Download
Share
Print this page
  1. Manuals
  2. Brands
  3. senseonics Manuals
  4. Blood Glucose Meter
  5. Eversense 365
  6. User manual

senseonics Eversense 365 User Manual

Hide thumbs

Advertisement

Quick Links

Download this manual
User Guide
Sensor
Smart Transmitter
App

Advertisement

loading
Need help?

Need help?

Do you have a question about the Eversense 365 and is the answer not in the manual?

Questions and answers

Related Manuals for senseonics Eversense 365

Summary of Contents for senseonics Eversense 365

  • Page 1 User Guide Sensor Smart Transmitter...
  • Page 3 Eversense 365 Continuous Glucose Monitoring (CGM) System, Eversense 365 CGM System, Eversense 365 Sensor, Eversense 365 Smart Transmitter, Eversense 365 App and the Eversense 365 logo are trademarks of Senseonics, Incorporated. Other brands and their products are trademarks or registered trademarks of their...
  • Page 4 Contents Glossary System Setup 4. Calibrating the System 1. Introduction How To Calibrate Help and Support Calibration Phases System Components 5. Daily Transmitter Wear System Requirements End User License Agreement and Daily Use Privacy Policy Smart Transmitter Care and Broken Screen or Button Maintenance Device Modifications Battery Indicator...
  • Page 5 14. Viewing Eversense Data on Alerts and Notifications Displayed on Wearables the Wearable Device Alerts and Notifications Displayed on 10. Event Log the Wearable Device Glucose 15. My Circle Meals Remote Monitoring with Insulin Eversense 365 CGM System and Health Eversense NOW App Exercise...
  • Page 6 Power Supply and Charger Removal Steps USB Cable* for Charging and 17. Travel Downloading Electrical and Safety Standards 18. Troubleshooting Symbols on the Eversense 365 App Symbols Glossary Smart Transmitter Security Information and Quality of Smart Transmitter Battery and Service Charging...
  • Page 7 Calibration Blood glucose reading from a fingerstick Electromagnetic Interference (EMI) A strong field of sample entered in the Eversense 365 App to check the energy generated by electrical or magnetic devices. accuracy of the system. With the Eversense 365 CGM...
  • Page 8 Eversense DMS A web-based application compatible Jailbroken Device A device (iPhone or iPod) that has with the Eversense 365 App where your glucose data is been modified to remove the controls and limits set by stored and can be viewed.
  • Page 9 Snooze Setting Used to set how often an alert repeats. Subcutaneous Located beneath the skin. Warm-Up Phase The period the sensor requires to adjust after the sensor has been inserted and before calibrations. Eversense 365 CGM System User Guide...
  • Page 10 This section reviews how to use your new Eversense 365 Continuous Glucose Monitoring (CGM) System. Your Eversense 365 CGM System is intended to continually measure glucose levels for up to 1 year after your sensor is inserted. Glucose information collected by the system is automatically sent to your mobile device. You must contact your health care provider to schedule the insertion and removal of your sensor.
  • Page 11 It wirelessly sends glucose data (via Bluetooth) to the app. The smart transmitter also provides on-body vibe alerts based on your glucose settings. It has a rechargeable battery and is reusable for up to one year. Smart Transmitter Eversense 365 CGM System User Guide...
  • Page 12 Disposable adhesive patches for daily use will be provided by your health care provider after your sensor has been inserted. The patch has an acrylic adhesive side that attaches to the back of the smart transmitter, and a silicone adhesive side that attaches to the skin. Eversense 365 CGM System User Guide...
  • Page 13 System Overview A separate blood glucose monitoring system (not provided by Senseonics) is required for calibrating the system, and to make treatment decisions under certain conditions. See Understanding Treatment Decisions with CGM. When used properly, these components work together to help ensure you get continuous glucose monitoring for up to 1 year.
  • Page 14 Removable and rechargeable smart transmitter. • Event entry capabilities (like meals, exercise and insulin). • Stores glucose data in the app and on the smart transmitter. • Provides remote monitoring capability to others using the Eversense NOW App. Eversense 365 CGM System User Guide...
  • Page 15 For a list of compatible devices and operating systems, please go to www.eversensediabetes.com. • The Eversense 365 App downloaded to your mobile device from the Apple App Store or on Google Play™. End User License Agreement and Privacy Policy Use of the system is subject to the terms and conditions of the most current Eversense End User License Agreement and Eversense Privacy Policy.
  • Page 16 MRI Safety Information The Eversense 365 Smart Transmitter is MR Unsafe and MUST BE REMOVED before undergoing an MRI procedure. Before you undergo an MRI procedure, tell the MRI staff that you have an Eversense 365 Sensor and Smart Transmitter.
  • Page 17 Implanted Sensor MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Eversense 365 Sensor may be safely scanned anywhere in the body at 1.5T or 3.0T under the following conditions. Failure to follow these conditions may result in injury.
  • Page 18 This guide describes how to use your CGM System. Read the entire guide before using the system. • Any warnings or precautions are highlighted in a box. •  User tips are preceded by the symbol. Eversense 365 CGM System User Guide...
  • Page 19 CGM System. The CGM System measures glucose in interstitial fluid (ISF) between the body’s cells. Your Eversense 365 CGM System and BG meter measure glucose differently. Glucose levels in ISF lag behind glucose levels in blood. Differences are more likely to be seen when your glucose is changing rapidly (e.g., after eating, dosing insulin, or exercising).
  • Page 20 Any medical issue related to the procedure or use of the device should be reported to your health care provider. Eversense 365 CGM System User Guide...
  • Page 21 Customer Support toll free in the US at 844-SENSE4U (844-736-7348). • Always calibrate the system using only a fingerstick blood sample. DO NOT use an alternative site (such as forearm or palm) blood glucose reading to calibrate the system. Eversense 365 CGM System User Guide...
  • Page 22 If you are allergic to any of the materials used in the sensor, insertion tools or smart transmitter that are listed in the Technical Specifications of this User Guide, DO NOT use the system. Eversense 365 CGM System User Guide...
  • Page 23 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. Eversense 365 CGM System User Guide...
  • Page 24 • Pay attention to the glucose alerts the system provides. Failure to appropriately respond to an alert might result in you missing a high or low glucose event. Eversense 365 CGM System User Guide...
  • Page 25 If using headphones with your mobile device, keep them in your ears. If you are not using headphones or speakers that are connected to your mobile device, you may not hear audible alerts from your CGM system. Always disconnect headphones or speakers when not using. Eversense 365 CGM System User Guide...
  • Page 26 3. Getting Started This section describes steps required before you can begin using your new Eversense 365 CGM System on a daily basis. You may perform these steps before your health care provider inserts the sensor. To get started you need: •...
  • Page 27 15 minutes and the LED flashes green. Plug the micro end of the USB cable into the LED Indicator USB port of the smart (lights green transmitter. or orange) Eversense 365 CGM System User Guide...
  • Page 28 LED response when you tap the soft-touch button. Plug the smart transmitter into the USB cable and charge it for a few minutes. Note: You must touch the button directly with your finger – it cannot detect a touch through clothing. Eversense 365 CGM System User Guide...
  • Page 29 Eversense 365 CGM System User Guide...
  • Page 30 Once the app is downloaded, create your Eversense account. You will be prompted to enable Bluetooth for pairing your smart transmitter to your mobile device, and enabling notifications. Tap Create an account. Launch the app by tapping the Eversense 365 App icon on your mobile device. The END USER LICENSE AGREEMENT will appear.
