Abbott FreeStyle Libre 2 Manual

Important Safety Information
Indications for Use
The FreeStyle Libre 2 Flash Glucose Monitoring System Reader (“Reader”)
when used with a FreeStyle Libre 2 Flash Glucose Monitoring System
Sensor (“Sensor”) is a real time, continuous glucose monitoring (CGM)
device indicated for measuring interstitial uid glucose levels in people
(age 4 and older) with insulin dependent diabetes mellitus. The Reader
and Sensor are designed to replace blood glucose testing in the self-
management of diabetes, and to support manual dosing of insulin.
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 Reader
and Sensor and also for interpreting or assisting the child to interpret
Sensor glucose readings. 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 only where
the user manually controls actions for therapy decisions.
Contraindications
The System must not be used with automated insulin dosing (AID)
systems, including closed loop and insulin suspend systems. The
Sensor
must be removed prior to Magnetic Resonance Imaging (MRI).
WARNING:
• The System is only intended to be used by patients (aged 4 years and
older) with insulin dependent diabetes mellitus.
• Health care professionals and consumers should be aware about the
limitations of available scientic evidence for use of this device in any
other groups of patients who require diabetes management.
• Do not ignore symptoms that may be due to low or high blood
glucose. If you have symptoms that do not match the Sensor glucose
reading or alarm or suspect that your reading may be inaccurate,
check the reading or alarm by conducting a ngerstick test using a
blood glucose meter. If you are experiencing symptoms that are not
consistent with your glucose readings or alarms, consult your health
care professional.
• The FreeStyle Libre 2 Flash Glucose Monitoring System contains small
parts that may be dangerous if swallowed.
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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