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 lead manual

Spinal Cord Stimulation SystemLINEAR™ Leadmodel SC2108Lead Extensionmodel SC3108
Physician Lead Manual9055095-001 Rev C
Physician Lead 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 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 TrademarksLinear™, 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 ContentsiiiTable of ContentsIntroduction ............................................... 1Manual Overview ...........................................................1Product Description ..........................................................1Lead ....................................................................... 1Lead Extension .......................................................... 2Indications for Use ...........................................................3Contraindications ............................................................ 4Safety Instructions ...................................... 5Warnings ......................................................................5Precautions ....................................................................5Adverse Effects ............................................................... 6Instructions for the Physician ...................... 8Package Contents ...................................... 9Lead Kit - Model SC 2108 ............................................... 9Lead Extension Kit - Model SC 3108 .................................. 9Sterilization and Handling ........................ 10Sterilization ..................................................................10Handling .....................................................................10Storage ....................................................................... 11Guidelines for Trial-phase Implantation .... 12Pre-op Instructions ..........................................................12Lead Placement ............................................................ 13Connecting the OR Cable Assembly .................................15Intraoperative Stimulation Testing ......................................18
ivPhysician’s Lead and Extension ManualOPTION A: Temporary Lead Trial .................................... 18OPTION B: Permanent Lead Trial ..................................... 20Removing the Needle .............................................. 20Anchoring the Lead ..................................................21Tunneling And Connecting Extension ........................... 22Connecting to the Trial Stimulator ............. 28Guidelines for Permanent Implantation .... 30Percutaneous Lead/Extension Removal ..............................30Option A. Temporary Lead Removal ...........................30Option B. Extension Removal ..................................... 31IPG Implantation ...................................... 32Tool Assembly .............................................................. 33Tunneling The Lead ........................................................33Connecting To the IPG ...................................................37Dual Lead Connection .............................................. 37Single Lead Connection ............................................37Specifications and Technical Data ............. 40Lead ........................................................................... 40Lead Extension .............................................................. 41Registration Information .......................... 42Technical Service ...................................... 43Limited Warranty ..................................... 44
Introduction1IntroductionManual OverviewThis 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 PrecisionTM Spinal Cord Stimu-lation (SCS) System to aid in the management of chronic intractable pain. Information on other system components and their operation can be found in the Physician Systems Handbook.General surgical guidelines are presented for temporary and perma-nent implantation of leads and extensions.Product DescriptionLeadThe lead functions as a component of the Precision system by deliver-ing electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation.Model SC 2108 has eight electrodes located near the distal end. Each electrode is 3 mm in length and is spaced 1 mm from the adjacent electrode. The lead body is made of medical grade polyurethane with a stiffer proximal end to aid insertion into the connector. To aid in intraoperative testing and positioning, a curved stylet is pre-inserted
2Physician Lead Manualinto the lead. The lead can be connected to either an extension or directly to an implantable pulse generator (IPG). Lead ExtensionLead 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
Introduction3a lead to externalize the lead for a trial phase or to extend a lead when a permanent IPG is implanted. Indications for UseThe Lead Model SC 2108, when used in conjunction with Advanced Bionics External Trial Stimulator Model SC 5100 or IPG Model SC 1100, is indicated for the management of chronic intractable pain of the trunk and limbs utilizing spinal cord stimulation. The therapy is generally most effective in patients who suffer neuropathic 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 outcomes occur with the fol-lowing:• Identifiable pathology • Pain of neuropathic origin
4Physician Lead Manual• 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 Instructions5Safety 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 which may result 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.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 speakersPrecautionsMRI. 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
6Physician Lead Manualdevice 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 8. Ultimately, however, the device may need to be explanted as a result of associated failure.Automobiles and Other Equipment. Patients should not operate automobiles, other motorized vehicles, or potentially dangerous machinery/equipment with therapeutic stimulation turned on. Stimu-lation must be turned off first. Sudden stimulation changes, if they occur, may distract patients from attentive operation of the vehicle or equipment.Adverse EffectsPotential risks are involved with any surgery. In addition to those typ-ically associated with surgery, possible risks of stimulation system implantation 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,
Safety Instructions7hardware 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.• Possible surgical procedural risks are: infection, cere-brospinal fluid (CSF) leakage and, although rare, epidu-ral 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.
8Physician Lead ManualInstructions for the PhysicianImplanted Stimulation Devices. If other 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.
