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The Partnerships Changing How You Manage Diabetes - Seite 3
WARNINGS/LIMITATIONS*:
The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. 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. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. Seek medical attention when appropriate and contact Abbott Toll Free (855-632-8658) or visit * www.freestylelibre.us for detailed indications for use and safety information.
*Please refer to www.freestylelibre.us for the indications and important safety information.
BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
Indications and Important Safety Information
The Bigfoot Unity Diabetes Management System is indicated for the management of diabetes in people ages 12 years and older. The Bigfoot Unity System provides glucose monitoring data via Abbott's FreeStyle Libre 2 integrated continuous glucose monitoring system. 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 people with diabetes mellitus who use disposable pen-injectors for the self-injection of insulin in implementing health care provider recommended insulin dose regimens. The device is intended for single patient use only and requires a prescription. The Bigfoot Unity System is also intended to communicate autonomously with digitally connected medical devices where the patient manually controls therapy sessions.
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).
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SOURCE: Abbott
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The Abbott Laboratories Stock at the time of publication of the news with a raise of +0,48 % to 101USD on Tradegate stock exchange (01. Februar 2023, 14:59 Uhr).