Boston Scientific Neuromodulation SC-5100 SCS Implant System External Trial Stimulator User Manual SCS Dr Covers

Boston Scientific Neuromodulation Corporation SCS Implant System External Trial Stimulator SCS Dr Covers

physician implant manual

Physician Implant Manual9055100-001 Rev D
Physician Implant Manualii ©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.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 TrademarksBionicNavigator™ 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 ContentsiiiTable of ContentsIntroduction ............................................... 1Manual Overview ........................................................... 1Device Description .......................................................... 1Features ........................................................................ 1Indications for Use ........................................................... 2Patient Selection .............................................................. 2Contraindications ............................................................ 2Safety Instructions ...................................... 3Warnings ...................................................................... 3Precautions ....................................................................4Adverse Effects ...............................................................5Instructions for the Physician ............................................... 6Package Contents ........................................................... 7Patient Identification ......................................................... 7Sterilization .................................................................... 7Handling ....................................................................... 8Storage ......................................................................... 8Guidelines for Permanent Implantation ...... 9Percutaneous Lead/Extension Removal ................................9Option A. Temporary Lead Removal .............................9Option B. Extension Removal .......................................9IPG Implantation ...........................................................11Tool Assembly .............................................................. 12Tunneling The Lead ........................................................ 12Connecting To the IPG ...................................................16Dual Lead Connection .............................................. 16Single Lead Connection ............................................16
ivPhysician Implant ManualIPG Explant or Replacement ..................... 19Rechargable Implant System .................... 20IPG Battery Status ..........................................................20Charging Steps ............................................................21Patient Remote Control ............................. 24Basic Operation ...........................................................24Basic Programming ....................................................... 25Stimulation On/Off .................................................25Stimulation Amplitude ...............................................25Coverage Area Selection .......................................... 25Program Selection ...................................................25Options .................................................................26Physician Mode ............................................................27Entering Physician Mode .......................................... 27Device Links and Resets ..................................................28Change Link (same patient use only) ...........................28Change Patient .......................................................29Changing Links and Resets ........................................29Reading Lead Impedances ..............................................30Stimulation Set Up (Programming) .....................................30Electrode Configuration ............................................ 31Parameters ............................................................. 32Exiting Clinician’s Programming Screen .......................32Programmer Communication ........................................... 32Specifications and Technical Data ............. 33IPG (SC-1100) ............................................................. 33Registration Information .......................... 34Registering the Implant ................................................... 34
Table of ContentsvTechnical Service ...................................... 35Limited Warranty ..................................... 36
viPhysician Implant Manual
Introduction1IntroductionManual OverviewThis manual provides basic information for the implantation and operation of the Precision™ Implantable Pulse Generator (IPG), SC Model 1100. This information includes an overview of accessories for programming and powering the IPG, clinical and surgical consid-erations, storage and handling requirements, and relevant precautions concerning an implanted neurostimulator. Additional information on system components and operation can be found in the Precision Phy-sician Systems Handbook.Device DescriptionThe Advanced Bionics® Precision implantable pulse generator system is intended to treat chronic pain by electrically stimulating the spinal cord. The multi-channel, multi-electrode device capability provides flexibility in conjunction with ease of programming. A rechargeable battery increases IPG longevity and output capability while reducing size and device replacement surgeries. The implant is controlled by a handheld Remote Control, and can be engaged by a clinician com-puter using proprietary BionicNavigator™software. Periodically, the implant battery requires replenishing with an RF charging device pro-vided in the Patient Take Home Kit SC-6000.Features • Stimulation electrode field navigation• Sixteen independent current-controlled electrodes• Four programmable stimulation areas per program; four possible programs• Long-life operation• High-range parameter capability•Small size• Two-foot programming range
