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PH29300Glucose Monitoring System

Dexcom, Inc.
Glucose Monitoring System - FCC ID PH29300 - Dexcom, Inc.
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Application Details

Equipment Class
TNT - Licensed Non-Broadcast Transmitter Worn on Body
Date of Grant
Mar 26, 2006
Application Purpose
Original Equipment
Date of Application
Dec 18, 2005
Equipment Note
Glucose Monitoring System
Frequency Range
402.14000000 - 402.14000000
Company
Dexcom, Inc.
Country
United States

Documents & Files

Select a file to view

Users Manual

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Attestation Statements

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Cover Letter(s)

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External Photos

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ID Label/Location Info

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RF Exposure Info

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Test Report

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Users Manual

Caution: Investigational device. Limited by Federal (United States) law to investigational use. CONFIDENTIAL Page 1 of 3  Under FDA Review DEXCOM™ STS™ CONTINUOUS GLUCOSE MONITORING SYSTEM USER GUIDE F OR TRANSMITTER MODEL NUMBER 9300 & RECEIVER MODEL NUMBER 8204 Starting Continuous Glucose Monitoring Choose a site on your abdomen (belly) to put the Sensor that is a flat area and where you don’t have any scarring or rough patches of skin and clean the site with an alcohol swab. Remove the adhesive backing from the STS™ Sensor Pod and place the STS™ Sensor on the selected site. 1. Pull the safety lock out from the Applicator. 2. Place 2 fingers under the collar, with your thumb on the plunger, and push the plunger down completely. 3. At the same time that you are pushing the plunger down, pull the collar back completely until you hear a click. 4. Press the tabs on the sides of the STS™ Sensor Pod and pull out the STS™ Applicator. 4. STEP 1- Inserting a New STS™ Sensor Push plunger Remove STS™ Applicator STS™ Sensor Pod remains adhered Press tabs Collar completely back Safety Lock 1. Pull Collar 2. 3. 4. STS™ Sensor & STS™ Applicator STS™ Sensor & STS™ Transmitter STS™ Receiver Caution: Investigational device. Limited by Federal (United States) law to investigational use. CONFIDENTIAL Page 2 of 3  Under FDA Review The antenna should appear here Place the STS™ Transmitter into the STS™ Sensor Pod with the flat side facing down. Pull the STS™ Transmitter Latch up onto the to STS™ Transmitter to snap it into place. Remove the STS™ Transmitter Latch by holding the end of the latch and quickly twisting off the latch away from your body. Press any button on the STS™ Receiver to check for the Antenna icon (Y) before you continue. Press the Down Arrow 3 times until you come to the 9-hour Glucose Trend Screen and then press and hold the Down Arrow for at least 7 seconds until you see the Sensor Insertion Screen. Press the OK button. Viewing your Glucose Trends You can view trends and patterns using the 1-hour, 3-hour, and 9-hour glucose screens. (See screens below). STS™ Receiver Alert Screens The device may vibrate and/or beep and display one of the following screens during use: STEP 2- Installing Your STS™ Transmitter STEP 3- Beginning your Continuous Glucose Monitoring Session CONTINUOUS MONITORING Calibration Update Screen Out of Calibration Screen Low Glucose Alert High Glucose Alert Low Glucose Alarm Error Code Remove STS™ Transmitter Latch STS™ Transmitter installed STS™ Transmitter Latch Install STS™ Transmitter in STS™ Sensor Pod Press  Press  1-hour Glucose Trend Screen 3-hour Glucose Trend Screen 9-hour Glucose Trend Screen Glucose Value Caution: Investigational device. Limited by Federal (United States) law to investigational use. CONFIDENTIAL Page 3 of 3  Under FDA Review If the Calibration Update Screen or the Out of Calibration Screen appears on the STS™ Receiver, clear the prompt, take a BG fingerstick to bring the STS™ System back into calibration. When the STS™ Sensor glucose value is above or below the alert settings you have selected (factory settings are 80 and 200), the STS™ Receiver will notify you of a high or low glucose value. Press any button on the STS™ Receiver to acknowledge the alert. Take a fingerstick before you make any treatment decisions. In addition to your personal glucose alert settings, your STS™ Receiver also has an automatic low glucose alarm set at 55mg/dL (3.1 mmol/L). The error code indicates the STS™ Receiver is not functioning properly. Note the Error code, use your meter to check your blood glucose readings, and contact Technical Support immediately . Your Continuous Glucose Monitoring Session is finished and you should remove the STS™ Sensor. STS™ Sensor Expiration Notification The STS™ Receiver will display screens that notify you how long you have until the end of your Continuous Glucose Monitoring Session. You will be notified at 6 hours, 2 hours, 30 minutes to the end of your sensing period, and when your session is finished. Press any button to clear the alert. This transmitter is authorized by rule under the Medical Implant Communication Service (47 C.F.R. Part 95) and must not cause harmful interference to stations operating in the 400.150 – 406.000 MHz band in the Meteorological Satelite, or Earth Exploration Satelite Services and must accept interference that may be caused by such aids, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Implant Communications Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. LBLXXXX, Rev. XX, © 2005. DexCom, Inc. ENDING YOUR CONTINUOUS GLUCOSE MONITORING SESSION CONSUMER INFORMATION AND FCC REQUIREMENTS

