Boston Scientific Neuromodulation SC-5100 SCS Implant System External Trial Stimulator User Manual SCS Patient Cvrs

Boston Scientific Neuromodulation Corporation SCS Implant System External Trial Stimulator SCS Patient Cvrs

patient system handbook

Patient System HandbookCAUTION: Investigational device. Limited by Federal (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 that 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 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.GuaranteesAdvanced 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 TrademarksVelcro® is a registered mark of Velcro Industries, Manchester, New Hampshire. Other brands and their products are trademarks or registered trademarks of their respective holders and should be noted as such.
Table of ContentsiiiTable of ContentsIntroduction .................................................... 1System Description ......................................... 2Safety Instructions .......................................... 5Warnings .................................................................................... 5Precautions ................................................................................... 7Adverse Effects ............................................. 11The Remote Control ....................................... 12Basic Operation ......................................................................... 14Stimulation On and Off ............................................................... 15Stimulation Level Control ............................................................ 16Selecting Areas (for Stimulation Control) ...................................... 17Selecting Programs (for Stimulation Control) ................................. 18Options ..................................................................................... 21Remote Control Battery Replacement .......................................... 25Charging the Implant .................................... 27
Patient System HandbookivGetting Started ........................................................................... 28Charging Your Implant ................................................................ 29Help ............................................................. 33Stimulation ................................................................................. 33Remote Control Display ............................................................... 34Accessories ................................................................................ 35Contacting Advanced Bionics ..................................................... 36Limited Warranty .......................................... 37Implanted Pulse Generator .......................................................... 37Externals .................................................................................... 39
Introduction1IntroductionThe 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 Handbook2System DescriptionThe 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 any questions, or need clarification of anything contained here, feel free to contact our Customer Service department at (866) 566-8913.
System Description3Before 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. (1) Remote Control(1) (IPG) Charger(1) Charger Base Station(1) Transformer (1) Belt Clip Holster(1) Velcro® Charging Belt(1) Charger Adhesives (52 pieces)(1) Remote Control Battery(1) Carrying Case
Patient System Handbook4Find 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. For now, that’s all you need to do to get started. For more information on the Charging System and its use, see “Charging the Implant” on page 27.
Safety Instructions5Safety InstructionsWarningsPregnancy. The safety considerations of totally implanted SCS devices for use during pregnancy are unknown. If you become pregnant, turn off the device when you become aware of your condition and consult your physician.Diathermy. As an SCS patient, you must not have any form of diathermy as either as treatment for a medical condition or as part of a surgical procedure. The high energy and heat generated by diathermy can be transferred through your stimulator system, causing tissue damage at the lead site and, possibly, severe injury or death.Cardiac Pacemakers. Spinal cord stimulators may interfere with the operation of implanted sensing stimulators, such as pacemakers and implantable cardiac defibrillators (ICDs). Be sure your physicians are aware of your spinal cord stimulator before going forward with other implantable device therapies so that medical decisions can be made and appropriate safety measures taken.Posture. Some changes in posture may cause decreased or uncomfortable increased stimulation levels. Keep the Remote Control with you at all times in order to be ready to adjust stimulation for unexpected changes.
Patient System Handbook6Electromagnetic Interference. Avoid or exercise care around electromagnetic fields generated by:• 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• Large magnetized stereo speakersAs you approach these devices you may become aware of changing stimulation levels. In rare instances, you could experience an increase in stimulation level to the point that the sensation is uncomfortably strong or possibly “jolting.” If this happens, turn off the IPG. If the IPG suddenly turns off by itself, first move away from the area. Next, check the implant status with the Remote Control by pressing the power button and observing the screen. The IPG may need to be recharged before stimulation can be re-started. (See “Charging the Implant” on page 27 for additional information.)Always be aware of your surroundings, particularly near theft detectors/security screeners. Ask for assistance to go around these devices if you feel at all uncomfortable.
