Physician Implant Manual DRAFT CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician.
Physician Implant Manual Copyright ©2004 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.
Table of Contents Table of Contents Introduction ............................................... 1 Manual Overview ........................................................... 1 Device Description .......................................................... 1 Features ........................................................................ 1 Indications for Use ........................................................... 2 Precision System Clinical Summary .....................................
Physician Implant Manual IPG Implantation ........................................................... 20 Tool Assembly .............................................................. 21 Tunneling The Lead ........................................................ 21 Connecting To the IPG ................................................... 25 Dual Lead Connection .............................................. 25 Single Lead Connection ............................................
Table of Contents Maximum Current Amplitude per Electrode versus Impedance .................................... 49 Registration Information .......................... 50 Registering the Implant ................................................... 50 Technical Service ...................................... 51 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), Model SC-1110. 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 Advanced Bionics PRECISION™ Spinal Cord Stimulator System (PRECISION™ System) is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.
Introduction for the same disease/conditions and patient population as the PRECISION System. The prospective study by Ohnmeiss et al. 1996, examined the longterm effectiveness of SCS in patients with intractable leg pain. Forty patients were implanted with SCS systems and evaluated at 6 weeks, 12 months, and 24 months follow-up. Outcome measures included the VAS, pain drawings, medication use, SIP (Sickness Impact Profile), isometric lower extremity testing, and patient questionnaires.
Physician Implant Manual in pain. Since the majority of the patients were treated for FBSS, this article supports the use of SCS for the treatment of FBSS. In this study, one patient required a revision because of electrode fracture. One patient required removal of the system due to local infection. One patient required replacement of the IPG due to mechanical failure. Overall, 16 of 27 (59%) patients required a total of 36 repositioning procedures.
Introduction opioids. Mean follow-up was 2.1 + 0.3 years. This analysis supports the use of SCS for intractable low back and leg pain. In this study, 7 (17%) patients suffered complications after implantation of the device; 5 (12%) patients required repositioning of catheter type electrodes and 2 patients required revision of the stimulator generator. Safety Evaluation Eleven studies were identified based on the detailed inclusion/exclusion criteria to demonstrate the safety of the PRECISION System.
Physician Implant Manual Over/Under Stimulation, Ineffective Pain Control 46 4.4% 5.2% Intermittent Stimulation 0 0% 0% Pain Over Implant 16 1.5% 1.8% Allergic Reaction 6 0.6% 0.7% Skin Erosion 0 0% 0% Lead Breakage 35 3.3% 4.0% Hardware Malfunction 22 2.1% 2.5% Loose Connection 0 0% 0% Battery Failure 2 0.2% 0.2% Other 45 4.3% 5.1% Clinical Experience-Safety Clinical data has been collected during a clinical study of the PRECISION™ System.
Introduction Infection 1 Infection treated Pain 1 Lead explanted Other minor adverse events reported by at least one patient included: receiver malfunction, skin irritation, unpleasant stimulation, CSF leak, infection at implant site, lead migration, and OR cable malfunction. Two of the subjects reported multiple events. References Burchiel, K.J., V.C. Anderson, F.D. Brown, R.G. Fessler, W.A. Friedman, S. Pelofsky, R.L. Weiner, J. Oakley,and D. Shatin.
Physician Implant Manual Lang, P. “The Treatment of Chronic Pain by Epidural Spinal Cord Stimulation.” AXON, 18(4): 71-73, 1997. Ohnmeiss, D., R. Rashbaum, M. Bogdanffy. Prospective Outcome Evaluation of Spinal Cord Stimulation in Patients With Intractable Leg Pain. Spine, 21:1344-1351, 1996. Rainov, N.G., V. Heidecke, and W. Burkert. “Short Test-Period Spinal Cord Stimulation for Failed Back Surgery Syndrome.” Minim Invasive Neurosurg, 39(2):41-44, 1996. Segal, R., B. Stacey, T. Rudy, S. Basser, J.
