Patient Trial Handbook CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician. Part No.
Patient Trial 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 What is Spinal Cord Stimulation? ........................................... 2 Caretaking During the Trial ..................................................... 3 How to Use This Manual During the Trial ................................ 6 2 Overview: The Trial Journal ...........................................7 Pain Profile ............................................................
Patient Trial Handbook The Trial Stimulator ............................................................... 32 The Remote Control .............................................................. 34 Basic Operation .................................................................. 35 Communicating with the Trial Stimulator ................................ 36 Stimulation On and Off ........................................................ 37 Signal Strength ......................................................
1 Introduction Welcome to the “Trial Phase” of the Advanced Bionics PrecisionTM SCS pain management program. You are about to test a pain treatment therapy that could result in a dramatic change in your life and your lifestyle. The trial you have agreed to participate in is intended to give you and your physician a chance to evaluate spinal cord stimulation (SCS) as an appropriate and effective long-term therapy option for your chronic pain.
Patient Trial Handbook What is Spinal Cord Stimulation? Most pain signals travel from the source problem or injury area to nerve pathways to the spine, then up the spine and to the brain. SCS uses electrical stimulation of the spinal cord to block the perception of those signals. To apply the stimulation during the trial phase, a small electrical pulse generator (ETS), or stimulator, is connected to one or two wires, called leads, which are placed along your spinal cord.
Introduction Caretaking During the Trial To speed-up your recovery following the surgery, your physician might require bed rest for the first several hours after the surgery; administer antibiotics; schedule a mid-trial followup visit; and limit your physical activity, including driving. CAUTION: If your doctor approves of you driving during the trial, always turn off the Trial Stimulator before getting behind the wheel.
Patient Trial Handbook Be aware that some changes in posture can cause a decrease or (at times) an uncomfortable increase in the strength of the stimulation. Keep the Remote Control with you at all times so that you can make adjustments quickly if necessary. You can help the recovery process by: • • • • 4 Keeping your incision dry. Be sure you understand instructions about cleaning the incision and sponge-bathing. You must not bathe or shower during the trial.
Introduction During sleep, bathing or for comfort, turn off the Trial Stimulator, remove it from the pocket, and disconnect the leads (see “The Trial Stimulator” on page 32 for information on disconnecting the leads). The position and stability of your leads is a vitally important part of the trial experience. Remember that, when they were placed along your spine, the leads were specifically located according to where you felt stimulation covering your pain.
Patient Trial Handbook How to Use This Manual During the Trial You will probably want to refer to this manual often during the trial period. For that reason, the content is arranged in the order you are most likely to need it. This section describes the SCS Trial Journal which is included. The journal is made up of a brief questionnaire, a simple chart, and a stimulation activity log. Start your journal the first full day following surgery. Overview: The Trial Journal. Using Your Trial Equipment.
2 Overview: The Trial Journal All trials or tryouts require careful record keeping of times or scores, and your SCS trial is no exception. In order for you and your doctor to decide to move on to the next step—a permanent implant— you will both need a way to review the details of each of your SCS trial days. The easiest way to do that is with the help of a journal.
Patient Trial Handbook score is marked, it becomes an important tool for determining your progress at the end of the trial. The Journal Seven log pages are included in your journal. We suggest that you begin keeping the log starting with the first full day following your surgery. An explanation of the columns follows: • • • • 8 Activity: Please name the activity whether it is getting out of bed, washing the dishes, or walking the dog.
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 Trial 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 Trial 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 Trial 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 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% 5.1% Clinical Experience-Safety Clinical data has been collected during a clinical study of the PRECISION System.
Patient Trial Handbook 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 Trial 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 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 adhesive patch or the Velcro® Belt with the Charger, 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).
Patient Trial Handbook 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. Implant Damage.
Safety Information 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 welder • Large magnetized stereo speakers As you approach these devices, you may become aware of changing stimulation levels.
Patient Trial Handbook Precautions Physician training is required. Medical Devices/Therapies.
Safety Information Before having procedures, medical therapies, or diagnostics, have your healthcare professional call our Customer Service department at (866) 360-4747 for proper instructions. 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.
Patient Trial Handbook 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. Never attempt to change the orientation or “flip” the implant. Do not “finger” or play with the implant.
