldest
test result is deleted to create space for the new one
when you perform a new test.
53
6.2 Retrieving results from the memory
1 With the meter turned off, press the M button.
You can also go directly to the saved results after a

test. To do so, press the M button while the result is
displayed.
Press briefly
The last saved (latest) result is displayed with the

time, date and .
54
Retrieving older results:
2 Press the S button.
While you press the S button, the memory location

number is displayed. When you release the button,
the corresponding result is displayed.
If you keep the S button pressed, the occupied
memory locations are displayed in quick succession.
Once you release the button, the corresponding
result is displayed.
After the oldest result in the memory, the latest
result is displayed again.
55
Turning the meter off again:
3 Press the M button briefly.
You can directly switch from the saved results to the

test by inserting a test strip into the meter.
Press briefly
56
If there are no results saved in the meter, the display

shown next to this text appears.
No result in the memory
If the time and date were not set at the time of

testing, 0:00 and 0- 0 are displayed instead.
Time and date not set
57
6.3 Retrieving averages
The meter can calculate averages from the saved 3. Only results which have been flagged with
results. (After Meals)
The averages are calculated for three groups of 1. for the last 7 days
results and for three time periods per group. The 2. for the last 14 days
calculation is performed in the following order: 3. for the last 30 days
Then the 7-day average for all results is displayed
1. All results
again.
1. for the last 7 days
2. for the last 14 days The following results are not included in the calcula-
3. for the last 30 days tion:
2. Only results which have been flagged with performance checks (flagged with ),
(Before Meals) results which were displayed as or .
58
1 With the meter turned off, press the M button

briefly.
You can also briefly press the M button directly after

a test while the result is being displayed.
Press briefly
The last saved (latest) result is displayed together

with the time, date and .
59
2 Press the M and S buttons briefly at the same

time.
You can not only call up the averages from within

the last saved result, but also from within each
saved result.
Press briefly at the same

time
The first average, the 7-day average of all results, is

displayed. The number of days taken into account for
the calculation of the average is displayed in the
upper right corner of the display.
60
Order of the averages To go the next average:

(7, 14, 30 = number of days taken into account)
all results Results flagged with Results flagged with 3 Press the M and S buttons briefly at the same
(Before Meals) (After Meals)
time.
7 ➞ 14 ➞ 30 ➞ 7 ➞ 14 ➞ 30 ➞ 7 ➞ 14 ➞ 30
The averages are displayed in the order shown next

to this text.
Averages “before meals” are flagged with .

Averages “after meals” are flagged with .
61
From within each average you can either go back to

the saved results or turn the meter off.
Go back to
saved results 4 Press the S button briefly to go back to the
saved results.
The result which was shown before the average was

Press briefly calculated is displayed again.
or Or:
turn the meter off. 4 Press the M button briefly to turn the meter off.
Press briefly
62
If there are no results saved for the selected average, In the event that you changed the date or time,
three dashes are displayed. performed a test and then re-set the date/time, only
The meter calculates the average for a period even those test results that the meter saved in uninter-
when the saved results cover a shorter period. For rupted chronological order will be taken into account.
example: Tests were only performed in the last 5 If the chronological order has been interrupted, the
days. In this case, the results of the last 5 days are earlier results will not be taken into account.
used to calculate the averages for all three periods You can switch directly from displaying any average
(7, 14 and 30 days). value to testing by inserting a test strip into the
meter.
63
6.4 Downloading test results
Your meter has a built-in infrared port which enables

wireless data downloading to a suitably equipped
computer or handheld device (PDA), or to a special
analysis system.
The infrared port is located at the front of the meter.
Roche Diagnostics offers a variety of special hard-

ware and software products for analysing your data
and which enhances the integrated notebook func-
Infrared port tions of your meter. With these products you and your
doctor can manage your data more effectively and,
using the graph and table views you can better
understand your test results.
64
Depending on which type of analysis you opt for, you please contact your customer support and service
will require either a special software programme and/ centre.
or special hardware products. For more information Your test results can only be fully analysed if all of the
please contact your customer support and service results have been saved with the date and time, i.e. if
centre. you have set the date and time.
If you already have a hardware or software product The results remain in the meter’s memory after
from Roche Diagnostics for transfering and evaluat- downloading.
ing test results, it may not recognise more recent
meters and the results will therefore not be down- You cannot perform a test while results are being
loaded. You may need a more recent software version downloaded.
for your hardware or software product. In this case
65
1 Read the operating instructions supplied with the

software and hardware you are using. There you
will find all the information needed for down-
loading data.
2 Prepare the receiving end (software product or
hardware) for downloading the test results.
3 With the meter turned off, press and hold the M
button (for more than 3 seconds) until flashes
in the display.
Press for more than 3

seconds
66
4 Place the meter approx. 5-20 cm away from the

infrared port of the receiving end. Position the
two infrared ports so that they are facing to-
wards one another.
5–20 cm
5 If necessary, start the test result download at the
receiving end (software product or hardware).
The meter automatically downloads all of the results

