Accu-Chek Active GB User manual

User’s Manual
Blood Glucose Meter
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Contents
Introduction .............................................................................................................................2
1 Your New System.............................................................................................................. 4
2 Steps Before Testing.........................................................................................................6
3 Changing Settings.............................................................................................................7
4 Blood Glucose Tests..........................................................................................................9
5 Using the Meter as a Diary ..............................................................................................15
6 Analyzing Test Results on a PC........................................................................................17
7 Control Tests................................................................................................................... 19
8 Cleaning the Meter..........................................................................................................22
9 Changing the Battery....................................................................................................... 23
10 Testing in More Than One Patient.................................................................................... 24
11 Test and Storage Conditions............................................................................................ 25
12 Symbols and Troubleshooting .........................................................................................27
13 Technical Information...................................................................................................... 31
14 Customer Support ...........................................................................................................33
Index .....................................................................................................................................34
This User’s Manual features the following 3 symbols:
W H i
This symbol indicates a
possible risk of injury or of
damage to your own health
or the health of others.
This symbol draws your
attention to actions that
could result in damage to
the meter.
This symbol draws your
attention to important
information.
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2
Introduction
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 the
Accu-Chek Active test strips. Consult the
package insert of the test strips if you
intend to use different 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 system does not require a code chip.
The meter must only be used for its
intended purpose; if used otherwise
preventive measures could be ineffective.
W WARNING
• Choking hazard. Small
parts. Keep away from
children under the age of
3 years.
• Keep new and used batteries away from
children. Ingestion or insertion into the
body may cause chemical burns,
perforation of soft tissues, and death.
Severe burns may occur within 2 hours
of swallowing. If you think a battery
might have been swallowed or placed
inside any part of the body, seek
medical attention immediately.
• If the battery compartment does not
close securely, stop using the product
and keep it away from children. Contact
Roche.
• 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 Occupationally
Acquired Infections; Approved Guideline
– Fourth Edition; CLSI document
M29-A4, May 2014).
• Healthcare professionals must also read
the instructions and notes in the Testing
in More Than One Patient chapter.
• 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. Other test strips
deliver incorrect results.
Introduction
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3
Introduction
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,
contact customer support.
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 off. This User’s
Manual assumes that the beep is on.
Note: Sample data screens are shown
throughout the manual. Your data will differ.
The Main Features
• No coding
No code chip is required for coding the
meter.
• Additional dosing option
To perform a test, the meter requires
1–2µL blood. The meter detects if the
amount of blood is insufficient, and more
blood can be applied.
• Marking test results
You can mark test results with different
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 averages for the last
7, 14, 30, and 90 days.
• Data transfer
The meter has a USB port. You can
transfer stored 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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4
1Your New System
The Accu-Chek Active Meter and its Components
5
43
1
2
7
8
9
6
1. Display
shows the current and stored test
results or device messages
2. Buttons
see the Button Functions section in this
chapter
3. Cover
covers the measurement window
4. Measurement Window
underneath the cover
5. Test Strip Guide
insert test strip here
6. Locking Catch
opens the battery door
7. USB Port
the USB cable is inserted here in order
to transfer data to a computer
8. Battery Compartment
right: open battery compartment,
battery type CR2032
9. Type Plate
10 11 12
13
10. Test Strip Container
11. Test Strip
apply blood drop or control solution
to the center of the test area (green
square)
12. Control Solution Bottles
13. Battery
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5
1 Your New System
Using the Meter Buttons
When instructed to press a meter button, press it briefly and release it.
When instructed to press and hold a meter button, press and hold it for 2 or more seconds.
Button Functions
Button / Action Function
Press to
turn the meter on and retrieve stored test
results
mark the test result after a test
change settings
retrieve the previous stored test result
change from the earliest stored test result to
the averages
retrieve the previous average
Press to
turn the meter on and access settings
mark the test result after a test
go to the next setting
retrieve the next stored test result
change from the averages to the stored test
results
retrieve the next average
Press and at the same time
to
perform a display check
save settings after the final screen is shown
and turn the meter off
turn the meter off
Press or to
turn the test reminder beep off
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6
2Steps 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 any content is missing, contact customer
support.
Checking the Unit of
Measurement
Test results can be displayed in two
different units of measurement (mg/dL or
mmol/L). 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. If you do not
know which unit of measurement is correct
for you, contact your healthcare
professional.
W WARNING
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 dealer to exchange the
meter or contact customer support. An
incorrect unit of measurement could lead
to test results being interpreted falsely
and to the wrong therapy
recommendations and thus produce
serious adverse health effects.