Safety Instructions7PrecautionsMRI. You mu st not be exposed to Magnetic Resonance Imaging (MRI). Exposure to this diagnostic 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” sensation.Medical Devices/Therapies. The following medical therapies or procedures may turn stimulation off or may cause permanent damage to the implant, particularly if used in close proximity to the device:• lithotripsy• electrocautery• external defribrillation• radiation therapy• ultrasonic scanning• high-output ultrasoundBefore having procedures, medical therapies, or diagnostics, have your healthcare professional call our Customer Service department at (866) 566-8913 for proper instructions.
Patient System Handbook8Automobiles and Other Equipment. Do not operate an automobile, other motorized vehicle, or any 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.Post Operative. During the two weeks following surgery, it is important to use extreme care so that appropriate healing will secure the implanted components and close the surgical incisions: Do not exercise or attempt to move heavy objects, and avoid deep bending and stretching. Temporarily, there may be some pain in the area of the implant as the incisions heal. If discomfort continues beyond two weeks, contact your physician.If you notice excessive redness around the wound areas during this time, contact your physician to check for infection and administer proper treatment. In rare cases, adverse tissue reaction to implanted materials can occur during this period.Implant Location. Never attempt to change the orientation or “flip” the implant. Do not “finger” or play with the implant. If the implant flips over in your body it cannot be charged. If you know that the device has turned, or if stimulation cannot be turned on after charging, contact your physician to arrange an evaluation of the system.In some cases, skin erosion at the implant location can occur over time. If this occurs, contact your physician.
Safety Instructions9Lead Location. In some instances a lead can move from its original location, and stimulation at the 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.Device Failure. Implants can fail at any time due to random component failure, loss of battery functionality, or lead breakage. If the device stops working even after complete charging (up to four hours), turn off the implant and contact your physician so that the system can be evaluated.Storage. Do not expose the Remote Control or Charging System components to excessively hot or cold conditions. Do not leave the devices in your car or outdoors for extended periods of time. The sensitive electronics can be damaged by temperature extremes, particularly high heat. If the Remote Control or the Charging System is to be stored for a period of time, be careful that the storage temperature does not exceed -20–60 °C (-4–140 °F).Handling. Handle the system components and accessories with care. Do not drop them or submerge them in water. Although reliability testing has been performed to ensure quality manufacturing and performance, dropping the devices on hard surfaces or in water, or other rough handling, can permanently damage the components. (See “Limited Warranty” on page 37.)Component Disposal. Do not dispose of the Remote Control or Charger in fire. The battery in these devices can explode in fire. Dispose of used batteries in accordance with local regulations.
Patient System Handbook10Remote Control Battery. Do not try to use a AA (1.5-volt) battery in the Remote Control unit. The control will only operate with the special 3.6-volt battery available from Advanced Bionics.Remote Control, Charging System Cleaning. The components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue. Residue from soapy detergents should be removed with a damp cloth. Do not use abrasive cleansers for cleaning.
Adverse Effects11Adverse EffectsPotential 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.• System failure, which can occur at any time due to random failure(s) of the components or the battery. These events, which may include device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control.• Tissue reaction to implanted materials can occur.• Skin erosion at the IPG site can occur over time.• Possible surgical procedural risks are: temporary pain at the implant site, infection, cerebrospinal fluid (CSF) leakage and, although rare, epidural hemorrhage, seroma, hematoma and paralysis.• External sources of electromagnetic interference may cause the device to malfunction and affect stimulation.• Exposure to MRI can result in heating of tissue, image artifacts, induced voltages in the neurostimulator and/or leads, lead dislodgement.
Patient System Handbook12The Remote ControlThe 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.
The Remote Control13The 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. As you move through the screen, the function labels for the buttons will change accordingly.
Patient System Handbook14Basic OperationWhen 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.Good communication between the implant and the Remote Control is very important. This is the reason you’ll often see the message “Connecting...” while you are adjusting the stimulation. This is normal because the Remote Control continually checks for the implant.Note: If you have trouble communicating with the implant, the message “No Response” will appear on the Remote Control screen. See “Help” on page 33 for more information.
