Freestyle Libre 14 day - Important Safety Information; Indications, Contraindications, and Warnings

Important Safety Information
Indications For Use
The FreeStyle Libre 14 day Flash Glucose Monitoring System is a
continuous glucose monitoring (CGM) device indicated for the
management of diabetes in persons age 18 and older. It is designed to
replace blood glucose testing for diabetes treatment decisions.
The System detects trends and tracks patterns aiding 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 intended for single patient use and requires a
prescription.
Contraindications
MRI/CT/Diathermy: The FreeStyle Libre 14 day Flash Glucose
Monitoring System must be removed prior to Magnetic Resonance
Imaging (MRI), Computed Tomography (CT) scan, or high-
frequency electrical heat (diathermy) treatment. The eect 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.
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