QHJ-2000AProgrammer Interface

Physician’s Manual Paired VNS Therapy ® Serenity System ® Model 2000 Wireless Transmitter & Model 4000 Tinnitus Application Programming Software (TAPS) For Healthcare Professionals November 2012 CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use. NOTE: This identifies the parts included in this Physician’s Manual. The information contained in any one part is not intended to serve as a substitute for a complete and thorough understanding of the material presented in all of the physician’s manual sections for the Paired VNS Therapy Serenity System and its component parts, nor does this represent full disclosure of all pertinent information concerning use of this product, potential safety complications, or efficacy outcomes. Copies of all Paired VNS Therapy Serenity System manuals must be included for full disclosure; copies are available from MicroTransponder Inc. This manual contains information that shall not be made available to patients. Released Version A 26‐0001‐0001‐ENG © Copyright November 2012 MicroTransponder Inc. Austin, TX all rights reserved. MicroTransponder, Paired VNS Therapy, Serenity System, are registered trademarks of MicroTransponder. Inc. 2 | Page Table of Contents 1. BRIEF DEVICE DESCRIPTION ............................................................ P. 4 1.1 Symbols and Definitions ...................................................................... P. 6 1.2 Intended Use / Indication ..................................................................... P. 7 1.3 System Requirements .......................................................................... P. 7 1.4 Conventions ......................................................................................... P. 7 1.5 Communication Signals ....................................................................... P. 8 1.6 Wireless Transmitter ............................................................................ P. 8 1.7 Tinnitus Application Software (TAPS) .................................................. P. 9 2. HOW TO GET STARTED ...................................................................... P. 10 3. HOW TO USE TAPS .............................................................................. P. 11 3.1 Overview of Physician/Audiologist Screens ......................................... P. 13 4.0 THERAPY TONE SETUP .................................................................... P. 14 5.0 PROGRAM IMPLANT .......................................................................... P. 21 6.0 DELIVER TINNITUS THERAPY .......................................................... P. 23 7.0 BATTERY ............................................................................................. P. 27 8.0 MAINTENANCE, HANDLING, STORAGE .......................................... P. 27 9.0 PRECAUTIONS ................................................................................... P. 28 10.0 TROUBLESHOOTING ....................................................................... P. 28 10.1 General Recommendations ............................................................... P. 28 10.2 Hardware Issues ................................................................................ P. 29 10.3 Troubleshooting in the OR ................................................................. P. 29 11.0 INFORMATION AND SUPPORT ....................................................... P. 31 12.0 GLOSSARY ....................................................................................... P. 32 3 | Page List of Figures & Tables Figure 1.0-1 – Device Placement and Treatment Set-up . . . . . . . . P. 5 Figure 1.6-1 – Wireless Transmitter . . . . . . . . . . . . . . . . . . . . . . . P. 8 Table 1.6-1 -- Characterization of the Wireless Transmitter - - - - P. 9 Figure 2.0-1 – Startup Menu Screen . . . . . . . . . . . . . . . . . . . . . . . P. 10 Figure 2.0-2 – Wireless Transmitter Connected Indicator (Green). . . . P. 11 Figure 2.0-3 – WT Disconnected Indicator (Red). . . . . . . . . . . . . . . . . . . . P. 11 Figure 2.0-4 – In Progress Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P. 11 Figure 3.0-1 – Physician Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P. 12 Figure 3.0-2 – Physician Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P. 13 Figure 4.0-1 – Audiogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P. 14 Figure 4.0-2 – Audiogram Entries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P. 15 Figure 4.0-3 –Interpolate Audiogram. . . . . . . . . . . . . . . . . . . . . . . . . . . . P. 16 Figure 4.0-4 – Therapy Tone Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . P. 17 Figure 4.0-5 – Left Tinnitus Frequency Entry . . . . . . . . . . . . . . . . . . . . . . P. 18 Figure 4.0-6 – Right Tinnitus Frequency Entry & Multiple Entry. . . . . . . . P. 18 Figure 4.0-7 – Two (2) Tinnitus Frequencies. . . . . . . . . . . . . . . . . . . . . . . P. 19 Figure 4.0-8 – Tone Volume Adjust. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P. 20 Figure 4.0-8 – Additional Notched-out Frequencies . . . . . . . . . . . . . . . . . P. 20 Figure 5.0-1 – Program Implant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P. 21 Figure 5.0-2 – Lead Impedance Check . . . . . . . . . . . . . . . . . . . . . . . . . . . P. 22 Figure 6.0-1 – Deliver Tinnitus Therapy. . . . . . . . . . . . . . . . . . . . . . . . . . . P. 24 Figure 6.0-2 – Therapy In Progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P. 25 Figure 6.0-3 – Paused Therapy Session . . . . . . . . . . . . . . . . . . . . . . . . . . P. 26 Figure 6.0-4 – Therapy Session Idle Time Out . . . . . . . . . . . . . . . . . . . . . P. 27 Figure 10.3-1 – Telemetry Lost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P. 29 4 | Page 1. BRIEF DEVICE DESCRIPTION The Paire…

