eversense CGM Sensor User Manual
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Sensor Smart Transmitter Mobile App
User Guide
A guide for using the Eversense
Continuous Glucose Monitoring System
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.
Contents
Glossary 5
1. Introduction 7
Eversense CGM System Components 8
What is Included in this Package
2. Benefits and Risks 15
3. Getting Started 21
Charge your Smart Transmitter 22
Step 1. Download and Install the App 24
Step 2. Set up the App – Account
Creation, Pairing and Settings 25
4. Inserting and Linking the
Sensor 32
5. Using the
Smart Transmitter 35
Secure the Smart Transmitter over
Turn the Smart Transmitter ON and OFF
Smart Transmitter Care and Maintenance
6. Calibrating the System 43
7. Using the App 51
Check Your Mobile Device Settings 52
Get To Know the “My Glucose” Screen 53
Understanding Treatment Decisions with CGM 57
Making Treatment Decisions with
Eversense Trend Arrows and Treatment Decisions 63
8. Customizing your Settings 72
Transmitter Disconnect Setting
9. Alert Descriptions
89
Alert Descriptions and Actions 93
10. Event Log 109
11. Reports
116
12. Share My Data 119
Eversense Data Management Software
13. Product and General
Information on the App 122
14. Viewing Eversense Data on the Apple Watch
Alerts and Notifications Displayed on the Apple Watch
124
15. My Circle 141
Remote Monitoring with Eversense CGM
System and Eversense NOW App 141
16. About the Sensor
17. Travel
147
150
18. Troubleshooting 151
Smart Transmitter Battery and Charging 153
Connection with Smart Transmitter 154
19. Device Performance 169
Clinical Study Performance 169
20. Technical Specifications 191
Electrical and Safety Standards 194
Symbols on Packaging and Devices 199
Legal Notices
204
Index 206
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.
Calibration Blood glucose reading from a fingerstick sample entered in the Eversense App to check the accuracy of the system. With the Eversense System, there are two phases: Initialization Phase during which
4 fingerstick tests are required, and the Daily Calibration
Phase, during which 1 fingerstick test is required twice daily.
CGM Continuous Glucose Monitoring. Continuously monitoring your glucose levels from interstitial fluid every few minutes.
Contraindication A condition or circumstance in which a person should not use the device.
CT Computed Tomography
Do Not Disturb Mode (DND in the Eversense App)
When enabled, the mobile app will stop displaying non-critical alerts, and the smart transmitter will stop providing vibratory notifications for non-critical alerts.
Critical alerts will still be provided. Many mobile devices have a separate Do Not Disturb Mode. Consult the manufacturer’s instructions for more information.
Electromagnetic Interference A strong field of energy generated by electrical or magnetic devices.
EULA End User License Agreement
Eversense App Software program that is installed on a mobile device and is used to display CGM glucose data sent from the smart transmitter.
Eversense DMS A web-based application compatible with the Eversense App where your glucose data is stored and can be viewed.
Eversense NOW A remote monitoring mobile application that allows you to share your glucose data with other people.
FAQ Frequently Asked Questions
Health Care Provider A physician, physician assistant, and/or nurse practitioner who has successfully completed the Eversense CGM Insertion and Removal Training
Program and has read and understood the Eversense
CGM Sensor Insertion and Removal Instructions.
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“HI” Reading Indicates a sensor glucose reading is
> 400 mg/dL.
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.
“LO” Reading Indicates sensor glucose reading is
< 40 mg/dL.
Mobile Device A handheld device built on a mobile operating system that runs the Eversense App and communicates with the smart transmitter. mg/dL Milligrams per deciliter, a unit of measure that shows the concentration of a substance in a specific amount of fluid. In some countries, including the United
States, glucose test results are reported as mg/dL, indicating how much glucose is in the blood when using a blood glucose meter, or how much glucose is in the interstitial fluid when using some CGM systems, like the
Eversense CGM System.
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Eversense CGM User Guide mmol/L Millimoles per liter, a unit of measure that shows the concentration of a substance in a specific amount of fluid. In many countries, glucose test results are reported as mmol/L, indicating how much glucose is in the blood when using a blood glucose meter, or how much glucose is in the interstitial fluid when using some
CGM systems, like the Eversense CGM System.
MRI Magnetic Resonance Imaging
Rate of change/trend arrows Indicators of direction and speed of change of your glucose levels.
Remote Monitoring An optional feature that allows you to invite others to view your CGM data using
Eversense NOW, a separate mobile app they download to a compatible mobile device.
Sensor A device inserted subcutaneously for continually measuring interstitial fluid glucose levels.
Snooze Setting Used to set how often an alert repeats.
Subcutaneous Located beneath the skin.
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.
Warm-Up Phase The period the sensor requires to adjust after the sensor has been inserted and before calibrations.
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 Eversense CGM 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. You must contact your health care provider (physician, physician assistant, and/or nurse practitioner) to schedule the insertion and removal of your sensor.
Help and Support
Please review this User Guide with your health care provider. For additional Eversense product questions and troubleshooting issues, contact Customer Support toll free in the US at 844-SENSE4U (844-736-7348). To download a copy of this User Guide in Spanish, please visit www.eversensediabetes.com.
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Eversense CGM System Components
The System includes 1) a small sensor inserted subcutaneously by a health care provider, 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.
Sensor
Eversense Smart Transmitter
The removable smart transmitter is worn externally over the sensor and powers the sensor. It wirelessly sends glucose data (via Bluetooth) to the mobile device app. The smart transmitter also provides on-body vibe alerts based on the glucose settings you choose. It has a rechargeable battery and is reusable for up to one year.
Smart Transmitter
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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.
The Eversense App screens layout will vary based on your mobile device’s model and/or operating system.
Throughout this User Guide, we have included some examples of these differences.
Make sure your mobile device is using the latest operating system.
1 iOS Android
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. Carefully read the instructions in this User Guide for downloading and installing the Eversense CGM Mobile
App, and for pairing your mobile device with the smart transmitter. If there is anything you do not understand in this
User Guide, please consult your health care provider. For product questions, contact Senseonics Customer Support.
Disposable adhesive patches for daily use are also included as part of the system, and will be provided to you by your health care provider after your sensor has been inserted. The patch has an adhesive side that attaches to the back of the smart transmitter, and a silicone adhesive side that attaches to the skin.
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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.
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.
Make sure your smart transmitter has enough battery power at all times.
Perform two blood glucose meter calibration tests each day when prompted.
Pay attention to alerts and notifications you receive from your smart transmitter and mobile device.
Replace the adhesive patch on your smart transmitter daily.
no data are collected when the 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.
When the smart transmitter and mobile device are not within range of each other, any data gathered by the smart transmitter is stored and sent to the app when the mobile device and smart transmitter are back within range.
flying, the smart transmitter performs similar to any other Bluetooth device. Be sure to follow the specific safety guidelines mandated by the airline.
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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.
•
On-body vibe alerts with the smart transmitter even when mobile device is not nearby.
• Provides readings within 40 - 400 mg/dL range every 5 minutes.
• Trend arrows that show whether your glucose values are rising or falling and how fast.
• Graphs and statistics that show your glucose results in easy-to-understand formats.
•
Removable and rechargeable smart transmitter.
• Event entry capabilities (like meals, exercise and insulin).
• Stores glucose data in the app and on the smart transmitter.
• Provides remote monitoring capability to others using the Eversense NOW Mobile App.
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System Requirements
• 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™.
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. Jailbroken devices do not provide an acceptable level of security for the user and are not approved for use by Senseonics.
Broken Screen or Button
If the screen of your mobile device is broken, or the buttons do not work, then you may not be able to use your
Eversense System and you may miss low or high glucose events.
Indications for Use
The Eversense CGM System is indicated for continually measuring glucose levels in adults (18 years or older) with diabetes for up to 90 days. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions.
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The system is intended to:
• Provide real-time glucose readings.
• Provide glucose trend information.
•
Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).
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.
The system is intended for single patient use.
MRI Safety Information
Non-clinical testing has demonstrated the Eversense Sensor is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 1.5T or 3.0T.
• Maximum spatial field gradient of 2000 gauss/cm (20 T/m).
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level
Controlled Operating Mode).
Under the scan conditions defined above, non-clinical testing results indicate the Eversense Sensor is expected to produce a maximum temperature rise of less than 5.4 °C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 2.83 inches (72 mm) from the
Eversense Sensor when imaged with a gradient echo pulse sequence and a 3T MR system.
The Eversense Smart Transmitter is MR Unsafe and MUST BE REMOVED before undergoing an MRI procedure. Before you undergo an MRI procedure, tell the MRI staff that you have an Eversense Sensor and Smart Transmitter.
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Contraindications
The smart transmitter is incompatible with magnetic resonance imaging (MRI) procedures. The smart transmitter is
MR Unsafe and MUST BE REMOVED before undergoing an MRI (magnetic resonance imaging) procedure.
For information on the sensor, please see MRI Safety Information.
The system is contraindicated in people for whom dexamethasone or dexamethasone acetate may be contraindicated.
Mannitol or sorbitol, when administered intravenously, or as a component of an irrigation solution or peritoneal dialysis solution, may increase blood mannitol or sorbitol concentrations and cause falsely elevated readings of your sensor glucose results. Sorbitol is used in some artificial sweeteners, and concentration levels from typical dietary intake do not impact sensor glucose results.
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, Quick Reference Guide and a wallet card (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 precautions are highlighted in a box.
• User tips are preceded by the symbol.
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2. Benefits and Risks
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.
The 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), and for some people, during the first several days after insertion due to inflammation that may result from the insertion procedure.
Glucose levels in ISF lag behind glucose levels in blood by several minutes.
IMPORTANT: If your symptoms do not match the glucose alerts and readings from the Eversense CGM
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 CGM System in accordance with the instructions for use may result in you missing a hypoglycemic or hyperglycemic glucose event, which may result in injury.
The sensor has a silicone ring that contains a small amount of an anti-inflammatory drug (dexamethasone acetate).
It has not been determined whether the risks associated with injectable dexamethasone acetate apply to the dexamethasone acetate elution ring inside the sensor. The elution ring releases a small amount of dexamethasone acetate when the sensor comes in contact with body fluids and serves to minimize the body’s inflammatory response to the inserted sensor. Dexamethasone acetate in the ring may also cause other adverse events not previously seen with the injectable form. For a listing of potentially adverse effects related to dexamethasone acetate, contact your health care provider.
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Unauthorized modifications of the equipment, improperly accessing information within it or “jailbreaking” your system, and taking any other unauthorized actions may cause the CGM system to malfunction and may put you at risk. Unauthorized modification of the equipment is not permitted and voids your warranty.
Caution: Federal (US) law restricts this device to sale by or on the order of a physician.
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. You may need medical attention in the event that you have high or low glucose and are unaware of it.
IMPORTANT: If you do not test your glucose with a blood glucose meter when your symptoms are not consistent with the sensor glucose readings, you may miss a high or low glucose event.
Treatment decisions should be made based on a review of the following: a sensor glucose value, trend arrow, recent glucose trend graph, and system alerts/notifications. You should not make a treatment decision unless you have considered all this information.
Be sure you talk with your health care provider about insulin action, so you understand how its impact on your glucose may factor into your treatment decisions.
The sensor is inserted by making a small incision and placing it under the skin. This process may cause infection, pain or skin irritation. Additionally, the adhesive may cause a reaction or skin irritation.
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Warnings
•
The Eversense CGM System has not been tested using insertion sites other than the upper arm.
•
If at any time your symptoms are not consistent with the sensor glucose readings, you should test your glucose with a blood glucose meter.
• 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 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.
• 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.
•
Close contact with direct EMI may interfere with the smart transmitter’s ability to send data to your mobile device. Move away from the source of EMI and check that your mobile device is connected to your smart transmitter.
•
Antibiotics of the tetracycline class may falsely lower sensor glucose readings. You should not rely on sensor glucose readings while taking tetracyclines.
• The bandage should remain covering the incision for 48 hours as this is a standard of care to allow formation of a water-tight seal to help protect against infection. 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. For additional Eversense product questions and troubleshooting issues, contact Customer Support toll free in the US at 844-SENSE4U (844-736-7348).
• Always calibrate the system using only a fingerstick blood sample. DO NOT use an alternative site (such as forearm or palm) blood glucose reading to calibrate the system.
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Warnings (continued)
•
DO NOT insert your infusion set or inject insulin within 4 in (10.16 cm) of the sensor site. If the insulin delivery site is within 4 in (10.16 cm) of the sensor site, it may interfere with sensor glucose readings and can cause inaccurate glucose readings.
•
Always follow your health care provider’s instructions for care after the sensor insertion or removal. Contact your health care provider if any of the following events occur:
– You have pain, redness, or swelling at the incision site(s) later than 5 days after the sensor insertion or removal.
•
If your sensor glucose is very low (below 40 mg/dL) or very high (above 400 mg/dL), you should perform a fingerstick blood glucose test prior to making a treatment decision.
• The Eversense CGM System requires calibration in order to provide accurate readings. You should not use CGM readings to make treatment decisions unless you have followed the instructions for daily calibration.
•
The Eversense CGM System will not provide readings during the 24 hour Warm-Up Phase and until a second calibration is successful during the Initialization Phase. During this time, you should monitor your glucose using a home blood glucose monitor.
• Certain conditions and alerts will prevent glucose data from being displayed. During these times, you should use a home blood glucose monitor to make treatment decisions. You should carefully read the Alerts and
Notifications section of their Eversense CGM System User Guide to understand these conditions.
• The glucose alerts and notifications will not audibly notify you 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.
• When the smart transmitter is not worn over the sensor, such as during charging, the Eversense CGM System will not provide alerts and notifications on the mobile device or through vibration alerts from the smart transmitter.
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Precautions
•
DO NOT exchange smart transmitters with another person. Each smart transmitter can be linked to only one sensor at a time. The system is to be used by one person in the home environment.
• 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. Energy from the diathermy can transfer through the sensor and cause tissue damage in the insertion area.
– Electrocautery – The use of electrocautery near the inserted sensor may damage the device. DO NOT use electrocautery near the sensor.
• Steroid use – It has not been determined whether the risks usually associated with injectable dexamethasone acetate apply to the use of this dexamethasone acetate elution ring, a highly localized, controlled-release device. The dexamethasone acetate ring could cause other adverse events not listed or previously seen.
• DO NOT wear the smart transmitter during medical x-rays or computed tomography (CT) scans. To avoid interference with results, remove the smart transmitter before undergoing medical x-ray or CT scans. Make sure your health care provider knows about your smart transmitter.
•
The sensor and smart transmitter should be linked the day of insertion. Failure to link the sensor and smart transmitter could result in a delay in receiving glucose readings.
• If the sensor, insertion site or smart transmitter feels warm, remove the smart transmitter immediately and contact your health care provider for further advice. A warm sensor could mean there is an infection or a sensor malfunction.
•
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.
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Precautions (continued)
• Use only the AC power adapter and USB cable provided with the smart transmitter when charging the smart transmitter battery. Use of another power supply could damage the smart transmitter, not allowing glucose readings to be received properly, and could result in voiding your warranty.
• If you have any concerns about allergic reaction to adhesive products containing silicone, contact your health care provider prior to use. Discard the Eversense adhesive patch after each use of up to 24 hours.
• DO NOT change the unit of measurement unless you have discussed it with your health care provider. Using the incorrect unit of measure could result in missing a high or low glucose event.
•
Entering incorrect blood glucose values for calibration can result in inaccurate sensor glucose readings, which may result in you missing a high or low glucose event.
• Follow your health care provider’s recommendation for setting your glucose alerts. Incorrectly setting your glucose alerts can result in you missing a high or low glucose event.
• Pay attention to the glucose alerts the system provides. Failure to appropriately respond to an alert might result in you missing a high or low glucose event.
• The Eversense NOW Remote Monitoring App does not replace the monitoring regimen as directed by your health care provider.
• The Eversense CGM System has not been tested in the following populations: women who are pregnant or nursing, people under the age of 18, critically ill or hospitalized patients, people receiving immunosuppressant therapy, chemotherapy or anti-coagulant therapy, those with another active implantable device, e.g., an implantable defibrillator (passive implants are allowed, e.g., cardiac stents), those with known allergies to or using systemic glucocorticoids (excluding topical, optical or nasal, but including inhaled). The system’s accuracy hasn’t been tested in these populations, and sensor glucose readings may be inaccurate, resulting in missing a severe low or high glucose event.
