User Guide A guide for using the Eversense Continuous Glucose Monitoring System Sensor Smart Transmitter LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.
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-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.
Contents Glossary 5 4. Inserting and Linking the Sensor 24 1. Introduction 7 5. Using the Smart Transmitter 26 Help and Support Eversense CGM System Components System Requirements End User License Agreement and Privacy Policy Jailbroken Devices Indications for Use Contraindications What is Included in this Package How to Use this User Guide 7 7 10 10 10 10 11 11 11 2. Benefits and Risks 12 Risks and Side Effects Warnings Precautions 13 13 14 3.
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 9. Alert Descriptions 48 49 50 51 52 53 55 57 58 Alerts and Notifications Alert History Alert Descriptions and Actions 58 59 60 10. Event Log 70 Glucose Meals Insulin Health Exercise 11. Glucose Reports and Sharing Weekly Modal Summary Glucose Pie Chart LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.
Glucose Readings Trend Arrows App Sensor Events Sync 95 96 96 97 98 98 17. Device Performance 99 Clinical Study Performance Overall System Performance Compared to YSI Clarke Error Grid Analysis Consensus (Parkes) Error Grid Analysis Calibration Performance Sensor Life Smart Transmitter Wear Safety 99 99 100 103 105 106 106 107 18.
Glossary Alert An alert warns you that a situation needs your attention and that you should respond/take appropriate action. Electromagnetic Interference A strong field of energy generated by electrical or magnetic devices. Blood Glucose Meter A commercially available device used to measure glucose using a blood sample from a fingerstick.
Mobile Device A handheld device built on a mobile operating system that runs the Eversense App and communicates with the smart transmitter. Smart Transmitter A reusable device worn externally over the inserted sensor that powers the sensor and sends glucose information to the mobile device for display in the Eversense App. mg/dL Milligrams per deciliter, a unit of measure that shows the concentration of a substance in a specific amount of fluid.
1. Introduction 1 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.
Eversense App 1 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.
You can remove the smart transmitter from the upper arm at any time, except during calibration. Remember that no data are collected when the 1 smart transmitter is not communicating with the sensor. When you place the smart transmitter back on the sensor site, it will take 10 minutes for sensor communication to re-start and for glucose readings to appear in the app.
System Requirements 1 • The Eversense CGM System. • A compatible smartphone for Android (version 4.4 or higher) or Apple iPhone® or iPod® or iPad® (iOS version 8.0 or higher) that has Bluetooth Smart (or Bluetooth Low Energy). The Eversense app also works with the Apple Watch®. • For a list of compatible devices, please go to www.eversensediabetes.com. • The Eversense App downloaded to your mobile device from the Apple App Store or on Google Play™.
The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time. 1 The system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices. Contraindications The sensor and smart transmitter are incompatible with magnetic resonance imaging (MRI) procedures.
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 The glucose alerts and notifications will not audibly notify the user when the sound on the 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) • Please review this User Guide with your health care provider. For additional Eversense product questions and troubleshooting issues, 2 contact Customer Support toll free in the US at 844-SENSE4U (844-736-7348). Outside the US, call your local distributor or visit www.eversensediabetes.com to locate your local distributor. • Always calibrate the system using only a fingerstick blood sample.
Precautions (continued) • If the sensor, insertion site or smart transmitter feels warm, remove the smart transmitter immediately and contact your physician for further 2 advice. A warm sensor could mean there is an infection or a sensor malfunction. • DO NOT immerse the smart transmitter in water or use the smart transmitter for any activity where it might be submerged in water. Immersing the smart transmitter in water may result in electrical shock.
3. Getting Started 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. 3 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 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.
Step 1. Download and Install the App The app is designed to work with the smart transmitter to automatically receive and display sensor glucose data. 3 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 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 icon on your mobile device. The END USER LICENSE AGREEMENT will appear. • Review the Agreement and tap Accept to agree to the terms of the License Agreement. 2.
To complete registration check the email address you provided and click the link in the email. 3 5. When you complete registration and log in, a WELCOME screen appears. 6. Choose one of the two options depending on whether you already have your smart transmitter or not: • Tap Done to return to the Eversense LOGIN screen. 4. Enter the email address you registered as (skip to step 7). your username and your password and tap LOG IN. You will see a confirmation screen. Tap OK.
7. With the smart transmitter turned 8. On the PAIR YOUR 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: 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.
10. “Connected” appears next to the 3 11. The DAILY CALIBRATION 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). • Tap Next. 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.
13. Next, the MY GLUCOSE screen appears. The screen will not have any glucose data to display at this time. Once the sensor is inserted by your physician and the 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.
4. Inserting 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. 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. When the smart transmitter and sensor are successfully linked, the LINKED SENSOR screen appears and displays the sensor ID number. 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.
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. Your Eversense Smart Transmitter does the following: 5 • Powers the sensor. • 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 or during showering/bathing or any other water related activity. The smart transmitter is not water resistant. Make sure your smart transmitter has enough battery power at all times. Perform two blood glucose meter calibration tests each day when prompted.
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.
4. Check the connection between the smart 5. Press the adhesive patch firmly on skin 6. Remove the two remaining clear liner tabs transmitter and the sensor. surface over the sensor. labeled “3” by pulling on the tabs. • Tap Menu > Placement Guide. • Refer to the Placement Guide • The smart transmitter should be • Smooth the adhesive onto the skin. when attaching your smart transmitter to ensure there is some connection between the sensor and smart transmitter.
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 the power button 5 2. To turn the smart transmitter OFF, press and hold the power button for about five seconds. for about five seconds. • The smart transmitter will vibrate once.
Smart Transmitter Care and Maintenance • Keep the smart transmitter clean (free of visible dirt) and protected when not in use. Wipe the outside with a cloth between uses to keep clean. • DO NOT spill fluid on the smart transmitter or submerge it in any liquid. • Charge the smart transmitter whenever the battery power is low. • Use only the power supply supplied with your system to charge the smart transmitter battery.
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. Warning: DO NOT use alternative test sites such as your forearm for calibration. To ensure best performance, routine calibration is required using fingerstick readings from a blood glucose meter. 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.
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. – 2nd calibration = 2 to 12 hours after 1st successful calibration. – 3rd calibration = 2 to 12 hours after 2nd successful calibration.
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. Notes • For daily calibrations your CGM System will alert you when it is time to calibrate based on your scheduled calibration times. • You can change your scheduled calibration times to better fit your schedule. Tap Menu > Settings > Daily Calibration. 1.
