Indication For Use; Important Safety Information - Dexcom SEVEN PLUS User Manual

INDICATION FOR USE

The SEVEN PLUS 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
SEVEN PLUS System is intended for use by patients at home and in health care facilities. The
device is for prescription use only.
The SEVEN PLUS 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 SEVEN PLUS 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 SEVEN PLUS 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 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 SEVEN PLUS User's
Guide. The Troubleshooting section (Chapter 8) contains important information on troubleshooting
your SEVEN PLUS. The Technical Information section (Chapter 10) provides information on the
performance characteristics of the device.
CONTRAINDICATIONS
The SEVEN PLUS System must be removed prior to Magnetic Resonance Imaging (MRI).
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Use of acetaminophen-containing medications while the SEVEN Sensor is inserted may affect the
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performance of the device.
WARNINGS
This device is not designed to replace a blood glucose meter. The SEVEN PLUS must be used with
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a blood glucose meter.
Treatment decisions should not be based solely on results from the SEVEN PLUS. You must
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confirm with a blood glucose meter before making therapeutic adjustments.
Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms
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of low or high glucose, use your blood glucose meter to check the SEVEN PLUS results.
You should update the SEVEN PLUS' calibration every 12 hours at a minimum. The performance of
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the SEVEN PLUS System when calibrated less frequently than every 12 hours has not been studied.
8 | SEVEN PLUS Continuous Glucose Monitoring System