2 • Safety Information | Stelo Glucose Biosensor User Guide 3
2 • Safety Information
Stelo Glucose Biosensor safety statements
Indications for use
The Stelo Glucose Biosensor System is an over-the-counter (OTC) integrated
Continuous Glucose Monitor (iCGM) intended to continuously measure, record,
analyze, and display glucose values in people 18 years and older not on insulin. The
Stelo Glucose Biosensor System helps to detect normal (euglycemic) and low or high
(dysglycemic) glucose levels. The Stelo Glucose Biosensor System may also help the
user better understand how lifestyle and behavior modification, including diet and
exercise, impact glucose excursion.
The user is not intended to take medical action based on the device output without
consultation with a qualified healthcare professional.
Contraindications
No MRI/CT/diathermy — MR unsafe: Don't wear any Stelo Glucose
Biosensor System component during magnetic resonance imaging (MRI) or
high-frequency electrical heat (diathermy) treatment. However, it's safe to
have a CT scan if you keep the sensor out of the scanned area and cover the
sensor with a lead apron during the scan.
The Stelo Glucose Biosensor System hasn't been tested in those situations when used
during an MRI scan, diathermy, or in the scanned area of a CT scan. The magnetic
fields and heat could damage Stelo Glucose Biosensor System components, which
may cause inaccurate sensor readings.
To Next Page
Loading...