from its memory. While the data is downloaded,
does not flash.
67
If the meter was not turned off automatically by the

receiving end when the download was completed,
is displayed.
6 Press the M button briefly to turn the meter off.
Press briefly
68
If downloading is unsuccessful
If the results are not downloaded ( is still flashing Another device with an infrared source turned on
in the display), the meter turns off automatically after or a strong light source is too close to one of the
approx. 90 seconds. There can be different reasons infrared ports.
for a failed download. Eliminate the cause and start Remove the device or light source.
the download again. Communication between the two infrared ports is
The infrared ports are too far apart or not properly blocked, e.g. by an object.
facing one another. Remove the object.
Reduce the distance between the two infrared The infrared port is dirty.
ports to 5-20 cm and position them so they are Clean the port (see Chapter 8).
facing one another.
The infrared port is defective.
Please contact your customer support and service
centre.
A download error or an error at the receiving end
has occurred.
Try again.
69
Checking your meter
7 Checking your meter

You can check whether the meter provides correct Perform a performance check using Accu‑Chek
results. To perform this performance check, a glucose Active control solutions,
control solution is applied to the test strip instead of whenever you open a new pack of test strips,
blood.
after you change the battery,
Also read the instrcutions in Chapter 5. after you clean the test strip guide and the meas-
uring window,
if you are in doubt about a test result.
Please ask your customer support and service centre

where you can obtain the control solutions.
70
Checking your meter
7.1 Preparing for a performance check
For a performance check, you need:

the meter with the code chip inserted
the Accu‑Chek Active test strips that belong to the
code chip
Accu‑Chek Active control solution Control 1 (low
glucose concentration) or Control 2 (high glucose
concentration)
the concentration table for the control solutions
(see label on the test strip container)
A performance check is in its main steps the same as

a normal test, except that you apply control solution
to the test strip instead of blood.
71
Checking your meter
7.2 Carrying out a performance check
1 Read the package insert which came with the

control solutions.
2 Take a test strip from the test strip container and
close it again immediately.
3 Hold the test strip so that the arrows printed on
it and the orange square face upwards.
4 Without bending it, gently push the test strip into
the test strip guide in the direction of the arrows
until you feel it lock into place.
72
Checking your meter
The meter turns on and first performs a default

display check (approx. 2 seconds).
5 Check that all the segments of the numeric

display (mg/dL meter) or (mmol/L
meter) are displayed.
mg/dL meter mmol/L meter If segments are missing, please contact your cus-
tomer support and service centre (see Chapter 17).
Following the display check, the code number is

displayed (689 is just an example).
73
Checking your meter
6 Check that this code number is the same as the

code number on the label of the test strip con-
tainer.
If the numbers do not match, even though the code

chip in the meter belongs to the test strip container,
please contact your customer support and service
centre.
Following the code number, the test strip symbol and

the flashing blood drop symbol appear in the display.
Now you have approx. 90 seconds to apply control
solution to the test strip. After this time, the meter
turns itself off.
74
Checking your meter
7 Open a bottle of control solution.

8 Wipe the tip of the dropper with a clean, dry
paper towel to remove any dried-on residues.
9 Invert the bottle and hold it downwards at an
angle. Squeeze it gently until a small drop which
is free of any air bubbles is suspended from the
tip.
10 Apply one drop to the centre of the orange field
without touching it with the tip of the dropper.
The field must be completely covered with
solution.
75
Checking your meter
The flashing hourglass symbol indicates that the

test is in progress. The test is complete after approx.
5 seconds and the result appears on the display. The
meter automatically saves the result.
To distinguish this performance check from blood
glucose test results at a later date, you need to flag it
as a performance check.
No flag Control (bottle) While the test result is displayed:
11 Press the S button briefly 4 times.
The symbol for control is displayed (see also

Press 4 times Chapter 5, “Flagging test results” section).
briefly
76
Checking your meter
After flagging the result as a performance check:
12 Compare the test result with the concentration

Accu‑Chek® Active Control
table on the label attached to the test strip
Unit of container.
mg/dL mmol/L
measurement
1 37 – 67 2,1 – 3,7
2 134 – 181 7,4 – 10,0 The result must be within the specified concentra-
Figures are examples tion range.
Control solution Make sure that you compare the test result with the
used
concentration data that corresponds to the relevant
control solution that you used (1 or 2) and to the unit
of measurement your meter displays (mg/dL or
mmol/L).
77
Checking your meter
13 Then remove the test strip from the meter.
The meter turns itself off.

