Medtronic GUARDIAN Manuel D'utilisation page 10

Diabetes treatment decisions
Use a BG meter reading to make treatment decisions if no sensor data is available or if unsure that SG
values are correct.
Indications for use
The Guardian app is intended to be used with the Guardian 4 system.
The Guardian 4 system is a real-time, CGM system indicated for the management of diabetes in persons
age 7 years and older.
The Guardian 4 system does not require calibration and is designed to replace finger stick BG testing
for diabetes treatment decisions. Treatment decisions should be made based on the combination of
SG readings and trend arrows. The system can track trends in glucose concentrations, and aid in
detecting events of hyperglycemia and hypoglycemia and helping both current and long-term
therapy decisions.
The system is intended for use only by patients and caregivers using a compatible mobile device and
operating system, and who have sufficient experience to adjust mobile device audio and notification
settings. The system may require a prescription.
Contraindications
Successful CGM use requires sufficient vision or hearing ability to allow recognition of the alerts
generated by the Guardian app.
Clinical benefits
The Guardian app is software that provides information that is used for diabetes management but does
not provide any direct therapy. As a result, the app does not have direct therapeutic benefits but can
support the management of diabetes by patients and caregivers.
User safety
Warnings
Follow the instructions and safety warnings in this user guide to receive alerts as intended. Missing
alerts from the Guardian app may result in undetected low and high glucose levels.
• CGM is not recommended for people who are unwilling or unable to perform BG tests as required
or for people who are unwilling or unable to maintain contact with their healthcare professional.
• Always allow notifications for the Guardian app. If notifications are turned off, the app will not send
any alerts, including Urgent Low Alert.
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