Q4DPSC5110WPrecision SCS System External Trial Stimulator

Patient System Handbook CAUTION:Federal law restricts this device to sale, distribution and use by or on the order of a physician. MP9055184 Rev A Patient System HandbookiiCopyright©2004 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 1 Introduction .......................................................................1 2 System Description ...........................................................3 3 Safety Information ............................................................7 Indications for Use ................................................................. 7 Precision System Clinical Summary .......................................... 7 Contraindications ................................................................. 16 Warnings ............................................................................ 16 Precautions .......................................................................... 19 Adverse Effects ..................................................................... 23 4 The Remote Control .......................................................27 Buttons and Basic Operation ................................................ 27 Stimulation On and Off ........................................................ 30 The Level Screen .................................................................. 30 Stimulation Level Control ....................................................... 33 Selecting Areas for Level Control ........................................... 34 Programs ............................................................................. 35 Selecting and Activating Programs ........................................ 36 Patient System Handbookiv Saving Program Changes ..................................................... 37 Options ............................................................................... 40 Understanding Battery Status Messages ................................ 46 Battery Replacement ............................................................. 50 5 Charging the Implant .....................................................51 Getting Started .................................................................... 53 Charging Your Implant ......................................................... 54 6 Help ..................................................................................59 Stimulation ........................................................................... 59 Remote Control Display Messages ........................................ 61 Accessories ......................................................................... 64 Contacting Advanced Bionics ............................................... 64 7 Limited Warranty ...........................................................65 Implanted Pulse Generator .................................................... 65 Externals .............................................................................. 67 Glossary ...........................................................................71Index..................................................................................75 1 1Introduction 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 perception of pain sign als 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 su rgically implanted, you Patient System Handbook2confirmed that paresthesia is capable of providing you with good to excellent pain relief. As you go forward with this therap y, your health professionals will work with you to find the most comfortable level of paresthesia to cove r the painful areas by adjusting your implant’s 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 like ly you are to achieve the best outcome possible from your new Precision system. Advanced Bionics is an orga nization dedicated to helping you manage your pain. We will help you make the most of this ther apy for an improved quality of life. 3 2 System Description The Precision system includes both implante d and external components: During your surgery, 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 implantable pulse generator (IPG), also referred to as an implant . The IPG is commonly placed in the abdomen, upper buttock, or subcla vicular area. 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 recharge d using a separate Charging System . The Remote Control, the heart of the Precision system, is a powerful yet easy to use tool for…

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Patient Trial Handbook CAUTION:Federal law restricts this device to sale, distribution and use by or on the order of a physician. MP9055185 Rev A Patient Trial HandbookiiCopyright©2004 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 1 Introduction .......................................................................1 What is Spinal Cord Stimulation? ........................................... 2 Caretaking During the Trial ..................................................... 3 How to Use This Manu al During the Trial ................................ 6 2 Overview: The Trial Journal ...........................................7 Pain Profile ............................................................................ 7 The Journal ............................................................................ 8 3 Using the Medical Equipment .........................................9 The Trial Stimulator System ...................................................... 9 Taking Care of Your Trial Equipment ..................................... 11 The Trial Stimulator ............................................................... 12 The Remote Control .............................................................. 14 Basic Operation .................................................................. 15 Stimulation On and Off ........................................................ 17 The Level Screen .................................................................. 17 Stimulation Level Control ....................................................... 