The Eversense^® 365 CGM System has not been tested using insertion sites other than the upper arm.

The Eversense^® 365 Sensor has a Warm-Up Phase, which is the period the sensor requires to adjust after the sensor has been inserted and before calibrations. The Warm-Up Phase lasts for 24 hours after the sensor is linked. Once the 24 hour period has passed, the Eversense^® 365 App will prompt the user to perform a calibration.

Polymethylmethacrylate (PMMA); Hydroxyethylmethacrylate (HEMA) based Hydrogel; Silicone and Dexamethasone Acetate (DXA); EPO-TEK 301-2; Platinum, Iridium, Molybdenum.

The sensor has a silicone ring that contains a small amount of an anti-inflammatory drug (dexamethasone acetate). For more information regarding dexamethasone acetate please contact your health care professional.

If you are concerned that you may be experiencing an adverse effect, contact your health care professional.

The following will cause the system to re-enter Initialization Phase.

• Not completing a calibration within a 12-hour period during the Initialization Phase.
• Not completing all 4 calibrations within 36 hours during the Initialization Phase.
• Not completing required calibration entries during the Daily or Weekly Calibration Phase.
  • 1 calibration every 24 hours when the system is in 1 Daily Calibration Phase.
  • 1 calibration a week when the system is in 1 Weekly Calibration Phase.
• When the last several blood glucose meter measurements are significantly different than the sensor glucose values.
• If the smart transmitter is out of battery power for more than 16 hours.
• When you receive a Sensor Check Alert.

The sensor should be replaced at the end of sensor life.  As reminders to be sure you’ve scheduled your replacement, the Sensor Replacement notifications and alerts appear 60, 30, 14, 7, 3, and 1 day before your sensor should be replaced.