User Guide A guide for using the Eversense Continuous Glucose Monitoring System Sensor Smart Transmitter Mobile App LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Eversense Trademark Eversense, Eversense Continuous Glucose Monitoring, Eversense CGM, Eversense Sensor, Eversense Smart Transmitter, Eversense App and the Eversense logo are trademarks of Senseonics, Incorporated. Other brands and their products are trademarks or registered trademarks of their respective holders. LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Contents Glossary 5 1. Introduction 7 Help and Support Eversense CGM System Components System Requirements End User License Agreement and Privacy Policy Jailbroken Devices Indications for Use What is Included in this Package How to Use this User Guide 7 8 11 12 12 12 14 14 2. Benefits and Risks 15 Warnings Risks and Side Effects Cautions 16 16 18 3. Getting Started 20 Charge your Smart Transmitter Step 1. Download and Install the App Step 2.
Profile Picture 8. Customizing your Settings 57 58 Setting Glucose Target Levels Setting Glucose Alert Levels Setting Predictive Alerts Setting Rate of Change Alerts Setting Daily Calibration Times Setting System Information Setting Mealtimes Schedule Setting Sounds Setting Temporary Profile Logging out 60 62 64 66 68 69 70 71 73 76 9. Alert Descriptions 77 Alerts and Notifications Alert History Alert Descriptions and Actions 77 78 79 10.
Removal Steps 118 17. Travel 119 18. Troubleshooting Smart Transmitter Smart Transmitter Battery and Charging Connection with Smart Transmitter Calibration Alerts and Notifications Glucose Readings Trend Arrows App Sensor Events Sync 19. Device Performance Clinical Study Performance Overall System Performance Compared to YSI Clarke Error Grid Analysis Consensus (Parkes) Error Grid Analysis Calibration Performance Sensor Life LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Glossary Alert An alert warns you that a situation needs your attention and that you should respond/take appropriate action. Blood Glucose Meter A commercially available device used to measure glucose using a blood sample from a fingerstick. Bluetooth® A brand name for a wireless networking technology that uses short wave radio frequencies (RF) to connect mobile devices and other wireless electronic devices.
Hyperglycemia An episode of high blood glucose. Hypoglycemia An episode of low blood glucose. Interstitial Fluid (ISF) The fluid between cells in the body. The Eversense CGM measures glucose from an interstitial fluid sample, versus glucose in a blood sample obtained from a fingerstick. Jailbroken Device A device (iPhone or iPod) that has been modified to remove the controls and limits set by the original manufacturer. LED Light Emitting Diode Linked Sensor A sensor that is connected to a smart transmitter.
1 1. Introduction This section reviews how to use this guide and describes your new Eversense CGM System, including its components and intended purpose. Congratulations on having the latest technology to assist you in managing your diabetes. Your Eversense CGM System is intended to continually measure glucose levels for up to 90 days after your sensor is inserted. Glucose information collected by the system is automatically sent to your mobile device.
1 Eversense CGM System Components The system includes 1) a small sensor inserted subcutaneously by a physician, 2) a removable smart transmitter worn over the sensor, and 3) a mobile app to display the glucose readings. Eversense Sensor The sensor is inserted under the skin (upper arm) and measures glucose in interstitial fluid for up to 90 days. These glucose levels are then calculated by the smart transmitter and sent to the app.
1 Eversense App The Eversense App is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data in a variety of ways. It also provides alerts based on the glucose settings you choose. IMPORTANT: In order to use the Eversense CGM System, you must have an understanding of downloading and using mobile apps on your handheld device. Data from the Eversense Smart Transmitter is sent wirelessly via Bluetooth.
1 Eversense System Overview A separate blood glucose monitoring system (not provided by Senseonics) is required for calibrating the CGM System, and to make treatment decisions. When used properly, these components work together to help ensure you get continuous glucose monitoring for up to 90 days. To ensure you receive continuous glucose readings and other information, follow these daily use tips: Wear your smart transmitter all the time except when charging.
1 Some of the features of the Eversense CGM System: • • • • • • • • • • • • • Wireless communication with the sensor, smart transmitter and app. Long-term sensor wear in the upper arm for up to 90 days. Alerts when pre-set Low or High Glucose Alert levels (hypoglycemia or hyperglycemia) are reached. Predictive Alerts let you know before reaching pre-set Low or High Glucose Alert levels. Use of mobile device (e.g., smartphone) to display glucose readings.
1 End User License Agreement and Privacy Policy Use of the Eversense App is subject to the terms and conditions of the most current Eversense App End User License Agreement and Eversense App Privacy Policy. These documents are updated from time to time and are posted at www.eversensediabetes.com. Jailbroken Devices DO NOT use the Eversense apps on jailbroken iPhones or iPods.
1 Contraindications The sensor and smart transmitter are incompatible with magnetic resonance imaging (MRI) procedures. Patients should not undergo an MRI procedure while the sensor is inserted or when wearing the smart transmitter. Should an MRI be required the sensor must be removed before the procedure. • The system is contraindicated in people for whom dexamethasone or dexamethasone acetate may be contraindicated.
1 What is Included in this Package This Eversense Smart Transmitter Pack contains the following: Eversense Smart Transmitter Charging Cradle Power Supply (USB cable and AC power adapter) Also included in this package is this User Guide and a Quick Reference Guide (not shown). How to Use this User Guide This guide describes how to use your CGM System. Read the entire guide before using the system. • Any warnings or cautions are highlighted in a box. • User tips are preceded by the symbol.
2. Benefits and Risks 2 This section describes the benefits, expectations and risks associated with using the Eversense CGM System. Continuous glucose monitoring aids in the management of diabetes and glucose control, which can improve your quality of life. Best results are achieved when you are fully informed about the risks and benefits, insertion procedure, follow-up requirements, and self-care responsibilities. You should not have the sensor inserted if you cannot properly operate the CGM System.
Risks and Side Effects 2 The glucose alerts and notifications will not audibly notify the user when the sound on your mobile device is turned off. If the system cannot display a glucose value, it also cannot provide glucose alerts. If you are unable to feel the vibration of the smart transmitter you may not notice the alerts. The system’s calculated glucose can be slightly different from your blood glucose meter.
Warnings (continued) 2 • High doses of aspirin (over 2000 mg), such as for chronic treatment of inflammatory conditions (e.g., rheumatoid arthritis), may falsely lower Sensor glucose readings. • Until it has healed, always cover the insertion site with a sterile bandage before placing the smart transmitter adhesive over the sensor. Failure to do so could result in infection at the insertion site. • Please review this User Guide with your health care provider.
Cautions 2 • DO NOT exchange smart transmitters with another person. Each smart transmitter can be linked to only one sensor at a time. • The following medical therapies or procedures may cause permanent damage to the sensor particularly if used in close proximity to the device: – Lithotripsy – The use of lithotripsy is not recommended for people who have an inserted sensor because the effects are unknown. – Diathermy – DO NOT use diathermy on people who have an inserted sensor.