  • Page 31 After clicking the link in the email, the app with the app installed will display a page will display that the account was successfully activated. with information on how to complete system setup. Eversense 365 CGM System User Guide...
  • Page 32 Tap OK to enable Bluetooth for pairing the the app is in use or in the background. smart transmitter to the mobile device. Note: Make sure to Allow Notifications from the app to receive alerts and notifications to your mobile device. Eversense 365 CGM System User Guide...
  • Page 33 • When the unit of measurement is confirmed, tap Finish. Precaution: DO NOT change the unit of measurement unless you have discussed it with your health care provider. Eversense 365 CGM System User Guide...
  • Page 34 Tap through the introduction screens that provide information about when to make treatment decisions with the system. Eversense 365 CGM System User Guide...
  • Page 35 If you select I have a Smart Transmitter, you will begin System Setup to pair the smart transmitter to your mobile device. • If you select I do not have a Smart Transmitter, you will be taken to the Home Screen. Eversense 365 CGM System User Guide...
  • Page 36 If the LED on the smart transmitter does not light up when you tap the soft-touch button, press and hold it for about 5 seconds to turn it on. The transmitter must be within 6 feet of the mobile device to pair. Eversense 365 CGM System User Guide...
  • Page 37 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 User Guide...
  • Page 38 The smart transmitter can only be paired with one mobile device at a time. The text next to the smart transmitter serial number you selected will display Connecting while the mobile device is trying to connect. Eversense 365 CGM System User Guide...
  • Page 39 Tegaderm is placed over the top. It’s important to understand how the smart transmitter should be positioned over the sensor to ensure linking can be completed. The smart transmitter should be centered over the sensor as shown to ensure linking can be completed. Sensor Incision Eversense 365 CGM System User Guide...
  • Page 40 This means the sensor is likely above the center of the Tegaderm. The first time you link the sensor, do not use an adhesive patch on the smart transmitter. Position the smart transmitter over the sensor, slightly above the center of the Tegaderm. Eversense 365 CGM System User Guide...
  • Page 41 Make sure your smart transmitter is turned ON and that your mobile device has access to the internet. • 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 User Guide...
  • Page 42 You do not need Excellent signal strength in order to link displays a higher resolution signal the sensor or use your system. strength indicator. • This may assist you in properly positioning the transmitter over the sensor. Eversense 365 CGM System User Guide...
  • Page 43 Tap Next on the top right corner of the app once you have confirmed there is a signal. Note: DO NOT use an adhesive patch with the transmitter if you have not completed the 24-hour Warm-Up Phase. They will be applied at the start of Initialization Phase. Eversense 365 CGM System User Guide...
  • Page 44 The linking process will begin. It may take up to 10 minutes for the process to complete. DO NOT remove the smart transmitter from your sensor site until the progress bar is completed and Sensor linked successfully is displayed. Tap Next. Eversense 365 CGM System User Guide...
  • Page 45 After the sensor is linked, you can remove the smart transmitter and charge for the next 24 hours. Precaution: The sensor and smart transmitter should be linked the day of the sensor insertion. Failure to link the sensor and smart transmitter could result in a delay in receiving glucose readings. Eversense 365 CGM System User Guide...
  • Page 46 Initialization Phase. During this time, you should monitor your glucose using a home blood glucose monitor. In the System Setup Menu, tap Warm-up Phase to see details about Warm-up Phase duration. Eversense 365 CGM System User Guide...
  • Page 47 Tap Exit to go to the Home Screen • Tap Glucose settings to set your target and alert settings. See Glucose Settings for more information. Once the 24-hour Warm-Up Phase is complete, the app will notify you to begin Initialization Phase. Eversense 365 CGM System User Guide...
  • Page 48 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, paired with the app, and linked to your sensor in order to calibrate. Eversense 365 CGM System User Guide...
  • Page 49 Until the transmitter is secured over the sensor and a signal is to begin the Initialization established, the Placement Guide screen will show No signal. See next Phase. section to Secure the Smart Transmitter over Inserted Sensor. Eversense 365 CGM System User Guide...
  • Page 50 (center) of patch and press firmly to secure. • sticky portion of the adhesive in the center. The smart transmitter should be placed so that its sides face the wings of the patch (as shown). Eversense 365 CGM System User Guide...
  • Page 51 Tegaderm with the adhesive patch after the 24-hour Warm-Up Phase is complete. Note: To see more information about signal strength and transmitter positioning, see Placement Guide – Show More Detail Screen in the Linking the Sensor section. Eversense 365 CGM System User Guide...
  • Page 52 • The smart transmitter should be positioned so that the patch wings lay horizontally on the arm. Eversense 365 CGM System User Guide...
  • Page 53 During the Initialization Phase, glucose readings will start displaying in the app a few minutes after the 2nd calibration is successfully completed. Note: Under certain conditions, the system may re-enter the Re-Initialization Phase. See Calibrating the System for more information. Eversense 365 CGM System User Guide...
  • Page 54 24 hours in order to provide accurate readings. In the 1 Weekly Calibration Phase, the system requires calibration once a week. You should not use CGM readings to make treatment decisions unless you have followed the instructions for daily and weekly calibration. Eversense 365 CGM System User Guide...
  • Page 55 You can enter additional calibration readings as long as each calibration is at least one hour apart. You can enter the calibration value by tapping Calibrate from the main menu or from the Calibrate Now Notification or Alert. Eversense 365 CGM System User Guide...
  • Page 56 Obtain a fingerstick reading from your blood glucose meter. glucose meter. • Tap Done. • Tap Notes to enter any notes. • Tap Done. Note: DO NOT enter a calibration value that is older than 10 minutes. Eversense 365 CGM System User Guide...
  • Page 57 15 minutes after the entry while calibration is in progress. The Status Bar at the top of the screen lets you know when calibration will be complete. If the smart transmitter is removed before the calibration is complete, you will be prompted to calibrate again. Eversense 365 CGM System User Guide...
  • Page 58 40 mg/dL.  Blood glucose meter reading is greater than 400 mg/dL.  Your smart transmitter was removed or could not collect sensor glucose data during the 15 minutes after you entered your calibration value. Eversense 365 CGM System User Guide...
  • Page 59 Blood glucose meter reading is less than 40 mg/dL.  Blood glucose meter reading is greater than 400 mg/dL.  Your smart transmitter was removed or could not collect sensor glucose data during the 15 minutes after you entered your calibration value. Eversense 365 CGM System User Guide...
  • Page 60 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. Eversense 365 CGM System User Guide...
  • Page 61 Calibration Past Due Alert and no glucose values will be available until a calibration value is entered. After 9 days without a calibration value entered, the system will display a Calibration Expired Alert and the system returns to Initialization Phase. Eversense 365 CGM System User Guide...
  • Page 62 You should carefully read the Alerts and Notifications section of this User Guide to understand these conditions. Note: After a calibration is complete, in some cases the system may request an additional calibration. Eversense 365 CGM System User Guide...
  • Page 63 • Uses USB port with charging cable to download data to compatible external applications. • Multi-color LED to indicate various system conditions. • Communicates with mobile device. • Can be powered ON or OFF. Eversense 365 CGM System User Guide...
  • Page 64 Collecting Data. You may see this status bar just after charging the smart transmitter. Warning : If your smart transmitter is damaged or cracked, DO NOT use, as this could create an electrical safety hazard or malfunction, and could result in electrical shock. Eversense 365 CGM System User Guide...
