SDYCHI2020Q-TECH Model 2020

Cameron Health, Inc. SIZE DWG. NO. A REV. MATERIAL: FINISH: SHEET 1 OF 1 FILE: THE INFORMATION CONTAINED IN THIS DRAWING IS THE SOLE PROPERTY OF CAMERON HEALTH, INC. ANY REPRODUCTION IN PART OR AS A WHOLE WITHOUT THE WRITTEN PERMISSION OF CAMERON HEALTH, INC. IS PROHIBITED. PROPRIETARY AND CONFIDENTIAL TITLE: 1 2 3 5 4 A B C D E UNLESS OTHERWISE SPECIFIED: SAN CLEMENTE, CA LABEL, PROGRAMMER, REGULATORY INFORMATION 103296-001 A 2 103296-001 Rev 1.pdf 3RD ANGLE PROJECTION INTERPRET DRAWING AND DIMENSIONS PER ASME Y14.5M-1994 (R2003). NONE UNTOLERANCED DIMENSIONS LOCATING TRUE POSITION ARE BASIC DO NOT SCALE DRAWING DIMENSIONS ARE IN INCHES [mm] TOLERANCES: FRACTIONAL ANGULAR: TWO PLACE DECIMAL .03 THREE PLACE DECIMAL FOUR PLACE DECIMAL NOTES: 1. SUPPLIED ON A ROLL, WITH RELEASE LINER. 2 MATERIALS: A. LABEL STOCK: THERMAL TRANSFER POLYESTER LABEL MATERIAL 7879FL. 3M INDUSTRIAL TAPE AND SPECIALTIES DIVISION. B. OVERLAMINATING FILM: VELVET LEXAN OVERLAMINATING FILM 7737FL. 3M INDUSTRIAL TAPE AND SPECIALTIES DIVISION. C. ADHESIVE: #350. 3M INDUSTRIAL TAPE AND SPECIALTIES DIVISION. 3. CERTIFICATE OF COMPLIANCE REQUIRED WITH EACH SHIPMENT. 4. COLORS: A. BACKGROUND: BLACK B. LETTERING: SILVER PMS 877C 5. VISUAL REQUIREMENTS (WHEN UNDER ILLUMINATION WITH THE UNAIDED EYE AT 12 - 18 INCHES): A. NO BLURRED PRINTING. B. NO FEATHERING. C. NO BLEEDING. D. NO WARPING. E. NO WRINKLES. F. NO CREASING. G. NO DIE MIS-CUTS. 6. THE LABELS SHALL WITHSTAND TEMPERATURE EXPOSURE FROM -18° TO 55°C WITHOUT AFFECTING THE LEGIBILITY AND INTEGRITY OF THE LABELS. 7. THE MANUFACTURER'S PACKAGE SHALL IDENTIFY: A. CAMERON HEALTH PART NUMBER AND REVISION. B. MANUFACTURER NAME. C. QUANTITY OF LABELS IN SHIPMENT. D. LOT NUMBER. This device may not interfere with stations operating in the 400.150-406.00 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation. FCC ID SDYCHI2020 PN 103296-001 Rev A 12/2008 2.25” 1.00”      4X R.15

Cameron Health, Inc. Programmer Radio Board 102808-004 Rev. A, RF Section Layout 102808-004 Rev. A, Photograph A RF Components Section With RF Shield in Place RF Input/Output MMCX Connector Cameron Health, Inc. Programmer Radio Board 102808-004 Rev. A, RF Section Layout RF Components Section With RF Shield Removed RF Input/Output MMCX Connector 102808-004 Rev. A, Photograph B Cameron Health, Inc. Programmer Radio Board 102808-004 Rev. A, RF Section Layout 102808-004 Rev. A, Photograph C RF Input/Output MMCX Connector RF Components Section

Summary of RF Exposure Compliance The EUT is a programmer / controller for a Medical Implant Communications system operating under Part 95I in the 402 – 405 MHz band. The EUT is not an implant. It can be used at a distance of less than 20 centimeters between the antenna and the body of the user or nearby persons and can therefore be considered a portable transmitter per 47 CFR 2.1093(b). The antenna is a Wand (GAP) antenna that has a gain of –5.0 dBi. The maximum peak conducted output power is 0.093 mW, therefore the maximum peak radiated power is 0.0295 mW EIRP. Per 95.603(f) only implant transmitters are subject to the radio frequency radiation exposure requirements specified in FCC Parts 1.1307 and 2.1093. Since the EUT is not a medical implant, and operates with such low power (<< 1mW), it is categorically excluded from routine environmental evaluation. This device is operated in a manner that ensures the public is not exposed to radio frequency energy levels in excess of the Commission's guidelines.