The Remote Control15Stimulation On and OffThe 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.
Patient System Handbook16Stimulation Level Control After stimulation is turned on, the Remote Control displays the main screen. From here, you may press the T (down) or S (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... or more than one.Note: • In some cases, health professionals can give you control over more than one stimulation area.•Multiple area control is available only if your system has been programmed to deliver stimulation to separate areas. If you do not have separate area control (for example, left leg vs. right leg) but feel that separate control might improve your stimulation therapy, contact your health profes-sional to determine what is possible.
The Remote Control17Selecting Areas (for Stimulation Control) 1. From the main screen, press the SEL 1 button as necessary to cycle through your programmed areas. Each area is given a number (1 through 4) or a name, for example LeftLeg.Note: If you only have one area of control, that area will appear each time you press SEL 1.2. When the named or numbered area that you want to adjust is displayed, press T or S to change the stimulation level for that area.
Patient System Handbook18Selecting 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. Program flexibility gives you and your healthcare professional a way to continually “fine-tune” your therapy.
The Remote Control19To select and activate programs: 1. Press the SEL 2 [NEXT] button from the main screen to go to the program screen.2. Press the SEL 1 [SEL] button as necessary to choose the program you want to activate.3. Once the desired program is highlighted, press T [ACT; activate] and that program will start running after a couple of seconds.Note: You might not have four (the maximum) programs saved in your Remote Control. Empty program slots will have an * (asterisk) symbol beside the program number. If you try to activate an empty program, nothing will happen.
Patient System Handbook20Once you have selected and activated a program, you can adjust the stimulation level using the T (down) or S (up) button.If you make a stimulation level adjustment and decide that you prefer it, go back and select the program again then press S [SAVE]. The program will be updated with the new level.You may also save to an empty program slot (*) if one is available.
The Remote Control21Options 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. The latter is an advantage if you’ve made a program adjustment that you’re not satisfied with.If you’ve been told about program options and instructed in how to use them, you may realize that you probably won’t use this special feature very often. However, if your Remote Control has been set up to access options, follow the steps below to make changes.There are three possible options. One of these, RESTORE, is not a stimulation setting but is similar to an “undo” feature, returning a program to settings from the clinic. The other two options are stimulation settings that can affect the feeling of stimulation:•rate, or how many times-per-second your implant sends a stimulation pulse, and•width (for pulse width), or how long each stimulation pulse lasts.Note: Any one or both of these may be locked out of the options feature by your clinician. Your choices would have been discussed with you at your first programming session.
Patient System Handbook22To Use Options 1. From the program screen, press and hold SEL 2 until you see the options screen.2. From the options screen, press SEL 1 to move through the choices shown on the screen. 3. When the option you want is highlighted, press S [GO].Note: If you change your mind about adjusting options, press SEL 2 [NEXT] to return to the main screen.
The Remote Control23If you selected Rate or Width 1. If the pain area you want to “option” is not displayed on the screen, first press SEL 1 to find the area. 2. When the desired area is displayed, press T or S to decrease or increase the Rate or Width (whichever you chose) to that area.3. If you want to adjust the same option for another area, press SEL 1 to find the area.Note: The Remote Control will beep to notify you if you reach a preset limit while increasing or decreasing either the Rate or Width. 4. When you’ve made all of your changes for one option, press SEL 2 [BACK] to return to the options screen.5. Press SEL 1 to work with another option (as described above), or press SEL 2 [NEXT] to return to the main screen.
Patient System Handbook24If you selected Restore Press SEL 1 as necessary to highlight the program you want to restore, then press S [GO]. The Remote Control will display a question for you to confirm; press S [RESTR]. You’ll then see a message that the selected program is being restored. When the operation is complete, the remote will return automatically to the main screen.
The Remote Control25Remote Control Battery Replacement If the Remote Control needs a new battery, a message will be displayed. Following the low battery message you will only be able to turn the implant on and off. If you try to use any button except the power button, you will be reminded “Replace Remote Battery ON/OFF ONLY.” The battery for your Remote Control is a special 3.6-volt battery available only from 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.