• The Apple Watch is a secondary display of Eversense CGM data and should not be used in place of the primary Eversense CGM display.
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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 health care provider 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.
Note: If you have not received your Smart Transmitter Pack skip to instructions on downloading and installing the
Eversense App to your mobile device later in this chapter.
You may complete the following start-up steps before your sensor is inserted so that you can familiarize yourself with the system.
2 easy start-up steps:
1. Download the Eversense App to your mobile device.
2. Set up the app – Create an Account, Pairing and Settings.
After you receive your smart transmitter it must be fully charged before pairing with the app.
Note: Your smart transmitter is set to “sleep” status for shipping. When you charge the smart transmitter for the first time, the status changes to active.
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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.
Precaution: Use only the AC power adapter and USB cable provided with the smart transmitter when charging the smart transmitter battery. Use of another power supply could damage the smart transmitter, not allowing glucose readings to be received properly, and could result in voiding your warranty.
1.
Plug the standard end of the USB cable into the adapter on the USB port.
2.
Plug the micro end of the USB cable into the charging cradle on the USB port.
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3.
Line up the four gold pins on the bottom of the smart transmitter with the four gold pins on the charging cradle.
•
Slide the smart transmitter into place in the charging cradle.
• Once positioned, push down on the smart transmitter until it snaps into place.
4.
Plug the adapter into an AC power outlet.
•
Once fully charged, a small green LED light appears on the top front of the smart transmitter
(above the power button).
• Disconnect the power supply from the smart transmitter after it is fully charged.
•
To release the smart transmitter from the charging cradle, pull back on the tab and lift the smart transmitter out of the cradle.
3
LED Indicator
(lights green or orange)
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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.
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.
On the install screen, tap
Install application and follow the installation instructions.
After 1 - 2 minutes, check your mobile device display for the
Eversense App icon (as shown to the left).
Eversense App Icon
Note: Make sure your mobile device is using the latest operating system.
IMPORTANT: Make sure that you have a wireless internet connection and that Bluetooth is turned ON before continuing.
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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.
After you accept the Agreement, you will be prompted to create and register an account with an Email and Password.
• You must register an account before you are able to log in. Tap Create an Account .
3
Note: If you forget your password, you can reset it via the app. If you forget your email associated with your account, contact Customer Support.
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3
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 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.
Note: If you have not received the confirmation email with the link to complete your registration within a few minutes, check your spam folder.
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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:
(skip to step 7).
(skip to step 12).
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 power button three times. Make sure your smart transmitter is not plugged into the power supply.
• The LED will blink green and orange to indicate the smart transmitter is in Discoverable mode.
3
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.
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8.
On the PAIR YOUR 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.
Tap Pair to complete the pairing process.
Note: The smart transmitter can only be paired with one mobile device at a time.
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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 ).
• Tap .
11.
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.
3
Precaution: DO NOT change the unit of measurement unless you have discussed it with your health care provider. When the unit of measurement is confirmed, tap Finish .
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12.
Tap through the introduction screens that provide information about when to make treatment decisions with the Eversense CGM System.
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13.
Next, the MY GLUCOSE screen appears.
The screen will not have any glucose data to display at this time.
Note: Once the sensor is linked to the smart transmitter, the red blood drop with the X will no longer appear and a black blood drop with signal bars will be displayed.
Once the sensor is inserted by your health care provider 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.
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4. Inserting and Linking the Sensor
This section describes how to link the sensor and smart transmitter after your health care provider has inserted the sensor. Only your health care provider 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 health care provider has inserted your sensor, the smart transmitter and the sensor must be linked in order to start the Warm-Up Phase. Your smart transmitter can only be linked to one sensor at a time.
1.
Make sure your smart transmitter is turned ON
(see Using the Smart Transmitter ) and that your mobile device has access to the internet.
• Position the smart transmitter directly over the inserted sensor until the Placement Guide in the app shows some connection. The
Placement Guide page is located in Menu >
Placement Guide .
2.
Navigate away from the Placement Guide page to the Main Menu screen once you have confirmed there is a signal.
Note: The connection between the sensor and the smart transmitter is sensitive to the orientation of the transmitter. If the smart transmitter is directly over the sensor and the Placement Guide indicates there is no connection, try rotating the smart transmitter slightly to the left or right so the power icon and LED are parallel to the sensor.
LED indicator
(lights green or orange)
Power button
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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 .
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. DO NOT remove the smart transmitter from your insertion site until the third check mark is displayed.
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Note: It may take up to 5 minutes for the
New Sensor Detected notification to be displayed.
If the smart transmitter is removed from the sensor site, the system will display a notification.
Precaution: The sensor and smart transmitter should be linked the day of the sensor insertion.
Failure to link the sensor and smart transmitter could result in a delay in receiving glucose readings.
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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.
The system will prompt you to calibrate using the app.
Warning : The Eversense CGM System will not provide readings during the 24 hour Warm-Up Phase and until a second calibration is successful during the Initialization Phase. During this time, you should monitor their glucose using a home blood glucose monitor.
IMPORTANT: If your smart transmitter is not turned on and paired with the Eversense App and linked to the sensor, the system is not able to prompt you to calibrate.
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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:
• Powers the sensor.
• Calculates and stores glucose data.
• Provides on-body vibe alerts when you have reached the glucose alert levels you set.
• Sends glucose data to the app via Bluetooth.
• Can be recharged using the charging cradle.
• USB port to download data to compatible external applications.
• Multi-color LED to indicate various modes of the smart transmitter.
• Communicates with mobile device.
• Can be powered ON or OFF.
LED indicator
(lights green or orange)
Power button
Top Back
Charging contact pins
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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 3.2 feet (1 meter) for 30 minutes. Exposing the smart transmitter to conditions beyond this will result in damage and void your warranty.
Make sure your smart transmitter has enough battery power at all times.
Perform a blood glucose meter calibration test when prompted.
Pay attention to alerts and notifications you receive from your smart transmitter and mobile device.
Replace the smart transmitter with a new adhesive patch on a daily basis.
no data are collected when the smart transmitter is not communicating with the sensor. When you place the smart transmitter back on the sensor site, it will take about 10 minutes for sensor communication to re-start and for glucose readings to appear in the app.
When the smart transmitter and mobile device are not within range of each other, any data gathered by the smart transmitter is stored and sent to the app when the mobile device and smart transmitter are back within range.
flying, the smart transmitter performs similar to any other Bluetooth device. Be sure to follow the specific safety guidelines mandated by the airline.
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.
Precaution: Always remove the smart transmitter from your body before charging the battery.
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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.
Note: You will receive adhesive patches from your health care provider.
Precaution: If you have any concerns about allergic reaction to silicones, contact your health care provider prior to use. Discard the patch after 24 hours of use.
1.
Peel off the paper backing with the Eversense
Smart Transmitter outline on it. Try not to touch the sticky portion of the adhesive in the center.
2.
Align the smart transmitter over the sticky side
(center) of patch and press firmly to secure.
• The smart transmitter should be placed so that its sides face the wings of the patch (as shown).
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3.
Remove the larger clear backing and position the smart transmitter directly over the sensor.
• For the optimal signal strength, the smart 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.
4.
Check the connection between the smart transmitter and the sensor.
• Tap > Placement Guide .
• Refer to the Placement Guide when attaching your smart transmitter to ensure there is some connection between the sensor and smart transmitter.
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5.
Press the adhesive patch firmly on skin surface over the sensor.
• The smart transmitter should be positioned so that the patch wings lay horizontally on the arm.
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.
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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 for about five seconds.
• The smart transmitter will vibrate once.
• Release the power button and the LED will blink once indicating the power is ON.
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.
2.
To turn the smart transmitter OFF, press and hold the power button for about five seconds.
• The smart transmitter will vibrate once.
• Release the power button and an orange light will blink once, indicating the power is OFF.
LED indicator
Power button
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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.
•
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. Using a power supply other than one provided by Senseonics may void your smart transmitter warranty. DO NOT use the power supply if it is damaged in any way.
•
To clean your smart transmitter, wipe it down with a water dampened cloth; dispose of the cloth according to your local regulations.
• Dispose of the smart transmitter and all other system components according to local regulations.
Battery Indicator
The smart transmitter battery power can be checked using the app, or on the smart transmitter itself.
With the app:
• Tap Menu > About > My Transmitter . Scroll down to the Battery Level line that indicates amount of battery power left.
Or
• Check the battery icon on the upper right corner on the MY GLUCOSE screen. A red battery icon indicates the smart transmitter battery is empty.
With the smart transmitter:
•
With the smart transmitter ON, press and release the power button. The LED will blink green once if the battery has at least 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
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LED Status Indicators
The smart transmitter communicates several different states based upon the color of the LED.
•
During smart transmitter use:
LED Status
Alternating green and orange when power button is pressed 3 times in
5 seconds
Does not blink when power button is pressed
Blinks green (once) when power button is pressed
Blinks orange (once) when power button is pressed
Status
Discoverable mode
Smart transmitter off
10% - 90% battery power
Low battery, less than 10% battery power remaining
Action
Pair smart transmitter with mobile device
Hold down power button for
5 seconds to turn on
No immediate action required
Charge battery soon
LED is orange for one minute An alert has been triggered
Check the app on your mobile device to understand the alert
•
During smart transmitter charging:
LED Status
Solid or flashing orange when connected to the USB cable
Solid green when connected to the
USB cable
Battery Status
0% - 65% charged
65% - 100% charged
Action
Charge for 15 minutes before disconnecting from power supply
Charge for 15 minutes before disconnecting from power supply
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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 when entering BG values 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. No calibration is required during this phase.
There are two calibration phases:
Initialization Phase – After the 24-hour Warm-Up Phase, you must complete 4 fingerstick calibration tests, spaced 2 to 12 hours apart.
Daily Calibration Phase – After the Initialization Phase, you must complete a fingerstick calibration test every
12 hours.
Warning: In the Daily Calibration Phase, the Eversense CGM System requires calibration every 12 hours in order to provide accurate readings. You should not use CGM readings to make treatment decisions unless you have followed the instructions for daily calibration.
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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.
Wash your hands with warm, soapy water and dry thoroughly before taking a blood glucose meter reading. It is very important to have clean, dry hands when you test your blood glucose.
Always follow the blood glucose meter manufacturer’s instructions to get accurate blood glucose readings for calibration.
Be sure the code on test strip vial matches the code on your blood glucose meter (if coding is required).
Calibration will NOT be complete or results NOT accepted if:
Blood glucose meter reading is less than 40 mg/dL.
Blood glucose meter reading is greater than 400 mg/dL.
Blood glucose meter reading was taken more than 10 minutes before entering the result in the Eversense App.
Sensor glucose reading is significantly different than the blood glucose meter reading.
Your smart transmitter was removed or could not collect sensor glucose data during the 15 minutes after you entered your calibration value.
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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. After 8 hours without a calibration entry, no glucose data will be displayed.
– 1 st calibration = 24 hours after sensor insertion.
– 2 nd calibration = 2 to 12 hours after 1st successful calibration.
– 3 rd calibration = 2 to 12 hours after 2nd successful calibration.
– 4 th calibration = 2 to 12 hours after 3rd successful calibration.
•
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.
Re-Entering Initialization Phase
The following will cause the system to re-enter Initialization Phase.
• Not completing a calibration test within a 12-hour period during the Initialization Phase.
• Not completing all 4 calibration tests within 36 hours during the Initialization Phase.
• Not completing 2 calibration tests within a 24-hour period during the Daily Calibration Phase
(see B. Daily Calibration Phase ).
• When the last several blood glucose meter measurements are significantly different than the sensor glucose values.
• If the smart transmitter is out of battery power for more than 16 hours.
•
When you receive a Sensor Check Alert.
• Six hours after you receive a Sensor Suspend Alert.
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B. Daily Calibration Phase
The Daily Calibration Phase requires a blood glucose meter test every 12 hours. The first Daily Calibration Phase will begin after successful completion of the Initialization Phase.
•
12 hours after your last successful calibration, the system prompts you to calibrate.
• You may optionally enter calibrations more frequently. Daily calibration entries must be spaced at least one hour apart.
• If you do not calibrate within 16 hours, you will receive a Calibration Past Due Alert and no glucose values will be displayed until a calibration value is entered. After 24 hours without a calibration value entered, you will receive a
Calibration Expired Alert and the system returns to Initialization Phase.
Warning: Certain conditions and alerts will prevent glucose data from being displayed. During these times, you should use a home blood glucose monitor to make treatment decisions. You should carefully read the
Alerts and Notifications section of this User Guide to understand these conditions.
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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: You can enter additional calibration readings as long as each calibration is at least one hour apart.
1.
You can enter the calibration value by tapping Calibrate from the main menu or from the Calibrate Now Notification.
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2.
Obtain a fingerstick reading from your blood glucose meter.
3.
Tap Glucose and enter the value from your fingerstick blood glucose test.
• Tap Done .
• Tap Notes to enter any notes.
• Tap Done .
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Note: You cannot enter a calibration value that is older than
10 minutes.
4.
The CALIBRATE screen now shows the time and glucose reading you entered.
If not correct, repeat steps 3.
• When correct, tap Submit .
5.
The CALIBRATION
IN PROGRESS screen appears.
• Tap OK .
6.
The MY GLUCOSE screen appears with a red blood drop icon to identify your fingerstick calibration.
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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. 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.
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Note: There may be conditions when your calibration result is NOT accepted.
Calibration will NOT be accepted if:
Blood glucose meter reading is less than 40 mg/dL.
Blood glucose meter reading is greater than 400 mg/dL.
Your smart transmitter was removed or could not collect sensor glucose data during the 15 minutes after you entered your calibration value.
The glucose value entered will be logged as a manual BG entry.
The blood drop icon on the trend line will be blue.
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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.
On the MY GLUCOSE screen, you have easy access to:
• Real-time sensor glucose measurements.
• Rate and direction of your changing glucose levels.
•
Graphical trends of your glucose levels.
• Alerts (hypoglycemia or hyperglycemia).
• Events such as meals, exercise, and medications.
Note: A wireless internet connection is required to download or update the Eversense App.
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Check Your Mobile Device Settings
You will need a mobile device (such as your smartphone) to use the Eversense 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:
• Time and date.
•
Bluetooth turned ON (enabled).
• Notifications turned on.
• Battery is charged.
• Geographic zone.
• Language.
•
Mobile device sound should not be on vibrate.
• Do Not Disturb should be OFF, some apps and settings such as Driving Mode may automatically enable
Do Not Disturb. Please refer to your mobile device instructions for more information.
If you have your mobile device set to Do No Disturb, you will not hear any notifications from the
Eversense App.
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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.
Menu icon
Temp Profile icon
Do Not Disturb icon
Current glucose reading
Status bar
Smart Transmitter battery power
Smart Transmitter connection to sensor
Trend arrow
Unit of measurement
Date and time
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Calibration mark
Multiple events mark
Event mark
High Glucose Alert level (Top red dashed line)
High Glucose Target level (Top green dashed line)
Low Glucose Target level (Bottom green dashed line)
Low Glucose Alert level (Bottom red dashed line)
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 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.
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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.
• 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.
Status bar
Smart Transmitter ID
Provides important information about your current glucose and system status.
This is the smart transmitter you are now using. You can change the name by tapping Settings > System .
Current real-time glucose level. This is updated every 5 minutes.
Current glucose reading
Date and time
Current date and time. You can scroll left or right to see different dates and times.
Smart Transmitter battery power
Smart Transmitter connection to sensor
Indicates battery power left in the smart transmitter.
Indicates the strength of your smart transmitter connection with the sensor.
Trend arrow
Unit of measurement
High/Low Glucose alert level
Shows the direction your glucose levels are moving.
This is the unit of measurement used to display all glucose data.
The levels set for the high and low glucose alerts.
High/Low Glucose target level The levels set for the high and low glucose targets (target range).
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Multiple events mark
Event mark
Calibration mark
Glucose trend graph
Menu
Indicates multiple events have occurred at the same time.