Cautions (continued) 2 • 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. • Use only the AC power adapter and USB cable provided with the smart transmitter when charging the smart transmitter battery.
3. Getting Started 3 This section describes the initial start-up steps required before you can begin using your new Eversense CGM System on a daily basis. You may perform these steps before your physician inserts the sensor. To get started you need: • • • Your mobile device to download the Eversense App. Wireless internet connection. This Eversense Smart Transmitter Pack that includes your smart transmitter and power supply.
Charge your Smart Transmitter 3 It is important to charge the smart transmitter battery daily to ensure data is collected from the sensor and sent to the app. The smart transmitter does not collect information from the sensor or send it to the app while charging. You may also charge your smart transmitter by connecting the USB cable to a computer USB port instead of the AC power adapter. Using a computer may take longer to fully charge the smart transmitter battery.
3. Line up the four gold pins on the bottom of the 4. Plug the adapter into an AC power outlet. smart transmitter with the four gold pins on the charging cradle. 3 • Slide the smart transmitter into place in the charging cradle. • Once positioned, push down on the smart LED Indicator (lights green or orange) transmitter until it snaps into place. 22 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Step 1. Download and Install the App 3 The app is designed to work with the smart transmitter to automatically receive and display sensor glucose data. 1. Select the mobile device you would like to use to display your glucose readings. In most cases, this would be a smartphone. 2. Download the free Eversense App from the Apple App Store or on Google Play. The prompts to install the app will vary between iOS and Android operating systems. 3.
Step 2. Set up the App – Account Creation, Pairing and Settings 3 Once the app is downloaded, connect the app and smart transmitter by pairing the smart transmitter with your mobile device. 1. Launch the app by tapping the Eversense App 2. After you accept the Agreement, you will be icon on your mobile device. The END USER LICENSE AGREEMENT will appear. prompted to create and register an account with an Email and Password.
3. Enter your account information and then tap Register. To complete registration check the email address you provided and click the link in the email. • Tap Done to return to the Eversense 3 LOGIN screen. 4. Enter your email address and password and tap LOG IN. You will see a confirmation screen. Tap OK. Note: The password is case sensitive. Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
5. When you complete registration and log in, a WELCOME screen appears. 3 6. Choose one of the two options depending on whether you already have your smart transmitter or not: (skip to step 7). 7. With the smart transmitter turned on, and when the PAIR YOUR TRANSMITTER screen appears on your mobile device, set your smart transmitter to “Discoverable” mode for the mobile device to find the smart transmitter: • Press the smart transmitter (skip to step 12). power button three times.
8. On the PAIR YOUR 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. TRANSMITTER screen, the smart transmitter ID detected by the app is listed as “Not Connected”. (Your smart transmitter ID matches the serial number found on the back of the smart transmitter.) Tap Not Connected to begin pairing process. 9. A BLUETOOTH PAIRING REQUEST pop-up screen appears.
10. “Connected” appears next to the smart transmitter ID once the pairing is complete. The smart transmitter will provide intermittent vibrations until the smart transmitter is linked with the inserted sensor (see Inserting and Linking the Sensor). 3 • 11. The DAILY CALIBRATION screen appears for you to set your morning and evening reminder times for your twice-a-day calibrations. You will automatically receive a notification when it is time to make a calibration entry.
12. The UNIT OF MEASUREMENT screen appears and indicates the standard unit of measurement for your region. Your glucose readings will always be displayed in this unit of measurement. 13. Next, the MY GLUCOSE screen appears. The screen will not have any glucose data to display at this time. 3 Note: Once the sensor is linked to the smart Note: DO NOT change the unit of measurement unless you have discussed it with your physician. When the unit of measurement is confirmed, tap Finish.
4. I nserting and Linking the Sensor This section describes how to link the sensor and smart transmitter after your physician has inserted the sensor. Only your physician can insert the sensor. See “About the Sensor” to learn more. 4 If the smart transmitter was sent directly to you, be sure to bring it and your mobile device to your insertion appointment. Once your physician has inserted your sensor, the smart transmitter and the sensor must be linked in order to start the Warm-Up Phase.
3. To link the smart transmitter and sensor, tap Link Sensor on either the New Sensor Detected pop-up screen or by tapping Menu > Settings > System> Linked Sensor and then tap Link Detected Sensor. Note: It may take up to 5 minutes for the New Sensor Detected notification to be displayed. 4. The linking process will begin. Each step will show a check mark when finished. It may take up to 10 minutes for the process to complete.
Note: The sensor requires a 24-hour Warm-Up Phase to stabilize in your body before glucose values will be collected by the smart transmitter. During the Warm-Up Phase, you do not need to wear the smart transmitter. If you decide to wear the smart transmitter over the sensor during this time, you will receive a message on the app indicating the Warm-Up Phase is in progress. Once the Warm-Up Phase is complete, turn ON the smart transmitter and place it over the sensor with the Eversense adhesive patch.
5. Using the Smart Transmitter This section describes the many features of the smart transmitter and how to get uninterrupted and continuous monitoring of your glucose levels. Your smart transmitter communicates with both the sensor and the app to provide CGM information. 5 Your Eversense Smart Transmitter does the following: • Powers the sensor. Top Back • Calculates and stores up to 90 days of glucose data. • Provides on-body vibe alerts when you have reached the glucose alert levels you set.
Daily Use To receive continuous glucose readings and information, keep the following in mind when using your smart transmitter: Wear your smart transmitter at all times except when charging. The smart transmitter is water-resistant to a depth of 1 meter (3.2 feet) for 30 minutes. Exposing the smart transmitter to conditions beyond this will result in damage and void your warranty. 5 Make sure your smart transmitter has enough battery power at all times.
Secure the Smart Transmitter over Inserted Sensor The smart transmitter must be secured on the skin directly over the sensor with the disposable adhesive patch. Each adhesive patch is designed to be replaced daily and has an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin. Both the skin and smart transmitter surfaces should be clean and dry to secure the adhesive surfaces of the patch.
3. Remove the larger clear backing and position the transmitter and the sensor. • For the optimal signal strength, the smart • Tap Menu > Placement Guide. • Refer to the Placement Guide when transmitter must be placed directly over the sensor. Signal strength can also be improved by rotating the smart transmitter over the sensor such that the sensor aligns with the smart transmitter. 5 36 4. Check the connection between the smart smart transmitter directly over the sensor.
5. Press the adhesive patch firmly on skin surface over the sensor. • The smart transmitter should be positioned so 6. Use the tab to pull off the remaining clear liner. • Smooth the adhesive onto the skin. Make sure the patch is flat on the skin surface. that the patch wings lay horizontally on the arm. 5 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Turn the Smart Transmitter ON and OFF The smart transmitter has a power button to turn the device on and off. The power button and two light emitting diodes (LED) lights are also used to indicate the remaining battery power. 1. To turn the smart transmitter ON, press and hold 5 2. To turn the smart transmitter OFF, press and hold the power button for about five seconds. the power button for about five seconds. • The smart transmitter will vibrate once.
