Senseonics orporated 3400 The Eversense Smart Transmitter User Manual

Download:
Mirror Download [FCC.gov]
Document ID	3112689
Application ID	kGzXG4HQynAY7DiMPMtVAg==
Document Description	Users Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	289.15kB (3614417 bits)
Date Submitted	2016-08-26 00:00:00
Date Available	2016-08-30 00:00:00
Creation Date	2016-08-05 17:37:22
Producing Software	Adobe PDF Library 15.0
Document Lastmod	2016-08-05 17:37:23
Document Title	Users Manual
Document Creator	Adobe InDesign CC 2015 (Macintosh)

User Guide
A guide for using the Eversense
Continuous Glucose Monitoring System
Sensor
Smart Transmitter
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 1
Mobile App
7/22/16 11:38 AM
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 2
7/22/16 11:38 AM
Eversense Trademark
Eversense, Eversense Continuous Glucose Monitoring, Eversense CGM, Eversense Sensor, Eversense Smart Transmitter, Eversense App and the Eversense
logo are trademarks of Senseonics, Incorporated. Other brands and their products are trademarks or registered trademarks of their respective holders.
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 1
7/22/16 11:38 AM
Contents
Glossary
4. Inserting and Linking the Sensor
24
1. Introduction
5. Using the Smart Transmitter
26
Help and Support
Eversense CGM System Components
System Requirements
End User License Agreement and Privacy Policy
Jailbroken Devices
Indications for Use
Contraindications
What is Included in this Package
How to Use this User Guide
10
10
10
10
11
11
11
2. Benefits and Risks
12
Risks and Side Effects
Warnings
Precautions
13
13
14
3. Getting Started
16
Charge your Smart Transmitter
Step 1. Download and Install the App
Step 2. Set up the App – Account Creation,
Pairing and Settings
17
18
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 2
19
Daily Use
27
Secure the Smart Transmitter over Inserted Sensor 28
Turn the Smart Transmitter ON and OFF
30
Smart Transmitter Care and Maintenance
31
Battery Indicator
31
LED Status Indicators
32
6. Calibrating the System
Calibration Phases
How To Calibrate
7. Using the App
Check Your Mobile Device Settings
Get To Know the “My Glucose” Screen
Trend Arrows
Trend Graph
Menu Options
8. Customizing your Settings
Setting Glucose Target Levels
Setting Glucose Alert Levels
33
34
35
38
38
39
41
42
43
44
46
47
7/22/16 11:38 AM
Setting Predictive Alerts
Setting Rate of Change Alerts
Setting Daily Calibration Times
Setting System Information
Setting Mealtimes Schedule
Setting Sounds
Setting Temporary Profile
Logging out
9. Alert Descriptions
48
49
50
51
52
53
55
57
58
Alerts and Notifications
Alert History
Alert Descriptions and Actions
58
59
60
10. Event Log
70
Glucose
Meals
Insulin
Health
Exercise
11. Glucose Reports and Sharing
Weekly Modal Summary
Glucose Pie Chart
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 3
71
72
73
74
75
76
77
78
Glucose Statistics
Eversense Data Management Software
(DMS) Program
Share My Data
78
79
79
12. Product and General Information
on the App
80
13. Viewing Eversense Data on the
Apple Watch
82
Glance View
14. About the Sensor
Insertion Steps
Removal Steps
82
84
84
85
15. Travel
86
16. Troubleshooting
87
Smart Transmitter
Smart Transmitter Battery and Charging
Connection with Smart Transmitter
Calibration
Alerts and Notifications
87
88
89
92
93
7/22/16 11:38 AM
Glucose Readings
Trend Arrows
App
Sensor
Events
Sync
95
96
96
97
98
98
17. Device Performance
99
Clinical Study Performance
Overall System Performance Compared to YSI
Clarke Error Grid Analysis
Consensus (Parkes) Error Grid Analysis
Calibration Performance
Sensor Life
Smart Transmitter Wear
Safety
99
99
100
103
105
106
106
107
18. Technical Specifications
Sensor
Smart Transmitter
Electrical and Safety Standards
Symbols on the Eversense Mobile App
Symbols on Packaging and Devices
Eversense Smart Transmitter Limited Warranty
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 4
Legal Notices
118
Apple Legal Notice
Google Legal Notice
About Bluetooth®
Bluetooth® Trademark
FCC Information
118
118
118
118
119
Index
120
108
108
108
109
113
115
116
7/22/16 11:39 AM
Glossary
Alert An alert warns you that a situation needs your attention and that
you should respond/take appropriate action.
