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

INDICATIONS FOR USE

The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a
glucose-monitoring device indicated for detecting trends and tracking patterns
in persons (age 2 and older) with diabetes. The system is intended for use by
patients at home and in healthcare facilities.
The Dexcom G4 PLATINUM System is indicated for use as an adjunctive device
to complement, not replace, information obtained from standard home glucose
monitoring devices.
The Dexcom G4 PLATINUM 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 PLATINUM 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 blood glucose value from your blood glucose meter should be used for
treatment decisions, such as how much insulin you should take. The Dexcom
G4 PLATINUM System does not replace a blood glucose meter.
• The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver must be
removed prior to Magnetic Resonance Imaging (MRI), CT scan, or diathermy
treatment. The Dexcom G4 PLATINUM 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 PLATINUM User's Guide | 7