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Manual Abbott FreeStyle Libre Peo Blood Glucose Monitor

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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.

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 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 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

signicant 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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ART26944_rev-C_manual.indd 2-3 9/23/16 9:19 AM

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Specifications

Brand	Abbott
Model	FreeStyle Libre Peo
Category	Blood Glucose Monitors
File type	PDF
File size	4.88 MB

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