Q4DSC-5100SCS Implant System External Trial Stimulator

Patient System Handbook CAUTION: Investigational device. Limited by Federa l (or United States) law to investigational use. 9055072-001 Rev C Patient System HandbookiiThis device complies with part 15 of the FCC Rules. 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 th at may cause undesired operation. The Precision System components should only be serviced by Advanced Bionics. Do not attempt to open or repair any of the components. Unauthorized opening of or attempts to repair th e components will void the warranty.Copyright ©2003 by Advanced Bionics Corporation. All Rights Reserved. Any copying, reproduction or translation of all or part of the contents of th is document without the ex press written permission of Advanced Bionics Corporation is strictly forbidde n by the provisions of the law of March 11th, 1957.GuaranteesAdvanced Bionics Corporation reserves the righ t to modify, without pr ior notice, information relating to its products in order to impr ove their reliability or operating capacity. Registered TrademarksVe l c r o ® is a registered mark of Velcro Industries , Manchester, New Hampshire. Other brands and their products are trademarks or registered trad emarks of their respective holders and should be noted as such. Table of Contents iii Table of Contents Introduction .................................................... 1 System Description ......................................... 2 Safety Instructions .......................................... 5 Warnings .................................................................................... 5 Precautions ................................................................................... 7 Adverse Effects ............................................. 11 The Remote Control ....................................... 12 Basic Operation ......................................................................... 14 Stimulation On and Off ............................................................... 15 Stimulation Level Control ............................................................ 16 Selecting Areas (for Stimulation Control) ...................................... 17 Selecting Programs (for Stimulation Control) ................................. 18 Options ..................................................................................... 21 Remote Control Battery Replacement .......................................... 25 Charging the Implant .................................... 27 Patient System Handbook iv Getting Started ........................................................................... 28 Charging Your Implant ................................................................ 29 Help ............................................................. 33 Stimulation ................................................................................. 33 Remote Control Display ............................................................... 34 Accessories ................................................................................ 35 Contacting Advanced Bionics ..................................................... 36 Limited Warranty .......................................... 37 Implanted Pulse Generator .......................................................... 37 Externals .................................................................................... 39 Introduction 1 Introduction The Advanced Bionics ® Precision ™ SCS (Spinal Cord Stimulation) system is prescribed for the management of chronic pain. The system electrically stimulates the spinal cord to alter the percep- tion of pain signals that move along the nerve pathways on either side of the spine. Paresthesia is the term that describes the light, tingling sensation—the “feeling”—of spinal cord stimulation. Before receiving your new implant, you had the opportunity to test stimulation therapy and decide if it would work for you. By choosing to have a stimulator surgically implanted, you confirmed that paresthesia is capable of providing you with good to excellent pain relief. Going forward with this therapy, your health professionals will work with you to find the most comfortable level of paresthesia to cover the painful areas through adjusting the settings. Although you may have pain areas that cannot be reached by spinal cord stimulation, the goal is to bring you the most effective pain relief possible. The more you help and work with your health professionals, the more likely you are to achieve the best outcome possible from your new Precision system. Advanced Bionics is an organization dedicated to helping you manage your pain. We will help you make the most of this therapy for an improved quality of life. Patient System Handbook 2 System Description The Precision system includes both implanted and external components: One or more wires called leads were placed along your spinal cord where pain signals to the brain can be intercepted. The lead was then attached to an implanted pulse generator (IPG), referred to as an implant. The implant sends a small electrical current to a series of stimulating contacts, called electrodes, at the end of the lead. The battery-powered implant is controlled by a hand-held programmer or Remote Control, and is periodically recharged using a separate Charging System. The Remote Control, the heart of the Precision system, is a powerful yet easy to use tool for managing every aspect of your pain treatment—from controlling the level, or strength, of stimulation to accessing special treatment programs and program options. For your Precision system, it’s important to learn 1) what to be aware of for safety, 2) how to use the Remote Control, and 3) how to re-charge the implant. These subjects are covered on the following pages, and we encourage you to read this manual entirely. If you have a…

