Page 1 User Guide A guide for using the Eversense E3 Continuous Glucose Monitoring System Sensor Smart Transmitter Mobile App...
Page 3 Eversense E3 Trademark Eversense E3, Eversense E3 Continuous Glucose Monitoring, Eversense E3 CGM, Eversense E3 Sensor, Eversense E3 Smart Transmitter, Eversense App and the Eversense E3 logo are trademarks of Senseonics, Incorporated. Other brands and their products are trademarks or registered trademarks of their respective holders.
Page 4: Table Of Contents
Creation, Pairing and Settings Smart Transmitter Connection Icons 1. Introduction 4. Linking the Sensor Help and Support Eversense E3 CGM System Components 8 5. Daily Transmitter Wear System Requirements Daily Use End User Licence Agreement Secure the Smart Transmitter over...
Page 5 CGM Meals Discuss with Your Healthcare Provider 66 Insulin Making Treatment Decisions with Health Eversense E3 Exercise Eversense E3 Trend Arrows and 11. Reports Treatment Decisions Weekly Modal Summary What Would You Do Glucose Pie Chart Trend Graph Glucose Statistics Menu Options 12.
Page 6 15. My Circle Clinical Study Performance Eversense E3 Accuracy to YSI Remote Monitoring with in PROMISE Study Eversense E3 CGM System and Sensor Life Eversense NOW App Safety 16. About the Sensor 20. Technical Specifications Insertion Steps Sensor Removal Steps Smart Transmitter 17.
Page 7: Glossary
Eversense App to check the a mobile device and is used to display CGM glucose data accuracy of the system. With the Eversense E3 System, sent from the smart transmitter. there are two phases: Initialisation Phase during which...
Page 8 Remote Monitoring An optional feature that allows you “LO” Reading Indicates sensor glucose reading is to invite others to view your CGM data using Eversense < 40 mg/dL. NOW, a separate mobile app they download to a compatible mobile device.
Page 9: Introduction
Congratulations on having Eversense E3 CGM technology to assist you in managing your diabetes. Your Eversense E3 CGM System is intended to continually measure glucose levels for up to 180 days after your sensor is inserted. Glucose information collected by the system is automatically sent to your mobile device.
Page 10: Eversense E3 Cgm System Components
Eversense E3 CGM System Components The System includes 1) a small sensor inserted subcutaneously by a healthcare provider, 2) a removable smart transmitter worn over the sensor, and 3) a mobile app to display the glucose readings. Eversense E3 Sensor The sensor is inserted under the skin (upper arm) and measures glucose in interstitial fluid for up to 180 days.
Page 11 In order to use the Eversense E3 CGM System, you must have an understanding of downloading and using mobile apps on your handheld device. Data from the Eversense E3 Smart Transmitter is sent wirelessly via Bluetooth. Carefully read the instructions in this User Guide for downloading and installing the Eversense Mobile App, and for pairing your mobile device with the smart transmitter.
Page 12 It is safe for you to wear your sensor and smart transmitter when you go through metal detectors at airports? While flying, the smart transmitter performs similarly to any other Bluetooth device. Be sure to follow the specific safety guidelines mandated by the airline. Eversense E3 CGM User Guide...
Page 13: System Requirements
End User Licence Agreement and Privacy Policy Use of the Eversense App is subject to the terms and conditions of the most current Eversense End User Licence Agreement and Eversense Privacy Policy. These documents are updated from time to time and are posted at https://global.eversensediabetes.com.
Page 14: Jailbroken Devices
Indications for Use 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.
Page 15: Mri Safety Information
Eversense E3 Sensor when imaged with a gradient echo pulse sequence and a 3 T MR system. The Eversense E3 Sensor has not been tested in MR systems that do not meet the conditions above. Exposing the Eversense E3 Sensor to MRI conditions which are outside of the conditions outlined above can cause potential complications such as device migration, heating and tissue damage or erosion through the skin.
Page 16: Contraindications
(Your Smart Transmitter kit will include a wall plug appropriate for use in your local region.) Also included in this package is this User Guide, Quick Reference Guide, Eversense DMS User Guide, Eversense NOW User Guide, and an Eversense Next Steps sheet (not shown).
Page 17: Benefits And Risks
System, a fingerstick blood glucose check with a home blood glucose meter should be performed prior to making treatment decisions. Failure to use the Eversense E3 CGM System in accordance with the instructions for use may result in you missing a hypoglycaemic or hyperglycaemic glucose event, which may result in injury.
Page 18 Unauthorised modification of the equipment is not permitted and voids your warranty. Any serious incident that has occurred relating to use of the device should be reported to the manufacturer and the competent authority of your Member State. Eversense E3 CGM User Guide Eversense E3 CGM User Guide...
Page 19: Risks And Side Effects
Additionally, the adhesive may cause a reaction or skin irritation. Any medical issue related to the procedure or use of the device should be reported to your healthcare provider. The sensor will require an additional removal procedure at the end of sensor life. Eversense E3 CGM User Guide...
Page 20: Warnings
Before making a treatment decision, you should take into account the sensor glucose value, the trend graph, the trend arrow and any alerts from the Eversense E3 CGM System. 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.
Page 21 • When the smart transmitter is not worn over the sensor, such as during charging, the Eversense E3 CGM System will not provide alerts and notifications on the mobile device or through vibration alerts from the smart transmitter.
Page 22: Cautions
A warm sensor could mean there is an infection or a sensor malfunction. • DO NOT attempt to use the Eversense App while operating a motor vehicle. • You should not receive massage therapy near the inserted sensor site. Massage therapy near the sensor site could cause discomfort or skin irritation.
Page 23 • The Apple Watch is a secondary display of Eversense E3 CGM data and should not be used in place of the primary Eversense E3 CGM display. Eversense E3 CGM User Guide...
Page 24: Getting Started
3. Getting Started This section describes the initial start-up steps required before you can begin using your new Eversense E3 CGM System on a daily basis. You may perform these steps before your healthcare provider inserts the sensor. To get started you need: •...
Page 25: Charge Your Smart Transmitter
Plug the standard end of the USB cable into the Plug the micro end of the USB cable into the adapter on the USB port. charging cradle on the USB port. Eversense E3 CGM User Guide...
Page 26 To release the smart transmitter from the charging cradle, pull back on the tab and lift the smart transmitter out of the cradle. LED Indicator (lights up green or orange) Eversense E3 CGM User Guide...