Safety Information charging (up to four hours), turn off the implant and contact your physician so that the system can be evaluated. Storage, Handling and Transport. 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. The sensitive electronics can be damaged by temperature extremes, particularly high heat.
Patient Trial Handbook 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. Remote Control, Charging System Cleaning. Cell Phones. While we do not anticipate any interference with cell phones, the full effects of interaction with cell phones are unknown at this time. If there is a concern or a problem is encountered, the physician should be contacted.
Safety Information • • • • • 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.
Patient Trial Handbook • 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.
4 Using the Trial Equipment The Trial Stimulator System The Trial Stimulator is a temporary external spinal cord stimulator that is connected to the lead(s) placed along the spinal cord. You will use this external system to test how effective stimulation is in relieving your pain. Table 3: Trial Equipment 1. Remote Control 2. Cable 3. Trial Stimulator 4. Velcro® Belt 5. Lead 42)!, %15)0-%.
Patient Trial Handbook The Trial System includes: • Trial Stimulator • Lead(s)—An implantable wire that sends stimulation pulses to the spinal cord. You may have one or two leads. • Remote Control—A small battery powered computer used to adjust stimulation. • Cable(s)—Thin plastic-coated wire(s) used to attach the Trial Stimulator to the lead. • Velcro® Belt—A waist wrap/pocket for wearing the Trial Stimulator. Note: • Use only accessories supplied by Advanced Bionics.
Using the Trial Equipment Taking Care of Your Trial Equipment All of the items that were sent home with you from the hospital are important to your trial success, so please follow the instructions listed. • Handle the Trial Stimulator and the Remote Control with care. These items are well-designed, quality-tested electronic components. However, they can be damaged if they are dropped on a hard surface.
Patient Trial Handbook • Carry your Temporary Patient Identification card (given to you by your healthcare provider) throughout the trial. The Trial Stimulator To turn stimulation on or off, press the button on the Remote Control. To minimize the movement of your leads, it is preferable to use the Remote Control. However, you may also turn the Stimulator on and off by pressing the E button on the Trial Stimulator. When the Stimulator is on, the indicator light will blink.
Using the Trial Equipment Disconnecting the Trial Stimulator The Trial Stimulator has connectors for both left and right leads, and a third connector for a patch electrode. Whether you have one or two leads, your doctor probably placed identifying labels on them before connecting them to matching plugs on the Stimulator. These labels are intended to make it as easy as possible for you to connect the leads properly. Remember to check the label(s) each time you need to reconnect the leads.
Patient Trial 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. The Remote Control is used to: • • • Turn stimulation on and off Change stimulation levels Activate or save new programs 1. Area Button 2. Up/Activate 3. Down/Save 4. Program Button 5.
Using the Trial Equipment 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.
Patient Trial Handbook Communicating with the Trial Stimulator Good communication between the Stimulator and the Remote Control is very important. For that reason, you will sometimes see the following icon while you are using the Remote Control because it is always checking for the Trial 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.
Using the Trial Equipment 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.
Patient Trial Handbook • • 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.
Using the Trial Equipment 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).
Patient Trial Handbook The graphic is easy to understand: Three filled-in bars means the battery is fully-charged. 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 “Understanding Battery Messages” on page 50.
Using the Trial Equipment • 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.
Patient Trial Handbook 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.
Using the Trial Equipment 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.
Patient Trial Handbook 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.
Using the Trial Equipment 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.
Patient Trial Handbook 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).
Using the Trial Equipment 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.
Patient Trial Handbook 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.
Using the Trial Equipment 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 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.
Patient Trial Handbook Understanding Battery Messages About the Remote Control Batteries When the Remote Control batteries are at a low power level, the message shown here will be displayed. It is a good idea to replace the batteries at this point. If you continue to use the Remote Control without replacing the batteries, you will eventually see the message “Replace Remote Battery.
Using the Trial Equipment • If the Stimulator’s battery is low, this message will be displayed. • If the Stimulator’s battery is very low, this message will be displayed. Respond to all battery messages as soon as possible to prevent an interruption of stimulation therapy during your trial period.
Patient Trial Handbook Trial Stimulator Battery Replacement It is not likely to happen over the short term of your SCS trial period, but your Trial Stimulator battery may drain to a very low level. If this happens, install a new battery right away. Be sure that stimulation is off (the indicator light is not blinking) before opening the Trial Stimulator’s battery compartment. Replace the old battery with a 6-volt lithium battery (for example: Duracell Lithium 28L) available at most stores.