20 Selecting Areas for Level Control ........................................... 21 Programs ............................................................................. 22 Patient Trial Handbookiv Selecting and Activating Programs ........................................ 23 Saving Program Changes ..................................................... 24 Battery Information ............................................................... 26 4 Safety Information ..........................................................31 Indications for Use ............................................................... 31 Precision System Clinical Summary ........................................ 31 Contraindications ................................................................. 40 Warnings ............................................................................ 41 Precautions .......................................................................... 43 Adverse Effects ..................................................................... 47 5 Help ..................................................................................51 Stimulation ........................................................................... 51 Remote Control Display ........................................................ 53 Accessories ......................................................................... 55 Contacting Advanced Bionics ............................................... 56 Glossary ...........................................................................57Index..................................................................................61 1 1Introduction Welcome to the “Trial Phase” of the Adva nced Bionics® Precision™ pain management program. You’re about to test a pain treatment therapy that coul d result in a dramatic change in your life and your lifestyle. The trial you’ve agreed to participate in is intended to give you and your physician a chance to evaluate spinal cord stimulation (SCS) as an appropriate and effective long-term thera py 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 sp inal 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 appropriate option for you. To prepare yourself for this important decision, you may want to spend at least some of the trial period carefully evaluati ng spinal cord stimulation. Patient Trial Handbook2What is Spinal Cord Stimulation?Most pain signals trav el from the source problem or injury area to nerve pathways to the spine, then up the spine and to the brain. SCS uses electrical stimulation of the spinal cord to block the perception of those signals. To a pply the stimulation, 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” produced by this stimulation is a light sensation called paresthesia . Thousands of SCS patients consider paresthesia not only a pl easant substitute feeling, but also an effective and 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 certa in types of pain over the area where the paresthesia is felt. Spinal cord stimulation is a treatm ent choice designed to provide you wit…

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Physician Implant Manual CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician. MP9055182 Rev A Physician Implant Manual ii©2004 by Advanced Bionics Corporation. All Rights Reserved. Copyright ©2004 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 Precision System Clinical Summary ..................................... 2 Efficacy Evaluation .................................................... 2 Safety Evaluation ....................................................... 5 ............................................................................. 6 Clinical Experience-Safety ........................................... 6 References ............................................................... 7 Contraindications ............................................................ 8 Safety Information ..................................... 9 Warnings ...................................................................... 9 Precautions .................................................................. 10 Adverse Effects ............................................................. 11 Instructions for the Physician ............................................. 13 Sterilization .................................................................. 13 Handling ..................................................................... 15 Storage ....................................................................... 15 Package Contents .................................... 16 Patient Identification ................................ 17 Guidelines for Permanent Implantation .... 18 Percutaneous Lead/Extension Removal .............................. 18 Option A. Temporary Lead Removal ........................... 18 Option B. Extension Removal ..................................... 18 iv Physician Implant Manual IPG Implantation ........................................................... 20 Tool Assembly .............................................................. 21 Tunneling The Lead ........................................................ 21 Connecting To the IPG ................................................... 25 Dual Lead Connection .............................................. 25 Single Lead Connection ............................................ 25 IPG Explant or Replacement ..................... 28 Rechargable Implant System .................... 29 IPG Battery Status .......................................................... 29 Charging Steps ............................................................ 30 Patient Remote Control ............................. 34 Basic Operation ........................................................... 34 Stimulation On/Off ................................................. 35 Stimulation Amplitude ............................................... 35 Coverage Area Selection .......................................... 