Electromagnetic Interference A strong field of energy generated by
electrical or magnetic devices.
Blood Glucose Meter A commercially available device used to
measure glucose using a blood sample from a fingerstick.
EULA End User License Agreement
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 every 12 hours.
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 (in the Eversense App) When enabled,
smart transmitter will stop providing vibratory and visual notification
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.
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.
FAQ Frequently Asked Questions
“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.
Eversense
CGM
Eversense
CGMUser
UserGuide
Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 5
7/22/16 11:39 AM
Mobile Device A handheld device built on a mobile operating system
that runs the Eversense App and communicates with the smart
transmitter.
Smart Transmitter A reusable device worn externally over the inserted
sensor that powers the sensor and sends glucose information to the
mobile device for display in the Eversense App.
mg/dL Milligrams per deciliter, a unit of measure that shows the
concentration of a substance in a specific amount of fluid. 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.
Warm-Up Phase The period the sensor requires to adjust after the
sensor has been inserted and before calibrations.
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.
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.
Eversense
CGM
User
Guide
Eversense
CGM
User
Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 6
7/22/16 11:39 AM
1. Introduction
This section reviews how to use this guide and describes your new Eversense CGM System, including its components and
intended purpose.
Congratulations on having the latest technology to assist you in managing your diabetes. Your Eversense CGM System is intended to continually measure
glucose levels for up to 90 days after your sensor is inserted. Glucose information collected by the system is automatically sent to your mobile device. You
must contact your physician’s office 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). Outside the US, call your local distributor or visit
www.eversensediabetes.com to locate your local distributor.
Eversense CGM System Components
Sensor
The System includes 1) a small sensor inserted subcutaneously by a physician, 2) a removable
smart transmitter worn over the sensor, and 3) a mobile app to display the glucose readings.
Eversense Sensor
The sensor is inserted under the skin (upper arm) and measures glucose in interstitial fluid for up
to 90 days. These glucose levels are then calculated by the smart transmitter and sent to the app.
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
Mobile App
Make sure your mobile
device is using the latest
operating system.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 7
7/22/16 11:39 AM
Eversense App
The Eversense App is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data in a variety of ways.
It also provides alerts based on the glucose settings you choose.
IMPORTANT: In order to use the Eversense CGM System, you must have an understanding of downloading and using mobile apps on your
handheld device. Data from the Eversense Smart Transmitter is sent wirelessly via Bluetooth. Carefully read the instructions in this User Guide for
downloading and installing the Eversense mobile app, and for pairing your mobile device with the smart transmitter. If there is anything you do not
understand in this User Guide, please contact your local distributor.
Disposable adhesive patches for daily use are also included as part of the system, and will be provided to you by your physician 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.
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 or during showering/bathing or any other water related activity. The smart transmitter
is not water resistant.
 Make sure your smart transmitter has enough battery power at all times.
 Perform two blood glucose meter calibration tests each day when prompted.
 Pay attention to alerts and notifications you receive from your smart transmitter and mobile device.
 Replace the adhesive patch on your smart transmitter daily.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 8
7/22/16 11:39 AM

You can remove the smart transmitter from the upper arm at any time, except during calibration. Remember that 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.