Attestation Statements

Federal Communications Commission FCC 06-1 Before the Federal Communications Commission Washington, D.C. 20554 In the Matter of DexCom, Inc . Request for Waiver of the Frequency Monitoring Requirements for the Medical Implant Communications Service Rules ) ) ) ) ) ) ) ) ET Docket No. 05-213 ORDER Adopted: January 12, 2006 Released: January 18, 2006 By the Commission: I. INTRODUCTION 1. By this Order, we grant a request for waiver filed by DexCom, Inc., 1 authorizing it to build and market its blood glucose monitoring system to operate in the Medical Implant Communications Service (MICS) band. 2 This waiver is granted for a period of three years, or until such time as the Commission amends its rules related to such devices to obviate the need for a waiver or to specify rules with which devices of this kind will be required to comply. 2. The DexCom STS (short-term) and LTS (long-term) blood glucose monitoring sensors are devices implanted into the body that combine a monitor with a low-power transmitter to provide frequent, periodic information regarding blood glucose levels. These monitor readings are transmitted to a receiver worn by a diabetic patient, so that the patient can continuously monitor his/her blood glucose level and take nutrition or medication (insulin) as necessary to maintain an appropriate glucose level in the blood. They can also send an alarm to the wearer when the blood glucose level falls outside acceptable levels. The devices operate on a single channel, and do not have a “listen before talk” (LBT) capability nor are they frequency agile, as required by the MICS rules. 3 Consequently, DexCom requests a waiver of these rules to permit it to manufacture and market, and for medical professionals to prescribe and diabetic patients to use, the STS and LTS as currently configured. 3. Opposition was filed by Medtronic, Inc. (Medtronic), the developer of a variety of medical implant devices, including implanted monitoring and communications devices for cardiac patients that comply fully with the MICS rules. 4 Comments supporting DexCom’s request were filed by the Juvenile Diabetes Research Foundation (JDRF); Biotronik, a maker of other implantable medical 1 Public Notice, June 15, 2005, DA 05-1670. 2 MICS operates at 402-405 MHz, and is governed by Part 95, Subpart I of the Commission’s rules (47 C.F.R §§ 95.1201ff; also 47 C.F.R. § 95.628). 3 47 C.F.R. § 95.1211. 4 Meditronic also makes insulin pumps and a monitor for diabetics that communicate on non-MICS frequencies. Federal Communications Commission FCC 06-1 2 devices with transmitters; and AMI Semiconductors, Inc. (AMI), a provider of integrated circuits to the medical industry. II. BACKGROUND 4. In 1999, the Commission established the MICS rules to allow the operation of radio transmitters that support the diagnostic and/or therapeutic functions associated with implanted medical devices to enable individuals and medical practitioners to utilize potential life-saving medical technology without causing interference to other users of the spectrum. 5 The Commission determined that the 402- 405 MHz band is particularly well suited for this service, due to the signal propagation characteristics in the human body, the relative dearth of other users of the band, the compatibility of the MICS service with the incumbent users of the band, and its use internationally for this purpose. 6 To avoid harming other users of the frequency band, MICS was provided a secondary allocation. The 402-405 MHz band was, and remains, allocated on a primary basis to Federal Government uses, including Meteorological Aids Service (Metaids), the Meteorological Satellite Service, and the Earth Exploration Satellite Service. 7 The Commission adopted technical rules for the MICS specifically designed to protect these incumbent Federal services, as well as to ensure compatibility among multiple MICS devices and users. 8 These rules establish a channel bandwidth of 300 kHz for this service within the allotted bandwidth, 9 provide for frequency sharing and cooperation in the selection and use of channels, 10 and establish specific guidelines for frequency monitoring prior to transmission by implant programmer/control transmitters. 11 12 Given these protections, the National Telecommunications and Information Administration (NTIA), representing the incumbent Federal user entitled to exclusive use of this band, interposed no objection to this allocation. 13 5. In 2003, the Commission found that another implanted medical device (a cardiac pacemaker with a transmitter for monitoring data concerning the heart) that operates similarly to the subject devices – at very low power with periodic, brief transmissions in the MICS band, lacking a listen- before-talk function and frequency agility – did not comply with the Commission’s rules when sending 5 Report and Order in WT Docket No. 99-66 (Amendment of Parts 2 and 95 of the Commission’s Rules to Establish a Medical Implant Communications Service in the 402-405 MHz Band) (“MICS Order”), 14 FCC Rcd, 21040 (1999). 6 Id. at 21042-43. 7 In this band, Metaids currently operates radiosondes, which are automatic transmitters, usually carried on an aircraft, free balloon, kite, or parachute, which transmit meteorological data during their journey through the atmosphere. (See 47 C.F.R. § 2.1.) 8 Id. at 21046. 9 47 C.F.R. § 95.628(c), (d). 10 47 C.F.R. § 95.1211. 11 47 C.F.R. § 95.625(a). 12 The Commission also provided that a MICS device could transmit without prior frequency monitoring, pursuant to a non-radio frequency actuation signal generated by a device external to the body (manual activation) (47 C.F.R. § 95.1209(b)), or in response to a medical implant event (47 C.F.R. §§ 95.628(b), 95.1209(b)). These functions are not the subject of the instant waiver request. 13 NTIA is responsible for managing the Government portion of the Table of Frequency Allocations. In bands shared between Federal and non-Federal Government…