Using the Trial Equipment 1. On the rear of the unit, press down on the ridged area of the battery compartment cover and push the cover off of the case. 2. Remove the old battery and place the new battery in the compartment matching the positive (+) and negative (-) markings. 3. Close the compartment by sliding the cover on the Stimulator case in the opposite direction.
Patient Trial Handbook Remote Control 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 cover on the case and slide the cover into position until it snaps closed. The Remote Control will connect to your Trial Stimulator in approximately 30 seconds.
5 Help Stimulation No Stimulation 1. When stimulating, the Trial Stimulator indicator light will blink. If it is not blinking, toggle the E or button on the Trial Stimulator or the Remote Control. When the Remote Control receives confirmation from the Trial Stimulator, it will display “Stimulation On.” 2.
Patient Trial Handbook a. Check to make sure the lead cable is properly connected to the Stimulator. Turn off stimulation before adjusting the cables, and then turn it back on. b. If you were provided a skin patch electrode, check that it is properly secured to your skin. Make sure to turn off stimulation first, and then turn it back on. c. Try increasing (S) the stimulation level. If this does not bring on stimulation, decrease the level (T) to the original setting. 3.
Help 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 “Remote Control 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 “Remote Control Battery Replacement” on page 54).
Patient Trial Handbook 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.
Help 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 Pbutton.
Patient Trial Handbook “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, move the Remote Control closer, wait a few seconds, 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.
Help Accessories Washing the Velcro® Belt 1. Wash the belt with mild soap and warm water.
Patient Trial Handbook 62
Glossary Glossary 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. C Area Button icon. CABLE. Thin plastic coated wire(s) connecting the exposed portion of temporary lead(s) to the Trial Stimulator. CARDIAC PACEMAKER. A small implantable device used to control the rhythm of the heart. DIATHERMY.
Patient System Handbook IDLE MODE. A time-out period when the Remote Control is not being used. See also Sleep Mode. IMPLANT. Small electrical pulse generator used to control stimulation. INCISION. Small surgical cut or opening in the skin. INDICATOR. A signal light used on the Trial Stimulator and the IPG Charger. LABELS. Adhesive tags (2-R) (1-L) placed on the trial lead cables to show where to attach the cables to the Trial Stimulator . LEAD MIGRATION.
II Patient Trial TC 3 US Glossary.fm Page 65 Friday, March 10, 2006 11:12 AM Glossary PATCH ELECTRODE. An adhesive patch placed on the skin and attached to the Trial Stimulator only when trial leads are not used. PATIENT IDENTIFICATION CARD. A wallet size card that lists the patient and physician names, and IPG model and serial number. PERMANENT IMPLANT. A stimulator system, pulse generator and leads, implanted in the body and maintained by a pulse generator battery Charging System. PRECAUTION.
II Patient Trial TC 3 US Glossary.fm Page 66 Friday, March 10, 2006 11:22 AM Patient System Handbook STIMULATION. When used as a therapy for TRIAL STIMULATOR SYSTEM. Precision 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. system components used during a limited time to evaluate SCS therapy.
Index Index P C Patient Identification card ..................12 cable ............................................. 10, 54 D diathermy ..................................... 43, 59 I paresthesia ............................................2 T Trial Journal .........................................7 V VAS ..................................................7, 8 indicator ............................................. 12 L label .................................................... 13 level ...............
Patient Trial Handbook 68
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. Do not attempt to open or repair any of the components.
IMAGINE the Possibilities CORPORATE HEADQUARTERS Advanced Bionics® Corporation 12740 San Fernando Road, Sylmar, CA 91342 (800) 678-2575 in US and Canada (818) 362-7588, (818) 362-5069 Fax (800) 678-3575 TTY www.advancedbionics.com Email: info@advancedbionics.com 9055426-001 Rev.A ® PAIN MANAGEMENT DIVISION Advanced Bionics® Corporation Mann Biomedical Park 25129 Rye Canyon Loop, Valencia, CA 91355 (661) 362-1400, (661) 362-1500 Fax ©2006 Advanced Bionics Corp. All rights reserved.