You can dispose of used test strips in your house-
hold waste.
78
Checking your meter
7.3 Possible sources of error during performance checks
If the result is outside the specified concentration If a performance check produces results that
range, repeat the performance check. If the result of are outside the specified concentration range,
the second check is also outside the concentration it is no longer certain that the meter and test
range, please check the following points. strips are functioning properly. Blood glucose
If your responses to the questions below are different tests may then produce incorrect results.
from those given, make the respective corrections Incorrect results can cause the wrong therapy
when you perform the next test. If you have taken all recommendation to be made and so lead to
of these points into account and the results are still serious adverse health effects.
outside the specified concentration range, contact
your customer support and service centre.
79
Checking your meter
Did you take the test strip from the container Did you apply a suspended drop of control
yes yes
which the code chip in the meter belongs to? solution?
Did you perform the performance check Did you apply only one drop of control
yes yes
according to the instructions for use? solution?
Did you bend the test strip while inserting it Were there air bubbles in the drop? no
no
into the meter? Did you wait for the drop symbol to flash in
yes
Did you use a used test strip? no the display before applying control solution?
Did you wipe the tip of the dropper before Was the orange field completely covered
yes yes
you applied control solution to the test strip? with control solution?
Did you bend or move the test strip before or
no
during the test?
Did you measure within the correct tempera-
yes
ture range (10–40 °C)?
80
Checking your meter
Did you compare the test result with the Did you observe the proper storage condi-
concentration data that corresponds to the yes tions for the meter, the test strips and the
yes
control solution you used? control solution (see Chapter 11 and the
Is the concentration table on the test strip package inserts)?
container from which you removed the test yes Has the expiry date of the test strips or the
strip? control solution elapsed see the label on the
Is the test strip guide and measuring window test strip container (next to the symbol
yes no
clean? and the label on the bottle next to the
symbol and eventually the symbol on
Has the control solution been open for less the display of the meter)?
than 3 months?
Once opened, control solutions are stable for yes If your meter has been dropped, it can also lead to
only 3 months and must not be used after implausible results or error messages. In this case
this period. also contact your customer support and service
centre.
81
Cleaning the meter
8 Cleaning the meter

You may need to clean the meter if it becomes dirty Use only cold water or 70 % ethanol to clean
through improper use. the meter. Any other cleaning agents may
damage the meter or impair its measuring
Healthcare professionals using the meter to function.
test several patients’ blood glucose must also Use a lightly moistened cloth or a lightly
read the instructions on disinfection in Chapter moistened cotton swab. Do not spray anything
10.2. onto the meter and do not immerse it in the
cleaning liquid. Internal components could
become damaged and thus impair the proper
functioning of the meter.
82
Cleaning the meter
8.1 External parts 8.2 Test strip guide and measuring
window
If the case of the meter or the display is dirty: You only need to clean the test strip guide and
measuring window
1 Wipe away any dirt using a cloth lightly mois-
if you notice that the test strip guide or the meas-
tened with cold water or 70 % ethanol.
uring window located beneath the cover are visibly
dirty,
if the error message or is displayed.
A dirty measuring window may be the cause.
83
Cleaning the meter
1 Pull the cover of the measuring window straight

towards you.
2 Wipe the cover and the test strip guide from the
outside and the inside using a lightly moistened
cloth or cotton swab.
84
Cleaning the meter
3 Carefully wipe the measuring window and its

surrounding area using a lightly moistened cloth
or a cotton swab.
Make sure that no liquid enters the meter.

Avoid scratching the measuring window, as
doing so could impair its measuring function.
4 Remove any fluff or lint that may remain.

5 Allow areas you have wiped time to dry thor-
oughly.
85
Cleaning the meter
6 Place the cover straight and centred onto the

meter.
7 Slide it closed until it audibly clicks into place.
In doing so, the guides on the inside of the cover and

on the meter must be perfectly aligned.
8 Carry out a performance check (see Chapter 7).
86
Changing the battery
9 Changing the battery

When the battery symbol appears in the display When you change the battery, your results always
for the first time, the battery is almost empty. You can remain saved. Time and date only remain saved as
perform approximately 50 more tests with the bat- long as
tery. We recommend that you replace the battery as you change the battery within one minute,
soon as possible. By then it will have lost a lot of
power and changeable conditions (e.g. a cold envi- you do not press any button while the battery is
ronment) can affect its performance even further. removed,
You need 1 battery of the type CR 2032. you do not insert a test strip in the test strip guide
without the battery inserted,
With a new battery you can perform approx. 1000
tests or test for approx. one year. you insert the battery the right way up, i.e. with the
+ symbol facing upwards.
If any of the four conditions stated above is not met,
you will need to re-enter the time and date. For
information on how to re-enter the time and date see
Chapter 3.
87
The battery compartment is located on the back of

the meter.
1 Push the locking catch downwards and remove

the battery compartment cover.
2 Remove the used battery.
88
3 Place the new battery in the compartment, with

the + symbol facing upwards.
4 Re-attach the battery compartment cover so the

two prongs on its lower edge engage with the
slots in the battery compartment.
89
5 Press the cover closed. It will click into place

