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Advanced Bionics Precision SCS Handbook

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Summary of Contents for Advanced Bionics Precision SCS

  • Page 2 Patient System Handbook CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use. 9055072-001 Rev C...
  • Page 3 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 the components will void the warranty.

  • Page 4: Table Of Contents

    Table of Contents 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 ...............
  • Page 5 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...

  • Page 6: Introduction

    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.

  • Page 7: System Description

    Patient System Handbook 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.
  • Page 8 System Description Before you continue, however, first check to be sure that all of the following items were included in your Patient Kit. (And check to be sure you have your Temporary Patient Identification Card; be sure to keep it with you until you receive your permanent card.) If any item is missing, please call our Customer Service department at (866) 566-8913.
  • Page 9 Patient System Handbook Find a convenient electrical outlet, one that won’t expose the parts to water or direct heat, and plug in the transformer. Next, connect the transformer to the Charger Base Station and locate the Base Station on a flat surface. Finally, place the Charger in the Base Station with the blue power button facing up.

  • Page 10: Safety Instructions

    Safety Instructions Safety Instructions Warnings The safety considerations of totally implanted SCS devices for use during pregnancy are Pregnancy. unknown. If you become pregnant, turn off the device when you become aware of your condition and consult your physician. As an SCS patient, you must not have any form of diathermy as either as treatment for a Diathermy.
  • Page 11 Patient System Handbook Avoid or exercise care around electromagnetic fields generated by: Electromagnetic Interference. • Theft detectors and security screeners (usually located at stores, airports, libraries, and government buildings) • Power lines and power generators • Electric steel furnaces, arc welders, and other heavy duty industrial electric equipment •...

  • Page 12: Precautions

    Safety Instructions Precautions You must not be exposed to Magnetic Resonance Imaging (MRI). Exposure to this diagnostic MRI. technology may result in dislodgement of your IPG or lead(s), heating of the IPG, severe damage to the IPG electronics and/or increased voltage through the leads or IPG which can cause an uncomfortable or “jolting”...
  • Page 13 Patient System Handbook Do not operate an automobile, other motorized vehicle, or any Automobiles and Other Equipment. potentially dangerous machinery/equipment with therapeutic stimulation switched on. Turn off stimulation first. Sudden stimulation changes, if they occur, may distract you from attentive operation of the vehicle or equipment.
  • Page 14 Safety Instructions In some instances a lead can move from its original location, and stimulation at the Lead Location. intended pain site can be lost. If this occurs, consult your physician who may able to restore stimulation by reprogramming the implant in the clinic or repositioning the lead during another operation.
  • Page 15 Do not try to use a AA (1.5-volt) battery in the Remote Control unit. The Remote Control Battery. control will only operate with the special 3.6-volt battery available from Advanced Bionics. The components can be cleaned using alcohol or a Remote Control, Charging System Cleaning.

  • Page 16: Adverse Effects

    Adverse Effects Adverse Effects Potential risks are involved with any surgery. The possible risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation include: • Lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief.

  • Page 17: The Remote Control

    Patient System Handbook The Remote Control The Remote Control unit is your direct link to choices available for tailoring spinal cord stimulation to suit your comfort and convenience requirements. Keep the Remote Control with you at all times, in a pocket, purse, or in your immediate vicinity.
  • Page 18 The Remote Control The Remote Control is used to: • Turn stimulation On and Off • Change stimulation levels • Activate or save new programs • Change stimulation options (If enabled by the clinician. See “Stimulation Level Control” on page 16.) Each button function label shown on the screen is related to the control button below it.

  • Page 19: Basic Operation

    Patient System Handbook Basic Operation When it is not being used, the Remote Control is in a “sleep” mode. Press any button and the Remote Control will wake up and look for the implant. Once connected, you can make adjustments. When you are done, the Remote Control will go to sleep after 60 seconds.

  • Page 20: Stimulation On And Off

    The Remote Control Stimulation On and Off The Remote Control uses a “dedicated” stimulation on/off switch.You may press the stimulation power button at any time to turn stimulation on or off. You don’t have to be concerned about whether or not the Remote Control is awake.

  • Page 21: Stimulation Level Control

    Patient System Handbook Stimulation Level Control After stimulation is turned on, the Remote Control displays the main screen. From here, you may press the (down) or (up) button to adjust the stimulation level (or intensity) until you are comfortable. The main screen controls all stimulation, whether you have one area of pain control...

  • Page 22: Selecting Areas (For Stimulation Control)

    The Remote Control Selecting Areas (for Stimulation Control) 1. From the main screen, press the button SEL 1 as necessary to cycle through your programmed areas. Each area is given a number (1 through 4) or a name, for example LeftLeg.

  • Page 23: Selecting Programs (For Stimulation Control)

    Patient System Handbook Selecting Programs (for Stimulation Control) Your Remote Control can store up to four stimulation programs that might have been set up by your healthcare professional. Each saved program will have certain differences in the settings. These differences allow you to vary your stimulation in many ways. You may have been encouraged to try using specific programs for different circumstances, postural positions or times in your daily routine.
  • Page 24 The Remote Control To select and activate programs: 1. Press the button from the SEL 2 [NEXT] main screen to go to the program screen. 2. Press the button as necessary to SEL 1 [SEL] choose the program you want to activate. 3.
  • Page 25 Patient System Handbook Once you have selected and activated a program, you can adjust the stimulation level using the (down) or (up) button. If you make a stimulation level adjustment and decide that you prefer it, go back and select the program again then press .