 It is safe for you to wear your sensor and smart transmitter when you go through metal detectors at airports. While flying, the smart transmitter
performs similar to any other Bluetooth device. Be sure to follow the specific safety guidelines mandated by the airline.
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.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 9
7/22/16 11:39 AM
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 and accuracy for the
user and are not approved for use by Senseonics.
Indications for Use
The Eversense CGM System is indicated for continually measuring interstitial fluid glucose levels in adults (18 years and older) with diabetes for the
operating life of the sensor.
The system is intended to:
• Aid in the management of diabetes.
• 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).
10
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 10
7/22/16 11:39 AM
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 indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring
devices.
Contraindications
The sensor and smart transmitter are incompatible with magnetic resonance imaging (MRI) procedures. DO NOT undergo an MRI procedure while the
sensor is inserted or when wearing the smart transmitter. Should an MRI be required, please contact your physician to arrange for sensor removal before
the procedure.
The system is contraindicated in people for whom dexamethasone or dexamethasone acetate may be contraindicated.
Therapeutics products such as mannitol intravenous and irrigation solutions may increase blood mannitol concentrations and cause falsely elevated
readings of your sensor glucose results.
What is Included in this Package
This Eversense Smart Transmitter Pack contains the following:
Also included in this package is this User Guide and a
Quick Reference Guide (not shown).
How to Use this User Guide
Eversense Smart
Transmitter
Power Supply
(USB cable and AC power adapter)
This guide describes how to use your CGM System. Read the entire guide before using the system.
• Any warnings or cautions are highlighted in a box.
• User tips are preceded by the  symbol.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 11
11
7/22/16 11:39 AM
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 safety and effectiveness of the CGM System has not been established for the following:
• Children or adolescents (younger than 18 years of age).
• Women who are pregnant.
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). Glucose levels in ISF lag behind glucose levels in blood by several minutes.
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 physician.
Caution: Federal (US) law restricts this device to sale by or on the order of a physician.
12
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 12
7/22/16 11:39 AM
Risks and Side Effects
The glucose alerts and notifications will not audibly notify the user when the sound on the mobile device is turned off. If the system cannot display a
glucose value, it also cannot provide glucose alerts. If you are unable to feel the vibration of the smart transmitter you may not notice the alerts. The
system’s calculated glucose can be slightly different from your blood glucose meter. This may cause an alert to activate at a different time than they
would have if the system’s values always matched the blood glucose meter values. If you do not take frequent blood glucose measurements and miss
an alert, you may not be aware of high or low glucose levels. You may need medical attention in the event that you have high or low glucose and are
unaware of it.
If you do not test your glucose with a blood glucose meter when you have symptoms of a low or high blood glucose level OR when your symptoms are
not consistent with the sensor glucose readings, you may miss a high or low glucose event. Treatment decisions made without confirming with a blood
glucose meter check may result in a high or low glucose event, since blood glucose values can be slightly different than your sensor glucose values
measured in interstitial fluid.
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.
Warnings
•	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.
•	Always test your glucose with your blood glucose meter before making a treatment decision.
•	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.
•	High doses of aspirin (over 2000 mg), such as for chronic treatment of inflammatory conditions (e.g., rheumatoid arthritis), may falsely lower
Sensor glucose readings.
•	Until it has healed, always cover the insertion site with a sterile bandage before placing the smart transmitter adhesive over the sensor. Failure to
do so could result in infection at the insertion site.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 13
13
7/22/16 11:39 AM
Warnings (continued)
•	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). Outside the US, call your local distributor or visit
www.eversensediabetes.com to locate your local distributor.
•	Always calibrate the system using only a fingerstick blood sample. DO NOT use an alternative site (such as forearm or palm) blood glucose
reading to calibrate the system.
•	DO NOT insert your infusion set within 10.16 cm (4 in) of the sensor site. If the insulin delivery site is within 10.16 cm (4 in) of the sensor site, it
may interfere with sensor glucose readings and can cause inaccurate glucose readings.
