Chapter 2: Indications For Use And Safety Statement; Indications For Use; Important User Information; Contraindications - Dexcom G4 PLATINUM User Manual

CHAPTER 2: INDICATIONS FOR USE AND SAFETY STATEMENT

2.1 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 18
and older) with diabetes. The system is intended for single patient use and requires a
prescription.
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.

2.2 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.

2.3 CONTRAINDICATIONS

Remove the Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver before
Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy
treatment. The device is MR Unsafe. Do not bring any portion of the device into the MR
environment. The Dexcom G4 PLATINUM System has not been tested during MRI or CT
scans or with diathermy treatment. The magnetic fields and heat could damage the
device so that it might not display sensor glucose readings or provide alerts, and you
might miss a low or high blood glucose value.
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• Taking medications with acetaminophen (such as Tylenol ) 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 may be different for each person.

2.4 WARNINGS

• Thoroughly review the training materials included with your CGM system before using
the Dexcom G4 PLATINUM CGM System. Incorrect use might lead to you
misunderstanding the information provided by your system, or might affect system
performance, and you might miss a low or high blood glucose value.
• Do not use the Dexcom G4 PLATINUM System for treatment decisions, such as how
much insulin you should take. The Dexcom G4 PLATINUM System does not replace a
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