Patient System Handbook CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.
Patient System Handbook 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. Do not attempt to open or repair any of the components.
Table of Contents Table of Contents Introduction .................................................... 1 System Description ......................................... 2 Safety Instructions .......................................... 5 Warnings .................................................................................... 5 Precautions ................................................................................... 7 Adverse Effects .............................................
Patient System Handbook Getting Started ........................................................................... 28 Charging Your Implant ................................................................ 29 Help ............................................................. 33 Stimulation ................................................................................. 33 Remote Control Display ............................................................... 34 Accessories ................................
Introduction Introduction 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. Paresthesia is the term that describes the light, tingling sensation—the “feeling”—of spinal cord stimulation.
Patient System Handbook System Description The Precision system includes both implanted and external components: 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 implanted pulse generator (IPG), referred to as an implant. The implant sends a small electrical current to a series of stimulating contacts, called electrodes, at the end of the lead.
System Description Before you continue, however, first check to be sure that all of the following items were included in your Patient Kit. (And check to be sure you have your Temporary Patient Identification Card; be sure to keep it with you until you receive your permanent card.) If any item is missing, please call our Customer Service department at (866) 566-8913.
Patient System Handbook Find a convenient electrical outlet, one that won’t expose the parts to water or direct heat, and plug in the transformer. Next, connect the transformer to the Charger Base Station and locate the Base Station on a flat surface. Finally, place the Charger in the Base Station with the blue power button facing up. 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 27.
Safety Instructions Safety Instructions Warnings Pregnancy. The safety considerations of totally implanted SCS devices for use during pregnancy are unknown. If you become pregnant, turn off the device when you become aware of your condition and consult your physician. Diathermy. As an SCS patient, you must not have any form of diathermy as either as treatment for a medical condition or as part of a surgical procedure.
Patient System Handbook Electromagnetic Interference. Avoid or exercise care around electromagnetic fields generated by: • Theft detectors and security screeners (usually located at stores, airports, libraries, and government buildings) • Power lines and power generators • Electric steel furnaces, arc welders, and other heavy duty industrial electric equipment • Large magnetized stereo speakers As you approach these devices you may become aware of changing stimulation levels.
Safety Instructions Precautions MRI. You must 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. Medical Devices/Therapies.
Patient System Handbook Do not operate an automobile, other motorized vehicle, or any potentially dangerous machinery/equipment with therapeutic stimulation switched on. Turn off stimulation first. Sudden stimulation changes, if they occur, may distract you from attentive operation of the vehicle or equipment. Automobiles and Other Equipment.
Safety Instructions Lead Location. 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. Implants can fail at any time due to random component failure, loss of battery functionality, or lead breakage.
Patient System Handbook Remote Control Battery. Do not try to use a AA (1.5-volt) battery in the Remote Control unit. The control will only operate with the special 3.6-volt battery available from Advanced Bionics. Remote Control, Charging System Cleaning. The components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue. Residue from soapy detergents should be removed with a damp cloth. Do not use abrasive cleansers for cleaning.
Adverse Effects 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.
Patient System Handbook The Remote Control 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, in a pocket, purse, or in your immediate vicinity.
The Remote Control The Remote Control is used to: • Turn stimulation On and Off • Change stimulation levels • Activate or save new programs • Change stimulation options (If enabled by the clinician. See “Stimulation Level Control” on page 16.) Each button function label shown on the screen is related to the control button below it. As you move through the screen, the function labels for the buttons will change accordingly.
Patient System Handbook Basic Operation When it is not being used, the Remote Control is in a “sleep” mode. Press any button and the Remote Control will wake up and look for the implant. Once connected, you can make adjustments. When you are done, the Remote Control will go to sleep after 60 seconds. Good communication between the implant and the Remote Control is very important. This is the reason you’ll often see the message “Connecting...” while you are adjusting the stimulation.
The Remote Control Stimulation On and Off The Remote Control uses a “dedicated” stimulation on/off switch.You may press the stimulation power button at any time to turn stimulation on or off. You don’t have to be concerned about whether or not the Remote Control is awake.
Patient System Handbook Stimulation Level Control After stimulation is turned on, the Remote Control displays the main screen. From here, you may press the T (down) or S (up) button to adjust the stimulation level (or intensity) until you are comfortable. The main screen controls all stimulation, whether you have one area of pain control... or more than one. Note: • In some cases, health professionals can give you control over more than one stimulation area.
