Dexcom G7 - Page 13

Indications for use
The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or
G7) is a real time, continuous glucose monitoring device indicated for the
management of diabetes in persons 2years and older.
The Dexcom G7 CGM System is intended to replace fingerstick BG testing for diabetes
treatment decisions. Interpretation of the Dexcom G7 CGM System results should be
based on the glucose trends and several sequential sensor readings over time. The
Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and
hypoglycemia, facilitating both acute and long-term therapy adjustments.
The Dexcom G7 CGM System is also intended to autonomously communicate with
digitally connected devices, including automated insulin dosing (AID) systems. The
Dexcom G7 CGM System can be used alone or in conjunction with these digitally
connected medical devices for the purpose of managing diabetes.
Contraindications
No MRI/CT/diathermy — MR unsafe: Don't wear any Dexcom G7 CGM
System component during magnetic resonance imaging (MRI) or
high-frequency electrical heat (diathermy) treatment. However, it's safe to
have a CT scan if you keep the sensor out of the scanned area and cover the
sensor with a lead apron during the scan.
MR
The Dexcom G7 CGM System hasn't been tested in those situations when used during
an MRI scan, diathermy, or in the scanned area of a CT scan. The magnetic fields and
heat could damage components of the Dexcom G7 CGM System, which may cause
inaccurate sensor readings or prevent alerts. Without sensor readings or alerts, you
might miss a severe low/high glucose event.
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