Roche Accu-Chek Active User manual

C
© 2013 Roche Diagnostics
ACCU‑CHEK is a trademark of Roche.
M Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
www.accu‑chek.com
06658768001(02) – 2013‑09 M_Version01_Rev2
User’s Manual
Blood Glucose Meter
ONR 4285 – 4all 4468 V1/1 – man_cover_06658768001_02_EN_ Format 127 x 154 mm – Black
(2013) Frau Ritzerfeld
Prüfmittelnummer n/a R2/1 – man_cover_06658768001_02_EN_ Format 127 x 154 mm – Black
R2/2 – man_cover_06658768001_02_EN_ Format 127 x 154 mm – PMS 287 CVC
man_cover_06658768001_02_EN.indd 4-1 03.09.2013 15:40:52

This User’s Manual features three types of warning:
W
This symbol indicates a possible risk of injury
or of damage to your own health or the health
of others.
H
This symbol draws attention to actions that could
result in damage to the meter.
i
This symbol draws your attention to important
information.
Last update: 2013‑08
Explanation of symbols
Various symbols are featured on the packaging and type plate of the meter. Their meanings are as
follows:
Symbol Meaning
BConsult instructions for use
WCaution, refer to safety‑related notes in the instructions for use accompanying this
product.
Biohazard risks – used meters carry a risk of infection.
2Temperature limitation (store at)
EUse by
MManufacturer
RCatalogue number
LBatch code
IIn vitro diagnostic medical device
CThis product fulfils the requirements of the European Directive 98/79/EC on in vitro
diagnostic medical devices.
The explanation of any other symbols can be found in the instructions for use and inserts accompanying
components within the packaging.
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1
Contents
Contents
Intended use � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 2
About this User’s Manual � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 3
1 Getting to know the blood glucose monitoring system � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 4
2 Steps before testing � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 7
3 Changing settings � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 10
4 Testing blood glucose � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 16
5 Using the meter as a diary � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 30
6 Analysing test results on the PC � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 35
7 Checking your meter � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 38
8 Cleaning the meter � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 44
9 Changing the battery� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 46
10 Testing blood glucose in more than one patient � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 48
11 Test and storage conditions � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 50
12 Symbols, problems and error messages � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 52
13 Disposing of your meter � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 59
14 Technical data and system components � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 60
15 Customer Support and Service Centre � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 63
16 Alphabetical index � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 65
Explanation of symbols � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � III
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2
Intended use
Intended use
The Accu-Chek Active blood glucose meter
The Accu‑Chek Active blood glucose meter is
intended to be used for quantitative blood
glucose tests in fresh capillary blood. The
meter may only be used together with
Accu‑Chek Active test strips. Consult the
package insert of the test strips if you intend to
use dierent sample material.
The blood glucose monitoring system
comprises the meter and test strips and is
suitable for self‑testing and for professional
use. People with diabetes can use this system
to self‑test their blood glucose. Healthcare
professionals can use this system to check
patients’ blood glucose values and they can
use it in suspected cases of diabetes and in
emergency diagnostics.
The system is suitable for testing blood glucose
with blood obtained from alternative sites.
The system must not be used to diagnose or
rule out diabetes.
The system is only suitable for use outside the
body.
Visually impaired persons must not use the
meter.
The meter must only be used for its intended
purpose; if used otherwise preventive
measures could be ineective.
W
• Healthcare professionals must also read the
instructions and notes in Chapter 10 “Testing
blood glucose in more than one patient”.
• All objects that could come into contact with
human blood are potential sources of
infection.
There is a risk of infections (e.g. hepatitis B,
hepatitis C, HIV) being transmitted if the meter
is used by other people, even family members,
or if healthcare professionals use the same
meter to test blood glucose in more than one
person.
• Only use the Accu‑Chek Active meter with
Accu‑Chek Active test strips that are approved
by Roche Diagnostics. Other test strips deliver
incorrect results.
• Keep the blood glucose monitoring system
with all its components away from children
under the age of 3. There is a risk of
suocation if small parts (e.g. covers, caps or
similar objects) are swallowed.
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3
About this User’s Manual
About this User’s Manual
Read this User’s Manual carefully and completely before testing blood glucose for the first time. If you
have any questions, please contact your customer support and service centre (see page 63).
This User’s Manual will provide you with all the information you need to operate, troubleshoot and care
for your blood glucose meter. Follow the correct operating procedures for the meter and comply with all
instructions for use. You can turn the beep tone of the meter on or o. This User’s Manual assumes that
the beep is on.
Actions to be taken appear as shown in the example below:
Gently slide the test strip into
the test strip guide in the
direction of the arrow until you
feel it lock into place.
The meter turns on and first
performs a default display check
(approx. 2 seconds).