Page 27: Step 1. Download And Install The App
IMPORTANT: Make sure that you have a wireless internet connection, the date and time are correct on your mobile device, and that Bluetooth is turned ON before continuing. Eversense E3 CGM User Guide...
Page 28: Step 2. Set Up The App - Account Creation, Pairing And Settings
Once the app is downloaded, connect the app and smart transmitter by pairing the smart transmitter with your mobile device. Launch the app by tapping the Eversense App icon After you accept the Agreement, you will be on your mobile device. The full version of the...
Page 29 Enter your email address and password and tap Submit. LOG IN. You will see a confirmation screen. • Tap OK. Tap Done to return to the Eversense LOGIN screen. Note: The password is case sensitive. Eversense E3 CGM User Guide...
Page 30 Note: Android OS 12 and above may see a different Choose one of the two options depending permission request pop up. on whether you already have your smart transmitter or not: (skip to step 12). Eversense E3 CGM User Guide...
Page 31 Discoverable mode. Power button Note: If you press the power button on the smart transmitter and no LED appears, press and hold the power button for about 5 seconds to turn it on. Eversense E3 CGM User Guide...
Page 32 • Linking the Sensor). When the unit of measurement is confirmed, • Tap Next. tap Finish. Caution: DO NOT change the unit of measurement unless you have discussed it with your healthcare provider. Eversense E3 CGM User Guide...
Page 33 Tap through the introduction screens that provide information about when to make treatment decisions with the Eversense E3 CGM System. Eversense E3 CGM User Guide...
Page 34 24-hour warm-up phase is completed, you can begin calibration. If you have not yet had your sensor inserted, you can review this User Guide to become familiar with the app and its features. Eversense E3 CGM User Guide...
Page 35: Smart Transmitter Connection Icons
The bars indicate the strength of the connection. Signal strength information is also displayed in Main Menu > Placement Guide in the Eversense App. Reminder: You cannot link to a sensor until your transmitter is paired with the Eversense App. Eversense E3 CGM User Guide...
Page 36: Linking The Sensor
You can link your sensor to the smart transmitter any time after the sensor is inserted and the smart transmitter is paired with the Eversense App. To link the sensor, your mobile device must be connected to the internet and your transmitter must be charged, turned on, and paired with your mobile device.
Page 37 Placement Guide page is located in Menu > Placement Guide. The first time you link the sensor, do not use an Eversense adhesive patch on the smart transmitter. When positioning the smart transmitter over the sensor, it should be slightly above the centre of the Tegaderm patch.
Page 38 Note: It may take up to 5 minutes for the New Sensor Detected notification to be displayed. Eversense E3 CGM User Guide...
Page 39 If the smart transmitter is removed from the sensor site, the system will display a notification. If your smart transmitter has expired, it cannot be linked to a sensor. Eversense E3 CGM User Guide...
Page 40 Warning : The Eversense E3 CGM System will not provide readings during the 24-hour Warm-Up Phase and until a second calibration is successful during the Initialisation Phase. During this time, you should monitor your glucose using a home blood glucose monitor.
Page 41 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 E3 CGM User Guide...
Page 42: Daily Transmitter Wear
For the first few days, you'll wear the smart transmitter over the Tegaderm™ bandage. Always start with a freshly charged smart transmitter. Your smart transmitter communicates with both the sensor and the app to provide CGM information. Your Eversense E3 Smart Transmitter does the following: • Powers the sensor.
Page 43: Daily Use
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 E3 CGM User Guide...
Page 44: Secure The Smart Transmitter Over Inserted Sensor
If you have any concerns about allergic reaction to silicones, contact your healthcare provider prior to use. Discard the patch after 24 hours of use. Peel off the paper backing with the Eversense E3 Align the smart transmitter over the sticky side Smart Transmitter outline on it.
Page 45 "and smart transmitter. the smart transmitter. You may wear the smart transmitter over the Tegaderm with the Eversense 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 –...
Page 46 Smooth the adhesive onto the skin. Make sure the first several days after insertion. patch is flat on the skin surface. • The smart transmitter should be positioned so that the patch wings lay horizontally on the arm. Eversense E3 CGM User Guide...
Page 47: Turn The Smart Transmitter On And Off
At any time, you can press the power button once to see if the smart transmitter is ON. If the LED appears, the smart transmitter is ON. If no LED appears, the smart transmitter is OFF. LED indicator Power button Eversense E3 CGM User Guide...
Page 48: Smart Transmitter Care And Maintenance
10% power. It is recommended to always charge the smart transmitter for a full 15 minutes using a wall outlet to ensure a full charge. See the next page for more information on the LED indicators Eversense E3 CGM User Guide...
Page 49: Led Status Indicators
Solid or flashing orange when connected to Charge for 15 minutes before 0%-65% charged the USB cable disconnecting from power supply Solid green when connected to the Charge for 15 minutes before 65%-100% charged USB cable disconnecting from power supply Eversense E3 CGM User Guide...
Page 50: Calibrating The System
6. Calibrating the System This section describes the calibration procedure and schedule of your Eversense E3 CGM System. Warning: DO NOT use alternative test sites such as your forearm when entering BG values for calibration. To ensure best performance, routine calibration is required using fingerstick readings from a blood glucose meter.
Page 51 In the 2 Daily Calibrations Phase, the Eversense E3 CGM System requires calibration every 12 hours in order to provide accurate readings. In the 1 Daily Calibration Phase, the Eversense E3 CGM System requires calibration every 24 hours. You should not use CGM readings to make treatment decisions unless you have followed the instructions for daily calibration.
Page 52: Calibration Phases
Glucose readings will start displaying in the app a few minutes after the 2nd calibration is successfully completed. IMPORTANT: If your smart transmitter is not turned on and paired with the Eversense App and sensor, the system is not able to prompt you to calibrate.
Page 53 If you do not calibrate within 28 hours, you will receive a Calibration Past Due Alert and no glucose values will be displayed until a calibration value is entered. After 40 hours without a calibration value entered, you will receive a Calibration Expired Alert and the system returns to Initialisation Phase. Eversense E3 CGM User Guide...
Page 54 Daily Calibration phase the system is in. In this situation, if you do not calibrate within 16 hours, no glucose values will be displayed. After 24 hours with no calibration, the system returns to Initialisation Phase. Eversense E3 CGM User Guide...
Page 55: How To Calibrate
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 E3 CGM User Guide...