2Physician Implant ManualIndications for UseThe Precision is indicated for the management of chronic intractable pain of the trunk and limbs utilizing spinal cord stimulation. Patient SelectionThe therapy is generally most effective in patients who suffer neuro-pathic pain. Careful patient selection, therefore, is an important factor in achieving efficacious outcomes. It is recommended that patients be screened for psychological factors that could reduce the likelihood of therapeutic success. (Specific information regarding patient selection is included in the Physician Systems Handbook.) Most successful out-comes occur with the following:• Identifiable pathology• Pain of neuropathic origin• Psychological screening• Patient understanding of risks, benefits and limitations, and a commitment to a successful therapy• Successful externalized stimulation trial prior to accep-tance of permanent IPG implantationContraindicationsPatients contraindicated for permanent SCS therapy are those who:• do not meet psychological selection criteria• have failed trial stimulation• are poor surgical risks• are pregnant
Safety Instructions3Safety InstructionsWarningsPregnancy. The safety and/or effectiveness of neurostimulation dur-ing pregnancy has not been established.Diathermy. Shortwave, microwave and/or therapeutic ultrasound diathermy are categorically contraindicated for SCS patients. The energy generated by diathermy can be transferred through the stimu-lator system, causing tissue damage at the lead site and resulting in severe injury or death.Implanted Stimulation Devices. Spinal cord stimulators may interfere with the operation of implanted sensing stimulators such as pacemakers or cardioverter defibrillators. The effects of implanted stimulation devices on neurostimulators is unknown.Implant Damage. Burns may result if the pulse generator case is ruptured or pierced and patient tissue is exposed to battery chemicals. Do not implant the device if the case is damaged.Postural Changes. Patients should be advised that changes in pos-ture or abrupt movements may cause decreases, or uncomfortable or painful increases in the perceived stimulation level.Electromagnetic Interference. Strong electromagnetic fields can potentially turn the stimulator off, or cause uncomfortable or jolting stimulation. Patients should be counseled to avoid or exercise care around:• Theft detectors or security screeners• Power lines or power generators• Electric steel furnaces and arc welders• Large, magnetized stereo speakers
4Physician Implant ManualPrecautionsMRI. Patients implanted with the Precision SCS system should not be subjected to MRI. MRI exposure may result in dislodgement of implanted components, heating of the neurostimulator, damage to the device electronics and/or voltage induction through the leads and stimulator causing 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 defibrillation• radiation therapy• ultrasonic scanning• high-output ultrasoundIf any of the above is required by medical necessity, refer to “Instruc-tions for the Physician” on page 6. Ultimately, however, the device may require explantation as a result of damage to the device.Automobiles and Other Equipment. Patients should not operate automobiles, other motorized vehicles, or potentially dangerous machinery/equipment with therapeutic stimulation switched on. Stim-ulation must be turned off first. Sudden stimulation changes, if they occur, may distract patients from attentive operation of the vehicle or equipment.
Safety Instructions5Adverse 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 ran-dom 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.
6Physician Implant ManualInstructions for the PhysicianImplanted Stimulation Devices. If such implanted devices are indicated for the patient, careful screening is required to determine if safe results can be achieved before permanently implementing con-current electrical therapies.Postural Changes. Depending on the activity level of the patient, postural changes may affect stimulation intensity. Instruct patients to keep the Remote Control at hand at all times, and ensure that they understand how to adjust stimulation levels.Medical Devices/Therapies. If the patient is required to undergo lithotripsy, electrocautery, external defibrillation, radiation therapy, ultrasonic scanning, or high-output ultrasound:• Adjust stimulation to its lowest level before the proce-dure or application, then turn off IPG.• All equipment, including ground plates and paddles, must be used as far away from the IPG as possible.• Every effort should be taken to keep fields, including current, radiation, or high-output ultrasonic beams, away from the IPG.• Equipment should be set to the lowest energy setting clinically indicated.• Instruct patients to confirm IPG functionality following treatment by turning on the IPG and gradually increas-ing stimulation to the desired level.
Safety Instructions7Package Contents(1) Precision Pulse Generator(1) Hex Wrench(1) Tunneling Tool(1) Tunneling Tool Extension(1) IPG Pocket Template(1) Skin Marker(2) Connector Plugs(1) Device Registration Form(1) Temporary Patient Identification Card(1) ManualPatient IdentificationPlease ensure that the patient receives a completed temporary identifi-cation card following surgery. Permanent cards will be mailed directly to the patient following patient registration.Sterilization• Before implanting the IPG, inspect the condition of the sterilization indicator and the sterile package before opening the package and using the contents. Do not use the contents if the indicator lines are not red, if the pack-age is broken or torn, or if contamination is suspected because of a defective sterile package seal. • Do not resterilize the IPG. If resterilization is required, obtain a sterile device for implantation.• The IPG is for single use only. Do not reuse.