audibly.
Never throw batteries into a fire. They may

explode.
Dispose of used batteries in an environmen-
i tally friendly way at a collection depot or
through your dealer.
Remove the battery if you will not be using the
i meter for a longer period of time.
90
Testing blood glucose in more than one patient – Information for healthcare professionals
10 Testing blood glucose in more than one patient – Information for health‑
care professionals
Only staff working in doctors’ practices, hospitals and Please also follow the instructions on the following
diabetes training centres, and nurses are allowed to pages to prevent the meter becoming contaminated.
perform blood glucose tests on more than one patient
using the same Accu‑Chek Active meter.
Any patient with an infection or suffering
When using the meter always follow the recognised from an infectious disease and any patient
procedures for handling objects that are potentially who is a carrier of a multi-resistant micro‑
contaminated with human material. Practise the organism must be assigned his/her own
health and safety policy of your laboratory or institu- meter. This also applies if it is suspected
tion. that a patient has one of the above. During
this time the meter must not be used to
test any other patient.
91
Patients and medical staff are potentially at Residues of water or disinfectant on the skin
risk of becoming infected if the same can dilute the drop of blood and so produce
Accu‑Chek Active meter is used to test blood incorrect results.
glucose in several patients. All objects that Dispose of used lancets or disposable lancing
come into contact with human blood are devices and used test strips according to the
potential sources of infection (see: Clinical and health and safety policy of your laboratory or
Laboratory Standards Institute: Protection of institution.
Laboratory Workers from Occupationally
Acquired Infections; Approved Guideline –
Third Edition; CLSI document M29-A3, 2005).
92
10.1 Testing blood glucose
1 Wear protective gloves. 5 Select a penetration depth to suit the nature of

2 The patient’s hands should be washed with the patient’s skin. Start with a shallow depth
warm water and soap and then dried well. If you setting.
are using alcohol wipes, the finger must also be 6 Select a puncture site along the side of a finger-
completely dry. On dry skin the drop of blood tip.
cannot spread so easily. 7 Turn the finger so that the chosen puncture site
3 Use only lancing devices approved for use by is facing upwards, and keep it facing upwards.
healthcare professionals. Then the drop of blood cannot spread so easily
4 Use a lancing device with adjustable penetration later.
depth settings. 8 Prick the side of the fingertip.
93

massaging the finger towards the fingertip. A
proper drop of blood must form.
10 Apply the drop of blood to the test strip.
We recommend that you apply the blood to the
test strip while it is outside the meter (see
Chapter 5.2, section “Applying blood with the
test strip outside the meter”).
94
10.2 Disinfecting the meter
The following parts of the meter may become con- Use a mixture of 1-propanol, 2-propanol and glutaral-
taminated: dehyde, known in some countries under the brand
the case Bacillol plus.
the measuring window cover Allow areas you have wiped time to dry thoroughly.
the measuring window Make sure that no liquid enters the meter.
The meter, the cover of the measuring window and Do not spray anything onto the meter and do
the measuring window itself must be thoroughly not immerse it in liquid. Internal components
cleaned and disinfected at least once a day after use. could become damaged and thus impair the
Remember to also clean recesses, grooves and gaps. proper functioning of the meter.
Cotton swabs, wipes and cloths lightly moistened

with disinfectant are all suitable for disinfecting the
meter.
95
Measurement and storage conditions
11 Measurement and storage conditions

So that the meter works reliably and you obtain accu- thermometer symbol will, however, be displayed
rate results, make sure that the conditions listed on (see also Chapter 12.1).
the following pages are met. Do not use results obtained at the limits of
the permitted temperature range as a basis
for making therapeutic decisions, as they
11.1 Temperature could be incorrect. Incorrect results can
For blood glucose tests and performance checks cause the wrong therapy recommendation
the temperature must be between +10 and to be made and so lead to serious adverse
+40 °C. health effects.
If the temperature is at the limits of the permitted
range (between +5 and +10 °C or between +40
and +45 °C), you can still perform a test. The
96
Tests cannot be performed at temperatures below tion to be made and so lead to serious
+5 °C and above +45 °C. In this case the following adverse health effects.
appears in the display: Keep the meter without battery at a temperature
between -25 and +70 °C.
Keep the meter with battery at a temperature
between -10 and +50 °C.
At temperatures above +50 °C the battery
could leak and damage the meter.
At temperatures below -10 °C the battery
does not have enough power to keep the
Never try to speed up warming or cooling of
internal clock functioning.
the meter, e.g. in a refrigerator or on a
radiator. The meter can be damaged and
provide incorrect results. Incorrect results
can cause the wrong therapy recommenda-
97
11.2 Atmospheric humidity 11.3 Light conditions
Only test blood glucose when atmospheric humidity Do not perform a test when the meter and the test
is below 85 %. strips are exposed to direct sunlight. Go to a shaded
Keep the meter below 93 % atmospheric humidity. place or shade the meter, for example with your body.
Sudden changes in temperature cause If the meter is exposed to too much light, tests
condensation to form in or on the meter. If this cannot be performed. In this case the following
has occurred, do not turn the meter on. Allow appears in the display:
the meter to slowly cool down or warm up.
Never keep it in a moisture-prone area (e.g. a
bathroom).
98
11.4 Sources of interference
Avoid sudden changes in light conditions while Strong electromagnetic fields may interfere
testing. The flashlight of a camera, for exam- with the proper operation of the meter. Do not
ple, can lead to incorrect results. use the meter in close proximity to a strong
Keep the meter away from very strong light electromagnetic field.
sources (e.g. direct sunlight, studio lighting, To avoid electrostatic discharge, do not use
etc.). These may stop the meter from function- the meter in a very dry environment, especially
ing correctly and lead to error messages. one in which synthetic materials are present.
99
Symbols, problems and error messages
12 Symbols, problems and error messages

