#Freestyle libre flash glucose monitoring system implant skin#

If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the System.

Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin.

The Sensor can be worn for up to 14 days.

What should you know about wearing a Sensor:

Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.

The System is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations.

Do not use the System in pregnant women or persons on dialysis.

Sensor glucose readings may be inaccurate in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect performance of the System. The System is not approved for use in these patients.

Do not use the System in critically ill patients.

In general, continuous glucose monitoring systems are recognized to be less accurate in children than in adults.

The System is not approved for use in people under 18 years of age and Sensor readings in this population may be inaccurate.

Do not use the System in people less than 18 years of age.

Take standard precautions for transmission of blood borne pathogens to avoid contamination.Review all product information before use.There are NO alarms or alerts unless you scan the Sensor.They are grouped into categories for easy reference. Choking hazard: The FreeStyle Libre 14 day system contains small parts that may be dangerous if swallowed.īelow are important cautions and limitations to keep in mind so you can use the System safely.For example, the System does not have an alarm that can alert or wake you when you are sleeping in the case of low or high glucose. No alarms without a Sensor scan: The System does not have alarms that will automatically notify you when you are having a severe low (hypoglycemic) or high (hyperglycemic) glucose event unless you scan your Sensor.Hypoglycemic unawareness: The System has not been evaluated for use in patients with hypoglycemic unawareness and will not automatically alert you of a hypoglycemic event without you scanning your Sensor.Sensor readings may not accurately reflect blood glucose levels. When you see the Check Blood Glucose symbol, you must check your blood glucose with a blood glucose meter before making any treatment decisions.In order to confirm hypoglycemia or impending hypoglycemia as reported by the Sensor.When the Sensor glucose reading does not include a Current Glucose number or Glucose Trend Arrow.During times of rapidly changing glucose (more than 2 mg/dL per minute).During the first 12 hours of wearing a FreeStyle Libre 14 day Sensor.When you are experiencing symptoms that do not match the Sensor glucose readings.When you are experiencing symptoms that may be due to low or high blood glucose.If you suspect that your reading may be inaccurate for any reason.Check Sensor glucose readings by conducting a fingerstick test with a blood glucose meter under the following conditions, when Sensor glucose readings may not be accurate and should not be used to make a diabetes treatment decision:.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 healthcare professional.The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. 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 System is intended for single patient use and requires a prescription. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.

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. It is designed to replace blood glucose testing for diabetes treatment decisions. 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.

#Freestyle libre flash glucose monitoring system implant full#

FULL INDICATIONS AND IMPORTANT SAFETY INFORMATION