Senseonics orporated 3400 The Eversense Smart Transmitter User Manual 5

Senseonics Incorporated The Eversense Smart Transmitter Users Manual 5

Users Manual 5

115
Eversense CGM User Guide
18
Symbol Explanation
Consult accompanying
documents
Caution, consult
accompanying documents
Use by
Manufacturer
Authorized representative
in the European
Community
Date of manufacture
Storage temperature limits
Lot number
Universal Serial Bus (USB)
Symbol Explanation
0123
Marking certifies that
the device meets the
European Council Directive
90/385/EEC
Part number
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
Symbols on Packaging and Devices
Symbol Explanation
Magnetic Resonance
Imaging (MRI) procedures
are contraindicated for
this device.
European Union WEEE
Directive 2012/19/EU
Single use only
Do not re-sterilize
Do not use if package is
damaged
Sterilized using
Ethylene Oxide
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.
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 eect. 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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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 aect
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.
Legal Notices
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 aect the operation of other nearby electronic devices. Additionally, other electronic
devices should not aect 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 o 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 o 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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Eversense CGM User Guide
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/o 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
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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 © Senseonics, Inc. 2016 PN: LBL-0202-01-001_Rev 1 07/2016
FPO
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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):
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