  • Page 26: Options

    The Remote Control Options Under some circumstances, and depending on your treatment prescription, your healthcare provider may have given you a level of control beyond selectable programs by making special options available to you. This feature allows you to change certain preset stimulation settings, and/or restore the original clinic settings for programs that you might have changed.
  • Page 27 Patient System Handbook To Use Options 1. From the program screen, press and hold until you see the options screen. SEL 2 2. From the options screen, press SEL 1 move through the choices shown on the screen. 3. When the option you want is highlighted, press [GO] Note: If you change your mind about adjusting...
  • Page 28 The Remote Control If you selected Rate or Width 1. If the pain area you want to “option” is not displayed on the screen, first press SEL 1 find the area. 2. When the desired area is displayed, press to decrease or increase the Rate or Width (whichever you chose) to that area.
  • Page 29 Patient System Handbook If you selected Restore Press as necessary to highlight the SEL 1 program you want to restore, then press [GO] The Remote Control will display a question for you to confirm; press . You’ll then see [RESTR] a message that the selected program is being restored.

  • Page 30: Remote Control Battery Replacement

    Advanced Bionics. Do not attempt to use a 1.5-volt AA battery in the Remote Control. If you do not have an extra battery in your Patient Take Home Kit, call Advanced Bionics Customer Service Department at (866) 566-8913 to request a new battery.
  • Page 31 Patient System Handbook To replace the Remote Control battery 1. On the rear of the remote, slide the battery compartment lock lever to the left to unlock the cover. 2. Press down on the ridged area below the lever using your thumb to release the cover. 3.

  • Page 32: Charging The Implant

    Charging the Implant Charging the Implant To provide stimulation, your implant uses a rechargeable battery. You should be given guidelines on when to charge your implant. The Remote Control will also provide battery status when your implant is low. Based on your stimulation settings, you may charge once a week or once a day.

  • Page 33: Getting Started

    Patient System Handbook Getting Started The Charging System for your implant consists of the Charger unit, a Base Station, and a transformer (plug). Adaptors are included for use in countries other than the U.S. The Base Station is designed to remain connected into a power outlet, and the Charger placed within to keep it ready for use.

  • Page 34: Charging Your Implant

    Charging the Implant The Charger is completely ready and able to fully charge your implant when the ready- indicator is green. If the light is yellow, the Charger can only partially charge the implant. It may be used, but it may not be able to return your implant to a full charge (so you may need to charge sooner than you normally would).
  • Page 35 Patient System Handbook 2. Using the Adhesive Patch: Apply the adhesive patch to the backside of the Charger by peeling the clear liner from the patch. Remove the skin side beige liner ® Using the Velcro Belt: Place the Charger in the pocket with the power button facing out.
  • Page 36 Charging the Implant 4. Locate the Charger over the implant. When aligned with the implant, the beeping will stop. Secure the Charger over the implant either by pressing the adhesive side to the location, or by ® attaching the Velcro belt.
  • Page 37 Patient System Handbook Note: • The end of a charge signal is a distinct double beep, and the alignment indicator is a steady continuous signal. • The implant battery will eventually need replacement. Over time (typically over years) you may start to charge more frequently. As long as it is convenient, you can use the system. When you are ready for a replacement, talk with your healthcare professional.

  • Page 38: Help

    Help Help Stimulation No Stimulation 1. Toggle the Remote Control implant power button to make sure that stimulation is ON. If the Remote Control receives confirmation from the implant, it will flash “Stimulation On.” 2. Turn up the level of stimulation from the main screen or area screens. 3.

  • Page 39: Remote Control Display

    If the implant regularly stops stimulating before you charge, you can charge more often. Remote Control Display “Remote Battery Low” on the Display The battery in your Remote Control needs to be replaced using the Advanced Bionics 3.6 Volt battery (refer to “Remote Control Battery Replacement” on page 25).

  • Page 40: Accessories

    Help “No Response” on the Display When the Remote Control displays “No Response,” it cannot find the implant because of orientation or interference. Move the remote closer and try again. Call our Customer Service Department at (866) 566-8913 if the problem continues. “Action Unsuccessful”...

  • Page 41: Contacting Advanced Bionics

    Patient System Handbook Contacting Advanced Bionics If you have any other questions, or need to contact Advanced Bionics for any reason, you may do so in any of the following ways: • Customer Service Phone: (866) 566-8913 • Customer Service Fax: (661) 362-1503 ®...

  • Page 42: Limited Warranty

    1. The product registration card must be completed and returned to Advanced Bionics® within 30 days of surgery in order to obtain warranty rights. 2. The IPG must be returned to Advanced Bionics® (or authorized agent) within 30 days of malfunction or discovery of defect, and shall be the property of Advanced Bionics®.
  • Page 43 5. The decision as to product replacement or credit shall be made solely at the discretion of Advanced Bionics®. For a replacement IPG, the warranty will run only to the end of the warranty period for the original IPG that was replaced.

  • Page 44: Externals

    1. The product registration card must be completed and returned to Advanced Bionics® within 30 days of surgery or receipt of product in order to obtain warranty rights. 2. The component must be returned to Advanced Bionics® (or authorized agent) within 30 days of malfunction or discovery of defect.
  • Page 45 4. The decision as to product replacement or credit shall be made solely at the discretion of Advanced Bionics®. For a replacement component, the warranty will run only to the end of the warranty period for the original component that was replaced.
  • Page 46 12740 San Fernando Road, Sylmar, CA 91342 25129 Rye Canyon Loop, Valencia, CA 91355 (800) 678-2575 in US and Canada (818) 362-7588, (818) 362-5069 Fax (661) 362-1400, (661) 1500 Fax (800) 678-3575 TTY www.advancedbionics.com Email:info@advancedbionics.com JUN03-080620-P ©2003 Advanced Bionics Corp. All rights reserved. 9055072 Rev C...

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