In addition to test results, time and date other sym- On the following pages you will find a complete
bols and error messages also appear in your meter’s overview of symbols and error messages, what they
display. Some of the screens that you see in normal mean and what actions you should take. Please pay
use have already been explained in previous chap- attention to all symbols and messages when you use
ters. the meter.They provide you with important informa-
tion. If you do not recognise a symbol or do not
understand an error message, please refer to this
chapter for an explanation. Otherwise, you run the
risk of misinterpreting your blood glucose results.
100
12.1 Symbols shown in the display
1 2 3 1
You are in the test-result memory. Either a saved
test result or an average is being displayed.
17 4 2
The battery is almost empty.
5 When the symbol first appears in the display, you
16 18 can perform approx. 50 more tests.
6
15 When the battery is so low that no more tests
7 can be performed, the meter turns itself off
14
8 immediately.
13
12 9
11 10
101
3 7
You are in the settings for time and date. General flag
4 8 or
When an average is displayed (test-result The unit your meter uses to display the blood
memory): the symbol is preceded by the number glucose result, either mg/dL or mmol/L.
of days taken into account. 9
+
5 (flashing) 10 The test strips are past their expiry date. Change
The meter is exposed to too much light. the test strips and code chip. Check the time and
date settings, as the meter compares these
6 (flashing) against the expiry date encoded in the code
A test is in progress or an average is being chip.
calculated.
102
10 There is no code chip in the meter. Insert the

+ (flashing) code chip belonging to the Accu‑Chek Active
11 test strips you are currently using.
The test strip was removed from the meter
before blood or control solution was applied, for 13
example to apply blood outside the meter.
After Meals flag
11 (flashing) 14
Now you can apply blood or control solution to Before Meals flag
the test strip.
15
12
The number being displayed is the code number. While the test is performed the temperature is or
was outside the permitted range of +10 to
(flashing) together with +40 °C.
The code chip has not been correctly inserted
into the meter. Remove the code chip and
re-insert it.
103
Do not use the result as a basis for therapeutic 18 Symbols appearing in the numeric field
decisions. In the numeric field (mg/dL meter) or
Ensure that the ambient temperature is between (mmol/L meter) the following symbols can appear:
+10 and +40 °C and wait for the meter to adapt
to that temperature. Repeat the test with a new
test strip. together with a flashing :
16 The code chip has not been correctly inserted into
the meter. Remove the code chip and re-insert it.
Flag for performance check There is no code chip in the meter. Insert the code
17 chip belonging to the Accu‑Chek Active test strips
Additional time information if 12-hour time you are currently using.
format is set.
104
together with : you changed the time and date and then per-
Averages cannot be calculated because formed a test. Then you re-set the time and date
and have not performed any more tests since.
you have not set the time and date,
only test results without a time and date are saved,
only test results that are not included in the calcu- The result is lower than 10 mg/dL (0.6 mmol/L).
lation are saved, e.g. results from performance may indicate that your blood glucose is
checks, very low (possibly a severe hypoglycemia).
no test results were saved in the period in ques- Follow your doctor’s instructions immediately
and repeat the test.
tion, e.g. all results in memory are more than 7
days old,
the date set is in the past,
105
(flashing)
The result is higher than 600 mg/dL (33.3 mmol/L). You have turned the meter on to download test
Repeat the test. results.
Decimal point: displayed by mmol/L meters and is

part of the result (e.g. 8.2 mmol/L is displayed as ).
The meter is downloading test results.
together with :
The meter has finished downloading test results.
No results have been saved.
together with :
The result has been lost from memory.
106
12.2 Problems
The meter will not turn on. The ambient temperature is low and the battery is
almost empty.
You have not removed the protective film from the
Ensure that the ambient temperature is between
battery.
+10 and +40 °C and wait for the meter to warm
Remove the film from the battery (see Chapter up. Insert a new battery.
2.3).
The electronics have become damp through
The battery is empty or there is no battery in the
condensation.
meter.
Allow the meter to dry slowly.
Insert a new battery.
The meter is defective.
You have inserted the battery the wrong way
Please contact your customer support and service
round.
centre.
Remove the battery and place it in the battery
compartment as specified.
107
The meter is turned on, but the display is blank. The time is shown as 0:00 or 0:00am and the
date as 0- 0.
The display is defective.
Please contact your customer support and service The meter was exposed to a temperature below
centre. -10 °C and the battery is beginning to freeze.
Turn the meter off. Ensure that the ambient
The clock has stopped or the clock is slow. temperature is between +10 and +40 °C and wait
for the meter to adapt to that temperature.
The meter was exposed to a temperature below
-10 °C and the battery is beginning to freeze. You have not set the time and date.
Turn the meter off. Ensure that the ambient tem- Set the time and date (see Chapter 3).
perature is between +10 and +40 °C and wait for
the meter to adapt to that temperature.
108
12.3 Error messages
If an error message is displayed, turn the meter off. If these error messages occur frequently, contact
Depending on the situation, either by briefly pressing your customer support and service centre.
the M or S button or by removing the test strip from If your meter has been dropped, it can also lead to
the meter. error messages. In this case also contact your cus-
tomer support and service centre.
109
You did not insert the test strip correctly or completely.

