Senseonics orporated 3400 The Eversense Smart Transmitter User Manual 5

Senseonics Incorporated The Eversense Smart Transmitter Users Manual 5

Users Manual 5

115Eversense CGM User Guide18Symbol ExplanationConsult accompanying documentsCaution, consult accompanying documentsUse byManufacturerAuthorized representative in the European CommunityDate of manufactureStorage temperature limitsLot numberUniversal Serial Bus (USB)Symbol Explanation0123Marking certifies that the device meets the European Council Directive 90/385/EECPart numberSerial numberType BF Applied PartNon-ionizing electromagnetic radiationNot made with natural rubber latexFCC ID is assigned to all devices subject to certificationNon-sterileSymbols on Packaging and DevicesSymbol ExplanationMagnetic Resonance Imaging (MRI) procedures are contraindicated for this device.European Union WEEE Directive 2012/19/EUSingle use onlyDo not re-sterilizeDo not use if package is damagedSterilized using Ethylene OxideU.S. (Federal) law restricts the sale of the Eversense CGM System to sale by or on the order of a physicianLBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 115 7/22/16 11:39 AM
116Eversense CGM User Guide18Eversense Smart Transmitter Limited Warranty1. 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 LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 116 7/22/16 11:39 AM
117Eversense CGM User Guide18and 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 NumberEversense Smart Transmitter Kit FG-3200-01-001Charging cable FG-6100-00-301Charging Adapter FG-6200-93-301Eversense Adhesive Patches FG-6300-00-301Eversense Quick Reference Guide LBL-0203-01-001Eversense CGM User Guide LBL-0202-01-001Eversense Data Management Software ApplicationFG-5200-01-300Eversense Mobile Application iOS FG-5100-01-300Eversense Mobile Application Android FG-5300-01-300LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 117 7/22/16 11:39 AM
118Eversense CGM User Guide18Apple 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 NoticeThe “Android” name, the Android logo, and Google Play are trademarks of Google Inc.Legal NoticesAbout 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® TrademarkThe Bluetooth® word mark and logos are owned by the Bluetooth® SIG, Inc. and any use of such marks by Senseonics, Inc. is under license. LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 118 7/22/16 11:39 AM
119Eversense CGM User Guide18FCC InformationYour 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.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 119 7/22/16 11:39 AM
120Eversense CGM User Guide120Eversense CGM User GuideIndexAdhesive patch 28, 29Alerts 43, 47, 48, 49, 53, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68App, about 8, 43App, download 18App, Glance View 82App, launch 19Apple Watch 82App, log out 57App, product information 80, 81App, using 38Battery, charging 17Battery power, indicator 31Bluetooth 43, 118Bluetooth, restart 89Button on smart transmitter 21, 26, 30Calibration, Daily Phase 33, 34Calibration, Initiation Phase 33, 34Calibration, procedure 33, 35, 43Calibration, reminders 22, 50Data Management System (DMS) 79Discoverable mode 21, 89, 91Do Not Disturb mode 54Events 43, 70Eversense DMS 79FCC Information 119LED indicator 17, 26, 30, 32Link, smart transmitter with sensor 24Mealtime schedule 52Menu 43Mobile device 18, 38MY GLUCOSE screen 23, 38, 39, 43Notifications 58, 69Pairing, smart transmitter and mobile device 19, 21, 89Placement guide, signal strength 29, 43Power adapter 11, 17Reports 43, 76Reset smart transmitter 64, 90Restart Bluetooth 89RF, radio frequency communication 118Sensor 84Sensor, about 7, 84, 86Sensor, insertion and removal 24, 84, 85Settings, app 19, 43, 44, 51Smart transmitter, about 7, 11Smart transmitter, attaching 28Smart transmitter, maintenance 31Smart transmitter, on/o 30Smart transmitter, reset 64, 90Smart transmitter, using 26, 27Snooze setting 53Symbols, alerts, notifications 113, 114Symbols, packaging and device 115System components 7, 11Target levels 46Temp Profile 55Travel 86Trend arrows 41Trend graph 42Troubleshooting, FAQs 87Unit of measurement 22USB, cable 17USB, port 17, 26Wireless 9, 16, 18, 38, 118LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 120 7/22/16 11:39 AM
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 3 7/22/16 11:39 AM
Manufactured and Distributed by Senseonics, Inc.20451 Seneca Meadows ParkwayGermantown, MD 20876-7005 USA844.SENSE4U 301.515.7260 (844.736.7348)eversensediabetes.com © Senseonics, Inc. 2016 PN: LBL-0202-01-001_Rev 1 07/2016FPOLBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 4 7/22/16 11:39 AM
Date: 7/22/16File name: LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6Job description: Eversense User GuideProject Manager: Erin Moody Art Director: Ivy TsangDimensions: Trim: 8.5” w X 5.7” h Bleed: .125”Folded (Include folded dimensions if applicable):Colors: 4/colorSpot (Name PMS colors if applicable): LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 5 7/22/16 11:39 AM

Navigation menu