8Physician Implant ManualHandlingHandle the IPG and implanted accessories with care. • Keep sharp instruments away from the components. • Do not use the IPG if it has been dropped on a hard sur-face from a height of more than one foot.• Do not incinerate an IPG. Improper disposal of the device could result in an explosion. Devices should be explanted in the case of cremation, and returned to Advanced Bionics Corporation.Storage• Store the IPG between 0° C and 45° C (32° F and 113° F). Devices should always be kept in temperature regulated areas within the acceptable temperature range. IPG damage can occur at temperatures outside of this range.
Guidelines for Permanent Implantation9Guidelines for Permanent ImplantationThis section details the procedures for • tunneling the lead/extension as part of an IPG implant, and• connection of lead/extension to the IPG.The Tunneling Tool Assembly used in this procedure is provided with the Precision device as part of the IPG Kit. Percutaneous Lead/Extension RemovalBefore revising a trial system for chronic stimulation, the nonsterile portion of the lead or extension must be removed. The method chosen from the choices below will depend upon how the patient was pre-pared for the trial phase.Remove bandages and properly cleanse the exit site.Option A. Temporary Lead RemovalRemove the lead(s) completely and discard them.Option B. Extension Removal1. Open the midline incision to expose the lead and connector.
10Physician Implant Manual2. Cut the lead extension at the connector. 3. Pull the lead extension through the tunnel and away from body at the externalized site.4. Loosen the connector setscrew using the torque wrench provided. Disconnect and discard the connector.Note: Connect a new lead extension, if necessary, to reach the selected IPG site.
Guidelines for Permanent Implantation11IPG Implantation1. Ensure that the area surrounding the lead entry site is incised to a dimension that will accommodate the tunneling tool. Check that the lead is securely sutured with the suture sleeve. 2. Select and mark the intended IPG site several inches away from the previously externalized leads, and create an incision at the top of the implant site. (Common sites are the abdomen, upper but-tock, or subclavicular area.)3. Create a subcutaneous pocket no larger than the IPG outline at a depth less than 3/4 inch (2.0 cm) from the surface. Note: • Using the template will help guide the correct pocket sizing. It is important to keep the pocket small to reduce the chances of patient twiddling and IPG flipping afforded by larger pockets.•Implant charging frequency or time will increase with pocket depths greater than 3/4 inch (2.0 cm), and could become ineffective at greater depths.
12Physician Implant ManualTool AssemblyThe tunneling tool provided with the IPG includes a shaft extender to be used for up to two leads.1. Attach the handle to the tunneling tool shaft by turning the lock-ing mechanism clockwise.Note: For more length, attach the shaft extension to the handle, and then attach the carrier shaft.2. Thread the tip cover onto the tunneling tool and tighten by turn-ing clockwise. Tunneling The Lead 1. Mark the desired route of the tunnel.2. Administer the appropriate local anesthetic along the tunneling path.
Guidelines for Permanent Implantation13Note: Check that the tunneling tool tip is securely threaded onto the carrier.3. OPTIONAL. If necessary, bend the tool shaft to conform to the patient’s body. Do not bend locking joints. 4. Create a subcutaneous tunnel from the IPG site to the midline incision.Note: Deep tunneling is not recommended.
14Physician Implant Manual5. Once the tunneling tip is completely exposed at midline, press it toward the shaft and turn it counterclockwise to remove it for access to the carrier. Note: You may feel the tip slide back before the cover begins to unscrew.
Guidelines for Permanent Implantation156. Carefully position each lead or extension into the carrier shaft and press the lead/extension into the groove.Note: If necessary, swivel the carrier by pulling it away from the handle and turning it to get better access to the cavities. 7. Gently pull the tunneling tool back through the tunnel.