Indicates manually entered events (e.g., exercise). See Logging Events for more information.
Indicates a blood glucose calibration entry.
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.
Provides easy navigation to various sections of the Eversense App:
My Glucose
Calibrate
Alert History
Event Log
Reports
Share My Data
Placement Guide
Connect
Settings
About
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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 0.0 mg/dL and 1.0 mg/dL per minute.
Moderately rising glucose level, rising at a rate between 1.0 mg/dL and 2.0 mg/dL per minute.
Moderately falling glucose levels, falling at a rate between 1.0 mg/dL and 2.0 mg/dL per minute.
Very rapidly rising glucose levels, rising at a rate more than 2.0 mg/dL per minute.
Very rapidly falling glucose levels, falling at a rate more than 2.0 mg/dL per minute.
The app uses the last 20 minutes of continuous glucose data for calculating glucose trends.
When there are not enough sensor values available to calculate a trend arrow, it is not displayed and the glucose value is grey instead of black.
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 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.
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Understanding Treatment Decisions with CGM
Read the entire Eversense 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 to make treatment decisions, talk with your health care provider about understanding how food, insulin, medications, stress, and exercise impact your glucose.
IMPORTANT:
• If your symptoms do not match the sensor glucose information displayed, or the app is not displaying both a
• number and a trend arrow, then use your BG meter to make treatment decisions.
Use your blood glucose meter to make treatment decisions until you understand how Eversense works for you.
It may take days, weeks, or even months for you to be comfortable using your CGM data to make treatment decisions.
Take your time and follow your health care provider’s recommendation for when to use Eversense instead of your
BG meter.
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Sensor Glucose and Blood Glucose
Sensor glucose is measured in the interstitial fluid, not in blood. Because of this, sensor glucose values may lag behind blood glucose values. For example, when your CGM trend arrow shows rapidly falling glucose, your blood glucose may be lower than the number shown; or when your CGM trend arrow shows a rapid rise, your blood glucose may be higher than the number shown. These examples are more likely when your glucose is changing rapidly, such as after a meal, after dosing insulin, or during and after exercise. Stress, illness, and even some medications you take can also impact your glucose. Sometimes the right treatment decision is to wait and check your CGM data frequently before taking action.
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Early Wear Time
During the 24-hour Warm up Phase, glucose values are not displayed. Also, during early wear time as your insertion site heals, your sensor glucose values may not match your blood glucose values as closely as they will when healing is complete. Use your BG meter to make treatment decisions during the Warm up Phase and until you are confident with your CGM values. Always remember, if the way you feel does not match the glucose value and trend arrow, use your BG meter.
Bluetooth Communication
The smart transmitter communicates wirelessly with your mobile device via Bluetooth to display your glucose reading. If the connection between your smart transmitter and your mobile device is interrupted, you will not see a glucose value or a trend arrow. Use your BG meter to make treatment decisions if your smart transmitter is not communicating with your mobile device.
On-body Vibe Alert
Your smart transmitter provides vibratory alerts when you have passed the glucose alert levels you set. However, do not use on-body vibe alerts to make treatment decisions. When you receive an on-body vibe alert, check your glucose reading and trend arrow on your Eversense app.
Remote Monitoring with Eversense NOW
Treatment decisions must not be made based on CGM information displayed on the Eversense NOW Remote
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.
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Discuss with Your Health Care Provider
Meals
Different types of meals and foods can impact your glucose levels and trend arrows in different ways, as can conditions such as delayed gastric emptying. Some foods will raise your glucose more rapidly than others. Before using CGM data to make treatment decisions, discuss with your health care provider about how to manage insulin dosing for different types of food, and how to accurately calculate carbohydrates.
Insulin
Insulin does not instantly impact your glucose. For example, depending on the brand of rapid-acting insulin used, onset of action can be from 5 to 15 minutes, peak effect in 1-2 hours and duration of action of 4-6 hours. Be sure to understand when you can expect the insulin you take to start lowering your glucose, when its maximum effectiveness is, and how long it lasts in your body continuing to lower your glucose. Working with your health care provider to understand the onset, peak, and duration of your insulin action will help you avoid stacking insulin. Stacking insulin is when you take a dose of insulin while a previous dose is still working at lowering your glucose. Hypoglycemia, sometimes severe, can result. Rather than reacting and taking insulin based on a high CGM value, be sure to consider whether insulin from your most recent dose is still actively lowering your glucose.
Exercise
Even relatively mild exercise, if it is not part of your normal routine, may cause your glucose to change more rapidly than usual. 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 hypoglycemia hours after exercise. You should follow your health care provider’s recommendation on dosing insulin following exercise to avoid low glucose.
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Illness & Stress
When you are ill or stressed, your glucose is impacted, and this may be a consideration for making treatment decisions. Keep in mind that stress is not always negative. You could find your glucose levels changing while headed on vacation or going to a fun social event. Your health care provider can help you create a plan for treatment decisions when you are sick or in stressful situations.
Medications
Understand how the medications you take impact your glucose. Some diabetes medications work to decrease your glucose, and some medications, like steroids, may increase your glucose levels. With Eversense, medications of the
Tetracycline class may falsely lower glucose and you should not rely on CGM readings when taking drugs in this class.
Talk with your health care provider about the medications you take and what to consider about them when making treatment decisions.
Eversense Glucose Alerts
Your health care provider will help you determine the target range and glucose alert levels that are right for you. Pay careful attention to your Eversense 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. Ask your health care provider about how treating very low and very high glucose may be different from the way you otherwise treat, and always use your BG meter to make a treatment decision.
Look Ahead
Carefully consider the time of day when making CGM treatment decisions, just like you do when using your BG meter.
For example, if your glucose is high and rising just before bedtime, adjust your insulin dose according to your health care provider’s recommendation. Also think about how to treat if you are planning to exercise or will be sitting in a meeting all day. Your health care provider may recommend adjusting your treatment decision based on what is about to happen in order to avoid high or low glucose.
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Making Treatment Decisions with Eversense
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.
• Recent trend information and alerts.
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When to NOT make a treatment decision:
• No glucose value is displayed.
• No trend arrow is displayed.
•
Your symptoms do not match the glucose information displayed.
• The current sensor glucose value is displayed in grey.
• The status bar is displayed in orange.
• 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.
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Eversense Trend Arrows and Treatment Decisions
Eversense 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 health care provider about using trend arrows to help you make treatment decisions. Generally, if the arrow is going down, you may consider taking less insulin, and if the trend arrow is going up, you may take more. Be careful not to take too much insulin in a short time, as that could result in low glucose from stacking insulin. The Eversense arrows are listed below, along with how you may use them when considering treatment. Talk with your health care provider about making adjustments to treatment based on trend arrows.
Never make a treatment decision using CGM if there is no arrow displayed.
Eversense
Trend Arrow
No trend arrow
Glucose is falling at a rapid rate
(> 2.0 mg/dL/ minute).
Glucose is falling at a moderate rate
(between 1.0 and 2.0 mg/ dL/minute).
What it
Indicates
Not enough data to calculate glucose trend direction or rate of change.
Your glucose could drop
30 mg/dL or more within 15 minutes.
Your glucose could drop between 15 and
30 mg/dL within
15 minutes.
Low
Glucose
Treat with carbs and consider if you recently have finished exercising or if you may have taken too much insulin.
High
Glucose
Do a fingerstick blood glucose check with your BG meter before making a treatment decision, even if your glucose is in range.
If you’ve recently taken insulin or are about to exercise, wait and check your
CGM value and trend arrow frequently before making a treatment decision.
Glucose in Range
Treat with carbs and consider if you recently have finished exercising or if you may have taken too much insulin.
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Eversense
Trend Arrow
Glucose is rising at a rapid rate
(> 2.0 mg/dL/ minute).
Glucose is rising at a moderate rate
(between 1.0 and 2.0 mg/ dL/minute).
What it
Indicates
Your glucose could rise
30 mg/dL or more within 15 minutes.
Your glucose could rise between 15 and
30 mg/dL within
15 minutes.
Low
Glucose
If you’ve recently taken insulin or are about to exercise, wait and check your CGM value and trend arrow frequently before making a treatment decision.
Glucose is changing gradually
(1.0 mg/dL/ minute or less).
Your glucose could rise or fall up to
15 mg/dL within
15 minutes.
Consider treating with carbs. If you’ve recently taken insulin, check your CGM value and trend arrow frequently.
High
Glucose
If you’ve recently taken insulin or are about to exercise, wait and check your
CGM value and trend arrow frequently.
If you have not recently taken insulin, and are not about to exercise, consider adjusting insulin correction dose up.
If you’ve recently taken insulin or are about to exercise, wait and check your
CGM value and trend arrow frequently.
If you have not recently taken insulin, consider adjusting insulin correction dose up.
Glucose in Range
If you’ve recently taken insulin or are about to exercise, wait and check your
CGM value and trend arrow frequently before making a treatment decision.
If you have not recently taken insulin or finished exercise, consider adjusting insulin correction dose up.
No treatment, but if you’ve recently taken insulin or are about to exercise, check your CGM value and trend arrow frequently.
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What Would You Do
This section provides examples of some situations you may encounter. It’s important to consider what has happened and what is about to happen when making treatment decisions with CGM. Review these examples carefully, and think about what you would consider before making a treatment decision. If you’re not sure, always check your BG with a fingerstick before making a treatment decision.
Glucose below target at 65, but rising moderately. Your glucose could reach 120 within 30 minutes.
It’s 7am, and you’re about to eat breakfast, and you drank a small glass of orange juice when you first woke up.
• Should you consider taking a little less insulin than you usually would for your meal?
• Should you take the amount of insulin you typically would for this breakfast, and keep an eye on your glucose value, the arrow and how you feel?
It’s 9am, and you dosed insulin for your breakfast about 2 hours ago.
• Should you wait and keep an eye on your glucose value and the arrow before making a treatment decision?
•
Should you consider taking carbs to treat the low now?
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Glucose in target at 90, but rising rapidly. Your glucose could reach 180 or higher within 45 minutes.
It’s noon, and you’re about to have lunch.
• What might be causing this rise in glucose?
• Should you consider taking more insulin than you usually would for your meal?
• What does your health care provider recommend for adjusting your insulin in this situation?
It’s 2pm, and you dosed insulin to cover your lunch, plus a little extra because of the rapidly rising arrow, about 90 minutes ago.
• Since it’s only been 90 minutes since you dosed insulin, should you wait and keep an eye on your glucose number and trend arrows?
• How long does your health care provider recommend you wait between insulin doses to help prevent stacking insulin?
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Glucose in target at 95, but falling rapidly. Your glucose could reach 65 or lower within 15 minutes.
You’re about to start your workout.
• What might be causing this rapid drop in glucose?
• Consider a snack to prevent a low glucose event.
•
Consider postponing your workout until your trend and glucose are more steady. Keep a close eye on your glucose number, trend arrow and how you feel.
You’ve just finished your workout.
• How does your health care provider recommend you prevent low glucose after a workout?
• Consider a snack to prevent a low glucose event.
• Keep a close eye on your glucose number and trend arrow, and how you feel.
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Glucose above high alert level at 220, and changing gradually. Your glucose could drop to 190 or rise to 250 within 30 minutes.
It’s 7pm, and you’re about to eat dinner.
It’s been 6 hours since you dosed insulin for lunch.
• What might be causing this high glucose so long after your last meal?
•
Are you having a stressful day; are you not feeling well?
• Should you consider taking more insulin or eating fewer carbs than you typically would for this meal?
It’s 10pm, and you’re about to go to bed. It’s been two and a half hours since you last dosed insulin.
• What might be causing this high glucose?
• How long does it usually take for the insulin you use to finish lowering your glucose?
• What bedtime glucose value is recommended by your health care provider?
•
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.
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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. The red dashed lines indicate your High and Low Glucose Alert levels, and the green dashed lines indicate your high and low glucose target levels (your target range).
• Shaded areas of the graph are color coded as follows depending on the glucose settings you enter:
– Glucose values that are outside of your glucose alert levels will be red.
– Glucose values that are within your glucose target levels will be green.
– Glucose values that are between your glucose target and alert levels will be yellow.
• Press and hold any point in the line graph to view a specific glucose reading for that point in time.
• Tap any of the marks on the app screen to get more information about the event or alert.
•
Pinch in and out on the screen to display different day/time ranges on the trend graph. You can zoom in and out to display as few as 3 hours or up to
3 days of information.
• To view trend graph data for a different date, tap the date on the screen and enter the desired date.
• 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.
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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
My Glucose
Calibrate
Main app screen that displays current CGM reading, direction and rate of change, trend graph, events and alerts.
Enter calibration test values. The CALIBRATION screen automatically appears when it is time to calibrate but you can also enter additional calibration values using this menu option.
Alert History Review past alerts and notifications. See Alert Descriptions for more information.
Event Log
Enter information about activities such as blood glucose tests, meals, insulin, health and exercise. See Event Log for more information.
Review a variety of reports about your CGM data. See Glucose Reports and Sharing for more information.
Reports
Share My
Data
Placement
Guide
Connect
Settings
About
Allow others to view your glucose data through the Eversense NOW Mobile App.
Check the communication between the smart transmitter and sensor. Use this screen whenever you are attaching the smart transmitter to be sure communication is established.
Check the connection between the smart transmitter and mobile device. A Bluetooth connection is required to send data to the app.
Customize settings such as glucose target levels, alert levels, sounds, and temporary profile. See Customizing your Settings for more information.
View information about your CGM System, including sensor and smart transmitter ID numbers.
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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.
• The photo you select will be displayed on the
Main Menu screen.
Note: You can also change your profile picture from your Eversense DMS account. See the
Eversense DMS User Guide for more information.
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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.
• System – identifies or lets you enter personalized information about your system.
• Sound Settings – change the sounds for some glucose alerts, set snooze times and Do No Disturb.
• Temp Profile – set a temporary glucose profile.
• Log Out – log out of your Eversense Account.
Glucose Levels
The Eversense 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 health care provider.
Warning: 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.
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IMPORTANT:
• Low and High Glucose Alerts are different from your Low and High Glucose Targets.
– Low and High Glucose Alerts notify you on your mobile device and smart transmitter when you have reached a certain low or high value.
– Glucose Targets are used in the reports and line graphs to show how your glucose levels have been performing compared to the targets you set. You will not receive an alert when you have reached your
Glucose Target levels.
– 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.
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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 passed 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.
Default setting
Allowable setting
On/Off setting
Notes
Low: 70 mg/dL
High: 200 mg/dL
You can change these alert levels based on what you and your health care provider agree are the right levels for you. Your Low Glucose Alert cannot be set above your Low Glucose Target, and your High Glucose Alert cannot be set below your High Glucose Target.
Low: 60 - 115 mg/dL
High: 125 - 350 mg/dL
Low Glucose Alert setting is Always ON
High Glucose Alert setting can be turned ON and OFF. No High Glucose alerts will display or vibe on the smart transmitter if this feature is turned off.
Audio notification and visual alerts on your mobile device and smart transmitter on-body vibe alerts.
IMPORTANT: The Low and High Glucose Alert levels you set are the same levels used to provide Predictive
Alerts. See this section, Setting Predictive Alerts .
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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 when complete.
• Repeat step to make your Low Alert selection.
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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
Allowable setting
On/Off setting
Notes
Low: 80 mg/dL
High: 140 mg/dL
You can change this target range based on what you and your health care provider agree are the right target levels for you.
Low: 65 - 120 mg/dL
High: 120 - 345 mg/dL
Always ON (cannot be turned OFF)
Used in graphs and charts on the app to show time spent in target range.
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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.
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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 previously set to provide an “early” warning. You set the early warning time (10, 20, or 30 minutes) to alert you in advance of reaching your alert levels, based on current glucose trends. 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.
Default setting
Allowable setting
On/Off setting
Notes
OFF
10, 20, or 30 minutes prior
You can turn these alerts ON and OFF.
No predictive alerts will occur until this feature is turned ON. The default is
20 minutes.
Audio notification and visual alerts on your mobile device and smart transmitter on-body vibe alerts.
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1.
To turn this feature ON, tap Menu >
Settings > Glucose to display the
GLUCOSE SETTINGS screen.
2.
