User Guide
1
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.
CONTRAINDICATIONS:
Automated Insulin Dosing: The System must not be used with
automated insulin dosing (AID) systems, including closed loop and insulin
suspend systems.
MRI/CT/Diathermy: The System must be removed prior to
Magnetic Resonance Imaging (MRI), Computed Tomography (CT)
scan, or high-frequency electrical heat (diathermy) treatment. The
eect of MRI, CT scans, or diathermy on the performance of the
System has not been evaluated. The exposure may damage the
Sensor and may impact proper function of the device which could
cause incorrect readings.