Checking the Display
You can check if all of the display segments
are properly displayed by carrying out a full
display check.
With the meter off,
press and hold the M
and S buttons at the
same time to turn
the meter on.
2
Check the meter display for missing
segments. All segments should look like the
picture above.
If any segments are missing from the
display or the unit of measurement shown
for the blood glucose results is not the
correct one, ask your dealer to exchange the
meter.
Press the M and S buttons at the same time
to end the display check and turn the meter
off.
1
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7
3Changing Settings
You can change the meter settings for the
time format, time, date, and beep. The
meter is delivered with pre-set time and
date. You may need to adjust the settings to
your time zone. In order to analyze your
stored test results properly, it is necessary
to set the correct time and date.
Press and hold the S button until
appears on the display. The setting that can
be changed flashes.
Press the M button to change the setting, if
required.
Press the S button to move to the next
setting. The meter settings are in the
following order: time format (24h, 12h),
hours, minutes, year, month, day, beep (on,
off).
Press the S button repeatedly until the final
screen appears on the display. Only then
will the modified settings be saved when
you turn the meter off.
Press the M and S buttons at the same time
to turn the meter off.
i
If you do not press any buttons, the meter
turns off automatically after approx.
30 seconds. If you have not reached the
final screen, all changes are lost and the
original settings remain unchanged.
Time Format
When you change the time format, the time
and date are changed accordingly. 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)
The time format flashes on the display.
Press the M button to switch from one
format to the other.
Press the S button.
Time and Date
Setting the time and date is explained in the
following examples using the 24-hour
format.
The hours flash on
the display.
Press the M button to
set the hours.
Press the S button.
The minutes flash on
the display.
Press the M button to
set the minutes.
Press the S button.
1
2
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8
Changing Settings3
The year flashes on
the display.
Press the M button to
set the year.
Press the S button.
The month flashes on
the display.
Press the M button to
set the month.
Press the S button.
The day flashes on
the display.
Press the M button to
set the day.
Press the S button.
Beep
The beep symbol appears together with
or on the display.
Press the M button to turn the beep on or
off.
Press the S button.
3
4
5
Final Screen
At the end of the
setting procedure,
the meter displays
the final screen with
the current settings.
Press the M and S
buttons at the same
time to turn the meter
off.
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9
4Blood Glucose Tests
There are 2 ways to perform a blood
glucose test with the Accu-Chek Active
meter. You can either apply the blood drop
to the test area while the test strip is in
the meter, or you can remove the test strip
from the meter and then apply the blood
drop to the test area.
You need the meter, a test strip, and a
lancing device with a lancet inserted to
perform a blood glucose test.
Wash your hands
with warm water and
soap, and dry them
well.
Prepare your lancing
device.
Check the use by
date on the test strip
container.
Use only test strips
which are within the
use by date.
Remove a test strip
from the test strip
container. Close the
cap tightly.
Hold the test strip
so that the arrows
printed on it and
the test area face
upwards.
Insert the test strip into the test strip guide.
Do not bend the test strip.
The test strip must lie flat on the
measurement window cover.
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1
2
3
The meter turns on
and performs a
default display check
(approx. 2 seconds).
Check that all
the segments are
displayed.
If any segments are
missing, contact customer support.
The test strip symbol
and the flashing drop
symbol appear on the
display. The meter
beeps.
The meter is ready to
perform a blood
glucose test. You
have approx. 90 seconds to apply blood to
the test strip.
Applying Blood
Lance the side of
a fingertip with your
lancing device.
Figure A shows the
recommended sites
for obtaining blood.
Massage the finger
in the direction of the
fingertip to encourage a blood drop to form
(see B).
If you want to apply the blood drop to the
test area while the test strip is in the meter,
proceed to step 7.
If you want to apply the blood drop to the
test area while the test strip is outside the
meter, proceed to step 8.
4
5
6
A
B
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10
Blood Glucose Tests4
Test Strip in the Meter
Apply the blood drop
to the center of the
test area and then
remove your finger
from the test strip.
As soon as the meter
detects the blood,
the meter beeps.
The flashing hourglass symbol indicates
that the test is in progress.
If the amount of blood you applied is
insufficient, 3 beeps will sound after a few
seconds. You can apply an additional
amount of blood.
The test is over in approx. 5 seconds.
Proceed to step 11.
Test Strip outside the Meter
When the test strip
symbol and the
flashing drop symbol
appear: Remove the
test strip from the
meter.