Smart Transmitter Care and Maintenance • Keep the smart transmitter and charging cradle clean (free of visible dirt) and protected when not in use. Wipe the outside with a cloth between uses to keep clean. • Charge the smart transmitter when the battery power is low. • Use only the power supply supplied with your system to charge the smart transmitter battery. Using a power 5 supply other than one provided by Senseonics may void your smart transmitter warranty.
LED Status Indicators The smart transmitter communicates several different states based upon the color of the LED.
6. Calibrating the System This section describes the calibration procedure and schedule of your Eversense CGM System. To ensure best performance, routine calibration is required using fingerstick readings from a blood glucose meter. DO NOT use alternative test sites such as your forearm when entering BG values for calibration. Any commercially available meter may be used for calibration. Once your sensor has been inserted and linked to your smart transmitter, the system begins a 24-hour Warm-Up Phase.
Routine calibration is critically important to ensuring the best performance of the Eversense CGM System. The following tips can help you improve your calibration measurements: Tips for ensuring good calibration: Calibrate at times when glucose is NOT changing rapidly (e.g., before meals, before dosing insulin). Calibrate when you know you will not be removing the smart transmitter during the next 15 minutes.
Calibration Phases A. Initialization Phase (after 24-hour Warm-Up Phase) During this phase, 4 fingerstick blood glucose meter tests are required. • The 4 calibration tests must be spaced 2 to 12 hours apart, and all 4 tests must be completed within a 36 hour period. – 1st calibration = 24 hours after sensor insertion. 6 – 2nd calibration = 2 to 12 hours after 1st successful calibration. – 3rd calibration = 2 to 12 hours after 2nd successful calibration.
B. Daily Calibration Phase The Daily Calibration Phase requires 2 blood glucose meter tests at the scheduled morning and evening calibration times. The first Daily Calibration Phase will begin after successful completion of the Initialization Phase. • Y our system will automatically tell you when it is time to perform the twice-daily calibration test. • Daily Calibration times must be spaced 10 to 14 hours apart.
How To Calibrate Warning: 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. Note: • For daily calibrations your CGM System will alert you when it is time to calibrate based on your scheduled 6 calibration times. • You can change your scheduled calibration times to better fit your schedule. Tap Menu > Settings > Daily Calibration.
1. When it is time for calibration, the app displays the CALIBRATE NOW screen. 2. Obtain a fingerstick reading from your blood glucose meter. • Tap Calibrate. • The CALIBRATE screen appears. • Tap Not Now if you want to wait until later. 6 46 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
3. Tap Time and enter the time of day when the fingerstick 4. Tap Glucose and enter the value from blood glucose test was taken. your fingerstick blood glucose test. • Tap Done. • Tap Done. 6 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
5. The CALIBRATE screen now shows the time 6. A CONFIRM CALIBRATION screen appears. and glucose reading you entered. If not correct, repeat steps 3 and 4. Make sure that the fingerstick blood glucose test result you entered is correct. • When correct, tap Submit. • Tap Cancel to go back and re-enter the correct time or glucose test result. • When correct, tap Submit. 6 48 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
7. The CALIBRATION ACCEPTED screen appears. • Tap OK. 8. The MY GLUCOSE screen appears with a red blood drop icon to identify your fingerstick calibration. 6 Note: There may be conditions when your calibration result is NOT accepted. See Calibrating the System for more information. IMPORTANT: The smart transmitter should not be removed from over the sensor for at least 5 minutes before the test to 15 minutes after the test while calibration is in progress.
7. Using the App This section describes the Eversense 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. 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.
Get To Know the “My Glucose” Screen The MY GLUCOSE screen is the main display screen for the app. It displays a variety of data, including sensor glucose readings, direction and rate of change arrow, trend graph, events, calibrations, alerts and notifications.
Note: • If your sensor is not linked to a smart transmitter the smart transmitter connection to sensor icon will appear as a red blood drop with a red X. • You can view a snapshot of the Home screen on your iOS device if you add the Eversense App widget to your widget page. For information on managing widgets, consult your iOS device user guide.
Multiple events mark Indicates multiple events have occurred at the same time. Event mark Indicates manually entered events (e.g., exercise). See Logging Events for more information. Calibration mark Indicates a blood glucose calibration entry. Glucose trend graph Glucose levels over time. You can scroll back and forth to see trends or zoom in to display as few as 3 hours of data, or zoom out to see up to 3 days.
Trend Arrows There are 5 different trend arrows that show the current direction of your glucose levels, and how fast they are changing. Gradually rising or falling glucose levels, falling or rising at a rate between 0.00 mmol/L and 0.06 mmol/L per minute. Moderately rising glucose level, rising at a rate between 0.06 mmol/L and 0.11 mmol/L per minute. 7 Moderately falling glucose levels, falling at a rate between 0.06 mmol/L and 0.11 mmol/L per minute.
Trend Graph The trend graph is used to review and analyze historical data and trends in your glucose values over time. It also displays marks for events you have manually logged in the app (e.g., calibration tests and exercise). There are several ways you can use the trend graph: • Quickly review how well you are doing when compared to the glucose targets and alert levels you set.
Menu Options The Menu icon ( ) appears at the top left corner of all app screens and provides easy navigation to other app features. The following menu items are available: Menu Options Description 7 My Glucose Main app screen that displays current CGM reading, direction and rate of change, trend graph, events and alerts. Calibrate Enter calibration test values.
Profile Picture You can add or change the profile picture in your Eversense account, which will be displayed in your Eversense CGM mobile app and in your Eversense DMS account. • Go to the Main Menu and tap on the picture of the silhouette. • Follow the prompt to either take a new photo or choose an existing photo that is saved on your device. 7 • 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.
8. Customizing your Settings This section describes how to customize settings in your Eversense CGM System. Areas where you can customize app settings include: • Glucose – glucose levels and change rates that will trigger an alert. • Daily Calibration – your morning and evening calibration reminders. • System – identifies or lets you enter personalized information about your system. • Mealtimes – your times for each meal so that glucose reports can help show how meals may affect readings.
Warning: • Before making a dosing decision, perform a fingerstick blood glucose test to confirm the sensor glucose result. • The Low and High Glucose Alerts are designed to assist you in managing your diabetes and should not be exclusively used to detect hypoglycemia or hyperglycemia. The alerts should always be used in conjunction with other indications of glycemic state such as your glucose level, trend, line graph etc.
Setting Glucose Target Levels Glucose Targets are the low and high levels of the range you are aiming for throughout the day. These settings are used in the app to indicate when glucose values are in your target range. Default setting Low: 4.4 mmol/L High: 7.8 mmol/L You can change this target range based on what you and your physician agree are the right target levels for you. 8 60 Allowable setting Low: 3.6 - 6.7 mmol/L High: 6.7 - 19.