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Patient Trial Handbook CAUTION: Investigational device. Limited by Federa l (or United States) law to investigational use. 9055078-001 Rev C Patient Trial HandbookiiThis device complies with part 15 of the FCC Rules. 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 th at may cause undesired operation. The Precision System components should only be serviced by Advanced Bionics. Do not attempt to open or repair any of the components. Unauthorized opening of or attempts to repair th e components will void the warranty.Copyright ©2003 by Advanced Bionics Corporation. All Rights Reserved. Any copying, reproduction or translation of all or part of the contents of th is document without the ex press written permission of Advanced Bionics Corporation is strictly forbidde n by the provisions of the law of March 11th, 1957.GuaranteesAdvanced Bionics Corporation reserves the righ t to modify, without pr ior notice, information relating to its products in order to impr ove their reliability or operating capacity. Registered trademarksVe l c r o ® is a registered mark of Velcro Industries , Manchester, New Hampshire. Other brands and their products are trademarks or registered trad emarks of their respective holders and should be noted as such. Table of Contents iii Table of Contents Introduction ........ ................ ................ ............ 1 What is Spinal Cord Stimulation? .................................................. 1 Caretaking During the Trial ........................................................... 2 How to Use This Manual During the Trial ....................................... 5 Overview: The Trial Journal ................ ............ 6 Pain Profile ................................................................................... 6 The Journal ................................................................................... 6 Using the Medical Equipment ............. ............ 8 The Trial Stimulator System ............................................................ 8 Taking Care of Your Trial Equipment ............................................. 9 The Trial Stimulator ..................................................................... 10 The Remote Control ................................................................... 11 Basic Operation ......................................................................... 12 Stimulation On and Off ............................................................... 13 Stimulation Level Control ............................................................. 14 Selecting Areas (for Stimulation Control) ...................................... 15 Selecting Programs (for Stimulation Control) ................................. 16 Battery Information ..................................................................... 18 Patient Trial Handbookiv Safety Instructions ......... ............ ........... ........ 22 Warnings ................................................................................. 22 Precautions ................................................................................. 23 Adverse Effects .............. ............ ........... ........ 25 Help ................. ................ ................ ............ 26 Stimulation ................................................................................. 26 Remote Control Display ............................................................... 27 Accessories ................................................................................ 28 Contacting Advanced Bionics ..................................................... 29 Introduction 1 IntroductionWelcome to the “Trial Phase” of the Advanced Bionics® Precision™ pain management program. You’re about to test a pain treatm ent therapy that could result in a dramatic change in your life and your lifestyle. The trial you’ve agreed to participat e in is intended to give you and your physician a chance to evaluate spinal cord stimulation (SCS) as an appropriate and effective long-term therapy option for your chronic pain.At the end of the trial period (approximately one week) you and your physician will meet to discuss your experience with spinal cord stimulation. The doctor will also want to explore your feelings about a permanent SCS implant so that, together, both of you can determine whether long-term treatment with spinal cord stimulation is an approp riate option for you. To prepare yourself for this important decision, you may want to spend at leas t some of the trial peri od carefully evaluating spinal cord stimulation.Contraindications: Patients who fail to receive pain relief during stimulation, do not meet psychological selection criteria, are poor surgical risks or are pregnant cannot be implanted with the permanent device. What is Spinal Cord Stimulation?Most pain signals travel from the so urce problem or injury area to ne rve pathways to the spine, then up the spine and to the brain. SCS uses electrical stimulation of the spinal cord to block the Patient Trial Handbook2perception of those signals. To apply the stimulatio n, a small electrical pulse generator is connected to one or two wires, called leads, which are placed along your spinal cord. The stimulator, internal or external, sends pulses of a low electrical current to a series of metal contacts, called electrodes, located at the end of the lead(s). The “feeling” produ ced by this stimulation is a light sensation called paresthesia . Thousands of SCS patients consider paresthe sia not only a pleasant substitute feeling, but also an effective an d welcome relief from pain. It’s important to understand that spinal cord stimulation cannot cure pain or eliminate its cause. It does, however, provide control of and relief from certain types of pain over the area where the paresthesia is felt. Spinal cord sti…

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The following is federal government communications regulation information about the Precision™ System. Changes or modifications to this product not authorized by Advanced Bionics Corporation could void the FCC Certification and negate your authority to operate this product. Contents