The Remote Control Selecting Areas (for Stimulation Control) 1. From the main screen, press the SEL 1 button as necessary to cycle through your programmed areas. Each area is given a number (1 through 4) or a name, for example LeftLeg. Note: If you only have one area of control, that area will appear each time you press SEL 1. 2. When the named or numbered area that you want to adjust is displayed, press T or S to change the stimulation level for that area.
Patient System Handbook Selecting Programs (for Stimulation Control) Your Remote Control can store up to four stimulation programs that might have been set up by your healthcare professional. Each saved program will have certain differences in the settings. These differences allow you to vary your stimulation in many ways. You may have been encouraged to try using specific programs for different circumstances, postural positions or times in your daily routine.
The Remote Control To select and activate programs: 1. Press the SEL 2 [NEXT] button from the main screen to go to the program screen. 2. Press the SEL 1 [SEL] button as necessary to choose the program you want to activate. 3. Once the desired program is highlighted, press T [ACT; activate] and that program will start running after a couple of seconds. Note: You might not have four (the maximum) programs saved in your Remote Control.
Patient System Handbook Once you have selected and activated a program, you can adjust the stimulation level using the T (down) or S (up) button. If you make a stimulation level adjustment and decide that you prefer it, go back and select the program again then press S [SAVE]. The program will be updated with the new level. You may also save to an empty program slot (*) if one is available.
The Remote Control Options Under some circumstances, and depending on your treatment prescription, your healthcare provider may have given you a level of control beyond selectable programs by making special options available to you. This feature allows you to change certain preset stimulation settings, and/or restore the original clinic settings for programs that you might have changed. The latter is an advantage if you’ve made a program adjustment that you’re not satisfied with.
Patient System Handbook To Use Options 1. From the program screen, press and hold SEL 2 until you see the options screen. 2. From the options screen, press SEL 1 to move through the choices shown on the screen. 3. When the option you want is highlighted, press S [GO]. Note: If you change your mind about adjusting options, press SEL 2 [NEXT] to return to the main screen.
The Remote Control If you selected Rate or Width 1. If the pain area you want to “option” is not displayed on the screen, first press SEL 1 to find the area. 2. When the desired area is displayed, press T or S to decrease or increase the Rate or Width (whichever you chose) to that area. 3. If you want to adjust the same option for another area, press SEL 1 to find the area. Note: The Remote Control will beep to notify you if you reach a preset limit while increasing or decreasing either the Rate or Width.
Patient System Handbook If you selected Restore Press SEL 1 as necessary to highlight the program you want to restore, then press S [GO]. The Remote Control will display a question for you to confirm; press S [RESTR]. You’ll then see a message that the selected program is being restored. When the operation is complete, the remote will return automatically to the main screen.
The Remote Control Remote Control Battery Replacement If the Remote Control needs a new battery, a message will be displayed. Following the low battery message you will only be able to turn the implant on and off. If you try to use any button except the power button, you will be reminded “Replace Remote Battery ON/OFF ONLY.” The battery for your Remote Control is a special 3.6-volt battery available only from Advanced Bionics. Do not attempt to use a 1.5-volt AA battery in the Remote Control.
Patient System Handbook To replace the Remote Control battery 1. On the rear of the remote, slide the battery compartment lock lever to the left to unlock the cover. 2. Press down on the ridged area below the lever using your thumb to release the cover. 3. Open the cover and remove the old battery. 4. Replace the new battery in the slot, matching the positive (+) and negative (-) markings. 5. Close the compartment by sliding the lock lever to the right.
Charging the Implant Charging the Implant To provide stimulation, your implant uses a rechargeable battery. You should be given guidelines on when to charge your implant. The Remote Control will also provide battery status when your implant is low. Based on your stimulation settings, you may charge once a week or once a day. You should be aware that if you do not charge your implant, stimulation will eventually stop until you charge again. Remember to schedule this important time.
Patient System Handbook Getting Started The Charging System for your implant consists of the Charger unit, a Base Station, and a transformer (plug). Adaptors are included for use in countries other than the U.S. The Base Station is designed to remain connected into a power outlet, and the Charger placed within to keep it ready for use. 1. Find a convenient place with a flat, clear surface to keep the Base Station plugged in. 2.