Always follow your physician’s instructions for care after the sensor insertion or removal. Contact your physician 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.
Precautions
•	DO NOT exchange smart transmitters with another person. Each smart transmitter can be linked to only one sensor at a time.
•	The following medical therapies or procedures may cause permanent damage to the sensor particularly if used in close proximity to the device:
– Lithotripsy – The use of lithotripsy is not recommended for people who have an inserted sensor because the effects are unknown.
– Diathermy – DO NOT use diathermy on people who have an inserted sensor. 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 physician 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.
14
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 14
7/22/16 11:39 AM
Precautions (continued)
•	If the sensor, insertion site or smart transmitter feels warm, remove the smart transmitter immediately and contact your physician for further
advice. A warm sensor could mean there is an infection or a sensor malfunction.
•	DO NOT immerse the smart transmitter in water or use the smart transmitter for any activity where it might be submerged in water. Immersing
the smart transmitter in water may result in electrical shock. Always remove the smart transmitter before bathing or swimming.
•	DO NOT switch back and forth between smart transmitters. Frequently pairing different smart transmitters with the sensor may result in
inaccurate glucose measurements.
•	Remove the smart transmitter from your arm before charging the smart transmitter battery. Failure to remove the smart transmitter while it is
charging could result in electrical shock.
•	DO NOT attempt to use the Eversense App while operating a motor vehicle.
•	You should not receive massage therapy near the inserted sensor site. Massage therapy near the sensor site could cause discomfort or skin
irritation.
•	Use only the AC power adapter and USB cable provided with the smart transmitter when charging the smart transmitter battery. Use of another
power supply could damage the smart transmitter, not allowing blood 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 physician prior to use. Discard the
Eversense adhesive patch after 24 hours of use.
•	DO NOT change the unit of measurement unless you have discussed it with your physician. 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.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 15
15
7/22/16 11:39 AM
3. Getting Started
This section describes the initial start-up steps required before you can begin using your new Eversense CGM System on
a daily basis. You may perform these steps before your physician inserts the sensor.
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.
16
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 16
7/22/16 11:39 AM
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 USB port.
2. Plug the micro end of the USB cable into
the smart transmitter USB port.
3. 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.
LED Indicator
(lights green
or orange)
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 17
17
7/22/16 11:39 AM
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.
18
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 18
7/22/16 11:39 AM
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 a Username and Password.
3. Enter your account information and then
tap Register. The email address you
enter will be your username for Login.
•	You must register an account before
you are able to log in. Tap Create an
Account.
Note: If you forget your password, you
can reset it via the app. If you forget your
username, contact Customer Support.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 19
19
7/22/16 11:39 AM
To complete registration check the email
address you provided and click the link in the
email.
5. When you complete registration and
log in, a WELCOME screen appears.
6. Choose one of the two options depending
on whether you already have your smart
transmitter or not:
•	Tap Done to return to the Eversense
LOGIN screen.
4. Enter the email address you registered as
(skip to step 7).
your username and your password and
tap LOG IN. You will see a confirmation
screen. Tap OK.
Note: The password is case sensitive.
20
(skip to step 12).
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 20
7/22/16 11:39 AM
7. With the smart transmitter turned
8. On the PAIR YOUR
on, and when the PAIR YOUR
TRANSMITTER screen appears
on your mobile device, set your smart
transmitter to “Discoverable” mode
for the mobile device to find the smart
transmitter:
TRANSMITTER screen, the smart
transmitter ID detected by the app
is listed as “Not Connected”. (Your
smart transmitter ID matches the serial
number found on the back of the smart
transmitter.)
•	Press the smart transmitter power
Tap Not Connected to begin pairing
process.
button three times. Make sure your
smart transmitter is not plugged into
the power supply.
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.
•	The LED will blink green and orange
to indicate the smart transmitter is in
Discoverable mode.
