Boston Scientific Neuromodulation PSC5210W Precision SCS Remote Control User Manual II Patient Trial RC 3 US
Boston Scientific Neuromodulation Corporation Precision SCS Remote Control II Patient Trial RC 3 US
Contents
Patient Trial Handbook
Patient Trial Handbook
CAUTION:
Federal law restricts this device to sale, distribution and use by or on the order of a physician.
Part No. 9055426-001 Rev A
Patient Trial Handbook
ii
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.
Guarantees
Advanced Bionics Corporation reserves the right to modify, without prior notice, information
relating to its products in order to improve their reliability or operating capacity.
Drawings are for illustration purposes only.
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their products are trademarks or registered trademarks of their respective holders and should be
noted as such.
Table of Contents
iii
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 ............................................................................ 7
The Journal ............................................................................ 8
3 Safety Information ............................................................9
Indications for Use ................................................................. 9
Precision System Clinical Summary .......................................... 9
Contraindications ................................................................. 18
Warnings ............................................................................ 19
Precautions .......................................................................... 22
Adverse Effects ............................................................ 26
4 Using the Trial Equipment .............................................29
The Trial Stimulator System .................................................... 29
Taking Care of Your Trial Equipment ..................................... 31
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The Trial Stimulator ............................................................... 32
The Remote Control .............................................................. 34
Basic Operation .................................................................. 35
Communicating with the Trial Stimulator ................................ 36
Stimulation On and Off ........................................................ 37
Signal Strength .................................................................... 37
The Level Screen .................................................................. 39
Stimulation Level Control ....................................................... 42
Selecting Areas for Level Control ........................................... 43
Programs ............................................................................. 44
Selecting and Activating Programs ........................................ 45
Saving Program Changes ..................................................... 47
Understanding Battery Messages .......................................... 50
5 Help ..................................................................................55
Stimulation ........................................................................... 55
Remote Control Display Messages ........................................ 57
Accessories ......................................................................... 61
Contacting Advanced Bionics ............................................... 61
Glossary ...........................................................................63
Index..................................................................................67
1
1Introduction
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.
At the end of the trial period (approximately one week) you and your physician will meet to
discuss your experience with spinal cord stimulation. The doctor will also want to explore
your feelings about a permanent SCS implant so that, together, both of you can determine
whether long-term treatment with spinal cord stimulation is an appropriate option for you.
To prepare yourself for this important decision, you may want to spend at least some of the
trial period carefully evaluating spinal cord stimulation.
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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. The stimulator, internal or external, sends
pulses of a low electrical current to a series of metal contacts, or electrodes, located at the
end of the lead(s). The “feeling” produced by this stimulation is a light sensation called
paresthesia. Thousands of SCS patients consider paresthesia not only a pleasant substitute
feeling, but also an effective and welcome relief from pain.
It is important to understand that spinal cord stimulation cannot cure pain or eliminate its
cause. It does, however, provide control of and relief from certain types of pain over the area
where the paresthesia is felt. Spinal cord stimulation is a treatment choice designed to
provide you with the most effective pain relief over the widest pain area possible. When that
goal is reached with the Precision system, you should experience good to excellent relief
from chronic pain.
Introduction
3
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 follow-
up 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. Please ask for specific instructions about what
you may do and should not do during the trial, and follow all instructions carefully!
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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.
• Checking the wound occasionally for
signs of redness or the presence of
fluid.
• Notifying your physician’s office if you
develop a fever, or if you experience
increased pain at the incision site.
• Limiting most physical activity during the trial.
Introduction
5
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. You want the leads to stay in
place! So, to prevent them from moving:
• Do not lift objects of more than 5 pounds.
• Do not engage in rigorous physical activity such as twisting, bending, or
climbing.
• Do not raise your arms above your head.
• Do not pull or jiggle the leads.
Again, call your doctor if you have any questions about an activity that you are not sure is
appropriate for you during the trial.
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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.
Overview: The Trial Journal. 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.
Using Your Trial Equipment. Turn to this section when you are ready to learn about the
many ways available for managing stimulation using the Remote Control unit to program
the Trial Stimulator. Depending upon the instructions you receive from your doctor you may
not need all of the information here during the trial, but it may help you in the future.