Hold the test strip so the arrows printed on it and the orange square face upwards.
Without bending it, gently push the test strip into the test strip guide in the direction of
the arrows until you feel it lock into place.
You removed the test strip from the meter in order to apply blood and did not re-insert
it within 20 seconds.
Dispose of the test strip, even if blood has not been applied yet. Start the blood
glucose test from the beginning with a new test strip.
A code chip from another blood glucose system has been inserted into the meter.
The code chip does not belong to the Accu‑Chek Active test strips.
Remove the code chip and insert the code chip that belongs to the Accu‑Chek Active
test strips you are currently using.
110
The code chip cannot be read.

Remove the code chip and re-insert it into the meter. If the error message appears
again, you cannot use the code chip and test strips belonging to it.
A code chip from another blood glucose system has been inserted into the meter.
The code chip does not belong to the Accu‑Chek Active test strips.
Remove the code chip and insert the code chip that belongs to the Accu‑Chek Active
test strips you are currently using.
The measuring window is dirty.
Clean the measuring window (see Chapter 8).
The test strip is bent or is not positioned straight and flat in the test strip guide.
Repeat the test with a new test strip.
111
You have inserted a used test strip into the meter.

Start again from the beginning with an unused test strip.
The measuring window is dirty.
Clean the measuring window (see Chapter 8).
Hold the test strip so that the arrows printed on it and the orange square face up-
wards. Without bending it, gently push the test strip into the test strip guide in the
direction of the arrows until you feel it lock into place.
You applied blood or control solution to the test strip too soon, i.e. before the drop
symbol flashed in the display.
The test strip was bent or moved while testing was in progress.
The meter was exposed to a strong electromagnetic field.
Change your position or turn off the source of radiation.
112
You removed the code chip while testing was in progress.

Re-insert the code chip into the meter and repeat the test with a new test strip.
The test strip was bent or moved while testing was in progress.
Hold the test strip so that the arrows printed on it and the orange square face up-
wards. Without bending it, gently push the test strip into the test strip guide in the
direction of the arrows until you feel it lock into place.
113
A meter error has occurred.

Start again from the beginning. If the error message appears again, the meter is defec-
tive. Please contact your customer support and service centre.
You applied too little blood or control solution to the test strip.
Repeat the test with a new test strip and a larger amount of blood or control solution.
114
The ambient temperature or the temperature of the meter is too low or too high for a
test.
Ensure that the ambient temperature is between +10 and +40 °C and wait for the meter
to adapt to that temperature.
115
Technical data
13 Technical data
Meter type Accu‑Chek Active (Model GC)

Catalogue no./Serial no. See type plate on the back of the meter
Test principle Determination of glucose in fresh capillary blood by reflectance photometry.
If using other sample material, please refer to the package insert that came with
the Accu‑Chek Active test strips.
Blood glucose concentrations may be tested 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 to 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. There you will also find
information on how the system works, on the test principle and on reference
methods.
116
Technical data
Measuring range 10–600 mg/dL (0.6–33.3 mmol/L)

Sample size 1–2 µL (1 µL (microlitre) = 1 thousandth of a millilitre)
Measuring time approx. 5 seconds if the test strip is in the meter when blood is applied
(depends on concentration)
approx. 10 seconds if the test strip is outside the meter when blood is applied
(depends on concentration)
Power supply 1 battery (type CR 2032)
Battery life approx. 1000 tests or approx. 1 year
Automatic power-off after 30 or 90 seconds depending on operating status
Memory 350 test results with time and date, as well as 7, 14 and 30 day averages
117
Technical data
Temperature
during testing +10 to +40 °C
during storage
without battery -25 to +70 °C
with battery -10 to +50 °C
Atmospheric humidity
during testing up to 85 % relative humidity
during storage up to 93 % relative humidity
Altitude sea level to 4000 m
Dimensions 104.5 × 51.5 × 22 mm
Weight
without battery approx. 55 g
with battery approx. 60 g
118
Technical data
Display 96-segment liquid crystal display (LCD)

Interface infrared port
Safety class III
LED/IRED Class 1
Electromagnetic This meter meets the electromagnetic immunity requirements as per ISO 15197
compatibility Annex A. The chosen basis for electrostatic discharge immunity testing 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.
119
Technical data
Performance analysis The performance data for the Accu‑Chek Active system (Accu‑Chek Active
meter with Accu‑Chek Active test strips) was obtained using capillary blood
from diabetic patients (method comparison, accuracy), venous blood (repeat-
ability) and control solution (reproducibility). The system is calibrated with
venous blood containing various glucose concentrations. The reference values
for this were obtained using the hexokinase method. For method comparison,
the results were compared with results obtained using the hexokinase method
with deproteination (automatic analyser). The hexokinase method is traceable to
a NIST standard.
The Accu‑Chek Active system meets the ISO 15197 requirements.
120
Disposing of your meter
14 Disposing of your meter