16Physician Implant Manual8. Gently lift the lead(s) out of the locking groove(s). 9. Wipe off any fluids from the proximal end of the lead(s). Connecting To the IPGDual Lead Connection• Superior (upper or left) leads connect to IPG port 1-L.• Inferior (lower or right) leads connect to IPG port 2-R. Single Lead Connection• Connect a single lead to IPG port 1-L.• Plug port 2-R with the connector plug supplied in the IPG Kit.
Guidelines for Permanent Implantation171. Fully insert the lead(s) into the IPG port(s). When the lead is properly inserted, the lead will stop and the retention ring will be located under the setscrew. 2. Pass the torque wrench through the slit in the septum located on the top of the IPG header and tighten both set screws, one at a time, until the torque wrench “clicks,” indicating lock.
18Physician Implant ManualNote: • If the connector plug is used in port 2-R, it is still necessary to tighten the setscrew as described. •The wrench is torque-limited and cannot be overtightened.•Ensure that the lead is fully inserted before tightening the setscrew to prevent lead damage.3. Place the IPG in the subcutaneous pocket with “This Side Up” facing anterior towards the skin.4. Coil excess lead or extension under the IPG.Note: To confirm good connections, check impedances.5. Secure the IPG in the pocket by suturing through the holes in the connector.6. Close and dress the wound(s).
IPG Explant or Replacement19IPG Explant or Replacement1. Turn off the IPG.2. Surgically open the IPG pocket and withdraw the device.3. Unscrew the connector setscrews to release the leads. 4. For replacement, connect the new IPG following steps 1-6 of “Connecting to the IPG,” preceding. Or, to terminate therapy, sur-gically remove the implanted lead system.
20Physician Implant ManualRechargable Implant SystemThe Precision spinal cord stimulator is rechargeable. Depending on stimulation power usage and programming, the majority of patients will need to recharge the implant once per week. High power users will require more frequent charging.The clinician programmer will estimate charging time based on 24 hours per day of stimulation at the programmed settings. Patients should be instructed to charge until the charger emits an end of charge beep signal.Estimated charge times for 1-4 stimulation areas set to stimulate at 40 pulses-per-second and 210 µs per area:*Beginning of LifeIPG Battery StatusThe patient Remote Control will display when the stimulator battery is low and when the stimulator battery is empty. If the IPG is not recharged before depletion, stimulation will automatically shut off 1 Area 2 Areas 4 AreasNominal PowerMedium PowerHigh PowerTotal Current < 4 mA 4-8 mA > 8 mAPer Week 1 hour 30 min. 4 hoursPer Day 15 min. 30 min. 1 hour
Rechargable Implant System21and the implant will need to be charged for approximately 2 hours before reactivation.Charging StepsThe Charger Base Station should be plugged in and the charger placed in the cradle until the indicator light is green. If the indicator is not green, the charger may not be able to fully charge the implant. Users may wear the charger over the implant using a Velcro® belt or adhesive patches. The patches are preferred to maintain proper align-ment throughout charging. 1. While the Charger is seated in the Base Station, check that the indicator light is green.2. Remove the Charger from the Base Station. (The indicator light will go out, regardless of the ready status.)
22Physician Implant Manual3. Apply the adhesive to the backside of the Charger by peeling the clear device side liner from the patch and applying the patch to the device, as shown, and then remove the skin side beige liner from the adhesive (only good for one fixation). ORPlace the Charger into the Velcro® belt with the power button facing out. 4. Press the power button, the large blue center of the Charger, to turn on the Charger. 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.
Rechargable Implant System235. Locate the Charger over the IPG. When the Charger is correctly aligned with the IPG, the beeping will stop. Press the Charger with the adhesive, or secure the Velcro® belt at this time.Note: • If the Charger loses contact with the IPG during charging, the steady alignment beep will sound. Readjust the belt or reapply the adhesive.6. When the Charger emits a distinct double beep, the implant is charged.
24Physician Implant ManualPatient Remote ControlBasic OperationThe Remote Control communicates with the implant through a radio frequency (RF) telemetry link from a distance of up to two feet. The Remote Control turns on automatically when any button is pressed. During normal patient use, the Remote Control will turn off automati-cally after 60 seconds of non-use. Button functions are identified above the buttons on the LCD screen. These function identifiers may change depending upon the actions being performed. Note: Electronic interference and poor orientation can result in a lack of communication that will be displayed as “No Response” on the device’s LCD screen. If this occurs, move the remote closer to the IPG and try the previous action again.