The test strip and
drop symbol flash on
the display. You have
approx. 20 seconds
to apply blood to the
test strip and to
reinsert it into the
meter.
Apply the blood drop to the center of the
test area.
Insert the test strip
into the test strip
guide in the direction
of the arrows with
the test area facing
up.
7
8
9
10
The test strip must lie flat on the
measurement window cover.
If you do not reinsert the test strip
moistened with blood into the meter within
the available time, a beep sounds once per
second during the last 5 seconds.
The test starts. The flashing hourglass
symbol indicates that the test is in
progress.
The test is over in approx. 8 seconds.
Test Result
The test result
appears on the
display and the
meter beeps. The
meter automatically
saves the test result.
Remove the test strip
from the meter.
The meter turns off.
Discard used test
strips according to
local regulations.
Healthcare
professionals must
discard used test strips according to the
hygiene and safety policy of their laboratory
or institution.
11
12
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11
Blood Glucose Tests4
Notes on Blood Glucose
Testing
W WARNING
Incorrect test results can cause the wrong
therapy recommendation to be made and
thus produce serious adverse health
effects.
• Use only test strips which are within the
use by date.
• Close the test strip container tightly with
its original cap immediately after
removing a test strip.
• This meter does not require an activation
chip or a code chip for measuring blood
glucose.
• If you have not applied blood to the test
strip within the available time and the
meter has turned off: Remove the test
strip from the meter and discard it.
• If an error message appears and you
have not yet applied any blood, you must
not use this test strip.
• Do not rub the blood drop onto the test
area when applying blood.
• Do not store used test strips in a test
strip container which still contains
unused test strips.
• Do not to bend or move the test strip
before or while applying blood, or while
the test is in progress.
i
If you want to apply the blood drop to the
test area while the test strip is outside the
meter: Do not remove the test strip until
the drop symbol flashes on the display. If
you remove the test strip before the drop
symbol flashes, the meter turns off.
Marking Test Results
You can mark test results to describe
certain events connected to the test result
or particular characteristics of the test
result. You can only mark a test result while
the test strip is still in the meter and the
test result is displayed.
You can choose from 5 markers:
Symbol Meaning
Before meal
(apple symbol)
After meal
(apple core symbol)
Test reminder
(apple + bell symbol)
Other (asterisk symbol):
You can define the meaning
of this marker yourself.
Control
(bottle symbol)
Press the M button
or S button
repeatedly until the
desired marker
appears at the
bottom of the display
(the example here is
symbol).
If you press the S button, the markers
appear in the following order: 1 Before
meal; 2 Test reminder; 3 After meal;
4 Other; 5 Control.
If you press the M button, the markers
appear in the reverse order.
If you decide not to mark the test result,
press the M button or S button repeatedly
until no marker is displayed.
The test result is saved together with the
marker.
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12
Blood Glucose Tests4
Setting a Test Reminder
You can only mark a
test result while the
test strip is still in
the meter and the
test result is
displayed.
Press the M button
or S button
repeatedly until the test reminder marker
(symbol) appears.
The test result is saved together with the
symbol.
In two hours, you will
be reminded to
perform a blood
glucose test. The
flashing symbol
appears on the
display. At the same
time, a beep sounds
once per second.
You can now perform a blood glucose test.
As soon as you insert the test strip into the
meter, the test reminder turns off.
The test result is saved together with the
symbol.
i
If the meter is on at the time of the test
reminder, the meter cancels the test
reminder.
If you perform a blood glucose test up to
1 hour before a test reminder, the meter
cancels the test reminder.
If you do not perform a blood glucose test
at the time of the test reminder, you can
still perform the blood glucose test within
half an hour of the test reminder.
In both cases, the test result is saved
together with the symbol.
1
2
Checking your Test Results
The test strip itself allows you to estimate
the test result through color comparison and
thus check the displayed test result in
addition.
Before the blood glucose test
On the back of the
test strip, there is a
round, colored
control window.
Compare the color of
this window with the
colored dots on the
label of the test strip
container.
The color of the control window must
match the color of the top dot (0mg/dL,
0mmol/L). If the control window is a
different color, you must not use the test
strip.
After the blood glucose test
The label on the test strip container shows
blood glucose values in mg/dL and mmol/L
next to each colored dot.
Within 30 to 60 seconds after applying blood
to the test strip, compare the color of the
control window on the back of the test strip
with the dot that comes closest to your test
result.