During blood glucose testing the meter itself may Dispose of used batteries in an environmen-
come into contact with blood. Used meters therefore i tally friendly way at a collection depot or
carry a risk of infection. After having removed the through your dealer.
battery, please dispose of your used meter according
to the regulations applicable in your country. For
information about correct disposal, please contact
your local council or authority.
The meter falls outside the scope of the European
Directive 2002/96/EC (Directive on waste electrical
and electronic equipment).
121
System components
15 System components
The Accu‑Chek Active blood glucose monitoring
system comprises the following components in
addition to the meter:
Accu‑Chek Active test strips
Use only these test strips when you test blood
glucose using the Accu‑Chek Active meter.
Accu‑Chek Active control solutions
Use only these control solutions when you carry
out performance checks using the Accu‑Chek
Active meter and the respective test strips.
122
Patents
16 Patents
US 5,366,609; US 5,424,035; US 5,463,467;
US 5,889,585; US 6,055,060; US 6,906,802
123
Customer support and service
17 Customer support and service

17.1 Information service and 17.2 Addresses
troubleshooting Roche Diagnostics Scientific Office
For questions on how to operate your Accu‑Chek PO Box 159, Dokki
Active meter, or regarding implausible results, or if 23, Iran Street – Dokki
you suspect the meter to be defective, please contact Guiza / CAIRO
your customer support and service centre. Do not Egypt
attempt to repair or modify the meter yourself. Our http://www.accu-chekarabia.com
staff will help you solve any problems you might be
experiencing with the meter or test strips from Roche Productos Roche Interamericana S. A.
Diagnostics. For the customer support and service 2a. Avenida 2-67, Zona 10 (Apartado Postal 1675)
addresses, see the next section. 01010 Guatemala C.A., República de Guatemala
Roche Diagnostics (Hong Kong) Limited

1316-1325 Metroplaza, Tower 1
223 Hing Fong Road
Kwai Chung
Hong Kong
Enquiry hotline : 852 2485 7512
124
PT. Roche Indonesia. Diagnostics Division. Roche Diagnostics (M) Sdn Bhd
Gedung Artha Graha, lt.21. SCBD - Lot 25. 2A, Jalan 13/1
Jl.Jendral Sudirman Kav. 52-53. Jakarta 12190, 46200 Petaling Jaya
Indonesia Selangor Darul Ehsan
Hotline: 0 800 1 222 999 Malaysia
Toll-Free Line: 1-800-88-1313
Promotional Office Levante
Nabih Nabulsi Drugstores Roche Pakistan Ltd.
Prince Shaker Ben Zeid Street 37 - C, Block 6
Shmeisani P.E.C.H.S.
P.O.Box 1066 P.O. BOX 20021
11118 AMMAN Karachi – 75400
Jordan Islamic Republic of Pakistan
http://www.accu-chekarabia.com
Roche (Philippines) Inc.
Diagnostics Division
2252 Don Chino Roces Ave.
1231 Makati City
Philippines
Customer contact number, Assist : +63 2 89308000
125
Roche Diagnostics Asia Pacific Pte. Ltd Roche Diagnostics Regional Office Gulf
298, Tiong Bahru Road Caterpiller building. – Salahedin Str. Deira
#16-01/06 Central Plaza DUBAI 2nd entrance – 3rd floor, Off. 4-3
Singapore 168730, Singapore P.O. Box 11397
DUBAI
Roche Products (Pty) Ltd. South Africa United Arabic Emirates
Diagnostics Division http://www.accu-chekarabia.com
9, Will Scarlet Road / Ferndale
P.O. Box 1927
Randburg 2125
South Africa
Accu-Chek Care Line 080-DIABETES: dial
080-34-22-38-37
Roche Diagnostics (Thailand) Ltd

18th Floor, Rasa Tower,
555 Phaholyothin Road, Chatuchak,
Chatuchak, Bangkok 10900
Thailand
Customer Service Line: +66 (0) 2791 2222
126
Alphabetical index
18 Alphabetical index
A Blood
Alternative sites 40 applying to test strip
Apple (symbol) 40, 103 with test strip inside the meter 34
Apple core (symbol) 40, 103 with test strip outside the meter 36
Asterisk (symbol) 40, 102 too little applied 114
Atmospheric humidity 98, 118 volume 14, 117
ave (symbol) 60, 102 Bottle (symbol) 40, 76, 104
Averages 58
C
B Causes of error
Battery downloading of results 69
changing 87 performance check 79
life 87, 117 test 51
removing protective film 18 Checking, meter 70
symbol 45, 87, 101 Cleaning 82
type 13, 87, 117 code (symbol) 103, 104
Battery compartment 13, 88 Code chip 12, 28
127
Alphabetical index
Code number 29, 32 Disposal