  • Page 65 Use only the power supply supplied with your system to charge the smart transmitter battery. Using a power supply other than one provided by Senseonics may void your smart transmitter warranty. DO NOT use the power supply if it is damaged in any way.
  • Page 66 ~ 24 hours of power. Charging for 15 minutes each day will ensure the transmitter has ~24 hours of power. See the following chart for more information on the LED indicators. For more information on using the smart transmitter’s soft-touch feature, see Daily Transmitter Wear. Eversense 365 CGM System User Guide...
  • Page 67 LED is orange for one minute An alert has been triggered device to understand the alert. Transmitter and sensor communication Position transmitter over sensor Blinks orange interrupted or not yet linked site. If prompted, link sensor. Eversense 365 CGM System User Guide...
  • Page 68 From the About screen, go to My Transmitter > Firmware Version, and tap on the icon to confirm an upgrade is available. For information on how to download and install the Eversense Data Hub, go to www.eversensediabetes.com to see the Eversense Data Hub User Guide. Eversense 365 CGM System User Guide...
  • Page 69 I have a new transmitter and sensor and follow the prompts. Once linking is complete, the system will begin the 24-hour Warm-Up Phase followed by Initialization Phase. For more information on system setup, see System Setup. Eversense 365 CGM System User Guide...
  • Page 70 During system setup, you may have seen these tutorials. The tutorials are helpful resources you may access at any time. Additional Resources The User Guide and system onboarding videos can be accessed by tapping the link. An internet connection is required to access these resources. Eversense 365 CGM System User Guide...
  • Page 71 7. Using the App This section describes the Eversense 365 App including the main screen, trend graph, trend arrows, and the menu screen. The app communicates with the smart transmitter to receive and then display glucose data, trends, graphs and alerts.
  • Page 72 30 minutes, including no data syncing to your DMS account, no Eversense NOW users can be added to your Circle, and no changes to your profile picture can be made. You should not log out of the app during this time. Eversense 365 CGM System User Guide...
  • Page 73 * For iOS 12 and above, and Android 6 and above, you can allow the Low Glucose and Out of Range Low Glucose Alerts to override your phone sound settings. See Sound Settings for more information. Eversense 365 CGM System User Guide...
  • Page 74 If no trend arrow is displayed, the system does not have enough data to display direction and rate of change. You should not make a treatment decision based solely on the sensor glucose value. Eversense 365 CGM System User Guide...
  • Page 75 High/Low Glucose target level The levels set for the high and low glucose targets (target range). Multiple events icon Indicates multiple events have occurred at the same time. Indicates manually entered events (e.g., exercise). See Logging Events for more Event icon information. Eversense 365 CGM System User Guide...
  • Page 76 The bars indicate the strength of the connection. Signal strength information is also displayed in Main Menu > Placement Guide in the app. Reminder: You cannot link to a sensor until your transmitter is paired with the app. Eversense 365 CGM System User Guide...
  • Page 77 If no trend arrow is displayed, the system does not have enough data to display direction and rate of change. You should not make a treatment decision based solely on the sensor glucose value. Eversense 365 CGM System User Guide...
  • Page 78 Stress, illness, and even some medications you take can also impact your glucose. Sometimes the right treatment decision is to wait and check your CGM data frequently before taking action. Eversense 365 CGM System User Guide...
  • Page 79 Eversense NOW App. Interruptions in any of these connections will delay data being displayed in Eversense NOW. Only the CGM information sent directly from the smart transmitter to your mobile device can be used to make treatment decisions. Eversense 365 CGM System User Guide...
  • Page 80 Keep in mind that stress is not always negative. You could find your glucose levels changing while headed on vacation or going to a fun social event. Your health care provider can help you create a plan for treatment decisions when you are sick or in stressful situations. Eversense 365 CGM System User Guide...
  • Page 81 Understand how the medications you take impact your glucose. Some diabetes medications work to decrease your glucose, and some medications, like steroids, may increase your glucose levels. With the Eversense 365 CGM System, medications of the Tetracycline class, such as tetracycline, doxycycline, minocycline, tigecycline, may falsely lower glucose and you should not rely on CGM readings when taking drugs in this class.
  • Page 82 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 User Guide...
  • Page 83 You are taking medications of the tetracycline class. Note: Always refer to the glucose information on your Eversense 365 App on your smartphone to make treatment decisions. Do not use a secondary display like the Apple Watch or Eversense NOW.
  • Page 84 CGM CGM value and trend your CGM value less). value and trend arrow frequently. and trend arrow arrow frequently. frequently. If you have not recently taken insulin, consider adjusting insulin correction dose up. Eversense 365 CGM System User Guide...
  • Page 85 (between 2.0 45 mg/dL within and 3.0 mg/ 15 minutes. dL/minute). Glucose is Your glucose falling at a could drop very rapid rate 45 mg/dL or more within (> 3.0 mg/dL/ minute) 15 minutes. Eversense 365 CGM System User Guide...
  • Page 86 Glucose is Your glucose dose up. rising at a could rise very rapid rate 45 mg/dL or more within (> 3.0 mg/dL/ minute). 15 minutes. Eversense 365 CGM System User Guide...
  • Page 87 Should you take the amount of insulin you typically • would for this breakfast, and keep an eye on your Should you consider taking carbs to treat the glucose value, the arrow and how you feel? low now? Eversense 365 CGM System User Guide...
  • Page 88 What does your health care provider recommend glucose number and trend arrows? for adjusting your insulin in this situation? • How long does your health care provider recommend you wait between insulin doses to help prevent stacking insulin? Eversense 365 CGM System User Guide...
  • Page 89 Keep a close eye on Keep a close eye on your glucose number and your glucose number, trend arrow and how you feel. trend arrow, and how you feel. Eversense 365 CGM System User Guide...
  • Page 90 How do you typically treat for a high glucose at bedtime? Remember, if you are not sure, always do a fingerstick check with your blood glucose meter before making a treatment decision. Eversense 365 CGM System User Guide...
  • Page 91 You can view the trend graph in either portrait or landscape mode. In landscape mode, you can see 7, 14, 30 and 90 day views. Note: All of your glucose data will be stored in the app as long as you have memory available on your mobile device. Eversense 365 CGM System User Guide...
  • Page 92 See Customizing your Settings for more information. View information about your CGM System, including sensor and smart transmitter ID About numbers. Change or delete your profile picture and log out of the app. Eversense 365 CGM System User Guide...
  • Page 93 8. Customizing your Settings This section describes how to customize settings in your Eversense 365 CGM System. Areas where you can customize app settings include: • Glucose – glucose levels and change rates that will trigger an alert. • Calibration Reminders – optionally set calibration reminder times.
  • Page 94 – Predictive Low and High Glucose alerts notify you on your mobile device and smart transmitter when your glucose is likely to reach the Low and High Glucose Alert levels you have set. On the Glucose Settings screen, tap the “carat symbols” to expand and collapse the settings options. Eversense 365 CGM System User Guide...
  • Page 95 For iOS 12 and above, and Android 6 and above, you can allow the Low Glucose and Out of Range Low Glucose Alerts to override your phone sound settings. See Sound Settings for more information. Eversense 365 CGM System User Guide...
  • Page 96 Under Glucose Alert Levels, tap High Alert and display the GLUCOSE SETTINGS select the appropriate High Glucose Alert level. screen. • Tap Done when complete. • Repeat step to make your Low Alert selection. Eversense 365 CGM System User Guide...
  • Page 97 Low: 60 - 120 mg/dL High: 120 - 345 mg/dL On/Off setting Always ON (cannot be turned OFF) Notes Used in graphs and charts on the app to show time spent in target range. Eversense 365 CGM System User Guide...