Patient System Handbook26To 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. Open the cover and remove the old battery.4. Replace the new battery in the slot, matching the positive (+) and negative (-) markings.5. Close the compartment by sliding the lock lever to the right.The Remote Control will connect and reload information from the implant in approximately 30 seconds.
Charging the Implant27Charging the ImplantTo 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. You should be aware that if you do not charge your implant, stimulation will eventually stop until you charge again. Remember to schedule this important time. Charging the implant is a simple process requiring little effort.
Patient System Handbook28Getting StartedThe 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.1. Find a convenient place with a flat, clear surface to keep the Base Station plugged in.2. Plug the transformer into a standard AC wall outlet, then plug the cord into the Base Station.3. Place the Charger in the base.When charging, you can opt to use either a Velcro® belt, or adhesive patches. To get started using a Velcro ® belt, you can cut it to your size for comfort. We recommend using the adhesive patches since they maintain nearly perfect alignment between the implant and the Charger. The patch adhesive is made of non-reactive material suitable for most sensitive skin types.
Charging the Implant29The 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).• Green – ready for full charge• Yellow – partial charge• Off – not ready for chargingCharging Your Implant1. When the indicator light is green, remove the Charger from the Base Station. (The indicator light will go out, regardless of the ready status.)
Patient System Handbook302. 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 linerUsing the Velcro® Belt: Place the Charger in the pocket with the power button facing out. 3. Press the power button. The indicator light will return to the status position, and the Charger will begin beeping steadily to signal that it is searching for the implant.
Charging the Implant314. 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.Note: If you accidentally locate the patch in the wrong place, or if the Charger moves out of alignment, the Charger will start beeping again. Use a new adhesive patch or readjust the Ve l c ro ® belt to place the Charger back to position.5. When the Charger emits a distinct double beep, the implant is charged. Switch off the Charger, remove the adhesive patch or Velcro ® belt, and return the Charger to the Base Station.Do not confuse the end of charge (a distinct double beep) signal with the steady, contin-uous misalignment signal.
Patient System Handbook32Note: • 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.
Help33HelpStimulationNo Stimulation1. 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. Charge the implant. When the charge is complete, try turning the stimulation on.4. Call our Customer Service Department at (866) 566-8913 if the above steps do not solve the problem.Stimulation Increases or Decreases on Its Own1. Stimulation can change depending on body position (lying down, standing or bending). 2. Always keep the Remote Control with you, so that you can adjust your stimulation levels as needed.
Patient System Handbook34Stimulation Shuts Off1. Although unlikely, Anti-Theft screeners can turn stimulation off. If you cannot turn the stimulator back on with your Remote Control, you may need to charge the implant.2. Large magnetized speakers or large power lines that emit interference may also turn off stimulation. If you cannot turn the stimulator back on with your Remote Control, you may need to charge the implant.3. When the implant battery needs to be recharged, it will stop stimulating. Recharge and turn stimulation back on. If the implant regularly stops stimulating before you charge, you can charge more often.Remote Control Display“Remote Battery Low” on the DisplayThe 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).
Help35“No Response” on the DisplayWhen 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” on the DisplayWhen the Remote Control displays “Action Unsuccessful,” press [OK] and try the action again. If pressing [OK] does not clear the message, call your physician’s office.AccessoriesAA BatteriesDo not use AA Batteries. The Remote Control requires the special 3.6-volt battery from Advanced Bionics, because a standard AA battery is not powerful enough. The two batteries may look the same, but they are very different when it comes to your device.Washing the Velcro® BeltWash the belt with mild soap and warm water.