Spinal Cord Stimulation System LINEAR ™ Lead model SC2108 Lead Extension model SC3108 Physician Lead Manual 9055095-001 Rev C Physician Lead Manual ii©2003 by Advanced Bionics Corporation. All Rights Reserved. CAUTION. Investigational device. Limited by federal law to investigational use. This device complies with part 15 of the FCC Rules. 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. The Precision System components should be serviced only by Advanced Bionics. Do not attempt to open or repair any of the components. Unauthorized opening of or attempts to repair the components will void the warranty. Copyright ©2003 by Advanced Bionics Corporation. All Rights Reserved. Any copying, reproduction or translation of all or part of the contents of this document without the express written permission of Advanced Bionics Corporation is strictly forbidden by the provisions of the law of March 11th, 1957. Guarantees Advanced Bionics Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity. Registered Trademarks Linear ™ , BionicNavigator ™ and Precision ™ are registered trademarks of Advanced Bionics Corporation. Velcro ® is a registered mark of Velcro Industries, Manchester, New Hampshire. Other brands and their products are trademarks or registered trademarks of their respec- tive holders and should be noted as such. Table of Contents iii Table of Contents Introduction ............................................... 1 Manual Overview ........................................................... 1 Product Description .......................................................... 1 Lead ....................................................................... 1 Lead Extension .......................................................... 2 Indications for Use ........................................................... 3 Contraindications ............................................................ 4 Safety Instructions ...................................... 5 Warnings ...................................................................... 5 Precautions .................................................................... 5 Adverse Effects ............................................................... 6 Instructions for the Physician ...................... 8 Package Contents ...................................... 9 Lead Kit - Model SC 2108 ............................................... 9 Lead Extension Kit - Model SC 3108 .................................. 9 Sterilization and Handling ........................ 10 Sterilization .................................................................. 10 Handling ..................................................................... 10 Storage ....................................................................... 11 Guidelines for Trial-phase Implantation .... 12 Pre-op Instructions .......................................................... 12 Lead Placement ............................................................ 13 Connecting the OR Cable Assembly ................................. 15 Intraoperative Stimulation Testing ...................................... 18 iv Physician’s Lead and Extension Manual OPTION A: Temporary Lead Trial .................................... 18 OPTION B: Permanent Lead Trial ..................................... 20 Removing the Needle .............................................. 20 Anchoring the Lead .................................................. 21 Tunneling And Connecting Extension ........................... 22 Connecting to the Trial Stimulator ............. 28 Guidelines for Permanent Implantation .... 30 Percutaneous Lead/Extension Removal .............................. 30 Option A. Temporary Lead Removal ........................... 30 Option B. Extension Removal ..................................... 31 IPG Implantation ...................................... 32 Tool Assembly .............................................................. 33 Tunneling The Lead ........................................................ 33 Connecting To the IPG ................................................... 37 Dual Lead Connection .............................................. 37 Single Lead Connection ............................................ 37 Specifications and Technical Data ............. 40 Lead ........................................................................... 40 Lead Extension .............................................................. 41 Registration Information .......................... 42 Technical Service ...................................... 43 Limited Warranty ..................................... 44 Introduction 1 Introduction Manual Overview This manual provides basic information for the implantation and use of the Advanced Bionics ® Lead Model SC 2108 and Lead Extension Model SC 3108. These products are designed to be percutaneously or surgically implanted for use with the Precision TM Spinal Cord Stimu- lation (SCS) System to aid in the management of chronic intractable pain. Information on other system components and their operation can be found in the Physician Systems Handbook. General surgical guidelines are presented for temporary and perma- nent implantation of leads and extensions. Product Description Lead The lead functions as a component of the Precision system by deliver- ing electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation. Model SC 2108 has eight electrodes located near the distal end. Each electrode is 3 mm in length and is spaced 1 mm from the adjacent electrode. The lead body is made of medical grade polyurethane with a stiffer proximal en…