Next to the High and Low Predictive Alerts , slide the OFF button to ON .
3.
Tap Minutes to select the amount of advance warning
• Tap Done when complete.
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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.
Default setting
Allowable setting
On/Off setting
Notes
OFF
1.5 - 5 mg/dL per minute
You can turn these alerts ON and OFF. No rate of change alerts will occur until this feature is turned ON.
Audio notification and visual alerts on your mobile device and transmitter vibration alerts.
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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 to ON .
3.
Tap Rate of Change to select the rate.
• Tap Done when complete.
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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:
• The unit of measurement for your glucose readings.
The App must be reinstalled to edit this setting.
• The serial number of your smart transmitter. You can also tap on the serial number displayed here and give your smart transmitter a custom name.
• Linked Sensor.
The serial number of the sensor currently linked with the smart transmitter. Tap this feature to access the ability to link or re-link a sensor.
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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.
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.
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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.
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Transmitter Disconnect Setting
There may be times when the Bluetooth connection between your smart transmitter and mobile device is interrupted. This may be due to the devices being out of range, smart transmitter battery empty, or the Bluetooth feature is turned off in your phone settings. You can customize how long before the system notifies you of a communication interruption. You can set the time to alert you 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.
The SOUND SETTINGS screen also allows you to enable and disable the Do Not Disturb mode.
• Do Not Disturb.
Places the app and smart transmitter in a “Do Not Disturb” mode.
• OFF – ALL notifications – alerts and notifications – regardless of critical nature will be provided by the smart transmitter and app.
• ON – ONLY critical alerts will be provided by the app and smart transmitter’s on-body vibe alerts.
Note: 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 .
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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.
Tap Menu > Settings > Temp Profile to display the TEMP PROFILE screen.
2.
Select the duration. You can set a Temp Profile for up to 36 hours in 30 minute increments.
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3.
Set the High and Low Alerts and High and Low Target 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
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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 .
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Logging out
To log out of your Eversense account, tap Settings > 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.
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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.
The table below describes the vibration patterns on the smart transmitter and the indicators on your app.
Alerts and Notifications
Alerts where no glucose values can be displayed
Requires immediate and appropriate action.
Low Glucose Alert
Requires immediate and appropriate action.
Alerts related to Predictive Low and Out-of-Range
Low Glucose
Requires immediate and appropriate action.
Alerts related to High Glucose
High Glucose Alert, Predictive High, and Out-of-Range High.
Requires immediate and appropriate action.
Smart Transmitter
Vibration Pattern
3 long vibes
3 short vibes x 3
3 short vibes
1 long vibe then
2 short vibes
App Alert
Indicators
MESSAGE APPEARS
IN YELLOW
MESSAGE APPEARS
IN YELLOW
MESSAGE APPEARS
IN YELLOW
MESSAGE APPEARS
IN YELLOW
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Alerts and Notifications
Alerts related to less critical issues
Requires some action but may not be as critical in nature.
See following section for examples.
Charge Smart Transmitter Alert
Your smart transmitter is running low on battery and should be charged.
Notifications
Requires some action but not critical in nature.
See following section for examples.
Smart Transmitter
Vibration Pattern
1 short vibe
3 quick vibes then
1 long vibe x 2
1 short vibe
App Alert
Indicators
MESSAGE APPEARS
IN YELLOW
MESSAGE APPEARS
IN YELLOW
MESSAGE APPEARS
IN BLUE
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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
Notifications
Glucose-related alerts
Battery Alerts
Note: 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 .
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1.
Tap Menu > Alert History .
• The ALERT HISTORY screen will list
ALL alerts and notifications for that day.
• Tap on any message to get more information.
2.
You can choose to include only certain messages
(alerts and notifications, etc.) for review by tapping selected alert icons.
• Tap ALL , then tap icons on top of the screen to select only the types of alerts you want displayed.
• Tap Menu when done.
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Example of ALL
Example of alerts only
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.
Alerts
Low Glucose*
Appears at the interval you enter in sound settings when your sensor glucose reading is at or below the low glucose alert level you set. The default repeat interval is 15 minutes.
High Glucose
Appears at the interval you enter in sound settings when your sensor glucose reading is at or above the high glucose alert level you set. The default repeat interval is 30 minutes.
Pay close attention to your glucose values, symptoms, and trends. If your symptoms do not match the sensor glucose value, confirm your glucose value with a blood glucose meter before making a treatment decision.
Pay close attention to your glucose values, symptoms, and trends. If your symptoms do not match the sensor glucose value, confirm your glucose value with a blood glucose meter before making a treatment decision.
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Alert Descriptions and Actions
(continued)
Alerts
9
Out of Range Low Glucose*
Appears when your glucose reading is lower than
40 mg/dL.
No glucose reading can be displayed (only LO is displayed on the MY GLUCOSE screen).
Confirm your glucose value with a blood glucose meter test before making a treatment decision.
Once the sensor glucose value is at or higher than
40 mg/dL, glucose readings will resume on the display.
Out of Range High Glucose*
Appears when your glucose value is higher than
400 mg/dL.
No glucose reading can be displayed (only HI is displayed on the MY GLUCOSE screen).
Confirm your glucose value with a blood glucose meter test before making a treatment decision.
Once the sensor glucose value is at or lower than
400 mg/dL, glucose readings will resume on the display.
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Alert Descriptions and Actions
(continued)
Alerts
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 is displayed until calibration is performed.
In the Initialization Phase, you must perform
4 fingerstick calibration tests spaced 2 - 12 hours apart. Display of glucose readings will resume after the 2nd successful fingerstick calibration test.
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Alert Descriptions and Actions
(continued)
Alerts
9
Battery Empty*
Appears once when your smart transmitter battery is empty and needs to be charged.
No glucose reading can be displayed until the smart transmitter is charged.
Sensor Replacement*
Appears once when your sensor needs to be replaced.
No glucose reading can be displayed until the sensor is replaced.
Charge the smart transmitter immediately. Remove the smart transmitter from your body before connecting it to the power supply.
Contact your health care provider to have your sensor replaced.
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Alert Descriptions and Actions
(continued)
Alerts
High Ambient Light
Appears every 60 minutes when your sensor is receiving too much ambient light, affecting its ability to communicate with the smart transmitter.
No glucose reading can be displayed until ambient light is reduced.
Reduce ambient light by doing one or more of the following:
•
Move to an area where there is less light exposure.
• Place a dark material over the smart transmitter.
•
Wear the smart transmitter under clothing.
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.
You may temporarily remove the smart transmitter to cool it down. Once the smart transmitter is back to a lower temperature, be sure to replace it over the sensor.
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Alert Descriptions and Actions
(continued)
Alerts
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Vibration Motor
Appears every 60 minutes when the vibration motor on your smart transmitter can no longer provide on-body vibe alerts. You will continue to get glucose readings up to 72 hours after receiving the alert message. 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 transmitter replaced immediately.
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).
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Alert Descriptions and Actions
(continued)
Alerts
High Sensor Temperature*
Appears every 20 minutes when the sensor temperature is too high. No glucose reading is displayed until the sensor temperature is within normal operating conditions.
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.
Go to a cooler environment to reduce the sensor temperature. Briefly remove the smart transmitter while the sensor temperature cools to between
26 - 40 °C (81 - 104 °F). Then put the smart transmitter back on to start receiving glucose values again from the sensor.
Follow the steps shown in the Troubleshooting section to reset your smart transmitter. If you are unable to complete the reset, contact Customer
Support.
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Alert Descriptions and Actions
(continued)
Alerts
9
Calibrate Now
Appears to alert you that your calibration is due.
If you do not calibrate within 4 hours, glucose values will no longer be displayed.
Sensor Check
Appears once when the system’s internal checks detect instability with the sensor which requires a return to calibration Initialization Phase.
Tap Calibrate to enter a calibration value.
In the Initialization Phase, you must perform
4 fingerstick calibration tests spaced 2 - 12 hours apart. Display of glucose readings will resume after the 2nd successful fingerstick calibration test.
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Alert Descriptions and Actions
(continued)
Alerts
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. If your symptoms are different than the sensor glucose values or what the alert indicates, confirm your glucose value with a blood glucose meter test before making a treatment decision.
Pay close attention to your glucose values, symptoms, and trends. If your symptoms are different than the sensor glucose values or what the alert indicates, confirm your glucose value with a blood glucose meter test before making a treatment decision.
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Alert Descriptions and Actions
(continued)
Alerts
9
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. If your symptoms are different than the sensor glucose values or what the alert indicates, confirm your glucose value with a blood glucose meter test before making a treatment decision.
Pay close attention to your glucose values, symptoms and trends. If your symptoms are different than the sensor glucose values or what the alert indicates, confirm your glucose value with a blood glucose meter test before making a treatment decision.
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Alert Descriptions and Actions
(continued)
Alerts
No Sensor Detected*
Appears when the connection between your sensor and transmitter is lost. No glucose data is available until the connection is restored.
Charge Smart Transmitter*
Appears when smart transmitter battery power is very low and you need to charge your battery very soon.
Using the Placement Guide for reference, place the smart transmitter over the sensor until it shows there is a connection.
Charge your smart transmitter as soon as possible.
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Alert Descriptions and Actions
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Alerts
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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.
Re-initialization of the system begins in 6 hours.
Data Unavailable
Appears when the system’s internal checks detect a system error. No glucose reading is displayed until the error is corrected.
Plug the charging cradle with cable into a wall outlet or USB port. Put the smart transmitter into the 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.
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Alert Descriptions and Actions
(continued)
Alerts
Calibration In Progress
Appears when your calibration value is significantly different from your sensor glucose value.
Incompatible Transmitter Software
Appears when the software in your smart transmitter is incompatible with the Eversense CGM Mobile App version on your mobile device.
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Do not remove your transmitter for 15 minutes.
Re-calibrate when prompted.
Contact Customer Support.
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Alert Descriptions and Actions
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Notifications
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Incompatible Device/Operating System
Appears when an incompatible device/operating system is being used with the app.
Calibrate Now
Appears when it is time for you to calibrate.
For a list of compatible devices/operating systems visit eversensediabetes.com.
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.
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Alert Descriptions and Actions
(continued)
Notifications
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.
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.
Tap Link Sensor to complete the linking process and begin the 24-hour Warm-Up Phase. You do not need to wear your smart transmitter over the sensor until the Warm-Up Phase is complete.
Contact your health care provider to schedule the removal and replacement of your sensor.
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Alert Descriptions and Actions
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Notifications
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Calibrate Again
Appears when not enough data has been collected during calibration.
New Calibration Needed
Appears if the calibration value entered is very 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.
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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:
Glucose
Meals
Insulin
Health
Exercise
Note: You can also access the ADD EVENT screen directly from the MY GLUCOSE screen with a single tap anywhere on the graph area.
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View Events
You can view past events entered from the EVENT LOG screen.
1.
Tap Menu > Event Log .
The EVENT LOG screen will appear.
2.
All your entered events will be listed.
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.
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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.
Tap Glucose to enter the correct blood glucose value.
Tap Done .
Note: You can enter a BG value between 20 and
600 mg/dL. Entries < 20 mg/dL will be converted to 20, and entries above 600 mg/dL will be converted to 600 for calculation and display purposes.
5.
Tap Save .
6.
On the Confirm Glucose pop up box, tap Submit to confirm the glucose event and return to the 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.
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Meals
Enter the type of meal, date and time and carbohydrate count.
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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.
Tap Type to enter the type of meal.
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.
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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.
Tap Units to enter the correct number of Units.
Tap Done .
Note: The maximum insulin units that can be entered is 200U.
5.
Tap 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. Tap
Cancel to exit without saving changes.
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Health
Enter the type of health condition, severity, and date and time.
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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.
Tap Severity to enter Low, Medium or High.
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.
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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.
Tap Intensity to enter Low, Medium or High.
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.
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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.
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.
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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.
• The green horizontal dotted lines are your pre-set High and Low Glucose
Target levels.
This report also provides summary statistics (average readings, standard deviation of readings), glucose target performance (percent within, above and below glucose target levels), and glucose reading highs and lows
(percent of readings that fall within the low and high glucose target levels).
The information is shown based on 6 hour time slots.
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Glucose Pie Chart
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.
Glucose Statistics
This report shows your average, low and high glucose readings, along with standard deviation within
6 hour time periods. You can choose the last 1, 7, 14, 30 or 90 days.
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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. 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. The Eversense NOW App
User Guide has more information on how to remotely view glucose data from the Eversense CGM System.
IMPORTANT: EVERSENSE DATA MANAGEMENT SYSTEM DOES NOT PROVIDE MEDICAL ADVICE. CHANGES
TO YOUR TREATMENT PLAN SHOULD ONLY BE MADE BY YOUR HEALTH CARE TEAM.
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Sync
As long as you have an internet connection, and you are logged into the app, your glucose readings sync to your Eversense DMS account about every 5 minutes.
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.
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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 .
IMPORTANT: Both the Eversense CGM Mobile App and the
Eversense NOW Remote Monitoring App must be downloaded from the US App Store in order for them to communicate.
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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.
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 MY SENSOR screen, you can view the sensor serial number and insertion details.
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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.
• Tap Contact Us to send an email to Senseonics, Inc.
To read the End User License
Agreement and the Privacy Policy, tap either option.
IMPORTANT: This email is not monitored 24/7. DO NOT use this email for health-related or any urgent issues.
To find your local distributor on our website, tap Help .
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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 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 CGM data and should not be used in place of the primary
Eversense CGM display.
Any problems with mobile devices, wireless internet, data connection, the Eversense Data Management System (DMS), the CGM user’s smart transmitter out of range of their mobile device, or charging their smart transmitter may cause data transfer to be delayed or not to be displayed.
If at any time you have symptoms of a low or high blood glucose level OR if your symptoms are not consistent with the sensor glucose readings, you should test your glucose with a blood glucose meter before making a treatment decision.
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To access additional app features, tap the Eversense icon on your watch HOME screen to open the app.
The My Glucose screen shows your current glucose with trend arrow, and a trend graph of your last three hours of CGM data.
You can also access the
MY GLUCOSE screen if you turn on notifications from
Eversense in your Apple Watch settings. When you receive a notification, you can also tap on the message to see the
MY GLUCOSE screen.
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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 up to display the same data shown as percentages.
Swipe left to the next screen showing your current glucose with trend arrow, your next calibration time, the current system calibration phase, and battery level of your smart transmitter.
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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.
If you dismiss an alert on the watch, the alert display will disappear from the phone lock screen. Once the mobile app is opened, the alert will be displayed with all of its information.
The following table lists the alerts and notifications you may receive on the Apple Watch from the Eversense App.
Some alerts and notifications are affected by the sound settings in the mobile app, and the Do Not Disturb function in the mobile app. See Setting Sounds and Alert Descriptions and Actions for more information.
Low Glucose
Appears at the interval you enter in sound settings when your sensor glucose reading is at or below the low glucose alert level you set.
High Glucose
Appears at the interval you enter in sound settings when your sensor glucose reading is at or above the high glucose alert level you set.
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Confirm the alert on your Eversense CGM
Mobile App.
Pay close attention to your glucose values, symptoms, and trends. If your symptoms do not match the sensor glucose value, confirm your glucose value with a blood glucose meter before making a treatment decision.
Confirm the alert on your Eversense CGM
Mobile App.
Pay close attention to your glucose values, symptoms, and trends. If your symptoms do not match the sensor glucose value, confirm your glucose value with a blood glucose meter before making a treatment decision.
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Alerts and Notifications Displayed on the Apple Watch
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Alerts
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Out of Range Low Glucose
Appears when your glucose reading is lower than
40 mg/dL.
No glucose reading can be displayed.
Out of Range High Glucose
Appears when your glucose value is higher than
400 mg/dL.
No glucose reading can be displayed.
Confirm the alert on your Eversense CGM
Mobile App.
Measure your glucose manually by using your blood glucose meter. Always confirm your glucose value with a blood glucose meter before making a treatment decision. Once the sensor glucose value is at or higher than
40 mg/dL, glucose readings will resume on the display.
Confirm the alert on your Eversense CGM
Mobile App.
