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Abbott FreeStyle Libre 3 - Important Safety Information; Indications for Use

Abbott FreeStyle Libre 3
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User's Manual
CAUTION: Federal law restricts
this device to sale by or on the
order of a physician.
WARNING:
Before you use the FreeStyle Libre 3 System, review all the product instructions
and the Interactive Tutorial. The Quick Reference Guide and Interactive Tutorial
give you quick access to important aspects and limitations of the System. The
User’s Manual includes all safety information and instructions for use. Talk to your
health care professional about how you should use your Sensor glucose
information to help manage your diabetes.
Failure to use the System according to the instructions for use may result in you
missing a severe low blood glucose or high blood glucose event and/or making a
treatment decision that may result in injury. If your glucose alarms and readings
from the System do not match symptoms or expectations, use a fingerstick blood
glucose value from a blood glucose meter to make diabetes treatment decisions.
Seek medical attention when appropriate.
Important Safety Information
Indications for Use
The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time
continuous glucose monitoring (CGM) device with alarms capability indicated for
the management of diabetes in persons age 4 and older. It is intended to replace
blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of
episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-
term therapy adjustments. Interpretation of the System readings should be based
DOC44383_rev-C 1:14pm 22-SEP-2021

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