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Cover Letter(s)

CORRECTION OF TECHNICAL INFORMATION FCC ID: PH29300 DexCom, Inc. herein corrects technical information pertaining to the above- referenced equipment under review. Please update the information as it pertains to the FCC Form 731 on file. For the sake of consistency, all of the information under “Equipment Specifications” is provided. Lower/Higher frequency: 402.14 MHz Rated RF power: 0.000025 W Frequency tolerance: 250 ppm Emission designator: 100KA1D

Cover Letter(s)

5555OberlinDrive SanDiego,CA92121 . ~oexcom . T:858.200.0200 F: 858.200.0201 www.dexcom.com 11-16-2005 FederalCommunicationsCommission AuthorizationandEvaluationDivision 7435OaklandMillsRoad Columbia,MD21046 RE:RequestofConfidentiality PursuanttoSections0.457(d)(1)(ii)and0.459oftheCommission'sRules,theApplicant herebyrequestsconfidentialtreatmentofinformationaccompanyingasoutlinedbelow: .BlockDiagrams .Schematics .PartsList .OperatingDescription .DeviceInternalPhotographs TheAboveMaterialscontaintradesecretsandproprietaryinformationnotcustomarily releasedtothepublic.Thepublicdisclosureofthesemattersmightbeharmfulto the Applicantandprovideunjustifiedbenefitstoitscompetitors. TheApplicantunderstandsthatpursuanttoRule0.457(d)(1)(ii),disclosureofthis Applicationandallnon-confidentialaccompanyingdocumentationwillnotbemade beforethedateoftheGrantforthisApplication. Sincerely, CS-~AuJ-L JorgeValdes VicePresidentofEngineering

External Photos

Report No. SC504737-03 Photograph of Test Setup: Frequency Stability Page A2 of A5 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Report No. SC504737-03 Photograph of Test Setup: Maximum Transmitter Power/Emissions Page A4 of A5 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Report No. SC504737-03 Photograph of Test Setup: Maximum Transmitter Power/Emissions Page A5 of A5 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364

ID Label/Location Info

STS Transmitter Equipment Identification Label (Bottom Side Of Transmitter) Label is physically engraved into the bottom of each STS Transmitter.

