Accu-Chek ACTIVE User manual

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ACCU-CHEK is a trademark of Roche.
Roche Diagnostics GmbH
68298 Mannheim, Germany
www.accu-chek.com
0 5241430001(02) – 2008-05
Blood Glucose Meter
Instructions for use
R4 406 – 3400
V6/1 – Man_05241430001_02_EN_148x105mm – Black
V6/2 – Man_05241430001_02_EN_148x105mm – Cyan
V6/3 – Man_05241430001_02_EN_148x105mm – Magenta
V6/4 – Man_05241430001_02_EN_148x105mm – Yellow
V6/5 – Man_05241430001_02_EN_148x105mm – PMS 5445
V6/6 – Man_05241430001_02_EN_148x105mm – PMS 327

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

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

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About these Instructions for use
About these Instructions for use
Please read these Instructions for use carefully and
completely before testing blood glucose for the rst
time. If you have any questions, please contact your
customer support and service centre (see Chapter
17).
These Instructions for use will help you get to know
your new meter step by step. They will provide you
with all the information you need to operate, trouble-
shoot 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 meter is a precision instrument.
Improper handling can impair its operation.
We recommend you start by studying the location of
the key features of your meter (see Chapter 1.1).
Practise all of the operations described in these
Instructions for use, and also practise testing.

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About these Instructions for use
In these Instructions for use you will come across
three kinds of notes. Please read these very care-
fully.
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.
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This symbol draws attention to important
information.
All instructions appear in a coloured frame as shown
below:
1 Insert the test strip into the meter.

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About these Instructions for use
In these Instructions for use you will see examples of
display screens. Elements that are surrounded by a
halo in these examples actually ash on the meter’s
display.
Please note:
All dates, times or results shown on the display
screens in these Instructions for use are intended
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).

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 lm 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
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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
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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
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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
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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
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Contents

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7
5
6
4
3
2
1
12
Getting to know your meter
Getting to know your meter1
1.1 Your meter at a glance
1
Display
2
S button (retrieving settings for time and date)
3
Measuring window cover
4
Measuring window (underneath the cover)
5
Test strip guide
6
M button (retrieving readings from the memory,
changing time / date)
7
Code chip
8
Infrared window

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13
12
9
10
11
13
Getting to know your meter
9
Code chip slot
10
Code chip (inserted)
11
Type plate
12
Battery compartment
13
Battery (type CR 2032)
14
Locking catch for opening the battery
compartment

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Getting to know your meter
1.2 The main features at a glance
Fast testing

The meter needs only approximately 5 seconds for
each test.
 Easy testing
For testing, you do not need to press a single
button. You insert a test strip into the meter, which
switches it on, apply blood to the test strip, read
the value and then pull the test strip out of the
meter.
 Blood volume checking
To perform a test, the meter requires 1–2 µL blood
(1 µL (microlitre) = 1 thousandth of a millilitre). The
meter detects if the applied amount is not suf-
cient.
 Flagging results
You can ag results with different symbols, which
indicate particular situations during the test.
 Memory
The meter automatically saves up to 350 results
with the time and date of the test and all other
information that is important for the test.
Integrated data analysis

From the stored test results your meter can calcu-
late your average values for the last 7, 14 or 30
days.

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Getting to know your meter
 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.

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Steps before testing
Steps before testing2
2.1 Checking the contents Check that the contents of the package are complete.
You will nd a list with the contents on the box.
If anything is missing, please contact your customer
support and service centre (see Chapter 17).

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Steps before testing
2.2 Checking the unit of measurement for blood glucose
Blood glucose results can be displayed in two differ-
ent units (mg/dL or mmol/L). Two different versions of
the same meter are therefore available. Please check
if your meter displays the unit you are accustomed to.
You can nd the unit of measurement that your meter
displays on the type plate on the back of your meter.
If you do not know which is the right unit for you, ask
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

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Steps before testing
2.3 Removingtheprotectivelmfromthebattery
The meter is supplied with a battery inserted. The
battery contacts are covered with a protective lm to
prevent the battery from becoming drained prema-
turely. Before using the meter, remove the protective
lm. You will see the lm projecting from the battery
compartment on the back of the meter.
1 Simply pull the lm vertically out of the meter.
You do not need to open the battery compart-
ment to do this.
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For how to change the battery, see chapter 9.

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Steps before testing
2.4 Performing a display check
Press at the same time
for more than 3 seconds
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).

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Steps before testing
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.
3 Press any button to terminate the display
check and turn off the meter.
mg/dL meter mmol/L meter