Measure your glucose manually by using your blood glucose meter. Always confirm your glucose value with a blood glucose meter before making a treatment decision. Once the sensor glucose value is at or lower than
400 mg/dL, glucose readings will resume on the display.
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Alerts and Notifications Displayed on the Apple Watch
(continued)
Alerts
Calibration Past Due
Appears when your system is past due for calibration.
No glucose readings can be displayed until calibration is entered in the Eversense CGM
Mobile App.
Confirm the alert on your Eversense CGM
Mobile App.
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 entered in the Eversense CGM
Mobile App.
Confirm the alert on your Eversense CGM
Mobile App.
In the Initialization Phase, you must perform 4 fingerstick calibrations spaced
2 - 12 hours apart. Display of glucose readings will resume after the 2nd successful fingerstick calibration.
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Alerts and Notifications Displayed on the Apple Watch
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Alerts
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Battery Empty
Appears once when your smart transmitter battery is empty and needs to be charged.
No glucose reading can be displayed until the smart transmitter is charged.
Sensor Replacement
Appears once when your sensor needs to be replaced.
No glucose reading can be displayed until the sensor is replaced.
Confirm the alert on your Eversense CGM Mobile
App.
Charge the smart transmitter immediately.
Remove the smart transmitter from your body before connecting it to the power supply.
Confirm the alert on your Eversense CGM
Mobile App.
Contact your health care provider to have your sensor replaced.
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Alerts and Notifications Displayed on the Apple Watch
(continued)
Alerts
High Ambient Light
Appears every 60 minutes when your sensor is receiving too much ambient light, affecting its ability to communicate with the smart transmitter.
No glucose reading can be displayed until ambient light is reduced.
Confirm the alert on your Eversense CGM
Mobile App.
Reduce ambient light by doing one or more of the following:
• Move to an area where there is less light exposure.
• Place a dark material over the smart transmitter.
• Wear the smart transmitter under clothing.
High 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.
Confirm the alert on your Eversense CGM Mobile
App.
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. You may temporarily remove the smart transmitter to cool it down. Once the smart transmitter is back to a lower temperature, be sure to replace it over the sensor.
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Alerts
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Vibration Motor
Appears every 60 minutes when the vibration motor on your smart transmitter can no longer provide on-body vibe alerts. You will continue to get glucose readings up to 72 hours after receiving the alert message. 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 App.
Contact Customer Support to have your smart transmitter replaced immediately.
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.
Confirm the alert on your Eversense CGM Mobile
App.
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).
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Alerts and Notifications Displayed on the Apple Watch
(continued)
Alerts
High Sensor Temperature
Appears every 20 minutes when the sensor temperature is too high.
No glucose reading is displayed until the sensor temperature is within normal operating conditions.
Transmitter Error
Appears when the system’s internal checks detect a smart transmitter error.
No glucose reading is displayed until the error is corrected.
Confirm the alert on your Eversense CGM Mobile
App.
Go to a cooler environment to reduce the sensor temperature. Briefly remove the smart transmitter while the sensor temperature cools to between 26 - 40 °C (81 - 104 °F). Then put the smart transmitter back on to start receiving glucose values again from the sensor.
Confirm the alert on your Eversense CGM
Mobile App.
Follow the steps shown in the
Troubleshooting section to reset your smart transmitter. If you are unable to complete the reset, contact Customer Support.
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Alerts and Notifications Displayed on the Apple Watch
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Alerts
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Calibrate Now
Appears to alert you that your calibration is due.
If you do not calibrate within 4 hours, glucose values will no longer be displayed.
Sensor Check
Appears once when the system’s internal checks detect instability with the sensor which requires a return to calibration Initialization Phase.
Confirm the alert on your Eversense CGM
Mobile App.
Tap Calibrate on your mobile device to enter a calibration value.
Confirm the alert on your Eversense CGM
Mobile App.
In the Initialization Phase, you must perform 4 fingerstick calibrations spaced
2 - 12 hours apart. Display of glucose readings will resume after the 2nd successful fingerstick calibration.
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Alerts and Notifications Displayed on the Apple Watch
(continued)
Alerts
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.
Confirm the alert on your Eversense CGM
Mobile App.
Pay close attention to your glucose values, symptoms, and trends. If symptoms do not match the sensor glucose value, confirm your glucose value with a blood glucose meter before making a treatment decision.
Confirm the alert on your Eversense CGM
Mobile App.
Pay close attention to your glucose values, symptoms, and trends. If symptoms do not match the sensor glucose value, confirm your glucose value with a blood glucose meter before making a treatment decision.
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Alerts and Notifications Displayed on the Apple Watch
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Alerts
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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.
Confirm the alert on your Eversense CGM
Mobile App.
Pay close attention to your glucose values, symptoms, and trends. If symptoms do not match the sensor glucose value, confirm your glucose value with a blood glucose meter before making a treatment decision.
Confirm the alert on your Eversense CGM
Mobile App.
Pay close attention to your glucose values, symptoms, and trends. If symptoms do not match the sensor glucose value, confirm your glucose value with a blood glucose meter before making a treatment decision.
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Alerts and Notifications Displayed on the Apple Watch
(continued)
Alerts
No Sensor Detected
Appears when the connection between your sensor and transmitter is lost. No glucose data is available until the connection is restored.
Charge Transmitter
Appears when smart transmitter battery power is very low and you need to charge your battery very soon.
Confirm the alert on your Eversense CGM
Mobile App.
Using the Placement Guide for reference, place the smart transmitter over the sensor until it shows there is a connection.
Confirm the alert on your Eversense CGM
Mobile App.
Charge your smart transmitter as soon as possible.
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Alerts and Notifications Displayed on the Apple Watch
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Alerts
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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.
Confirm the alert on your Eversense CGM
Mobile App.
Re-initialization of the system begins in 6 hours.
Calibrate Now
Appears every 60 minutes when it is time for you to calibrate.
Confirm the alert on your Eversense CGM
Mobile App.
Do a fingerstick blood glucose test and enter the reading as your calibration value in the mobile app. DO NOT use an alternative site
(such as forearm) to obtain your blood glucose reading.
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Alerts and Notifications Displayed on the Apple Watch
(continued)
Notifications
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.
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.
Confirm the alert on your Eversense CGM Mobile
App.
In your mobile app, tap Link Sensor to complete the linking process and begin the
24-hour Warm-Up Phase. You do not need to wear your smart transmitter over the sensor until the Warm-Up Phase is complete.
Confirm the alert on your Eversense CGM
Mobile App.
Contact your health care provider to schedule the removal and replacement of your sensor.
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Alerts and Notifications Displayed on the Apple Watch
(continued)
Notifications
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Calibrate Again
Appears when not enough data has been collected during calibration.
New Calibration Needed notification
Appears if the calibration value entered is very different from the sensor glucose value. After
60 minutes, you will receive a Calibrate Now notification.
Confirm the alert on your Eversense CGM
Mobile App.
Tap Calibrate on your mobile device to enter a new calibration value.
Confirm the alert on your Eversense CGM
Mobile App.
Enter a new calibration value when prompted.
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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.
Risks
There may be times when glucose data cannot be sent to the Eversense NOW App. lf a member of your Circle is not receiving glucose data from your Eversense CGM System, they cannot assist you in the event of a high or low glucose value. The secondary display and notifications on the Eversense NOW Mobile App are not a replacement for the primary display on your Eversense CGM System Mobile App.
Members of your Circle may not always have a connection to support data transfer such as internet/wifi or 3G/4G/LTE.
If you or a member of your Circle does not have an internet connection, your glucose data will not be available for viewing on a secondary display. Any problems with mobile devices, wireless internet, data connection, the Eversense
Data Management System (DMS) System, having your smart transmitter out of range of your mobile device, or charging your smart transmitter may prevent data from being displayed to members of your Circle. You should not rely on people remotely monitoring your glucose data to assist you in the event of a high or low glucose event.
The remote monitoring feature provides a secondary display of notifications and data to those in your Circle. It is not a real-time remote monitoring system.
Benefits
The Eversense CGM System used with the Eversense NOW Remote Monitoring App may provide CGM users with additional confidence, knowing that others can also view their CGM data.
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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.
• You should not rely on those who are remotely monitoring your glucose to notify you about high or low glucose events.
Precautions
•
The Eversense NOW Mobile App does not replace the monitoring regimen as directed by your health care provider.
• If you and the members of your Circle do not have an internet connection, or the mobile device has shut down due to a low or empty battery, your Eversense CGM data cannot be displayed on the Eversense NOW App.
• If the members of your Circle turn off the sounds on their mobile device, they will not receive audible alerts about your CGM data on their Eversense NOW App.
•
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.
•
The Eversense NOW App does not communicate directly with the Eversense Sensor and/or with the Eversense
Smart Transmitter.
• The Eversense NOW App cannot change the settings on the Eversense CGM App.
• If the Eversense NOW user does not allow notifications from the Eversense NOW App, they will not receive glucose related alerts from you.
• If you have your mobile device set to Do Not Disturb, you will not hear any notifications from the Eversense
NOW App.
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Through the MY CIRCLE screen on your Eversense CGM 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.
As long as your Eversense CGM System App and the Eversense NOW App have an internet connection, your glucose data is synced to the Eversense NOW App approximately every 5 minutes. Calibration values may take longer to sync to the Eversense NOW App.
1.
From the Main Menu, tap Share My Data >
My Circle to display the MY CIRCLE screen.
2.
To invite a new member to view your glucose data, tap Invite to My Circle .
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3.
Enter the email for the person you 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.
4.
An Invitation Sent screen appears. Tap OK .
When the invitation has been accepted, the member’s name will appear in your Members List on the MY CIRCLE screen in your app.
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Tip: Nicknames are optional, and are used to help you easily manage your Circle Members. If you choose not to give a nickname to a Circle
Member, their email address will show in place of a nickname.
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Note: Profile pictures of those remotely viewing your glucose data are set up in the DMS account by the account owner. You cannot change profile pictures of those you have invited to your Circle.
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.
Tap Remove to remove the member from your circle.
Tap Yes when prompted.
The member you remove will be notified on their Eversense
NOW App if they have already accepted.
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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. 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.
Note: The Eversense NOW user can also remove you from their app. It can take up to 2 hours for these changes to display on your Eversense CGM App.
For more information about the Eversense NOW App, please visit eversensediabetes.com.
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16. About the Sensor
This section describes the Eversense Sensor and how it is inserted by your health care provider.
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.
The sensor is encased in a biocompatible material and utilizes a unique fluorescent, glucose indicating polymer. A light emitting diode embedded in the sensor excites the polymer, and the polymer then rapidly signals changes in glucose concentration via a change in light output. The measurement is then relayed to the smart transmitter. Measurements are completed automatically and require no action by the user.
The sensor is approximately 3.5 mm x 18.3 mm and has a silicone ring that contains a small amount of dexamethasone acetate, an anti-inflammatory steroid drug. The dexamethasone acetate minimizes inflammatory responses, very similar to common medical devices, such as pacemakers.
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Insertion Steps
Your health care provider 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. Placement in this area minimizes the chance of the sensor and smart transmitter being bumped by doorways, walls or other narrow passages. If possible, avoid areas with loose skin, scars, tattoos, nevus, or blood vessels that could be incised during the procedure. It is recommended to alternate arms for subsequent insertion sites.
Step 1:
Site preparation – the insertion site will be cleaned, disinfected, then anesthetized using lidocaine.
Step 2:
Incision – a small (less than 1 centimeter) incision will be made at the insertion site.
Step 3:
Sensor insertion – a subcutaneous pocket will be created under the skin and the sensor will be inserted in this pocket.
Step 4:
Site closure – the incision will be closed with an adhesive bandage. Steri Strips™ are typically used to close the incision.
Step 5:
Sensor and smart transmitter linking – link the sensor and smart transmitter to begin the 24-hour
Warm-Up Phase.
Note: After insertion, link the smart transmitter and the sensor and then allow the incision site to heal 24 hours before replacing the transmitter .
The sensor requires 24 hours to stabilize within the insertion site, this period is known as the Warm-up Phase. After the first 24 hours of sensor insertion, position and secure the smart transmitter over the sensor and ensure you have a connection. (See Secure the Smart Transmitter over Inserted Sensor.
) Then you can perform your Initialization Phase calibration of 4 fingerstick blood glucose tests to start getting glucose readings.
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Removal Steps
Similarly to the insertion steps, your health care provider 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.
Step 4:
Site closure – once removed, the incision will be closed with a Steri Strips™ (sutures may be used depending on provider’s preference).
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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. The Eversense 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.
(Reference FAA Advisory, Circular #21-16G, dated 6.22.2011.) To use, turn your mobile device’s Bluetooth feature on after you have put your mobile device in airplane mode. For flights outside the US, follow local security regulations for use of medical devices in flight.
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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.
2. Use the PLACEMENT GUIDE screen on the app to confirm connection between the sensor and the transmitter.
• Tap Placement Guide .
• Position the smart transmitter over the sensor so that a connection is confirmed.
Q: How do I turn my smart transmitter ON?
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 properly position the smart transmitter over the sensor?
A: There are two ways to ensure proper positioning:
1. When using the adhesive patch to secure the smart transmitter, make sure the power button symbol and the LED are lined up in parallel with your arm.
Q: My smart transmitter will not vibrate. Why?
A: If the smart transmitter does not vibrate, try the following steps:
• Check that the smart transmitter is connected to your mobile device.
• Check that the Do Not Disturb is disabled by tapping Menu > Settings > Sound
Settings.
• Check that your smart transmitter has enough battery power and charge if necessary.
If the smart transmitter still will not vibrate, contact
Customer Support or your local distributor for further troubleshooting.
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Q: Can I use the same adhesive patch more than once a day?
A: The individual adhesive patch is intended to be used for a 24 hour period.
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. Once you have paired your smart transmitter and mobile device, you can also find the serial number and model by tapping
Menu > About > My Transmitter .
Q: How do I customize the name of my smart transmitter?
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.
Q: Why does my smart transmitter show a continuous solid orange LED?
A: Follow the steps below to troubleshoot the smart transmitter:
1. Make sure the smart transmitter is paired with your mobile device.
2. Make sure the smart transmitter is charged.
3. Check your app for any alerts or notifications.
4. Remove the smart transmitter from your arm and wait for a few minutes. A No Sensor
Detected message will appear and the smart transmitter should vibrate more frequently as it searches for a sensor. If the smart transmitter does not vibrate or if the app does not show
No Sensor Detected , contact Customer
Support in the US. Outside the US, contact your local distributor. Place the smart transmitter back over the sensor to see if the orange LED disappears and observe any notifications on the app.
If the orange LED continues to stay lit, contact
Customer Support.
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Smart Transmitter Battery and
Charging
Q: How long does a fully charged smart transmitter battery last?
A: A fully charged smart transmitter battery typically lasts approximately 24 to 36 hours.
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. It may take longer if charging via a computer USB port or when the battery is empty.
Q: How do I check the smart transmitter battery status?
A: There are three ways to check battery status:
1. Tap Menu > About > My Transmitter . Scroll down to the Battery Level line that indicates amount of battery power left.
2. Check the battery symbol in the upper right corner on the MY GLUCOSE screen. A red battery icon indicates the smart transmitter battery is empty.
3. Power ON the smart transmitter. Press and release the smart transmitter power button. An orange
LED on the smart transmitter indicates low battery.
A green LED indicates the battery is at least 10% charged.
Q: What happens if my smart transmitter battery is completely drained?
A: No glucose readings will be displayed. Always charge immediately when the smart transmitter battery is completely drained.
Q: On the About > My Transmitter page, the battery level shows 65% and then drops to 35%.
Why is that?
A: The rate battery levels discharge varies widely based on use; the same battery model in two devices will not discharge at the same rate. This is why we show battery level indicators on this screen in large increments: 100%, 65%, 35%, 10% and 0%. Our testing shows that the “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.
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Connection with Smart
Transmitter
Q: How do I pair my mobile device and smart transmitter for the first time?
A: Follow the steps below to pair your mobile device and smart transmitter. Please read this User Guide for more detailed information.
1. Launch the Eversense App.
2. Press the smart transmitter power button three times to get it into “Discoverable” mode.
3. When the smart transmitter blinks green and orange, tap the smart transmitter ID on the
CONNECT screen. The app will then begin the searching process.
