Product Overview
Reader
App
Sensor
Product Use
More Information
Important information about the FreeStyle Libre System
Important Safety Information
Indications for Use
The FreeStyle Libre 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 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 which
could cause incorrect readings.
WARNINGS:
Do not ignore symptoms that may be due to low or high blood glucose: if you are experiencing symptoms that are not consistent
with your glucose readings, consult your health care professional.
Checking Sensor glucose readings with a blood glucose meter: Under the following conditions, Sensor glucose readings may not
be accurate and you should conduct a fingerstick test using a blood glucose meter. You should not use Sensor glucose readings
to make a diabetes treatment decision:
If you suspect that your reading may be inaccurate for any reason
When you are experiencing symptoms that may be due to low or high blood glucose
When you are experiencing symptoms that do not match the Sensor glucose readings
During times of rapidly changing glucose (more than 2 mg/dL per minute), when interstitial fluid glucose levels as measured
by the Sensor may not accurately reflect blood glucose levels
When the Sensor glucose reading does not include a Current Glucose number or Glucose Trend Arrow
In order to confirm hypoglycemia or impending hypoglycemia as reported by the Sensor
Summary of Contents for FreeStyle Libre
Page 64: ...Previous Next ...
