Important Information About Your Blood Glucose Monitoring System; Intended Use - Freestyle LITE Owner's Booklet

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 effectiveness of a
diabetes control program by quantitatively measuring glucose in fresh whole blood from the finger,
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 fingertips, 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.
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 Notification: 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
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Contact Customer Care Toll Free at 1-888-522-5226 www.MyFreeStyle.com
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The expected glucose level for a non-diabetic, non-pregnant fasting adult is under
100 mg/dL.
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Two hours after meals, levels should be less than 140 mg/dL.
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Consult your healthcare professional to determine the range that is appropriate for you.
Warning:
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Test on your fingers if you are testing for low blood glucose (hypoglycemia) or if you suffer
from hypoglycemia unawareness.
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This system contains small parts that may be dangerous if swallowed.
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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3 American Diabetes Association. (2015). 2. Classification and Diagnosis of Diabetes. Diabetes Care, 38(Supplement 1), S8-S16.
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