Page 56 Obtain a fingerstick reading from your blood glucose meter. glucose test. • Tap Done. • Tap Notes to enter any notes. • Tap Done. Note: You cannot enter a calibration value that is older than 10 minutes. Eversense E3 CGM User Guide...
Page 57 15 minutes after the test 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 E3 CGM User Guide...
Page 58 15 minutes after you entered be Used again when your blood glucose value is your calibration value. between 40 and 400 mg/dL. Blood Glucose Displayed when a manual BG value is Event Entry entered via the Event Log. Eversense E3 CGM User Guide...
Page 59: Using The App
The app also stores your glucose history with up to 90 days of stored data. Note: When you log out of the Eversense App, your smart transmitter will not send glucose data to the app until you log back in.
Page 60: Eversense Account Management
If you cannot access your CGM data, you should monitor your glucose using a home blood glucose monitor. The Eversense Mobile App will periodically check to confirm your log in information has not been changed via your Eversense DMS account.
Page 61: Check Your Mobile Device Settings
Check Your Mobile Device Settings You will need a mobile device (such as your smartphone) to use the Eversense E3 CGM System. It is very important that your mobile device is set up properly to ensure accurate display of your glucose data in the app. Follow the manufacturer’s instructions for your mobile device to set up the following:...
Page 62: Get To Know The "My Glucose" Screen
Before making a treatment decision, you should take into account the sensor glucose value, the trend graph, the trend arrow and any alerts from the Eversense E3 CGM System. If no trend arrow is displayed, the system does not have enough data to display direction and rate of change.
Page 63 Note: • You can view a snapshot of Eversense information on your iOS or Android devices. For information on managing widgets, consult your mobile device user guide. • You can view the MY GLUCOSE screen in landscape orientation to access short cut buttons to view the last 7, 14, 30 or 90 days and you can email this view with a single tap.
Page 64 Glucose levels over time. You can scroll back and forth to see trends or zoom Glucose trend graph in to display as few as 3 hours of data, or zoom out to see up to 3 days. Menu Provides easy navigation to various sections of the Eversense App: My Glucose Reports Settings...
Page 65: Trend Arrows
Before making a treatment decision, you should take into account the sensor glucose value, the trend graph, the trend arrow and any alerts from the Eversense E3 CGM System. If no trend arrow is displayed, the system does not have enough data to display direction and rate of change.
Page 66: Understanding Treatment Decisions With Cgm
Understanding Treatment Decisions with CGM Read the entire Eversense E3 CGM System User Guide and be sure you are familiar with when you should and should not make treatment decisions based on your CGM information. Before you begin using Eversense E3 to make treatment decisions, talk with your healthcare provider about understanding how food, insulin, medications, stress, and exercise impact your glucose.
Page 67 Monitoring Mobile App. Remote monitoring relies on data being sent from your mobile device through the Eversense cloud and then to the 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.
Page 68: Discuss With Your Healthcare Provider
If your symptoms do not match your CGM value, or if your CGM value and trend arrow are not what you expect, use your BG meter to make treatment decisions. Some people experience delayed-onset hypoglycaemia hours after exercise. You should follow your healthcare provider’s recommendation on dosing insulin following exercise to avoid low glucose. Eversense E3 CGM User Guide...
Page 69 Your healthcare provider will help you determine the target range and glucose alert levels that are right for you. Pay careful attention to your Eversense E3 glucose alerts – you may need to make a treatment decision. When you receive an Out of Range Glucose Alert, the sensor glucose value is below 40 mg/dL with LO displayed instead of a number, or above 400 mg/dL with HI displayed instead of a number.
Page 70: Making Treatment Decisions With Eversense E3
Making Treatment Decisions with Eversense E3 To make a treatment decision, you should consider: • Status bar information. • Current sensor glucose value – the current glucose value should be displayed in black. • Trend arrow – a trend arrow should be displayed.
Page 71 You are taking medications of the tetracycline class. Note: Always refer to the glucose information on your Eversense CGM App on your smartphone to make treatment decisions. Do not use a secondary display like the Apple Watch or Eversense NOW.
Page 72: Eversense E3 Trend Arrows And Treatment Decisions
Eversense E3 Trend Arrows and Treatment Decisions Eversense E3 trend arrows show the direction and rate of change of your glucose to give you an idea of where your glucose is headed. Talk with your healthcare provider about using trend arrows to help you make treatment decisions.
Page 73 15 minutes. check your CGM CGM value and trend your CGM value 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 E3 CGM User Guide...
Page 74: What Would You Do
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 E3 CGM User Guide...
Page 75 What does your healthcare provider recommend glucose number and trend arrows? for adjusting your insulin in this situation? • How long does your healthcare provider recommend you wait between insulin doses to help prevent stacking insulin? Eversense E3 CGM User Guide...
Page 76 • and glucose are more steady. 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 E3 CGM User Guide...
Page 77 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 E3 CGM User Guide...
Page 78: Trend Graph
You can view the trend graph in either portrait or landscape mode. In landscape mode, there are shortcut buttons to 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 E3 CGM User Guide...
Page 79: Menu Options
Reports Review a variety of reports about your CGM data. See Reports for more information. Share My Data Allow others to view your glucose data through the Eversense NOW Mobile App. Placement Check the communication between the smart transmitter and sensor. Use this screen Guide whenever you are attaching the smart transmitter to be sure communication is established.
Page 80: Customising Your Settings
Glucose Levels The Eversense E3 CGM System is designed to provide alerts on your smart transmitter and mobile device when your glucose level has reached the alert levels you set. You will decide the settings for your glucose alerts, targets, and rates of change based on input from your healthcare provider.
Page 81 – 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 E3 CGM User Guide...
Page 82: Setting Glucose Alert Levels
Setting Predictive Alerts. • For iOS 12 and above, and Android 6 and above, you can allow the Eversense Low Glucose and Out of Range Low Glucose Alerts to override your phone sound settings. See Sound Settings for more information.
Page 83 Tap Menu > Settings > Glucose to Under Glucose Alert Levels, tap High Alert display the GLUCOSE SETTINGS and select the appropriate High Glucose Alert level. screen. • Tap Done when complete. • Repeat step to make your Low Alert selection. Eversense E3 CGM User Guide...
Page 84: Setting Glucose Target Levels
Allowable setting Low: 65-120 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 E3 CGM User Guide...
Page 85 Tap Menu > Settings > Glucose to 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 E3 CGM User Guide...
Page 86: Setting Predictive Alerts
You can turn these alerts ON and OFF. 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 E3 CGM User Guide...
Page 87 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 E3 CGM User Guide...