Patient System Handbook36Contacting Advanced BionicsIf 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• Address: Advanced Bionics® CorporationPain Management DivisionMann Biomedical Park25129 Rye Canyon LoopValencia CA 91355
Limited Warranty37Limited WarrantyImplanted Pulse GeneratorAdvanced Bionics® Corporation (hereinafter referred to as Advanced Bionics®) warrants to the patient who receives a Precision™ System that the implanted pulse generator (hereinafter referred to as the IPG), Model SC 1100, is free from defects in workmanship and materials for a period of one (1) year from the date of surgical implant of the IPG. This warranty only applies to the patient (recipient, hereinafter referred to as the patient), and no other individual.An IPG that fails to function within normal tolerances within (1) year from the date of surgery is covered under this Limited Warranty. The liability of Advanced Bionics® under this warranty shall be limited to: (a) replacement with a functionally equivalent IPG; or (b) full credit equal to the original purchase price to be applied towards the purchase of a new IPG. Product claims under Advanced Bionics® Limited Warranty are subject to the following conditions and limitations: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®.3. The IPG must be implanted prior to the “use before” date.
Patient System Handbook384. Failure of the IPG must be confirmed by Advanced Bionics®. This warranty specifically excludes defects or malfunctions caused by: (a) fire, floods, lightning, natural disasters, water damage and other calamities commonly defined as “Acts of God”; (b) accident, misuse, abuse, negligence, or customer’s failure to operate the IPG in accordance with manufacturer’s instructions; (c) unauthorized attempts to repair, maintain, or modify the equipment by the customer or any unauthorized third party; or (d) attachment of any equipment not supplied by Advanced Bionics® without prior approval.This warranty does not include the leads, extensions or surgical accessories used with the Preci-sion™ IPG.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.This warranty is in lieu of any other warranty, expressed or implied, including any warranty of merchantability or fitness for intended use. Except as expressly provided by this Limited Warranty, Advanced Bionics® shall not be responsible or liable for any direct, consequential or incidental damages caused by device malfunction, failure or defect, whether the claim is based on warranty, contract, tort or otherwise.
Limited Warranty39ExternalsAdvanced Bionics® warrants to the patient that the Remote Control device, Model SC 5200, and Charger System (Charger, Model SC 5300, and/or Charger Base Station, Model SC 5305) are free from defects in workmanship and materials for a period of one (1) year from the date of purchase of a new Precision™ Patient Kit.A Remote Control device or Charger or Charger Base Station component that fails to function within normal tolerances within one (1) year from the date of surgery or purchase is covered under this Limited Warranty. The liability of Advanced Bionics® under this warranty shall be limited to: (a) replacement with a functionally equivalent component; or (b) full credit equal to the original purchase price to be applied towards the purchase of a replacement device. Product claims under Advanced Bionics® Limited Warranty are subject to the following conditions and limitations: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.3. The component failure must be confirmed by Advanced Bionics®. This warranty specifically excludes defects or malfunctions caused by: (a) fire, floods, lightning, natural disasters, water damage and other calamities commonly defined as “Acts of God”; (b) accident, misuse, abuse, negligence, or the customer’s failure to operate the system and its components in accordance
Patient System Handbook40with manufacturer’s instructions; (c) unauthorized attempts to repair, maintain, or modify the equipment by the customer or any unauthorized third party; or (d) attachment of any equipment not supplied by Advanced Bionics® without prior approval.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.This warranty is in lieu of any other warranty, expressed or implied, including any warranty of merchantability or fitness for intended use. Except as expressly provided by this Limited Warranty, Advanced Bionics® shall not be responsible or liable for any direct, consequential or incidental damages caused by device malfunction, failure or defect, whether the claim is based on warranty, contract, tort or otherwise.
CORPORATE HEADQUARTERSAdvanced Bionics®Corporation12740 San Fernando Road, Sylmar, CA 91342(800) 678-2575 in US and Canada(818) 362-7588, (818) 362-5069 Fax(800) 678-3575 TTYwww.advancedbionics.comEmail:info@advancedbionics.comPAIN MANAGEMENT DIVISIONAdvanced Bionics®CorporationMann Biomedical Park 25129 Rye Canyon Loop, Valencia, CA 91355(661) 362-1400, (661) 1500 FaxJUN03-080620-P ©2003 Advanced Bionics Corp. All rights reserved.9055072 Rev CIMAGINE the Possibilities®

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