Power button
Note: If you press the power button on the
smart transmitter and no LED appears, press
and hold the power button for about
5 seconds to turn it on.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 21
21
7/22/16 11:39 AM
10. “Connected” appears next to the
11. The DAILY CALIBRATION
smart transmitter ID once the pairing
is complete. The smart transmitter will
provide intermittent vibrations until
the smart transmitter is linked with
the inserted sensor (see Inserting and
Linking the Sensor).
•
Tap Next.
screen appears for you to set your
morning and evening reminder times
for your twice-a-day calibrations. You
will automatically receive a notification
when it is time to make a calibration
entry.
12. 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.
•	Tap Morning to change the time and
repeat for Evening.
•
Tap Next when done.
Precaution: DO NOT change the unit
of measurement unless you have discussed
it with your physician. When the unit of
measurement is confirmed, tap Finish.
22
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 22
7/22/16 11:39 AM
13. Next, the MY GLUCOSE screen
appears. The screen will not have any
glucose data to display at this time.
Once the sensor is inserted by your physician
and the 24-hour Warm-Up Phase is
completed, you can begin calibration. If you
have not yet had your sensor inserted, you can
review this User Guide to become familiar with
the app and its features.
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.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 23
23
7/22/16 11:39 AM
4. Inserting and Linking the Sensor
This section describes how to link the sensor and smart transmitter after your physician has inserted the sensor. Only your
physician can insert the sensor. See “About the Sensor” to learn more.
If the smart transmitter was sent directly to you, be sure to bring it and your mobile device to your insertion appointment. Once your physician has
inserted your sensor, the smart transmitter and the sensor must be linked in order to start the Warm-Up Phase. Your smart transmitter can only be linked
to one sensor at a time.
1. Make sure your smart transmitter is turned ON
2. To link the smart transmitter and sensor,
(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.
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.
24
tap Link Sensor on either the New
Sensor Detected pop-up screen or by
tapping Menu > Settings > System>
Linked Sensor and then tap Link
Sensor.
LED indicator
(lights green
or orange)
Power button
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 24
7/22/16 11:39 AM
3. When the smart transmitter and sensor
are successfully linked, the LINKED
SENSOR screen appears and displays
the sensor ID number.
Note: The sensor requires a 24-hour Warm-Up Phase to
stabilize in your body before glucose values will be collected
by the smart transmitter. During the Warm-Up Phase, you do
not need to wear the smart transmitter. If you decide to wear
the smart transmitter over the sensor during this time, you will
receive a message on the app indicating the Warm-Up Phase is
in progress. Once the Warm-Up Phase is complete, and you are
wearing the smart transmitter, the system will prompt you to
calibrate using the app.
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.
Precaution: The sensor and smart
transmitter should be linked the day of the
sensor insertion. Failure to link the sensor
and smart transmitter could result in a
delay in receiving glucose readings.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 25
25
7/22/16 11:39 AM
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 up to 90 days of glucose data.
• Provides on-body vibe alerts when you have reached the glucose alert levels you set.
LED indicator (lights green or orange)
• Sends glucose data to the app via Bluetooth.
USB port (power supply)
• USB port to download data to external application or use for charging.
Power button
• Multi-color LED to indicate various modes of the smart transmitter.
• Communicates with mobile device.
• Can be powered ON or OFF.
26
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 26
7/22/16 11:39 AM
Daily Use
To receive continuous glucose readings and information, keep the following in mind when using your smart transmitter:
	Wear your smart transmitter at all times except when charging or during showering/bathing or any other water related activity. The smart transmitter
is not water resistant.
 Make sure your smart transmitter has enough battery power at all times.
 Perform two blood glucose meter calibration tests each day when prompted.
 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.

You can remove the smart transmitter from the upper arm at any time, except during calibration. Remember that 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.
 It is safe for you to wear your sensor and smart transmitter when you go through metal detectors at airports. While flying, the smart transmitter
performs 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:
• Your smart transmitter is not water resistant. DO NOT wear it during any water-related activities. DO NOT submerge in water.