Title bar of the figure
with a number or figure
caption
Figure displaying actions
to be taken
Action to be taken (blue
text)
Information on action to
be taken (black text)
1Flashing elements
In this User’s Manual you will see
examples of display screens.
Elements that are surrounded by
a halo in these examples actually
flash on the meter’s display.
Please note: All dates, times or
results shown on the display
screens in this User’s Manual are
intended only as examples.
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4
Getting to know the blood glucose monitoring system
1
Getting to know the blood glucose monitoring system
The Accu-Chek Active blood glucose meter and its components
1. Display
displays the current and saved test results or
device messages
2. Buttons
see “Buttons of the blood glucose meter”
overview
3. Cover
covers the measurement window
4. Measurement window
underneath the cover
5. Test strip guide
slide the test strip in here
8
5
43
1
2
7
9
10
6
6. Locking catch
opens the battery compartment cover
7. USB port
the USB cable is inserted here in order to
transfer data to a computer
8. Code chip
code chip inserted in the code chip slot
9. Battery compartment
right: open battery compartment, battery type
CR2032
10. Type plate
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5
1
Getting to know the blood glucose monitoring system
11. Test strip container
12. Test strip
13. Control solutions
14. Code chip
15. Battery
Buttons of the blood glucose meter
Overview of the M and S button functions:
11 12 13
14 15
M button S button
Press the M button to Press the S button to
turn the meter on and call up
saved values
turn the meter on and call up
settings, e.g. for the time
mark the test result after a test mark the test result after a test
change settings go to the next setting
call up the previous saved test
result
call up the next saved test result
change from the earliest saved
test result to the averages
change from the averages to the
saved test results
call up the previous average call up the next average
Press the M and S buttons at the same time to
perform a display check
save settings after the final display is shown on the display and
turn the meter o
turn the meter o
Press the M or S button to
turn the test reminder beep o
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6
Getting to know the blood glucose monitoring system
1
The main features
• Short testing time
The meter needs only approximately 5 seconds
for each test.
• Testing without pressing buttons
For testing, you do not need to press a single
button.
• Additional dosing option
To perform a test, the meter requires 1–2 µL
blood (1 µL (microlitre) = 1 thousandth of a
millilitre). The meter detects if the amount of
blood is insucient, and more blood can be
applied.
• Marking test results
You can mark test results with dierent symbols
which indicate particular situations during the
test.
• Memory
The meter automatically saves up to 500 test
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
calculate your average values for the last 7, 14,
30 and 90 days.
• Data transfer
The meter has a USB port. You can transfer
saved test results to a computer.
• Flexible blood application
You can apply blood to the test strip while the
test strip is in the meter or after you have
removed it from the meter.
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7
2
Steps before testing
Steps before testing
Unpacking 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 page 63).
Checking the unit of measurement
Test results can be displayed in two dierent units of measurement (mg/dL or mmol/L). Two dierent
versions of the same meter are therefore available. Check if your meter displays the unit of measurement
you are accustomed to. You can find the unit of measurement that your meter displays on the type plate
on the back of your meter 1. If you do not know which is the right unit for you, ask your healthcare
professional.
W
The unit of measurement that
your meter displays cannot be
changed. If the wrong unit of
measurement is printed on the
type plate, ask your healthcare
professional to exchange the
meter or contact your
customer support and service
centre. Using the wrong unit of
measurement may cause
misinterpretation of your actual
blood glucose level and may
lead to improper therapy.
1
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8
Steps before testing
2
Checking the display
You can check if all of the display elements are properly displayed, by carrying out a full display check.
1
Compare the elements displayed on your meter with the display
shown here.
If any of the display elements are missing or the unit of measurement
shown for the blood glucose results is not the correct one, please ask
your healthcare professional to exchange the meter.
Press the M and S buttons at the same time to end the display check
and turn the meter o.
With the meter turned o, press
the M and S buttons at the same
time for approximately 2 seconds
until the meter is switched on.
mg/dL meter mmol/L meter
2
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9
2
Steps before testing
21
Inserting the code chip
A code chip is used to give the meter information about the properties of the test strips. This is why each
test strip box contains a code chip.
W
• Each time you open a new
test strip box, you must
replace the old code chip
from the meter with the new
one from the new test strip
box. Code chips from other
test strip boxes may contain
information that is incorrect
for your new test strips, and
can therefore lead to
incorrect test results.
Incorrect test results can
cause the wrong therapy
recommendation to be
made and so produce
serious adverse health
eects.
• If the code number on the
display does not match the
code number on the test
strip container, do not
perform blood glucose tests.
Compare the code number on
the code 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 o.
Gently slide the code chip
straight into the code chip slot on
the side of the blood glucose
meter.
You must feel the code chip lock
into place.
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10
Changing settings
3
31 2
Changing settings
Overview
You can make changes to the meter settings for the time format, time, date and beep.
The meter is delivered with the date and time pre‑set. You may need to adjust the settings to your time
zone. In order to analyse your saved test results properly, it is necessary to set the correct time and date.