1. Tap Menu > Settings > Glucose to display the GLUCOSE SETTINGS screen. 2. Under Glucose Target Levels, tap High Target and select the appropriate High Glucose Target level. • Tap Done when complete. • Repeat step to make your Low Target selection. 8 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Setting Glucose Alert Levels Your Eversense CGM System will alert you when your glucose levels are outside the alert settings you choose. When you have reached your low and high glucose alert levels, the smart transmitter vibrates, and the mobile app gives an audible alert as well as displays a message on the screen. You should immediately perform a fingerstick blood glucose test before making a treatment decision. Default setting Low: 3.9 mmol/L High: 11.
1. Tap Menu > Settings > Glucose to display the GLUCOSE SETTINGS screen. 2. Under Glucose Alert Levels, tap High Alert and select the appropriate High Glucose Alert level. • Tap Done when complete. • Repeat step to make your Low Alert selection. 8 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Setting Predictive Alerts Predictive Alerts let you know in advance that a high or low glucose event is likely to occur if current trends continue. Predictive Alerts use the Low and High Glucose Alert levels to provide an “early” warning. When you have reached the early warning time, the smart transmitter vibrates, and the mobile app gives an audible alert as well as displays a message on the screen. You should immediately perform a fingerstick blood glucose test before making a treatment decision.
1. To turn this feature ON, tap Menu > Settings > Glucose to display the GLUCOSE SETTINGS screen. 2. Next to Predictive Alerts, slide the OFF button right to ON. 3. Tap Minutes to select the amount of advance warning • Tap Done when complete. 8 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Setting Rate of Change Alerts The Rate of Change Alerts let you know when your glucose level is falling or rising faster than the Rate Alert setting you choose. 8 66 Default setting OFF Allowable setting 0.08 - 0.28 mmol/L per minute. On/Off setting You can turn this feature ON. 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.
1. To turn this feature ON, tap Menu > Settings > Glucose to display the GLUCOSE SETTINGS screen. 2. Next to Rate Alerts, slide the OFF button right to ON. 3. Tap Rate of Change to select the rate. • Tap Done when complete. 8 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Setting Daily Calibration Times The morning and evening calibration times are set to remind you when to calibrate. You can calibrate up to 2 hours before your scheduled calibration time. Your morning and evening calibration times must be between 10 and 14 hours apart. 1. Tap Menu > Settings > Daily Calibration. 2. Tap Morning to set your morning calibration time. 4. When both times are correct, tap Save. • Tap Done when complete. 3. Tap Evening to set your 8 evening calibration time.
Setting System Information The SYSTEM screen lets you view and edit other settings in your Eversense CGM System. 1. Tap Menu > Settings > System to display the SYSTEMS screen. 2. On the SYSTEMS screen, you can tap each of the following to set: • Glucose Units. The unit of measurement for your glucose readings. The app must be reinstalled to edit this setting. • Name. The serial number of your smart transmitter.
Setting Mealtimes Schedule The MEAL TIMES screen displays the time slots for your Breakfast, Lunch, Snack, Dinner and Sleep times. The time intervals set in the MEAL TIMES screen are used on the Reports graph view to indicate the high, low and average CGM values during each mealtime interval. 1. Tap Menu > Settings > Meal Times to display the MEAL TIMES screen. 2. Tap each meal time listed, then tap Start and End to set a beginning and end mealtime.
Setting Sounds The SOUND SETTINGS screen displays the alert sound settings for Low Glucose and High Glucose. This screen also allows you to enter a snooze setting for the alerts listed. 1. Tap Menu > Settings > Sound Settings to display the SOUND SETTINGS screen. 2. Tap each alert to select the alert sound. Tap Back to get back to the SOUND SETTINGS screen. 8 IMPORTANT: Be sure the sound on your mobile device is turned on.
By setting the snooze alert, you can set how often an alert repeats after you have received a Low Glucose and High Glucose alert. 3. Tap each snooze alert to set how often the alert repeats. Tap Done when complete. The SOUND SETTINGS screen also allows you to enable and disable the Do Not Disturb mode. • o Not Disturb. Places the smart transmitter in a D “Do Not Disturb” mode.
Setting Temporary Profile During activities or conditions outside your normal routine, you may wish to temporarily use glucose settings that are different from the standard glucose settings you have entered. The TEMP PROFILE screen allows you to temporarily change glucose target and alert settings for the duration you choose. When the Temp Profile duration is over, the standard glucose settings you entered in Settings > Glucose will automatically resume. 1.
3. Set the High and Low Targets and High and Low Alert levels desired. Tap START. The Temp Profile selections cannot be changed when the duration has been started. While a Temp Profile is active, the Temp Profile icon will be displayed on the MY GLUCOSE screen. Temp Profile icon 8 74 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
When the Temp Profile duration is finished, the app displays a notice and the Temp Profile icon is no longer displayed on the MY GLUCOSE screen. To end the Temp Profile earlier than the time you set, go to Settings > Temp Profile and tap STOP. 8 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Logging out To log out of your Eversense account, tap Settings > Log Out. 8 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 for the first time. 76 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
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. The smart transmitter provides on-body vibe alerts when an alert level has been reached. The mobile device app sounds an alert and displays messages on the MY GLUCOSE screen.
Alert History The ALERT HISTORY screen lists alerts and notifications you have received. The following icons are used to indicate the severity level of messages. Alerts 1. T ap Menu > Alert History. • The ALERT HISTORY screen will list ALL alerts and notifications for that day. • Tap on any message to get more information. Notifications More than 1 Alert in Same Period 9 2. You can choose to include only certain messages (alerts and notifications, etc.) for review by tapping selected alert icons.
Alert Descriptions and Actions The following table lists the alerts and notifications you may receive on the Eversense App. Note: For each message, you can also tap the information icon to receive additional details about the message. IMPORTANT: On-body vibe alerts for the alerts marked with a * cannot be turned off using DND in the app.
Alert Descriptions and Actions (continued) App Display Alerts Actions Description 9 80 Out of Range Low Glucose* Appears when your glucose reading is lower than 2.2 mmol/L. Out of Range High Glucose* Appears when your glucose value is higher than 22.2 mmol/L. No glucose reading can be displayed (only LO is displayed on the MY GLUCOSE screen). No glucose reading can be displayed (only HI is displayed on the MY GLUCOSE screen).
Alert Descriptions and Actions (continued) App Display Alerts Actions Description 9 Calibration Past Due Appears when your system is past due for calibration. No glucose readings can be displayed until calibration is performed. Perform a fingerstick calibration in order to resume displaying glucose values. Calibration Expired Appears when a calibration has not been performed in 24 hours. The system returns to the Initialization Phase. No glucose reading can be displayed until calibration is performed.
Alert Descriptions and Actions (continued) App Display Alerts Actions Description 9 82 Battery Empty* Appears once when your smart transmitter battery is empty and needs to be charged. Sensor Replacement (7 days) Appears when your sensor will stop collecting glucose data in 7 days. No glucose reading can be displayed until the smart transmitter is charged. Charge the smart transmitter immediately. Remove the smart transmitter from your body before connecting it to the power supply.
