PHZ-BRAVO100pH Probe

(Photo Art Under Development) The Bravo™ pH Receiver is designed to work with the Bravo pH System™ and assist medical personnel in diagnosing and monitoring gastroesophageal reflux disease (GERD). Bravo Users Guide

Endonetics Incorporated FCC ID#: PHZ-BRAVO100 Photo 1 Exterior View of pH Probe from Endonetics. Photo with U.S. Currency to provide size relationship. Due to 1) the size of the probe, 2) the encapsulating material as defined by the FDA and 3) the positioning of the probe within the esophagus of the patient, NO FCC ID NUMBER is printed on the probe. The FCC ID Number appears on the label of the sterile package the probe is shipped in. Please see the “FCC ID Label File” for FCC ID Documentation. Endonetics Incorporated FCC ID#: PHZ-BRAVO100 Photo 2 Exterior View of pH Probe from Endonetics. Photo with U.S. Currency to provide size relationship. Probe laid on side to view edge of PCB

This document contains confidential, proprietary information of ENDONETICS, INC. It may not be copied or reproduced without prior written permission from ENDONETICS, INC. CAT NO: 20000 Bravo ™ pH Probe with Delivery System Contents: 1 Bravo Probe and Delivery System Overall Length: XX mm Working Length: XX mm Dimensions of Bravo Probe: XX x YY x ZZ mm Caution: Federal (U.S.A) law restricts this device to use by or on the order of a physician. ! YYYY-MM YYYY-MM NonSterile. For one procedure only. Do not use open or damaged package. Store at 15-45 0 C. Refer to accompanying Instructions for Use Patents Pending Manufactured and distributed by: Endonetics, Inc. 11100 Roselle Street San Diego, CA 92121 USA P/N: 051-0002 (800) 925-2567 (USA only) Rev (858) 450-6767 2 LOT STERILE Compliance Statement This device complies with Part 15 of the FCC. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. FCC ID: PHZ-BRAVO100

Endonetics, Inc. 11100 Roselle Street San Diego, CA 92121 Voice: 858.450.6767 Fax: 858.450.9249 DATE: February 21st, 2001 TO: Jim Blaha – L.S. Compliance FROM: Ross Tsukashima Project Manager - Endonetics Subject: Transmitter Label Dear Mr. Blaha; Attached is a copy of the label for the Bravo Transmitter. Due to the transmitters small size and medical restrictions, FCC I.D. numbers will be placed on the transmitters packaging label. Respectfully, Ross Tsukashima MEMO

Endonetics Incorporated FCC ID#: PHZ-BRAVO100 Photo 3 Interior View of pH Probe from Endonetics. Photo with encapsulating material removed. PCB on side showing battery. Antenna left side, Lower Square. Endonetics Incorporated FCC ID#: PHZ-BRAVO100 Photo 4 Interior View of pH Probe from Endonetics. Photo with encapsulating material removed. Top view of PCB showing two batteries. Antenna left side, Blue square in color. Endonetics Incorporated FCC ID#: PHZ-BRAVO100 Photo 5 Interior View of pH Probe from Endonetics. Photo with encapsulating material removed. Flip Side of PCB showing two batteries.