  • Page 98 Under Glucose Target Levels, tap High Target display the GLUCOSE SETTINGS and select the appropriate High Glucose Target level. screen. • Tap Done when complete. • Repeat step to make your Low Target selection. Eversense 365 CGM System User Guide...
  • Page 99 On/Off setting No predictive alerts will occur until this feature is turned ON. The default is 20 minutes. Notes Audio notification and visual alerts on your mobile device and smart transmitter on-body vibe alerts. Eversense 365 CGM System User Guide...
  • Page 100 Next to the High and Low Predictive Alerts, Settings > Glucose to display the slide the OFF button to ON. GLUCOSE SETTINGS screen. Tap Minutes to select the amount of advance warning • Tap Done when complete. Eversense 365 CGM System User Guide...
  • Page 101 You can turn these alerts ON and OFF. No rate of change alerts will occur until this feature is turned ON. Notes Audio notification and visual alerts on your mobile device and transmitter vibration alerts. Eversense 365 CGM System User Guide...
  • Page 102 To turn this feature ON, tap Menu > Next to Rate Alerts, slide the OFF button to ON. Settings > Glucose to display the GLUCOSE SETTINGS screen. Tap Rate of Change to select the rate. • Tap Done when complete. Eversense 365 CGM System User Guide...
  • Page 103 If you delete the app and re-install, these reminders must be reset. These reminders are not stored in Alert History. If you pair a new transmitter with the existing app, the settings will remain the same. See Do Not Disturb on Eversense 365 App and Mobile Devices for more information.
  • Page 104 • 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. Eversense 365 CGM System User Guide...
  • Page 105 Re-linking does not impact the life of your sensor. Tap Re-link detected Tap Cancel or OK to Confirm with Customer sensor. Support that you should continue. re-link your sensor. Tap Linked Sensor. Tap Cancel or Re-link. Eversense 365 CGM System User Guide...
  • Page 106 Before a sensor has been linked. • Certain sensor replacement alerts. • If no sensor is detected. • If any of the below alerts are active: – Transmitter End of Life – System Time Error Eversense 365 CGM System User Guide...
  • Page 107 Tap Done when complete. IMPORTANT: Be sure the sound on your mobile device is turned on. If you turn the sound on your mobile device off, you will not hear any sounds from the app. Eversense 365 CGM System User Guide...
  • Page 108 Silent Mode is on, or Do Not Disturb is on. You must allow this in your mobile device settings. iOS Devices Tap Settings. Tap Allow. Tap the button to turn on the override. Eversense 365 CGM System User Guide...
  • Page 109 Apple device’s Silent/Vibration Mode is on, or Do Not Disturb is on. Note: This feature works similar to apps with an alarm clock feature that will always sound regardless of your phone sound settings. Eversense 365 CGM System User Guide...
  • Page 110 Settings from Step 2, the Eversense settings in your mobile device settings page will be displayed. Tap Notifications > Allow Critical Alerts. Then you can turn on the switch for Low Glucose Override in the Eversense 365 App. Eversense 365 CGM System User Guide...
  • Page 111 Android Devices For devices with Android 6 and above: Tap Settings. Tap the button to turn on the Tap on Eversense 365 from the override. Do Not Disturb access page. Eversense 365 CGM System User Guide...
  • Page 112 Tap Allow. Tap the button next to Eversense 365 to allow the app to override the Do Not Disturb settings. Eversense 365 CGM System User Guide...
  • Page 113 Return to the Eversense 365 App. Tap on the Low Glucose Override switch to sound the Low and Out of Range Low Glucose alerts at maximum volume even if your device’s Silent Mode, Vibration Mode, or Do Not Disturb is on.
  • Page 114 5 to 30 minutes after a connection is lost. When there is no communication between the smart transmitter and the app, you will only receive vibratory alerts from the smart transmitter. See next section regarding Do Not Disturb mode. Eversense 365 CGM System User Guide...
  • Page 115 When you enable Do Not Disturb mode on your mobile device you will not receive any alerts or notifications from the app. The DND icon will appear on the Home Screen. For a list of alerts, please see Alert Descriptions. Eversense 365 CGM System User Guide...
  • Page 116 Do Not Disturb on Eversense 365 App and Mobile Devices Eversense 365 Eversense 365 Eversense 365 Eversense 365 App DND off; App DND on; App DND off; App DND on; Mobile device Mobile device Mobile device Mobile device DND off...
  • Page 117 Settings > Glucose will automatically resume. Tap Menu > Settings > Temp Profile to Select the duration. You can set a Temp Profile for display the TEMP PROFILE screen. up to 36 hours in 30 minute increments. Eversense 365 CGM System User Guide...
  • Page 118 Set the High and Low Alerts and High and Low Target changed when the duration has been started. levels desired. Tap START. While a Temp Profile is active, the Temp Profile icon will be displayed on the MY GLUCOSE screen. Temp Profile icon Eversense 365 CGM System User Guide...
  • Page 119 To end the Temp Profile earlier than the time you set, go to Settings > Temp Profile and tap STOP. displays a notice and the Temp Profile icon is no longer displayed on the MY GLUCOSE screen. Eversense 365 CGM System User Guide...
  • Page 120 Requires immediate and appropriate action. IN YELLOW Alerts related to High Glucose 1 long vibe then MESSAGE APPEARS High Glucose Alert, Predictive High, and Out-of-Range High. IN YELLOW 2 short vibes Requires immediate and appropriate action. Eversense 365 CGM System User Guide...
  • Page 121 Your smart transmitter has successfully synced with your 2 quick vibes x 3 IN YELLOW sensor. Notifications MESSAGE APPEARS Requires some action but is lower priority in nature. 1 short vibe IN BLUE See following section for examples. Eversense 365 CGM System User Guide...
  • Page 122 When you receive 2 or more alerts that have not been acknowledged, the app will display an option to Dismiss All. This can happen when your mobile device has been out of range of your smart transmitter and then re-syncs. You can review each alert in Alert History. Eversense 365 CGM System User Guide...
  • Page 123 Tap ALL, then tap icons on top of the screen • Tap on any message to get more information. to select only the types of alerts you want displayed. • Tap Menu when done. Example of ALL Example of alerts only Eversense 365 CGM System User Guide...
  • Page 124 Eversense 365 CGM System User Guide...
  • Page 125 Once the sensor glucose value is at or higher than Once the sensor glucose value is at or lower than 40 mg/dL, glucose readings will resume on the 400 mg/dL, glucose readings will resume on the display. display. Eversense 365 CGM System User Guide...
  • Page 126 Eversense 365 CGM System User Guide...
  • Page 127 Eversense 365 CGM System User Guide...
  • Page 128 No glucose readings can be displayed until the sensor restored. is replaced. Using the Placement Guide for reference, place the Contact your health care provider to have your sensor smart transmitter over the sensor until it shows replaced. there is a connection. Eversense 365 CGM System User Guide...
  • Page 129 10 days after day 365. Contact your health care provider to have your Contact your health care provider to have your sensor sensor replaced as soon as possible. replaced. Eversense 365 CGM System User Guide...
  • Page 130 No glucose readings can be displayed until the smart transmitter is charged. Charge your smart transmitter as soon as possible. Charge the smart transmitter immediately. Remove the smart transmitter from your body before connecting it to the power supply. Eversense 365 CGM System User Guide...
