Indications For Use; Important User Information - Dexcom G4 User Manual

INDICATIONS FOR USE

The Dexcom G4 Continuous Glucose Monitoring System is a glucose-
monitoring device indicated for detecting trends and tracking patterns in
persons (age 18 and older) with diabetes. The system is intended for use by
patients at home and in healthcare facilities and requires a prescription (United
States).
The Dexcom G4 System is indicated for use as an adjunctive device to
complement, not replace, information obtained from standard home glucose
monitoring devices.
The Dexcom G4 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 G4 System
results should be based on the trends and patterns seen with several sequential
readings over time.

IMPORTANT USER INFORMATION

Please review your product instructions before using your continuous glucose
monitoring system. Contraindications, warnings, precautions, cautions, and
other important user information can be found in your product instructions.
Discuss with your healthcare professional how you should use your sensor
trend information to help manage your diabetes. Your product instructions
contain important information on troubleshooting your system and on the
performance characteristics of the device.
CONTRAINDICATIONS
• The Dexcom G4 Sensor, Transmitter, and Receiver must be removed prior
to Magnetic Resonance Imaging (MRI), CT scan, or diathermy treatment.
The Dexcom G4 System has not been tested during MRI or CT scans or with
diathermy treatment, and it is unknown if there are safety or performance
issues.
• Taking acetaminophen (paracetamol) containing products (such as Tylenol)
while wearing the sensor may falsely raise your sensor glucose readings. The
level of inaccuracy depends on the amount of acetaminophen (paracetamol)
active in your body.
Dexcom G4 User's Guide | 7