Freestyle Lite User manual

Blood Glucose Monitoring System
Sistema de Control de Glucosa en la Sangre
ART22813-003_rev-A.indd 1
Owner’s Booklet
Manual del Usuario
11/9/16 1:28 PM

i
Sample Areas (dark-colored 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).
c (Configure) Button
• Marks a control solution test
• Scrolls forward
• Displays clock
• Silences a reminder alarm
Bottom
FreeStyle Lite test strip
Sample area
Top
Data Port
Downloads test results. Requires
a compatible data management
system. For more information,
please go to our website or
contact Customer Care.
Display Screen
Displays your test results and other
important information.
m (Mode) Button
• Moves to different mode settings
• Scrolls backward
• Silences a reminder alarm
Light Button
Controls the display backlight and test
strip port light .
The FreeStyle Lite® Meter and How It Works
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.
System Check Screen
This display always appears when the meter
is turned on. You should check that your
meter matches the example exactly
every time your meter turns on. Do
not use the meter if the display
check screen does not exactly match the example.
If the screen does not match, the meter may show
an incorrect result. Please contact Customer Care.
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ART22813-003_rev-A.indd 2-1 1:28 PM11/9/16

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English
Table of Contents
ART22813-003_rev-A.indd 2-3
The FreeStyle Lite® Meter and How It Works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i
Important Information About Your Blood Glucose Monitoring System. . . . . . 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Setting Up the Meter ........................................................4
Purpose .......................................................................4
Set Sound Volume .............................................................5
Set Time.......................................................................6
Set Date.......................................................................7
Using Meter Lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Testing Your Blood Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Purpose ......................................................................10
Prepare to Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Important Test Strip Information ..............................................12
Performing a Blood Glucose Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Understanding Blood Glucose Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Low and High Blood Glucose Results ..........................................16
Error Codes .................................................................19
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
FreeStyle® Control Solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Purpose ......................................................................24
Control Solution Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Out of Range Control Solution Results.........................................25
Performing a Control Solution Test ............................................26
Using Your Meter Memory ..................................................29
Purpose ......................................................................29
Viewing Blood Glucose Averages in Memory ..................................29
Viewing Test Results in Memory ...............................................30
Setting Reminder Alarms (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Purpose ......................................................................31
Transferring Test ResultsTo a Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Maintaining the Meter......................................................33
Replacing the Battery.........................................................33
Cleaning and Disinfecting the Meter and Lancing Device ......................35
Specications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Denition of Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
11/9/16 1:28 PM

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.
3American Diabetes Association. (2015). 2. Classication and Diagnosis of Diabetes. Diabetes Care, 38(Supplement 1), S8-S16.
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1
Important Information About Your Blood Glucose Monitoring System
Intended Use
The FreeStyle Lite Blood Glucose Monitoring System is intended for self-testing outside the body (in
vitro diagnostic use) by people with diabetes at home as an aid in monitoring the eectiveness of a
diabetes control program by quantitatively measuring glucose in fresh whole blood from the nger,
upper arm and palm. The FreeStyle Lite Blood Glucose Monitoring System should not be used for the
diagnosis of or screening of diabetes or for neonatal use. It is intended to be used by a single person
and should not be shared. Alternate site testing should be done only during steady state times (when
glucose is not changing rapidly). The FreeStyle Lite Blood Glucose Test Strips are for use with the
FreeStyle Lite Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole
blood samples drawn from the ngertips, upper arm and palm.
IMPORTANT:
The device must not be used on more than one person including other family members due to the
risk of spreading infection. All parts of the device and its accessories are considered biohazardous
and can potentially transmit infectious diseases, even after performing the cleaning procedure.1,2
If the meter is being operated by a second person who is providing testing assistance to the user,
the meter and lancing device should be cleaned and disinfected prior to use by the second person.
Use only FreeStyle Lite test strips and FreeStyle® control solution with this meter. Other products
can produce inaccurate results.
1“FDA Public Health Notication: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne
Pathogens: Initial Communication” (2010) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
2“CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens”
(2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
ART22813-003_rev-A.indd 1-2
• The expected glucose level for a non-diabetic, non-pregnant fasting adult is under
100 mg/dL.3
• Two hours after meals, levels should be less than 140 mg/dL.3
• Consult your healthcare professional to determine the range that is appropriate for you.
Warning:
• Test on your ngers if you are testing for low blood glucose (hypoglycemia) or if you suer
from hypoglycemia unawareness.
• This system contains small parts that may be dangerous if swallowed.
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2