Cameron Health, Inc. Page 1 of 20 Report – MICS Testing and Analysis Performed at Cameron Health Facilities Appendix to 17 Programmer Test Report Cameron Health, Inc. San Clemente, CA 92673 www.cameronhealth.com CONFIDENTIAL - This document contains proprietary information. It may not be reproduced or disclosed without the express written consent of Cameron Health, Inc. 1.0 Executive Summary This report documents testing and analysis performed at Cameron Health facilities relating to characteristics of the telemetry devices and methods used in the S-ICD system. 2.0 Overview This document provides supporting material for the Programmer Test Report that is submitted for FCC Review. In particular, testing is detailed herein that addresses the requirements stated in §§95.628(a)(1-4) to fill in gaps remaining after testing by the TCB. These sections are as follows: (a)(1): The monitoring system BW is equal to or greater than the emission BW of intended transmission. (a)(2): Within 5 seconds prior to initiating a communications session, circuitry must monitor the intended channel for at least 10 milliseconds. (a)(3): Threshold power level of better than 10log(B)(Hz) – 150 (dBm/Hz) + G (dBi) (a)(4), sentences 1 & 3: MICS communications may be started if channel has signal below power threshold of (a)(3) or, if no channel having that low signal is available, may use channel with lowest ambient power level. (a)(4), sentence 2: Communication session may continue as long as any silent period does not last more than 5 seconds. Our analysis is informed through our communications with the FCC. Copies of the email communications have been cut and pasted into the end of this document. These include a discussion regarding the use of a system with single channel operability. We address the email communication separately in association with discussion of (a)(4), sentences 1 & 3, below. 3.0 Test Equipment and Devices under Test The following Materials and Devices under Test are not applicable for §3.6.1, which relies on activities performed offsite, as documented in the Appendix, and §3.6.2, which includes a separate listing of materials and devices under test. Materials Description Manufacturer Model/Make Serial # PSA Series Spectrum Agilent E4443A 1063825 Cameron Health, Inc. Page 2 of 20 Report – MICS Testing and Analysis Performed at Cameron Health Facilities Appendix to 17 Programmer Test Report Cameron Health, Inc. San Clemente, CA 92673 www.cameronhealth.com CONFIDENTIAL - This document contains proprietary information. It may not be reproduced or disclosed without the express written consent of Cameron Health, Inc. Analyzer Spectrum Analyzer Agilent E4446A NW EMC Signal Generator Hewlett Packard 8648B WDC865113 Description Serial # Q-Tech Programmer Model 20202020-A 100102 SQ-RX Pulse Generator 130 4.0 Definitions PG Pulse Generator. All references to PG herein refer to the Cameron Health SQ-RX Pulse Generator. PRC Programmer Radio Card. A custom-built communications card that is used with the Programmer to effect telemetry with the PG. All PRC-related data and analysis included herein is based on PRC(s) configured in a manner that conforms in relevant respects to the intended actual use. Q-Tech A dedicated, portable computer adapted for radio communication with the PG. The Programmer is designed to operate with the PRC installed and uses the Wand Antenna during communications with a PG. RSSI Received Signal Strength Indicator. The RSSI tracks the amount of power received at a selected frequency. The PRC includes an RSSI output that can be read by the Q-Tech or by a testing device such as a laptop computer. S-ICD® System Refers to a system developed by Cameron Health including the SQ-RX Pulse Generator and the Q-Tech Programmer. S-ICD is a registered trademark of Cameron Health. Wand Antenna An apparatus that is attached to and used with the Q-Tech as an antenna. Cameron Health, Inc. Page 3 of 20 Report – MICS Testing and Analysis Performed at Cameron Health Facilities Appendix