Alert Descriptions and Actions (continued) App Display Alerts Actions Description 9 Sensor Replacement* Appears once when your sensor needs to be replaced. No glucose reading can be displayed until the sensor is replaced. High Ambient Light Appears every 20 minutes when your smart transmitter is receiving too much ambient light, affecting its ability to communicate with the sensor. No glucose reading can be displayed until ambient light is reduced. Contact your physician to have your sensor replaced.
Alert Descriptions and Actions (continued) App Display Alerts Actions Description 9 84 High Smart Transmitter Temperature* Appears every 20 minutes when your smart transmitter temperature is too high. No glucose reading is displayed until the smart transmitter temperature is within normal operating conditions. Reduce the smart transmitter temperature by moving to a cooler environment. Once the smart transmitter temperature is below 42 °C (108 °F), it will resume displaying glucose values.
Alert Descriptions and Actions (continued) App Display Alerts Actions Description 9 Low Sensor Temperature* Appears every 20 minutes when the sensor temperature is too low. No glucose reading is displayed until the sensor temperature is within normal operating conditions. Go to a warmer environment to increase the sensor temperature. Keep your smart transmitter turned on so you will start receiving glucose values when the sensor temperature is between 26 - 40 °C (81 - 104 °F).
Alert Descriptions and Actions (continued) App Display Alerts Actions Description 9 86 Smart Transmitter Error* Appears when the system’s internal checks detect a smart transmitter error. No glucose reading is displayed until the error is corrected. Follow the steps shown in the Troubleshooting section to reset your smart transmitter. If you are unable to complete the reset, contact Customer Support.
Alert Descriptions and Actions (continued) App Display Alerts Actions Description 9 Predicted Low Glucose Appears every 60 minutes when your glucose values are trending low and will reach your Low Glucose Alert level within the time you entered in Settings. Predicted High Glucose Appears every 60 minutes when your glucose values are trending high and will reach your High Glucose Alert level within the time you entered in Settings. Pay close attention to your glucose values, symptoms, and trends.
Alert Descriptions and Actions (continued) App Display Alerts Actions Description 9 88 Rate Falling Appears every 60 minutes when your glucose values are falling at a rate equal to or faster than the rate of change you entered in Settings. Rate Rising Appears every 60 minutes when your glucose value is rising at a rate equal to or faster than the rate of change you entered in Settings. Pay close attention to your glucose values, symptoms, and trends.
Alert Descriptions and Actions (continued) App Display Alerts Actions Description 9 Charge Smart Transmitter Appears when smart transmitter battery power is very low and you need to charge your battery very soon. Sensor Suspend Appears when the system’s internal checks detect a need to restart the Initialization Phase for additional calibrations. Glucose values will be displayed a few minutes after the second successful calibration during the Initialization Phase.
Alert Descriptions and Actions (continued) App Display Alerts Actions Description 9 90 Calibration Under Review Appears when your calibration value is significantly different from your sensor glucose value. Incompatible Firmware Version Appears when the firmware in your smart transmitter is incompatible with the Eversense mobile app version on your mobile device. Re-calibrate when prompted. Contact Customer Support. Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Alert Descriptions and Actions (continued) Actions Description App Display Alerts 9 Upgrade Eversense App Appears when a newer version of the Eversense App is available to download. Incompatible Device/Operating System Appears when an incompatible device/operating system is being used with the app. Tap Yes to install the update. For a list of compatible devices/operating systems visit eversensediabetes.com. Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Alert Descriptions and Actions (continued) App Display Notifications Actions Description 9 92 Calibrate Now Appears when it is time for you to calibrate. New Sensor Detected Appears when the smart transmitter detects a new sensor. The inserted sensor and the smart transmitter must be linked to begin communication. Do a fingerstick blood glucose test and enter the reading as your calibration value. DO NOT use an alternative site (such as forearm) to obtain your blood glucose reading.
Alert Descriptions and Actions (continued) App Display Notifications Actions Description 9 Sensor Replacement Appears 30, 14, 7, 3, 2, and 1 day before your sensor has completed its 90-day wear period as a reminder to replace your sensor. Contact your physician to schedule the removal and replacement of your sensor. Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
10. Event Log This section describes how to review and log events to help better track glucose patterns. The Eversense 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. Types of Events: 10 Glucose Meals Insulin View Events You can view past events entered from the EVENT LOG screen. 1. T ap Menu > Event Log.
Log Specific Events Glucose Enter and track blood glucose meter tests (test results other than calibrations). 1. Tap Menu > Event Log. 2. Add an event using the event icon “+” > Glucose. 3. Tap Time to enter the correct date and time. Tap Done. 4. T ap Glucose to enter the correct blood glucose 10 value. Tap Done. Note: You can enter a BG value between 1.1 and 33.3 mmol/L. Entries < 1.1 mmol/L will be converted to 1.1, and entries above 33.3 mmol/L will be converted to 33.
Meals Enter the type of meal, date and time and carbohydrate count. 1. Tap Menu > Event Log. 2. Add an event using the event icon “+” > Meals. 3. Tap Time to enter the correct date and time. Tap Done. 4. T ap Type to enter the type of meal. 10 Tap Done. 5. Tap Carbs to enter correct number of carbohydrates. Tap Done. 6. Tap Notes to enter any notes. Tap Done. 7. Tap Save to save entry and return to EVENT LOG screen. Tap Cancel to exit without saving changes.
Insulin Enter the units of insulin according to Time and Insulin type. 1. Tap Menu > Event Log. 2. Add an event using the event icon “+” > Insulin. 3. Tap Time to enter the correct date and time. Tap Done. 4. T ap Units to enter the correct number of Units. 10 Tap Done. Note: The maximum insulin units that can be entered is 200U. 5. T ap Type to enter the correct Type of Insulin. Tap Done. 6. Tap Notes to enter any notes. Tap Done. 7. Tap Save to save entry and return to EVENT LOG screen.
Health Enter the type of health condition, severity, and date and time. 1. Tap Menu > Event Log. 2. Add an event using the event icon “+” > Health. 3. Tap Time to enter the correct date and time. Tap Done. 4. T ap Severity to enter Low, Medium or High. 10 Tap Done. 5. Tap Condition to enter the health condition. Tap Done. 6. Tap Notes to enter any notes. Tap Done. 7. Tap Save to save entry and return to EVENT LOG screen. Tap Cancel to exit without saving changes.
Exercise Enter exercise type, duration, and intensity. 1. Tap Menu > Event Log. 2. Add an event using the event icon “+” > Exercise. 3. Tap Time to enter the correct date and time. Tap Done. 4. T ap Intensity to enter Low, Medium or High. 10 Tap Done. 5. Tap Duration to enter the duration. Tap Done. 6. Tap Notes to enter any notes. Tap Done. 7. Tap Save to save entry and return to EVENT LOG screen. Tap Cancel to exit without saving changes.