Package Contents9Package ContentsLead Kit - Model SC 2108(1) Lead (1) Curved Stylet (pre-loaded in Lead)(1) Straight Stylet (2) Suture Sleeves (1) Insertion Needle(1) Lead Blank(1) OR Cable Assembly (2) Lead Position Labels—left and right (non-sterile)(1) Manual(1) Product Registration Form(1) Temporary Patient Identification CardLead Extension Kit - Model SC 3108(1) Lead Extension(1) Skin Marker(1) Hex Torque Wrench(1) Tunneling Tool Assembly(1) Manual(1) Product Registration Form(1) Temporary Patient Identification Card
10Physician Lead ManualSterilization and HandlingSterilizationThe Advanced Bionics Lead Model SC 2108 and Lead Extension Model SC 3108 and accessories (except for the Lead Position Labels) were sterilized with ethylene oxide prior to shipment. Red lines on the green tape located near the bottom of the inner tray cover indicates exposure to the sterilization process.Inspect the condition of the sterilization indicator and the sterile pack-age before opening the package and using the contents. Do not use the contents if the indicator lines are not red, if the package is broken or torn, or if contamination is suspected because of a defective sterile package seal. • Do not use any component that shows signs of damage.• Do not resterilize the package or the contents. Obtain a sterile package from Advanced Bionics.• Do not use if “Use Before” date is exceeded.Note: The lead, lead extension and accessories are intended for single use only.HandlingThe lead is designed to perform in the hostile environment of the human body. Care must be taken to avoid damaging the lead with sharp instruments or excessive force during surgery. The following guidelines will help to ensure the longevity of components:• Do not sharply bend or kink the lead or extension.• Do not tie suture(s) directly to the lead or extension body; use the provided suture sleeves.• Avoid forcing the lead into the epidural space by care-fully clearing a path using the lead blank.
Sterilization and Handling11• Avoid pulling an implanted lead taut; provide a stress relief loop at the insertion site to minimize tension on the lead.• Avoid handling the lead with sharp instruments; use only rubber-tipped forceps.• Take care when using sharp instruments such as hemo-stats or scalpels to prevent damaging the lead.• Wipe off any body fluids from the lead connector end before connecting it to any other component. Fluid con-tamination of these connections could compromise the integrity of the stimulation circuit.• Wipe off any body fluids from the stylet before inserting or reinserting it into the lead.StorageStore components between 5 °C and 40 °C (41 °F–104 °F) in an area where they are not exposed to liquids or excessive moisture. Temper-atures outside of the stated range can cause damage.
12Physician Lead ManualGuidelines for Trial-phase ImplantationThis section details the recommended procedures for trial-phase tem-porary implantation of the lead. Pre-op Instructions• Check that the sterile package is intact. (See “Steriliza-tion” on page 10.)• Ensure that a Trial Stimulator and Patient Trial Kit are available for use following lead placement. Install a new 6 volt battery (included in the Patient Trial Kit) in the Trial Stimulator.• Be sure the Trial Stimulator and Remote Control stimu-lation settings have been reset. Refer to the IPG manual for links and resets.• If monopolar testing is anticipated, place the monopolar/indifferent electrode (available separately) on the patient’s shoulder or leg and run the cable to the Trial Stimulator testing site before the patient is prepped and draped.
Guidelines for Trial-phase Implantation13Lead PlacementNote: Fluoroscopic evaluation of the lead position during this procedure will aid the physician in achieving an optimum pain coverage location, and is recommended.1. Position, prep and drape the patient in the usual accepted manner. Inject a local anesthetic at the needle insertion site.2. Insert the needle into the epidural space with the opening facing up using an angle of 45° or less. Use only the insertion needle provided in the Lead Kit. Otherneedles may damage the lead. The stamped number on theneedle hub corresponds to the orientation of the bevel,which must face up. Turning the bevel ventral (down) mayresult in lead damage. An angle of more than 45º increasesthe risk of lead damage.3. Remove the needle stylet and verify entry into the epidural space using the standard technique.
14Physician Lead Manual4. OPTIONAL. Under fluoroscopic guidance, insert the lead blank through the needle and into the epidural space. Advance the lead blank to the target location, then withdraw the blank.5. Slowly insert the lead, with stylet, through the needle (lead stylet should extend completely to the tip of the lead). 6. Advance the lead to the appropriate vertebral level using fluoro-scopic guidance. A sufficient length of lead (i.e., at least 10 cm, or approximately three vertebrae) aids in lead stabilization. To facilitate advancement and placement, the lead body may be rotated.
Guidelines for Trial-phase Implantation15Connecting the OR Cable Assembly The OR cable extension is designed for temporary connection to the OR cable to facilitate stimulation testing outside of the sterile field. After stimulation testing, the cable extension is typically removed and the OR cable is connected directly to the Trial Stimulator for use dur-ing the trial phase. Do not immerse the OR cable connector or plug in water orother liquids. The OR Cable Assembly is intended for one-time only use; do not resterilize.1. If two leads are being implanted, wrap the non-sterile 1-L and 2-R labels around the cables at the Trial Stimulator to identify lead connections.2. Verify that the Trial Stimulator is off.Always turn the Trial Stimulator off before connecting ordisconnecting the Cable Assemblies.3. Check that the locking lever on the OR cable connector is in the open position (0).4. Slide the proximal end of the lead, with stylet, into the open port on the OR cable connector.
