MP9055184 Rev A Federal law restricts this device to sale, distribution and use by or on the order of a physician.
ii Velcro® is a registered mark of Velcro Industries, Manchester, New Hampshire. Other brands and their products are trademarks or registered trademarks of their respective holders and should be noted as such. Registered Trademarks Advanced Bionics Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity. Guarantees ©2004 by Advanced Bionics Corporation. All Rights Reserved.
Safety Information ............................................................7 3 4 System Description ...........................................................3 2 Buttons and Basic Operation ................................................ 27 Stimulation On and Off ........................................................ 30 The Level Screen .................................................................. 30 Stimulation Level Control .......................................................
iv 7 6 5 Saving Program Changes ..................................................... 37 Options ............................................................................... 40 Understanding Battery Status Messages ................................ 46 Battery Replacement ............................................................. 50 Index..................................................................................75 Glossary ....................................................................
Introduction Before receiving your new implant, you had the opportunity to test stimulation therapy and decide if it would work for you. By choosing to have a stimulator surgically implanted, you The Advanced Bionics® Precision™ SCS (Spinal Cord Stimulation) system is prescribed for the management of chronic pain. The system electrically stimulates the spinal cord to alter the perception of pain signals that move along the nerve pathways on either side of the spine.
2 Advanced Bionics is an organization dedicated to helping you manage your pain. We will help you make the most of this therapy for an improved quality of life. confirmed that paresthesia is capable of providing you with good to excellent pain relief. As you go forward with this therapy, your health professionals will work with you to find the most comfortable level of paresthesia to cover the painful areas by adjusting your implant’s settings.
System Description 3 The Remote Control, the heart of the Precision system, is a powerful yet easy to use tool for managing every aspect of your pain treatment—from controlling the level, or strength, of stimulation to accessing special treatment programs and program options. The Precision system includes both implanted and external components: During your surgery, one or more wires called leads were placed along your spinal cord where pain signals to the brain can be intercepted.
4 These subjects are covered on the following pages, and we encourage you to read this manual entirely. If you have any questions, or need clarification of anything contained in this manual, feel free to contact our Customer Service Department at (866) 360-4747. 3. how to recharge the implant. 2. how to use the Remote Control, and 1.
Remote Control Charger Charger Base Station Power Supply Remote Control Cover Velcro® Charging Belt Charger Adhesives (52 pieces) Remote Control Batteries (3) Carrying Case (1) (1) (1) (1) (1) (1) (1) (1) (1) Permanent Patient Identification Card Back Front Before reading more about the Precision System, first check that all of the following items were included in your Patient Kit.
6 For now, that’s all you need to do to get started. For more information on the Charging System and its use, see “Charging the Implant” on page 51. Find a convenient electrical outlet, one that won’t expose the Charging System parts to water or direct heat, and plug in the Base Station Power Supply. Next, connect the Power Supply to the Base Station, and locate the Base Station on a flat surface. Finally, place the Charger in the Base Station with the stimulation on/ off button facing up.
Safety Information Precision System Clinical Summary Determination of the safety and effectiveness of the PRECISION System was based on available published clinical studies for similar implanted spinal cord stimulation systems. The PRECISION System is similar to the SCS systems reported in published literature in intended use, target patient population, technology, device design, and output characteristics.
8 The prospective study by Ohnmeiss et al. 1996, examined the long-term 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 Efficacy Evaluation Three (3) clinical literature studies were used to support the effectiveness of the PRECISION System (Ohnmeiss et al.
9 The prospective study performed by Villavicencio et al. 2000 included 41 patients with pain of various etiologies. The majority of the patients, 24 (59%), had Failed Back Surgery Syndrome (FBSS), 7 (17%) had Complex Regional Pain Syndrome (CRPS I and II), 4 (10%) had neuropathic pain syndrome, and 6 (15%) were diagnosed as stroke or other. Patients underwent an initial trial period for SCS with temporary leads.
10 A retrospective analysis performed by Hassenbusch SJ et al. 1995 included patients with chronic lower body pain, predominately neuropathic pain and pain either midline lower back and/or unilateral or bilateral leg pain treated over a 5 year period. The study was a comparison of SCS to spinal infusion of opiods. For patients with radicular pain involving one leg with or without unilateral buttock pain, a trial of SCS was recommended first.