to 17 Programmer Test Report Cameron Health, Inc. San Clemente, CA 92673 www.cameronhealth.com CONFIDENTIAL - This document contains proprietary information. It may not be reproduced or disclosed without the express written consent of Cameron Health, Inc. 5.0 Test Activities The Q-Tech and PG use a portion of the MICS band around a center frequency at 403.5108 MHz. Each device is configured to receive signals within a given bandwidth and transmit signals within a given bandwidth. The receiving bandwidth of the Q-Tech is measured and compared to the emission bandwidth of the PG in §5.1. This comparison shows the system meets the requirements of 95.628(a)(1). The Q-Tech listens on the system’s selected channel prior to initiating communication with a PG. This listening is performed over several intervals, each representing a minimum time period. Analysis of the Listen procedure is performed in §5.2. This analysis shows the system meets the requirements of 95.628(a)(2). §95.628(a)(3) calls for a monitoring system threshold power level. Calculation of the required monitoring system threshold power level is performed using a formula combining the widest emission bandwidth in the S-ICD system and the gain of the Wand Antenna. Calculation of the monitoring system threshold power level is performed in §5.3. §95.628(a)(3) does not specify how the monitoring system threshold power level is to be used. §95.628(a)(4), sentence 1 permits use of channels having lower ambient power level than the calculated threshold. Further, 95.628(a)(4) sentence 3 indicates that, if ambient power levels are above the threshold on all channels, communication may start on the channel having lowest noise. Email communications with the FCC indicate that single channel systems are allowed, and operation using a single channel can be consistent with 95.628(a) even when ambient power level is above the calculated threshold. §5.4 explains operations and analysis…

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Cameron Health, Inc Page 1 of 5 Summary Report: Cameron Health Q- TECH Programmer FCC Test Report DN-12856, Rev A Cameron Health, Inc. San Clemente, CA 92673 www.cameronhealth.com CONFIDENTIAL - This document contains proprietary information. It may not be reproduced or disclosed withou t the expressed written consent of Cameron Health, Inc. 1 Executive Summary This report references three detailed reports: NWEMC Testing Report: Cameron Health Q-TECH Programmer (Referred to below as NWEMC – Q-TECH) – subject of the current application for equipment authorization. NWEMC Testing Report: Cameron Health SQRX Pulse Genera tor (Referred to below as NWEMC – SQRX) – subject of a separate application for equipment authorization. Cameron Health Testing Report: System Telemetry Testing At Cameron Health (Ref erred to below as CH – Telemetry) – attached hereto as an appendix. This report documents the testing and test results showing compliance with applicable sections of the FCC Regulations relating to the operational aspects of the Cameron Health Q-TECH Programmer. The Q-TECH Programmer is part of the Cameron Health S-ICD® System, which also includes the SQRX Pulse Generator. To the extent necessary, this report will include discussion or analysis of relevant features of th e SQRX Pulse Generator. * S-ICD® is a registered trademar k of Cameron Health, Incorporated. 2 Applicable Regulations The Cameron Health Q-TECH Programmer is intended for use as pa rt of a medical implant syst em having telemetry capabilities intended to use the Medical Impl ant Communications Service band (MICS). This document covers: §95.628 MICS Transmitters Subparts (a)-(f) §95.631 Emission Types Subpart (h) MICS Stations §95.633 Emission Bandwidth Subpart (e ) For transmitters in the MICS §95.635 Unwanted Emissions Subpart (d) For tr ansmitters designed to operate in the MICS §95.639 Maximum Transmitter Power Subpart (f) Cameron Health, Inc Page 2 of 5 Summary Report: Cameron Health Q- TECH Programmer FCC Test Report