Test Report

Report No. SC405780-03 Page 1 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 EMC - TEST REPORT UNITED STATES STANDARD FCC PART 95 Test Report File No. : SC405780-03 Date of Issue: 02 December 2005 Model / Serial No. : 9300 / -- Product Type : STS Transmitter Applicant : DEXCOM INCORPORATED Manufacturer : DEXCOM INCORPORATED License holder : DEXCOM INCORPORATED Address : 5555 Oberlin Drive : San Diego, CA 92121 Test Result : See General Remarks (page 9). Test Project Number Reference(s) : SC405780-03 Total pages - Test Report : 21 NOTE: All test equipment used during testing is calibrated and traceable to NIST. TÜV America reports apply only to the specific sample tested under stated test conditions. It is the manufacturer’s responsibility to assure the continued compliance of production units of this model. TÜV America, Inc. shall have no liability for any deductions, inferences or generalizations drawn by the client or others from TÜV America, Inc. issued reports. This report is the confidential property of the client. As a mutual protection to our clients, the public and ourselves, extracts from the test report shall not be reproduced except in full without our written approval. This report shall not be used by the client to claim product endorsement by NVLAP or any agency of the US government. TÜV America, Inc. and its professional staff hold government and professional organization certifications and are members of AAMI, ACIL, AEA, ANSI, IEEE, NVLAP, and VCCI Report No. SC405780-03 Page 2 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 DIRECTORY Test Report Pages Test Report 1 - 9 Directory 2 Test Regulations 3 General Remarks and Summary 9 Equipment Frequency Stability 5 Emission Bandwidth 6 Maximum Transmitter Power 7 Technical Documentation Test Data Sheets and Test Setup Drawing(s) TD1 Appendices Appendix A - Test Setups (Photographs) A1 Appendix B - Product Information Form(s) B1 Appendix C - Change History C1 Appendix D - Supplemental Information D1 Report No. SC405780-03 Page 3 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 TEST REGULATIONS: The tests were performed according to the following regulations: † - EN 50081-1: 1991 † - EN 55011: 1998, Amendment A2: 2002 † - Group 1 † - Group 2 † - Class A † - Class B † - EN 55013: 1990 † - EN 55014: 1993 † - Household appliances and similar † - Portable tools † - Semiconductor devices † - EN 55022: 1987 † - Class A † - Class B † - EN 55022: 1998, Amendment A2: 2003 † - Class A † - Class B † - VCCI † - Class A ITE † - Class B ITE † - CNS 13438: 1994 † - Class A † - Class B „ - FCC Part 95 † - AS/NZS 3548: 1995 † - Class A † - Class B † - CISPR 11: 1997 † - Group 1 † - Group 2 † - Class A † - Class B † - CISPR 22: 1997 † - Class A † - Class B Report No. SC405780-03 Page 4 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Environmental Conditions In The Laboratory: Actual Temperature : 23 °C Relative Humidity : 50 % Atmospheric Pressure : 100.0 kPa Power Supply Utilized: Power supply system : Battery Operated Symbol Definitions: „ - Applicable † - Not Applicable Report No. SC405780-03 Page 5 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Test Conditions: FREQUENCY STABILITY The FREQUENCY STABILITY measurements were performed in the following location at the San Diego Testing Facility: † - Test not applicable „ - TR-2, Test Room, 16’ x 10’ x 9’ Test Equipment Used: Model No. Prop. No. Description Manufacturer Serial No. Date Cal’ed E4446A 6823 Spectrum Analyzer Agilent US44300486 04/04 T30RC 6225 Environmental Chamber Tenney Environmental 27244-02 05/04 E3612A 6456 DC Power Supply Hewlett Packard KR83006892 N/A 34401A 6709 Digital Volt Meter Hewlett Packard 3146A03945 07/04 Remarks: One year calibration cycle for all test equipment and sites. Report No. SC405780-03 Page 6 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Test Conditions: EMISSION BANDWIDTH The EMISSION BANDWIDTH measurements were performed in the following location at the San Diego Testing Facility: † - Test not applicable „ - SR-3, Shielded Room, 12’ x 20’ x 8’, Metal Chamber Test Equipment Used: Model No. Prop. No. Description Manufacturer Serial No. Date Cal’ed E4446A 6823 Spectrum Analyzer Agilent US44300486 04/04 E3612A 6456 DC Power Supply Hewlett Packard KR83006892 N/A 34401A 6709 Digital Volt Meter Hewlett Packard 3146A03945 07/04 Remarks: One year calibration cycle for all test equipment and sites. Report No. SC405780-03 Page 7 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Test Conditions: MAXIMUM TRANSMITTER POWER The MAXIMUM TRANSMITTER POWER measurements were performed in the following location at the San Diego Testing Facility: † - Test not applicable „ - Roof (Small Open Area Test Site) Test Equipment Used: Model No. Prop. No. Description Manufacturer Serial No. Date Cal’ed 3146 6641 Log Periodic Antenna EMCO 106X 06/04 E4440A 6814 Spectrum Analyzer Hewlett Packard MY42510441 12/03 8648C 6586 Signal Generator Hewlett Packard 3642U01074 12/03 UHA 9105 6651 Dipole Antenna Schwarzbeck EMACO1 Verified Remarks: One year calibration cycle for all test equipment and sites. Report No. SC405780-03 Page 8 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Equipment Under Test (EUT) Test Operation Mode: The equipment under test was operated under the following conditions during testing: † - Standby † - Test Program (H - Pattern) † - Test Program (Color Bar) † - Test Program (Customer Specified) † - Practice Operation „ - Normal Operating Mode † - Configuratio…