Patient Remote Control25Basic ProgrammingStimulation On/OffThe stimulation is turned on and off with a dedicated power switch on the Remote Control keypad. Simply press the stimulation power but-ton at any time to change the on/off state of the implant. Stimulation Amplitude Press the T or S button from the main screen to decrease or increase amplitude. Coverage Area SelectionPress the SEL 1 [SEL] button from the main screen to cycle to a spe-cific stimulation coverage area. Press the T or S button to adjust the amplitude of the selected area. Program SelectionPress the SEL 2 [NEXT] button to display the program screen. Press the SEL 1 [SEL] button to cycle through saved programs. Program selections can be either activated (press T) or saved (press S) from this screen.
26Physician Implant ManualOptions Press and hold the SEL 2 button for 3 seconds to access the Rate and (Pulse) Width parameters and the program restore function. Use the SEL 1 button to highlight the desired option, then press S [GO]. Note: Rate and Pulse Width are blocked from patient access by default, but may be made available using the Clinician’s Programmer.
Patient Remote Control27For Rate and Pulse Width: When the desired option screen is dis-played, first use the SEL 1 button to find the desired area, then use the T or S button to decrease or increase the parameter setting for that area. To restore a program: Press SEL 1 to highlight the desired program, then press SEL 2 [RESTR]. The restore function returns a program to the last clinic programmed settings.Physician ModePatient-restricted physician screens provide access to these advanced programming and interrogation functions:• Communication with the clinician programmer • Electrode and stimulation parameter programming • Electrode impedance monitoring • Remote Control and trial stimulator resetting/re-linkingEntering Physician Mode1. To access physicians screens, press SEL 1 and SEL 2 simulta-neously.2. The Remote Control will request a code. (To obtain the code, refer to the Physician Systems Handbook.) Use the S and T buttons to scroll through the characters, and the SEL 1 [SEL] but-ton to advance to the next entry. After entering the code, press SEL 2 [ENTER]. Once the code is entered, the screen will appear as shown.
28Physician Implant ManualDevice Links and ResetsA Remote Control can communicate with only one stimulator at a time. This prevents the remote device from accidentally controlling an unintended stimulator. To start a trial for a new patient, the remote settings and programs must be reset or cleared.Change Link (same patient use only) Change the link when the remote is intended for continued use by the same patient with a new stimulator. All programs set for the patient will be maintained and can be used with the new stimulator. Change the link when:• converting from a trial stimulator to a permanent IPG • replacing an IPG
Patient Remote Control29Change Patient When a Remote Control is to be used with a different patient than was previously using the remote, reset the system. This will clear all pre-viously stored programs and will allow you the option of resetting a trial stimulator when one is detected. Always reset the system when using a remote with a different patient, such as when:• Programming an IPG or trial stimulator of a new or dif-ferent patientChanging Links and Resets1. Access the physician mode and enter the code.2. When the screen displays “CLINIC OPTIONS PC READY” press S [RSET] to access the links and resets.3. Use SEL 1 to select “Link” or “Patient” from the following screen, and press S [RSET].