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Page 1 of 1 FCC 7435 Oakland Mills Road Columbia, MD 21046 To whom it may concern: The enclosed documents constitute a formal submittal and application for Equipment Authorization for a programmer interface pursuant to the following rules: Part 95 of FCC Rules (Med Radio) The programmer interface communicates with an implantable neurostimulator which is being submitted separately. Elliott Laboratories, as duly authorized agent prepared this submittal. A copy of the letter of our appointment as agent is included with the application. If there are any questions or if further information is needed, please contact Elliott Laboratories for assistance. Sincerely, David W. Bare Chief Engineer

TRANSPONDER 2802 Flintrock Trace, Suite 226 Austin, TX 78738 Memo To: Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 F~ ChesrerBurress Date: 11/0812012 Re: FCC IDs: QHJ-1001001A & QHJ-2000A Dear Examiner: I am writing to avoid the possibility of an inadvertent disclosure of proprietary information. The accompanying Form 731 is being filed with the commission on our behalf by Elliott Laboratories, LLC., a conSUlting and testing laboratory. Included as exhibits with the enclosed application are block diagrams, schematics, parts lists and a detailed description of the theory of operation of the device. It is our intention to provide the commission with a full disclosure of our product so that its merits can be evaluated. Indeed, we are pleased to provide any further information that the commission might wish to see. It is not our intention, however, to make our proprietary process a matter of public record. In view of the fact that the block diagrams, schematics, and associated theory of operation disclose the mechanism of our process, we ask that these portions (block diagrams, schematics, parts lists and theory of operation) of our application be withheld from public inspection as provided under FCC 47 CRF O.457(d) and 0.459. These documents contain details of the proprietary operation of product. These details are not readily discemible -even to technically sophisticated individuals -from our hardware and constitute trade secrets. We request therefore that these documents be segregated from the body of our evaluation report and withheld from public inspection. Thank you for your attention. Please let the undersigned know if the Commission disagrees with our position or reqUires further justification. Sincerely,

MicroTransponder Wireless Transmitter model 2000 Why there is no tuning of RF circuitry in production: The tests in production are performed using a reference set‐up. In this set‐up, the programmer being tested is placed at certain distances from a reference IPG. The tests are the following: 1) Communication through 8 channels . It must pass for 160 cm between the devices. 2) Reception . Distance is 40 cm. IPG transmits a CW through channels 2 and 7, one at a time. Programmer measures signal level in channels 1 to 8 each time. The SNR shall be high enough. 3) Transmission . Distance is 40 cm. Programmer transmits a CW through channels 0, 3, 6 and 9, one at a time. a. IPG shall receive the appropriate sequence through those channels. b. SNR at IPG Rx shall be high enough. c. Signal level received by IPG shall be lower than a maximum (about 6 dB higher than the typical value) The following table tries to explain why there is no need for tuning in production: Tunable characteristic Limit Fact Test in Production Tx Power ‐16 dBm ‐14 dB margin for unit tested in NTS. Production test #3. Frequency 100 ppm Information provided by the manufacturer of the transceiver: < 70 ppm between programmer and IPG frequencies for correct communication. Production test #1. Regarding frequency stability, the 3.3V voltage regulator is tested. Spurious emissions Several requirements See test results. Production test #3 checks levels inside the MedRadio band.

