Patient System Handbook CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician. Part No.
Patient System Handbook Copyright ©2006 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 1 Introduction .......................................................................1 2 System Description ...........................................................3 3 Safety Information ............................................................7 Indications for Use ................................................................. 7 Precision System Clinical Summary .......................................... 7 Contraindications .....................................
Patient System Handbook Programs ............................................................................. 39 Selecting and Activating Programs ........................................ 40 Saving Program Changes ..................................................... 42 Options ............................................................................... 45 Understanding Battery Messages .......................................... 51 5 Charging the Stimulator ............................................
1 Introduction The Advanced Bionics PrecisionTM 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. Paresthesia is the term that describes the light, tingling sensation—the “feeling”—of spinal cord stimulation.
Patient System Handbook confirmed that paresthesia is capable of providing you with good to excellent pain relief. As you go forward with this therapy, your healthcare professionals will work with you to find the most comfortable level of paresthesia to cover the painful areas by adjusting your Stimulator’s settings. Although you may have pain areas that cannot be reached by spinal cord stimulation, the goal is to bring you the most effective pain relief possible.
2 System Description 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. The lead was then attached to an implantable pulse generator (IPG or Stimulator), also referred to as an implant, or Stimulator. The Stimulator is commonly placed in the abdomen, upper buttock, or subclavicular area.
Patient System Handbook To make the most of your Precision system, it is important to learn: 1. what to be aware of for safety, 2. how to use the Remote Control, and 3. how to recharge the Stimulator. 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.
System Description Before reading more about the Precision System, first check that you have received all of the following items. (And check to be sure you have your Temporary Patient Identification Card; keep it with you until you receive your permanent card.) If any item is missing, please call our Customer Service department for a replacement.
Patient System Handbook Find a convenient electrical outlet, one that will not 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. For now, that is all you need to do to get started.
3 Safety Information Indications for Use The Advanced Bionics PrecisionTM 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.
Patient System Handbook the treatment 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 and leg pain. Efficacy Evaluation Three (3) clinical literature studies were used to support the effectiveness of the PRECISION System (Ohnmeiss et al. 1996, Villavincencio et al. 2000, Hassenbach SJ et al. 1995). The studies included a total of 116 patients that were implanted with an SCS system.
Safety Information included the VAS, pain drawings, medication use, SIP (Sickness Impact Profile), isometric lower extremity testing, and patient questionnaires. An intent-to-treat analysis was performed. After patients had SCS for 24 months, leg pain, pain when walking, standing pain, pain’s effect on overall lifestyle, and the total analog scale scores were significantly improved from baseline. In this study, 25% of the implanted patients had greater than 50% improvement in pain rating.
Patient System Handbook implanted with a SCS system. In this study, 27/41 patients, 66%, had permanent implants. All patients were examined after 6 weeks. Pain measurements were assessed at 3-6 month intervals for the first year and annually thereafter. The median long-term follow-up was 34 months. A total of 24/27 (89%), reported greater than 50% reduction in pain. Since the majority of the patients were treated for FBSS, this article supports the use of SCS for the treatment of FBSS.
Safety Information internalized. A retrospective analysis of patients with unilateral leg and/or buttock pain treated initially with SCS and bilateral leg or mainly low back pain treated initially with spinal infusions of opioids was then done. In this study, 42 patients were screened; 26 (62%) patients received spinal stimulation; 16 (38%) received opioids via a spinal infusion pump.
Patient System Handbook 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 patients that were trialed with SCS systems and 880 patients that received implants. The table below depicts the number of patients, the number of events, and the percentage of occurrences of each event compared to the total number of patients.
Safety Information Paralysis 0 0% 0% CSF Leak 5 0.5% 0.6% 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.
Patient System Handbook Clinical Experience-Safety Clinical data has been collected during a clinical study of the PRECISION System. As of January 15, 2004, 35 subjects were enrolled in the study at multiple sites and 26 subjects had a successful trial stimulation period and were implanted with the PRECISION System. The follow-up period for the 26 implanted patients ranged from two weeks to six months. The following major adverse events were reported.
