Important Information About Your Blood Glucose Monitoring System; Intended Use - Abbott FreeStyle Freedom Lite Manual Del Usuario

Important Information About Your Blood Glucose Monitoring System

Intended Use

The FreeStyle Freedom 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 Freedom 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 Freedom 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 .
"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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Contact Customer Care Toll Free at 1-888-522-5226 www.MyFreeStyle.com
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