Freestyle Lite User manual

Table of Contents
Important Information About Your
FreeStyle Lite Blood Glucose Monitoring System .................................................................2-3
Important Health-Related Information ..................................................................................... 4
The FreeStyle Lite Meter and FreeStyle Lite Test Strip
The FreeStyle Lite Meter and How It Works..........................................................................5-6
The FreeStyle Lite Meter Display ............................................................................................7-8
The FreeStyle Lite Test Strip.................................................................................................. 9-10
The FreeStyle Control Solution
The FreeStyle Control Solution........................................................................................... 10-11
Performing a Control Solution Test.................................................................................... 12-13
Testing Your Blood Glucose
Testing Your Blood Glucose .... .................................................................................................14
Performing a Blood Glucose Test ....................................................................................... 15-17
LO and HI Readings ...................................................................................................................18
Meter Set-Up
Using Your Meter’s Lights .......................................................................................................... 19
Setting Up Your Meter................................................................................................................ 20
Setting the Reminder Alarms.............................................................................................. 20-21
Setting the Sound, Time, Time Format ................................................................................... 22
Setting the Date and Date Format ...........................................................................................23
Meter Results
Meter Memory, 7-, 14- and 30-Day Averages......................................................................... 24
Test Results (Blood Glucose, Control Solution) .....................................................................25
Data Download............................................................................................................................ 26
Meter Maintenance
Battery...........................................................................................................................................27
Replacing the Battery............................................................................................................ 27-28
Caring for Your Meter ................................................................................................................28
System Troubleshooting
Error Messages....................................................................................................................... 29-31
Troubleshooting........................................................................................................................... 32
FreeStyle Lite System Specifications......................................................................................... 33
english
Consult instructions for use
Temperature limitation
Manufactured by
Caution
Batch code
english
European Authorised Representative
in vitro diagnostic medical device
CE mark reg. IVDD 98/79/EC
Use by
Catalogue Number
Do not reuse
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Important Information About Your FreeStyle Lite
Blood Glucose Monitoring System
How the FreeStyle Lite System Should Be Used
The FreeStyle Lite system is intended for use outside the body (in•
other words, in vitro diagnostic use only).
The FreeStyle Lite system is used for measuring blood glucose (also•
known as blood sugar) from samples taken from the forearm, upper
arm, hand, thigh, calf or fingers.
Do use the FreeStyle Lite system for:
Testing blood glucose.•
Testing only with fresh capillary whole blood samples.•
Do not use the FreeStyle Lite system for:
The diagnosis of diabetes.•
Testing on newborns.•
Testing of arterial blood.•
Important: The FreeStyle Lite meter should only be used with
FreeStyle Lite test strips and FreeStyle control solution. Using
other test strips and control solution with this meter can produce
inaccurate results.
The FreeStyle Lite System Uses a Tiny Sample of
0.3µl So You Can Test on a Variety of Locations
The human figure above shows the areas where you can test with the
FreeStyle Lite system. Avoid moles, veins, bones and tendons.
WARNING:
We recommend that you test on your fingers if you are testing
for hypoglycaemia (low blood glucose) or if you suffer from
hypoglycaemia unawareness.
Upper arm
Forearm
Hand
Fingertips
Thigh
Calf
Suggested Test
Areas for the Hand
Many Test Sites Available
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Important Health-Related Information
Severe dehydration and excessive water loss may cause false low•
results. If you believe you are suffering from severe dehydration,
consult your physician immediately.
Test results below 3.3 mmol/L (60 mg/dL) mean low blood glucose•
(hypoglycaemia).
Test results greater than 13.3 mmol/L (240 mg/dL) mean high blood•
glucose (hyperglycaemia).
If you get results below 3.3 mmol/L (60 mg/dL) or above 13.3 mmol/L•
(240 mg/dL) and do not have symptoms of hypoglycaemia or
hyperglycaemia, repeat the test. If you have symptoms or continue to
get results that fall below 3.3 mmol/L (60 mg/dL) or above 13.3 mmol/L
(240 mg/dL), follow the treatment advice of your healthcare
professional.
