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The Bigfoot Unity
™
Diabetes Management System User Guide | Chapter 3
• Bigfoot Unity is intended to be used after you have consulted with
your health care provider so that the insulin and glucose information
entered in the App is right for you. You should check carefully to
make sure the information you enter is correct. Always consult with
your health care provider before you begin using Bigfoot Unity and
for the information you are required to enter in the App.
• Bigfoot Unity provides the capability of Notifications and Alerts
to help you know if your glucose level requires your immediate
attention or if there is a problem with the Sensor. It is possible that
you may not see, hear, or feel the Notification or Alert, depending
on how you set up the App and your phone and what you are doing
at the time. Make sure you read all safety information in this User
Guide, use recommended phone settings (see section 5.3
Enter
Settings
), and know what to do if you receive a Notification or Alert.
• If Bigfoot Unity is not working properly, you may need another way
to track insulin dosing and/or make insulin dosing decisions until
you can resume using Bigfoot Unity. You will still be able to use
your insulin pens without the Caps, App, Sensor or Meter. Consult
with your health care provider about a backup glucose monitoring
and insulin dosing plan, supplies and what to do in case of an
emergency.
• If you do not have your phone, or if your phone is not charged,
you will not receive any Alerts or Notifications. Because you will not
receive any alerts, you should monitor your glucose frequently until
your phone is restored. You will still be able to scan your Sensor
with your White Cap, use your Meter, and use your insulin pen.
IMPORTANT:
Do NOT use Bigfoot Unity with the FreeStyle
LibreLink or FreeStyle Libre Readers. When a Sensor is used with
Bigfoot Unity, it is not compatible with these devices.
3.3 Contraindications
Automated Insulin Dosing: Bigfoot Unity must not be used with
automated insulin dosing (AID) systems, including closed loop and
insulin suspend systems.
MRI/CT/Diathermy: The FreeStyle Libre 2 Sensor 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
Sensor has not been evaluated. The exposure may damage the Sensor
and may impact proper function of the device which could cause
incorrect readings.