Safety Information Safety Information Warnings Magnetic Resonance Imaging (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. Pediatric Use.
Physician Implant Manual 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 such as those used at entrances/exits of department stores, libraries, and other public establishments, and/or airport security screening devices. It is recommended that patients request assistance to bypass the device.
Safety Information Automobiles and Other Equipment. Patients should not operate automobiles, other motorized vehicles, or potentially dangerous machinery/equipment with therapeutic stimulation switched on. Stimulation must be turned off first. Sudden stimulation changes, if they occur, may distract patients from attentive operation of the vehicle or equipment. Cell Phones. While we don’t anticipate any interference with cell phones, the full effects of interaction with cell phones are unknown at this time.
Physician Implant Manual 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.
Safety Information 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 14 • Over time, the implant may move from its original position. • Weakness, clumsiness, numbness or pain below the level of implantation. • Persistent pain at the IPG or lead site.
Safety Information 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.
Physician Implant Manual 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. 16 • 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.
Safety Information 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 • Store the IPG between 0° C and 45° C (32° F and 113° F).
Physician Implant Manual 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 18
Patient Identification 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 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.
Guidelines for Permanent Implantation 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.
Physician Implant Manual 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.
Guidelines for Permanent Implantation 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.
Physician Implant Manual 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. CAUTION: Do not bend locking joints. 4. Create a subcutaneous tunnel from the IPG site to the midline incision. Note: Deep tunneling is not recommended.
Guidelines for Permanent Implantation 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.
Physician Implant Manual 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. 26 Gently pull the tunneling tool back through the tunnel.
Guidelines for Permanent Implantation 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 • Connect a single lead to IPG port 1-L. • Plug port 2-R with the connector plug supplied in the IPG Kit.
Physician Implant Manual 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.
Guidelines for Permanent Implantation CAUTION: Ensure that the lead is fully inserted before tightening the setscrew to prevent lead damage. 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.
Physician Implant Manual 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 and remove 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.
Rechargable Implant System 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. Advanced Bionics recommends any recharge schedule (daily, bi-daily, weekly, bi-weekly) that fits the patient’s schedule and lifestyle while maintaining sufficient charge to maintain stimulation.
Physician Implant Manual hours, and the implant will need to be charged for approximately two hours before reactivation. If the patient reports that stimulation has stopped but does not also report having seen the Remote Control warning messages “Recharge Stimulator Now” and “Must Recharge,” instruct the patient to check the implant battery status with the Remote Control first.
Rechargable Implant System 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 of the Charger.) Note: If the implant is not recharged as recommended, stimulation will eventually stop due to a low battery. If this happens, the implant must be recharged within three days from loss of stimulation.
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. 34 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. When it is not being used, the remote is in an idle (or sleep) mode from which it can be reactivated by any button press. During normal patient use, the device will transition to idle mode automatically after 60 seconds of non-use.
Patient Remote Control Stimulation On/Off Stimulation is turned on and off via a dedicated power switch on the Remote Control keypad. Simply press the stimulation on/off button at any time to change the stimulation status of the implant. Stimulation Amplitude The Level screen is the Remote Control’s “default” screen. The remote will automatically return to this screen within 15 seconds of any button activity.
Physician Implant Manual Coverage Area Selection 1. Press the Cbutton as needed from the Level screen to cycle to a specific stimulation coverage area. 2. Press the S or T button to adjust the amplitude of the selected area. Program Selection Note: The most recently retrieved or saved program will be underlined. Empty program slots are denoted by an X. 1. Press the Dbutton as needed from the Level screen to cycle to a specific saved program. 2. Press S to activate the selected program.
Patient Remote Control 2. Press S to activate the selected program. 3. After the remote times out to the Level screen, you may change the amplitude of all areas in the program, or you may adjust the Rate or Pulse Width of an individual area by navigating to the Options settings (see “Options” on page 40). 4. To save/store changes, select the program again and press T. You will be required to confirm the adjustment first. 5. Press tion.