If you are experiencing symptoms that are not consistent with your•
blood glucose test and you have followed all instructions described in
the FreeStyle Lite Owner’s Booklet, call your healthcare professional.
Important Information About Your FreeStyle Lite
Blood Glucose Monitoring System (cont)
WARNING:
The FreeStyle Lite system contains small parts that may be•
dangerous if swallowed.
Peritoneal dialysis solutions containing Icodextrin or compounds•
of Galactose ≥ 0.7 mmol/L (≥ 13 mg/dL), Maltose ≥ 0.6 mmol/L
(≥ 20 mg/dL) or Lactose ≥ 0.3 mmol/L (≥ 10 mg/dL) cause the
FreeStyle Lite blood glucose monitoring system to overestimate
blood glucose test results.
Caution:Please read all the instructions provided in this Owner’s
Booklet and practice the testing procedures before using the
FreeStyle Lite system. Blood glucose monitoring should be done
with the guidance of a healthcare professional.
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The FreeStyle Lite Meter and How It Works
Display Screen
Displays your test results and other important information.
m(Mode) Button
Move to different mode settings.•
Scrolls backward.•
Silences a reminder alarm.•
Sample Areas (dark-coloured half-circles on Test Strip)
Apply blood or control solution to one Sample Area only.
Insert strip into the meter printed side up (see image to the
right).
Light Button
Controls the display backlight and test light.
c(Configure) Button
Marks a control solution test.•
Scrolls forward.•
Displays clock.•
Silences a reminder alarm.•
Test Strip Port
Insert the Top end of a new FreeStyle
Lite test strip here. The meter powers
on when you insert the test strip.
Bottom
FreeStyle Lite Test Strip
Sample Area
Top
System Check Screen
This screen always appears when the meter is turned on
so that you can make sure the display is working properly.
Do not use the meter if the system check screen does not
match the example here. Please call Customer Care.
Data Port
Download test results. Requires a
compatible data management system.
For more information, please go to our
website or call Customer Care.
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The FreeStyle Lite Meter Display
Control Solution Test Result Symbol
Shows that you have marked a test result as a
control solution test.
Test Result Area
Displays test results.
Message Area
Displays date, time and number of tests.
Battery Symbol
Appears when you should replace
your meter battery.
Blood Drop and
Test Strip Symbols
These symbols work together in
an animation to tell you when
the meter is ready for you to
apply blood or control solution.
Thermometer Symbol
Appears if your meter
is out of the operating
temperature range.
Sound Level
Symbols
Indicates high,
low or off sound
volume.
mg/dL or mmol/L
Either mg/dL or mmol/L will
display, indicating the unit of
measurement setting of
your meter.
The unit of measurement setting
of your FreeStyle Lite meter is
preset and cannot be changed.
Day Average Symbol
Shows the average
value of glucose read-
ings from the last 7, 14
or 30 days.
P Symbol
Indicates PM in 12-hour format
only (for example 4:00 p.m.)
Memory Mode Symbol
Shows you test results stored in the
meter memory.
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WARNING:
The cap or vial contains drying agents that may be harmful if
inhaled or swallowed and may cause skin or eye irritation.
Important: The FreeStyle Lite meter should only be used with FreeStyle
Lite test strips. Using other test strips with this meter can produce
inaccurate results.
Important Test Strip Information
The FreeStyle Lite system has an operating range of 4° to 40° C•
(40° to 104° F).
Store the test strip package in a cool, dry place between 4° to 30° C•
(40° and 86° F).
Use test strips only within the system operating temperature range.•
Keep away from direct sunlight and heat.•
Store your test strips in their original vial only; never transfer them•
to another vial or any other container.
Never store individual test strips outside the vial.•
After removing a FreeStyle Lite test strip from the vial, immediately•
close the vial cap tightly.
With clean, dry hands you may touch the test strip anywhere when•
removing it from the vial or inserting it into the meter.
The FreeStyle Lite Test Strip
Apply blood or control solution to only
one Test Strip Sample Area per test.