Page 88: Setting Rate Of Change Alerts
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 E3 CGM User Guide...
Page 89 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 E3 CGM User Guide...
Page 90: Setting Daily Calibration Reminders
These reminders are not stored in Alert History. If you pair a new transmitter with the existing app, the settings will remain intact. See Do Not Disturb on Eversense App and Mobile Devices for more information.
Page 91: Setting System Information
Setting System Information The SYSTEM screen lets you view and edit other settings in your Eversense E3 CGM System. Tap Menu > Settings > System to display the SYSTEMS screen. On the SYSTEMS screen, you can tap each of the following to set: •...
Page 92: Re-Linking A Sensor
Initialisation Phase, requiring 4 blood glucose fingerstick calibrations within 36 hours. Confirm with Customer Tap Re-link detected Tap Cancel or OK to Support that you should sensor. continue. re-link your sensor. Tap Linked Sensor. Tap Cancel or Re-link. Eversense E3 CGM User Guide...
Page 93 While calibration is in progress. • Before a sensor has been linked. • Certain sensor replacement alerts. • If any of the below alerts are active: – Transmitter End of Life – System Time Error – Sensor Suspend Eversense E3 CGM User Guide...
Page 94: Setting Sounds
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 E3 CGM User Guide...
Page 95: Low Glucose Override Setting
Low Glucose Override Setting If your mobile device is running iOS 12 and above or Android 6 and above, you can optionally allow Eversense Low and Out of Range Low Glucose alerts to always override your mobile device sound settings. When turned on, the Low and Out of Range Low Glucose alerts will be played at your phone's maximum volume.
Page 96 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 E3 CGM User Guide...
Page 97 If you tap Don’t Allow in Step 3, you cannot turn on the Low Glucose Override setting. To turn this setting on at another time, when you tap Settings from Step 2, the Eversense settings in your mobile device settings page will be displayed. Tap Notifications > Allow Critical Alerts.
Page 98 Android Devices For devices with Android 6 and above: Tap Settings. Tap the button to turn on the Tap on Eversense from the override. Do Not Disturb access page. Eversense E3 CGM User Guide...
Page 99 Tap Allow. Tap the button next to Eversense to allow Eversense to override the Do Not Disturb settings. Eversense E3 CGM User Guide...
Page 100 Return to the Eversense CGM mobile 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 101: Transmitter Disconnect Setting
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 E3 CGM User Guide...
Page 102 When you enable Do Not Disturb mode on your mobile device you will not receive any alerts or notifications from the Eversense App. The DND icon will appear on the Home Screen. For a list of alerts, please see Alert Descriptions.
Page 103 Do Not Disturb on Eversense App and Mobile Devices Eversense Eversense Eversense Eversense App DND off; App DND on; App DND off; App DND on; Mobile device Mobile device Mobile device Mobile device DND off DND off DND on DND on...
Page 104: Setting Temporary Profile
Settings > Glucose will automatically resume. Tap Menu > Settings > Temp Profile Select the duration. You can set a Temp Profile to display the TEMP PROFILE screen. for up to 36 hours in 30 minute increments. Eversense E3 CGM User Guide...
Page 105 Set the High and Low Alerts and High and Low Target 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 E3 CGM User Guide...
Page 106 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 E3 CGM User Guide...
Page 107: Alert Descriptions
9. Alert Descriptions This section describes the various alerts and notification messages you may see on the Eversense App screens and actions you may need to take. Your CGM System provides you with alerts and notifications related to glucose readings and system status on both your smart transmitter and mobile device.
Page 108 Your smart transmitter is running low on battery and should IN YELLOW 1 long vibe x 2 be charged. Notifications MESSAGE APPEARS Requires some action but not critical in nature. 1 short vibe IN BLUE See following section for examples. Eversense E3 CGM User Guide...
Page 109: Alert History
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 E3 CGM User Guide...
Page 110 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 E3 CGM User Guide...
Page 111: Alert Descriptions And Actions
Alert Descriptions and Actions The following table lists the alerts and notifications you may receive on the Eversense App. IMPORTANT: Alerts marked with a * cannot be turned off in the app or in the smart transmitter using the DND in the app settings.
Page 112 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 E3 CGM User Guide...
Page 113 Eversense E3 CGM User Guide...
Page 114 Eversense E3 CGM User Guide...
Page 115 No glucose readings can be displayed until the sensor restored. is replaced. Using the Placement Guide for reference, place the Contact your GP to have your sensor replaced. smart transmitter over the sensor until it shows that there is a connection. Eversense E3 CGM User Guide...
Page 116 No glucose readings can be displayed until the very soon. sensor is replaced. Contact your GP to have your sensor replaced. Charge your smart transmitter as soon as possible. Eversense E3 CGM User Guide...
Page 117 No glucose readings can be displayed until the smart transmitter is charged. Tap Calibrate to enter a calibration value. Charge the smart transmitter immediately. Remove the smart transmitter from your body before connecting it to the power supply. Eversense E3 CGM User Guide...
Page 118 Re-initialisation of the system begins in 6 hours. Perform a fingerstick calibration in order to resume Glucose values will be displayed a few minutes displaying glucose values. after the second successful calibration during the Initialisation Phase. Eversense E3 CGM User Guide...
Page 119 If you do not calibrate within 16 hours, no glucose values will be displayed, and after 24 hours with no calibration, the system returns to Initialisation Phase. Eversense E3 CGM User Guide...
Page 120 Contact your distributor to order a new transmitter. Contact your distributor to order a new transmitter. Eversense E3 CGM User Guide...
Page 121 Place a dark material over the smart transmitter. to cool it down. Once the smart transmitter is back • Wear the smart transmitter under clothing. to a lower temperature, be sure to replace it over the sensor. Eversense E3 CGM User Guide...
Page 122 26-40°C (81-104°F). Then put the smart transmitter 26-40°C (81-104°F). back on to start receiving glucose values again from the sensor. Eversense E3 CGM User Guide...
Page 123 If you are 4 fingerstick calibration tests spaced 2-12 hours unable to complete the reset, contact Customer apart. Display of glucose readings will resume after Support. the 2nd successful fingerstick calibration test. Eversense E3 CGM User Guide...
Page 124 After 72 hours, you will receive a Transmitter Error Alert every 20 minutes until you replace the smart transmitter. Contact Customer Support to have your smart Contact your distributor to order a new transmitter. transmitter replaced immediately. Eversense E3 CGM User Guide...