If the color deviates significantly, repeat
the test. If the color still deviates in further
tests, contact customer support.
The color comparison serves only as a
plausibility check of the test result.
Lo or Hi Screen
The or screen may appear instead of
a test result.
may indicate that your blood glucose is
lower than the measuring range of the
system.
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13
Blood Glucose Tests4
may indicate that your blood glucose is
higher than the measuring range of the
system.
For more information about the symbols that
can appear on the display before, during, or
after a test, refer to the Symbols and
Troubleshooting chapter.
W WARNING
may indicate that your blood glucose
value is very low (possibly a severe
hypoglycemia). may indicate that your
blood glucose value is very high (possibly
a severe hyperglycemia).
If or reflects the way you feel,
follow your healthcare professional’s
instructions immediately. If or does
not reflect the way you feel, perform a
control test. Repeat the blood glucose
test. If the new test result still does not
reflect the way you feel, contact your
healthcare professional.
Evaluating Test Results
Blood glucose results are influenced,
amongst others, by nutritional choices,
medicine taken, state of health, stress, and
physical activity.
W WARNING
• Do not change your therapy without
talking to your healthcare professional
first.
• If the blood glucose result is above or
below the target range that you have set
together with your healthcare
professional, contact your healthcare
professional.
• If the test result reflects the way you
feel, follow your healthcare
professional’s instructions.
• If the test result does not reflect the way
you feel, e.g. it is unexpectedly high or
low, perform a control test. Repeat the
blood glucose test. If the new test result
still does not reflect the way you feel,
contact your healthcare professional.
• Contact your healthcare professional
immediately if your blood glucose values
are too low or too high.
• If test results repeatedly do not reflect
the way you feel, check the points in the
section Sources of Implausible Test
Results.
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14
Blood Glucose Tests4
Sources of Implausible Test Results
If your meter repeatedly displays implausible test results or error messages, check the
following points. If your responses to the questions are different from those given, make the
respective corrections when you perform the next test.
If you have taken all of these points into account and still obtain implausible test results or
error messages, contact customer support.
Did you perform the test following the instructions in the User’s Manual? yes
Did you wash your hands with warm water and soap and dry them well? yes
Did you use a used test strip? no
Did you apply blood after the beep sounded and the drop symbol began to flash
on the display?
yes
Did you bend the test strip while inserting it into the meter? no
Did you apply the blood drop immediately after it had formed on your finger? yes
Did you bend or move the test strip before or during the test? no
Are the test strips past their use by date (check next to the esymbol on the
label of the test strip container)?
no
Are the test strip guide and measurement window clean? yes
Did you perform the test within the acceptable temperature range (+8 to
+42°C)?
yes
Did you follow the storage conditions for the meter and the test strips? yes
Have you read the section Sources of error which may produce incorrect test
results in the test strip package insert?
yes
If your meter has been dropped, it can no longer be certain that the meter is functioning
properly.
Perform a control test. Repeat the blood glucose test.
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15
5Using the Meter as a Diary
The meter can save up to 500 test results
with time and date and calculate averages
from the stored test results. If the memory
is full, the oldest test result is deleted to
create space for the new one, when you
perform a new blood glucose test.
Retrieving Test Results from
the Memory
With the meter off,
press the M button to
turn the meter on
and retrieve stored
test results.
The most recent test
result appears
together with the
time, the date and
.
If you marked the
test result with a
marker, the marker is
also displayed.
No stored test result
If there are no stored
test results in the
meter, this screen
appears on the
display.
Order of the stored test results
Press the M button to view previous test
results from the most recent to the oldest.
Press the S button to retrieve the stored test
results in the reverse order.
As long as you press the M button or S
button, the memory location number is
displayed. When you release the button, the
corresponding test result is displayed. If you
1
2
press and hold the M button or S button,
the occupied memory locations are
displayed in quick succession. When you
release the button, the corresponding test
result is displayed.
When the oldest stored test result is
displayed and you press the M button again,
the meter beeps. When the most recent
stored test result is displayed and you press
the S button again, you reach the averages.
Retrieving Averages
The meter calculates the 7, 14, 30, and
90-day averages for 3 groups of test results:
• All test results
• Test results marked with the symbol
• Test results marked with the symbol
Control results (marked with ), test results
without a valid time or date as well as test
results that were displayed as or are
not included in the calculation.
With the meter off,
press the M button to
turn the meter on.
The most recent test
result appears.
Press the S button.
The first average, the
7-day average of all
test results, appears.