1. With the meter o, press and hold
m
for 3seconds until appears.
2. Press
m
to bypass setting the optional reminder alarms. You may choose to
set these later (see Setting Reminder Alarms section).
4 Atkins SH, Dasmahapatra A, Jaker MA, Chorost MI, Reddy S: Fingerstick glucose determination in shock. Ann Int Med 114: 1020-
1024. 1991.
5 Sandler M, Low-Beer T: Misleading capillary glucose measurements. Practical Diabetes 7: 210. 1990.
6 Wickham NWR, Achar KN, Cove DH: Unreliability of capillary blood glucose in peripheral vascular disease. Practical Diabetes 3: 100. 1986.
Setting Up the Meter
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Limitations:
• For in-vitro diagnostic use only (external use only).
• Not for diagnosis of or screening for diabetes.
• Not for testing of neonates.
• The test strips are for single use only. Do not reuse test strips.
• The system can give false results greater than 10,000 feet (3,048 meters) above sea level.
• The system can give false results outside the hematocrit range: 15% to 65%.
• Individuals experiencing a hypoxia state may yield falsely low results.
• In situations of decreased peripheral blood ow, capillary blood testing may not be
appropriate as it may not represent the true physiological state. Examples would include but
are not limited to: severe dehydration caused by diabetic ketoacidosis or the hyperosmolar
non-ketotic state, hypotension, shock, or peripheral vascular disease.4, 5, 6
• This device should not be used to test critically ill patients.
• Alternative site testing (AST) should not be used to calibrate continuous glucose monitors
(CGMs) nor for use in insulin dose calculations.
• AST testing should only be done during steady-state times (when glucose is not changing rapidly).
• For single patient use at home by a lay user.
• Severe dehydration or excessive water loss may cause false low results. If you believe you are
suering from severe dehydration, consult your physician immediately.
• Cholesterol up to 500 mg/dL or triglycerides up to 3,000 mg/dL do not signicantly aect test
results. However, glucose values in specimens beyond these levels, should be interpreted with
caution.
Purpose
The purpose of this section is to set the meter sound volume, time and date.
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Time Format
Note: Your meter can display either the 12-hour (1:23P) or the 24-hour (13:23)
time formats. If you prefer the 12-hour format, there is no “Afor AM. If setting a
PM time, continue to press
c
until you see the“Pdisplayed for PM.
Hour
4. Set hour
• Press
c
to display correct hour
• Press
m
to save
Minutes
5. Set minutes
• Press
c
to display correct minutes
• Press
m
to save
Time Format
6. Set time format
• Press
m
to accept time format or
• Press
c
to change
• Press
m
to save
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Set Sound Volume Set Time
With the sound volume on, your meter will beep when:
• The test strip is full of blood ”
• The test result appears on the display ”
• An error occurs
You may also choose to silence your meter.
3. Set sound volume
If you prefer: Press
c
until you see: Then
No sound
•Press
m
to save
A low beep
A louder beep
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7 8
Set Date
Note: The date format can display either:
Year Month Day
OR
Year Day Month
Month
The month will ash rst
7. Set month
• Press
c
to display correct month
• Press
m
to save
Day
8. Set day
• Press
c
to display correct day
• Press
m
to save
Date Format
9. Set date format
• Press
m
to accept date format or
• Press
c
to change
• Press
m
to save
Year
10. Set year
• Press
m
to accept year or
• Press
c
to change
• Press
m
to save
11. Press and hold
m
for 3seconds until meter turns o. Meter set up is
complete.
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ART22813-003_rev-A.indd 7-8 1:28 PM11/9/16

