Dexcom G4 User Manual page 3

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.
Dexcom G4 PLATINUM User's Guide | 19
2
2.3 CONTRAINDICATIONS
‡ 5HPRYH WKH 'H[FRP * 3/$7,180 6HQVRU 7UDQVPLWWHU
and Receiver before Magnetic Resonance Imaging (MRI),
Computed Tomography (CT) scan, or diathermy treatment.
The Dexcom G4 PLATINUM System has not been tested
during MRI or CT scans or with diathermy treatment. The
PDJQHWLF ¿HOGV DQG KHDW FRXOG GDPDJH WKH GHYLFH VR WKDW LW
might not display sensor glucose readings or provide alerts,
and you might miss a low or high blood glucose value.
‡ 7DNLQJ PHGLFDWLRQV ZLWK DFHWDPLQRSKHQ VXFK DV 7\OHQRO
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
‡ 7KRURXJKO\ UHYLHZ WKH WUDLQLQJ PDWHULDOV LQFOXGHG
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.
‡ 'R QRW XVH WKH 'H[FRP * 3/$7,180 6\VWHP IRU
treatment decisions, such as how much insulin you should
take. The Dexcom G4 PLATINUM System does not replace
a blood glucose meter. Always use the values from your
blood glucose meter for treatment decisions. Blood glucose
values may differ from sensor glucose readings. Using the
sensor glucose readings for treatment decisions could lead
to low or high blood glucose value.
‡ 'R QRW LJQRUH V\PSWRPV RI KLJK DQG ORZ JOXFRVH ,I \RXU
sensor glucose readings do not match your symptoms,
20 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System