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Test Report

Report No. SC405780-03 Page 1 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 EMC - TEST REPORT UNITED STATES STANDARD FCC PART 95 Test Report File No. : SC405780-03 Date of Issue: 28 February 2006 Model / Serial No. : 9300 / -- Product Type : STS Transmitter Applicant : DEXCOM INCORPORATED Manufacturer : DEXCOM INCORPORATED License holder : DEXCOM INCORPORATED Address : 5555 Oberlin Drive : San Diego, CA 92121 Test Result : See General Remarks (page 9). Test Project Number Reference(s) : SC405780-03 Total pages - Test Report : 33 NOTE: All test equipment used during testing is calibrated and traceable to NIST. TÜV America reports apply only to the specific sample tested under stated test conditions. It is the manufacturer’s responsibility to assure the continued compliance of production units of this model. TÜV America, Inc. shall have no liability for any deductions, inferences or generalizations drawn by the client or others from TÜV America, Inc. issued reports. This report is the confidential property of the client. As a mutual protection to our clients, the public and ourselves, extracts from the test report shall not be reproduced except in full without our written approval. This report shall not be used by the client to claim product endorsement by NVLAP or any agency of the US government. TÜV America, Inc. and its professional staff hold government and professional organization certifications and are members of AAMI, ACIL, AEA, ANSI, IEEE, NVLAP, and VCCI Report No. SC405780-03 Page 2 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 DIRECTORY Test Report Pages Test Report 1 - 9 Directory 2 Test Regulations 3 General Remarks and Summary 9 Equipment Frequency Stability 5 Emission Bandwidth 6 Maximum Transmitter Power 7 Technical Documentation Test Data Sheets and Test Setup Drawing(s) TD1 Appendices Appendix A - Test Setups (Photographs) A1 Appendix B - Product Information Form(s) B1 Appendix C - Change History C1 Appendix D - Supplemental Information D1 Report No. SC405780-03 Page 3 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 TEST REGULATIONS: The tests were performed according to the following regulations: † - EN 50081-1: 1991 † - EN 55011: 1998, Amendment A2: 2002 † - Group 1 † - Group 2 † - Class A † - Class B † - EN 55013: 1990 † - EN 55014: 1993 † - Household appliances and similar † - Portable tools † - Semiconductor devices † - EN 55022: 1987 † - Class A † - Class B † - EN 55022: 1998, Amendment A2: 2003 † - Class A † - Class B † - VCCI † - Class A ITE † - Class B ITE † - CNS 13438: 1994 † - Class A † - Class B „ - FCC Part 95 † - AS/NZS 3548: 1995 † - Class A † - Class B † - CISPR 11: 1997 † - Group 1 † - Group 2 † - Class A † - Class B † - CISPR 22: 1997 † - Class A † - Class B Report No. SC405780-03 Page 4 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Environmental Conditions In The Laboratory: Actual Temperature : 23 °C Relative Humidity : 50 % Atmospheric Pressure : 100.0 kPa Power Supply Utilized: Power supply system : Battery