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

Important Information About Your Blood Glucose Monitoring System

Intended Use

Use outside the body only (in vitro diagnostic use) .
The FreeStyle Freedom Lite® Blood Glucose Monitoring System is intended for use in the quantitative
measurement of glucose in capillary whole blood from the finger, upper arm and palm and venous
whole blood . It is intended for use by healthcare professionals and people with diabetes mellitus
at home as an aid in monitoring the effectiveness of a diabetes control program . It is not intended
for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or
arterial blood .
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 .
Healthcare professionals handling this system must always wear gloves and should follow the
infection control policies and procedures approved by their facility .
Use only FreeStyle Lite® test strips and FreeStyle® control solution with this meter . Other products
can produce inaccurate results .
"FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne
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Pathogens: Initial Communication" (2010) http://www .fda .gov/MedicalDevices/Safety/AlertsandNotices/ucm224025 .htm .
"CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens"
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(2010) http://www .cdc .gov/injectionsafety/Fingerstick-DevicesBGM .html
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