Safety Information 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. “Prospective, Multicenter Study of Spinal Cord Stimulation for Relief of Chronic Back and Extremity Pain.” Spine, 21:2786-2793, 1996. Hassenbusch, S.J., M. Stanton-Hicks, E.C. Covington. “Spinal cord stimulation verses spinal infusion for low back and leg pain”. Acta Neurochirgica, 64:109-115, 1995. Kemler, M.A., G.A.M. Barendse, M. Van Kleef, H.C.W.
Patient System Handbook 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. Markham. “Spinal Cord Stimulation Revisited.” Neurological Research, 20:391-396, 1998. Spieglemann, R. and W.A. Friedman. “Spinal Cord Stimulation: A Contemporary Series.” Neurosurg 28:6571, 1991. Villavicencio, A.T., J.C. Leveque, L. Rubin, K. Bulsara, and J.P. Gorecki.
Safety Information Contraindications Patients contraindicated for permanent SCS therapy are those who: • are unable to operate the SCS system • have failed trial stimulation by failing to receive effective pain relief • are poor surgical risks • are pregnant 17
Patient System Handbook Warnings Do not charge while sleeping. This may result in a burn. While charging, the Charger may become warm. It should be handled with care. Failure to use the Charger with either the Charging Belt or an adhesive patch, as shown, may result in a burn. If you experience pain or discomfort, cease charging and contact Advanced Bionics. Heat Due to Charging. You should not be exposed to Magnetic Resonance Imaging (MRI).
Safety Information Spinal cord stimulators may interfere with the operation of implanted sensing stimulators, such as pacemakers and implantable cardiac defibrillators (ICDs). Be sure your physicians are aware of your spinal cord stimulator before going forward with other implantable device therapies so that medical decisions can be made and appropriate safety measures taken. Cardiac Pacemakers. Stimulator Damage.
Patient System Handbook 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. • Power lines or power generators • Electric steel furnaces and arc welders • Large magnetized stereo speakers As you approach these devices you may become aware of changing stimulation levels.
Safety Information Precautions Physician training is required. The following medical therapies or procedures may turn stimulation off or may cause permanent damage to the Stimulator, particularly if used in close proximity to the device: Medical Devices/Therapies.
Patient System Handbook • high-output ultrasound — high frequency sound waves which may be applied as physical therapy to treat certain bone/muscle injuries, or for muscle stimulation, or to improve blood flow Before having procedures, medical therapies, or diagnostics, have your healthcare professional call our Customer Service department at (866) 360-4747 for proper instructions.
Safety Information Temporarily, there may be some pain in the area of the implant as the incisions heal. If discomfort continues beyond two weeks, contact your physician. If you notice excessive redness around the wound areas during this time, contact your physician to check for infection and administer proper treatment. In rare cases, adverse tissue reaction to implanted materials can occur during this period. Be sure to consult your physician before making lifestyle changes due to decreases in pain.
Patient System Handbook Stimulators 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 stimulation and contact your physician so that the system can be evaluated. Device Failure. Storage, Handling and Transport. Do not expose the Remote Control or Charging System components to excessively hot or cold conditions.
Safety Information Component Disposal. Do not dispose of the Remote Control or Charger in fire. The battery in these devices can explode in fire. Dispose of used batteries in accordance with local regulations. The Stimulator should be explanted in the case of cremation, and returned to Advanced Bionics. External devices to be disposed of per local regulatory requirements. Please contact your healthcare professional for information.
Patient System Handbook 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: • The lead(s) which deliver stimulation may move from their original implanted location, 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.
Safety Information surgery. Very rarely, you may develop an internal blood clot (hematoma) or blister (seroma); or you may experience brain hemorrhage or paralysis. Your spinal cord may become compressed. • External sources of electromagnetic interference may cause the device to malfunction and affect stimulation. • MRI.
Patient System Handbook • You may experience weakness, clumsiness, numbness or pain below the level of implantation. • You may experience persistent pain at the Stimulator or lead site. In any event, you should contact your physician and inform him/her.
4 The Remote Control 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. 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 47. 1. Area Button 2. Up/Activate 3. Down/Save 4. Program Button 5.
