User's Manual

G4-Global System User’s Guide | 7
INDICATION FOR USE
The G4-Global Continuous Glucose Monitoring System is a glucose-monitoring
device indicated for detecting trends and tracking patterns in adults (age 18 and
older) with diabetes. The G4-Global System is intended for use by patients at
home and in health care facilities. The device is for prescription use only.
The G4-Global Continuous Glucose Monitoring System is indicated for use as
an adjunctive device to complement, not replace, information obtained from
standard home glucose monitoring devices.
The G4-Global Continuous Glucose Monitoring 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 G4-Global System results should be based on the trends
and patterns seen with several sequential readings over time.
IMPORTANT SAFETY INFORMATION
Read this entire guide before using your G4-Global Continuous Glucose
Monitoring System. If you do not understand something or have any questions,
please ask your Diabetes Management Team or another health care provider.
Contraindications, warnings, precautions, cautions, and other important
safety information can be found in this section and in boxes throughout your
G4-Global System User’s Guide. The Troubleshooting section (Chapter 9)
contains important information on troubleshooting your G4-Global System. The
Technical Information section (Chapter 11, Section 11.2) provides information on
the performance characteristics of the device.
CONTRAINDICATIONS
•
The G4-Global System must be removed prior to Magnetic Resonance
Imaging (MRI).
•
Use of acetaminophen-containing medications while the Sensor is inserted
may affect the performance of the device.