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 highfrequency 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.
WARNING:
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
first 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.
If you are using FreeStyle Libre 2 app, you must have access to a blood glucose monitoring system as the App
does not provide one.
Choking hazard: The System contains small parts that may be dangerous if swallowed.
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 Alarms:
For you to receive alarms, they must be on and your device 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 alarms.
To prevent missed alarms, make sure your device has sufficient charge. If using the Reader, make sure that
sounds and/or vibration are turned on.
Alarms you receive do not include your glucose reading so you must scan your Sensor to check your glucose.
If your phone is not configured properly, you will not be able to use the App, so you will not receive alarms or be
able to check your glucose. Refer to the User Manual to make sure you have the correct settings and
permissions enabled on your phone.
What to know before using the System:
Review all product information before use.
Take standard precautions for transmission of blood borne pathogens to avoid contamination.
Make sure that your devices and Sensor kits are kept in a safe place, and maintain your devices under your
control during use. This is important to help prevent anyone from accessing or tampering with the System.
Who should not use the System:
Do not use the System in people less than 4 years of age. The System is not cleared for use in people
under 4 years of age.
Do not use the System if you are pregnant, on dialysis, or critically ill. The System is not cleared for use in
these groups and it is not known how different conditions or medications common to these populations may
affect performance of the System.
Performance of the System when used with other implanted medical devices, such as pacemakers, has not
been evaluated.
What should you know about wearing a Sensor:
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