Section 2
Indications for Use and Safety Statement
Indications for Use
The Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System is a glucose
monitoring system indicated for detecting trends and tracking patterns in persons (age
2 years and older) with diabetes. The system is intended for single patient use and
requires a prescription.
The Dexcom G5 Mobile CGM System is indicated for use as an adjunctive device to
complement, not replace, information obtained from standard home glucose monitoring
devices.
The Dexcom G5 Mobile CGM System aids in the detection of episodes of hyperglycemia
and hypoglycemia, facilitating both acute and long-term therapy adjustments, which
may minimize these excursions. Interpretation of the Dexcom G5 Mobile CGM System
results should be based on the trends and patterns seen with several sequential
readings over time.
Contraindications
MRI/CT/ Diathermy
Remove the Dexcom G5 Mobile CGM System (sensor, transmitter, and receiver)
before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or
high-frequency electrical heat (diathermy) treatment.
The system hasn’t been tested during MRI, CT scans, or with diathermy treatment.
Magnetic fields and heat could damage the components, stopping sensor glucose
readings or Alarm/Alert notifications. Without sensor glucose readings or Alarm/Alert
notifications, you might miss a severe low or high glucose event.
Medications
Taking medications with acetaminophen (such as Tylenol® or Excedrin Extra
Strength®) while wearing the sensor may falsely raise your sensor glucose readings.
The level of inaccuracy depends on the amount of acetaminophen active in your body
and is different for each person.
Dexcom G5 Mobile CGM System Quick Start Guide
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Summary of Contents for G5 Mobile
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