Patient Trial Handbook CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.
Patient Trial 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 What is Spinal Cord Stimulation? .................................................. 1 Caretaking During the Trial ........................................................... 2 How to Use This Manual During the Trial ....................................... 5 Overview: The Trial Journal ............................ 6 Pain Profile ............................................................................
Patient Trial Handbook Safety Instructions ........................................ 22 Warnings ................................................................................. 22 Precautions ................................................................................. 23 Adverse Effects ............................................. 25 Help ............................................................. 26 Stimulation .................................................................................
Introduction Introduction Welcome to the “Trial Phase” of the Advanced Bionics® Precision™ pain management program. You’re about to test a pain treatment therapy that could result in a dramatic change in your life and your lifestyle. The trial you’ve 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 perception of those signals. To apply the stimulation, a small electrical pulse generator is connected to one or two wires, called leads, which are placed along your spinal cord. The stimulator, internal or external, sends pulses of a low electrical current to a series of metal contacts, called electrodes, located at the end of the lead(s). The “feeling” produced by this stimulation is a light sensation called paresthesia.
Introduction 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: • 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.
Patient Trial Handbook 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 10 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.
Introduction 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 at the back of this manual. 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.
Patient Trial Handbook 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’ll 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.
Overview: The Trial Journal • Activity: Please name the activity whether it’s getting out of bed, washing the dishes, or walking the dog. • Time: Fill in the approximate time (starting, during or ending) of the activity. • VAS: Use this column to enter a Visual Analog Scale pain score for what your pain level was during the activity. The VAS score is a number between zero (0) and ten (10), where 10 is the worst pain imaginable and 0 is no pain. Rate the pain level you had while doing the activity.
Patient Trial Handbook Using the Medical 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. The Trial System includes: 8 • Lead—An implantable cable that sends stimulation pulses to the spinal cord. • Remote Control—A small battery powered computer used to adjust stimulation.
Using the Medical 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, qualitytested electronic components. However, they can be damaged if they’re dropped on a hard surface.
Patient Trial Handbook The Trial Stimulator You may turn off the Trial Stimulator by pressing its power on/off button, or by pressing the power button on the Remote Control unit. When the stimulator is on, the indicator light will blink Always turn the stimulator off before connecting or disconnecting your lead wires. Disconnecting the Trial Stimulator The Trial Stimulator has connectors for both left and right leads, and a third connector for a patch electrode.
Using the Medical Equipment 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.
Patient Trial 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 stimulator. 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.
Using the Medical Equipment 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 immediately turn stimulation on or off. You don’t have to be concerned about whether or not the Remote Control is awake.
Patient Trial Handbook Stimulation Level Control A few seconds after stimulation is turned on, the Remote Control displays the main screen. From here, you may press the [down] or [up] button to adjust the stimulation level (or intensity) until you’re 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.
Using the Medical Equipment 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 LeftArm. Note: If you only have one area of control, then that one area will appear each time you press SEL 1. 2. When the named or numbered area that you want to adjust is displayed, press or to change the stimulation level for that area.
Patient Trial Handbook Selecting Programs (for Stimulation Control) Your Remote Control can store up to four stimulation programs which may 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 and compare specific programs for different circumstances or times in your daily routine. This is especially helpful during the trial period.
Using the Medical Equipment 3. Once the desired program is highlighted, [ACT] and that program will start press running after a couple of seconds. Note: You might not have all four programs saved in your Remote Control. Empty program slots will have an * (asterisk) symbol beside the program number. If you try to activate an empty program, nothing will happen. Once you’ve selected and activated a program, you can adjust its stimulation level using the and buttons.
Patient Trial Handbook Battery Information Remote Control: 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.
Using the Medical Equipment 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.
Patient Trial Handbook Trial Stimulator: If the message “REPLACE STIMULATION BATTERY” appears on the Remote Control screen accompanied by a three-beep alarm, press SEL2 [OK] to acknowledge the message, then install a new battery right away. The battery for your Trial Stimulator is a 6-volt battery (lithium Duracell 28L). This type of battery can be purchased at most drug and convenience stores.
Using the Medical Equipment To replace the Trial Stimulator battery: 1. On the rear of the unit, press down on the ridged area and slide to release the cover. 2. Open the cover and remove the old battery. 3. Replace the new battery in the slot, matching the positive and negative markings. 4. Close the compartment by sliding the cover in the opposite direction.
Patient Trial Handbook Safety Instructions Warnings The safety considerations of SCS devices for use during pregnancy are unknown. If you become pregnant, turn off the External Trial Simulator when you become aware of your condition and consult your physician. Pregnancy. Diathermy. As an SCS patient, you must not have any form of diathermy either as treatment for a medical condition or as part of a surgical procedure.
Safety Instructions • Large magnetized stereo speakers. As you approach these devices you may become aware of changing stimulation levels. In rare instances, you could experience an increase in stimulation level to the point that the sensation is uncomfortably strong or possibly “jolting.” If this happens, turn off the External Trial Stimulator. If the stimulator suddenly turns off by itself, first move away from the area.
Patient Trial Handbook • external defribrillation • radiation therapy • ultrasonic scanning • high-output ultrasound Before having procedures, medical therapies, or diagnostics, have your healthcare professional call our Customer Service department at (866) 566-8913 for proper instructions. Automobiles and Other Equipment. Do not operate an automobile, other motorized vehicle, or potentially dangerous machinery/equipment with stimulation turned on. Turn off stimulation first.
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 Trial Handbook Help Stimulation No Stimulation 1. When stimulating, the Trial Stimulator status light will blink. If it is not blinking, toggle the power button on the Trial Stimulator or the Remote Control. When the Remote Control receives confirmation from the Trial Stimulator, it will flash “Stimulation On.” 2. When the status light is blinking and you still do not feel stimulation: a. Check to make sure the lead cable is properly connected to the stimulator.
Help 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 Coverage is in a Different Area Than at the Doctor’s Office 1. If stimulation is moved, and you did not activate a different program, you should call your doctor. It is possible that the leads may have moved during the trial.
Patient Trial Handbook “Action Unsuccessful” on the Display 1. 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. Accessories Washing the Velcro® Belt 1. Wash the belt with mild soap and warm water.
Help 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: • 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 29
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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 9055078 Rev C ©2003 Advanced Bionics Corp. All rights reserved.