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

Important Information About Your Blood Glucose Monitoring System

Intended Use

Use outside the body only (in vitro diagnostic use).
The FreeStyle 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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Contact Customer Care Toll Free at 1-888-522-5226 www.MyFreeStyle.com
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