  • Page 131 Weekly Calibration Phase). No glucose readings can be displayed until calibration is performed. Tap Calibrate to enter a calibration value. Perform a fingerstick calibration in order to resume displaying glucose values. Eversense 365 CGM System User Guide...
  • Page 132 In the Initialization Phase, you must perform Contact your distributor to order a new transmitter. 4 fingerstick calibrations spaced 2 - 12 hours apart. Glucose readings will display after the 2nd successful calibration. Eversense 365 CGM System User Guide...
  • Page 133 Contact your distributor to order a new transmitter. Contact your distributor to order a new transmitter. Eversense 365 CGM System User Guide...
  • Page 134 26 - 40 °C (81 - 104 °F). You may temporarily remove the smart transmitter to cool it down. Once the smart transmitter is back to a lower temperature, be sure to replace it over the sensor. Eversense 365 CGM System User Guide...
  • Page 135 Briefly remove the smart transmitter while the sensor temperature cools to between 26 - 40 °C (81 - 104 °F). Then put the smart transmitter back on to start receiving glucose values again from the sensor. Eversense 365 CGM System User Guide...
  • Page 136 In the Initialization Phase, you must perform Contact Customer Support to have your smart 4 fingerstick calibrations spaced 2 - 12 hours apart. transmitter replaced immediately. Display of glucose readings will resume after the 2nd successful fingerstick calibration. Eversense 365 CGM System User Guide...
  • Page 137 Plug the cable into the smart transmitter and remove it. If the condition persists, follow the steps shown in the Troubleshooting section to reset your smart transmitter. If you are unable to complete the reset, contact Customer Support. Eversense 365 CGM System User Guide...
  • Page 138 Try linking again. If the error is displayed on the Set your mobile device clock to your current local second attempt, contact Customer Support. time. If the error persists, contact Customer Support. Eversense 365 CGM System User Guide...
  • Page 139 Eversense DMS account. Try linking again. If the error is displayed on the Log out of the app and log back in with the new second attempt, contact Customer Support. password. Eversense 365 CGM System User Guide...
  • Page 140 Sensor Linking Error* Appears when the transmitter needs to be Appears when there is an error during sensor linking. repositioned over the sensor. Use the placement guide to establish a better signal Contact Customer Support. strength. Eversense 365 CGM System User Guide...
  • Page 141 Try again. If the error persists, contact Customer Confirm your glucose value with a blood glucose Support. meter before making a treatment decision until the values begin being displayed again. Eversense 365 CGM System User Guide...
  • Page 142 Appears if pairing the mobile device with the Appears when the transmitter has successfully transmitter fails. synced with the sensor. Follow the steps to pair the transmitter again. If the No action needed. error persists, contact Customer Support. Eversense 365 CGM System User Guide...
  • Page 143 Ensure your transmitter is connected to your mobile Contact Customer Support. device and remains over top of your sensor to complete linking. Eversense 365 CGM System User Guide...
  • Page 144 Remain logged in to the app to continue viewing For a list of compatible devices/operating systems your glucose data. If you log out, you must log back visit www.eversensediabetes.com. in with your username and password to continue using the app. Eversense 365 CGM System User Guide...
  • Page 145 Bluetooth connection was changed via your Eversense DMS account. and to receive alerts. Tap OK to acknowledge. Log out of the app and log back in with the new password. Eversense 365 CGM System User Guide...
  • Page 146 Use the correct password to log in to the app. Wait 30 minutes. Log in with correct password or reset your password. Eversense 365 CGM System User Guide...
  • Page 147 Contact Customer Support if you wish to proceed. Devices that have been jailbroken should not be used with the app. The app may not work as expected and your device may be vulnerable to outside cyber attack. Eversense 365 CGM System User Guide...
  • Page 148 Eversense Smart Transmitter. Charge your smart transmitter and try the action Go to us.eversensedms.com, log in and follow again. the prompts to download the Eversense Upgrade Application to upgrade your smart transmitter. Eversense 365 CGM System User Guide...
  • Page 149 Connect the mobile device to the internet and try the action again. and begin the 24-hour Warm-Up Phase. You do not need to wear your smart transmitter over the sensor until the Warm-Up Phase is complete. Eversense 365 CGM System User Guide...
  • Page 150 Tap Calibrate to enter a new calibration value. Do a fingerstick blood glucose calibration. DO NOT use an alternative site (such as forearm) to obtain your blood glucose reading. Eversense 365 CGM System User Guide...
  • Page 151 Enter a new calibration value when prompted. Contact your health care provider to schedule the removal and replacement of your sensor. Eversense 365 CGM System User Guide...
  • Page 152 Appears once when the system requires calibration Appears once 35 days before your transmitter once a week. warranty expires. Enter a new calibration value when prompted. Contact your distributor to order a new transmitter. Eversense 365 CGM System User Guide...
  • Page 153 Invalid Transmitter Time Battery Status The time on the smart transmitter is out of sync with Transmitter has approximately 24 hours of life your app. remaining. If the error persists, contact Customer Support. Charge transmitter soon. Eversense 365 CGM System User Guide...
  • Page 154 Wearable devices are a secondary display to the Eversense 365 App. Any alerts or notifications received on the wearable should be confirmed on the Eversense 365 App before any action is taken. Screen shape format may vary based on the wearable device. If you dismiss an alert on the watch, the alert display will disappear from the phone lock screen.
  • Page 155 Types of Events: Glucose Meals Insulin Health Exercise Note: You can also access the ADD EVENT screen directly from the MY GLUCOSE screen with a single tap anywhere on the graph area. Eversense 365 CGM System User Guide...
  • Page 156 You can also select specific event types to view by tapping a selected event type. • Tap ALL, then tap icons on top of the screen to select only the types of events you want displayed. Eversense 365 CGM System User Guide...
  • Page 157 EVENT LOG screen, or tap Cancel to exit without saving changes or to edit the information before saving. Note: Glucose Events do not replace calibration measurements. You will still have to enter calibration readings. Android Eversense 365 CGM System User Guide...
  • Page 158 Tap Carbs to enter correct number of carbohydrates. Tap Done. Tap Notes to enter any notes. Tap Done. Tap Save to save entry and return to EVENT LOG screen. Tap Cancel to exit without saving changes. Eversense 365 CGM System User Guide...
  • Page 159 Tap Type to enter the correct Type of Insulin. Tap Done. Tap Notes to enter any notes. Tap Done. Tap Save to save entry and return to EVENT LOG screen. Tap Cancel to exit without saving changes. Eversense 365 CGM System User Guide...
  • Page 160 Tap Condition to enter the health condition. Tap Done. Tap Notes to enter any notes. Tap Done. Tap Save to save entry and return to EVENT LOG screen. Tap Cancel to exit without saving changes. Eversense 365 CGM System User Guide...
  • Page 161 Tap Duration to enter the duration. Tap Done. Tap Notes to enter any notes. Tap Done. Tap Save to save entry and return to EVENT LOG screen. Tap Cancel to exit without saving changes. Eversense 365 CGM System User Guide...
  • Page 162 To view the glucose reports tap Menu > Reports and swipe to move across the three different reports. You can also email each report as a pdf file by tapping the email icon in the top right hand corner. Eversense 365 CGM System User Guide...
  • Page 163 This report shows in graphical format what percent of your readings within a given time period are within, below or above your Glucose Target levels. You can choose the last 1, 7, 14, 30 or 90 days. Android Eversense 365 CGM System User Guide...
