RIASJMRFCIPG with Bluetooth radio

Implantable Pulse Generator Proclaim™ IPG Clinician's Manual CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies. © 2015 St. Jude Medical, Inc. All Rights Reserved. For a listing of patents for St. Jude Medical neuromodulation products, visit http://patent.sjmneuro.com. i Contents Prescription and Safety Information ........................................................................... 1 Intended Use .................................................................................................................... 1 Indications for Use ............................................................................................................ 1 Contraindications ............................................................................................................... 1 Warnings .......................................................................................................................... 1 Precautions ....................................................................................................................... 2 Adverse Effects.................................................................................................................. 3 Product Description ................................................................................................... 3 Package Contents .............................................................................................................. 4 Identifying the IPG ............................................................................................................. 4 Directions for Use...................................................................................................... 5 Creating an IPG Pocket ...................................................................................................... 5 Connecting a Lead or Extension to the IPG .......................................................................... 5 Implanting the IPG ............................................................................................................ 7 Replacing the IPG ............................................................................................................. 8 Disposing of Explanted Components ................................................................................... 8 Checking the Status of the IPG Battery ....................................................................... 8 Technical Support ..................................................................................................... 9 Appendix A: Product Specifications ........................................................................... 9 Storage Specifications ........................................................................................................ 9 Product Materials .............................................................................................................. 9 IPG Specifications ........................................................................................................... 10 Appendix B: System Components and Accessories .................................................. 11 IPGs ............................................................................................................................... 11 Programmers and Controllers ........................................................................................... 11 Leads and Extensions ...................................................................................................... 11 Trial System .................................................................................................................... 12 Appendix C: Regulatory Statements ......................................................................... 12 Disposal Guidelines for Battery-Powered Devices .............................................................. 12 Statement of FCC Compliance .......................................................................................... 12 Statement of Compliance With License-Exempt RSS Standard (Canada) ............................. 13 Identification Information for Product Registration ............................................................. 13 Wireless Technology Information ...................................................................................... 13 Radio Transmitter, Cables, Transducers ........................................................................... 14 Quality of Service for Wireless Technology ......................................................................... 14 Appendix D: Symbols and Definitions....................................................................... 15 Additional Symbols for Product Labels .............................................................................. 16 Appendix E: CE Mark Date ...................................................................................... 16 1 Prescription and Safety Information Read this section to gather important prescription and safety information. Intended Use This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system. Indications for Use This neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain. Contraindications This system is contraindicated for patients who are unable to operate the system or who have failed to rec…

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St. Jude Medical Implantable Electronic Systems 15900 Valley View Court Sylmar, CA 91342 USA Main 818 362 6822 Fax 818 364 5814 October 23, 2014 TUV SUD BABT TCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Dear Sir or Madam, We, St. Jude Medical IES Division, hereby authorize Alex Chang (858-678-1467), from TUV SUD America, to act as our agent in all matters relating to applications for equipment authorization, including the signing of all documents relating to these matters. This authorization expires on May 1 st , 2015. Sincerely, Company Officer: Jorge Amely Telephone Number: 818-493-2818 Email: [email protected]

St. Jude Medical Implantable Electronic Systems 15900 Valley View Court Sylmar, CA 91342 USA Main 818 362 6822 Fax 818 364 5814 October 23 rd , 2014 TUV SUD BABT TCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Confidentiality Request FCC ID: RIASJMRFC Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules, St. Jude Medical Implantable Electronic Systems Division hereby requests permanent confidential treatment of information accompanying this application as outlined below: Schematics Bill of Materials/Parts List Block Diagrams Theory of Operation St. Jude Medical Implantable Systems Division also hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of (up to 180) days: Internal Photos External Photos User Manual Test Set-up Photographs The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, Company Officer: Jorge Amely Telephone Number: 818-493-2818 Email: [email protected]

St. Jude Medical Implantable Electronic Systems 15900 Valley View Court Sylmar, CA 91342 USA Main 818 362 6822 Fax 818 364 5814 March 30, 2014 TUV SUD BABT FCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Model Names and Differences We, St. Jude Medical IESD, hereby request Family certification for the following RF electrically identical implantable pulse generators. The differences consist of battery capacities (either 5.3 or 7.5 Ah), type of therapy (Tonic or non-Tonic SCS/DBS, controlled by software) and method of connecting patient electrodes to the device (SJM or 1.27 mm header). Model 3660 Orion IPG, 5.3Ah, SCS, SJM header Model 3661 Orion IPG, 5.3Ah, SCS, 1.27mm header Model 3662 Orion IPG, 7.5Ah, SCS, SJM header Model 3663 Orion IPG, 7.5Ah, SCS, 1.27mm header Model 6660 Orion IPG, 5.3Ah, DBS, Tonic, SJM header Model 6661 Orion IPG, 5.3Ah, DBS, Tonic, 1.27mm header Model 6662 Orion IPG, 7.5Ah, DBS, Tonic, SJM header Model 6663 Orion IPG, 7.5Ah, DBS, Tonic, 1.27mm header Model 3665 Orion IPG, 5.3Ah, SCS, Tonic, SJM header Model 3667 Orion IPG, 7.5Ah, SCS, Tonic, SJM header Sincerely, Name: Jorge Amely-Velez Title: Senior Principal Engineer St. Jude Medical IESD 15900 Valley View Court Sylmar, CA 91342

FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 Internal photos FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 External photos FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553

FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 Internal photos FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 External photos FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No.: SC1406553

Report No. SC1406553A Rev.02 February 2015 America Report On Application for Grant of Equipment Authorization of the St. Jude Medical IESD IPG (Implantable Pulse Generator) Models: SCS (Spinal Cord Stimulation) and DBS (Deep Brain Stimulation) FCC Part 15 Subpart C §15.247 IC RSS-210 Issue 8 December 2010 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No. SC1406553A Rev.02 Page 2 of 62 TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 REPORT ON TEST REPORT NUMBER PREPARED FOR Radio Testing of the St. Jude Medical IESD IPG (Implantable Pulse Generator) SC1406553A Rev.02 St. Jude Medical IESD 15900 Valley View Court Sylmar, CA 91342 CONTACT PERSON Jorge Amely-Velez Sr. Principal Engineer (818) 493-2818 [email protected] PREPARED BY Alex Chang Name Title: EMC/Wireless Test Engineer APPROVED BY Ferdinand S. Custodio Name Authorized Signatory Title: EMC/Senior Wireless Test Engineer DATED February 02, 2015 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No. SC1406553A Rev.02 Page 3 of 62 TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 Revision History SC1406553A Rev.02 St. Jude Medical IESD IPG (Implantable Pulse Generator) SCS (Spinal Cord Stimulation) and DBS (Deep Brain Stimulation) DATE OLD REVISION NEW REVISION REASON PAGES AFFECTED APPROVED BY 01/14/2015 Initial Release Ferdinand Custodio 01/30/2015 Rev.01 Report number correction All Alex Chang 02/02/2015 Rev.02 Antenna gain revised 9 Alex Chang FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No. SC1406553A Rev.02 Page 4 of 62 TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 CONTENTS Section Page No 1 REPORT SUMMARY ............................................................................................................................... 5 1.1 Introduction ................................................................................................................................................ 6 1.2 Brief Summary of Results ............................................................................................................................ 7 1.3 Product Information ................................................................................................................................... 8 1.4 EUT Test Configuration ............................................................................................................................. 10 1.5 Deviations From The Standard ................................................................................................................. 15 1.6 Modification Record ................................................................................................................................. 15 1.7 Test Methodology ..................................................................................................................................... 15 1.8 Test Facility Location ................................................................................................................................. 15 1.9 Test Facility Registration ........................................................................................................................... 15 2 TEST DETAILS ...................................................................................................................................... 17 2.1 Peak Output Power ................................................................................................................................... 18 2.2 99% Emission Bandwidth .......................................................................................................................... 20 2.3 Minimum 6 dB RF Bandwidth ................................................................................................................... 23 2.4 Out-Of-Band Emissions - Conducted ........................................................................................................ 26 2.5 Band-Edge Compliance of RF Conducted Emissions ................................................................................. 29 2.6 Spurious Radiated Emissions .................................................................................................................... 31 2.7 Radiated Band Edge Measurements And Immediate Restricted Bands ................................................... 48 2.8 Power Spectral Density ............................................................................................................................. 52 3 TEST EQUIPMENT USED ...................................................................................................................... 55 3.1 Test Equipment Used ................................................................................................................................ 56 3.2 Measurement Uncertainty ....................................................................................................................... 57 4 DIAGRAM OF TEST SETUP ................................................................................................................... 58 4.1 Test Setup Diagram ................................................................................................................................... 59 5 ACCREDITATION, DISCLAIMERS AND COPYRIGHT ............................................................................... 61 5.1 Accreditation, Disclaimers And Copyright ................................................................................................ 62 FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No. SC1406553A Rev.02 Page 5 of 62 TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 SECTION 1 REPORT SUMMARY Radio Testing of the St. Jude Medical IESD IPG (Implantable Pulse Generator) FCC ID: RIASJMRFC IC: 8454A-M3660123 Report No. SC1406553A Rev.02 Page 6 …

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FCC ID: RIASJMRFC IC: 8454AM3660123 Report No.: SC1406553 Radiated Emission Below 1GHz Front FCC ID: RIASJMRFC IC: 8454AM3660123 Report No.: SC1406553 Radiated Emission Below 1GHz Back FCC ID: RIASJMRFC IC: 8454AM3660123 Report No.: SC1406553 Radiated Emission Above 1GHz Front FCC ID: RIASJMRFC IC: 8454AM3660123 Report No.: SC1406553 Radiated Emission Above 1GHz Back FCC ID: RIASJMRFC IC: 8454AM3660123 Report No.: SC1406553 Conducted Port Measurement