LSC-301126tx BRAVO 100 . . . . . . . . . . . . . . . . . . . L. S. Compliance, Inc. Compliance Testing of: BRAVO pH System Probe transmitter Prepared for: Endonetics, Incorporated San Diego, CA Test Report Number: 301126TX Date(s) of Testing: March 5, 2001 All results of this report relate only to the items that were tested.All results of this report relate only to the items that were tested. This report may not be reproduced, except in full, without written approval of L. S. Compliance, Inc.This report may not be reproduced, except in full, without written approval of L. S. Compliance, Inc. L. S. Compliance, Inc. W66 N220 Commerce Court Cedarburg, Wisconsin 53012 Phone: 414 - 375 - 4400 Fax: 414 - 375 - 4248 L. S. COMPLIANCE, Inc. FCC IDFCC ID:PHZ-BRAVO100:PHZ-BRAVO100 LSC-301126tx BRAVO 100 pageof 21 0 Table of Contents SectioSectio nn DescriptionDescription PagePage ## Index0 Description of Measurement Facilities, A2LA accreditation1 1.2Signature Page2 1.3Summary of Test Report3 1.4Introduction4 1.5Purpose4 1.6Radiated Emission Test Setup4 1.7Radiated Emission Test Procedure5 1.8Radiated Emission Test Equipment Utilized6 1.9Conducted Emission Measurements6 1.10Restricted Bands (Frequencies and Limits)7 1.11Photos taken during testing8 1.12Summary of Results and Conclusions9 1.13Test Equipment List10 Appendices ASample Calculations:11 Calculation of Radiated Emissions Limits, occupied bandwidth12 Calculation of Duty Cycle and Relaxation factor13 BData Charts14 CGraphs16 L. S. COMPLIANCE, Inc. FCC IDFCC ID:PHZ-BRAVO100:PHZ-BRAVO100 LSC-301126tx BRAVO 100 pageof 21 1 DESCRIPTION OF MEASUREMENT FACILITIES Site on File with the FCC ID Number: 31040/SIT 1300F2 Site on file with Industry Canada: ID Number: IC 3088 “ The site referenced above has been found to comply with the test site criteria found in ANSI C63.4-1992 and 47CFR Section 2.948.” L. S. COMPLIANCE, Inc. FCC IDFCC ID:PHZ-BRAVO100:PHZ-BRAVO100 LSC-301126tx BRAVO 100 pageof 21 2 1.21.2 SIGNATURESIGNATURE PAGEPAGE Tests performed by: 10 April, 2001 Thomas T. Lee, EMC engineer Date Prepared By: Approved By: 10 April, 2001 Kenneth L. Boston, EMC Lab ManagerDate PE #31926 Registered Professional Engineer (State of Wisconsin) L. S. COMPLIANCE, Inc. FCC IDFCC ID:PHZ-BRAVO100:PHZ-BRAVO100 LSC-301126tx BRAVO 100 pageof 21 3 1.3SUMMARY OF TEST REPORT MANUFACTURER:Endonetics, Incorporated MODEL:BRAVO 100 SERIAL:engineering unit DESCRIPTION:433.9 MHz miniature sensor transmitter FREQUENCY RANGE:433.9 MHz fixed frequency The BRAVO 100 probe transmitter was found to meetmeet the radiated emission specification of Title 47 CFR FCC, Part 15, subpart C. for an intentional radiator L. S. COMPLIANCE, Inc. FCC IDFCC ID:PHZ-BRAVO100:PHZ-BRAVO100 LSC-301126tx BRAVO 100 pageof 21 4 1.4INTRODUCTION On March 5 of 2001, a series of Radiated Emissions tests were performed on two sample models of the Endonetics pH system probe, a small invasive 'pill' which is designed to transmit a coded signal used to measure pH while deposited in the human trachea via an outpatient medical procedure. The 'pill' transmitter is utilized in studies of GERD, (Gastroesophageal Reflux Disease), and runs at extremely low power due to its' proximity to human tissue. These tests were performed using the test procedures outlined in ANSI C63.4-1992 for intentional radiators, and in accordance with the limits set forth in FCC Part 15.249 for a low powered transmitter. These tests were performed by Kenneth L. Boston PE, of L. S. Compliance, Inc. 1.5PURPOSE The above mentioned tests were performed in order to determine the compliance of the Endonetics Pill transmitter with limits contained in various provisions of Title 47 CFR, FCC Part 15, including: 15.10915.20915.231c 15.20515.231e All radiated emissions tests were performed to measure the emissions in the frequency bands described by the above sections, and to determine whether said emissions are below the limits established by the above sections. These tests were performed in accordance with the procedure described in the American National Standard for methods of measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz (ANSI C63.4-1992). Another document used as reference for the EMI receiver specification was the International Special Committee on Radio Interference (CISPR) number 16-1 (1993). 1.6RADIATED EMISSIONS TEST SETUP Several test samples were operated within the 3 meter Semi-Anechoic, FCC listed chamber located at L.S. Compliance in Cedarburg, WI. The sample was placed on an 80cm high wooden pedestal, which was centered on the flush-mounted 2m diameter metal turntable. The test samples were operated on its own [new] internal battery. The battery voltage at the beginning of the tests was measured to be 6.5 volts. Since the battery was encapsulated within the pill structure, and shut off via a magnet and reed switch, several samples were needed because they were exhausted relatively quickly and became unusable for measurement. Several of the test samples contained modified software, allowing them to transmit a continuous dead carrier, in order to facilitate measurement of the fundamental, spurious and harmonic emissions. Other test samples were left as manufactured, with the transmitter sending out short bursts at a 12 second repetition interval, in order to check peak emissions, bandwidth and duty cycle. Please refer to Section 1.11 for pictures of the test setup. L. S. COMPLIANCE, Inc. FCC IDFCC ID:PHZ-BRAVO100:PHZ-BRAVO100 LSC-301126tx BRAVO 100 pageof 21 5 1.7RADIATED EMISSION TEST PROCEDURE The fundamental and spurious (harmonic) emissions of the transmitter were tested for compliance to Title 47 CFR, FCC Part 15.231e limits for low powered automatically timed periodic devices. For the calculations used to determine the limits applicable for the test samples, refer to Appendix A. These limits are expressed in decibels (dB) above 1 microvolt per meter (μV…

Text truncated - open the document above for the full version.

L. S. COMPLIANCE, Inc. FCC IDFCC ID:PHZ-BRAVO100:PHZ-BRAVO100 LSC-301126tx BRAVO 100 pageof 21 8 1.11 – Photos taken during testing View of the Endonetics Pill transmitter during the Radiated Emissions tests. Close up of the Pill transmitter