Page 125 Customer Support. cradle 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 E3 CGM User Guide...
Page 126 Set your mobile device clock to your current Try linking again. If the error is displayed on the local time. If the issue persists, contact Customer second attempt, contact Customer Support. Support. Eversense E3 CGM User Guide...
Page 127 Log Out Required Appears once when the system detects the Appears every 24 hours for iOS users when the password was changed via your Eversense DMS system detects that your Eversense credentials account. are not available via the iOS keychain feature.
Page 128 Appears when your calibration value is significantly when the system detects frequent app crashes different from your sensor glucose value. due to the Eversense App being included in battery optimisation settings. Go to your phone’s battery optimisation settings Do not remove your transmitter for 15 minutes.
Page 129 Appears when the software in your smart transmitter Appears when you attempt to log out of the mobile is incompatible with the Eversense CGM Mobile App app. If you log out, you will not be able to view version on your mobile device.
Page 130 For Android only. Explains the use of location system is being used with the app. services is required to enable Bluetooth connection and to receive alerts. Tap OK to acknowledge. For a list of compatible devices/operating systems visit https://global.eversensediabetes.com. Eversense E3 CGM User Guide...
Page 131 Incorrect Password Appears once when the system detects the password Appears when the system detects one or two incorrect was changed via your Eversense DMS account. passwords have been entered consecutively via your mobile app. Log out of the mobile app and log back in with the Use the correct password to log in to the mobile app.
Page 132 Appears when Delete Account is tapped on the log entered consecutively via your mobile app. in page. Wait 30 minutes. Log in with correct password or Contact Customer Support if you wish to proceed. reset your password. Eversense E3 CGM User Guide...
Page 133 DO NOT use an need to wear your smart transmitter over the sensor alternative site (such as forearm) to obtain your until the Warm-Up Phase is complete. blood glucose reading. Eversense E3 CGM User Guide...
Page 134 Appears if the calibration value entered is very during calibration. different from the sensor glucose value. After about 1 hour, you will receive a Calibrate Now notification. Tap Calibrate to enter a new calibration value. Enter a new calibration value when prompted. Eversense E3 CGM User Guide...
Page 135 24 hours. replace your sensor. Contact your GP to schedule the removal and Enter a new calibration value when prompted. replacement of your sensor. Eversense E3 CGM User Guide...
Page 136 Transmitter End of Life Day 330 Appears once when the system requires calibration Appears once 35 days before your transmitter twice a day. warranty expires. Enter a new calibration value when prompted. Contact your distributor to order a new transmitter. Eversense E3 CGM User Guide...
Page 137: Event Log
This section describes how to review and log events to help better track glucose patterns. The Eversense E3 CGM System allows you to log and track events in addition to continually monitoring glucose levels. You can manually enter events that will appear on the trend graph and glucose reports to help you find patterns in your glucose profile.
Page 138 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 E3 CGM User Guide...
Page 139: Glucose
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 E3 CGM User Guide...
Page 140: Meals
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 E3 CGM User Guide...
Page 141: Insulin
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 E3 CGM User Guide...
Page 142: Health
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 E3 CGM User Guide...
Page 143: Exercise
Tap Done. 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 E3 CGM User Guide...
Page 144: Reports
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 E3 CGM User Guide...
Page 145: Weekly Modal Summary
(percent of readings that fall within the low and high glucose target levels). The information is shown based on 6-hour time slots. Eversense E3 CGM User Guide Eversense E3 CGM User Guide...
Page 146: Glucose Pie Chart
Target levels. You can choose the last 1, 7, 14, 30 or 90 days. standard deviation within 6-hour time periods. You can choose the last 1, 7, 14, 30 or 90 days. Android Eversense E3 CGM User Guide...
Page 147: Sharing Data
CGM System Mobile App. This program is offered at no cost to users of the Eversense E3 CGM System. To learn about the Eversense DMS Program, go to https://global.eversensediabetes.com. When you create and register your account during the installation of the Eversense CGM Mobile App, an Eversense DMS account is automatically created for you.
Page 148: Sync
As long as you have an internet connection, Auto Sync is turned on, and you are logged into the app, your glucose readings sync to your Eversense DMS account about every 5 minutes. You can turn off Auto Sync. To turn off Auto Sync, tap Sync on the SHARE MY DATA screen. Tap the Auto Sync button to off.
Page 149: My Circle
My Circle My Circle is an optional feature that allows you to activate remote monitoring of your Eversense E3 CGM data. For more information on this feature, see My Circle - Remote Monitoring. Eversense E3 CGM User Guide Eversense E3 CGM User Guide...
Page 150: Application Sharing
Application Sharing 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.
Page 151: Product And General Information On The App
13. Product and General Information on the App This section describes the information available from the About section of the Main Menu. You can view product information about your smart transmitter, your sensor and your Eversense CGM Mobile App. On the My Transmitter screen, On the My Sensor screen, you Tap Menu >...
Page 152: Profile Picture
On the My Account screen, Profile Picture you can edit your profile picture, You can update the profile picture in your Eversense account, which will be view the email address used to displayed in your Eversense Mobile App and in your Eversense DMS account.
Page 153 Agreement and Privacy Policy tap either option. version and Senseonics, Inc., the from the About menu. manufacturer of the Eversense E3 • Tap Contact Us to send an CGM System. email to your local customer support team.
Page 154: Logging Out
Logging out To log out of your Eversense account, tap My 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.
Page 155: Viewing Eversense E3 Data On The Apple Watch
Eversense CGM Mobile App on your mobile device, follow the Apple Watch instructions for adding the app to your watch. The Apple Watch is a secondary display of Eversense E3 CGM data and should not be used in place of the primary Eversense E3 CGM display.
Page 156 CGM data. Eversense E3 in your Apple Watch settings. When you receive a notification, you can also tap on the message to see the MY GLUCOSE screen.
Page 157 24 hours. time, the current system calibration phase, and battery level of your smart transmitter. Eversense E3 CGM User Guide Eversense E3 CGM User Guide...
Page 158: Alerts And Notifications Displayed On The Apple Watch
Alerts and Notifications Displayed on the Apple Watch The Apple Watch is a secondary display to the Eversense CGM Mobile App. Any alerts or notifications received on the Apple Watch should be confirmed on the Eversense CGM Mobile App before any action is taken.
Page 159 400 mg/dL. No glucose readings can be displayed. No glucose readings can be displayed. Confirm the alert on your Eversense CGM Mobile Confirm the alert on your Eversense CGM Mobile App. Measure your glucose manually by using your App. Measure your glucose manually by using your blood glucose meter.
