Important Safety Information; Indications For Use; Contraindications - Freestyle LIBRE PRO Operator's Manual

Important Safety Information

Indications for Use

The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional
continuous glucose monitoring (CGM) device indicated for detecting trends
and tracking patterns in persons (age 18 and older) with diabetes . The System
is intended for use by health care professionals and requires a prescription .
Readings from the FreeStyle Libre Pro Sensor are only made available to
patients through consultation with a health care professional . The System
does not require user calibration with blood glucose values .
The FreeStyle Libre Pro System aids in the detection of glucose level
excursions above or below the desired range, facilitating therapy adjustments .
Interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System
readings should be based on the trends and patterns analyzed through time
using the reports available .
IMPORTANT: The device may inaccurately indicate hypoglycemia.
The results of the clinical study conducted for this device
showed that 40% of the time when the device indicated that
user sensor glucose values were at or below 60 mg/dL, user
glucose values were actually in the range of 81-160 mg/dL.
Therefore, interpretation of the FreeStyle Libre Pro Flash Glucose
Monitoring System readings should only be based on the trends
and patterns analyzed through time using the reports available
per the intended use.
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Contraindications

The FreeStyle Libre Pro 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 effect 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 to detect
trends and track patterns in the user's glucose values during
the wear period .
WARNING: The FreeStyle Libre Pro Flash Glucose Monitoring
System contains small parts that may be dangerous if
swallowed .
CAUTION:
•
Performance of the System when used with other implanted
medical devices, such as pacemakers, has not been evaluated .
•
Some individuals may be sensitive to the adhesive that
keeps the Sensor attached to the skin . If your patient notices
significant skin irritation around or under their Sensor, they
should remove the Sensor and stop using the FreeStyle Libre
Pro System . Follow your facility's procedures for handling
skin reactions .
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