DN-12856, Rev A Cameron Health, Inc. San Clemente, CA 92673 www.cameronhealth.com CONFIDENTIAL - This document contains proprietary information. It may not be reproduced or disclosed withou t the expressed written consent of Cameron Health, Inc. §95.645 Control Accessibility §95.649 Power Capability Controls §95.1211 Channel Use Policy Included based on Email with FCC. Several subsections that are iden tified above are applicable to onl y one of the Q-TECH or SQRX; those that do not apply for thi s report are indicated in the table below. Fo r “system” requirements, reference is made to testing reports for both the Q-TECH a nd SQRX. 3 Section-by-Section Analysis Rule Subject Matter Applicable Report Comments §95.628(a)(1) The monitoring system BW is equal to or greater than the emission BW of intended transmission. NWEMC – SQRX & NWEMC – Q-Tech & CH – Telemetry NWEMC - SQRX shows emission BW of SQRX is 107 kHz (pp 36-39). CH – Telemetry shows 20 dB down receive points are spaced greater than 130 kHz (§5.1). §95.628(a)(2) Within 5 seconds prior to initiating a communications session, circuitry must monitor the intended channel for at least 10 milliseconds. CH – Telemetry CH – Telemetry shows that the Q-TECH monitors the communications channel for more than 10 milliseconds immediately prior to initiating communication (§5.2). §95.628(a)(3) Threshold power level of better than 10log(B)(Hz) – 150 (dBm/Hz) + G (dBi) NWEMC – SQRX & CH – Telemetry B is the emission BW of SQRX, found in NWEMC – SQRX as 107 kHz (pp 36-39). G is the gain of the antenna, measured as explained in CH – Telemetry (§5.3). Analysis showing the threshold power level is also explained in CH – Telemetry (§5.4). §95.628(a)(4), sentences 1 & 3. MICS communications may be started if channel has signal below power threshold of (a)(3) or, if no channel having that low CH – Telemetry As noted in communication with FCC, rules do not prohibit single channel operation. Since no channeling scheme is required, this portion of this Cameron Health, Inc Page 3 of 5 Summary Report: Cameron Health Q- TECH Programmer FCC Test Report DN-12856, Rev A Cameron Health, Inc. San Clemente, CA 92673 www.cameronhealth.com CONFIDENTIAL - This document contains proprietary information. It may not be reproduced or disclosed withou t the expressed written consent of Cameron Health, Inc. Rule Subject Matter Applicable Report Comments signal is available, may use channel with lowest ambient power level. section has been read as set forth in CH – Telemetry and passed (§5.5). §95.628(a)(4), sentence 2. Communication session may continue as long as any silent period does not last more than 5 seconds. CH – Telemetry No such silent periods occur as shown in CH – Telemetry (§5.6). §95.628(a)(5) Alternate channel selection protocol. n/a This provision is explicitly optional and is not used in the S-ICD® System. §95.628(b) MICS Communications initiated by impl ant n/a Section limits SQRX ability to initiate communication; does not specify Q-TECH activity. §95.628(c) Reference to out of band attenuation per §95.635 n/a See reference for §95.635, below. §95.628(d) Authorized emission bandwidth less than 300 kHz – single device. Authorized emission bandwidth less than 300 kHz – session requirement. NWEMC – SQRX & NWEMC - Q-TECH NWEMC - Q-TECH shows BW of 101 kHz (pp 36-39) centered at 403.514-403.516 kHz (pp 40-45). NWEMC - SQRX shows BW of 107 kHz (pp 36-39) centered at 403.512-403.514 MHz (pp 32-35). Combined numbers demonstrate session BW less than 300 kHz. §95.628(e)(1) Frequency stability for medical implant transmitter. n/a Applies to the implant. §95.628(e)(2) Frequency stability for programmer. NWEMC – Q-TECH NWEMC – Q-TECH shows frequency stability is better than 100 ppm across specified temperature range (pp 40-45). §95.628(f) “The provisions of this section shall not be used to extend the range of spectrum occupied over space or time for the purpose of denying fair access to s…

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