PH29006Dexcom Share Cradle

User Manual 1 © 2013 Dexcom, Inc. All rights reserved. The Dexcom logo, Dexcom and Dexcom G4 are registered trademarks of Dexcom, Inc. Dexcom G4 PLATINUM, Dexcom SHARE, Dexcom Share, Dexcom Follower, Follow Dashboard and GlucoMonster are trademarks of Dexcom, Inc. Apple, the Apple logo, iPad, iPhone and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple, Inc. The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. LTE is a trademark of ETSI. All other product or company names that may be mentioned in this publication are tradenames, trademarks or registered trademarks of their respective owners. 2 CHAPTER ONE Learning About Dexcom SHARE 08 Glossary 14 Symbols 15 System Overview 16 System Components 17 Conditions That Affect Use 17 Benefits 18 Indications for Use 18 Contraindications 18 Important User Information 19 Warnings 19 Precautions 23 Risks 25 User Agreement CHAPTER TWO Setting Up the Dexcom Share App 27 Dexcom Share App Description 28 Setting Up Cradle 30 Creating a Dexcom Share Account 31 Pairing Cradle 32 Inviting Followers 3 Table of Contents CHAPTER THREE Using the Dexcom Share App 35 Dexcom Share Status 36 Status Tabs 36 Troubleshooting Status 38 GlucoMonster 39 Follower List 41 Inviting Followers 41 Editing Followers 41 Stop Sharing with Followers 42 Removing Followers 42 Account Tab 42 Pairing New iPhone or iPod touch 43 Replacing Cradle 44 Registering New Receiver 45 The More Tab CHAPTER FOUR Using the Dexcom Follow App 47 Dexcom Follow App Description 47 Receiving Follow Invitation Email 48 Types of Glucose Notifications 49 Changing Glucose Notifications 51 Type of Status Change Notifications 51 Follow Dashboard 52 Sharer Statuses 4 Table of Contents 53 Sharer Trend Graph 55 Finding Out More CHAPTER FIVE Maintaining Dexcom SHARE 57 Cradle Working and Storage Conditions 57 Cradle Maintenance and Cleaning 57 USB Cable Maintenance CHAPTER SIX Troubleshooting, Warranty and Customer Support 60 Dexcom Share App Troubleshooting 61 Receiver Troubleshooting 61 Cradle Troubleshooting 64 Sharing Checklist 65 Dexcom Follow App Troubleshooting 66 Follower Questions 67 Following Checklist 69 Warranty Information 72 Contact Customer Support 5 Table of Contents CHAPTER SEVEN Technical Information 74 Guidance and Manufacturer’s Declaration 76 FCC Requirements CHAPTER EIGHT Index 82 Index 6 Table of Contents CHAPTER ONE Learning About Dexcom SHARE 7 Glossary Term Definition Airplane mode A setting on iPhone ® or iPod touch ® where wireless features are disabled in order to comply with airline regulations. Application or app A software program, such as the Dexcom Share TM app and the Dexcom Follow TM app, designed to run on iPhone or iPod touch. Blood glucose meter A device used to measure how much glucose is in the blood. Blood glucose value The measurement of glucose in the blood. Bluetooth Bluetooth ® wireless technology allows devices to wirelessly communicate when positioned less than 30 feet apart. Cradle Allows the Dexcom G4 TM PLATINUM Receiver to send sensor glucose information and notifications to the Sharer’s iPhone or iPod touch using Bluetooth. Default A manufacturer’s preset option for a device setting. Delay Amount of set time that passes before a notification is sent to a Follower. Dexcom SHARE Cloud A secure online storage server where Dexcom Share app information is stored and then shared with Followers. Dexcom Follow app Receives the Sharer’s glucose information and notifications data from the Dexcom SHARE Cloud. 8 Learning About Dexcom SHARE Dexcom G4 PLATINUM Receiver The Dexcom G4 ® PLATINUM System part that collects glucose information from the sensor and transmitter. It is also referred to as receiver. Dexcom G4 PLATINUM Sensor The Dexcom G4 PLATINUM System part that includes an applicator and wire. Dexcom G4 PLATINUM System Continuous glucose monitoring system made of a sensor, transmitter, and receiver. Dexcom G4 PLATINUM Transmitter The Dexcom G4 PLATINUM System part that wirelessly sends glucose information to the receiver. Dexcom Share app Receives glucose information when the Dexcom G4 PLATINUM Receiver is in the Cradle. Sends glucose information to the Dexcom SHARE Cloud using an internet connection. Dexcom SHARE System Secondary notification system using the following components: the Dexcom G4 PLATINUM System, the Cradle, Bluetooth wireless technology, the Sharer’s iPhone or iPod touch, the Dexcom Share app, the internet, the Follower’s iPhone or iPod touch and the Dexcom Follow app. 9 Learning About Dexcom SHARE 10 Learning About Dexcom SHARE Do Not Disturb A setting on iPhone or iPod touch where all incoming calls, alerts, and notifications are silenced. Do not disturb can be set to specific times and can be set to allow exceptions (people who can disturb you). Follower A person that receives the Sharer’s shared information. Follow Dashboard On the Dexcom Follow app, the Follow Dashboard TM shows the glucose information of up to five (5) Sharers. Follower’s iPhone or iPod touch Runs the Dexcom Follow app. GlucoMonster The GlucoMonster TM character displays the status of Dexcom SHARE. Hyperglycemia High blood glucose. Same as “high.” The default high alert in your receiver is set to 200 mg/dL. Consult your health care provider to determine the appropriate hyperglycemic setting for you. Hypoglycemia Low blood glucose. Same as “low.” The default low alert in your receiver is set to 80 mg/dL. Consult your health care provider to determine the appropriate hypoglycemic setting for you. Invite/ Follow Invitation email An email request for a person to download the Dexcom Follow app and receive the Sharer’s shared information. iPhone The Dexcom Share app is compatible with an iPhone 4S or later. The Dexcom Follow app is compatible with an iPhone 4 or later. iPod touch The Dexcom Share app is compatible with an iPod touch 5th generation or later. The Dexcom Follow…

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end view, connections for test only.