• Your smart transmitter ID is the same as the serial number listed on the back of the smart transmitter.
4. When the app finds your smart transmitter, a
BLUETOOTH PAIRING REQUEST pop-up screen appears.
5. Tap Pair to confirm the pairing.
6. The app will display Connected next to the smart transmitter ID once the pairing is completed.
Q: My smart transmitter and mobile device do not appear to be connected.
A: There may be several reasons why you do not have a connection.
•
Make sure the Bluetooth setting on your mobile device is ON and the smart transmitter’s name or serial number appears on the device list.
• The condition may only be temporary. Tap
Menu > Connect . If your smart transmitter name indicates Disconnected , tap the smart transmitter name to connect manually.
• Your smart transmitter and mobile device may be out of wireless range. Move your mobile device closer to the smart transmitter.
• Your smart transmitter may be turned off, out of battery power or is currently being charged. You may need to restart the Bluetooth (BLE) function on the smart transmitter by following the steps below.
1. Power off the smart transmitter – Press and hold the power button for 5 seconds and wait for the vibration to confirm it is powered off.
2. Wait 2 seconds and press the power button three times to restart BLE. (Note: When doing a BLE restart, do not remove/forget the paired device via your mobile device’s Bluetooth Settings.)
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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. If the problem still exists, you may need to reset your smart transmitter.
Q: How do I reset my smart transmitter?
A: Follow the steps below.
1. Place the smart transmitter into the charging cradle and connect the USB cable. Plug the cable into the wall outlet. (You can also plug the standard USB end of the cable directly into a
USB port on your computer.)
2. Press and hold the power button (for approx.
14 seconds) on the smart transmitter while connected to the USB. Release the power button.
3. The LED will start blinking in about two seconds indicating the smart transmitter is going through a self-test sequence. The LED will blink in various colors. Once the self test is complete, the smart transmitter will vibrate and a steady green or orange
LED will stay on.
4. If the self-test does not complete, repeat steps 1 through 3.
5. If step 3 is successfully completed, the smart transmitter is now ready for use.
6. Disconnect the smart transmitter from the USB cable and proceed with pairing. Once paired, the system will be in the Initialization Phase. If you are unable to complete the reset, contact Customer Support.
Q: Can other people connect to my smart transmitter?
A: The Eversense CGM System utilizes a secure Bluetooth connection and will not allow others to connect.
Q: What happens if my smart transmitter is disconnected from my mobile device or app?
A: The smart transmitter will vibrate and the app will provide a “Transmitter Disconnected” notification every 5 to 30 minutes, based on your sound settings, 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.
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Q: Why am I unable to connect my mobile device to my smart transmitter ( No Transmitter
Connected is displayed in the app status bar)?
A: The smart transmitter may fail to connect with your mobile device for any of the following reasons:
• The smart transmitter is currently charging.
• 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 do I see Searching on the CONNECT screen?
A: The app will continue to show Searching for any of the following reasons:
• The smart transmitter is currently charging.
• 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: What is “Discoverable” (Pairing) mode?
A: Discoverable mode is the smart transmitter state that enables it to be located by your mobile device for pairing. See Getting Started for more information.
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 do I see other smart transmitters listed on the
CONNECT screen?
A: If other Eversense CGM users are around you, then the app may find those devices. However, the app connects only to the smart transmitter that was paired with your mobile device. DO NOT attempt to pair your mobile device to other smart transmitters that are not yours.
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Q: I just received a new smart transmitter. How do
I unlink the old one and link the new one to my sensor?
A: On the Main Menu, tap Connect . Tap and hold the name of your old smart transmitter. Tap OK to stop the app from automatically connecting with the old smart transmitter. Follow the steps in this
User Guide for pairing the new smart transmitter with the app and linking it to your sensor.
Calibration
Q: Will doing more than 2 fingerstick calibrations per day affect the accuracy of the system?
A: The accuracy will not be negatively impacted if you do more than the required 2 calibrations per day.
Q: What time should I enter on the CALIBRATE screen when I am notified to calibrate?
A: Enter the time you tested your blood glucose with your meter. You must enter the blood glucose reading within
10 minutes of doing the test.
Q: Why was my calibration rejected?
A: The system will reject the calibration for the any of the following reasons:
• 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.
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Q: Why am I unable to calibrate?
A: You may not be able to calibrate for any of the following reasons:
• Not enough sensor glucose data has been 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 40 mg/dL.
• The blood glucose reading is greater than
400 mg/dL.
• The blood glucose reading was taken more than
10 minutes prior to entering it in the Eversense
App.
• The last sensor glucose value is significantly different than the blood glucose reading entered.
• A calibration is in progress.
• It is less than 1 hour since the last successful calibration.
• Your transmitter is disconnected.
• Transmitter is not linked to your sensor.
•
Your sensor needs to be replaced.
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 .
Q: What are the different types of calibration phases?
A: The Eversense CGM System has two types of
Calibration Phases, the Initialization Phase and the
Daily Calibration Phase. Initialization Phase begins
24 hours after sensor insertion and requires
4 fingerstick blood glucose tests for calibration. The
Daily Calibration Phase occurs after the Initialization
Phase and requires you to calibrate every 12 hours.
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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?
A: A Notification is a non-critical, low priority message
(e.g., calibration reminder).
An Alert is an important message that needs your attention and may require you to respond/take action.
Q: Can I increase the volume of the app sounds coming from my mobile device?
A: You may increase the volume of the app sounds by connecting your mobile device to an external device to amplify the sound.
Q: Can I change the number of alerts I receive?
A: If you feel that you are getting too many alerts, you should first discuss the alert settings best suited for you with your health care provider. If you need to change your glucose alert settings, tap Menu >
Settings > Glucose .
Q: What are predictive alerts?
A: Predictive Alerts notify you in advance of an event that is likely to occur if current trends continue.
Predictive Alerts use High and Low Glucose Alert levels you set to determine when the Predictive Alerts occur. You can set the alerts to notify you at 10, 20, or 30 minutes in advance of when the CGM System anticipates you reaching the alert levels you set.
Your smart transmitter will vibrate, and your app will sound an alert and display a message on the
MY GLUCOSE screen to notify you of a predicted high or low glucose. If your symptoms do not match the sensor glucose value, or what the alerts indicate, you should immediately perform a fingerstick blood glucose test before making a treatment decision.
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 .
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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 .
Q: Why am I unable to see notifications when the app is in the background?
A: Refer to your mobile device instructions to enable the notifications in the background.
Q: What happens to the notifications if my app is disconnected from my smart transmitter?
A: If the app is disconnected from your smart transmitter, but you have been wearing your smart transmitter over your sensor, the alerts received during that time will be sent to the app once it is reconnected and synced with the smart transmitter.
Q: How can I sort the notifications on the ALERT
HISTORY screen?
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.
Q: How do I silence glucose alerts?
A: Glucose Alerts can be silenced by confirming the alert on your mobile device and taking the appropriate action if necessary.
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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), and for some people, during the first several days after insertion due to inflammation that may result from the insertion procedure. On average, glucose levels in ISF lag behind glucose levels in blood by several minutes. Until you are aware of what these differences are, confirm sensor readings with a fingerstick blood glucose check. Also, if your symptoms do not match the sensor glucose readings, you should confirm with a fingerstick blood glucose check.
Q: I am getting “-- -- --” in place of sensor glucose readings on the app.
A: You may not get any sensor glucose readings when there is no connection between your smart transmitter and your sensor or smart transmitter and mobile device.
You may also not get any readings when one of the alerts below is activated:
• No sensor detected.
• Out of Range High or Out of Range Low Glucose
Sensor reading.
• Low Sensor Temperature.
• High Ambient Light.
•
Sensor Check.
• High Smart Transmitter Temperature.
• High Sensor Temperature.
• Empty Battery.
•
Calibration Past Due.
• New Sensor Detected.
• Sensor Replacement.
•
Calibration Expired.
• Smart Transmitter Error.
• Sensor Suspend Alert.
Please follow the instructions provided in the notification message to clear the Alert.
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Making Treatment Decisions
Q: What information should be considered before I make a treatment decision?
A: 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 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.
Q: When should I do a fingerstick test with a blood glucose meter?
A: You should perform a blood glucose test on a meter:
• When it is time to calibrate.
• No glucose value is displayed.
• No trend arrow is displayed.
•
Your symptoms do not match the glucose information displayed.
• The current sensor glucose value is displayed in grey.
• The status bar is displayed in orange.
• You are taking medications of the tetracycline class.
Q: Why is my glucose value grey?
A: When the system does not have enough data to provide a trend arrow, the sensor glucose value may be displayed in grey. You should not make a treatment decision based solely on the sensor glucose value.
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Trend Arrows
Q: My trend arrows and glucose alerts do not match.
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: My trend arrow is missing.
A: The CGM System uses the last 20 minutes of continuous glucose data for calculating and displaying the trend arrow. When there are not enough sensor values available for the calculation, the arrow is not displayed. You should not make treatment decisions unless you see a glucose value, a trend arrow, and consider recent trends and alerts.
App
Q: What will happen if I re-install the app?
A: Upon re-installing the app, the app will download historical data only from the last 3 days.
Q: What version of the app is installed on my mobile device?
A: You can find the app software version by tapping
Menu > About > Product Information .
Q: How will my app be updated?
A: Visit www.eversensediabetes.com for instructions on updating the app software.
Q: What devices are compatible with the Eversense
App?
A: Visit www.eversensediabetes.com for a list of compatible devices.
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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: Why does my status bar say “syncing”?
A: “Syncing” will appear in the status bar when the app on your mobile device is connecting to your smart transmitter.
Q: My Glucose Settings and Temp Profile Settings are grayed out and I cannot adjust them.
A: Your app must be paired to a smart transmitter to be able to adjust your Glucose and Temp Profile settings.
Q: What is the Do Not Disturb option?
A: When Do Not Disturb is enabled in the Eversense
App Settings, the mobile app will stop displaying non-critical alerts. The smart transmitter will also stop providing vibratory alerts for non-critical alerts.
Critical alerts will still be provided by the smart transmitter and the mobile app.
Note that the Do Not Disturb feature on your smartphone overrides the Do Not Disturb option in the app. So if the Do Not Disturb feature on your smartphone is turned on, you will not receive the alerts on the smart transmitter or in the app.
Be aware that some apps may automatically enable
Do Not Disturb on your phone.
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Sensor
Q: Can the sensor be inserted in another body part besides my upper arm?
A: The Eversense CGM System was only tested in the upper arm during clinical studies, and the sensor should not be inserted in other locations.
Q: When do I need to replace my sensor?
A: Your sensor lasts up to 90 days. You will receive periodic notices (30, 14, 7, 3, 2, and 1 day prior) to remind you when the sensor needs to be replaced.
Contact your health care provider to schedule a sensor replacement.
Q: Can I extend the 90 day life of the sensor?
A: The sensor will no longer provide glucose readings after 90 days of wear and must be replaced.
Q: Where can I find the sensor serial number?
A: You can view the sensor serial number by tapping
Menu > About > My Sensor .
Q: I have just linked a sensor and smart transmitter for the first time, but the insertion date and/or time do not show when I tap About > My Sensor .
A: It may take up to 10 minutes for the linking process to complete. Be sure the smart transmitter is on top of the sensor. Confirm the LINKED SENSOR screen shows a check mark for Linking Process
Complete. Navigate to the MY GLUCOSE screen and wait about 2 minutes. Return to the
MY SENSOR screen.
If the correct insertion date and time are still not displayed, follow these steps:
1. Remove the smart transmitter from the insertion site. Connect it with the charging cable and power supply. Plug the power supply into the wall outlet and then unplug it and disconnect it from charging cable.
2. Replace smart transmitter over sensor. Navigate to About > My Sensor and confirm correct insertion date and time. If problem persists, contact Customer Support.
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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: Is it okay for an MRI technician to wear the
Eversense CGM System?
A: Yes, MRI technicians can wear the Eversense
CGM System. However, for people undergoing an
MRI with a static magnetic field of 1.5T or 3.0T, the sensor can stay in place under the skin, but the smart transmitter must be removed and left outside the room.
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 different than the current sensor glucose readings.
• Y our smart transmitter has not been charged within
16 hours of the empty battery alert.
• If you manually change the time on your mobile device your smart transmitter will sync and reinitialize to your mobile device.
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Events
Q: How can I sort my events on the EVENT LOG screen?
A: The 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. The default sort option is to show ALL events.
Sync
Q: Why do I sometimes see a blue and white progress bar across the top of my screen?
A: You will see this syncing progress bar for several reasons:
• Your smart transmitter was out of range of your 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.
• Your data is being uploaded to your Eversense DMS account.
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Shortcuts
Q: Is there a way to select a date to view on the
MY GLUCOSE screen, instead of scrolling backwards?
A: Yes, tap the “ Today ” bar right above the graph.
A pop-up will appear for you to select the desired date to be displayed on the graph.
Q: If I’m viewing a date/time in the past on the
MY GLUCOSE screen, is there a short cut back to the current date and time?
A: Yes, tap the glucose value/trend arrow to return to the current date/time on the MY GLUCOSE screen.
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.
Q: Is there a shortcut to the CONNECT screen?
A: If your smart transmitter is disconnected from the app, when you tap the status bar at the top of the screen, the CONNECT screen is displayed.
Q: Is there a shortcut to enter an event, like meals or exercise?
A: From the MY GLUCOSE screen, tap on the graph to display the EVENT ENTRY screen.
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19. Device Performance
This section lists Device Performance Characteristics.
Clinical Study Performance
The safety and effectiveness of the Eversense CGM System has been evaluated in several feasibility and pivotal studies. Two studies – PRECISE II (2016) and PRECISION (2018) – were conducted in the U.S. to evaluate the
Eversense CGM System performance in terms of safety and effectiveness. The data collected was analyzed using a new algorithm, SW 602. Accuracy assessments were made at various points during the studies and subjects were asked to report any adverse events throughout the studies.
PRECISE II Study
PRECISE II was a multi-site, non-randomized single-arm pivotal clinical study. Ninety (90) adults (18 years and older) with type 1 or type 2 diabetes participated in the study across 8 sites in the U.S. Each had a sensor inserted in the upper arm to collect glucose data but not be displayed to the subject. Some participants had a sensor inserted into each arm for clinical data collection. Participants interacted with the system to calibrate and address notifications not related to glucose data. Accuracy was measured during day-long clinic visits, with blood taken about every
15 minutes. These visits occurred on Days 1, 30, 60, and 90. At each visit, sensor accuracy was evaluated relative to a standard laboratory analyzer known as the YSI. Glucose readings were compared at the same moment in time between the reference analyzer and the continuous device. A safety follow-up visit occurred at Day 100, or ten days after the sensor was removed.
PRECISION Study
PRECISION was a second non-randomized single-arm pivotal clinical study conducted in the U.S. in 3 sites.
Thirty-five (35) adults (18 years and older) with type 1 or type 2 diabetes participated in the study which was similar in study design as PRECISE II, except glucose readings and high/low glucose alerts were not blinded to the participants, and study visits on days 7 and 14 were added. The table below characterizes accuracy of the system by assessing the sensor glucose values against the YSI reference values.
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Table 1 – Accuracy to YSI in PRECISE II* and PRECISION*
Study
PRECISE II
PRECISION
Number of
Participants
Total
Number of Paired
CGM and YSI
Values
15,753
Percent
Within
15/15%
Percent
Within
20/20%
Percent
Within
30/30%
Percent
Within
40/40%
MARD
87% 94% 99% 100% 8.5% 90 adults
(18 years and older)
35 adults
(18 years and older)
15,170 85% 93% 98% 99% 9.6%
*Data is from primary sensors only; glucose values between 40 and 400 mg/dL.
Since the two studies are similar, the PRECISION study is included in this report. For detailed information on the
PRECISE II results, please go to our website www.eversensediabetes.com.
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Eversense Accuracy to YSI in PRECISION Study
Accuracy was measured by comparing the Eversense 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.
For values greater than 80 mg/dL, the mean absolute relative difference was calculated.