Coding 28 battery 90, 121
Concentration table 71, 77 meter 121
Control solution 70 test strips 39, 78
stability 81 Downloading, results 64
Control window, test strips 43 causes of error 69
Customer support and service 124 Drop (symbol) 33, 103
D E
Data downloads 15, 64 E and number (display) 110
Date setting 26 EEE (display) 114
day (symbol) 60, 102 Electromagnetic compatibility 119
Disinfection 95 End (display) 68
Display 12 Error messages 100, 109
example 6 exp (symbol) 46, 52, 102
symbols in the ~ 101 Expiry date
Display check 20, 32 control solution 81
test strips 52, 81
128
Alphabetical index
F M
Flagging, result 40 M button 12
Measurement conditions 96
H Measuring range 50, 117
Healthcare professionals 3, 91 Measuring time 35, 38, 117
Hi (display) 45, 50, 106 Measuring window 12
Hourglass (symbol) 35, 102 cleaning 83, 85
Memory 53
I memory (symbol) 54, 101, 105
Infection risk 91, 92 Memory, results 53
Infrared port 12, 64 Meter
Intended use 3 checking 70
cleaning 83
L disinfecting 95
Light conditions 98 disposal of 121
Lo (display) 45, 50, 105 overview 12
storage 96
turning off 23, 39, 56
turning on 22, 31, 54, 66
129
Alphabetical index
mg/dL (symbol) 102 R

mmol/L (symbol) 102 Result
averages 58
O downloading 64
Overview flagging 40
meter 12 retrieving from memory 54
symbols 101
S
P S button 12
Patents 123 Settings (date and time) 21
PC (display) 66, 106 changing, overview 22
Performance analysis 120 date 26
Performance check factory defaults 21
causes of error 79 order 21
flagging 76 time 25
procedure 70 time and date format 24
Problems 107 year 26
130
Alphabetical index
set-up (symbol) 22, 102 Test principle 116

Sources of electromagnetic interference 99 Test strip guide 12
Sources of interference cleaning 83, 84
electromagnetic ~ 99 Test strips
light 98 disposal of 39, 78
Storage conditions 96 expiry date 52, 81
Sun (symbol) 98, 102 symbol 33, 36, 102, 103
Symbols 101 Thermometer (symbol) 45, 103
during testing 45 Time and date format setting 24
System components 122 Time setting 25
ttt (display) 97, 115
T Turning off
Technical data 116 after testing 39, 78
Temperature 96, 118 automatic ~ 34, 39, 69
Testing closing settings 23, 27
causes of error 51 exiting memory 56
healthcare professionals 93
procedure 30
131
Alphabetical index
Turning on U
changing settings 22 Unit of measurement for results (mg/dL, mmol/L)
downloading results 66 17, 102
retrieving results 54
testing 31 Y
Type plate 13, 17 Year setting 26
132

Instructions For Use: Blood Glucose Meter

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Blood Glucose Meter

Instructions for use

ACCU-CHEK is a trademark of Roche.

Roche Diagnostics GmbH

IVD For in vitro diagnostic use

Last update: 2008-05

About these Instructions for use

5 Testing blood glucose 30

6 Using the meter as a diary 53

9 Changing the battery 87

13 Technical data 116

1 Getting to know your meter

9 Code chip slot

 Fast testing  Flagging

2 Steps before testing

The meter is supplied with a battery inserted. The

1 Simply pull the film vertically out of the meter.

i For how to change the battery, see chapter 9.

You can check if all of the display elements are

Press at the same time

2 Compare the display of your meter with the

3 Setting the time and date

If you do not wish to set the time and date, proceed

Turning the meter on

Press the S button and hold it down (for more than 3

When set-up appears in the display, you can make

Press the M button.

Holding down the M button increases the number

Turning the meter off at any time

Press the M and S buttons briefly at the same time.

First confirm your last change with the S button,

1 Press the M button briefly to switch from one

1 Press the M button to set the hours.

The minutes flash in the display.

3 Press the M button to set the minutes.

1 Press the M button to set the year.

1 Press the M button to set the month.

The day flashes in the display.

3 Press the M button to set the day.

1 Check that time and date are correct.

1 Compare the code number on the chip with the

The three-digit number on the code chip (e.g. 689)

Leave the meter turned off.

2 Gently slide the code chip into the slot on the

You must feel the code chip lock into place.

5 Testing blood glucose

2 Hold the test strip so the arrows printed on it and

The meter turns on and first performs a default

4 Check that all the segments of the numeric

Following the display check, the code number is

5 Check that this code number is the same as the

If the numbers do not match, even though the code

Following the code number, the test strip symbol and

When the test strip and the flashing blood drop

1 Prick the side of a fingertip with your lancing

The flashing hourglass symbol indicates that the

Now you can

When the test strip and the flashing blood drop

1 Remove the test strip from the meter.

Fast testing Flagging