Safety Evaluation Eleven studies were identified based on the detailed inclusion/exclusion criteria to demonstrate the safety of the PRECISION System. The studies included a total of 1056 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.
12 # Patients With Adverse Event 175 39 0 0 1 0 5 Risks Lead Migration Infection Epidural Hemorrhage Seroma Hematoma Paralysis CSF Leak 0.5% 0% 0.1% 0% 0% 3.7% 16.6% Intent-toTreat Basis N = 1056 0.6% 0% 0.1% 0% 0% 4.4% 19.9% Implanted Patient Basis N = 880 Table 1: Summary of Risks Identified in the Retrospective Clinical Studies patients that were trialed with SCS systems and 880 patients that received implants.
0 16 6 0 35 22 0 2 45 Intermittent Stimulation Pain Over Implant Allergic Reaction Skin Erosion Lead Breakage Hardware Malfunction Loose Connection Battery Failure Other 4.3% 0.2% 0% 2.1% 3.3% 0% 0.6% 1.5% 0% 4.4% 5.1% 0.2% 0% 2.5% 4.0% 0% 0.7% 1.8% 0% 5.2% 13 Clinical Experience-Safety Clinical data has been collected during a clinical study of the PRECISION™ System.
1 1 1 1 Lead Migration Output malfunction Infection Pain Lead explanted Infection treated Device replaced Lead repositioning and subsequent replacement Resolution 14 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. “Prospective, Multicenter Study of Spinal Cord Stimulation for Relief of Chronic Back and Extremity Pain.” Spine, 21:2786-2793, 1996.
Segal, R., B. Stacey, T. Rudy, S. Basser, J. Markham. “Spinal Cord Stimulation Revisited.” Neurological Research, 20:391-396, 1998. 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. Ohnmeiss, D., R. Rashbaum, M. Bogdanffy. Prospective Outcome Evaluation of Spinal Cord Stimulation in Patients With Intractable Leg Pain. Spine, 21:1344-1351, 1996. 15 Lang, P.
are unable to operate the SCS system have failed trial stimulation by failing to receive effective pain relief are poor surgical risks are pregnant 16 Magnetic Resonance Imaging (MRI). You should not be exposed to Magnetic Resonance Imaging (MRI). Exposure to this diagnostic technology may result in dislodgement of your IPG or lead(s), heating of the IPG, severe damage to the IPG electronics and/or increased voltage through the leads or IPG which can cause an uncomfortable or “jolting” sensation.
Posture. 17 Changes in posture or abrupt movements may cause decreases, or uncomfortable or painful increases in the perceived stimulation level. Keep the Remote Control with you at 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. Cardiac Pacemakers.
18 • 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 you request assistance to bypass the device. If you must proceed through the device, turn off the stimulator and proceed with caution, and move through the center of the screener as quickly as possible.
• • • • lithotripsy — high-output sound or shock waves often used to treat gall stones and kidney stones electrocautery — the use of a heated electric probe to stop bleeding during surgery external defibrillation — the use of electrically charged paddles to restart the heart in an emergency radiation therapy — ionizing energy commonly used to treat cancer Medical Devices/Therapies.
20 Post Operative. During the two weeks following surgery, it is important to use extreme care so that appropriate healing will secure the implanted components and close the surgical incisions: Automobiles and Other Equipment. Do not operate an automobile, other motorized vehicle, or any potentially dangerous machinery/equipment with therapeutic stimulation switched on. Turn off stimulation first.
Lead Location. 21 In some instances a lead can move from its original location, and stimulation at the intended pain site can be lost. If this occurs, consult your physician who may able to restore stimulation by reprogramming the implant in the clinic or repositioning the lead during another operation. In some cases, the skin over your implant may become very thin over time. If this occurs, contact your physician. Implant Location. Never attempt to change the orientation or “flip” the implant.