Physician Implant Manual Note: To save the modifications as a new program, simply select an empty (X) program slot and press Tinstead of overwriting the existing program. Options With the Precision SCS system, the Rate and Pulse Width parameters are generally considered programming “options” in that relatively few patients will actually use these settings. By default, Rate and Pulse Width are off-limits to the patient Remote Control unless you allow access using BionicNavigator software.
Patient Remote Control 3. When the desired area screen is displayed, press S or T to increase or decrease the Rate. 4. To continue with a Pulse Width adjustment, press and hold the Area button from any Rate Area screen to navigate to Pulse Width Area 1. 5. As necessary, press the Cbutton normally to cycle to the area you wish to adjust. 6. When the desired area screen is displayed, press S or T to increase or decrease the Pulse Width. To Access the Restore Option 1.
Physician Implant Manual stimulator for communication.The second step in establishing the link depends on: • Whether the stimulator is an External Trial Stimulator (ETS) or an IPG; • Whether the Remote Control or the stimulator has stored programs or whether they are clear of programs; • Where a different program set is present in both devices, which set is to be cleared.
Patient Remote Control 1. Press Dto initiate communication between the remote and the stimulator within telemetry range. The remote will identify the device by ID number. 2. Press Dto confirm and continue. The Precision system software will automatically detect whether the stimulator is a trial or a permanent device, and whether program sets are available and where.
Physician Implant Manual to the desired device (remote or stimulator). You may also need to enter the clinician’s password. If an error occurs during the process or if the password is incorrect linking will be aborted. For further information, including information about the clinician’s password, see “To Clear Link” following.
Patient Remote Control To Clear Link When the Dbutton is pressed from the Enter Clinician Options screen, you will immediately be required to enter the clinician’s password in order to continue. To enter the password: The first character is highlighted when the Enter Password screen opens. To select/confirm any character and/or move to the next character position, press D. To scroll through possible characters, use S or T.
Physician Implant Manual When clearing a link: If the password is entered correctly, the link between the Remote Control and the “previous” stimulator is broken immediately , and the remote displays the Not Linked screen. The Remote Control’s programs remain intact. If the password is entered incorrectly, the process is aborted and the remote will return to the Enter Clinician Options screen.
Patient Remote Control 2. Place the remote and the IR dongle in the IR Holder with their communication ports facing. 3. Plug the dongle’s USB connector into the slot in the CP and power-on the programmer. 4. Launch the BionicNavigator software and wait for the IR Communication Established display. For Impedances When S is selected from the Enter Clinician Options screen, the Remote Control will take the measurements via telemetry; this will take a few seconds.
Physician Implant Manual Eventually, the remote will display the Electrode Impedance Status screen. Electrodes 1 through 8 (lead position 1-L) are represented by the rectangles in the top row; electrodes 9 through 16 (lead position 2-R) are represented by the rectangles in the bottom row. Electrodes within the acceptable impedance range are displayed as solid rectangles; high impedance electrodes (above 4500 ohms) are represented by hollow rectangles.
Patient Remote Control • Whenever the remote is re-activated from idle mode the display will default to the Level screen. Programmer Communication The Clinician Programmer can communicate with either an External Trial Stimulator or an IPG. In order to begin a programming session, the CP and the Remote Control IR 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 programmer to the stimulator.
Physician Implant Manual Specifications and Technical Data Parameter Range Default Areas (Channels) 4 — Amplitude 0 – 20 mAa 0 mA Rate 0 – 1200 ppsb 40 pps Width 0 – 1000 µsec 210 µsec Cycle 0 – 90 min, OFF OFF Ramp ON 1 – 10 secs 3 secs Contacts 1 – 16; +, -, OFF 1 – 16: OFF a.The Precision System includes programmable coverage areas with each individual electrode contact limited to 12.7 mA.
Maximum Current Amplitude per Electrode versus Impedance Maximum Current Amplitude per Electrode versus Impedance 51
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 1110, 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.
Physician Implant Manual The following is federal government communications regulation information about the Precision™ System. 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 only be serviced by Advanced Bionics.