11. Reports This section describes the different glucose reports available for a summary of your glucose profile. You may choose specific dates or select pre-selected time ranges. Types of reports • Weekly Modal Summary. • Glucose Pie Chart. • Glucose Statistics. Note: Be sure to set the mobile device date and time correctly. The accuracy of the graphs and reports depends upon the date and time being correct.
Weekly Modal Summary This report shows your last seven days of glucose readings summarized in a 24-hour line graph format to help find patterns during the day. • The blue line is the average of the last seven days of your readings in an hour time block. • The red bars show the highest and lowest actual readings in the same hour time block. • The red horizontal dotted lines are your pre-set High and Low Glucose Alert levels.
Glucose Pie Chart Glucose Statistics 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. This report shows your average, low and high glucose readings, along with standard deviation within a mealtime slot period. You can choose the last 1, 7, 14, 30 or 90 days. 11 102 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
12. Share My Data Eversense Data Management Software (DMS) Program The Eversense DMS Program is a web-based application that enables patients, caregivers, and health care professionals to view and analyze glucose data that has been transmitted from the Eversense Smart Transmitter or the Eversense CGM System mobile app. This program is offered at no cost to users of the Eversense CGM System. To learn about the Eversense DMS Program, go to www.eversensediabetes.com.
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. 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.
My Circle My Circle is an optional feature that allows you to activate remote monitoring of your Eversense CGM data. For more information on this feature, see My Circle - Remote Monitoring. My Reports You may also choose to export your glucose readings in a CSV-file format. Tap Menu > Share My Data > My Reports • Select the number of days of your glucose readings you want to export then tap Done. • Tap Export. • Email the CSV-file format by tapping the email icon on the top right hand corner.
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 mobile app. 1. Tap Menu > About and then tap My Transmitter, My Sensor or Product Information. On the MY TRANSMITTER screen, you can find information that includes the serial number, calibration information and battery level.
On the PRODUCT INFORMATION screen, you can view information about the mobile app software version and Senseonics, Inc., the manufacturer of the Eversense CGM System. You can also send feedback or view the End User License Agreement and Privacy Policy from the About menu. To read the End User License Agreement and the Privacy Policy, tap either option. • Tap Contact Us to send an email to Senseonics, Inc. 13 IMPORTANT: This email is not monitored 24/7.
14. Viewing Eversense Data on the Apple Watch You can view a snapshot of your Eversense CGM data on your Apple Watch. Once you’ve downloaded and installed the Eversense mobile app on your mobile device, follow the Apple Watch instructions for adding the app to your watch.
The My Glucose screen shows your current glucose with trend arrow, and a trend graph of your last three hours of CGM data. Swipe left to the next screen showing a pie chart of your total time within and outside your target range for the past 24 hours. Swipe left to the next screen showing your current glucose with trend arrow, your next scheduled calibration time, and the current system calibration phase. Swipe up to display the same data shown as percentages.
15. My Circle Remote Monitoring with Eversense CGM System and Eversense Now App The Eversense CGM App includes an optional remote monitoring feature. The Eversense CGM App interacts with the Eversense Now Remote Glucose Monitoring App to allow other people to view your data. Note: The Eversense Now Remote Monitoring App is only available for iOS. If you invite a member to your Circle who does not use an iOS mobile device, they will not be able to use the Eversense Now App to view your glucose data.
Warnings • Glucose information displayed on the Eversense Now App should not be used to make treatment decisions. Always use blood glucose values from your meter to make treatment decisions. Using a sensor glucose value to make a treatment decision could result in a high or low blood glucose. The Eversense Now App is a secondary display of Eversense CGM data and should not be used in place of the primary Eversense CGM display.
Through the MY CIRCLE screen on your Eversense mobile app, you can invite up to five people to view your data. When you invite someone to join your Circle, an invitation will be sent to the email address you entered. Once the invitation is accepted, and the Eversense Now App is downloaded, members of your Circle can view your recent glucose data, events and alerts. IMPORTANT: Members of your Circle who do not have the Eversense Now App will not be able to see your data.
3. Enter the email for the person you 4. An Invitation Sent screen appears. Tap OK. would like to invite to your Circle, and tap Send when complete. Note: You can tap the “+” next to the email field to select an email address from your Contact list. When the invitation has been accepted, the member’s name will appear in your Members List on the MY CIRCLE screen in your app. 15 Tip: Nicknames are optional, and are used to help you easily manage your Circle Members.
Remove a Member from Your Circle 1. To remove a member or an invitation, tap the person’s name in the Members List or the Invitations Sent List on the MY CIRCLE screen. 2. T ap Remove to remove the member from your circle. Tap Yes when prompted. 15 The member you remove will be notified on their Eversense Now App if they have already accepted. 114 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Temporarily Stop Sharing Data There may be times when you wish to temporarily stop sharing data with a member, but not remove them from your Circle. 1. Tap the member’s name in the My Circle list to open the MEMBER screen. 2. Tap the Share My Data button to turn on/off data share with this member. 15 IMPORTANT: If you have disabled the Share My Data feature for a member, that member will not see any of your Eversense CGM System glucose data, alerts or event history.
16. About the Sensor This section describes the Eversense Sensor and how it is inserted by your physician. The Eversense Sensor is a miniaturized 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. The sensor remains in place and provides CGM measurements for up to 90 days.
Insertion Steps Your physician will explain and perform the simple and quick steps to insert the sensor. You will be fully awake during the approximately 5-minute insertion procedure. Insertion site: It is important to choose a site that is comfortable for you to wear the sensor and smart transmitter for the entire 90 day period. It is recommended to have the sensor inserted toward the back of the upper arm.
Removal Steps Similarly to the insertion steps, your physician will explain the simple and quick steps for the sensor removal and you will be fully awake during the 5-minute (approximate) removal process. Step 1: Site preparation – the sensor site will be cleaned, disinfected, then anesthetized using lidocaine. Step 2: Incision – a small (less than 1 centimeter) incision will be made at the sensor site. Step 3: Sensor removal – the sensor will be removed and discarded.
17. Travel This section describes the safety issues when traveling with your Eversense smart transmitter and sensor. When traveling, your smart transmitter and sensor are safe to go through airport security without removing them. You may inform security that you have an implanted medical device. Your smart transmitter will automatically sync to your smartphone’s current time and date when time zones are changed. The Eversense CGM System is safe for use on U.S. commercial airlines.
18. Troubleshooting This section lists information about troubleshooting your Eversense CGM System and includes a list of frequently asked questions (FAQs). Smart Transmitter Q: How do I turn my smart transmitter OFF? A: Press and hold the smart transmitter power button for 5 seconds. Release the button when the smart transmitter begins to vibrate. Q: How do I turn my smart transmitter ON? A: Press and hold the smart transmitter power button for 5 seconds.
Q: Can I use the same adhesive patch more than once a day? Q: Why does my smart transmitter show a continuous solid orange LED? A: The individual adhesive patch is intended to be used for a 24-hour period. A: Follow the steps below to troubleshoot the smart transmitter: Q: What is the serial number and model number of my smart transmitter? A: You can find the serial number and model on the back of your smart transmitter.