22 in these devices can explode in fire. Dispose of used batteries in accordance with local Component Disposal. Do not dispose of the Remote Control or Charger in fire. The battery Handling. Handle the system components and accessories with care. Do not drop them or submerge them in water. Avoid all sources of water that can come into contact with the devices.
• • The lead(s) which deliver stimulation may move from their original implanted location, resulting in undesireable changes in stimulation and subsequent reduction in pain relief. System failure, which can occur at any time due to random failure(s) of the components or the battery. These events, which may include battery leakage, device failure, lead breakage, hardware malfunctions, loose connections, Adverse Effects Potential risks are involved with any surgery.
24 • • • • • electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control. Your body may react negatively to the materials used to manufacture the stimulator or the leads. You may notice redness, warmth or swelling of the implant area. The skin over your implant may become thin and increasingly tender over time. A seroma may be formed. The most common surgical procedural risks are temporary pain at the implant site and infection.
• • • • • 25 the implant programming, destroy the leads, or cause the leads to move from their intended location. Undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure. You may experience painful electrical stimulation of your chest wall as a result of stimulation of certain nerve roots several weeks after surgery. Over time, your implant may move from its original position.
26 Patient System Handbook
The Remote Control Buttons and Basic Operation To use most Remote Control functions, you will simply press a button as you would on a TV remote control. Other functions require a “long press,” which is described in “Selecting Options” on page 41. Each button on the Remote Control activates one or more of the stimulation functions which are described in detail on the following pages of this section.
28 When it is not being used, the Remote Control sets itself in a “sleep” or idle mode and the display screen is blank. When you press any button except E (stimulation on/off) during this sleep mode, the Remote Control will “wake up” and display the screen shown on the right. After you unlock the buttons by pressing D, the remote will immediately look for your implant and then connect with it, allowing you to make adjustments to your stimulation.
The Remote Control unit is your direct link to choices available for tailoring spinal cord stimulation to suit your comfort and convenience requirements. Keep the Remote Control with you at all times. Note: If there is a problem communicating with the implant, the message “No Response” will appear on the Remote Control screen. See “Help” on page 59 for more information. Good communication between your implant and the Remote Control is very important.
30 The Level Screen Whenever stimulation is turned on, or after the Remote Control is awakened from sleep/idle mode, the remote display defaults to the Level screen. When you press the S or T button from this display, you’re able to increase or decrease the stimulation strength, or level, of all of your pain areas at once (if your implant was programmed to treat more than one Stimulation On and Off The Remote Control uses a “dedicated” stimulation on/off switch.
The Level screen also displays a bar graphic in the upper right corner to indicate the battery charge level of your implant. The graphic is very easy to understand: Three filled-in bars means that your IPG has a fully-charged battery. As the battery strength wears down, depending on your stimulation settings and usage, the bars will “empty” accordingly.
32 • Multiple area control is available only if your system has been programmed to deliver stimulation to separate areas. If you do not have separate area control (for example, left leg vs. right leg) but feel that separate control might improve your therapy, contact your health professional to determine what is possible. Note: • Remember, the Level screen will remain on the display for approximately one minute if you don’t press a button to perform an action with the Remote Control.
The bar replacing the up arrow means that you have reached the maximum allowable level and can only decrease the stimulation setting. The bar replacing the down arrow means that you have reached the minimum level and can only increase the stimulation setting. Stimulation Level Control Occasionally, you may see one of the accompanying messages on the Remote Control screen while changing the stimulation level.
34 When you’ve finished making your change, the Remote Control will return to the Level screen. 2. When the named or numbered area that you want to adjust is shown on the screen, press S or T to change the stimulation level for that area. Note: Button presses will move from one area to the next and will eventually return you to the Level screen. 1. From the main Level screen, press the Cbutton as many times as necessary to cycle through your programmed area Level screens.
35 Programs A stimulation program may provide paresthesia to cover a single pain area, or up to four areas, depending on how the program was set up by your clinician. Your Remote Control can store up to four programs—numbered 1 through 4—for you to select and activate at any time. Often, the programs will have certain differences in the settings to allow you to vary your stimulation in several ways.