Table 2 – Accuracy to YSI in PRECISION Study
YSI Glucose Ranges
(mg/dL)
Overall
< 40
40 - 60
61 - 80
81 - 180
181 - 300
301 - 350
351 - 400
> 400
Paired CGM-YSI
(n)
15,170
15
1,267
2,212
5,685
3,210
1,527
1,174
80
Mean Absolute Relative
Difference (%)
9.6
16.2
8.1
8.6
9.7
7.7
6.8
6.5
11.2
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Performance was also measured by calculating the percentage of sensor glucose readings within 15 mg/dL or 15% of the YSI reference. These tables show the percent agreement at multiple levels, at different glucose ranges, and at different days during the sensor wear. Results in the glucose ranges of 80 mg/dL or less reflect the percentage of values within mg/dL, and results in the glucose ranges over 80 mg/dL reflect the percentage within reference. As an example, glucose values between 40 and 60 mg/dL were within 15 mg/dL of the reference value 91.9% of the time.
Table 3 – Eversense Percentage of Readings in Agreement Overall in the PRECISION Study
CGM
System
Glucose
Range
(mg/dL)
Overall
40 - 60
61 - 80
81 - 180
181 - 300
301 - 350
351 - 400
Percent of CGM System Readings Within
Paired
CGM and YSI
References
Percent
15/15% of
Reference
Percent
20/20% of
Reference
Percent
30/30% of
Reference
Percent
40/40% of
Reference
> 40/40% of
Reference
15,170
1,236
2,003
5,786
3,566
1,628
951
85.4%
91.9%
87.3%
80.5%
84.8%
92.8%
91.5%
92.8%
96.0%
94.1%
89.9%
92.8%
97.5%
95.8%
98.1%
98.4%
99.1%
97.2%
98.1%
99.1%
98.6%
99.3%
99.3%
99.6%
99.0%
99.2%
99.9%
99.8%
0.7%
0.7%
0.4%
1.0%
0.8%
0.1%
0.2%
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Table 4 – Eversense Percentage of Readings in Agreement on Day 1 in the PRECISION Study
CGM
System
Glucose
Range
(mg/dL)
Overall
40 - 60
61 - 80
81 - 180
181 - 300
301 - 350
351 - 400
Percent of CGM System Readings Within
Paired
CGM and YSI
References
Percent
15/15% of
Reference
Percent
20/20% of
Reference
Percent
30/30% of
Reference
Percent
40/40% of
Reference
> 40/40% of
Reference
2,665
274
378
962
585
250
216
79.1%
86.5%
81.7%
76.7%
80.3%
77.6%
74.5%
88.9%
91.2%
87.8%
87.8%
91.1%
90.4%
85.2%
95.8%
96.4%
97.1%
95.6%
96.1%
95.2%
94.0%
98.5%
97.8%
98.7%
98.9%
97.8%
99.2%
99.1%
1.5%
2.2%
1.3%
1.1%
2.2%
0.8%
0.9%
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Table 5 – Eversense Percentage of Readings in Agreement on Day 7 in the PRECISION Study
CGM
System
Glucose
Range
(mg/dL)
Overall
40 - 60
61 - 80
81 - 180
181 - 300
301 - 350
351 - 400
Percent of CGM System Readings Within
Paired
CGM and YSI
References
Percent
15/15% of
Reference
Percent
20/20% of
Reference
Percent
30/30% of
Reference
Percent
40/40% of
Reference
> 40/40% of
Reference
2,926
214
404
1,053
630
385
240
86.1%
93.0%
87.6%
80.0%
84.6%
94.3%
95.0%
93.3%
98.1%
94.3%
89.3%
93.5%
97.4%
97.5%
98.1%
99.5%
99.3%
96.7%
97.5%
99.7%
100.0%
99.0%
100.0%
99.8%
97.9%
99.2%
100.0%
100.0%
1.0%
0.0%
0.2%
2.1%
0.8%
0.0%
0.0%
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Table 6 – Eversense Percentage of Readings in Agreement on Day 14 in the PRECISION Study
CGM
System
Glucose
Range
(mg/dL)
Overall
40 - 60
61 - 80
81 - 180
181 - 300
301 - 350
351 - 400
Percent of CGM System Readings Within
Paired
CGM and YSI
References
Percent
15/15% of
Reference
Percent
20/20% of
Reference
Percent
30/30% of
Reference
Percent
40/40% of
Reference
> 40/40% of
Reference
2,997
269
407
999
663
383
276
88.1%
87.0%
84.0%
82.0%
91.3%
97.1%
96.7%
94.6%
92.6%
93.4%
91.7%
95.9%
99.0%
99.6%
98.8%
96.7%
99.5%
98.0%
99.4%
99.5%
100.0%
99.6%
98.9%
100.0%
99.1%
99.8%
100.0%
100.0%
0.4%
1.1%
0.0%
0.9%
0.2%
0.0%
0.0%
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Table 7 – Eversense Percentage of Readings in Agreement on Day 30 in the PRECISION Study
CGM
System
Glucose
Range
(mg/dL)
Overall
40 - 60
61 - 80
81 - 180
181 - 300
301 - 350
351 - 400
Percent of CGM System Readings Within
Paired
CGM and YSI
References
Percent
15/15% of
Reference
Percent
20/20% of
Reference
Percent
30/30% of
Reference
Percent
40/40% of
Reference
> 40/40% of
Reference
2,284
209
416
936
492
183
48
88.0%
98.6%
92.8%
81.1%
87.4%
99.5%
100.0%
94.3%
99.5%
97.6%
90.0%
94.7%
100.0%
100.0%
98.9%
100.0%
100.0%
97.4%
99.8%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
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Table 8 – Eversense Percentage of Readings in Agreement on Day 60 in the PRECISION Study
CGM
System
Glucose
Range
(mg/dL)
Overall
40 - 60
61 - 80
81 - 180
181 - 300
301 - 350
351 - 400
Percent of CGM System Readings Within
Paired
CGM and YSI
References
Percent
15/15% of
Reference
Percent
20/20% of
Reference
Percent
30/30% of
Reference
Percent
40/40% of
Reference
> 40/40% of
Reference
2,133
165
176
880
592
239
81
86.9%
98.2%
89.2%
85.9%
79.1%
96.7%
98.8%
93.7%
100.0%
96.6%
94.2%
86.8%
100.0%
100.0%
98.5%
100.0%
100.0%
98.3%
97.1%
100.0%
100.0%
99.6%
100.0%
100.0%
99.4%
99.5%
100.0%
100.0%
0.4%
0.0%
0.0%
0.6%
0.5%
0.0%
0.0%
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Table 9 – Eversense Percentage of Readings in Agreement on Day 90 in the PRECISION Study
CGM
System
Glucose
Range
(mg/dL)
Overall
40 - 60
61 - 80
81 - 180
181 - 300
301 - 350
351 - 400
Percent of CGM System Readings Within
Paired
CGM and YSI
References
Percent
15/15% of
Reference
Percent
20/20% of
Reference
Percent
30/30% of
Reference
Percent
40/40% of
Reference
> 40/40% of
Reference
2,165
105
222
956
604
188
90
83.9%
93.3%
90.5%
77.7%
85.9%
89.9%
95.6%
92.2%
100.0%
96.8%
86.7%
94.9%
98.9%
98.9%
98.5%
100.0%
99.1%
97.5%
98.8%
100.0%
100.0%
99.3%
100.0%
99.1%
99.2%
99.2%
100.0%
100.0%
0.7%
0.0%
0.9%
0.8%
0.8%
0.0%
0.0%
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Glucose values below 40 mg/dL or above 400 mg/dL are shown on the mobile app as “LO” or “HI”. The table below shows, as a percentage, agreement of sensor glucose values when outside the display range of 40 mg/dL to 400 mg/dL.
Table 10 – Eversense Agreement when “LO” or “HI” is Displayed in the PRECISION Study
CGM
Readings
‘LO’
CGM-Ref pairs n
%
< 50
Reference mg/dL
< 60 < 70
6
66.7%
7
77.8%
9
100%
< 80
9
100%
> 80
0
0%
Total
9
100%
CGM
Readings
‘HI’
CGM-Ref pairs n
%
> 340
Reference mg/dL
> 320 > 280
359
88.6%
383
94.6%
399
98.5%
> 240
404
99.8%
< 240
1
0.2%
Total
405
100%
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Eversense Alert Performance
The tables in this section show an alert performance assessment. The Confirmed Event Detection Rate shows the percentage of time the Eversense CGM System confirmed the reference value by presenting an alert within a 15 minute window of a reference value beyond the alert setting threshold. The Missed Detection Rate shows the percentage of time the Eversense 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. The False Alert Rate shows the percentage of time the alert from the CGM system was not confirmed by a reference value within a 15 minute window of the alert being presented.
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The table below shows an assessment of the ability of the Eversense 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.
Table 11 – Eversense High and Low Glucose Alert Performance (Threshold Only) in the PRECISION Study
Alert Setting
(mg/dL)
Low
Alert
High
Alert
90
120
140
180
60
70
80
200
220
240
300
Confirmed
Event Detection
Rate
76%
90%
94%
96%
99%
99%
98%
98%
98%
98%
93%
Missed
Detection
Rate
24%
10%
6%
4%
1%
1%
2%
2%
2%
2%
7%
True Alert
Rate
81%
95%
96%
95%
96%
96%
95%
95%
95%
95%
94%
False Alert
Rate
5%
4%
4%
5%
19%
5%
4%
5%
5%
5%
6%
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The table below shows an assessment of the ability of the Eversense 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.
Table 12 – Eversense High, Low, and Predictive Alert Performance (Threshold and Predictive) in the
PRECISION Study
Alert Setting
(mg/dL)
Low
Alert
High
Alert
120
140
180
200
60
70
80
90
220
240
300
Confirmed
Event Detection
Rate
89%
95%
97%
98%
99%
99%
99%
98%
98%
99%
95%
Missed
Detection
Rate
11%
5%
3%
2%
1%
1%
1%
2%
2%
1%
5%
True Alert
Rate
96%
94%
93%
94%
77%
92%
93%
93%
94%
94%
92%
False Alert
Rate
4%
6%
7%
6%
23%
8%
7%
7%
6%
6%
8%
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Eversense Rate of Change Trend Agreement
The shaded area of the table below shows agreement between the Eversense glucose trends and the YSI reference trends while glucose is trending at different rates (mg/dL per minute). As an example, when glucose is trending at a rate of between -1 and 1 mg/dL/minute, Eversense glucose trends are in agreement with the reference trends 89% of the time.
Table 13 – Eversense Rate of Change Trend Agreement in the PRECISION Study
CGM Trend
(mg/dL/min)
< -3
[-3, -2)
[-2, -1)
[-1, 1]
(1, 2]
(2, 3]
> 3
Total
0%
0%
0%
0%
57
14%
5%
1%
Reference Rate of Change (mg/dL/min)
Percent of Matched Pairs in Each Reference
Trend Range for Each CGM ROC Range
< -3 [-3, -2) [-2, -1) [-1, 1] (1, 2] (2, 3] > 3
1%
0%
0%
1%
155
20%
12%
3%
30%
38%
24%
5%
1%
2%
0%
990
36%
44%
71%
89%
55%
36%
25%
11,137
0%
1%
1%
5%
35%
41%
35%
1,085
1%
8%
18%
30%
288
0%
1%
0%
0%
1%
4%
10%
57
0%
0%
0%
Total
135
338
1,115
10,655
997
354
175
13,769
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Eversense Concurrence with YSI Values
The shaded areas of 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 71% of the time.
Table 14 – Concurrence with YSI Range All Days in the PRECISION Study
Percent of Matched Pairs in Each YSI Glucose Range for Each CGM Glucose Range
YSI (mg/dL)
CGM
(mg/dL)
Paired
CGM-YSI
(n)
< 40 40-60 61-80 81-120 121-160 161-200 201-250 251-300 301-350 351-400 > 400
40 - 60 1,236 1% 63% 34% 2% 0%
61 - 80 2,003 0% 22% 67% 10% 0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
81 - 120 2,524 0% 2% 17% 71% 10%
121 - 160 2,342 0% 0% 0% 18% 71%
0%
11%
161 - 200 1,727 0% 0% 0% 1% 24% 59%
201 - 250 1,502 0% 0% 0% 0% 1% 19%
0%
0%
16%
65%
0%
0%
0%
14%
0%
0%
0%
1%
0%
0%
0%
0%
0%
0%
0%
0%
251 - 300 1,257 0% 0% 0% 0%
301 - 350 1,628 0% 0% 0% 0%
351 - 400 951 0% 0% 0% 0%
0%
0%
0%
1%
0%
0%
18%
1%
0%
51%
10%
2%
27%
57%
26%
3%
32%
0%
1%
65% 7%
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Table 15 – Concurrence with YSI Range Day 1 in the PRECISION Study
Percent of Matched Pairs in Each YSI Glucose Range for Each CGM Glucose Range
YSI (mg/dL)
CGM
(mg/dL)
Paired
CGM-YSI
(n)
< 40 40-60 61-80 81-120 121-160 161-200 201-250 251-300 301-350 351-400 > 400
40 - 60 274 1% 59% 36% 4% 0% 0% 0% 0% 0% 0% 0%
61 - 80 378 0% 14% 65% 19% 1%
81 - 120 516 0% 1% 23% 63% 12%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
121 - 160 332 0% 0% 0% 17% 70% 12%
161 - 200 226 0% 0% 0% 1% 23% 58%
201 - 250 268 0% 0% 0% 0%
251 - 300 205 0% 0% 0% 0%
4%
0%
25%
2%
301 - 350 250 0% 0% 0% 0%
351 - 400 216 0% 0% 0% 0%
0%
0%
0%
0%
1%
17%
55%
25%
4%
1%
0%
0%
15%
57%
27%
9%
0%
0%
0%
14%
42%
46%
0%
0%
0%
1%
26%
40%
1%
4%
0%
0%
0%
0%
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Calibration Stability Agreement
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, 88% of the Eversense 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.
Table 16 – Eversense Calibration Stability Agreement in the PRECISION Study
Time from
Calibration
0 - 2 Hours
2 - 4 Hours
4 - 6 Hours
6 - 8 Hours
8 - 10 Hours
10 - 12 Hours
Number of
Paired
CGM-YSI
4,034
3,979
2,308
1,614
1,372
1,295
Percent of CGM System Readings Within
Percent
15/15% of
Reference
86.0%
Percent
20/20% of
Reference
93.6%
Percent
30/30% of
Reference
98.0%
Percent
40/40% of
Reference
99.3%
> 40/40% of
Reference
0.7%
85.6%
84.3%
92.8%
92.2%
98.4%
97.7%
99.5%
99.0%
0.5%
1.0%
84.3%
88.0%
86.1%
92.7%
94.4%
92.9%
97.8%
98.5%
98.1%
99.4%
99.6%
99.2%
0.6%
0.4%
0.8%
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PARD (Paired Absolute Relative Difference) and Percent Coefficient of Variation
In the PRECISION Study, 27 participants had two sensors inserted. The table below shows the precision of the sensor’s performance by comparing readings between the two sensors worn by each participant. As an example, the absolute relative difference between the sensors worn by each person is 9.9%, and the percent coefficient of variation is 7.0%, showing the sensor values generally in agreement throughout the 90 day study period.
PARD
PCV
9.9%
7.0%
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Sensor Life
Sensor life measured the percentage of sensors being able to function through the intended 90 day durations of each study. In the PRECISE II study, nine sensors did not function through the 90 day period. Function stopped at days
10, 30, 53, 67, 70, 80, 81, 83, and 85. The sensor failure on day 10 was due to a software anomaly that has since been resolved. Overall, the analysis estimated that 91% of sensors remained functioning through 90 days. In the PRECISION study, all sensors functioned through 90 days.
Percentage of Sensors that lasted 30, 60, and 90 days
Table 16A
Days
30
60
90
PRECISE II
Sensor Life
99%
97%
91%
Table 16B
Days
30
60
90
PRECISION
Sensor Life
100%
100%
100%
Table 16C
Mean
# of Days
88
PRECISE II
Median
# of Days
91
Table 16D
Mean
# of Days
92
PRECISION
Median
# of Days
91
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Data Availability
A total of 97% (821,296 out of expected 842,814) glucose values were available during the 90 day study.