Page 160 High Glucose Alert level within the time you entered in Settings. entered in Settings. Confirm the alert on your Eversense CGM Mobile Confirm the alert on your Eversense CGM Mobile App. Pay close attention to your glucose values, App. Pay close attention to your glucose values, symptoms, and trends.
Page 161 Settings. the rate of change you entered in Settings. Confirm the alert on your Eversense CGM Mobile Confirm the alert on your Eversense CGM Mobile App. Pay close attention to your glucose values, App.
Page 162 No glucose data is available until the connection is restored. Confirm the alert on your Eversense CGM Mobile Confirm the alert on your Eversense CGM App. Using the Placement Guide for reference, Mobile App.
Page 163 No glucose readings can be displayed until the very soon. sensor is replaced. Confirm the alert on your Eversense CGM Confirm the alert on your Eversense CGM Mobile Mobile App. Contact your GP to have your sensor App. Charge your smart transmitter as soon as replaced.
Page 164 No glucose readings can be displayed until the smart transmitter is charged. Confirm the alert on your Eversense CGM Mobile Confirm the alert on your Eversense CGM Mobile App. Tap Calibrate on your mobile device to App.
Page 165 Eversense CGM during the Initialisation Phase. Mobile App. Confirm the alert on your Eversense CGM Mobile Confirm the alert on your Eversense CGM Mobile App. Re-initialisation of the system begins in App. Perform a fingerstick calibration in order 6 hours.
Page 166 After 395 days of use, your transmitter will no No glucose readings can be displayed until calibration longer provide glucose readings. is entered in the Eversense CGM Mobile App. Confirm the alert on your Eversense CGM Mobile Confirm the alert on your Eversense CGM Mobile App.
Page 167 Glucose readings cannot be displayed until you date of this alert until you replace your transmitter. replace your transmitter Confirm the alert on your Eversense CGM Mobile Confirm the alert on your Eversense CGM Mobile App. Contact your distributor to order a new App.
Page 168 Confirm the alert on your Eversense CGM Mobile Confirm the alert on your Eversense CGM Mobile App. Reduce ambient light by doing one or more App. Reduce the smart transmitter temperature by of the following: moving to a cooler environment.
Page 169 No glucose readings are displayed until the sensor temperature is within normal operating conditions. temperature is within normal operating conditions. Confirm the alert on your Eversense CGM Mobile Confirm the alert on your Eversense CGM Mobile App. Go to a warmer environment to increase the App.
Page 170 No glucose readings are displayed until the error is corrected. Confirm the alert on your Eversense CGM Confirm the alert on your Eversense CGM Mobile Mobile App. Follow the steps shown in the App. In the Initialisation Phase, you must perform Troubleshooting section to reset your smart 4 fingerstick calibrations spaced 2-12 hours apart.
Page 171 After 72 hours, you will receive a Transmitter Error Alert every 20 minutes until you replace the smart transmitter. Confirm the alert on your Eversense CGM Mobile Confirm the alert on your Eversense CGM Mobile App. Contact Customer Support to have your App.
Page 172 No glucose readings are displayed until the error is corrected. Confirm the alert on your Eversense CGM Mobile Confirm the alert on your Eversense CGM Mobile App. Plug the charging cradle with cable into App. Set your mobile device clock to your current a wall outlet or USB port.
Page 173 Confirm the alert on your Eversense CGM Mobile Confirm the alert on your Eversense CGM Mobile App. In your mobile app, tap Link Sensor App. Log out of the mobile app and log back in with the new password.
Page 174 Confirm the alert on your Eversense CGM Mobile Confirm the alert on your Eversense CGM Mobile App. Tap Calibrate on your mobile device to App. Do a fingerstick blood glucose test and enter the reading as your calibration value.
Page 175 60 minutes, you will receive a Calibrate Now reminder to replace your sensor. notification. Confirm the alert on your Eversense CGM Confirm the alert on your Eversense CGM Mobile Mobile App. Enter a new calibration value when App. Contact your GP to schedule the removal and prompted.
Page 176 Appears once when the system requires calibration once every 24 hours. twice a day. Confirm the alert on your Eversense CGM Confirm the alert on your Eversense CGM Mobile App. Enter a new calibration value when Mobile App. Enter a new calibration value when prompted.
Page 177 Notifications Transmitter End of Life Day 330 Appears once 35 days before your transmitter warranty expires. Confirm the alert on your Eversense CGM Mobile App. Contact your distributor to order a new transmitter. Eversense E3 CGM User Guide Eversense E3 CGM User Guide...
Page 178 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 Eversense E3 CGM System, they cannot assist you in the event of a high or low glucose value.
Page 179 If you set your status to offline with any of the members of your Circle, they will not receive any of your CGM data on their Eversense NOW App. DO NOT set your status to offline if you want members of your Circle to see your CGM data.
Page 180 • If you have your mobile device set to Do Not Disturb, you will not hear any notifications from the Eversense NOW App. Through the MY CIRCLE screen on your Eversense CGM Mobile App, you can invite up to five people to view your data.
Page 181 Circle change profile pictures of those you have invited to your Circle. Member, their email address will show in place of a nickname. Eversense E3 CGM User Guide Eversense E3 CGM User Guide...
Page 182 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 E3 CGM User Guide...
Page 183 Eversense E3 CGM System glucose data, alerts or event history. 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.
Page 184 16. About the Sensor This section describes the Eversense E3 Sensor and how it is inserted by your healthcare provider. The Eversense E3 Sensor is a miniaturised fluorometer that uses fluorescent intensity to measure glucose in interstitial fluid. The sensor is implanted subcutaneously (under the skin) on the upper arm, leaving no part of the sensor protruding from the skin.
Page 185 24 hours of sensor insertion, position and secure the smart transmitter over the sensor and ensure you have a connection (see Daily Transmitter Wear). Then you can perform your Initialisation Phase calibration of 4 fingerstick blood glucose tests to start getting glucose readings. Eversense E3 CGM User Guide Eversense E3 CGM User Guide...
Page 186 Incision – a small (less than 1 centimetre) incision will be made at the sensor site. Step 3: Sensor removal – the sensor will be removed and discarded. Step 4: Site closure – once removed, the incision will be closed with Steri-Strips™ (sutures may be used depending on provider’s preference). Eversense E3 CGM User Guide...