36 2. Press Duntil the program you want is highlighted, then press S to activate the program. Selecting and Activating Programs 1. Press the Dbutton from the Level screen to go to the Program screen. From the Program screen, each additional Dbutton press cycles you through the program numbers. The black highlight box shows where you are in the cycle. Pressing Dfrom program 4 returns you to the Level screen.
Saving Program Changes If you do make a stimulation level adjustment and decide that you prefer it to the original setting, you can save the new level (or any other change) and make it a permanent part of the program: Once you have selected and activated a program, the Remote Control will return to the Level screen. Use the S or T to adjust the stimulation level of the program, if you wish.
38 If you confirm the change (Yes, or D), the program will be updated and saved. If you decide not to make a permanent change, pressing Cwill return you to the Program screen. The Remote Control will first ask you to confirm that you want to “overwrite” the program; press the appropriate button. 3. With the active program selected, press T to save the change in the remote’s memory. 2.
39 You may also save a program change as a completely new program if an empty program slot (X) is available: Simply select the empty slot using D and press T. After saving the new program, the Remote Control will return to the Level screen.
40 If you’ve been told about program options and instructed in how to use them, you may realize that you probably won’t “exercise” your option settings very often. However, if your Remote Control has been set up to access options, please follow the steps detailed in “Selecting Options” on page 41 to make adjustments.
Rate, or how many times-per-second your implant sends a stimulation pulse, and Pulse Width, or how long each stimulation pulse lasts. 41 Selecting Options To access the options that may be available through your Remote Control, you will need to use a “long” button press. This simply means that you will press and hold a button until a Note: Restore is available to all patients. However, Rate and/or Pulse Width may not be available to you.
42 Note: The Remote Control will beep to notify you if you reach a preset limit while increasing or decreasing the Rate. 3. Press either S or T to increase or decrease the Rate. 2. To move to another area, press Cbriefly (a “normal” press) to cycle through your programmed areas until you find the Rate Area screen (2, 3 or 4) that you want. To Adjust Stimulation Rate: 1. From the Level screen, press and hold Cuntil you see the Rate Area 1 screen.
43 3. To move to another area, press Cbriefly (a “normal” press) to cycle through your programmed areas until you find the Pulse Width Area screen (2, 3 or 4) that you want. 2. If the Rate Area 1 screen is displayed, make another long Cbutton press to Pulse Width Area 1. If this is the area you want to adjust, press either S or T to increase or decrease the Pulse Width. Note: If you don’t have access to the Rate option, the long press will take you directly to the Pulse Width Area 1 screen.
44 To Restore a Clinic Program Over time, you may have made changes to one or more of the programs originally saved to your Remote Control. The Restore option allows you to return to those original stimulation settings if ever you become dissatisfied with a changed program. To return to the Level screen from any Pulse Width screen, press and hold C. • The Remote Control will beep to notify you if you reach a preset limit while increasing or decreasing the Pulse Width.
2. If necessary, press Dto cycle through the program numbers to select the program you want to restore. When the desired program is highlighted, press S. The Remote Control will briefly flash a message confirming the restoration. Note: The highlighted program is the current selection; an underline indicates the last program saved, activated, or restored; an X indicates an empty program slot. 1. From the Level screen, press and hold Dto reach the Restore screen. Program 1 will be highlighted.
46 If the implant battery is full or OK, the Remote Control will return to the Level screen. To learn about the messages you will see when the implant’s battery is less than full, see page 48. When the Remote Control batteries are at a low power level, the battery message shown here will be displayed. When you press the Dbutton from this screen, the remote will make a check of your implant’s battery status also.
Note: Make a habit of replacing the Remote Control batteries when you first see the Remote Battery Low message. See “Battery Replacement” on page 50. Next, you’d see the more urgent message shown opposite. You must respond immediately! When you press D, the remote will make another check of your implant battery and may display one of the messages shown on the following page.
48 If the implant battery is low, the Remote Control will display the message shown at right. Press Dto return to the Level screen. If the implant battery is very low, the remote will display this notice to recharge the stimulator battery immediately. Stimulation has most likely been turned off automatically. Pressing Dfrom this screen will prompt the message explained on the following page.