Press the S button for longer
than 2 seconds.
The display above appears on
the display.
When appears on the
display, it is possible to make
changes to the settings.
The setting which can be now
changed begins to flash.
You can now adjust the time
format (24h or 12h).
Press the M button.
The changed time format
appears on the display.
Turning the meter on Changing settings
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11
3
Changing settings
Turning o
Press the M and S buttons briefly
at the same time.
When the final display appears
on the display, the modified
settings are also saved.
i
If you do not press any buttons,
the meter turns o
automatically after approx.
30seconds. If you have not
reached the final display, all
changes are lost and the
original settings remain
unchanged.
Press the S button briefly to go to the next setting.
Press the S button repeatedly until the final display appears on the
display.
Only then will the modified settings be saved when you turn the
meter o.
Go to the next setting Turning the meter o
Order of the settings
Time format
Time (hour)
Time (minute)
Year
Date (month)
Date (day)
Beep (on, o)
Final display
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12
Changing settings
3
24-hour format 12-hour format
The time format flashes on the
display.
Press the M button briefly to
switch from one format to the
other.
Press the S button. Next comes
the time.
Setting the time format
You can choose between two formats:
24-hour format Time from 0:00 to 23:59, date in the day‑month format (DD‑MM)
12-hour format 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 format, the time and date are changed accordingly.
Setting the time format
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13
3
Changing settings
24-hour format
12-hour format
24-hour format
Year
12-hour format
24-hour format
12-hour format
24-hour format
12-hour format
Setting the hours
Setting the minutes�
Setting the year
The hours flash on the display.
The minutes flash on the display.
The year flashes on the display.
Press the M button to set the
hours.
Press the M button to set the
minutes.
Press the M button to set the
year.
Press the S button. Next come
the minutes.
Press the S button. Next comes
the year.
Press the S button. Next comes
the month.
Setting the time and date
Year
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14
Changing settings
3
Setting the month
Setting the day
24-hour format
12-hour format
24-hour format
12-hour format
24-hour format
12-hour format
24-hour format
12-hour format
The month flashes on the
display.
The day flashes on the display.
Press the M button to set the
month.
Press the M button to set the
day.
Press the S button. Next comes
the day.
Press the S button. Next comes
the beep.
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15
3
Changing settings
Setting the beep
Final display on the display
Beep is on
24-hour format 12-hour format
Turning the beep on or o
The beep symbol appears
together with (on) on the
display.
At the end of making settings, the meter displays the current
settings.
Press the M and S buttons briefly at the same time to turn the meter
o.
Press the M button briefly to turn
the beep on or o.
The beep symbol appears
together with (o) on the
display.
Press the S button. Next comes
the final display.
Beep is o
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16
Testing blood glucose
4
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21
Read the package insert which
comes with the test strips.
3
Prepare your lancing device to
obtain blood.
Wash your hands thoroughly with
soap and warm water and dry
them well. This reduces
contamination of the puncture
site and stimulates blood flow.
Testing blood glucose
Using the Accu‑Chek Active meter, you can test blood glucose in two dierent ways. You can either apply
the blood drop to the test field while the test strip is in the meter (see page 19), or you can remove the test
strip from the meter and then apply the blood drop to the test field (see page 20).
Please also consult “Notes on blood glucose testing” (see page 22).
Preparing to test blood glucose
You need the following items to carry out the blood glucose test:
• your meter with the code chip inserted
• the Accu‑Chek Active test strips that belong to the code chip
• a lancing device to obtain blood
• a lancet for the lancing device
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17
4
Testing blood glucose
Testing blood glucose
Turning the meter on
21
Take a test strip from the test
strip container. Close the test
strip container again
immediately.
Hold the test strip so that the
arrows printed on it and the
green square face upwards.
Gently slide the test strip into the
test strip guide in the direction of
the arrows until you feel it lock
into place.Do not bend the test
strip.
The test strip must lie flat on the
measurement window cover.
Following the display check, the
code number is displayed (689 is
just an example).
The meter turns on and first
performs a default display check
(approx. 2 seconds).
Check that all the segments of
the numeric display (mg/dL
meter) or (mmol/L meter) as
well as the unit of measurement
are displayed.
If segments are missing, please
contact your customer support
and service centre (see page 63).
mg/dL meter
mmol/L
meter
3
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18
Testing blood glucose
4
54
Following the code number, the
test strip symbol and the flashing
blood drop symbol appear on the
display. You now hear a beep.
The meter is now ready to
perform a blood glucose test. You
have approx. 90 seconds to
apply blood to the test strip. After
this time, the meter turns itself
o.
Check that this code number is
the same as the code number on
the label of the test strip
container.
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.
i
If you missed the code number
on the display after sliding in
the test strip, remove the test
strip from the meter and slide
it in again.
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