  • Page 164 Very High: > 250 mg/dL • High: 181 mg/dL - 250 mg/dL • In Range: 70 mg/dL - 180 mg/dL • Low: 54 mg/dL - 69 mg/dL • Very Low: < 54 mg/dL Source: http://www.agpreport.org/agp/agpreports Eversense 365 CGM System User Guide...
  • Page 165 (percent of readings that fall within the low and high glucose target levels). The information is shown based on 6 hour time slots. Eversense 365 CGM System User Guide...
  • Page 166 Glucose Statistics This report shows your average, low and high glucose readings, along with standard deviation within 6 hour time periods. You can choose the last 1, 7, 14, 30 or 90 days. Eversense 365 CGM System User Guide...
  • Page 167 When you create and register your account during the installation of the Eversense 365 App, an Eversense DMS account is automatically created for you. The Eversense NOW App User Guide has more information on how to remotely view glucose data from the Eversense 365 CGM System. IMPORTANT: EVERSENSE DATA MANAGEMENT SYSTEM DOES NOT PROVIDE MEDICAL ADVICE.
  • Page 168 To manually sync your data, tap the START SYNC button. Data for the number of days set as your default will be synced. You can set the Default Syncing Days to 1, 3, 7, 14 or 30 days. Eversense 365 CGM System User Guide...
  • Page 169 My Circle is an optional feature that allows you to activate remote monitoring of your CGM data. For more information on this feature, see My Circle - Remote Monitoring. IMPORTANT: Both the Eversense 365 App and the Eversense NOW Remote Monitoring App must be downloaded from the US App Store in order for them to communicate.
  • Page 170 Application Sharing is an optional feature that allows you to share certain Eversense data with another compatible health application. Tap the application and turn on Share Data. You may need to also allow sharing via the health application. Eversense 365 CGM System User Guide...
  • Page 171 Tap OK to confirm the invitation. Once the clinic has accepted the invitation, they will be listed on the My Clinics page. To access this page, tap Menu > Share My Data > Clinic Share > My Clinics. Eversense 365 CGM System User Guide...
  • Page 172 Tap Accept on the pop-up. Once you have accepted the invitation, the clinic will be listed on the My Clinics page. To access this page, tap Menu > Share My Data > Clinic Share > My Clinics. Eversense 365 CGM System User Guide...
  • Page 173 This will remove you from the clinic's Eversense DMS Pro list of patients. You can send this clinic another invitation in the future, or the clinic may send you an invitation in the future. Eversense 365 CGM System User Guide...
  • Page 174 My Transmitter, includes the serial number, calibration number and insertion details. My Sensor or Product information and battery level. You Information. can also demonstrate the vibration feature of the smart transmitter. Eversense 365 CGM System User Guide...
  • Page 175 The photo you select will be displayed on the Main Menu screen. Note: You can also change your profile picture from your Eversense DMS account. See the Eversense DMS User Guide for more information. Eversense 365 CGM System User Guide...
  • Page 176 Tap Contact Us to send an CGM System. email to your local Customer Support team. For more product information, tap Help. IMPORTANT: This email is not monitored 24/7. DO NOT use this email for health-related or any urgent issues. Eversense 365 CGM System User Guide...
  • Page 177 Account > Log Out. IMPORTANT: If you log out, no glucose data will be displayed on the app until you log back in using the email and password you entered when you set up your account. Eversense 365 CGM System User Guide...
  • Page 178 You can view a snapshot of your CGM data on your Apple Watch. Once you’ve downloaded and installed the Eversense 365 App on your mobile device, follow the device’s instructions for adding the app to your watch. The wearable is a secondary display of Eversense data and should not be used in place of the primary CGM app display.
  • Page 179 CGM data. Eversense 365 App in your Apple Watch settings. When you receive a notification, you can also tap on the message to see the MY GLUCOSE screen.
  • Page 180 24 hours. time, the current system calibration phase, and battery level of your smart transmitter. Eversense 365 CGM System User Guide...
  • Page 181 Wearable devices are a secondary display to the Eversense 365 App. Any alerts or notifications received on the wearable should be confirmed on the Eversense 365 App before any action is taken. Screen shape format may vary based on the wearable device. If you dismiss an alert on the watch, the alert display will disappear from the phone lock screen.
  • Page 182 Remote Monitoring with Eversense 365 CGM System and Eversense NOW App The Eversense 365 App interacts with the Eversense NOW App to allow other people to view your data. Risks There may be times when glucose data cannot be sent to the Eversense NOW App. lf a member of your Circle is not receiving glucose data from your CGM System, they cannot assist you in the event of a high or low glucose value.
  • Page 183 Eversense NOW App. DO NOT set your status to offline if you want members of your Circle to see your CGM data. • The Eversense NOW App does not communicate directly with the Eversense 365 Sensor and/or with the Eversense 365 Smart Transmitter. •...
  • Page 184 Through the MY CIRCLE screen on your Eversense 365 App, you can invite as many people as you wish to view your data. When you invite someone to join your Circle, an invitation will be sent to the email address you entered.
  • Page 185 Member, their email address will show data are set up in the DMS account by the account owner. You cannot in place of a nickname. change profile pictures of those you have invited to your Circle. Eversense 365 CGM System User Guide...
  • Page 186 Members List or the Invitations Sent List on the MY CIRCLE screen. The member you remove will be notified on their Eversense NOW App if they have already accepted. Eversense 365 CGM System User Guide...
  • Page 187 Members will see your status as Offline on their Eversense NOW App when you have disabled the Share my Data feature. It can take up to 10 minutes for the change to display on the Eversense NOW user’s app. Eversense 365 CGM System User Guide...
  • Page 188 16. About the Sensor This section describes the Eversense 365 Sensor and how it is inserted by your health care provider. The sensor uses fluorescence to measure glucose in interstitial fluid. It is inserted under the skin and provides glucose readings for up to 1 year.
  • Page 189 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 wearing the transmitter. Eversense 365 CGM System User Guide...
  • Page 190 Sensor removal – the sensor will be removed and discarded. Step 4: Site closure – once removed, the incision will be closed with a Steri Strips™ (sutures may be used depending on provider’s preference). Eversense 365 CGM System User Guide...
  • Page 191 Your smart transmitter will automatically sync to your smartphone’s current time and date when time zones are changed. The Eversense 365 CGM System is safe for use on U.S. commercial airlines. The Eversense 365 Smart Transmitter is a Medical Portable Electronic Device (M-PED) with emission levels that meet FAA mandates for use in all modes while in flight.
  • Page 192 18. Troubleshooting This section lists information about troubleshooting your Eversense 365 CGM System and includes a list of frequently asked questions (FAQs). Smart Transmitter • Position the smart transmitter over the sensor so that a connection is confirmed. Q: How do I turn my smart transmitter OFF?
  • Page 193 LED? A: The system has detected a transmitter error. Contact Q: Why does my smart transmitter show a continuous Customer Support. solid orange LED? A: Follow the steps below to troubleshoot the smart transmitter: Eversense 365 CGM System User Guide...
  • Page 194 A: There are three ways to check battery status: 1. Check the battery icon and percentage in the upper right corner on the MY GLUCOSE screen. A red battery icon indicates the smart transmitter battery is empty. Eversense 365 CGM System User Guide...
  • Page 195 2. Tap the soft-touch button three times to activate The condition may be temporary. pairing mode. 1. On the Eversense 365 App, tap Menu > 3. When the smart transmitter blinks blue, tap the Connect. If your smart transmitter name smart transmitter ID on the CONNECT screen.
  • Page 196 4. If the self-test does not complete, repeat steps 1 • through 3. Bluetooth on your mobile device is turned OFF. 5. If step 3 is successfully completed, the smart transmitter is now ready for use. Eversense 365 CGM System User Guide...
