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1. Important Safety Information
General Description
The Continuous Glucose Monitoring (CGM) System is indicated for the continuous monitoring
of interstitial fluid glucose levels in patients with diabetes mellitus. The system provides real-
time glucose levels, detects glucose trends, fluctuations and TIR (time in range). Glucose levels
are monitored by an electrochemical sensor which is factory calibrated, not requiring
fingerstick calibration. The Sensor is a single-use device that can be worn for up to 14 days by
a single user.
Intended Use/Purpose
The CGM System is intended for the continuous monitoring of interstitial fluid glucose levels.
Indication for Use
The CGM System is indicated for use in patients with diabetes mellitus type 1 or 2. The GS1
CGM System is a real-time continuous glucose monitoring device for single-use only.
Intended Users
The CGM System is intended to be used by patients 18 years and older with Type 1 or Type 2
Diabetes Mellitus.
Target Population
The System is intended for patients with Type 1 or Type 2 Diabetes Mellitus, 18 years and older.
Clinical Benefits
The expected clinical benefits of using the GS1 CGM System include:
Improved quality of life by increasing hypoglycemic awareness.
Contraindications
The system must be removed prior to Magnetic Resonance Imaging (MRI) or computed
tomography (CT) scan.
The system must not be used with automated insulin dosing (AID) systems, including
closed loop and insulin suspend systems, or used with software to guide the dosing of
insulin.
The Sensor should not be inserted at a site where severe skin scald, burns, sunburns,
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