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Physician Implant Manual 9055100-001 Rev D Physician Implant Manual ii©2003 by Advanced Bionics Corporation. All Rights Reserved. CAUTION. Investigational device. Limited by federal law to investigational use. This device complies with part 15 of the FCC Rules. 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. The Precision System components should be serviced only by Advanced Bionics. Do not attempt to open or repair any of the components. Unauthorized opening of or attempts to repair components will void the warranty. Copyright ©2003 by Advanced Bionics Corporation. All Rights Reserved. Any copying, reproduction or translation of all or part of the contents of this document without the express written permission of Advanced Bionics Corporation is strictly forbidden by the provisions of the law of March 11th, 1957. Guarantees Advanced Bionics Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity. Registered Trademarks BionicNavigator ™ and Precision ™ are registered trademarks of Advanced Bionics Corporation. Velcro ® is a registered mark of Velcro Industries, Manchester, New Hampshire. Other brands and their prod- ucts are trademarks or registered trademarks of their respective hold- ers and should be noted as such. Table of Contents iii Table of Contents Introduction ............................................... 1 Manual Overview ........................................................... 1 Device Description .......................................................... 1 Features ........................................................................ 1 Indications for Use ........................................................... 2 Patient Selection .............................................................. 2 Contraindications ............................................................ 2 Safety Instructions ...................................... 3 Warnings ...................................................................... 3 Precautions .................................................................... 4 Adverse Effects ............................................................... 5 Instructions for the Physician ............................................... 6 Package Contents ........................................................... 7 Patient Identification ......................................................... 7 Sterilization .................................................................... 7 Handling ....................................................................... 8 Storage ......................................................................... 8 Guidelines for Permanent Implantation ...... 9 Percutaneous Lead/Extension Removal ................................ 9 Option A. Temporary Lead Removal ............................. 9 Option B. Extension Removal ....................................... 9 IPG Implantation ........................................................... 11 Tool Assembly .............................................................. 12 Tunneling The Lead ........................................................ 12 Connecting To the IPG ................................................... 16 Dual Lead Connection .............................................. 16 Single Lead Connection ............................................ 16 iv Physician Implant Manual IPG Explant or Replacement ..................... 19 Rechargable Implant System .................... 20 IPG Battery Status .......................................................... 20 Charging Steps ............................................................ 21 Patient Remote Control ............................. 24 Basic Operation ........................................................... 24 Basic Programming ....................................................... 25 Stimulation On/Off ................................................. 25 Stimulation Amplitude ............................................... 25 Coverage Area Selection .......................................... 25 Program Selection ................................................... 25 Options ................................................................. 26 Physician Mode ............................................................ 27 Entering Physician Mode .......................................... 27 Device Links and Resets .................................................. 28 Change Link (same patient use only) ........................... 28 Change Patient ....................................................... 29 Changing Links and Resets ........................................ 29 Reading Lead Impedances .............................................. 30 Stimulation Set Up (Programming) ..................................... 30 Electrode Configuration ............................................ 31 Parameters ............................................................. 32 Exiting Clinician’s Programming Screen ....................... 32 Programmer Communication ........................................... 32 Specifications and Technical Data ............. 33 IPG (SC-1100) ............................................................. 33 Registration Information .......................... 34 Registering the Implant ................................................... 34 Table of Contents v Technical Service ...................................... 35 Limited Warranty ..................................... 36 vi Physician Implant Manual Introduction 1 Introduction Manual Overview This manual provides basic information for the implantation and operation of the Precision ™ Implantable Pulse Generator (IPG), SC Model 1100. This information inc…

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Back of External Trial Stimulator Front of External Trial Stimulator

Back of External Trial Stimulator

Front of External Trial Stimulator Circuit Board Back of External Trial Stimulator Circuit Board

The SCS system is divided into Surgical, Clinician, and Patient Equipment. Patient Equipment includes all equipment the patient needs to have a workable system. Surgical equipment permits successful and verifiable implantation. Clinician equipment is primarily the programming system that enables stimulus parameters and patient databases to be recorded. In the block diagram below, please note that the PRECISION System was formerly referred to as Stimulus and Novus. This submission covers the ETS, shown in the box above. The description and features of each component follows. Hand Held Programmer (HHP) Description: Programmer that may be used by the patient or clinician to change the stimulus parameters of the IPG or ETS via a telemetry link. RF Link to ETS ETS Clinician Programmer with Windows-based Application Software Remote Control (Handheld Programmer) Charger and Base Station RF Charging Link Infrared Communication between Remote Control and Clinician Programmer Features: 1) Small programmer with easy to read LCD screen, 2) Software for ease of programming and user interface, and 3) Powered by field replaceable primary battery. External Trial Stimulator (ETS) Description: The External Trial Stimulator is an externally worn pulse generator that is used for 7 to 10 days for evaluation purposes before the implantation of the IPG. The ETS is applied with an adhesive patch to the skin of the patient, or by a belt clip or other form of convenient carrying pouch. Features: 1) Device used in OR to test the electrode array during placement, 2) Full bi-directional communication to the Clinician’s Programming System, and 3) Allows the patient or clinician to evaluate the stimulus levels.

TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC205502(HHPETS)-03 Page 1 of 10 Rev.No 1.0 MEASUREMENT AND TECHNICAL REPORT ADVANCED BIONICS CORPORATION 12740 San Fernando Road Sylmar, CA 91342 DATE: 05 November 2002 This Report Concerns: Original Grant: X Class II Change: Equipment Type: SCS Implant System External Trial Simulator (Model SC-5100) Deferred grant requested per 47 CFR 0.457(d)(1)(ii)? Yes: Defer until: No: X Company Name agrees to notify the Commission by: N/A of the intended date of announcement of the product so that the grant can be issued on that date. Transition Rules Request per 15.37? Yes: No: X* (*) FCC Part 15, Paragraph(s) 15.209(a) Report Prepared by: TÜV AMERICA, INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 546 3999 Fax: 858 546 0364 TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC205502(HHPETS)-03 Page 2 of 10 Rev.No 1.0 TABLE OF CONTENTS Pages 1.0 GENERAL INFORMATION 3 1.1 Product Description 3 1.2 Related Submittal Grant 4 1.3 Tested System Details 4 1.4 Test Methodology 4 1.5 Test Facility 4 2.0 SYSTEM TEST CONFIGURATION 5 2.1 Justification 5 2.2 EUT Exercise Software 6 2.3 Special Accessories 6 2.4 Equipment Modifications 6 2.5 Configuration of Test System 6 3.0 RADIATED EMISSIONS EQUIPMENT/DATA 7 4.0 ATTESTATION STATEMENT 10 TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC205502(HHPETS)-03 Page 3 of 10 Rev.No 1.0 1.0 GENERAL INFORMATION 1.1 Product Description Model Number SC-5100 Model Description SCS External Trial Stimulator length 2.7" width 2.2" height 0.7" weight 45g (w/o battery) Power source (if battery, voltage and size) Battery 6V Power type (if battery, chemistry) Lithium Power capacity 170mAhr Cable - signal type 2x Omnetics cable and 1x patch cable Cable - connector type 2x Omnetics; 1x Amp (mini shrouded banana) Cable - shielded/unshielded Omnetics = Shielded; patch = not shielded Cable - length Omnetics = 5' ; patch cable = 5' Cable - removable (y/n) yes Support Equipment (additionally, see section 2.1) Model Number SC-5200 Model Description SCS Handheld Programmer length 3.5" width 2.7" height 0.8" weight 76g (w/o battery) Power source (if battery, voltage and size) Battery 3.6V Power type (if battery, chemistry) Lithium Power capacity 2.6AHr Cable - signal type na Cable - connector type na Cable - shielded/unshielded na Cable - length na Cable - removable (y/n) na TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC205502(HHPETS)-03 Page 4 of 10 Rev.No 1.0 1.2 Related Submittal Grant None 1.3 Tested System Details The FCC ID’s for all equipment, plus descriptions of all cables used in the tested system are: None 1.4 Test Methodology Purpose of Test: To demonstrate compliance with the following tests. TEST FCC CFR 47# PASS/FAIL Radiated Emissions 15.209(a) Pass Unless otherwise stated, testing was performed according to the procedures in FCC/ANSI C63.4 and CSA 108.8-M1983.. 1.5 Test Facility The open area test site and conducted measurement data were tested by: TÜV AMERICA, INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 546 3999 Fax: 858 546 0364 The Test Site Data and performance comply with ANSI C63.4 and are registered with the FCC, 7435 Oakland Mills Road, Columbia Maryland 21046. All Measurement Data is acquired according to the content of FCC Measurement Procedure and ANSI C63.4, unless supplemented with additional requirements as noted in the test report. TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC205502(HHPETS)-03 Page 5 of 10 Rev.No 1.0 2.0 …

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