PH29433Glucose Monitor

USER’S GUIDE G4-Global Continuous Glucose Monitoring System CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use. G4-Global Continuous Glucose Monitoring System 4 | Continuous Glucose Monitoring System IMPORTANT CONTACTS AND NUMBERS DexCom Website: www.DexCom.com Your Transmitter ID Number: Your Transmitter Expiration Date: Your Rec eiver I D: Your Healthcare Professional: Nearest Hospital: Other Notes: © 2010 DexCom, Inc. All rights reserved. DexCom TM , STS ® , SEVEN ® , DexCom DM ® , DexCom Studio ® Software, GVI TM , OpenChoice TM , Take Control – Live Uninterrupted ® , Live Uninterrupted ® , Between the Lines TM , SENSYNC TM , Stay Between the Lines ® , DexCom Glucose Sensing™, Glucose Sensor Company™ and Dex™ are trademarks of DexCom, Inc. All other trademarks and copyrights are the property of their respective owners. G4-Global System User’s Guide | 5 G4-GLOBAL CONTINUOUS GLUCOSE MONITORING SYSTEM KIT CONTENTS: G4-GLOBAL CONTINUOUS GLUCOSE MONITORING SYSTEM G4-Global Sensor and Applicator G4-Global Receiver G4-Global Transmit ter NOTE: Sensors are sold separately. Commercially distributed blood glucose meter required for use. Make sure to use the correct version of DexCom Studio ® with your G4-Global System. The G4-Global Sensor works with the G4-Global family of products. The G4-Global Sensor, Transmitter and Receiver are not backwards compatible with the SEVEN/SEVEN ® PLUS Transmitter and Receiver. • Transmitter • Receiver • DexCom Studio ® Accessory Software • Receiver Charging Cable • Receiver Case • User’s Guide • Quick Start Guide The G4-Global Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. 6 | Continuous Glucose Monitoring System DexCom would like to thank you for purchasing the G4-Global Continuous Glucose Monitoring System (G4-Global System)! When you use the G4-Global System, you will see real-time continuous glucose readings every 5 minutes for up to 7 days. These readings will help you detect trends and patterns in your glucose levels. Glucose trends let you see where your glucose levels have been, which direction your levels are headed, and how fast they may be rising or falling. The G4-Global System is made up of three technologies that all work together: the Sensor, the Transmitter, and the Receiver. The Sensor is a disposable unit that you insert into your abdomen (belly) to continuously monitor your glucose levels for up to 7 days. The Transmitter is a reusable device that snaps into the Sensor Pod. Your Transmitter will wirelessly send your Sensor-measured glucose information to your Receiver. The Receiver is a hand-held device that receives and displays your glucose information every 5 minutes. The Receiver displays your current glucose reading and shows your glucose trend information from the past 1-hour, 3-hour, 6-hour, 12-hour, and 24-hour periods. You will also see adjustable High and Low Glucose Alerts, and a Low Glucose ALARM to tell you when you are outside of your target glucose levels. Rise and Fall (Rate of Change) Alerts will let you know when your glucose levels are changing fast. You can use any FDA-cleared blood glucose meter for calibration on the G4-Global System. This User’s Guide describes how to use your G4-Global System from start to fi nish of a continuous glucose monitoring session. Important safety information, warnings, precautions, cautions, and contraindications of the G4-Global System are described in the next few pages and throughout this guide. Be sure to read this entire User’s Guide before beginning a continuous glucose monitoring session. G4-Global System User’s Guide | 7 INDICATION FOR USE The G4-Global Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The G4-Global System is intended for use by patients at home and in health care facilities. The device is for prescription use only. The G4-Global Continuous Glucose Monitoring System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The G4-Global Continuous Glucose Monitoring System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the G4-Global System results should be based on the trends and patterns seen with several sequential readings over time. IMPORTANT SAFETY INFORMATION Read this entire guide before using your G4-Global Continuous Glucose Monitoring System. If you do not understand something or have any questions, please ask your Diabetes Management Team or another health care provider. Contraindications, warnings, precautions, cautions, and other important safety information can be found in this section and in boxes throughout your G4-Global System User’s Guide. The Troubleshooting section (Chapter 9) contains important information on troubleshooting your G4-Global System. The Technical Information section (Chapter 11, Section 11.2) provides information on the performance characteristics of the device. CONTRAINDICATIONS • The G4-Global System must be removed prior to Magnetic Resonance Imaging (MRI). • Use of acetaminophen-containing medications while the Sensor is inserted may affect the performance of the device. 8 | Continuous Glucose Monitoring System WARNINGS • This device is not designed to replace a blood glucose meter. The G4-Global System must be used with a blood glucose meter. • Treatment decisions should not be based solely on results from the G4-Global System. You must confi rm results with fi ngerstick readings from a blood glucose meter before making therapeutic adjustments. • Symptoms related to low or high blood glucose levels should not be ignored. If you have …