Page 187 Your smart transmitter will automatically sync to your smartphone’s current time and date when time zones are changed. The Eversense E3 CGM System is safe for use on U.S. commercial airlines. The Eversense E3 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 188 18. Troubleshooting This section lists information about troubleshooting your Eversense E3 CGM System and includes a list of frequently asked questions (FAQs). Smart Transmitter 2. Use the PLACEMENT GUIDE screen on the app to confirm connection between the sensor and Q: How do I turn my smart transmitter OFF? the transmitter.
Page 189 A: Tap Menu > Settings > System > Transmitter Name. Type in the name you desire. The updated name of the smart transmitter will appear in your connection status screen. Eversense E3 CGM User Guide Eversense E3 CGM User Guide...
Page 190 “Low Battery” alert is triggered consistently at the point the smart transmitter still has approximately 2 hours of power left (at about the 10% indicator level). It is important to charge your battery when you receive the “Low Battery” alert. Eversense E3 CGM User Guide...
Page 191 ID once the pairing is completed. Note: times to restart BLE. ( When doing a BLE restart, do not remove/forget the paired device via your mobile device’s Bluetooth Settings.) Eversense E3 CGM User Guide Eversense E3 CGM User Guide...
Page 192 Q: Can other people connect to my smart transmitter? A: Follow the steps below. A: The Eversense E3 CGM System utilises a secure Bluetooth 1. Place the smart transmitter into the charging connection and will not allow others to connect.
Page 193 The smart transmitter is currently charging. CONNECT screen? • The smart transmitter is turned OFF. • A: If other Eversense E3 CGM users are around you, The smart transmitter battery is completely then the app may find those devices. However, the drained. •...
Page 194 • The blood glucose reading entered is less than 40 mg/dL. • The blood glucose reading entered is greater than 400 mg/dL. If another calibration is needed, the system will prompt you. Eversense E3 CGM User Guide...
Page 195 Q: What are the different types of calibration phases? • The blood glucose reading is less than 40 mg/dL. A: The Eversense E3 CGM System has three types of • The blood glucose reading is greater than Calibration Phases: the Initialisation Phase, 2 Daily 400 mg/dL.
Page 196 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 E3 CGM User Guide...
Page 197 A: The ALERT HISTORY screen has a sort filter at the top. You can sort based on the severity levels (yellow and blue), and alert type. Tap the desired sort filter icon. Eversense E3 CGM User Guide Eversense E3 CGM User Guide...
Page 198 A: You may not get any sensor glucose readings glucose meter reading? when there is no connection between your smart A: The Eversense E3 CGM System measures glucose transmitter and your sensor or smart transmitter in interstitial fluid (ISF) between the body’s cells.
Page 199 • trend graph, the trend arrow and any alerts from No trend arrow is displayed. the Eversense E3 CGM System. If no trend arrow • Your symptoms do not match the glucose is displayed, the system does not have enough data information displayed.
Page 200 Store. enough sensor values available for the calculation, the arrow is not displayed. You should not make Q: What devices are compatible with the Eversense treatment decisions unless you see a glucose value, App? a trend arrow, and consider recent trends and alerts.
Page 201 Q: What is the Do Not Disturb option? Q: Can I edit a manual BG entry event? A: When Do Not Disturb is enabled in the Eversense App Settings, the mobile app will stop displaying A: Manual BG entries and calibration entries cannot be non-critical alerts.
Page 202 A: It may take up to 10 minutes for the linking process to A: The Eversense E3 CGM System was only tested in complete. Make sure that the smart transmitter is on the upper arm during clinical studies, and the sensor top of the sensor.
Page 203 Eversense E3 CGM System? smart transmitter, tap Not Now. If unsure, contact A: Yes, MRI technicians can wear the Eversense E3 CGM Customer Support for more information. System. However, for people undergoing an MRI with a static magnetic field of 1.5 T or 3.0 T, the sensor can...
Page 204 Your smart transmitter was out of range of your sort option is to show ALL events. sensor for a while and it is re-syncing. • You closed the Eversense App completely and re-launched it. • Your mobile device lost battery power and was recharged.
Page 205 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 E3 CGM User Guide Eversense E3 CGM User Guide...
Page 206 Clinical Study Performance The safety and effectiveness of the Eversense E3 CGM System has been evaluated in the PROMISE clinical study conducted in the U.S. The data included in this Device Performance section is based on the data collected during the PROMISE study with new algorithm (SW604) and minor design modification in the Sensor (E3 Sensor).
Page 207 Percent Percent Percent of Paired 15/15% 20/20% 30/30% 40/40% CGM and YSI Values Reference Reference Reference Reference 12,034 87.3 93.9 98.6 99.6 8.5% *Glucose values between 40 and 400 mg/dL. Eversense E3 CGM User Guide Eversense E3 CGM User Guide...
Page 208 Eversense E3 Accuracy to YSI in PROMISE Study Accuracy was measured by comparing the Eversense E3 sensor glucose values to YSI blood glucose values. For blood glucose values less than or equal to 80 mg/dL, the mean absolute difference between the two results was calculated.
Page 209 40 and 60 mg/dL were within 15 mg/dL of the reference value 91.6% of the time. Table 3 – Eversense E3 Percentage of Readings in Agreement Overall in the PROMISE Study Percent of CGM System Readings Within...
Page 210 Table 4 – Eversense E3 System Accuracy by Day Percent of CGM System Readings Within Mean Percent Percent Percent Percent Percent Absolute 15/15% 20/20% 30/30% 40/40% > 40/40% Relative Difference Reference Reference Reference Reference Reference Day 1 11.2 78.6 87.4 96.5...
Page 211 15 minute window of a reference value beyond the alert setting threshold. The Missed Detection Rate shows the percentage of time the Eversense E3 CGM System did not present an alert within a 15 minute window of a reference value beyond the alert setting threshold. The True Alert Rate shows the percentage of time the alert from the CGM system was confirmed by a reference value within a 15 minute window of the alert being presented.
Page 212 The table below shows an assessment of the ability of the Eversense E3 CGM System to detect high and low glucose levels, and assess true positive alerts vs false positive alerts. These are shown as a percentage of alerts provided compared to the YSI reference values at various thresholds.
Page 213 The table below shows an assessment of the ability of the Eversense E3 CGM System to detect high, low, and predictive high and low alerts, and assess true positive alerts vs false positive alerts. These are shown as a percentage of alerts provided compared to the YSI reference values at various thresholds.