36 Program Selection ................................................... 36 Modifying and Saving Programs ................................ 36 Options ................................................................. 38 Device Linking .............................................................. 39 Clinician Options .......................................................... 42 To Clear Link .......................................................... 43 For CP Mode ......................................................... 44 For Impedances ...................................................... 45 Programmer Communication ........................................... 47 Specifications and Technical Data ............. 48 ................................................................................. 48 Materials ..................................................................... 48 Table of Contents v Maximum Current Amplitude per Electrode versus Impedance .................................... 49 Registration Information .......................... 50 Registering the Implant ................................................... 50 Technical Service ...................................... 51 Limited Warranty ..................................... 52 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), Model SC-1110. This information includes an overview of accesso- ries for programming and powering the IPG, clinical and surgical con- siderations, storage and handling requirements, and relevant precautions concerning an implanted neurostimulator. Additional information on system components and operation can be found in the BionicNavigator ™ Software Guide. Device Description The Advanced Bionics ® Precision implantable p…

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Physician Trial Kit Copyright 2004, Advanced Bionics® Co rporation. All Rights Reserved. Part No. MP9055214 Rev. A Physician Trial Kit Model SC-7005-02Trial Stimulator Model SC-5110Remote Control Model SC-5210CAUTION:Federal law restricts this de vice to sale, distribution and use by or on the order of a physician.The Advanced Bionics® Trial Stimulator is intended to be used during a screening trial to assess the efficacy of spinal cord stim ulation in the treatment of patients with chronic pain of the trunk or limbs. The Trial Stimulator communicates with, and is controlled by, both a patient programmer (the Remote Control) and a clinician programmer via a wireless link.The Remote Control unit is a hand-held device for patient control of both the external Trial Stimulator and the permanent, impl antable pulse generator (IPG) models of the Precision™ SCS device. Following set up of the Remote Control by the clinician, the Trial Stimulator is able to respond to patient control of: • stimulation on/off functions• stimulation amplitude and other (optional) parameters • stimulation delivery areas• individualized stimulat ion therapy programs. Patient use instructions ar e outlined in the Patient Trial Handbook. CAUTION: • To avoid unexpected stimulation results, never make connections while the Trial Stimulator is on. • The battery used in the Trial Stimulator may present a risk of fire or chemical burn if mis- treated. Do not disassemble, heat above 100ºC (212ºF), or incinerate. • Handle the devices with care. Although dura- bility testing has been performed to ensure quality manufacturing and performance, drop-ping the devices on hard surfaces or in water, or other destructive handling, can cause per-manent damage. • Avoid all sources of water that can come into contact with the devices. • Do not expose the devices to extreme tempera- tures. Store between 5 – 40 ºC (41 – 104 ºF). • Do not dispose of the devices in fire. Trial StimulatorGeneral Instructions1. Ensure that the Trial Stimulator is equipped with a new 6-volt battery before conducting intraop-erative stimulation testing, and for each new trial. (A battery is included in the Patient Trial Kit.) 2. Before connecting the OR Cable for intraopera- tive testing, ensure that the Trial Stimulator is off (no indicator light). Turn the stimulator on for testing, then return it to off before discon-necting the test cables. 3. When fitting the patien t with the Trial Stimula- tor, ensure that the OR Cables are properly con-nected and labelled. Superior (upper or left) leads connect to socket 1- L. Inferior (lower or right) leads connect to socket 2-R. If only a sin-gle lead is being used, connect it to 1-L. 4. Before releasing the patient, ensure that he/she understands: • Basic control of the Trial Stimulator using the Remote Control, and that stimulation may be turned on and off with the E button on either unit. • How to disconnect and reconnect the OR Cable(s) with the power off. • How to replace the Trial Stimulator battery. (See illustration below) NOTE: Immediately followin g a Trial Stimulator battery replacement, th e linked Remote Control will display an error/reset message. Press D to reset the stimulator . Remote ControlBattery InformationThe Remote Control uses three AAA batteries. The device will issue warnings when its batteries are low and when the Trial Stimulator battery needs replacement. Instruct patien ts to pay close attention to all battery messages.NOTE: The first time it comes on following a battery replacement, the Remote Control will reload information from the implanted or exter-nal stimulator. The remote must be within com-munication range (two f eet) of the stimulator during this period.Battery Replacement1. On the rear of the remote, push in slightly and slide the battery compartment cover down. 2. Remove the old batteries.3. Place the new batteries in the slots by matching the positive (+) and ne gative (-) battery ends with the + / - markings in the compartment. 