Patient System Handbook Basic Operation When it is not being used, the Remote Control sets itself in a “sleep” or idle mode and the display screen is blank. During this sleep mode when you press any button except the button (stimulation on/off), the Remote Control will “wake up” and display the screen shown on the right. To unlock the Remote Control, press and hold P, until “Release P To Unlock” appears.
The Remote Control Communicating with the Stimulator Good communication between your Stimulator and the Remote Control is very important. For that reason, you will sometimes see the following icon on your screen. This indicates that the Remote Control is checking for the Stimulator. Note: If there is a problem communicating with the Stimulator, the message “No Response” will appear on the Remote Control screen. Press to retry, or press to cancel. See “Help” on page 65 for more information.
Patient System Handbook Stimulation On and Off The Remote Control uses a “dedicated” stimulation on/off switch. You may press at any time—even during the Remote Control’s sleep or idle mode—to turn stimulation on or off. The Remote Control will briefly display a message notifying you of the on or off status.
The Remote Control • If there are 3 or 4 signal bars, the Remote Control is achieving optimum communication with the Stimulator. • After missing a telemetry message, the Remote Control will display the "Searching" message. The Remote Control will then start looking for signal strength every second. Move to a better spot and wait for the signal strength to display. To cancel searching press . Note: Avoid common sources of interference, such as televisions and computer monitors.
Patient System Handbook The Level Screen Whenever stimulation is turned on, or after the Remote Control is awakened from sleep/idle mode, the Remote Control display defaults to the Level screen. When you press the S or T button from this display, you are able to increase or decrease the stimulation strength, or level, of all of your pain areas at once (if your Stimulator was programmed to treat more than one area).
The Remote Control The graphic is easy to understand: Three filled-in bars means that the Stimulator has a fully-charged battery. As the battery strength wears down, depending on your stimulation settings and usage, the bars will “empty” accordingly. For complete information on maintaining your Stimulator’s battery for uninterrupted delivery of the therapy prescribed for you, see “Charging the Stimulator” on page 55.
Patient System Handbook • 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 healthcare professional to determine what is possible.
The Remote Control Stimulation Level Control Occasionally, you may see one of the accompanying messages on the Remote Control screen while changing the stimulation level. These displays, and a “beep” from the Remote Control, alert you that you have reached either a maximum or a minimum level: The bar replacing the up arrow means that you have reached the maximum allowable level and can only decrease the stimulation setting.
Patient System Handbook Selecting Areas for Level Control Your Remote Control may have as many as four therapy areas stored for your use. Each area will have a name or a number (1 through 4) which was assigned during your programming at the clinic. The stimulation level for each of these areas is controlled from an individual “area level” screen. To change the stimulation strength of a single area: 1.
The Remote Control 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.
Patient System Handbook Selecting and Activating Programs 1. Press the P button from the Level screen to go to the Program screen. From the Program screen, each additional P button press selects the next program number. Press to select the previous program number. The black highlight box shows where you are in the cycle. Pressing P from program 4 returns you to the Level screen. Pressing from program 1 also returns you to the Level screen.
The Remote Control 2. Press P or to move until the program you want is highlighted, then press S to activate the program. Note: You might not have four programs saved in your Remote Control. Empty program slots will have a blank box with no program number. If you try to activate an empty program, nothing will happen. • An underline (_ ) beneath a program number means that program was the most recently activated or saved (see below).
Patient System Handbook 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.
The Remote Control 1. After making a change to a program, press P from the Level screen to return to the Program screen. 2. From the Program screen, press P as many times as necessary to select the active program; that is, the program that is currently running and the one you have just changed. 3. With the active program selected, press T to save the change in the Remote Control’s memory.
Patient System Handbook The Remote Control will first ask you to confirm that you want to “overwrite” the program; press the appropriate button. If you confirm the change by pressing P, the program will be updated and saved. If you decide not to make a permanent change, pressing Cwill return you to the Program screen. You may also save a program change as a completely new program if an empty program slot [] is available: Simply select the empty slot using P and press T.
The Remote Control Options Under some circumstances, and depending on your treatment prescription, your healthcare provider may have given you therapy control beyond selectable programs by making special options available to you. Program options make it possible for you to change certain preset stimulation settings, and/or return changed programs to their original clinic settings. The ability to go back to original settings allows you to change your mind... then change your mind again...