Smart Transmitter Battery and Charging Q: How do I check the smart transmitter battery status? Q: How long does a fully charged smart transmitter battery last? A: There are three ways to check battery status: A: A fully charged smart transmitter battery typically lasts about a day and half. Q: How long does it take to charge a smart transmitter? A: It takes approximately 15 minutes to fully charge a smart transmitter when plugged into a wall outlet.
Connection with Smart Transmitter Q: My smart transmitter and mobile device do not appear to be connected. Q: How do I pair my mobile device and smart transmitter for the first time? A: There may be several reasons why you do not have a connection. A: Follow the steps below to pair your mobile device and smart transmitter. Please read this User Guide for more detailed information. • Make sure the Bluetooth setting on your mobile 1. Launch the Eversense App. 2.
3. Press the power button 3 times again to place the smart transmitter in discoverable mode and pair with your mobile device. Tap Menu > Connect to see if your smart transmitter is connected. If not connected, tap to select your smart transmitter from the list. If these steps do not resolve the problem, you may need to go to the Bluetooth Settings feature on your mobile device and unpair or forget the smart transmitter and then press the smart transmitter power button 3 times to re-pair.
Q: What happens if my smart transmitter is disconnected from my mobile device or app? Q: Why do I see Searching on the CONNECT screen? A: The smart transmitter will vibrate and the app will provide a “Transmitter Disconnected” notification every 30 minutes until the app is launched or the smart transmitter is reconnected. Once the connection is re-established, the data collected will sync with the mobile app.
Q: My smart transmitter is not listed on the CONNECT screen? A: The smart transmitter will not be listed on the CONNECT screen for any of the following reasons: • The smart transmitter is currently charging via USB. • The smart transmitter is turned OFF. • The smart transmitter battery is completely drained. • Bluetooth on your mobile device is turned OFF. • Smart transmitter pairing to your mobile device has not been established or has been “un-paired”. You must re-establish pairing.
Q: Why am I unable to calibrate? Q: Why was my calibration rejected? A: You may not be able to calibrate for any of the following reasons: A: T he system will reject the calibration for the any of the following reasons: • Not enough sensor glucose data has been • The blood glucose reading entered is less than collected, which may take up to 5 minutes. • Sensor glucose values are changing rapidly, such as after eating or taking insulin. • The blood glucose reading is less than 2.2 mmol/L.
Q: Where can I find details for Calibration Phase, number of calibrations and last calibration date and time? A: You can view calibration details by tapping Menu > About > My Transmitter. Alerts and Notifications Q: Can I change the vibration alert pattern on my smart transmitter? A: Smart transmitter vibe patterns are fixed and cannot be changed. The repeat interval can be changed for some alerts in Settings > Sound Settings.
Q: What is the difference between a notification and alert? Q: Why am I unable to see notifications when the app is in the background? A: A Notification is a non-critical, low priority message (e.g., calibration reminder). A: Refer to your mobile device instructions to enable the notifications in the background. An Alert is an important message that needs your attention and may require you to respond/take action.
Glucose Readings Q. Why is my sensor reading different from my blood glucose meter reading? A: The Eversense CGM System measures glucose in interstitial fluid (ISF) between the body’s cells. Physiologic differences between ISF and blood from a fingerstick may result in differences in glucose measurements. These differences are especially evident during times of rapid change in blood glucose (e.g., after eating, dosing insulin, or exercising).
Trend Arrows App Q: My trend arrows and glucose alerts do not match. Q: What will happen if I re-install the app? A: Trend arrows indicate the rate and direction of change in glucose levels. For example, you may have a trend arrow that points up or down (indicating slow or rapid changes). Glucose alerts notify you when your current glucose level reaches the alert level you set, regardless of the rate or direction of change.
Q: Can I still use the same smart transmitter if I switch to a new mobile device? A: You will need to install the app on your new mobile device and pair it with your smart transmitter. The last 3 days of historical data will be synced to the app on the new mobile device. Q: What is the Do Not Disturb option? A: When Do Not Disturb is enabled in the Eversense App Settings, the smart transmitter will stop providing vibratory notifications for non-critical alerts.
Q: Why do I see a “New Sensor Detected” notification? A: This message appears when your smart transmitter detects a new sensor so you may link the smart transmitter and sensor. The smart transmitter can only be linked to one sensor at a time. If you see a New Sensor Detected message and you already have a sensor inserted and linked to your smart transmitter, tap Not Now. If unsure, contact Customer Support for more information.
Q: Why did my CGM System re-enter Initialization Phase? A: You will re-enter Initialization Phase for any one of the following reasons: • Calibration period has expired without you having entered a fingerstick test value. • 3 or more blood glucose readings are significantly Events Q: How can I sort my events on the EVENT LOG screen? A: T he EVENT LOG screen has a sort filter at the top of the screen. Tap the desired sort filter icon to include and exclude events from the list.
19. Device Performance This section lists Device Performance Characteristics. Clinical Study Performance The performance of the Eversense CGM System was evaluated in a multi-site, non-randomized clinical study. Adult (older than 17 years old) subjects with diabetes were enrolled at 7 different sites in 3 different countries. Each subject had 2 separate sensors inserted, one in each upper arm.
Overall System Performance Compared to YSI The study demonstrated that 83.8% of overall CGM System readings were within ± 20% of YSI values, 93.9% were within ± 30% of YSI values, and 97.5% were within ± 40% of YSI values. The chart below provides a percentage breakdown by glucose range.
Clarke Error Grid Analysis The Clarke Error Grid Analysis (EGA) is one of the standards for quantifying the accuracy of CGM systems. Clarke EGA measures accuracy by comparing subject glucose values taken from their CGM system to reference values taken in a lab. Clarke EGA calculates accuracy by looking at the number and percentage of data points that fell into 5 “clinical risk” zones. Data is presented in both graph and chart formats.
Clarke Error Grid Scatterplot Clarke Error Grid percentages were calculated by glucose range, and at certain “wear duration” points in the study. 22.2 19.4 Eversense CGM (mmol/L) 16.7 13.9 11.1 8.3 5.6 2.8 0 0 2.8 5.6 8.3 11.1 13.9 16.7 19.4 22.2 YSI (mmol/L) 19 138 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Clarke Error Grid Accuracy by Glucose Level Clarke Score YSI Glucose Range (mmol/L) Number of paired CGM-YSI Readings A B C D E ≤ 3.9 422 77.2% 2.4% 0.0% 20.4% 0.0% 3.9 - 10.0 6633 80.6% 19.4% 0.0% 0.0% 0.0% > 10.0 3387 90.4% 9.4% 0.1% 0.1% 0.0% Overall 10442 83.6% 15.4% 0.1% 0.9% 0.0% Overall, 83.6% of CGM readings fell within zone A. This indicates CGM readings were in close agreement with reference values for the great majority of readings.
