Abbott FreeStyle Libre 3 - Important Safety Information; Indications for Use

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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
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 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.
• Use your blood glucose meter to make diabetes treatment decisions
when you see the
symbol during the 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.
• If you are using the FreeStyle Libre 3 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 33 feet of you at all times. The transmission range is 33 feet
unobstructed. If you are out of range, you may not receive alarms.
• To prevent missed alarms, make sure your device has sucient charge.
If using the Reader, make sure that sounds and/or vibration are turned
on.
• If your phone is not congured 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’s Manual to make sure you have the correct
settings and permissions enabled on your phone.
• Disable your phone’s automatic operating system (OS) updates. Prior
to updating your phone’s OS or updating the App, you should check
the Mobile Device and OS Compatibility Guide to determine if the
FreeStyle Libre 3 app is compatible with your OS and your phone. The