The upper left corner
of the display shows
the number of test
results included in
the average. The upper right corner of the
display shows the number of days included
in the average.
1
2
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16
Using the Meter as a Diary5
Order of the averages
All test results / Test results marked with
/ Test results marked with
Press Press
Press the S button to retrieve the averages
in the order shown in the table. Press the M
button to retrieve the averages in the
reverse order.
If you press the S button repeatedly, the 14,
30, and 90-day averages for all test results
are displayed after the 7-day average for all
test results.
If you continue to press the S button, the
averages for “Before meal” and “After
meal” are displayed in the same order.
When the last average is displayed
(= 90-day average marked with ) and you
press the S button again, the meter beeps.
If you press and hold the M button or S
button, the averages are displayed in quick
succession.
No average
If there are no stored
test results for the
selected average,
three dashes are
displayed.
If you changed the date or time, performed
a test, and then reset the date or time, the
chronological order of the test results is
interrupted. As the meter can only calculate
averages based on test results in an
uninterrupted chronological order, it
therefore does not take into account test
results prior to the interruption.
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17
6Analyzing Test Results on a PC
The meter has a built-in USB port for
transferring stored test results to a
computer (PC) that is equipped accordingly.
Roche offers a variety of special diabetes
management hardware and software which
enhance the integrated diary functions of
your meter. With these diabetes
management hardware and software, you
and your healthcare professional can
manage your test results more effectively
and use graphs and tables to understand
them better. For more information on
diabetes management software, contact
customer support.
The USB port 1 is
located on the left
side of the meter.
To connect the meter
to the computer, you
need a USB cable
that is not longer
than 1.5 m. 2 =
small end (micro B
connector) 3 =
large end (USB
A connector).
Plug the small end
into the USB port on
the meter.
Plug the large end
into a USB port on
your computer.
1
1
3
2
2
3
If the meter is off, it
turns on.
Read the instructions
for use of the
diabetes
management
software in use.
If necessary, start the
diabetes management software on your
computer.
While the connection is being established,
flashes on the meter display.
The meter transfers
all stored test results.
During the data
transfer, does not
flash.
The test results
remain in the meter
memory after being
transferred.
To turn the meter off,
unplug the small end
of the USB cable
from the meter once
the data transfer is
complete.
For approx.
3 seconds, is
displayed.
The meter turns off.
4
5
6
7
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18
Analyzing Test Results on a PC6
i
• If you already have a diabetes
management software from Roche, it
may not recognize more recent meters
and the results will therefore not be
transferred. You may need a more
recent version of your diabetes
management software. In this case,
contact customer support.
• You cannot perform a test during the
data transfer. You have to unplug the
small end of the USB cable from the
meter in order to perform a test.
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19
7Control Tests
Performing a control test lets you know the
meter and test strips are working properly.
Perform a control test after you clean the
test strip guide and the measurement
window, or if you are in doubt about a test
result.
A control test is performed in the same way
as a blood glucose test, except that you
apply control solution to the test strip
instead of blood.
You need the meter, a test strip, the
Accu-Chek Active control solution Control 1
(low glucose concentration) or Control 2
(high glucose concentration), a clean, dry
paper towel, and the concentration table for
the control solutions (see label of the test
strip container).
Ask customer support where you can obtain
control solutions.
Read the package
insert which comes
with the control
solutions.
Insert the test strip
into the test strip
guide in the direction
of the arrows with
the test area facing
up.
The test strip must lie flat on the
measurement window cover.
The meter turns on
and performs a
default display check
(approx. 2 seconds).
Check that all the
segments are
displayed.
If any segments are missing, contact
customer support.
1
2
When test strip
symbol and the
flashing drop symbol
appear on the display
and the beep sounds,
you have approx.
90 seconds to apply
control solution to
the test strip.
Open a bottle of control solution.
Wipe the tip of the bottle with a clean, dry
paper towel.
Hold the bottle
downwards at an
angle.
Squeeze the bottle
gently until a small
drop without air
bubbles is suspended
from the tip of the
bottle.
Apply one drop of control solution to the
center of the test area without touching the
test area with the tip of the bottle.
The test area must be completely covered
with control solution.
As soon as the meter detects the control
solution, the meter beeps.
Do not remove the test strip from the meter.
The test starts. The
flashing hourglass
symbol indicates
that the test is in
progress. The test is
over in approx.
5 seconds and the
meter beeps. The
control result appears on the display.
To distinguish this control result from blood
glucose results at a later date, you need to
mark it as a control test.
3
4
5
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