Senseonics orporated 3400 The Eversense Smart Transmitter User Manual 5

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Document ID	3112693
Application ID	kGzXG4HQynAY7DiMPMtVAg==
Document Description	Users Manual 5
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	48.26kB (603198 bits)
Date Submitted	2016-08-26 00:00:00
Date Available	2016-08-30 00:00:00
Creation Date	2016-08-05 17:37:24
Producing Software	Adobe PDF Library 15.0
Document Lastmod	2016-08-05 17:37:24
Document Title	Users Manual 5
Document Creator	Adobe InDesign CC 2015 (Macintosh)

Symbols on Packaging and Devices
Symbol
Explanation
Consult accompanying
documents
Caution, consult
accompanying documents
Symbol
0123
Explanation
Symbol
Explanation
Marking certifies that
the device meets the
European Council Directive
90/385/EEC
Magnetic Resonance
Imaging (MRI) procedures
are contraindicated for
this device.
Part number
European Union WEEE
Directive 2012/19/EU
Use by
Serial number
Single use only
Manufacturer
Authorized representative
in the European
Community
Date of manufacture
Storage temperature limits
Type BF Applied Part
Non-ionizing
electromagnetic radiation
Not made with natural
rubber latex
Lot number
FCC ID is assigned to
all devices subject to
certification
Universal Serial Bus (USB)
Non-sterile
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
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Eversense Smart Transmitter Limited Warranty
1. Coverage and duration of limited warranty.
Senseonics, Incorporated (“Senseonics”) warrants to the original end user (“you”) of the Eversense Smart Transmitter that the Smart Transmitter
shall be free from defects in material and workmanship under normal use for a period of one year commencing on the date that you first received the
Smart Transmitter from your physician. 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 physician, and this warranty will be void with respect to
the original Smart Transmitter.
2. Exclusions to the limited warranty.
The limited warranty 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) equipment that has been dissembled; and f) damage caused by improper operation, testing, maintenance, installation or adjustment. The
Smart Transmitter cannot be exposed to water, and this limited warranty does not cover any damage resulting from such exposure. This limited warranty
does not apply to collateral services, equipment or software that may be used with the Smart Transmitter.
3. Senseonics’ obligations under the limited warranty.
18
The sole obligation of Senseonics under this limited warranty is to repair or replace, at its sole discretion, without charge to you, any defective Eversense
Smart Transmitter, provided the warranty period is still in effect. You must return the defective product to an authorized Senseonics Customer Support
Department in an appropriate shipping container that will adequately protect the Smart Transmitter from further damage, accompanied by your name
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and address, the name and address of the physician 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 Eversense Smart
transmitter 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.
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, NON-INFRINGEMENT. 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 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 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
Part Number
Eversense Smart Transmitter Kit
FG-3200-01-001
Charging cable
FG-6100-00-301
Charging Adapter
FG-6200-93-301
Eversense Adhesive Patches
FG-6300-00-301
Eversense Quick Reference Guide
LBL-0203-01-001
Eversense CGM User Guide
LBL-0202-01-001
Eversense Data Management Software
Application
FG-5200-01-300
Eversense Mobile Application iOS
FG-5100-01-300
Eversense Mobile Application Android
FG-5300-01-300
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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.
18
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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
28, 29
Alerts
43, 47, 48, 49, 53, 58, 59, 60, 61, 62,
63, 64, 65, 66, 67, 68
App, about
8, 43
App, download
18
App, Glance View
82
App, launch
19
Apple Watch
82
App, log out
57
App, product information
80, 81
App, using
38
Battery, charging
17
Battery power, indicator
31
Bluetooth
43, 118
Bluetooth, restart
89
Button on smart transmitter
21, 26, 30
Calibration, Daily Phase
33, 34
Calibration, Initiation Phase
33, 34
Calibration, procedure
33, 35, 43
Calibration, reminders
22, 50
Data Management System (DMS)
79
Discoverable mode
21, 89, 91
Do Not Disturb mode
54
Events
43, 70
Eversense DMS
79
FCC Information
119
LED indicator
17, 26, 30, 32
Link, smart transmitter with sensor
24
Mealtime schedule
52
Menu
43
Mobile device
18, 38
MY GLUCOSE screen
23, 38, 39, 43
Notifications
58, 69
Pairing, smart transmitter
and mobile device
19, 21, 89
Placement guide, signal strength
29, 43
Power adapter
11, 17
Reports
43, 76
Reset smart transmitter
64, 90
Restart Bluetooth
89
RF, radio frequency communication
118
Sensor
84
Sensor, about
7, 84, 86
Sensor, insertion and removal
24, 84, 85
Settings, app
19, 43, 44, 51
Smart transmitter, about
7, 11
Smart transmitter, attaching
28
Smart transmitter, maintenance
31
Smart transmitter, on/off
30
Smart transmitter, reset
64, 90
Smart transmitter, using
26, 27
Snooze setting
53
Symbols, alerts, notifications
113, 114
Symbols, packaging and device
115
System components
7, 11
Target levels
46
Temp Profile
55
Travel
86
Trend arrows
41
Trend graph
42
Troubleshooting, FAQs
87
Unit of measurement
22
USB, cable
17
USB, port
17, 26
Wireless
9, 16, 18, 38, 118
Eversense
CGM
User
Guide
CGM
User
Guide
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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)
eversensediabetes.com
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 4
FPO
© Senseonics, Inc. 2016 PN: LBL-0202-01-001_Rev 1 07/2016
7/22/16 11:39 AM
Date: 7/22/16
File name: LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6
Job description: Eversense User Guide
Project Manager: Erin Moody
Art Director: Ivy Tsang
Dimensions:
Trim: 8.5” w X 5.7” h
Bleed: .125”
Folded (Include folded dimensions if applicable):
Colors: 4/color
Spot (Name PMS colors if applicable):
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 5
7/22/16 11:39 AM

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