Quick Reference Guide Your Eversense XL CGM System includes a sensor inserted in your upper arm, a smart transmitter worn over the sensor, and a mobile device app to display your glucose readings. Schedule the insertion and removal of your sensor with your health care provider.
Refer to the Eversense XL CGM User Guide for more detailed information. Indications for Use The Eversense XL CGM System is intended for continually measuring interstitial glucose levels in adults (18 years and older) with diabetes for the operating life of the sensor. The system is intended to: • • • • Contraindications • People for whom dexamethasone or dexamethasone acetate may be contraindicated. • The smart transmitter is incompatible with magnetic resonance imaging (MRI) procedures.
Eversense XL Smart Transmitter Top Back LED indicator (lights green or orange) Wearing the smart transmitter • Replace the adhesive patch on your smart transmitter daily. • The smart transmitter can be removed and reapplied to the skin at any time. To ensure continuous glucose readings: Power button Charging contact pins • Charge the smart transmitter battery daily (15 minutes to fully charge) using a wall outlet.
Warnings • The Eversense CGM System has not been tested using insertion sites other than the upper arm. • If at any time you have symptoms of a low or high blood glucose level OR if your symptoms are not consistent with the sensor glucose readings, you should test your glucose with a blood glucose metre. • Always test your glucose with your blood glucose metre before making a treatment decision.
Cautions • DO NOT wear the smart transmitter during medical x-rays or computed tomography (CT) scans. To avoid interference with results, remove the smart transmitter before undergoing medical x-ray or CT scans. Make sure your health care provider knows about your smart transmitter. • The smart transmitter is intended to be single-patient use only. DO NOT exchange smart transmitters with another person or with another sensor. Each smart transmitter can be linked to only one sensor at a time.
Cautions (continued) • If the sensor, insertion site or smart transmitter feels warm, remove the smart transmitter immediately and contact your health care provider for further advice. A warm sensor could mean there is an infection or a sensor malfunction and should be removed. • Remove the smart transmitter from your arm before charging the smart transmitter battery. Failure to remove the smart transmitter while it is charging could result in electrical shock.
Eversense XL App The smart transmitter communicates wirelessly with the app to display glucose data, trends, graphs and alerts. The app also stores glucose value history and statistics.
Calibration To help ensure accurate glucose readings, you must routinely calibrate your CGM System with a fingerstick test from a blood glucose metre. Your CGM System automatically notifies you when it’s time to calibrate: • 24 hours after inserting your sensor, you must complete 4 fingerstick calibration tests spaced 2 to 12 hours apart. • Every day thereafter you must complete 2 fingerstick calibration tests per day, spaced 10 to 14 hours apart.
Getting Started Steps Steps 1 and 2 take you up to the point of sensor insertion. Schedule an appointment with your health care provider to have the sensor inserted. After insertion, you will need to wait 24 hours to perform the first set of calibrations and start receiving glucose readings on your app. To get started you need: • A compatible mobile device (like your smartphone) – For a list of compatible devices, visit https://global.eversensediabetes.com/ compatibility.
Step 1. Download and Install Step 2. Set up the App - the App Account Creation, Pairing and Settings 1. Select the mobile device you want to display your glucose readings. Make sure the date and time are correct and Bluetooth is enabled. 1. Launch the app by tapping the Eversense XL icon. The END USER LICENSE AGREEMENT appears. 2. From your mobile device, download the mobile Eversense XL App from the Apple® App Store℠ or on Google Play™. 2.
4. Enter your account information and tap Register. Before receiving your smart transmitter you may begin familiarizing yourself with the app before completing these next steps. If you have received your smart transmitter you may proceed with pairing your smart transmitter to the app.
7. On the PAIR YOUR TRANSMITTER screen the smart transmitter serial number detected by the app is listed as “Not Connected”. Tap Not Connected to begin the pairing process. 9. The app displays “Connected” next to your smart transmitter serial number once the pairing is complete. The smart transmitter will provide intermittent vibrations until the smart transmitter is linked with the inserted sensor. Tap Next. 8. A Bluetooth Pairing Request pop-up appears. Tap Pair to confirm the pairing. 10.
11. The UNIT OF MEASUREMENT screen appears to indicate the standard unit of measurement used for calculating and displaying glucose readings in your region. DO NOT change the unit of measurement until you consult with your health care provider. Tap Finish to keep the unit of measure and continue. 12. Next, the MY GLUCOSE main screen appears. This screen will not have any glucose data to display until your sensor has been inserted and you have started calibrating the system.
Inserting and Linking the Sensor Work with your health care provider to schedule your sensor insertion. Once the sensor has been inserted, your sensor will need to be linked to your smart transmitter. Note: Your mobile device needs an internet connection in order to be linked to the sensor. 1. Position the smart transmitter directly over the inserted sensor until the smart transmitter stops vibrating and the New Sensor Detected message appears on the app. 2. Tap Link Sensor and then Link Detected Sensor.
3. When the smart transmitter and sensor are successfully linked, the LINKED SENSOR screen displays the sensor ID number. Important 24-hour Warm-Up Phase: • The sensor requires 24 hours to stabilise in your body before the smart transmitter will calculate glucose values. • You do not need to secure the smart transmitter over the sensor during the 24-hour Warm-Up Phase.
Distributed by: DYN Diagnostics Ltd. 7 Ha‘eshel St. P.O. Box 3063 Caesarea Industrial Park 3079504, Israel Phone: 04-6175390 Email: patient.care@dyn.co.il Manufactured by: Senseonics, Inc. 20451 Seneca Meadows Parkway Germantown, MD 20876-7005 USA 844.SENSE4U | 301.515.7260 (844.736.7348) global.eversensediabetes.com The Apple App Store and Google Play and their products are trademarks or copyrights of their respective holders.
