Chapter 2 Dexcom One Safety Statements; Indications For Use; Important User Information; Contraindication - Dexcom one User Manual

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Chapter 2
Dexcom ONE safety
statements

Indications for use

The Dexcom ONE Continuous Glucose Monitoring
System (Dexcom ONE) is a glucose monitoring
system indicated for persons, including pregnant
women, ages 2 years and older. Dexcom ONE is
designed to replace fingerstick blood glucose (BG)
testing for diabetes treatment decisions.
Interpretation of Dexcom ONE results should be
based on the glucose trends and several sequential
readings over time. Dexcom ONE also aids in
the detection of episodes of hyperglycemia and
hypoglycemia, facilitating both acute and long-term
therapy adjustments.
Dexcom ONE is intended for use by patients at
home and in healthcare facilities.

Important user information

Please review the product instructions before
using Dexcom ONE. Indications, contraindications,
warnings, precautions, and other important user
information can be found in the product instructions
that are included with Dexcom ONE. You and your
healthcare professional must discuss how you
should use the information displayed on Dexcom
ONE to help manage your diabetes. Getting familiar
with the system could take days, weeks, or even
months. The product instructions contain important
information on troubleshooting Dexcom ONE and on
the performance characteristics of the system.

Contraindication

• No MRI/CT/diathermy – MR unsafe
Do not wear any component of Dexcom ONE
during magnetic resonance imaging (MRI),
computed tomography (CT) scan, or high-
frequency electrical heat (diathermy) treatment.
Dexcom ONE User Guide
Dexcom ONE safety statements
MR
5

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