• Always remove the smart transmitter from your body before charging the battery.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 27
27
7/22/16 11:39 AM
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 physician.
Precaution: If you have any concerns about allergic reaction to silicones, contact your physician prior to use. DO NOT reuse the adhesive
patch. Discard the patch after 24 hours of use.
1. Hold the tabbed side of the patch and
remove the backing labeled “1”. Try not to
touch the sticky portion of the adhesive.
2. Align the smart transmitter over the sticky
side (center) of patch and press firmly to
secure.
position the smart transmitter directly
over the sensor.
•	The smart transmitter should be placed
•	For the maximum signal strength,
so that its sides face the wings of the
patch (as shown).
28
3. Remove the backing labeled “2” and
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.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 28
7/22/16 11:39 AM
4. Check the connection between the smart
5. Press the adhesive patch firmly on skin
6. Remove the two remaining clear liner tabs
transmitter and the sensor.
surface over the sensor.
labeled “3” by pulling on the tabs.
• Tap Menu > Placement Guide.
•	Refer to the Placement Guide
•	The smart transmitter should be
•	Smooth the adhesive onto the skin.
when attaching your smart transmitter
to ensure there is some connection
between the sensor and smart
transmitter.
positioned so that the patch wings lay
horizontally on the arm.
Make sure the patch is flat on the skin
surface.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 29
29
7/22/16 11:39 AM
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
2. To turn the smart transmitter OFF, press and hold the power button
for about five seconds.
for about five seconds.
•	The smart transmitter will vibrate once.
•	Release the power button and the LED will blink once indicating
•	The smart transmitter will vibrate once.
•	Release the power button and an orange light will blink once,
the power is ON.
indicating the power is OFF.
At any time, you can press the power button once to see if the smart
transmitter is ON. If the LED appears, the smart transmitter is ON.
If no LED appears, the smart transmitter is OFF.
LED indicator
Power button
30
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 30
7/22/16 11:39 AM
Smart Transmitter Care and Maintenance
• Keep the smart transmitter clean (free of visible dirt) and protected when not in use. Wipe the outside with a cloth between uses to keep clean.
• DO NOT spill fluid on the smart transmitter or submerge it in any liquid.
• Charge the smart transmitter whenever the battery power is low.
•	Use only the power supply supplied with your system to charge the smart transmitter battery. 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, NOT WET, cloth; dispose of the cloth according to your local regulations.
•	Dispose of the smart transmitter 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 is charged. The LED will blink orange
once if the battery is low. See the next page for more information on the LED indicators.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 31
31
7/22/16 11:39 AM
LED Status Indicators
The smart transmitter communicates several different states based upon the color of the LED.
• During smart transmitter use:
LED Status
Status
Action
Alternating green and orange when power button
is pressed 3 times in 5 seconds
Discoverable mode
Pair smart transmitter with mobile
device
Does not blink when power button is pressed
Smart transmitter off
Hold down power button for
5 seconds to turn on
Blinks green (once) when power button is pressed
10% - 90% battery power
No immediate action required
Blinks orange (once) when power button is pressed
Low battery, less than 10% battery power remaining
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
LED Status
Battery Status
Action
Solid orange when connected to the USB cable
Not yet fully charged
Continue charging until complete
Solid green when connected to the USB cable
100% charged
Disconnect from power supply
• During smart transmitter charging:
32
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 32
7/22/16 11:39 AM
6. Calibrating the System
This section describes the calibration procedure and schedule of your Eversense CGM System.
Warning: DO NOT use alternative test sites such as your forearm for calibration.
To ensure best performance, routine calibration is required using fingerstick readings from a blood glucose meter. Any commercially available meter
may be used for calibration. Once your sensor has been inserted and linked to your smart transmitter, the system begins a 24-hour Warm-Up Phase.
No calibration is required during this phase.
There are two calibration phases:
Initialization Phase – After the 24 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 2 fingerstick calibration tests per day, spaced 10 to 14 hours apart.