The Must Recharge message means that your implant has turned itself off and gone into a “hibernation” mode. You may expect a three--four hour charge period before you can resume your therapy.
50 The Remote Control will connect to the implant in approximately 30 seconds. 4. Align the battery compartment cover on the case and slide the cover into position until it snaps closed. 3. Place the three new AAA batteries in the slots, matching the positive (+) and negative (-) markings. 2. Remove the old batteries. Battery Replacement 1. On the rear of the remote, push in slightly and slide down the battery compartment cover.
Charging the Implant • • • once a day every other day once or twice a week. Based on your stimulation settings, you may charge: 51 The Remote Control provides an easy-view implant battery charge status graphic on the Level screen as well as messages to inform you of the battery’s condition. These messages are explained beginning on page 48. Your Precision implant uses a rechargeable battery to provide stimulation.
52 If discontinuing stimulation for an extended period of time, the implant should first be fully charged. Additionally, the implant should be fully charged every month if stimulation is not used. Note: If the implant is not recharged as recommended, stimulation will stop due to a low battery. If this happens, the implant must be recharged within three days from loss of stimulation.
Note: Advanced Bionics recommends the use of the Velcro® belt for charging. When charging, you can opt to use either a Velcro® belt or adhesive patches to hold the Charger over the implant. Before using the Velcro® belt, you may cut it to a more convenient size, but be careful not to cut too much. The patch adhesives are made of nonreactive material suitable for most sensitive skin types. 3. Place the Charger in the Base Station. 2.
Light Status: Green – ready for full charge Amber – partial charge Off – not ready for charging 54 Charging Your Implant 1. When the indicator light is green, remove the Charger from the Base Station. (The indicator will go off, regardless of the ready status of the Charger.) Indicator • • • The Charger is completely ready and able to fully charge your implant when the indicator light is green. If the light is amber-colored, the Charger can only partially charge the implant.
55 Place the Charger in the pocket with the power button facing out. Using the Velcro® Belt: 3. Press the power button. The indicator light will come on again, and the Charger will begin beeping steadily to signal that it is searching for the implant. Apply the adhesive patch to the backside of the Charger by peeling the clear liner from the patch. Remove the skin side beige liner. 2.
56 Note: If you accidentally locate the patch in the wrong place, or if the Velcro® belt moves out of alignment, the Charger will start beeping again. Use a new adhesive patch or readjust the belt to place the Charger back into position. Secure the Charger over the implant either by pressing the adhesive side of the patch to the location, or by attaching the Velcro® belt. 4. Locate the Charger over the implant. When the Charger is aligned with the implant, the beeping will stop.
Do not confuse the end of charge signal (a distinct double beep) with the steady, continuous misalignment signal. 5. When the Charger emits a distinct double beep, the implant is charged. Switch off the Charger, remove the adhesive patch or Velcro® belt, and return the Charger to the Base Station.
58 The rechargable implant battery should provide you with at least five years of service. Over time and with repeated charging, the battery in your implant will lose the ability to recover its full capacity. As a result, you may need to recharge your implant for longer periods and/ or more often after five years of service. Your implant will need replacement when stimulation can no longer be maintained with routine charging.
Help 3. Charge the implant. When the charge is complete, try turning the stimulation on. 2. Turn up the level of stimulation from the main screen or area screens. 1. Toggle the Remote Control stimulation on/off button to make sure that stimulation is ON. If the Remote Control receives confirmation from the implant, it will flash “Stimulation On.
60 3. Large magnetized speakers or large power lines that emit interference may also turn off stimulation. If you cannot turn the stimulator back on with your Remote Control, you may need to charge the implant. 2. Although unlikely, anti-theft screeners can turn stimulation off. If you cannot turn the stimulator back on with your Remote Control, you may need to charge the implant. 1. When the implant battery needs to be recharged, it will stop stimulating.
Stimulation has stopped if you see this message. You will probably need to recharge your implant for as long as 3–4 hours before stimulation resumes.
62 When the Remote Control displays “No Response,” there is a communication problem between the remote and the implant probably caused by a weak implant battery. Press the Dbutton. If the Remote Control is still not able to communicate with your implant, the “No Response” message will appear again; press D again.