Patient System Handbook There are three possible options. One of these, Restore, is not a stimulation setting but is similar to an “undo” feature. It returns a changed program back to its original settings. The other two options are stimulation settings that can affect the overall feeling of the stimulation you receive: • Pulse Width, or how long each stimulation pulse lasts, and • Rate, or how many times-per-second your Stimulator sends a stimulation pulse. Note: Restore is available to all patients.
The Remote Control 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 particular option screen is displayed. The action you take next depends on which option you want to adjust. Follow the appropriate instructions below: To Adjust Stimulation Pulse Width: 1. From the Level screen, press and hold Cuntil you see the Width Area 1 screen.
Patient System Handbook Note: The Remote Control will beep to notify you if you reach a preset limit while increasing or decreasing the Pulse Width. To return to the Level screen from any Pulse Width screen, press and hold Cuntil Rate Area 1 is displayed, then press and hold Cagain to see the Level screen. If you do not have access to the Rate option, the Level screen will appear right away. To Adjust Stimulation Rate 1. From the Level screen make a long Cbutton press to Pulse Width Area 1.
The Remote Control 3. 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. 4. Press either S or T to increase or decrease the Rate. Note: • You may also find Rate Area 1 by making a long Cbutton press from any Pulse Width screen. • The Remote Control will beep to notify you if you reach a preset limit while increasing or decreasing the Rate.
Patient System Handbook 1. From the Level screen, press and hold P to reach the Restore screen. Program 1 will be highlighted. Note: The highlighted program is the current selection; an underline (_ ) indicates the last program restored; a [] indicates an empty program slot. 2. If necessary, press P to 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.
The Remote Control Understanding Battery Messages About the Remote Control Batteries As an SCS patient, it is essential that you appreciate the importance of battery power! The replaceable batteries in your Remote Control and the rechargeable battery in your stimulator work together to provide you with consistent, dependable paresthesia. Always pay close attention to the battery status messages described in this section.
Patient System Handbook If the Stimulator battery is full or OK, the Remote Control will return to the Level screen. To learn about the messages you will see when the Stimulator’s battery is less than full, see page 53. If you do not respond to the Remote Battery Low message in a timely manner, the batteries will eventually drain to the point of not having enough power to manage your stimulator. Next, you would see the more urgent message shown opposite.
The Remote Control About Your Stimulator Battery When the Remote Control checks the condition of your Stimulator battery, you may see one or more of the following messages depending on the battery’s charge level: • If the Stimulator battery is low, the Remote Control will display the message shown at right. Press P to return to the Level screen. • If the Stimulator battery is very low, the Remote Control will display this notice to recharge the stimulator battery immediately.
Patient System Handbook Battery Replacement 1. On the rear of the Remote Control, push in slightly and slide down the battery compartment cover. 2. Remove the old batteries. 3. Place the three new AAA batteries in the slots, matching the positive (+) and negative (-) markings in the compartment. 4. Align the battery compartment cover on the case and slide the cover into position until it snaps closed. The Remote Control will connect to the Stimulator in approximately 30 seconds.
5 Charging the Stimulator Your Precision Stimulator uses a rechargeable battery to provide stimulation. The Precision System’s programming software gives your healthcare provider a conservative recommendation for how often to charge. This estimate is based on 24 hours per day/7 days a week at the maximum energy output level. While you may want to follow these recommendations, you can also develop a charge routine that fits best into your own lifestyle.
Patient System Handbook In most cases, the Stimulator will need to be recharged at intervals ranging from once a week to once a month. The Remote Control provides an easy-view Stimulator 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 53. Following the general recommendations made by your healthcare provider, you have the freedom to establish the charging routine that suits you best.
Charging the Stimulator Getting Started WARNINGS: • Do not charge while sleeping. This may result in a burn. • While charging, the Charger may become warm. It should be handled with care. • Failure to use the Charger with either the Charging Belt or an adhesive patch, as shown, may result in a burn. If you experience pain or discomfort, cease charging and contact Advanced Bionics. The Charging System for your Stimulator consists of the Charger unit, a Base Station, and a Power Supply.
