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Important Safety Information
Indications for Use
The FreeStyle Libre Flash Glucose Monitoring System is indicated for
measuring interstitial uid glucose levels in people (age 4 and older) with
diabetes mellitus. The indication for children (age 4 - 17) is limited to those
who are supervised by a caregiver who is at least 18 years of age. The
caregiver is responsible for managing or assisting the child to manage the
FreeStyle Libre Flash Glucose Monitoring System and also for interpreting
or assisting the child to interpret FreeStyle Libre readings. It is designed to
replace blood glucose testing in the self-management of diabetes with the
exceptions listed below.
Under the following circumstances, use a blood glucose meter
to check the current glucose readings from the FreeStyle Libre Flash
Glucose Monitoring System Sensor:
• During times of rapidly changing glucose levels, interstitial glucose
levels as measured by the Sensor and reported as current may not
accurately reect blood glucose levels. When glucose levels are falling
rapidly, glucose readings from the Sensor may be higher than blood
glucose levels. Conversely when glucose levels are rising rapidly, glucose
readings from the Sensor may be lower than blood glucose levels.
• In order to conrm hypoglycaemia or impending hypoglycaemia as
reported by the Sensor.
• If symptoms do not match the FreeStyle Libre Flash Glucose Monitoring
System reading. Do not ignore symptoms that may be due to low blood
glucose or high blood glucose.
3
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