16Physician Lead Manual5. Push the end of the lead into the port until it stops. Hold the lead in place while sliding the locking lever to the “1” (locked) posi-tion. Note: Once the lead is secured in the connector, the stylet can be manipulated in, but not removed from, the lead.
Guidelines for Trial-phase Implantation176. Plug the OR Cable Assembly into the Trial Stimulator socket(s) labeled 1-L (left) and 2-R (right). Superior (upper or left) leads connect to socket 1-L. Inferior (lower or right) leads connect to socket 2-R. If only a single lead is being used, connect it to 1-L.
18Physician Lead ManualIntraoperative Stimulation TestingNote: The following steps are for procedural reference only. Please refer to the Physician Systems Handbook for detailed stimulation testing procedures and guidelines.1. Test various electrode configurations to obtain paresthesia. Note: If lead repositioning is necessary, turn stimulation off before proceeding.2. When the desired paresthesia is achieved:• turn the Trial Stimulator off • unlock each OR cable connector and disconnect from the lead(s)• slowly withdraw the stylet(s) 3. Record the lead position by capturing a fluoroscopic image to be sure the leads have not moved. Retest if necessary. The image can also be used for a position comparison at closure to ensure that the leads did not move.OPTION A: Temporary Lead Trial1. Hold the lead distal to the needle hub to maintain lead position during needle removal.2. Carefully withdraw the insertion needle from the epidural space by slowly pulling the needle up towards the proximal end of the lead. 3. Continue to pull the needle back approximately one centimeter at a time until the needle tip is exposed.
Guidelines for Trial-phase Implantation194. Once the needle tip is exposed, hold the lead as close to the per-cutaneous exit site as possible, then carefully pull the needle completely from the lead.5. If desired, a small suture may be used to close the wound and sta-bilize the lead. Place and tape a stress relief loop and dress the wound.6. Continue with “Connecting to the Trial Stimulator” on page 28.
20Physician Lead ManualOPTION B: Permanent Lead TrialRemoving the Needle1. Cut down around the needle to access the supraspinous ligament.2. Hold the lead distal to the needle hub to maintain lead position during needle removal.3. Carefully withdraw the insertion needle from the epidural space by slowly pulling the needle up towards the proximal end of the lead.4. Continue to pull the needle back approximately one centimeter at a time until the needle tip is exposed.
Guidelines for Trial-phase Implantation215. Once the needle tip is exposed, hold the lead as close to the tip as possible, then carefully pull the needle completely from the lead.Anchoring the Lead1. Place a suture through the supraspinous ligament or deep fascial tissue.2. Slide a suture sleeve over the lead and down to the supraspinous ligament.3. Ligate the sleeve onto the lead by tying a 2-0 silk or other nonab-sorbable suture around the center groove of the sleeve to prevent sliding. Do not use polypropylene sutures as they may damage thesuture sleeve. Do not suture directly onto the lead or use ahemostat on the lead body. This may damage the leadinsulation.
22Physician Lead Manual4. Suture the sleeve to the supraspinous ligament or deep fascia through the suture sleeve holes.Tunneling And Connecting ExtensionA tunneling tool and straw are provided with the Lead Extension Kit to facilitate percutaneous tunneling of the lead or extension. • Attach the tunneling tool handle to the shaft by turning the locking mechanism clockwise.
Guidelines for Trial-phase Implantation231. Mark the desired route of the tunnel.2. Administer the appropriate local anesthetic along the tunneling path.3. Make a small incision at the desired exit site.
24Physician Lead Manual4. Create a subcutaneous tunnel from the exit site to the midline incision until the straw is visible and accessible at the exit point.5. Unscrew and remove the tool handle.
Guidelines for Trial-phase Implantation256. Grasp the tip of the tool with one hand while holding the straw in place with the other hand. Pull the tunneling tool shaft out through the straw.7. Push the lead or extension proximal ends through the straw, then withdraw the straw.8. Wipe clean the proximal end of the lead, then insert the proximal end into the extension connector until it stops and the last contact disappears.Note: If there appears to be an obstruction, use the torque wrench to loosen (counterclockwise) the setscrew and/or gently rotate the lead to help advance the proximal end.