Important: Use only one sample area of the test strip per
test. Do not apply blood to both sample areas. Test strips
may be used only once. Discard used test strips. You can
continue to fill the test strip for up to 60 seconds. Be sure
to reapply the sample to the same sample area. Test Strip
Sample Area
Do not use test strips beyond the expiry date. This may cause•
inaccurate results.
Do not bend, cut or alter FreeStyle Lite test strips.•
Note: For further information, refer to the FreeStyle Lite test strip
package insert.
The FreeStyle Control Solution
FreeStyle control solution is a red liquid that contains
a fixed amount of glucose that is used to:
Practise testing without having to use your own•
blood.
Ensure that your meter and test strips are working•
together properly.
A control solution test should be performed when you
question your results and want to confirm that your monitor and test
strips are working properly.
For information on how to obtain control solution, call Customer
Care.
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Important Control Solution Information
FreeStyle control solution is good for three months after opening
the bottle or until the expiry date printed on the label, whichever
comes first.
Important: Count forward three months from the date you open a new
bottle of control solution. This is your discard date. Write this date on
the side of the control solution bottle.
Example: You open the control solution on January 15th. Count
forward three months to April 15th. This is the discard date that you
record on the bottle.
Use only FreeStyle control solution with your FreeStyle Lite system.•
Replace the cap on the control solution bottle immediately after•
using.
Do not use control solution after the expiry date.•
Do not add water or any liquid to control solution.•
Control solution tests are specified to be accurate only when used•
between 15° to 40° C (59° to 104° F).
Control solution test results should fall within the appropriate range•
printed on the test strip vial label.
Important: The control solution range is a target range for control
solution only. It is not a target range for your blood glucose level.
If control solution results are out of this range, repeat the test.•
If your control solution test results continue to fall outside of the•
appropriate range printed on the test strip vial, do not use the
FreeStyle Lite system to test your blood glucose. Contact Customer
Care.
Caution: Results from FreeStyle control solution tests do not
reflect your blood glucose level.
2
1
3
Performing a Control Solution Test
Insert the top of the test strip into your meter
until it stops. This will switch on the meter.
System Check Screen
When the meter switches on, this screen
will appear so that you can make sure the
display is working properly.
Wait for the meter to display the blood drop
and test strip symbols.
Gently touch only the Sample Area of the test
strip to the control solution.
Important: Do not apply control solution to both
Test Strip Sample Areas.
If the sound prompt is on, your meter will beep when the test strip
is full. A short line then moves clockwise around the display screen
while the sample is processing.
System Check
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The result will appear on the display screen and if the sound is on,
your meter will beep twice. To mark the result as a control solution
result, press and hold the “c” button for two seconds until the control
solution symbol ( ) appears at the top left of the display screen.
If you have marked a blood glucose test as a control solution test by
mistake, you can unmark it by pressing and holding the “c” button
again for two seconds.
Compare your control solution test result to the
appropriate range printed on your test strip vial
label. Your control solution results should fall
within the appropriate range printed on the side
of your test strip vial.
Out of range test results may be caused by:
Expired or bad control solution.•
Expired or bad test strip.•
Error in performing test.•
Watered-down control solution.•
Meter malfunction.•
Control solution test done outside 15° to 40° C (59° to 104° F).•
To turn the meter off, remove the test strip.
4
Testing Your Blood Glucose
Important: To ensure accurate results, wash your
hands and test site (for example, your forearm) with
soap and water. Make sure there is no cream or lotion
on the test site. Thoroughly dry your hands and test
site.
With the FreeStyle Lite meter, you can test your blood glucose on•
your forearm, fingers, upper arm, hand, thigh or calf.
Testing with the FreeStyle Lite meter requires a very small sample•
size, 0.3 microlitre of blood; about the size of pinhead
(example:•).
Times when you may be checking for low blood glucose include:
When you are feeling symptoms such as weakness, sweating,•
nervousness, headache or confusion.
When you have delayed a meal after taking insulin.•
When your healthcare professional advises you to do so.•
WARNING:
We recommend that you test on your fingers if you are testing
for hypoglycaemia (low blood glucose) or if you suffer from
hypoglycaemia unawareness.