Charging the Implant The Charger is completely ready and able to fully charge your implant when the readyindicator is green. If the light is yellow, the Charger can only partially charge the implant. It may be used, but it may not be able to return your implant to a full charge (so you may need to charge sooner than you normally would). • Green – ready for full charge • Yellow – partial charge • Off – not ready for charging Charging Your Implant 1.
Patient System Handbook 2. Using the Adhesive Patch: Apply the adhesive patch to the backside of the Charger by peeling the clear liner from the patch. Remove the skin side beige liner Using the Velcro® Belt: Place the Charger in the pocket with the power button facing out. 3. Press the power button. The indicator light will return to the status position, and the Charger will begin beeping steadily to signal that it is searching for the implant.
Charging the Implant 4. Locate the Charger over the implant. When aligned with the implant, the beeping will stop. Secure the Charger over the implant either by pressing the adhesive side to the location, or by attaching the Velcro® belt. Note: If you accidentally locate the patch in the wrong place, or if the Charger moves out of alignment, the Charger will start beeping again. Use a new adhesive patch or readjust the Velcro® belt to place the Charger back to position. 5.
Patient System Handbook Note: • The end of a charge signal is a distinct double beep, and the alignment indicator is a steady continuous signal. • The implant battery will eventually need replacement. Over time (typically over years) you may start to charge more frequently. As long as it is convenient, you can use the system. When you are ready for a replacement, talk with your healthcare professional.
Help Help Stimulation No Stimulation 1. Toggle the Remote Control implant power button to make sure that stimulation is ON. If the Remote Control receives confirmation from the implant, it will flash “Stimulation On.” 2. Turn up the level of stimulation from the main screen or area screens. 3. Charge the implant. When the charge is complete, try turning the stimulation on. 4. Call our Customer Service Department at (866) 566-8913 if the above steps do not solve the problem.
Patient System Handbook Stimulation Shuts Off 1. 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. 2. 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. 3. When the implant battery needs to be recharged, it will stop stimulating.
Help “No Response” on the Display When the Remote Control displays “No Response,” it cannot find the implant because of orientation or interference. Move the remote closer and try again. Call our Customer Service Department at (866) 566-8913 if the problem continues. “Action Unsuccessful” on the Display When the Remote Control displays “Action Unsuccessful,” press [OK] and try the action again. If pressing [OK] does not clear the message, call your physician’s office.
Patient System Handbook 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: 36 • Customer Service Phone: (866) 566-8913 • Customer Service Fax: (661) 362-1503 • Address: Advanced Bionics® Corporation Pain Management Division Mann Biomedical Park 25129 Rye Canyon Loop Valencia CA 91355
Limited Warranty Limited Warranty Implanted Pulse Generator Advanced Bionics® Corporation (hereinafter referred to as Advanced Bionics®) warrants to the patient who receives a Precision™ System that the implanted pulse generator (hereinafter referred to as the IPG), Model SC 1100, is free from defects in workmanship and materials for a period of one (1) year from the date of surgical implant of the IPG.
Patient System Handbook 4. Failure of the IPG must be confirmed by Advanced Bionics®.
Limited Warranty Externals Advanced Bionics® warrants to the patient that the Remote Control device, Model SC 5200, and Charger System (Charger, Model SC 5300, and/or Charger Base Station, Model SC 5305) are free from defects in workmanship and materials for a period of one (1) year from the date of purchase of a new Precision™ Patient Kit.
Patient System Handbook with manufacturer’s instructions; (c) unauthorized attempts to repair, maintain, or modify the equipment by the customer or any unauthorized third party; or (d) attachment of any equipment not supplied by Advanced Bionics® without prior approval. 4. The decision as to product replacement or credit shall be made solely at the discretion of Advanced Bionics®.
IMAGINE the Possibilities ® CORPORATE HEADQUARTERS PAIN MANAGEMENT DIVISION Advanced Bionics® Corporation 12740 San Fernando Road, Sylmar, CA 91342 (800) 678-2575 in US and Canada (818) 362-7588, (818) 362-5069 Fax (800) 678-3575 TTY www.advancedbionics.com Email:info@advancedbionics.com Advanced Bionics® Corporation Mann Biomedical Park 25129 Rye Canyon Loop, Valencia, CA 91355 (661) 362-1400, (661) 1500 Fax JUN03-080620-P 9055072 Rev C ©2003 Advanced Bionics Corp. All rights reserved.
