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eversense 365 Quick Reference Manual

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Quick Reference Guide
Sensor
Smart Transmitter
App
To access additional reference materials, go to: www.eversensediabetes.com

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Summary of Contents for eversense 365

  • Page 1 Quick Reference Guide Sensor Smart Transmitter To access additional reference materials, go to: www.eversensediabetes.com...
  • Page 3 Refer to the Eversense 365 CGM System User Guide for more detailed information. Indications for Use The Eversense 365 Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to 1 year in people (18 years or older) with diabetes. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions.
  • Page 4 The smart transmitter is MR Unsafe and MUST BE REMOVED before undergoing an MRI (magnetic resonance imaging) procedure. The sensor is MR Conditional. For more information on the sensor, see MRI Safety Information in the Eversense 365 CGM System User Guide. •...
  • Page 5 To turn the smart transmitter OFF, touch and hold the soft-touch button for about five seconds. To see if your smart transmitter is ON, tap the soft-touch button once. If the LED appears, the smart transmitter is ON. If no LED appears, the smart transmitter is OFF. Eversense 365 CGM System Quick Reference Guide...
  • Page 6 About 24 hours of power Use or continue charging until LED connected to the USB cable available is solid green. Solid green when 100% charged Ready to use. connected to the USB cable Eversense 365 CGM System Quick Reference Guide...
  • Page 7 Check the app on your mobile minute triggered device to understand the alert. Blinks orange Transmitter and sensor Position transmitter over sensor site. communication interrupted If prompted, link sensor. or not yet linked Eversense 365 CGM System Quick Reference Guide...
  • Page 8 If your power adapter or USB cable is damaged or lost, contact Customer Support for a replacement to ensure safe operation of the device. Eversense 365 CGM System Quick Reference Guide...
  • Page 9 Downloading the Eversense 365 App and Pairing the Smart Transmitter Download and Install the App Download the free app from the On the install screen, tap Install application Apple App Store or on Google Play. and follow the installation instructions.
  • Page 10 Launch the App by Tapping the Eversense 365 Icon Tap Create an account Enter your account information and then tap Submit. to create your Eversense • To activate your Eversense account, click the link in the account. email sent from donotreply@eversensediabetes.com.
  • Page 11 The app will open. Tap the link The app will ask you to enable notifications and to log in. Bluetooth. • • Enter your email address and Tap NEXT to continue. password and tap LOG IN. Eversense 365 CGM System Quick Reference Guide...
  • Page 12 DO NOT change the unit of measurement until you consult with your health care provider. • Tap Next to continue. Eversense 365 CGM System Quick Reference Guide...
  • Page 13 Select I have a Smart Transmitter and you will begin System Setup to pair the smart transmitter to your mobile device. Eversense 365 CGM System Quick Reference Guide...
  • Page 14 Warm-up Phase: The 24-hour period after the sensor is linked with the smart transmitter. • Initialization Phase: Enter 4 calibrations 2 to12 hours apart. Connect On the System Setup Menu, tap Connect to pair your transmitter. Eversense 365 CGM System Quick Reference Guide...
  • Page 15 Back LED indicator Serial Number Soft-touch button Note: Your mobile device must be connected to the internet in order to pair with the smart transmitter. Internet is only required at pairing. Eversense 365 CGM System Quick Reference Guide...
  • Page 16 • Tap Next. Note: If the transmitter detects software that appears to be invalid trying to communicate with the transmitter over BLE, device pairing will be prevented. Eversense 365 CGM System Quick Reference Guide...
  • Page 17 Wait about 1 second for the Placement guide to refresh between each adjustment to the smart transmitter’s position over the sensor. For details on linking the sensor, please review Linking the Sensor in the Eversense 365 CGM System User Guide.
  • Page 18 • Position the smart transmitter directly over the inserted sensor until the Placement Guide in the app shows some connection and keep in position without applying pressure. Eversense 365 CGM System Quick Reference Guide...
  • Page 19 To get the best signal, gently lift and move the smart transmitter as needed until the placement guide shows 2-3 bars (good to excellent). Tip: It may be helpful to look in a mirror as you position your smart transmitter. Sensor Incision Eversense 365 CGM System Quick Reference Guide...
  • Page 20 The linking process will begin. DO NOT remove the smart transmitter from your insertion site until the progress bar is completed and Sensor linked successfully is displayed. Eversense 365 CGM System Quick Reference Guide...
  • Page 21 The system will not provide readings during the 24-hour Warm-Up Phase and until a second calibration is successful during the Initialization Phase. During this time, you should monitor your glucose using a home blood glucose monitor. Eversense 365 CGM System Quick Reference Guide...