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EXTERNAL PHOTOS Company Name DexCom, Inc Model # 9438‐01 FCC ID # PH29433 Page 1 of 1 Front Side of Transmitter Back Side of Transmitter

LABEL PHOTO Company Name DexCom, Inc Model # 9438‐01 FCC ID # PH29433 Page 1 of 1

INTERNAL PHOTOS Company Name DexCom, Inc Model # 9438‐01 FCC ID # PH29433 Page 1 of 2 Front side of transmitter open for inspection Back side of transmitter open for inspection INTERNAL PHOTOS Company Name DexCom, Inc Model # 9438‐01 FCC ID # PH29433 Page 2 of 2 Side view 1 Side view 2

W66 N220 Commerce Court ● Cedarburg, WI 53012 Phone: 262.375.4400 ● Fax: 262.375.4248 www.lsr.com TEST REPORT #: C-986 LSR Job #: 310250 Compliance Testing of: 2.4 GHz Transmitter Test Date(s): September 8 th -20 th , 2010 Prepared For: DexCom, Inc. Attn: Shawn Larvenz 6340 Sequence Drive San Diego, CA 92121 In accordance with: Federal Communications Commission (FCC) Part 15, Subpart C, Section 15.249 Industry Canada (IC) RSS 210 Annex 2 Transmitters Operating in the Frequency Band 2400 – 2483.5 MHz This Test Report is issued under the Authority of: Thomas T. Smith, Manager EMC Test Services Signature: Date: 10/29/2010 Quality Assurance by: Thomas T. Smith, Manager EMC Test Services Signature: Date: 10/29/2010 Tested by: Shane D. Rismeyer, EMC Engineer Signature: Date: 10/8/10 This Test Report may not be reproduced, except in full, without written approval of LS Research, LLC. LS Research, LLC Page 2 of 29 Prepared For: DexCom, Inc. Model Number: 9438-01 Report #: 310250 EUT: 2.4 GHz Transmitter Serial Number: 60113 LSR Job #: C-986 TABLE OF CONTENTS TABLE OF CONTENTS .................................................................................................................... 2 EXHIBIT 1. INTRODUCTION ........................................................................................................... 4 1.1 - Scope ............................................................................................................................................................... 4 1.2 - Normative References ............................................................................................................................ 4 1.3 - LS Research, LLC in Review .............................................................................................................. 5 EXHIBIT 2. PERFORMANCE ASSESSMENT .............................................................................. 6 2.1 – Client Information ..................................................................................................................................... 6 2.2 – Equipment under Test (EUT) Information ................................................................................... 6 2.4 – EUT Technical Specifications ................................................................................................................. 7 2.5 – Product Description ................................................................................................................................. 8 EXHIBIT 3. EUT OPERATING CONDITIONS AND CONFIGURATION .................................. 9 3.1 – Climate Conditions During Testing ................................................................................................. 9 3.2 – Applicability and Summary of EMC Emission Test Results ............................................... 9 3.3 – Modifications Incorporated in the EUT for Compliance Purposes .................................. 9 3.4 – Deviations and Exclusions from Test Specifications ............................................................. 9 EXHIBIT 4. DECLARATION OF CONFORMITY ........................................................................ 10 EXHIBIT 5. RADIATED EMISSIONS TEST................................................................................. 11 5.1 - Test Setup ................................................................................................................................................... 11 5.2 - Test Procedure ......................................................................................................................................... 11 5.3 - Test Equipment Utilized ....................................................................................................................... 11 5.4 - Test Results ............................................................................................................................................... 11 5.5 – Calculation of Radiated Emissions Limits ................................................................................. 12 5.6 - Radiated Emissions Test Data Chart ........................................................................................... 13 5.7 - Test Setup Photo(s) – Radiated Emissions Test .................................................................... 15 5.8 - Screen Captures - Radiated Emissions Test............................................................................ 16 EXHIBIT 6. OCCUPIED BANDWIDTH ......................................................................................... 21 6.1 - Limits .............................................................................................................................................................. 21 6.2 - Method of Measurements ................................................................................................................... 21 6.3 - Test Data ..................................................................................................................................................... 21 6.4 - Screen Captures - Occupied Bandwidth ..................................................................................... 22 EXHIBIT 7. BAND-EDGE MEASUREMENTS ............................................................................. 24 LS Research, LLC Page 3 of 29 Prepared For: DexCom, Inc. Model Number: 9438-01 Report #: 310250 EUT: 2.4 GHz Transmitter Serial Number: 60113 LSR Job #: C-986 7.1 - Method of Measurements ................................................................................................................... 24 APPENDIX A: Test Equipment ...................................................................................................... 26 APPENDIX B: Test Standards – Current Publication Dates Radio .......................................... 28 APPENDIX C: Uncertainty Statement..............................................................…

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TEST SETUP PHOTOS Company Name DexCom, Inc Model # 9438-01 FCC ID # PH29433 Page 1 of 1 Test Setup Photo(s) – Radiated Emissions Test