Page 1 of 1 December 20, 2012 FCC 7435 Oakland Mills Road Columbia, Maryland, 21046 RE: MicroTransponder, Inc FCC ID: QHJ-2000A Corresopndence Reference Number: 43099 Form 731 Confirmation Number: EA641244 To whom it may concern: Based upon output power, the MicroTransponder, Inc. programmer interface qualifies for SAR exclusion per Section 4.2.4 of KDB publication 447498. Please supersede the SAR reports. Sincerely, David W. Bare Chief Engineer

File: R89115 Page 1 Radio Test Report FCC Part 95 MedRadio Transmitter Wireless Transmitter model 2000 FCC ID: QHJ-2000A COMPANY: MicroTransponder Inc. 2802 Flintrock Trace, Suite 225 Austin, TX 78738 TEST SITE(S): NTS Silicon Valley 41039 Boyce Road. Fremont, CA. 94538-2435 REPORT DATE: October 30, 2012 FINAL TEST DATES: August 15, 21 and September 7, 2012 TOTAL NUMBER OF PAGES: 46 PROGRAM MGR / QUALITY ASSURANCE DELEGATE / TECHNICAL REVIEWER: FINAL REPORT PREPARER: ______________________________ ______________________________ David W. Bare David Guidotti Chief Engineer Senior Technical Writer NTS Silicon Valley is accredited by the A2LA, certificate number 0214.26, to perform the test(s) listed in this report, except where noted otherwise. This report and the information contained herein represent the results of testing test articles identified and selected by the client performed to specifications and/or procedures selected by the client. National Technical Systems (NTS) makes no representations, expressed or implied, that such testing is adequate (or inadequate) to demonstrate efficiency, performance, reliability, or any other characteristic of the articles being tested, or similar products. This report should not be relied upon as an endorsement or certification by NTS of the equipment tested, nor does it represent any statement whatsoever as to its merchantability or fitness of the test article, or similar products, for a particular purpose. This report shall not be reproduced except in full NTS Silicon Valley -- EMC Department Test Report Report Date: October 30, 2012 File: R89115 Page 2 REVISION HISTORY Rev# Date Comments Modified By - 10-30-2012 First release NTS Silicon Valley -- EMC Department Test Report Report Date: October 30, 2012 File: R89115 Page 3 TABLE OF CONTENTS REVISION HISTORY ................................................................................................................................................ 2 TABLE OF CONTENTS ............................................................................................................................................ 3 SCOPE .......................................................................................................................................................................... 4 OBJECTIVE ................................................................................................................................................................ 5 STATEMENT OF COMPLIANCE ........................................................................................................................... 5 DEVIATIONS FROM THE STANDARDS .............................................................................................................. 5 TEST RESULTS .......................................................................................................................................................... 6 FCC PART 95............................................................................................................................................................ 6 EXTREME CONDITIONS ...................................................................................................................................... 7 MEASUREMENT UNCERTAINTIES .................................................................................................................... 8 EQUIPMENT UNDER TEST (EUT) DETAILS ...................................................................................................... 9 GENERAL ................................................................................................................................................................ 9 OTHER EUT DETAILS ........................................................................................................................................... 9 ENCLOSURE ........................................................................................................................................................... 9 MODIFICATIONS ................................................................................................................................................... 9 SUPPORT EQUIPMENT ......................................................................................................................................... 9 EUT INTERFACE PORTS .................................................................................................................................... 10 EUT OPERATION ................................................................................................................................................. 10 TESTING ................................................................................................................................................................... 11 GENERAL INFORMATION ................................................................................................................................. 11 BANDWIDTH MEASUREMENTS ...................................................................................................................... 11 FREQUENCY STABILITY ................................................................................................................................... 11 RADIATED EMISSIONS MEASUREMENTS ...................................................................................................... 12 INSTRUMENTATION .......................................................................................................................................... 13 FILTERS/ATTENUATORS .................................................................................................................................. 13 ANTENNAS ........................................................................................................................................................... 13 ANTENNA MAST AND EQUIPMENT TURNTABLE ............…

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