Nemko USA, Inc. 2210 Faraday Ave, Suite 150 Carlsbad, CA 92008 Phone (760) 444-3500 Fax (760) 444-3005 FCC Part 15 Subpart C, 15.249 : 11 July 2013 CERTIFICATION TEST REPORT Report Number: 2013 03232163 FCC Project Number: 10228553 Nex Number: 232163 Applicant: D EXCOM, INC. 6340 SEQUENCE DRIVE San Diego, CA, 92121 Equipment Under Test (EUT): DEXCOM SHARE CRADLE Model: MT22006 FCC ID: PH29006 In Accordance With: FCC Part 15 Subpart C, 15.249 Tested By: Nemko USA Inc. 2210 Faraday Avenue, Suite 150 Carlsbad, CA 92008 Date: M ARCH 21, 2013 Total Number of Pages: 22 Nemko USA, Inc. 2210 Faraday Avenue, Suite 150, Carlsbad, CA 92008 Phone (760) 444-3500 Fax (760) 444-3005 Report Number: 2013 03232163 FCC FCC ID: PH29006 Specification: FCC Part 15 Subpart C, 15.249 Page 2 of 22 1 Applicant Affirmation Shawn S Larvenz, representing DexCom, Inc. hereby affirms: a) That he/she has reviewed and concurs that the test shown in this report are reflective of the operational characteristics of the device for which certification is sought; b) That the device in this test report will be representative of production units; c) That all changes (in hardware and software/firmware) to the subject device will be reviewed. d) That any changes impacting the attributes, functionality or operational characteristics documented in this report will be communicated to the body responsible for approving (certifying) the subject equipment. Shawn Larvenz Printed name of official Signature of official 6340 Sequence Drive March 21, 2013 Address Date 858-875-5303 [email protected] Telephone number Email address of official NOTE—This affirmation must be signed by the responsible party before it is submitted to a regulatory body for approval. Nemko USA, Inc. 2210 Faraday Avenue, Suite 150, Carlsbad, CA 92008 Phone (760) 444-3500 Fax (760) 444-3005 Report Number: 2013 03232163 FCC FCC ID: PH29006 Specification: FCC Part 15 Subpart C, 15.249 Page 3 of 22 Section1: Summary of Test Results General All measurements are traceable to national standards These tests were conducted on a sample of the equipment for the purpose of demonstrating compliance with FCC Part 15; Subpart C and IC RSS-210. Radiated tests were conducted is accordance with ANSI C63.4-2003. Radiated emissions are made in a 10m semi-anechoic chamber. A description of the test facility is on file with the FCC and IC. The assessment summary is as follows: Apparatus Assessed: Dexcom Share Cradle Model: MT22006 Specification: FCC Part 15 Subpart C, 15.249 Date Received in Laboratory: March 11, 2013 Compliance Status: Complies Exclusions: None Non-compliances: None Nemko USA, Inc. 2210 Faraday Avenue, Suite 150, Carlsbad, CA 92008 Phone (760) 444-3500 Fax (760) 444-3005 Report Number: 2013 03232163 FCC FCC ID: PH29006 Specification: FCC Part 15 Subpart C, 15.249 Page 4 of 22 1.1 Report Release History REVISION DATE COMMENTS - March 21, 2013 Prepared By: Mark Phillips - March 21, 2013 Initial Release: Alan Laudani Note that the results contained in this report relate only to the items tested and were obtained in the period between the date of initial receipt of samples and the date of issue of the report. This test report has been completed in accordance with the requirements of ISO/IEC 17025. Nemko USA Inc. authorizes the applicant to reproduce this report provided it is reproduced in its entirety and for use by the company’s employees only. Any use which a third party makes of this report, or any reliance on or decisions to be made based on it, are the responsibility of such third parties. Nemko USA Inc. accepts no responsibility for damages, if any, suffered by any third party as a result of decisions made or actions based on this report. TESTED BY: _ Date: March 21, 2013 Mark Phillips, EMC Test Engineer Alan Laudani, Test Report Verificator Nemko USA, Inc. 2210 Faraday Avenue, Suite 150, Carlsbad, CA 92008 Phone (760) 444-3500 Fax (760) 444-3005 Report Number: 2013 03232163 FCC FCC ID: PH29006 Specification: FCC Part 15 Subpart C, 15.249 Page 5 of 22 TABLE OF CONTENTS 1 Applicant Affirmation ............................................................................................. 2 Section1: Summary of Test Results ................................................................................ 3 1.1 Report Release History ..................................................................................... 4 Section 2: Equipment Under Test ................................................................................... 6 2.1 Product Identification ........................................................................................ 6 2.2 Theory of Operation .......................................................................................... 7 2.3 Technical Specifications of the EUT ................................................................. 7 Section 3: Test Conditions .............................................................................................. 8 3.1 Specifications .................................................................................................... 8 3.2 Deviations From Laboratory Test Procedures ................................................... 8 3.3 Test Environment .............................................................................................. 8 3.4 Test Equipment ................................................................................................. 8 Section 4: Observations .................................................................................................. 9 4.1 Modifications Performed During Assessment ................................................... 9 4.2 Record Of Technical Judgements ..................................................................... 9 4.3 EUT Parameters Affecting Compliance ............................................................ 9 4.4 Test Deleted .....................................................................................…

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