Page 214 (mg/dL per minute). As an example, when glucose is trending at a rate of between -1 and 1 mg/dL/minute, Eversense E3 glucose trends are in agreement with the reference trends 90% of the time.
Page 215 Eversense E3 Concurrence with YSI Values The shaded area in the tables below show what percentage of YSI reference values were in the same range as the sensor glucose values. As an example, when sensor glucose is between 81 and 120 mg/dL, YSI reference values are in the same range 76% of the time.
Page 216 < 40 40-60 61-80 81-120 121-160 161-200 201-250 251-300 301-350 351-400 > 400 (mg/dL) CGM-YSI 40 - 60 61 - 80 81 - 120 121 - 160 161 - 200 201 - 250 251 - 300 301 - 350 351 - 400 > 400 Eversense E3 CGM User Guide...
Page 217 The table below compares the percentage of sensor glucose values to the YSI reference at various time points after a calibration entry. As an example, in the table below, 89.7% of the Eversense E3 values were within 15 mg/dL (for reference readings of 80 mg/dL or less), and within 15% (for reference readings over 80 mg/dL) of the reference value 8 to 10 hours after a calibration entry.
Page 218 Table 10 – Eversense E3 Calibration Stability Agreement in the PROMISE Study (continued) Percent of CGM System Readings Within Percent Percent Percent Percent Percent Time Number 15/15% 20/20% 30/30% 40/40% > 40/40% from of Paired Calibration CGM-YSI Reference Reference Reference...
Page 219 Safety The PROMISE study lasted for 180 days, and the number of related adverse events was recorded. The Eversense E3 CGM System was well tolerated in the study. During the study's 31,373 sensor wear days, there were no unanticipated adverse events. Fifty-nine adverse events were reported in 37 participants. None of the adverse events resulted in hospitalisation.
Page 220 Silicone - 4.1 mg, Dexamethasone Acetate - 1.7 mg, epoxy 301-2 - 0.62 mg Glucose Range 40-400 mg/dL Sensor Life Up to 180 days Calibration Commercially available self-monitoring blood glucose meter Calibration Range 40-400 mg/dL Sterilisation Sterile by Ethylene Oxide Eversense E3 CGM User Guide...
Page 221 Wireless communication to the app will not function well when communicating through water. The range will decrease if you are in a bath, water bed, pool, etc. Cabin Pressure 700 hPa to 1060 hPa Relative Humidity Range 15% to 90% (non-condensing) Altitude 10,000 ft Eversense E3 CGM User Guide...
Page 222 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 E3 CGM User Guide...
Page 223 Power Frequency Power frequency magnetic fields (110 VAC/60 Hz, 230 should be at levels characteristic 30 A/m 30 A/m VAC/50 Hz) Magnetic of a typical location in a typical Field IEC 61000-4-8 commercial or hospital environment. Eversense E3 CGM User Guide...
Page 224 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Eversense E3 CGM System is used exceeds the applicable RF compliance level above, the Eversense E3 CGM System should be observed to verify normal operation.
Page 225 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Eversense E3 CGM Mobile 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 226 Symbols on the Eversense CGM Mobile 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 227 Symbols on the Eversense CGM Mobile App (continued) Symbol Explanation Calibration in Progress Appears on the glucose trend line and the Event Log during the ~15 minutes while a calibration is in progress. The icon will turn either red, black or blue when calibration is no longer in progress.
Page 228 Symbols on the Eversense CGM Mobile App (continued) Symbol Explanation Event Icons Appear on the glucose trend line and in the EVENT LOG after an event is entered. The events that can be entered are: Glucose Insulin Exercise Meals Health Temp Profile Appears when the Temp Profile is active.
Page 229 Not made with natural rubber latex FCC ID is assigned to all devices Storage temperature limits subject to certification Lot number Non-sterile Universal Serial Bus (USB) Magnetic Resonance Imaging (MRI) procedures are contraindicated for the smart transmitter Eversense E3 CGM User Guide...
Page 230 U.S. (Federal) law restricts the sale fields and the radio frequency of the Eversense E3 CGM System to fields. Please refer to the MRI sale by or on the order of a doctor Safety Information section for complete information.
Page 231 Symbols on Packaging and Devices (continued) Symbol Explanation Symbol Explanation Implanting healthcare centre or Recycling information doctor Patient identification (name) Distributor Patient information website Importer Authorised representative in the European Community Single patient multiple use Contains a medicinal substance Eversense E3 CGM User Guide...
Page 232 Eversense E3 Smart Transmitter Limited Warranty 1. Coverage and duration of limited warranty. Senseonics, Incorporated (“Senseonics”) warrants to the original patient end user (“you”) of the Eversense E3 Smart Transmitter (the “Smart Transmitter”) that the Smart Transmitter shall be free from defects in material and workmanship under normal use for a period of one year (365 days) commencing on the date that you first received the Smart Transmitter from your healthcare provider (“Limited Warranty Period”).
Page 233 ANY WAY OUT OF THE SALE, USE, MISUSE OR INABILITY TO USE THE SMART TRANSMITTERS OR ANY SENSEONICS EVERSENSE E3 SYSTEM. THIS LIMITATION SHALL APPLY EVEN IF SENSEONICS OR ITS AGENT HAS BEEN ADVISED OF SUCH DAMAGES AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF THIS LIMITED REMEDY.
Page 234 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. Eversense E3 CGM User Guide...
Page 235 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 licence. Eversense E3 CGM User Guide...
Page 236 Radio Equipment Directive Senseonics, Inc. declares the radio equipment type Eversense E3 Smart Transmitter is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: https://global.eversensediabetes.com/declarationofconformity.
Page 237 Restart Bluetooth Troubleshooting, FAQs Data Management RF, radio frequency Unit of measurement System (DMS) communication USB, cable Discoverable mode Sensor USB, port Do Not Disturb mode Sensor, about Wireless Events Sensor, insertion Eversense DMS and removal Eversense E3 CGM User Guide...
Page 238 Notes Eversense E3 CGM User Guide...
Page 239 Notes Eversense E3 CGM User Guide...
Page 241 Basic UDI/DI: - Eversense E3 Smart Transmitter Kit: 081749102FG3500T8 - Eversense E3 Adhesive Patches Kit: 081749102FG6400TQ - Eversense Charging Cradle: 081749102FG6501TX - Eversense Mobile App iOS: 081749102FG5101T4 - Eversense Mobile App Android: 081749102FG5301TE Call 04-6175390 for Customer Support. Emergo Europe...

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