Table 17 – Eversense Data Availability in the PRECISION Study
Days 1 - 30 Days 31 - 60 Days 61 - 90 All Days
Number of
Displayed
Glucose Values
Expected
Number of
Glucose Values
% of Displayed
Glucose Values
279,674
285,579
98%
274,727
280,478
98%
266,895
276,757
96%
821,296
842,814
97%
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Safety
Both the PRECISE II and PRECISION studies lasted 90 days, and the number of related adverse events was recorded.
The Eversense CGM System was well tolerated in the studies. During the studies’ 15,921 sensor wear days, there were no unanticipated adverse events. Twenty-two adverse events were reported in 12 participants, including one serious adverse event related to the removal procedure. There were no infections. Mild irritation, pain and redness at the sensor insertion site were observed at a low rate of occurrence. None of the adverse events resulted in hospitalization.
Table 18 – Adverse Events
Event Type
Pain/Discomfort
Redness/Erythema
Dermatitis at Patch Location
Bruising
Skin Hyperpigmentation
Paresthesia
Syncope-vasovagal
Pain
Device Fragment not Recovered
Additional Procedure to Remove Sensor
Following First Attempt
TOTAL
Number of Events
6
2
1
2
2
2
1
1
2
3
22
Patients (n = 125)
5 (4.0%)
1 (0.8%)
1 (0.8%)
1 (0.8%)
1 (0.8%)
1 (0.8%)
1 (0.8%)
1 (0.8%)
2 (1.6%)
2 (1.6%)
12 (9.6%)
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20. Technical Specifications
Sensor
Characteristic
Dimensions
Materials
Glucose Range
Sensor Life
Calibration
Calibration Range
Sterilization
Description
Length: 18.3 mm
Diameter: 3.5 mm
Homopolymer polymethylmethacrylate (PMMA), Hydroxyethylmethacrylate
(HEMA) based Hydrogel, Platinum, Silicone, Dexamethasone Acetate, epoxy 301-2
40 - 400 mg/dL
Up to 90 days
Commercially available self-monitoring blood glucose meter
40 - 400 mg/dL
Sterile by Ethylene Oxide
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Smart Transmitter
Characteristic
Dimensions
Materials
Weight
Power Supply
Operational Conditions
Operational Life
Storage Conditions
Moisture Protection
Protection Against Electrical Shock
Charge time using AC adapter
Communication Distance
Cabin Pressure
Relative Humidity Range
(non-condensing)
Altitude
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Description
Width: 37.6 mm
Length: 48.0 mm
Thickness: 8.8 mm
Body: polycarbonate
11.3 g
Rechargeable lithium polymer batteries (not replaceable)
5 - 40 °C (41 - 104 °F)
12 months
0 - 35 °C (32 - 95 °F)
IP67: submerged up to 1 meter of water for up to 30 minutes
Type BF applied part
15 minutes to fully charge
Between app and smart transmitter is up to 24.9 feet
Wireless communication to the app will not function well when communicating through water. The range will decrease if you are in a bathtub, water bed, pool, etc.
700 hPa to 1060 hPa
15% to 90%
10,000 ft
Power Supply and Charger
Characteristic
Class
Input
DC Output
Moisture Protection
(charging cradle)
Description
II
AC Input, 100-240Vac, 50/60Hx, 0.3-0.15A
5V DC, 1A (5.0 watts)
IP22
USB Cable* for Charging and Downloading
Characteristic
Input/Output
Type
Length
Description
5V DC, 1A
USB-A to USB micro-B
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. 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.
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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.
Transmitter Electromagnetic Immunity Specifications
Immunity
Test
Immunity
Test
Transmitter
Compliance
Level
Electrostatic Discharge
(ESD) IEC 61000-4-2 ± 8 kV Contact
± 15 kV Air
± 8 kV Contact
± 15 kV Air
Power Frequency
(110VAC/60Hz,
230VAC/50 Hz)
Magnetic Field IEC
61000-4-8
30 A/m 30 A/m
Electromagnetic
Environment
Guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
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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.
System Electromagnetic Immunity Specifications
Immunity
Test
Conducted RF
IEC 61000-4-6
(Smartphone only
(Receiving Device))
Radiated RF
IEC 61000-4-3
IEC 60601
Test Level
≥ 3 Vrms
(150 kHz to 80 MHz)
≥ 10 V/m at 80 MHz to 2700 MHz (AM
Modulation)
Transmitter
Compliance
Level
3 Vrms
3 Vrms
Electromagnetic
Environment
Guidance
Interference may occur in the vicinity of equipment marked with following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Eversense
CGM System is used exceeds the applicable RF compliance level above, the Eversense CGM System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Eversense CGM
System. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
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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
Group 1
Class B
Electromagnetic Environment
Guidance
The Eversense CGM System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
The Eversense CGM System is suitable for use in all establishments including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Recommended Separation Distances Between Other Portable/Mobile RF Communications Equipment and the Smartphone (Receiving Device)
Follow the smartphone (or other receiving device) manufacturer’s instructions for separation distances. The customer or the user of the smartphone (or other receiving device) can help prevent electromagnetic interference by maintaining a minimum distance between other portable/mobile RF communications equipment (transmitters) and the smartphone of at least 30 cm (about 12 inches). Portable/mobile RF equipment include: baby monitors, Bluetooth wireless headsets, wireless routers, microwave ovens, laptops with internal Wi-Fi adapters, GSM cell phones, RFID scanners and hand-held security metal detector often used by security screeners.
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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. The icon appears in the ALERT
HISTORY screen and on the home screen trend line.
Predicted High or Rate Rising Alert
Indicates a Rate Rising or Predicted High Alert occurred. The icon appears in the ALERT
HISTORY screen and on the home screen trend line.
Empty Battery Alert
Appears when the smart transmitter battery is empty.
Low Battery Alert
Appears when the smart transmitter battery is less than 10% charged.
Smart Transmitter/Sensor Alert
The icon appears in the ALERT HISTORY screen.
Smart Transmitter/Sensor Notifications
Appears when there are notifications related to the smart transmitter or sensor.
Calibration Alert
Appears when there are calibration-related alerts.
Calibration Notification
Appears in ALERT HISTORY when there are calibration-related notifications. The icon also appears on the My Glucose trend line and Event Log when a manual BG entry is logged.
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Symbols on the Eversense CGM Mobile App
(continued)
Symbol Explanation
Calibration
Appears on the glucose trend line and ALERT HISTORY when a calibration is entered and accepted.
Connection Failure
Appears when the smart transmitter is disconnected from the smartphone or when the sensor is not linked to the smart transmitter.
Multiple Alerts (more than one alert or event)
Appears when there are two or more alerts or events in a short interval.
Event Icons
Appear on the glucose trend line and in the EVENT LOG after an event is entered.
The events that can be entered are:
Glucose
Meals
Insulin
Health
Exercise
Temp Profile
Appears when the Temp Profile is active.
Do Not Disturb (DND)
Appears when the DND setting is active.
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Symbols on Packaging and Devices
Symbol Explanation
Consult accompanying documents
Caution, consult accompanying documents
Use by
Manufacturer
Date of manufacture
Storage temperature limits
Lot number
Universal Serial Bus (USB)
Part number
Symbol Explanation
Serial number
Type BF Applied Part
Non-ionizing electromagnetic radiation
Not made with natural rubber latex
FCC ID is assigned to all devices subject to certification
Non-sterile
Magnetic Resonance Imaging (MRI) procedures are contraindicated for the smart transmitter
No known hazards for leaving the sensor inserted in use with MR with a static magnetic field of 1.5T or 3.0T
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Symbols on Packaging and Devices
(continued)
Symbol Explanation
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
U.S. (Federal) law restricts the sale of the Eversense CGM System to sale by or on the order of a physician
Follow instructions for use
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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 health care provider (“Limited Warranty Period”). This warranty gives you specific legal rights, and you may also have other rights which vary from jurisdiction to jurisdiction. This limited warranty is made on the condition that you provide Senseonics with written notice of any defects in material and/or workmanship immediately upon discovery, and provided that Senseonics determines that your claim is due to defects in original material and/or workmanship. If Senseonics provides you with a replacement Smart Transmitter pursuant to the terms of this limited warranty, any remaining warranty on the original Smart Transmitter will transfer to the replacement Smart Transmitter, the warranty period for the replacement Smart Transmitter shall end on the one year anniversary of the date that you first received the Smart Transmitter from your health care provider, and this warranty will be void with respect to the original Smart Transmitter.
2. Exclusions to the limited warranty.
The limited warranty applies only to the Smart Transmitter manufactured by Senseonics, and is conditioned upon proper use of the product by you. The limited warranty does not cover a) cosmetic damage, scratching or other damage to surfaces and exposed parts due to normal use; b) damage resulting from accident, neglect and other negligence, misuse, unusual physical, electrical or electromechanical stress, or modification of any part of the product; c) equipment that has been altered to remove, alter or otherwise make illegible the ID number; d) malfunctions resulting from use with products, accessories or peripheral equipment not furnished or approved in writing by
Senseonics; e)consumables (batteries), f) equipment that has been dissembled; and g) damage caused by improper operation, testing, maintenance, installation or adjustment.
The Smart Transmitter is water-resistant to the specification listed in the User Guide. This limited warranty does not cover water damage if the Smart Transmitter housing is cracked, or otherwise damaged. This limited warranty does not apply to collateral services, equipment or software that may be used with the Smart Transmitter.
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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. You must return the defective Smart Transmitter to an authorized Senseonics Customer Service Department in an appropriate shipping container that will adequately protect the Smart Transmitter from further damage, accompanied by your name and address, the name and address of the health care provider from whom you obtained the Smart Transmitter, and the date and the ID number of the Smart Transmitter. To find out where to send the Smart Transmitter, please visit our website www.eversensediabetes.com. Upon receipt, if Senseonics determines that the Smart Transmitter is covered by the limited warranty and that coverage is not excluded, Senseonics will promptly replace the Smart Transmitter.
If Senseonics determines that the Smart Transmitter is not covered by the limited warranty, you may purchase a replacement or if you want the original Smart Transmitter returned, you must prepay all shipping charges.
A repaired or replacement Smart Transmitter assumes the remaining warranty of the original Smart Transmitter, or
[30] days from the date of replacement or repair, whichever is longer.
4. Limits of Senseonics’ obligations under the limited warranty.
THE LIMITED WARRANTY OF SENSEONICS DESCRIBED ABOVE IS EXCLUSIVE AND IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, STATUTORY OR OTHERWISE,
AND SENSEONICS EXPRESSLY EXCLUDES AND DISCLAIMS ALL SUCH OTHER WARRANTIES, INCLUDING WITHOUT
LIMITATION, ANY IMPLIED WARRANTY OR CONDITION OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
NON-INFRINGEMENT, SATISFACTORY QUALITY, NON-INTERFERENCE, ACCURACY OF INFORMATIONAL CONTENT, OR
ARISING FROM A COURSE OF DEALING, LAW, USAGE, OR TRADE PRACTICE.. EXCEPT TO THE EXTENT PROHIBITED
BY APPLICABLE LAW, SENSEONICS SHALL NOT BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR
INDIRECT DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, ARISING IN ANY WAY OUT OF THE
SALE, USE, MISUSE OR INABILITY TO USE THE SMART TRANSMITTERS OR ANY SENSEONICS EVERSENSE 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. THIS LIMITED WARRANTY
SHALL NOT EXTEND TO ANYONE OTHER THAN YOU, THE ORIGINAL END USER OF THIS PRODUCT AND IT STATES
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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.
System component
Eversense Smart Transmitter Kit
Part Number
FG-3300-01-001
Eversense Smart Transmitter Kit – Provider Purchase Only FG-3302-01-001
Charging Cable FG-6100-00-301
Charging Adapter
Charging Cradle
Eversense Adhesive Patches, White, 30 Pack
Eversense Adhesive Patches, Clear, 30 Pack
FG-6201-91-301
FG-6701-00-301
FG-6402-01-300
FG-6401-01-300
Eversense Quick Reference Guide
Eversense CGM User Guide
Eversense Data Management Software Application
Eversense Mobile Application iOS
Eversense Mobile Application Android
LBL-1603-01-001
LBL-1602-01-001
FG-5700-01-300
FG-5501-01-300
FG-5502-01-300
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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. Please note that the use of this accessory with iPod touch, iPhone or iPad may affect wireless performance.
Apple, iPad, iPhone, iPod, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries.
Google Legal Notice
The “Android” name, the Android logo, and Google Play are trademarks of Google Inc.
About Bluetooth®
Bluetooth® is a type of wireless (RF) communication. Mobile devices like smartphones use Bluetooth® technology as do many other devices. Your smart transmitter uses Bluetooth® Smart to pair with the mobile device and to send results to the app.
Bluetooth® Trademark
The Bluetooth® word mark and logos are owned by the Bluetooth® SIG, Inc. and any use of such marks by
Senseonics, Inc. is under license.
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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.
These guidelines help ensure that your smart transmitter will not affect the operation of other nearby electronic devices. Additionally, other electronic devices should not affect the use of your smart transmitter.
With the exception of your mobile device, other electronic wireless devices that are in use nearby, such as a cell phone, microwave or a wireless network, may prevent or delay the transmission of data from your smart transmitter to the app. Moving away from or turning off these electronic devices may allow communication.
The smart transmitter has been tested and found to be appropriate for use at home. In most cases, it should not interfere with other home electronic devices if used as instructed. However, this smart transmitter gives off RF energy.
If not used correctly, your smart transmitter may interfere with your TV, radio or other electronic devices that receive or transmit RF signals.
If you experience smart transmitter interference problems, try moving away from the source of the interference. You can also move the electronic device or its antenna to another location to solve the problem.
If you continue to experience interference, contact customer service for the manufacturer of the electronic device causing the interference.
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Index
Adhesive patch
Alerts
91, 93, 94, 95, 96, 97, 98, 99, 100,
101, 102, 103, 104, 105, 106, 107, 108
Alerts and Notifications, Apple
Watch 127, 128, 129, 130, 131, 132,
133, 134, 135, 136, 137, 138, 139, 140
App, about
App, download
App, launch
App, log out
App, product information 122, 123
App, using
Battery, charging
Battery power, indicator
Bluetooth
Bluetooth, restart
Button on smart transmitter
Calibration, Daily Phase
Calibration, Initiation Phase 43, 45
Calibration, procedure 43, 47, 70
Charging cradle
Data Management System
(DMS)
Discoverable mode
Do Not Disturb mode
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Events
Eversense DMS
FCC Information
LED indicator
Link, smart transmitter with sensor
Menu
Mobile device
Mobile device, Apple Watch 124
MRI, Magnetic Resonance
Imaging
My Circle
MY GLUCOSE screen 31, 51, 53, 70
Notifications
Pairing, smart transmitter and mobile device
Placement guide, signal strength
Power adapter
Reports
Reset smart transmitter
Restart Bluetooth
RF, radio frequency communication
Sensor
Sensor, about
Sensor, insertion and removal 32,
Settings, app
Share My Data
Smart transmitter, about
Smart transmitter, attaching
Smart transmitter, maintenance 41
Smart transmitter, on/off
Smart transmitter, reset
Smart transmitter, using
Snooze setting
Symbols, alerts, notifications
Symbols, packaging and device
System components
Target levels
Temp Profile
Travel
Trend arrows
Trend graph
Troubleshooting, FAQs
Unit of measurement
USB, cable
USB, port
Wireless
Notes
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Notes
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Manufactured and Distributed by Senseonics, Inc.
20451 Seneca Meadows Parkway
Germantown, MD 20876-7005 USA
844.SENSE4U | 301.515.7260
(844.736.7348)
Customer Support Hours:
8am to 8pm (Eastern US Time) eversensediabetes.com
© Senseonics, Inc. 2020 PN: LBL-1602-01-001 Rev N 02/2020
Date: 2/26/2020
File name: LBL-1602-01-001 Rev N_Eversense User Guide_mgdL_R1
Job description: Eversense User Guide
Project Manager: Erin Moody Art Director: Ivy Tsang
Dimensions:
Trim: 6.75” w X 5.8” h
Folded
( Include folded dimensions if applicable )
:
Colors: 4/color
Spot
( Name PMS colors if applicable )
: N/A
Bleed: 0.125”
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