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:
Calibration will NOT be complete or results NOT accepted if:
 Calibrate at times when glucose is NOT changing rapidly (e.g., before
 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
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).
entering the result in the Eversense App.
 Sensor glucose reading is significantly different than the blood
glucose meter reading.
 Your smart transmitter was being charged during the 15 minutes after
you entered your calibration value.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 33
33
7/22/16 11:39 AM
Calibration Phases
A. Initialization Phase (after 24-hour Warm-Up Phase)
During this phase, 4 fingerstick blood glucose meter tests are required.
•	The 4 calibration tests must be spaced 2 to 12 hours apart, and all
4 tests must be completed within a 36 hour period.
– 1st calibration = 24 hours after sensor insertion.
– 2nd calibration = 2 to 12 hours after 1st successful calibration.
– 3rd calibration = 2 to 12 hours after 2nd successful calibration.
– 4th 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 C. Daily Calibration Phase).
34
•	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.
B. Daily Calibration Phase
The Daily Calibration Phase requires 2 blood glucose meter tests
at the scheduled morning and evening calibration times. The first
Daily Calibration Phase will begin after successful completion of the
Initialization Phase.
•
Your system will automatically tell you when it is time to perform the
twice-daily calibration test.
•	Daily Calibration times must be spaced 10 to 14 hours apart.
•	The system allows the calibration test to be taken up to 2 hours before
the scheduled time. If you miss your scheduled calibration time, the
system will prompt you hourly.
•	The CALIBRATE screen provides the next allowable calibration
time.
Note: If a Daily Calibration test is missed, no additional CGM readings
will be displayed after 16 hours have elapsed since the last accepted
calibration result. If a calibration test result is not entered within
24 hours from the last accepted calibration, the system will re-enter the
Initialization Phase.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 34
7/22/16 11:39 AM
How To Calibrate
Warning: Always calibrate the system using only a fingerstick blood sample. DO NOT use an alternative site (such as forearm or palm) blood
glucose reading to calibrate the system.
Notes
•	For daily calibrations your CGM System will
alert you when it is time to calibrate based
on your scheduled calibration times.
•	You can change your scheduled calibration
times to better fit your schedule.
Tap Menu > Settings > Daily
Calibration.
1. When it is time for calibration, the app
displays the CALIBRATE NOW
screen.
2. Obtain a fingerstick reading from your
blood glucose meter.
•	Tap Calibrate.
•	The CALIBRATE screen appears.
•	Tap Not Now if you want to wait
until later.
•	You can calibrate up to 2 hours before your
scheduled calibration time. If you miss your
scheduled calibration time, the system will
prompt you hourly.
•	You can enter additional calibration
readings as long as each calibration is
at least one hour apart. Tap Menu >
Calibrate.
•	If the time chosen is not within the
calibration time frame, the CALIBRATE
screen will indicate that it is not yet time for
a calibration test.
Eversense CGM User Guide
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 35
35
7/22/16 11:39 AM

---

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.6
Linearized                      : No
Has XFA                         : No
XMP Toolkit                     : Adobe XMP Core 5.6-c015 84.158975, 2016/02/13-02:40:29
Modify Date                     : 2016:08:05 17:37:23-04:00
Create Date                     : 2016:08:05 17:37:22-04:00
Metadata Date                   : 2016:08:05 17:37:23-04:00
Creator Tool                    : Adobe InDesign CC 2015 (Macintosh)
Format                          : application/pdf
Document ID                     : uuid:aebd4284-b925-4a96-a25a-176df112fe66
Instance ID                     : uuid:01d32afa-a739-47e1-aaa6-b1b6bef1786a
Producer                        : Adobe PDF Library 15.0
Trapped                         : False
Page Count                      : 37
Creator                         : Adobe InDesign CC 2015 (Macintosh)

EXIF Metadata provided by EXIF.tools