Operated Symbol Definitions: „ - Applicable † - Not Applicable Report No. SC405780-03 Page 5 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Test Conditions: FREQUENCY STABILITY The FREQUENCY STABILITY measurements were performed in the following location at the San Diego Testing Facility: † - Test not applicable „ - TR-2, Test Room, 16’ x 10’ x 9’ Test Equipment Used: Model No. Prop. No. Description Manufacturer Serial No. Date Cal’ed E4446A 6823 Spectrum Analyzer Agilent US44300486 04/04 T30RC 6225 Environmental Chamber Tenney Environmental 27244-02 05/04 E3612A 6456 DC Power Supply Hewlett Packard KR83006892 N/A 34401A 6709 Digital Volt Meter Hewlett Packard 3146A03945 07/04 Remarks: One year calibration cycle for all test equipment and sites. Report No. SC405780-03 Page 6 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Test Conditions: EMISSION BANDWIDTH The EMISSION BANDWIDTH measurements were performed in the following location at the San Diego Testing Facility: † - Test not applicable „ - SR-3, Shielded Room, 12’ x 20’ x 8’, Metal Chamber Test Equipment Used: Model No. Prop. No. Description Manufacturer Serial No. Date Cal’ed E4446A 6823 Spectrum Analyzer Agilent US44300486 04/04 E3612A 6456 DC Power Supply Hewlett Packard KR83006892 N/A 34401A 6709 Digital Volt Meter Hewlett Packard 3146A03945 07/04 Remarks: One year calibration cycle for all test equipment and sites. Report No. SC405780-03 Page 7 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Test Conditions: MAXIMUM TRANSMITTER POWER The MAXIMUM TRANSMITTER POWER measurements were performed in the following location at the San Diego Testing Facility: † - Test not applicable „ - Roof (Small Open Area Test Site) Test Equipment Used: Model No. Prop. No. Description Manufacturer Serial No. Date Cal’ed 3146 6641 Log Periodic Antenna EMCO 106X 06/04 E4440A 6814 Spectrum Analyzer Hewlett Packard MY42510441 12/03 8648C 6586 Signal Generator Hewlett Packard 3642U01074 12/03 UHA 9105 6651 Dipole Antenna Schwarzbeck EMACO1 Verified Remarks: One year calibration cycle for all test equipment and sites. Report No. SC405780-03 Page 8 of 9 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Equipment Under Test (EUT) Test Operation Mode: The equipment under test was operated under the following conditions during testing: † - Standby † - Test Program (H - Pattern) † - Test Program (Color Bar) † - Test Program (Customer Specified) † - Practice Operation „ - Normal Operating Mode † - Configuratio…

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Contact Information

Applicant

Vivian Wu(Staff Quality Compliance Engineer)
[email protected]8585294141Fax: 858-200-0202

Technical Contact

Dexcom IncJorge Valdes
[email protected]--

xxx · San Diego, California · United States

Test Firm

TUV America Inc.Jim Owen
[email protected]8586781435Fax: 8585460364

Technical Specifications

#Rule PartsFrequency RangePower OutputEmissionTolerance
195I402.14 MHz - 402.14 MHz10.00 µW100KA1D100.0000000000 ppm
Confidentiality
Long Term

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