Note: The remote will go to idle mode when D is pressed, or within fifteen seconds if D is not pressed. Please call our Customer Service Department at your earliest convenience to report the error code. If the Remote Control displays the error screen shown at right, try to make a note of the numbers (the error code) on the top line. Then press D, wait a few seconds, and try the action again. “Action Failed” on the Display Call our Customer Service Department at (866) 360-4747 if the problem continues.
64 Customer Service Phone: (866) 360-4747 Customer Service Fax: (661) 362-1503 Address: Advanced Bionics® Corporation Pain Management Division Mann Biomedical Park 25129 Rye Canyon Loop Valencia CA 91355 • • • Contacting Advanced Bionics If you have any other questions, or need to contact Advanced Bionics for any reason, you may do so in any of the following ways: Wash the belt with mild soap and warm water.
Limited Warranty 65 An IPG that fails to function within normal tolerances within (1) year from the date of surgery is covered under this Limited Warranty.
66 This warranty does not include the leads, extensions or surgical accessories used with the Precision™ IPG. 4. Failure of the IPG must be confirmed by Advanced Bionics®.
67 A Remote Control device or Charger or Charger Base Station component that fails to function within normal tolerances within one (1) year from the date of surgery or purchase is covered under this Limited Warranty.
68 3. The component failure must be confirmed by Advanced Bionics®.
69 This warranty is in lieu of any other warranty, expressed or implied, including any warranty of merchantability or fitness for intended use. Except as expressly provided by this Limited Warranty, Advanced Bionics® shall not be responsible or liable for any direct, consequential or incidental damages caused by device malfunction, failure or defect, whether the claim is based on warranty, contract, tort or otherwise. 4.
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CARDIAC PACEMAKER. A small implantable device used to control the rhythm of the heart. AREA. A location on the body such as right leg or left leg where stimulation will occur. AMPLITUDE. The measure-of-strength of delivered stimulation. (See Level.). ADVERSE EFFECT. Undesirable result. ADHESIVE PATCH. Non-reactive skin patch designed to temporarily attach the Charger to the skin over the IPG site. C Area Button icon. This figure respresents the area button on the Remote Control.
72 IMPLANT. Small implantable electrical pulse generator used to control stimulation. IDLE MODE. A time-out period when the Remote Control is not being used. Also known as sleep mode. ELECTROMAGNETIC INTERFERENCE (EMI). Electromagnetic signals that interfere with a variety of electrical signals including spinal cord stimulation. ELECTRICAL STIMULATION.The energy created by a pulse generator. ELECTRICAL PULSE GENERATOR.
PERMANENT IMPLANT. A stimulator system, pulse generator and leads, 73 RATE. The number of times–per-second (speed) at which stimulation pulses are delivered to the spinal cord. An option setting available from the Remote Control. PATIENT IDENTIFICATION CARD. A wallet size card that lists the patient and physician names, and IPG model and serial number. PROGRAM. Combination of one or more stimulation areas. D Program Button icon. This symbol represents the Program button on the remote control.
74 STIMULATION. When used as a therapy for pain, an artificially applied, low-level, pulsating electrical "shock" felt as a tingling or pulsating sensation in the area of pain and perceived enough to reduce the awareness of pain. SPINAL CORD STIMULATION (SCS). A method of applying electrical pulses to the spinal cord to block/mask pain signals to the brain. SLEEP MODE. A time-out period when the Remote Control is not being used. Also known as idle mode. SAVE.
diathermy ..................................... 17, 71 D control buttons ................................... 71 charge signal ...................................... 58 charge indicator ............................ 54, 55 C battery .......................................... 23, 62 B area ............................................... 71, 74 amplitude ............................... 71, 72, 73 Adhesive Patch ............................ 55, 71 A Index program ....................................
76 SAVE .................................................
77 Changes of modifications to this product not authorized by Advanced Bionics Corporation could void the FCC Certification and negate your authority to operate this product. The Precision™ System components should only be serviced by Advanced Bionics. Do not attempt to open or repair any of the components. Unauthorized opening of or attempts to repair the components will void the warranty. This device complies with part 15 of the FCC Rules.
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