  • Page 22 Warm-up Phase to see Phase is complete, the app details about Warm-up Phase will notify you to begin • Tap Glucose settings to duration. Initialization Phase. set your target and alert settings. Eversense 365 CGM System Quick Reference Guide...
  • Page 23 Glucose readings will start displaying in the app a few minutes after the 2nd calibration is successfully completed. IMPORTANT: Your smart transmitter must be turned on and paired with the app and linked to your sensor in order to calibrate. Eversense 365 CGM System Quick Reference Guide...
  • Page 24 Tap on Placement Guide. notification, tap Continue to Until the transmitter is secured over the sensor and begin the Initialization Phase. a signal is established, the Placement Guide screen will show No signal. Eversense 365 CGM System Quick Reference Guide...
  • Page 25 Peel off the paper backing of the Remove the larger clear backing and adhesive patch with the Eversense logo position the smart transmitter directly on it and place the smart transmitter in over the sensor. the center. Eversense 365 CGM System Quick Reference Guide...
  • Page 26 Note: For more information on using the Placement Guide, review Placement Guide - Show More Detail Screen in the Linking the Sensor section of the Eversense 365 CGM System User Guide. Eversense 365 CGM System Quick Reference Guide...
  • Page 27 You can complete all 4 calibrations in as quickly as 6 hours. All 4 calibrations must be completed within 36 hours. You can record the times below as a reference. Eversense 365 CGM System Quick Reference Guide...
  • Page 28 Once the Initialization Phase has passed, the system requires one calibration each day for the first 13 days. After 13 days, the system will prompt you for calibration once a week. Please see Calibrating the System in the Eversense 365 CGM System User Guide for more information. Eversense 365 CGM System Quick Reference Guide...
  • Page 29 Status bar information • Current sensor glucose value – the current glucose value should be displayed in black • Trend arrow – a trend arrow should be displayed • Recent trend information and alerts Eversense 365 CGM System Quick Reference Guide...
  • Page 30 You are taking medications of the tetracycline class Note: Always refer to the glucose information on your app on your smartphone to make treatment decisions. Do not utilize a secondary display like the Apple Watch or Eversense NOW. Eversense 365 CGM System Quick Reference Guide...
  • Page 31 My Glucose home screen. Recent trend information • and alerts You are currently taking a medication of the tetracycline class. Additional resource: Eversense 365 CGM System User Guide: Using the App. Eversense 365 CGM System Quick Reference Guide...
  • Page 32 Rapidly falling glucose levels, falling at a rate between 2.0 mg/dL and 3.0 mg/dL per minute. Very rapidly rising glucose levels, rising at a rate more than 3.0 mg/dL per minute. Very rapidly falling glucose levels, falling at a rate more than 3.0 mg/dL per minute. Eversense 365 CGM System Quick Reference Guide...
  • Page 33 • Typically, the difference you see is the sensor glucose level "lags behind" the blood glucose level by several minutes. Eversense 365 CGM System Quick Reference Guide...
  • Page 34 High glucose target level  Low glucose target level  Low glucose alert level  Event Log icon   Exercise Insulin   Multiple Event Calibration  Predicted High Glucose Alert  Eversense 365 CGM System Quick Reference Guide...
  • Page 35 BOTH your mobile device and smart transmitter provide alerts to notify you when your CGM readings have reached certain alert settings or if your CGM System requires attention. • See the Eversense 365 CGM System User Guide for a complete listing of alerts on your app. Eversense 365 CGM System Quick Reference Guide...
  • Page 36 Tip: A “No Sensor Detected” alert may pop-up in your app. This will happen if your smart transmitter is powered on, but not on your arm. Clear the alert by tapping Not Now. Eversense 365 CGM System Quick Reference Guide...
  • Page 37 Set how often alerts repeat (snooze) Your alerts sounds are also customizable. See the Eversense 365 CGM System User Guide Section 8. Eversense 365 CGM System Quick Reference Guide...
  • Page 38 2 short vibes • Alerts are sortable. 3 quick vibes then Alerts related to low transmitter battery 1 long vibe x 2 Alerts related to less critical issues, or 1 short vibe notifications Eversense 365 CGM System Quick Reference Guide...
  • Page 39 To share your Eversense data with your health care provider, ask them for their Eversense Clinic ID number. See the Eversense 365 CGM System User Guide for more information on sharing data with your health care provider via the app.
  • Page 40 Notes...
  • Page 41 Notes...
  • Page 42 Notes...
  • Page 44 Contact your health care provider if you have a medical question or concerns about your diabetes treatment plan. • Contact Customer Care if you have technical questions about the system. Eversense Customer Care: 1-844-SENSE4U (736-7348) Support@eversensediabetes.com Distributed by: Ascensia Diabetes Care US, Inc.