4. Align the cover on the case and slide the cover into position util it snaps closed. Physician Trial Kit Model SC 7005-02 Copyright 2004, Advanced Bionics® Co rporation. All Rights Reserved. Part No. MP9055214 Rev. A General Instructions1. To turn stimulation on or off, press the E but- ton.If the Remote Control is in sleep/idle mode and you press any button other than E , the remote will display a “Keys Lock ed” message. You must press D to unlock the “function” buttons when reactivating the Remote Control from sleep mode. 2. To increase or decrease the stimulation level of all programmed therapy areas, press either S or T . 3. To change the stimulation level of just one area: a) From the level screen, press C as many times as necessary to find the desired area by name or number. b) Press S or T to make the change. 4. To activate a stimulation program: a) Press D from the level screen. b) From the program screen press D as many times as necessary to hi ghlight the desired pro- gram.c) Press S to activate the selected program. Once the program is running, you may change the stimulation level by pressing S or T . To save the new level in a program, return to the program screen, select the intended program number, and press T . 5. To access patient options:Rate1. Press and hold C from the level screen to acti- vate the Rate Area 1 screen. 2. Press C (normal press) as necessary to cycle to the area you want to adjust, then press S or T to increase or decrease the Rate. Pulse Width1. From the level screen press and hold C to access the Rate Area 1 screen. 2. From any Rate screen, press and hold C again to access the Width Area 1 screen. 3. Press C (normal press) as necessary to cycle to the desired area. 4. Press S or T to increase or decrease Pulse Width. To save a Rate or Pulse Width change--1. Press D from the level screen. 2. From the program screen press D as necessary to cycle to the active program. 3. With the program highlighted, press T to save…

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Physician Lead Manual CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician. MP9055183 Rev A Physician Lead Manual ii©2004 by Advanced Bionics Corporation. All Rights Reserved. Copyright ©2004 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 i Table of Contents Introduction ............................................... 1 Manual Overview ........................................................... 1 Product Description .......................................................... 1 Indications for Use ........................................................... 3 Precision System Clinical Summary ..................................... 3 Contraindications .......................................................... 10 Safety Information ................................... 11 Warnings .................................................................... 11 Precautions .................................................................. 12 Adverse Effects ............................................................. 14 Instructions for the Physician ............................................. 16 Package Contents .................................... 17 Lead Kit - Model SC-2108 ............................................. 17 Lead Extension Kit - Model SC-3108 ................................ 17 Sterilization and Handling ........................ 18 Sterilization .................................................................. 18 Handling ..................................................................... 18 Storage ....................................................................... 19 Guidelines for Trial-phase Implantation .... 20 Pre-op Instructions .......................................................... 20 Lead Placement ............................................................ 21 Connecting the OR Cable Assembly ................................. 23 Intraoperative Stimulation Testing ...................................... 26 OPTION A: Temporary Lead Trial .................................... 26 OPTION B: Permanent Lead Trial ..................................... 28 ii Physician’s Lead and Extension Manual Connecting to the Trial Stimulator ............. 36 Guidelines for Permanent Implantation .... 38 Percutaneous Lead/Extension Removal .............................. 38 IPG Implantation ...................................... 40 Tool Assembly .............................................................. 41 Tunneling The Lead ........................................................ 41 Connecting To the IPG ................................................... 45 Specifications and Technical Data ............. 48 Lead .......................................................................... 48 Lead Extension ............................................................. 49 Registration Information .......................... 50 Technical Service ...................................... 51 Limited Warranty ..................................... 52 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 BionicNavigator TM Software Guide. 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 electrode contacts located near the distal end. Each contact is 3 mm in length and is spaced 1 mm from the adjacent contact. The lead body is made of medical grade polyure- thane with a stiffer proximal end to aid insertion into the connector. To aid in intraoperative testing and positioning, a curved stylet is pre- 2 Physician Lead Manual inserted into the lead. The lead can be connected to either an exten- sion or directly to an implantable pulse generator (IPG). Lead Extension Lead Extension Model SC-3108 is designed to connect the Lead Model SC-2108 to the Advanced Bionics Precision implantable pulse generator for spinal cord stimulation. The extension may be added to Introduction 3 a lead to externalize the lead for a trial phase or to extend a lead when a permanent IPG is implanted. Indications for Use The Advanced Bionics Precision ™ Spinal Cord Stimulator System (Precision 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, intractable low back pain and leg pain. Precision System Clinical Summary Determination of the safety and effectiveness of the PRECISION Sys- tem was based on available published clinical studies for si…

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