Consensus (Parkes) Error Grid Analysis The Consensus Error Grid Analysis (CEG) is another standard for quantifying the accuracy of CGM systems. CEG is similar to the Clarke EGA in that it assigns the differences (errors) between the CGM system values and reference values to one of 5 “clinical risk” regions. But the CEG differs from the Clarke EGA in that the risk regions are continuous (A through E), whereas with the Clarke EGA they are not continuous (e.g., A is next to D).
Consensus Error Grid Accuracy by Glucose Level Zone Frequency Percent A 8922 85.4% B 1481 14.2% C 39 0.4% D 0 0.0% E 0 0.0% Total 10442 100.0% Overall, 85.4% of CGM readings fell within zone A. This indicates CGM readings were in close agreement with reference values for the great majority of readings. 19 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Calibration Performance Calibration performance looks at whether accuracy is affected by how much time has elapsed since the last system calibration with a blood glucose value. CGM System Performance by Time Since Last Calibration Time from Calibration Number of paired CGM-YSI Readings Percent within 20% Percent within 30% Percent within 40% 0-4 hrs 6043 83.1% 93.1% 97.0% 4-8 hrs 2479 85.0% 94.5% 97.7% 8-12 hrs 1663 83.6% 95.6% 98.6% Total 10185 83.6% 93.8% 97.
Sensor Life Sensor life measured how many days out of the intended 90-day duration period subjects were able to continue using the sensor to record CGM readings. Overall, the analysis estimated that 87.5% of sensors remained functioning through 90 days. Smart Transmitter Wear Smart transmitter wear measured how many hours of the day subjects wore the smart transmitter. Overall, subjects wore their smart transmitters an average of 22.3 hours per day, with a median of 23.5 hours.
20. Technical Specifications Sensor Characteristic Description Dimensions Length: 18.3 mm Diameter: 3.5 mm Materials Homopolymer polymethylmethacrylate (PMMA), Hydroxyethylmethacrylate (HEMA) based Hydrogel, Platinum, Silicone, Dexamethasone Acetate, epoxy 301-2 Glucose Range 2.2 - 22.2 mmol/L Sensor Life Up to 90 days Calibration Commercially available self-monitoring blood glucose meter Calibration Range 2.2 - 22.
Smart Transmitter Characteristic Description Dimensions Length: 37.6 mm Width: 48.0 mm Thickness: 8.8 mm Materials Body: polycarbonate Weight 11.
Power Supply and Charger Characteristic Description Class II Input AC Input, 100-240Vac, 50/60Hx, 0.3-0.15A DC Output 5V DC, 1A (5.0 watts) Moisture Protection (charging cradle) IP22 USB Cable* for Charging and Downloading Characteristic Description Input/Output 5V DC, 1A Type USB-A to USB micro-B Length 36 inches (91 cm) *If misused, the USB cable can pose a strangulation risk. The USB cable can be connected to the power supply/charger and charged using an AC power outlet.
Electrical and Safety Standards Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The transmitter is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the transmitter should ensure that it is used in such an environment.
Electrical and Safety Standards (continued) The Eversense CGM System is intended to be used in the electromagnetic environment detailed in the table below. Users of the System should ensure it is used according to these specifications.
Electrical and Safety Standards (continued) Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Eversense 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. Emissions Test RF Emissions CISPR 11 RF Emissions CISPR 11 Compliance Electromagnetic Environment Guidance Group 1 The Eversense CGM System uses RF energy only for its internal function.
Symbols on the Eversense 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. Falling Rate Alert Appears when the glucose value is falling beyond a defined rate. Rising Rate Alert Appears when the glucose value is rising beyond a defined rate. Empty Battery Alert Appears when the smart transmitter battery is empty.
Symbols on the Eversense Mobile App (continued) Symbol Explanation Calibration Alert Appears when there are calibration-related alerts. Calibration Notification Appears when there are calibration-related notifications. Calibration Failure Appears when the smart transmitter rejects the user-entered calibration value. Connection Failure Appears when the smart transmitter is disconnected from the smartphone or when the sensor is not linked to the smart transmitter.
Symbols on Packaging and Devices Symbol Explanation Consult accompanying documents Symbol 0086 Caution, consult accompanying documents Explanation Marking certifies that the device meets the European Council Directive 90/385/EEC Part number Use by Serial number Manufacturer Type BF Applied Part Authorized representative in the European Community Non-ionizing electromagnetic radiation Date of manufacture Storage temperature limits Lot number Not made with natural rubber latex # 2AHYA-3401 FCC I
Symbols on Packaging and Devices (continued) Symbol Explanation Magnetic Resonance Imaging (MRI) procedures are contraindicated for this device. European Union WEEE Directive 2012/19/EU Single use only Do not re-sterilize Do not use if package is damaged Sterilized using Ethylene Oxide Follow instructions for use 20 Eversense CGM User Guide LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Eversense 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 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 physician (“Limited Warranty Period”).
3. Senseonics’ obligations under the limited warranty. Your sole and exclusive remedy, and the sole and exclusive obligation of Senseonics under this limited warranty is to repair or replace, at its sole discretion, without charge to you, any defective Smart Transmitter, provided that the defect arises and a valid claim is received by Senseonics within the Limited Warranty Period.
THIS LIMITED WARRANTY SHALL NOT EXTEND TO ANYONE OTHER THAN YOU, THE ORIGINAL END USER OF THIS PRODUCT AND IT STATES 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.
Legal Notices Apple Legal Notice “Made for iPod touch”, “Made for iPhone” and “Made for iPad” mean that an electronic accessory has been designed to connect specifically to iPod touch, iPhone or iPad, respectively, and has been certified by the developer to meet Apple performance standards. Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards.
FCC Information Your smart transmitter complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (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.
Index Adhesive patch 35, 37 Alerts 56, 62, 64, 66, 71, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91 App, about 9, 57 App, download 23 App, Glance View 108 App, launch 24 App, log out 76 App, product information 106, 107 App, using 50 21 Battery, charging Battery power, indicator 39 Bluetooth 57, 157 Bluetooth, restart 123 Button on smart transmitter 27, 33, 38 41, 44 Calibration, Daily Phase Calibration, Initiation Phase 41, 43 Calibration, procedure 41, 45, 56 Calibration, reminders 28, 68 Ch
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Manufactured by Senseonics, Inc. 20451 Seneca Meadows Parkway Germantown, MD 20876-7005 USA 844.SENSE4U 301.515.7260 (844.736.7348) eversensediabetes.com Distributed by: For Placement Only Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands 0086 Authorized 2016 FPO © Senseonics, Inc. 2016 PN: 0302-01-101_Rev 1 11/2016 LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
Date: 11/4/16 File name: LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5 Job description: Eversense User Guide Project Manager: Tom Paradiso Art Director: Ivy Tsang Dimensions: Trim: 6.75” w X 5.8” h Bleed: .125” Folded (Include folded dimensions if applicable): Colors: 4/color Spot (Name PMS colors if applicable): LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.