  • Page 197 “un-paired”. You must re-establish pairing. A: If other Eversense 365 CGM users are around you, then the app may find those devices. However, the app connects only to the smart transmitter that was Q: What is pairing mode? paired with your mobile device.
  • Page 198 400 mg/dL. • The blood glucose reading was taken more than 10 minutes prior to entering it in the app. • The last sensor glucose value is significantly different than the blood glucose reading entered. Eversense 365 CGM System User Guide...
  • Page 199 Q: What are rate of change alerts? A: Rate of Change Alerts notify you when your glucose level is falling or rising faster than the setting you entered in Settings > Glucose. Eversense 365 CGM System User Guide...
  • Page 200 Q: How do I silence glucose alerts? glucose measurement before making a treatment A: Glucose Alerts can be silenced by confirming the alert decision. on your mobile device and taking the appropriate action if necessary. Eversense 365 CGM System User Guide...
  • Page 201 A: The system measures glucose in interstitial fluid (ISF) transmitter and your sensor or smart transmitter and between the body’s cells. Your Eversense 365 CGM mobile device. System and BG meter measure glucose differently.
  • Page 202 Q: When should I do a fingerstick with a blood glucose meter? A: You should perform a blood glucose fingerstick on a meter: • When it is time to calibrate. • No glucose value is displayed. • No trend arrow is displayed. Eversense 365 CGM System User Guide...
  • Page 203 Q: What devices are compatible with the Eversense consider recent trends and alerts. 365 App? A: Visit www.eversensediabetes.com for a list of compatible devices. Eversense 365 CGM System User Guide...
  • Page 204 High Q: Can I edit a manual BG entry event? priority alerts will still be provided by the smart A: Manual BG entries and calibration entries cannot be transmitter and the app. edited. Eversense 365 CGM System User Guide...
  • Page 205 365, for up to 10 days. Q: Where can I find the sensor serial number? A: You can view the sensor serial number by tapping Menu > About > My Sensor. Eversense 365 CGM System User Guide...
  • Page 206 Y our smart transmitter has not been charged contact Customer Support. within 16 hours of the empty battery alert. • If you manually change the time on your mobile device your smart transmitter will sync and reinitialize to your mobile device. Eversense 365 CGM System User Guide...
  • Page 207 Q: Is it okay for an MRI technician to wear the Eversense 365 CGM System? A: Yes, MRI technicians can wear the Eversense 365 CGM System. However, for people undergoing an MRI with a static magnetic field of 1.5T or 3.0T, the sensor can...
  • Page 208 Q: Is there a shortcut to the ALERT HISTORY screen? A: If your smart transmitter is connected to the app, you can tap the status bar at the top of the screen to display the ALERT HISTORY screen. Eversense 365 CGM System User Guide...
  • Page 209 Clinical Study Performance The safety and effectiveness of the Eversense 365 CGM System has been evaluated in the ENHANCE clinical study conducted in the U.S. Accuracy assessments were made at various points during the study and subjects were asked to report any adverse events throughout the study.
  • Page 210 [Mean (SD)] kg/m 32.0 (6.8) Min, Max 19.0, 52.0 Normal (< 25 kg/m ) n (%) 12 (10.9%) Overweight (> 25 and < 30) n (%) 30 (27.3%) Obese (> 30) n (%) 68 (61.8%) Eversense 365 CGM System User Guide...
  • Page 211 MARD result: The result is derived from the mean absolute relative difference (%) across the entire measuring range of the device over 365 days. MAD result: The result is derived from the mean absolute difference (mg/dL). Eversense 365 CGM System User Guide...
  • Page 212 Table 3 – Sensor Accuracy to YSI by YSI Glucose Range YSI Glucose Range Total Number of Paired MARD (mg/dL) CGM and YSI Values (mg/dL) < 54 15.8 54 - 69 2,446 12.5 70 - 180 23,130 181 - 250 7,997 > 250 6,566 Eversense 365 CGM System User Guide...
  • Page 213 -11.0 17.9 11.6 54 - 69 2,353 90.4 94.8 99.2 -3.8 11.1 70 - 180 23,049 81.9 90.9 99.4 -1.9 181 - 250 8,198 88.0 94.9 99.7 -2.4 > 250 6,210 91.1 97.1 99.8 Eversense 365 CGM System User Guide...
  • Page 214 95.0 99.4 15.8 54 - 69 2,446 89.8 96.7 99.6 12.5 70 - 180 23,130 82.4 91.4 99.4 -0.3 181 - 250 7,997 87.1 94.5 99.9 -3.1 > 250 6,566 89.5 95.9 100.0 -2.9 Eversense 365 CGM System User Guide...
  • Page 215 15.8% 66.0% 16.8% 1.0% 251 - 300 3,494 0.1% 0.4% 17.5% 63.8% 17.4% 0.7% 301 - 350 2,052 0.5% 28.1% 64.5% 6.6% 0.2% 351 - 400 3.3% 61.3% 34.0% 1.4% > 400 0.6% 22.4% 55.1% 21.8% Eversense 365 CGM System User Guide...
  • Page 216 0.2% 251 - 300 3,774 0.0% 1.1% 23.8% 59.1% 15.3% 0.6% 0.0% 301 - 350 2,427 0.0% 2.1% 25.1% 54.5% 16.8% 1.4% 351 - 400 5.3% 28.8% 47.8% 18.2% > 400 10.4% 18.8% 70.8% Eversense 365 CGM System User Guide...
  • Page 217 >= 80 Total Readings Readings Cumulative Percent 71.1% 84.2% 93.4% 94.7% 5.3% CGM Comparator > 340 > 320 > 280 > 250 >= 250 Total Readings Readings Cumulative Percent 85.9% 91.7% 100.0% 100.0% 0.0% Eversense 365 CGM System User Guide...
  • Page 218 98.8 99.6 241 - 270 1,951 82.7 91.3 98.2 99.9 271 - 300 2,718 88.3 95.4 99.5 99.9 301 - 330 2,257 89.0 94.9 99.2 99.9 331 - 365 3,337 86.9 94.8 99.1 99.8 Eversense 365 CGM System User Guide...
  • Page 219 97.4% 2.6% 88.0% 12.0% 98.6% 1.4% 96.7% 3.3% 98.4% 1.6% 96.0% 4.0% 97.9% 2.1% 94.0% 6.0% High 97.2% 2.8% 93.5% 6.5% Alert 96.4% 3.6% 93.0% 7.0% 95.8% 4.2% 92.1% 7.9% 93.5% 6.5% 83.0% 17.0% Eversense 365 CGM System User Guide...
  • Page 220 94.0% 6.0% 91.7% 8.3% 97.6% 2.4% 97.5% 2.5% 97.4% 2.6% 97.2% 2.8% 96.4% 3.6% 95.5% 4.5% High 95.3% 4.7% 95.4% 4.6% Alert 94.5% 5.5% 95.3% 4.7% 93.7% 6.3% 94.5% 5.5% 89.6% 10.4% 87.8% 12.2% Eversense 365 CGM System User Guide...
  • Page 221 21.0% 0.5% 0.0% [-2, -1) 13.4% 40.2% 44.2% 1.8% 0.4% 2,026 [-1, 1] 1.1% 6.5% 85.3% 5.8% 1.3% 32,531 (1, 2] 0.2% 0.7% 43.9% 36.9% 18.2% 2,861 > 2 0.0% 0.4% 21.7% 28.6% 49.3% Eversense 365 CGM System User Guide...