Patient System Handbook 3. Place the Charger in the Base Station. When charging, you must use the Charger with either the Charging Belt or an adhesive patch to hold the Charger over the Stimulator. Before using the Charging Belt, you may cut it to a more convenient size, but be careful not to cut too much. The adhesive patches are made of non-reactive material suitable for most sensitive skin types. Note: Advanced Bionics recommends the use of the Charging Belt for charging.
Charging the Stimulator The Charger is completely ready and able to fully charge your Stimulator when the indicator light is green. If the light is amber-colored, the Charger can only partially charge the Stimulator. It may be used, but it may not be able to return your Stimulator to a full charge (and you may need to charge sooner than you normally would). Indicator Light Status: • Green – ready for full charge • Amber – partial charge • Off – not ready for charging 1.
Patient System Handbook Charging Your Stimulator 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.) 2. Using the Adhesive Patch: • Apply the adhesive patch to the backside of the Charger by peeling the clear liner from the patch and applying the white side with the blue stripe to the rear of the Charger, as shown. (See diagram below.
Charging the Stimulator 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 Stimulator.
Patient System Handbook 4. Locate the Charger over the Stimulator. When the Charger is aligned with the Stimulator, the beeping will stop. 5. Secure the Charger over the Stimulator either by pressing the adhesive to the skin over the Stimulator, or by securing the Charging Belt. Note: If you accidentally locate the patch in the wrong place, or if the Charging Belt moves out of alignment, the Charger will start beeping again.
Charging the Stimulator 6. When the Charger emits a distinct double beep, the Stimulator is charged. Switch off the Charger, remove the Charging Belt or adhesive patch, and return the Charger to the Base Station. Do not confuse the end of charge signal (a distinct double beep) with the steady, continuous misalignment signal.
Patient System Handbook Note: • Depending on your program parameters, you may expect daily recharging times from as low as 10 minutes up to four hours, or weekly recharging times from as low as one hour up to four hours. • The end of a charge signal is a distinct double beep, and the alignment indicator is a steady continuous signal. The rechargeable Stimulator battery should provide you with at least five years of service.
6 Help Stimulation No Stimulation 1. Toggle the Remote Control stimulation on/off button to make sure that stimulation is ON. If the Remote Control receives confirmation from the Stimulator, it will flash “Stimulation On.” 2. Turn up the level of stimulation from the main screen or area screens. 3. Charge the Stimulator. When the charge is complete, try turning the stimulation on.
Patient System Handbook 4. Call our Customer Service Department at (866) 360-4747 if the above steps do not solve the problem. Stimulation Increases or Decreases on Its Own 1. Stimulation can change depending on body position (lying down, standing or bending). 2. Always keep the Remote Control with you, so that you can adjust your stimulation levels as needed. Stimulation Shuts Off 1. When the Stimulator battery needs to be recharged, it will stop stimulating.
Help 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 Stimulator.
Patient System Handbook Remote Control Display Messages “Remote Battery Low” on the Display The batteries in your Remote Control should be replaced soon. All of the Remote Control functionality is still available (refer to “Battery Replacement” on page 54). “Replace Remote Battery” on the Display The batteries in your Remote Control need to be replaced with three fresh AAA batteries in order to have full functionality of the Remote Control (refer to “Battery Replacement” on page 54).
Help Searching “Searching” on the Display In the event of communication interference, the Remote Control will automatically begin “searching” for the Stimulator. Try to reposition the Remote Control closer to the Stimulator to help it locate the Stimulator. “No Response” on the Display When the Remote Control displays “No Response,” there is a communication problem between the Remote Control and the Stimulator. Press the P button to activate automatic searching for the Stimulator.
Patient System Handbook Once the Remote Control connects with your Stimulator, you will be returned to the display you were using before the problem began. If the problem persists, replace the Trial Stimulator battery and check to see if the problem is solved. Occasionally, telemetry problems occur because orientation or interference prevent the Remote Control from finding the Stimulator. Move the Remote Control closer to your Stimulator and then press the P button.
Help “Error Code” on the Display 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 P, wait a few seconds, move the Remote Control closer and try the action again. Since most of the error codes you might encounter are related to communication, always try to resolve the problem by moving the Remote Control closer to the Stimulator. If this does not work, please contact our Customer Service Department.
