Physician Implant Manual 9055100-001 Rev D
Physician Implant Manual 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.
Table of Contents Table of Contents Introduction ............................................... 1 Manual Overview ........................................................... 1 Device Description .......................................................... 1 Features ........................................................................ 1 Indications for Use ........................................................... 2 Patient Selection ..............................................................
Physician Implant Manual IPG Explant or Replacement ..................... 19 Rechargable Implant System .................... 20 IPG Battery Status .......................................................... 20 Charging Steps ............................................................ 21 Patient Remote Control ............................. 24 Basic Operation ........................................................... 24 Basic Programming .......................................................
Table of Contents Technical Service ...................................... 35 Limited Warranty .....................................
Physician Implant Manual vi
Introduction Introduction Manual Overview This 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 considerations, storage and handling requirements, and relevant precautions concerning an implanted neurostimulator.
Physician Implant Manual Indications for Use The Precision is indicated for the management of chronic intractable pain of the trunk and limbs utilizing spinal cord stimulation. Patient Selection 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.
Safety Instructions Safety Instructions Warnings Pregnancy. The safety and/or effectiveness of neurostimulation during 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 stimulator system, causing tissue damage at the lead site and resulting in severe injury or death. Implanted Stimulation Devices.
Physician Implant Manual Precautions MRI. 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.
Safety Instructions Adverse Effects Potential risks are involved with any surgery. The possible risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation include: • Lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief. • System failure, which can occur at any time due to random failure(s) of the components or the battery.
Physician Implant Manual Instructions for the Physician Implanted 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 concurrent electrical therapies. Postural Changes. Depending on the activity level of the patient, postural changes may affect stimulation intensity.
Safety Instructions Package 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) Manual Patient Identification Please ensure that the patient receives a completed temporary identification card following surgery. Permanent cards will be mailed directly to the patient following patient registration.
Physician Implant Manual Handling Handle 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 surface 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 • 8 Store the IPG between 0° C and 45° C (32° F and 113° F).
Guidelines for Permanent Implantation Guidelines for Permanent Implantation This 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 Removal Before revising a trial system for chronic stimulation, the nonsterile portion of the lead or extension must be removed.
Physician Implant Manual 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 discard the connector. Note: Connect a new lead extension, if necessary, to reach the selected IPG site.
Guidelines for Permanent Implantation IPG Implantation 1. 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 buttock, or subclavicular area.) 3.
Physician Implant Manual Tool Assembly The 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 locking 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 turning clockwise. Tunneling The Lead 1. Mark the desired route of the tunnel. 2.
Guidelines for Permanent Implantation Note: 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.
Physician Implant Manual 5. 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 Implantation 6. 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.
Physician Implant Manual 8. 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 IPG 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 16 • 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 Implantation 1. 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.
Physician Implant Manual Note: • 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.
IPG Explant or Replacement IPG Explant or Replacement 1. 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, surgically remove the implanted lead system.
Physician Implant Manual Rechargable Implant System The 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.
Rechargable Implant System and the implant will need to be charged for approximately 2 hours before reactivation. Charging Steps The 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 alignment throughout charging. 1.
Physician Implant Manual 3. 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). OR Place the Charger into the Velcro® belt with the power button facing out. 4. 22 Press the power button, the large blue center of the Charger, to turn on the Charger.
Rechargable Implant System 5. 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.
Physician Implant Manual Patient Remote Control Basic Operation The 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 automatically after 60 seconds of non-use. Button functions are identified above the buttons on the LCD screen.
Patient Remote Control Basic Programming Stimulation On/Off The stimulation is turned on and off with a dedicated power switch on the Remote Control keypad. Simply press the stimulation power button 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 Selection Press the SEL 1 [SEL] button from the main screen to cycle to a specific stimulation coverage area.
Physician Implant Manual Options 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 Control For Rate and Pulse Width: When the desired option screen is displayed, 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 Implant Manual Device Links and Resets A 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.
Patient Remote Control Change 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 previously 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 different patient Changing Links and Resets 1.
Physician Implant Manual The 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 Impedances From 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+.
Patient Remote Control programmable parameters, which are combined into a program to achieve optimal pain coverage.) Separately controlled areas within the same program cannot share the same electrodes when the stimulation is monopolar, utilizing the IPG or external patch electrode as the anode. Electrode Configuration 1. 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.
Physician Implant Manual Parameters 1. Use the SEL 1 button to cycle through various parameters including 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 Screen 1. 2. Upon completion, press SEL 1 and SEL 2 simultaneously. This will advance to the PROGRAMS screen. Select the program number you wish to save to by pressing SEL 1.
Specifications and Technical Data Specifications and Technical Data IPG (SC-1100) Parameter Range Default Areas (Channels) 4 — Amplitude 0 – 20 mA 0 mA Rate 0 – 1200 pps 40 pps Width 0 – 1000 µsec 210 µsec Cycle 0 – 90 min OFF Ramp ON 1 – 10 sec 2 sec Contacts 1 – 16; +, -, OFF 1 – 16: OFF Materials Size Case Titanium Header Epoxy Strain Relief Silicone Size 55mm x 45mm x 11mm 33
Physician Implant Manual Registration Information Registering the Implant In 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.
Technical Service Technical Service Advanced Bionics Corporation has highly trained service professionals located worldwide to assist you. The Technical Service Department is available to provide technical consultation 24 hours a day. In North America, please call (866) 566-8913 to speak to a representative.
Physician Implant Manual Limited Warranty Advanced 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.
Limited Warranty a. 5. This warranty does not include the leads, extensions or surgical accessories used with the Precision™ IPG. 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.
IMAGINE the Possibilities ® CORPORATE HEADQUARTERS Advanced Bionics® Corporation 12740 San Fernando Road, Sylmar, CA 91342 (800) 678-2575 in US and Canada (818) 362-7588, (818) 362-5069 Fax (800) 678-3575 TTY www.advancedbionics.com Email:info@advancedbionics.com PAIN MANAGEMENT DIVISION Advanced Bionics® Corporation Mann Biomedical Park 25129 Rye Canyon Loop, Valencia, CA 91355 (661) 362-1400, (661) 1500 Fax JUN03-080620-P 9055100 Rev D ©2003 Advanced Bionics Corp. All rights reserved.