1. Select your test site.
Note: Avoid moles, veins, bones, and tendons. Bruising may occur at the test site. If bruising occurs,
consider selecting another site.
There are dierences in testing on ngers versus alternative sites.
Warning:
Test on your ngers if you are testing for low blood glucose (hypoglycemia) or if you suer from
hypoglycemia unawareness.
Check for low blood glucose when:
• You feel symptoms such as weakness, sweating, shakiness, headache, or confusion
• You eat a delayed meal after taking insulin
• You are following your healthcare professional’s advice
Testing Your Blood Glucose
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Using Meter Lights
You can light the display screen or test strip port by pressing on meter when Purpose
the meter is turned on. The purpose of this section is to produce an accurate blood glucose test result.
To light your display backlight, press Prepare to Test
The light turns o:
• When you press again
• After 10 seconds of inactivity
To light the test strip port after you’ve inserted the test strip, press
The light turns o:
• When you press again
• After 60 seconds of inactivity
• When the test strip is lled
• When the test strip is removed from the meter
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Warning: Drying agents in the test strip vial may be harmful if inhaled or
swallowed and may irritate skin and eyes.
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11
IMPORTANT:
2. Wash your hands and the test site with warm water and soap to ensure
accurate results.
• Thoroughly dry your hands and the test site.
• Do not use lotion or cream on the test site.
3. Check test strip expiration date.
Do not use expired test strips; they may produce inaccurate results.
IMPORTANT: Use only FreeStyle Lite® test strips. Other test strips can
produce inaccurate results. The test strips are for single use only.
ART22813-003_rev-A.indd 11-12
Important Test Strip Information
Please read the FreeStyle Lite® test strip package insert for more information.
• Use the test strips within the meter’s operating range: 40° – 104° F (4° – 40° C).
• Store test strips in a cool, dry place between 40° – 86° F (4° – 30° C).
• Store test strips away from direct sunlight and heat.
• Store test strips in their original vial only.
• Clean and dry your hands before removing a strip from the vial.
• Close the vial cap tightly immediately after removing a test strip.
• Do not transfer test strips to another container.
• Do not store test strips outside the vial.
• Do not bend, cut, or alter test strips.
• Do not apply blood to both sides of the test strip.
• Do not press the test strip against the test site.
• Do not scrape the blood onto the test strip.
• Do not apply blood to the at side of the test strip.
• Do not apply blood to the test strip when the test strip is out of the meter.
• Do not put blood or foreign objects into the meter.
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12

5. Apply and hold blood to 1 sample area of the test strip until:
• You see short lines moving clockwise on the display or
• You hear a beep
This indicates the test strip obtained enough blood and the meter is checking
your glucose level. If a short line does not appear after 5 seconds, the sample may
be too small. You can add blood to the same side only for up to 60 seconds. If the
test does not start after applying blood drop, go to Troubleshooting section.
(Example only)
6. View result
The result appears on the display when the test is complete. The time that the
meter takes to display a result depends on your blood glucose level. Higher
glucose levels require more time.
Note: If you see an“Er1, Er2, Er3, or Er4” on the display, it is an error code. Go to
Error Codes section.
7. Remove test strip to turn meter o.
Discard used lancet and test strip properly.
8. Wash your hands and test site thoroughly with warm water and soap after
handling the meter, lancing device or test strips.
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Performing a Blood Glucose Test
1. Remove test strip from vial. Top
2. Insert test strip to turn meter on.
Note: The meter turns o after 2 minutes of inactivity. Printed side up
Remove and reinsert the unused test strip to restart
the meter.
Sample areas
If the meter does not turn on, go to Troubleshooting section.
3. Conrm System Check Screen.
• This display appears when you turn on the meter. Do not use the meter if
the display check screen does not exactly match the example. Contact
Customer Care.
• See The FreeStyle Lite® Meter and How It Works section for more information.
• If the system check screen does not appear, go to Troubleshooting section.
4. Obtain a blood drop.
When the and appears, use the lancing device to obtain a blood drop.
(See FreeStyle® lancing device insert for instructions.)
The test strip requires only a 0.3 microliter of blood for accurate results.
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