26Physician Lead Manual9. Using the torque wrench supplied, turn the extension connector setscrew clockwise until it clicks, indicating lock.Note: • Ensure the wrench is fully seated in the setscrew before tightening.•The wrench is torque-limited and cannot be overtightened.10. Form an appropriately-sized pocket using blunt dissection on either side of midline for coiled excess lead and extension con-nectors.11. Place a small loop at the lead for slack. If necessary, loosely tie a suture around the lead-loop, but do not tighten onto the lead.
Guidelines for Trial-phase Implantation27Tightening sutures directly on the lead can damage the lead. 12. Carefully remove excess slack by gently pulling the extensions from the exit wound.13. Close the midline incision. 14. If desired, a small suture may be used to close the exit wound of the extension. Place and tape a stress relief loop and dress the wound.
28Physician Lead ManualConnecting to the Trial Stimulator1. Wipe fluids off the exposed lead connections.2. Disconnect and discard the excess OR cable extension, unless extra length is needed for trial use.3. Connect the OR cable(s) to the lead(s) or lead extensions: Slide the locking lever to “0,” fully insert the end of the extension into the port, slide the locking lever to “1.”4. Connect the cable labeled 1-L to the upper or left lead, and the cable labeled 2-R to the lower or right lead. Labels are provided.5. Connect the right and left-sided OR cables to the Trial Stimula-tor, referencing the position labels previously fixed to the cables.
Connecting to the Trial Stimulator296. Fit the Velcro® belt to the patient, cut off the excess length, and place the Trial Stimulator in the belt pocket.
30Physician Lead ManualGuidelines for Permanent ImplantationThis section details the procedures for • tunneling the lead/extension as part of an IPG implant• connection of lead/extension to the IPGThe 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 exposed 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 Removal1. Clip sutures if used to secure the trial lead(s) in place.2. Remove the lead(s) completely and discard.
Guidelines for Permanent Implantation31Option B. Extension Removal1. Open the midline incision to expose the lead and connector.2. 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 remove the connector.Note: Connect a new lead extension, if necessary, to reach the selected IPG site.
32Physician Lead ManualIPG 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 site.3. Create a subcutaneous pocket no larger than the IPG outline at a depth of up to 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.
IPG Implantation33Tool AssemblyThe tunneling tool provided with the IPG includes a shaft extender to be used for up to two leads (with or without extensions).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.
34Physician Lead ManualNote: 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.
IPG Implantation355. 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.
36Physician Lead Manual6. 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.
IPG Implantation378. 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 IPGBefore implanting the IPG, refer to the IPG Implant Manual.Dual 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.
38Physician Lead Manual1. 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.
IPG Implantation39Note: • 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).
40Physician Lead ManualSpecifications and Technical DataLead Part SpecificationsModel Number SC 2108Lead Lengths 30, 50, 70 cmLead Shape In-lineLead Diameter 1.3 mmNumber of Electrodes 8Electrode Length 3 mmElectrode Spacing 1 mmContact Material Platinum/IridiumInsulation Material PolyurethaneConductor Material MP35N Conductor Resistance < 7 Ohms
Specifications and Technical Data41Lead Extension Part SpecificationsModel Number SC 3108Extension Lengths 15, 25 cmExtension Diameter 1.3 mmNumber of Contacts 8Contact Material Platinum/Iridium, MP35N, Stainless SteelInsulation Material Polyurethane, SiliconeConductor Material MP35N Conductor Resistance < 10 Ohms
42Physician Lead ManualRegistration InformationIn accordance with international practice and regulatory legislation in some countries, a registration form is packed with each Advanced Bionics Corporation lead/lead extension.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 Service43Technical Service Advanced 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 representa-tive.
44Physician Lead ManualLimited WarrantyAdvanced Bionics® Corporation warrants to the patient that the Lin-ear Lead, Model SC 2108, and Extension, Model 3108, are free from defects in workmanship and materials for a period of one (1) year from the date of implantation.A Lead or Extension 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 Lead or Extension; or (b) full credit equal to the original purchase price to be applied towards the purchase of a new Lead or Extension. Product claims under Advanced Bionics® Limited Warranty are sub-ject 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 Lead or Extension 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 Lead or Extension must be implanted prior to the “use before” date.4. Failure of the Lead or Extension must be confirmed by Advanced Bionics®. This warranty specifically excludes defects or malfunc-tions 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 Lead or Extension in accordance with man-ufacturer's instructions; (c) unauthorized attempts to repair, main-tain, 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 Warranty45a. This warranty does not include surgical accessories used with the Linear Lead or Extension.5. The decision as to product replacement or credit shall be made solely at the discretion of Advanced Bionics®. For a replacement Lead or Extension, the warranty will run only to the end of the warranty period for the original Lead or Extension 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.9055095 Rev CIMAGINE the Possibilities®

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