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1: Based on available products in the US as of May 2021. In order to receive alerts, notifications and Critical Alerts must be turned on and the sensor must be within 20 feet of the phone with the Bigfoot Unity Mobile App active. Alerts only available on the phone. For compatible phones, please visit www.bigfootbiomedical.com/compatible. 2:Transfer of data depends on availability of Wi-Fi or cellular data signal WARNINGS AND INDICATIONS Important Safety Information for the Bigfoot Unity Diabetes Management System
The Bigfoot Unity System is indicated for management of diabetes in persons 12 years and older. Bigfoot Unity provides glucose monitoring data via the Abbott FreeStyle Libre 2 Flash Glucose Monitoring sensor. The system incorporates real-time alarm capabilities and is designed to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The device is intended to provide insulin dose information using the available glucose data to assist persons with diabetes mellitus who use disposable pen-injectors for the self-injection of insulin in implementing health care provider recommended insulin dose regimens. The system must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. The Bigfoot Unity System requires a prescription. A health care professional must provide appropriate settings for the device based on user specific criteria. It is not intended to be used by individuals who dose insulin in ½ unit increments, take multiple daily doses of long-acting insulin or take high doses of vitamin C (more than 500 mg per day). The system provides dose recommendations; however, the final decision on when and how to dose is up to the individual user. Failure to use the system according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury.For complete details of the system and its components, including warnings, contraindications, and precautions, please consult the Bigfoot Unity User Guide. WEB-400110 Rev B 05/2022
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