  • Page 222 132 - 144 hours 2,750 85.6 93.3 99.0 99.9 144 - 156 hours 1,978 83.9 93.7 99.5 100.0 156 - 168 hours 2,627 85.8 93.8 98.6 99.6 168 - 174 hours 86.8 96.1 97.4 100.0 Eversense 365 CGM System User Guide...
  • Page 223 The system is designed to capture and display a glucose value every 5 minutes, or up to 288 readings per day, after Warm Up Phase. The table below shows the Eversense 365 Sensors captured readings at least 99.9% of the time.
  • Page 224 Sensor to Sensor Precision For subjects who had two Eversense 365 Sensors (one inserted in each arm), CGM data from both sensors was evaluated for precision. The overall PARD (paired absolute relative difference ) of 8.0% and PCV (percent coefficient of variation) of 5.7% demonstrate high precision.
  • Page 225 ENHANCE study, 90.0% of sensors functioned through the 365 day period. Table 16 – Sensor Survival by Day Survival Rate (%) Days since Sensor Insertion 97.0 97.0 97.0 96.0 96.0 96.0 96.0 95.0 95.0 93.0 92.0 92.0 90.0 Eversense 365 CGM System User Guide...
  • Page 226 Skin irritation, adhesive location 2 (1.8) Skin irritation, sensor site 2 (1.8) Skin atrophy/discoloration/hyperpigmentation 3 (2.7) Insertion site pain 2 (1.8) Vasovagal episode 2 (1.8) Nausea 1 (0.9) Bleeding, excessive, removal site 1 (0.9) Eversense 365 CGM System User Guide...
  • Page 227 Glucose Range 40 - 400 mg/dL Sensor Life Up to 1 year Calibration Commercially available self-monitoring blood glucose meter Calibration Range 40 - 400 mg/dL Sterilization Sterile by Ethylene Oxide Non-pyrogenic Free from fever-causing substances Eversense 365 CGM System User Guide...
  • Page 228 Cyanoacrylate adhesive and 304 Stainless Steel (an alloy of Carbon, Manganese, Phosphorus, Sulfur, Silicon, Chromium and Nickel) Storage Temp Between 50 °F (10 °C) and 86 °F (30 °C) Sterilization Sterile by Ethylene Oxide Non-pyrogenic Free from fever-causing substances Eversense 365 CGM System User Guide...
  • Page 229 The range will decrease if you are in a bathtub, water bed, pool, etc. Cabin Pressure 700 hPa to 1060 hPa Relative Humidity Range (non-condensing) 15% to 90% Altitude 10,000 ft Eversense 365 CGM System User Guide...
  • Page 230 AC power outlet. To isolate the system, unplug the charger/power supply from the outlet. If you charge the smart transmitter using a USB port on your personal computer, ensure the personal computer complies the IEC 60950-1 (or equivalent) safety standard. Eversense 365 CGM System User Guide...
  • Page 231 30%. Power Frequency Power frequency magnetic fields (110VAC/60Hz, should be at levels characteristic 230VAC/50 Hz) 30 A/m 30 A/m of a typical location in a typical Magnetic Field IEC commercial or hospital environment. 61000-4-8 Eversense 365 CGM System User Guide...
  • Page 232 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Eversense 365 CGM System is used exceeds the applicable RF compliance level above, the Eversense 365 CGM System should be observed to verify normal operation.
  • Page 233 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Eversense 365 CGM System is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the System should ensure that it is used in such an environment.
  • Page 234 Symbols on the Eversense 365 App Symbol Explanation Glucose Alert Appears when the glucose is above the high glucose alert range and below the low glucose alert range. The icon appears in the ALERT HISTORY screen. Predicted Low or Rate Falling Alert Indicates a Rate Falling or Predicted Low Alert occurred.
  • Page 235 Symbols on the Eversense 365 App (continued) Symbol Explanation Calibration Accepted Appears on the glucose trend line and EVENT LOG when a calibration is entered and accepted. Calibration in Progress Appears on the glucose trend line and the Event Log during the ~15 minutes while a calibration is in progress.
  • Page 236 Symbols on the Eversense 365 App (continued) Symbol Explanation Multiple Alerts (more than one alert or event) Appears when there are two or more alerts or events in a short interval. Event Icons Appear on the glucose trend line and in the EVENT LOG after an event is entered.
  • Page 237 Symbols Glossary The symbols glossary for the Eversense 365 CGM System can be found here: www.eversensediabetes.com/symbols_glossary Eversense 365 CGM System User Guide...
  • Page 238 Security Information and Quality of Service The Eversense 365 CGM System components are designed to securely connect with compatible devices using industry standard communication protocols, as well as additional security measures. The sections below provide information on security and quality of service for the various system components. A software bill of materials is available upon request by contacting Customer Support.
  • Page 239 It is your responsibility to use your devices in a secure manner. As with other apps you use that include your personal information, only install Eversense 365 Apps from Google Play or the Apple App Store to ensure their authenticity.
  • Page 240 When you delete and reinstall the app, or get a new mobile device, once you pair your transmitter, glucose settings are restored to the app. Eversense 365 CGM System User Guide...
  • Page 241 This limited warranty is made on the condition that you provide Senseonics with written notice of any defects in material and/or workmanship immediately upon discovery, and provided that Senseonics determines that your claim is due to defects in original material and/or workmanship.
  • Page 242 Smart Transmitter, provided that the defect arises and a valid claim is received by Senseonics within the Limited Warranty Period. You must return the defective Smart Transmitter to an authorized Senseonics Customer Service Department in an appropriate shipping...
  • Page 243 YOUR EXCLUSIVE REMEDY. IF ANY PORTION OF THIS LIMITED WARRANTY IS ILLEGAL OR UNENFORCEABLE BY REASON OF ANY LAW, TO THE EXTENT THAT SENSEONICS MAY NOT, AS A MATTER OF APPLICABLE LAW, DISCLAIM ANY IMPLIED WARRANTY OR LIMIT ITS LIABILITIES, THE SCOPE AND DURATION OF SUCH WARRANTY AND THE EXTENT OF LIABILITY OF SENSEONICS SHALL BE THE MINIMUM PERMITTED UNDER SUCH APPLICABLE LAW.
  • Page 244 Your smart transmitter uses Bluetooth® Smart to pair with the mobile device and to send results to the app. Bluetooth® Trademark The Bluetooth® word mark and logos are owned by the Bluetooth® SIG, Inc. and any use of such marks by Senseonics, Inc. is under license. Eversense 365 CGM System User Guide...
  • Page 245 (1) This device may not cause harmful interference. (2) This device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Senseonics, Inc., could void the user’s authority to operate the equipment.
  • Page 246 Sensor USB, port (DMS) Sensor, about 9, 186, 189 Wireless 12, 24, 27, 69, 242 Do Not Disturb mode Sensor, insertion and removal 187, Events 90, 153 Settings, app 90, 91, 102 Eversense DMS Eversense 365 CGM System User Guide...
  • Page 248 Ascensia Diabetes Care US, Inc. 5 Wood Hollow Road Parsippany, NJ 07054 USA 844.SENSE4U (844.736.7348) www.ascensia.com/eversense Manufactured by: Senseonics, Inc. 20451 Seneca Meadows Parkway Germantown, MD 20876-7005 USA www.eversensediabetes.com Patents: www.senseonics.com/products/patents © Senseonics, Inc. 2024 PN: LBL-7702-01-001 Rev A 09/2024...
Save PDF