The Eversense E3 CGM System is indicated for continually measuring glucose levels in adults (18 years or older) with diabetes for up to 180 days. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions.

The system is intended to:

• Provide real-time glucose readings.
• Provide glucose trend information.
• Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).

The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time.
The system is intended for single patient use.

The Eversense^® Charging Accessory Pack includes:

• Charging Cradle (that is used to charge the Smart Transmitter)
• Charging Cable
• Wall Plug

Sensor: The sensor is considered medical waste and will be disposed of by your health care professional.
Transmitter: The transmitter contains a reusable battery and should be disposed of based on your local regulations.
Adhesive patch: The adhesive patch can be thrown away with normal household trash.

Your Eversense Inserter will explain and perform the simple and quick steps to insert the sensor. You will be fully awake during the approximately 5-minute insertion procedure. (The entire procedure, including preparation, usually takes about 15 minutes.)

It is important to choose a site (on the upper arm) that is comfortable for you to wear the sensor and smart transmitter for up to 180 days. It is recommended to have the sensor inserted toward the back of the upper arm. Placement in this area minimizes the chance of the sensor and smart transmitter being bumped by doorways, walls or other narrow passages. It is recommended to avoid areas with loose skin, scars, tattoos, nerves, or blood vessels that could be incised during the procedure. It is recommended to alternate arms for subsequent insertion sites.

Step 1: Site preparation – the insertion site will be cleaned, disinfected, then anesthetized using lidocaine.
Step 2: Incision – a small (less than 1 centimeter) incision will be made at the insertion site.
Step 3: Sensor insertion – a subcutaneous pocket will be created under the skin and the sensor will be inserted in this pocket.
Step 4: Site closure – the incision will be closed with Steri-Strips™. Sutures are not usually required.
Step 5: Sensor and smart transmitter linking – link the sensor and smart transmitter to begin the 24-hour Warm-Up Phase.

Note: After insertion, link the smart transmitter and the sensor and then allow the incision site to heal 24 hours before replacing the transmitter.

The sensor requires 24 hours to stabilize within the insertion site, this period is known as the Warm-up Phase. After the first 24 hours of sensor insertion, position and secure the smart transmitter over the sensor and ensure you have a connection. Then you can perform your Initialization Phase calibration of 4 fingerstick blood glucose tests to start getting glucose readings.

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You can find the Sensor Serial number in the Eversense^® App that is connect to your Sensor and Transmitter.

1. Tap Menu > Settings > System to display the SYSTEMS screen.
2. On the SYSTEMS screen, you can tap each of the following:

• Name: The serial number of your smart transmitter. You can also tap on the serial number displayed here and give your smart transmitter a custom name.
• Linked Sensor: The serial number of the sensor currently linked with the smart transmitter. Tap this feature to access the ability to link or re-link a sensor.