Indications For Use
Indications For Use
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability
indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment
decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids 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 also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction
with these digitally connected devices where the user manually controls actions for therapy decisions.
Compatible Devices, Apps, and Software
Compatible Devices, Apps, and Software
For a list of compatible devices, apps, and software that can be used with the FreeStyle Libre 2 Sensor, please go to:
https://freestylelibre.us/support/overview.html
Use of the Sensor with devices, apps, and software that are not listed may cause inaccurate glucose readings.
Contraindications
Contraindications
Automated Insulin Dosing:
The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin
suspend systems.
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 eff 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.
WARNINGS:
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.
•
Use your blood glucose meter to make diabetes treatment decisions when you see the
symbol during the fi rst 12 hours of wearing a
Sensor, if your Sensor glucose reading does not match how you feel, or if the reading does not include a number.
Choking hazard:
The System contains small parts that may be dangerous if swallowed..
Cautions and Limitations
Cautions and Limitations
Below are important cautions and limitations to keep in mind so you can use the System safely. They are grouped into categories for easy reference.
What to know about Glucose Alarms:
•
For you to receive alarms, they must be on and your Reader should be within 20 feet of you at all times. The transmission range is 20 feet
unobstructed. If you are out of range, you may not receive glucose alarms.
To prevent missed alarms, make sure the Reader has suffi cient charge and that sound and/or vibration are turned on.
Important Safety Information
Important Safety
Information
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