30Physician Implant ManualThe Remote Control will turn off after breaking the existing link and/or clearing the programs. Press any button to turn on the remote and re-establish the link. Reading Lead ImpedancesFrom the physician OPTIONS screen, press T [IMP] to check lead electrode impedances. It will take a few seconds to display the detected values. Note: Failed electrodes that are not currently assigned will not be displayed on the programming screen. Otherwise, failed anodes will be displayed H+. Failed cathodes will be displayed H-. You may wish to make note of problem contacts from this screen to serve as a programming reference.Stimulation Set Up (Programming)Note: When using the Remote Control for a new or different patient, be sure it has been reset. See “Change Patient” on page 29 for instructions.1. Enter the physician mode (see “Entering Physician Mode” on page 27) and press SEL 1 [CLIN] to access the programming screen. 2. The SEL 2 button toggles between the electrode configuration and the parameters.The screen displays the settings and configuration for one program-mable area at a time. Up to four independent areas can be configured for each of the four programs available with the IPG.When there are separately controlled areas of stimulation, thestimulation rates for the individual areas must be in descendingorder or be equal. This means that Area 1 must have a ratehigher than or equal to Area 2, and Area 2 must have a ratehigher than or equal to Area 3, and so forth. (Coverage areasare separate groups of electrodes, with independent
Patient Remote Control31programmable parameters, which are combined into aprogram to achieve optimal pain coverage.)Separately controlled areas within the same program cannotshare the same electrodes when the stimulation is monopolar,utilizing the IPG or external patch electrode as the anode.Electrode Configuration1. Electrodes are numbered 1-16 (8 per side), and displayed as shown in the figure below. Use the T (down) and S(up) buttons to cycle E1 through E16. 2. When the desired electrode number is reached, configure the polarity (+/ -/0) by pressing the SEL 1 button until the intended polarity is shown on the respective electrode.Note: When changing a configuration, the amplitude of the edited area will be reduced to 0.0 and stimulation to all other areas will be turned off.3. If you have changed a configuration, gradually increase the amplitude of the edited area to a comfortable level.4. To restore stimulation at previous levels to all other areas, briefly press the power button once, then press it a second time.
32Physician Implant ManualParameters1. Use the SEL 1 button to cycle through various parameters includ-ing amplitude, rate, and pulse width, and to program or view another area.2. Use the T (down) and S(up) buttons to adjust the selected parameter.Exiting Clinician’s Programming Screen1. Upon completion, press SEL 1 and SEL 2 simultaneously. This will advance to the PROGRAMS screen.2. Select the program number you wish to save to by pressing SEL 1. You can overwrite an existing program or save to an empty program slot (*) if one is available. 3. Press the up button (S) to save. You will return to the clinician Options screen.For more information on how to use the physician screen, see the Physician Systems Handbook.Programmer CommunicationThe clinician’s programmer can communicate with either an external trial stimulator or an IPG. In order to begin a programming session, the clinician programmer and the Remote Control infrared windows must be aligned. Arrange for the patient to be seated within two feet of the Remote Control to ensure a complete communication link from the program-mer to the stimulator. For instructions on how to use the clinician’s programmer with the BionicNavigator software to program the IPG and transfer programs to the Remote Control, see the Physician Systems Handbook.
Specifications and Technical Data33Specifications and Technical DataIPG (SC-1100)Parameter Range DefaultAreas (Channels) 4 —Amplitude 0 – 20 mA 0 mARate 0 – 1200 pps 40 ppsWidth 0 – 1000 µsec 210 µsecCycle 0 – 90 min OFFRamp ON 1 – 10 sec 2 secContacts 1 – 16; +, -, OFF 1 – 16: OFFMaterials SizeCase TitaniumHeader EpoxyStrain Relief SiliconeSize 55mm x 45mm x 11mm
34Physician Implant ManualRegistration InformationRegistering the ImplantIn accordance with international practice and regulatory legislation in some countries, a registration form is packed with each Advanced Bionics Corporation neurostimulator.The purpose of this form is to maintain traceability of all products and to secure warranty rights. It also allows the institution involved in the evaluation or replacement of a specific implanted lead, accessory or device to gain quick access to pertinent data from the manufacturer.Fill out the registration form included in the package contents. Return one copy to Advanced Bionics, keep one copy for patient records, and provide one copy to the patient and physician. Advanced Bionics Corporation25129 Rye Canyon LoopValencia, California 91355Attention: Customer Service Department
Technical Service35Technical ServiceAdvanced Bionics Corporation has highly trained service profession-als located worldwide to assist you. The Technical Service Depart-ment is available to provide technical consultation 24 hours a day.In North America, please call (866) 566-8913 to speak to a represen-tative.
36Physician Implant ManualLimited WarrantyAdvanced 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 War-ranty 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.4. 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 the 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.
Limited Warranty37a. This warranty does not include the leads, extensions or surgical accessories used with the Precision™ 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, consequen-tial or incidental damages caused by device malfunction, failure or defect, whether the claim is based on warranty, contract, tort or other-wise.
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.9055100 Rev DIMAGINE the Possibilities®

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