Abbott FreeStyle Libre 2 User Manual

Important Safety Information
Indications For Use
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous
glucose monitoring (CGM) device with real time 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 on the glucose trends and several
sequential readings over time.
The System is also intended to autonomously communicate with digitally
connected devices. The System can be used alone or in conjunction
with these digitally connected devices where the user manually controls
actions for therapy decisions.
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Abbott FreeStyle Libre 2 Specifications

General

Sensor Life	14 days
Communication	Bluetooth
Water Resistance	IP27
Calibration	Factory calibrated
Manufacturer	Abbott
Model	FreeStyle Libre 2
Sensor Type	Flash glucose monitoring
Requires Finger Prick	No
Warm-up Time	1 hour
Operating Temperature	10°C to 45°C (50°F to 113°F)
Meter Category	Continuous Glucose Monitoring (CGM)
Accuracy	MARD 9.2%
Storage Temperature	-20°C to 60°C (-4°F to 140°F)
Compatibility	FreeStyle LibreLink app
Measurement Range	20 to 500 mg/dL
Data Storage	8 hours