Patient System Handbook Accessories Washing the Charging Belt Wash the Charging Belt with mild soap and warm water.
7 Limited Warranty Implanted Pulse Generator Advanced Bionics® Corporation (referred to as Bionics) warrants to the patient who receives a Precision® Implantable Pulse Generator (referred to as the IPG) that the IPG will be free from defects in workmanship and materials for a period of (5) five years from the date of surgical implant of the IPG. This warranty applies only to the patient who has the IPG implanted and no other person or entity.
Patient System Handbook of the original IPG. Claims under this limited warranty are subject to the following additional conditions and limitations: 1. The product registration card must be completed and returned to Bionics within 30 days of surgery. 2. The IPG must be purchased after January 1, 2005 and implanted before the “use before” date. 3. Failure of the IPG must be confirmed by Bionics. 4.
Limited Warranty (c) unauthorized attempts to repair, maintain, or modify the IPG by the patient or any unauthorized third party; or (d) attaching equipment to the IPG that is not supplied or expressly authorized by Bionics. THIS LIMITED WARRANTY IS THE ONLY WARRANTY THAT APPLIES TO THE IPG, AND BIONICS EXPRESSLY DISCLAIMS ANY OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
Patient System Handbook If a Remote Control Device or Charging System component fails to function within normal ranges within one year after the date of purchase, Bionics will replace the device or component with a functionally equivalent device or component made by Bionics. No other relief whatsoever is available under this limited warranty. The limited warranty for a replacement device or component will last only for one year after the date of purchase.
Limited Warranty (b) accident, misuse, abuse, negligence, or the customer’s failure to operate the device or component in accordance with manufacturer's instructions; (c) unauthorized attempts to repair, maintain, or modify the device or component by the patient or any unauthorized third party; or (d) attaching equipment to the device or component that is not supplied or expressly authorized by Bionics.
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Glossary Glossary C Area Button icon. This figure respresents the area button on the Remote Control. ADHESIVE PATCH. Non-reactive skin patch designed to temporarily attach the Charger to the skin over the Stimulator site. ADVERSE EFFECT. Undesirable result. AMPLITUDE. The measure-of-strength of delivered stimulation. (See Level.) AREA. A location on the body such as right leg or left leg where stimulation will occur. CARDIAC PACEMAKER. A small implantable device used to control the rhythm of the heart.
Patient System Handbook DISPLAY. The Remote Control screen. ELECTRICAL PULSE GENERATOR. Also called an implantable pulse generator (IPG or Stimulator); used to send electrical pulses to the spinal cord or other parts of the body. ELECTRICAL STIMULATION.The energy created by a pulse generator. ELECTROMAGNETIC INTERFERENCE (EMI). Electromagnetic signals that interfere with a variety of electrical signals including spinal cord stimulation. IDLE MODE.
Glossary OPTIONS. Methods for adjusting stimulation beyond amplitude, or level, using the Remote Control. Your healthcare provider may or may not provide you with all available options. P Program Button icon. This symbol represents the Program button on the remote control. PRECAUTION. Generally, situations that you should be aware of in order to avoid potentially uncomfortable stimulation sensations and/or damage to your stimulation system. PROGRAM. Combination of one or more stimulation areas.
Patient System Handbook SAVE. The Remote Control button command used to store a newly created or modified stimulation program. SLEEP MODE. A time-out period when the Remote Control is not being used. Also known as idle mode. SPINAL CORD STIMULATION (SCS). A method of applying electrical pulses to the spinal cord to block/mask pain signals to the brain. STIMULATION.
Index Index A Adhesive Patch ............................ 57, 73 amplitude ............................... 73, 74, 75 area ............................................... 73, 76 B battery .......................................... 23, 64 C charge indicator ............................ 56, 58 charge signal ...................................... 60 control buttons ................................... 73 D diathermy ..................................... 17, 73 I indicator .....................................
Patient System Handbook S SAVE .................................................
The following is federal government communications regulation information about the Precision™ Spinal Cord Stimulation 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.
Patient System Handbook
CORPORATE HEADQUARTERS PAIN MANAGEMENT DIVISION Part No. 9055520-001 Rev A ©2006 Advanced Bionics Corp. All rights reserved. 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.