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Prepare Your Meter
Insert a FreeStyle Lite test strip into the meter
until it stops. e meter will switch on.
Note: If you do not start the test within two minutes, the meter will
turn o. To restart your meter, take out the unused FreeStyle Lite test
strip and reinsert it into the meter.
System Check Screen
When the meter switches on, this screen will
appear so that you can make sure the display is
working properly.
e blood drop and test strip symbols will appear
on the display screen. Your meter is now ready to
apply the blood sample.
Important: The FreeStyle Lite meter should only be used with
FreeStyle Lite test strips. Using other test strips with this meter can
produce inaccurate results.
Performing a Blood Glucose Test
1
System Check
Blood Drop and
Test Strip Symbols
Obtain a Blood Sample
Select a test site. ere are dierences in testing on ngers versus
other alternative sites.
Use your lancing device to obtain a blood sample. Refer to the
Lancing Device Insert for detailed instructions on how to use
the FreeStyle lancing device.
Filling the FreeStyle Lite Test Strip
with Blood
Make sure that the FreeStyle Lite test stripa.
is in the meter and the meter is switched
on. (If the meter is off, take out the test
strip and reinsert it into the meter.) You
are now ready to apply the blood sample.
Bring the FreeStyle Lite test strip to theb.
blood sample at a slight angle.
The FreeStyle Lite test strip acts like ac.
sponge and pulls the blood into the strip
through the sample area.
3
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WARNING: If you are testing for hypoglycaemia (low blood
glucose), or if you suffer from hypoglycaemia unawareness, we
recommend that you test on your fingers.
Test Strip Sample Area
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4
Do not press the FreeStyle Lite test strip against the test site.•
Do not scrape the blood onto the FreeStyle Lite test strip.•
Do not apply blood to the flat side of the FreeStyle Lite•
test strip.
Do not apply blood to the FreeStyle Lite test strip when the•
FreeStyle Lite test strip is out of the meter.
Do not put blood or foreign objects into the FreeStyle Lite•
test strip port.
Waiting for Result
Do not pull the• FreeStyle Lite test strip away
until you hear one beep or see the short line
moving clockwise on your meter screen. This
means you have enough blood and the meter
is reading your glucose.
If after five seconds your meter does not show a short line moving•
around the display screen, the sample may be too small. You may
add blood to the same sample area of the test strip with which you
started for up to 60 seconds from the time of the first application.
T• he test result is complete when your blood
glucose test result is shown on the display
screen and you will hear two beeps.
O• n average, your reading will display in 5
seconds. The time that the meter takes depends
on your blood glucose level. The higher your
glucose level, the longer it takes to get a result.
Potential Bruising
It is possible you may experience bruising at the test site. If bruising
does occur, you may choose to lance another test site.
LO and HI Readings
Important: Low or high blood glucose readings can indicate a potentially
serious medical condition. The FreeStyle Lite meter displays results from
1.1 to 27.8 mmol/L (20 to 500 mg/dL).
If your test result is lower than 1.1 mmol/L (20 mg/dL), LO will
appear on the meter display screen. This reading indicates severe
hypoglycaemia (low blood glucose).
LO Reading with Symptoms
If you have a LO reading and have symptoms
such as weakness, sweating, nervousness,
headache or confusion, then follow your doctor’s
recommendation to treat hypoglycaemia.
LO Reading without Symptoms
If you get a LO reading, but have no symptoms of low blood glucose,
then retest with a new test strip on your fingers. If you still get a LO
reading, follow your doctor’s recommendation to treat hypoglycaemia.
If your test is above 27.8 mmol/L (500 mg/dL), HI will appear on
the display screen. This indicates severe hyperglycaemia (high blood
glucose).
HI Reading with Symptoms
If you feel symptoms such as fatigue, thirst, excess
urination or blurry vision, then follow your
doctor’s recommendation to treat hyperglycaemia.
HI Reading without Symptoms
If you get a HI reading, but have no symptoms of high blood glucose,
then retest with a new test strip. If you still get a HI reading, follow
your doctor’s recommendation to treat hyperglycaemia.
LO Reading
HI Reading
Equivalent to
102 mg/dL
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