Chapter 2 | Indications For Use And Safety Statements; Dexcom Pro Q Safety Statements - Dexcom Pro Q User Manual

Chapter 2
Safety Statements

2.1 Dexcom Pro Q Safety Statements

Indications for Use
The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a
factory calibrated continuous glucose recording device indicated for the retrospective
discovery, analysis and interpretation of glycemic variability in persons age 2 years and
older under the supervision of a healthcare professional. The Dexcom Pro Q System
collects and processes data for aiding in the management of a disease or condition
related to glycemic control.
Interpretation of the data recorded by the Dexcom Pro Q System results should be
made only by a qualified healthcare professional based on glucose trends and several
sequential readings over time. The Dexcom Pro Q System aids in detecting glucose
excursions facilitating care plan adjustments. The Dexcom Pro Q System is also
intended to interface with digitally connected devices.
Contraindication
• No MRI/CT/Diathermy – MR Unsafe
Don't wear the system (sensor, transmitter) for magnetic resonance imaging (MRI),
computed tomography (CT) scan, or high-frequency electrical heat (diathermy)
treatment.
The Dexcom Pro Q hasn't been tested in those situations. The magnetic fields
and heat could damage the components of the Dexcom Pro Q, which may cause
inaccurate Dexcom Pro Q sensor glucose readings (Dexcom Pro Q readings).
Warnings
• Do not use the Dexcom Pro Q if participant is pregnant, on dialysis, or critically
ill. It is not known how different conditions or medications common to theses
populations may affect performance of the system.
Dexcom Pro Q ™ System User Guide
Chapter 2: Indications for Use and Safety Statements
|
Indications for Use and
MR
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