7
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. Your journal consists of
the following:
Pain Profile
You may think of the Pain Profile as a way to make a starting point for this trial and for the
journal. The simple questions you answer here will establish a detailed, personal description
of your pain condition. The profile includes a simple graph called a Visual Analog Scale
(VAS), commonly used to measure the before-and-after pain levels of SCS trial patients.
You may have completed a VAS before in your doctor’s office or at a clinic. Once your VAS
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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:
• Activity: Please name the activity whether it is 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.
• STIM ON (Program No.) or STIM OFF: Indicate if stimulation was on or off
during the activity. If you know which program you were using, write the
program number (1, 2, 3 or 4).
9
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.
Precision System Clinical Summary
Determination of the safety and effectiveness of the PRECISION System was based on
available published clinical studies for similar implanted spinal cord stimulation systems.
The PRECISION System is similar to the SCS systems reported in published literature in
intended use, target patient population, technology, device design, and output
characteristics. Therefore, the clinical data from the published literature described below
represents evidence supporting the safety and effectiveness of the PRECISION System for
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10
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.
A total of approximately 3166 device months of experience was depicted from the
retrospective clinical evaluation. All three studies examined the effectiveness of SCS on
patients with chronic pain of the trunk and/or limbs including unilateral or bilateral pain
associated with the following: failed back surgery syndrome or intractable low back and leg
pain. In all studies, a totally implantable spinal cord stimulator was used in association with
a percutaneous and/or surgical lead. These studies provide the same diagnostic or
therapeutic intervention for the same disease/conditions and patient population as the
PRECISION System.
The prospective study by Ohnmeiss et al. 1996, examined the long-term effectiveness of
SCS in patients with intractable leg pain. Forty patients were implanted with SCS systems
and evaluated at 6 weeks, 12 months, and 24 months follow-up. Outcome measures
Safety Information
11
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.
In addition, 3 patients from this study had their stimulators repositioned due to pain at the
original location. Three patients had reoperations to adjust lead position; 1 patient required 2
reoperations, 1 patient had the device removed due to infection and later to have a new
device implanted. A diabetic patient had skin problems which required device removal; a
new device was later implanted. Two patients had the device removed due to unsatisfactory
pain relief.
The prospective study performed by Villavicencio et al. 2000 included 41 patients with pain
of various etiologies. The majority of the patients, 24 (59%), had Failed Back Surgery
Syndrome (FBSS), 7 (17%) had Complex Regional Pain Syndrome (CRPS I and II), 4
(10%) had neuropathic pain syndrome, and 6 (15%) were diagnosed as stroke or other.
Patients underwent an initial trial period for SCS with temporary leads. If the trial resulted
in greater than 50% reduction in the patient’s pain, as measured by the VAS, the patient was
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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.
In this study, one patient required a revision because of electrode fracture. One patient
required removal of the system due to local infection. One patient required replacement of
the IPG due to mechanical failure. Overall, 16 of 27 (59%) patients required a total of 36
repositioning procedures.
A retrospective analysis performed by Hassenbusch SJ et al. 1995 included patients with
chronic lower body pain, predominately neuropathic pain and pain either midline lower
back and/or unilateral or bilateral leg pain treated over a 5 year period. The study was a
comparison of SCS to spinal infusion of opiods. For patients with radicular pain involving
one leg with or without unilateral buttock pain, a trial of SCS was recommended first. For
patients with midline back pain and /or bilateral leg pain, a trial of long-term spinal infusion
was recommended first. If the patients failed screening with either of these modalities, the
other was then tested. If the treatment reduced the pain by 50%, the systems were
Safety Information
13
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. Five patients did not receive adequate
pain relief with SCS; 3 (7%) of these patients underwent trial spinal infusions and had
effective pain relief. There were 4 (10%) patients who underwent a trial of spinal infusion of
opioid but did not receive adequate pain relief; these patients were not tested with SCS. Pain
severity was rated using a verbal digital pain scale: “On a scale of 0 to 10 where 0 is no pain
and 10 is the worst pain you could ever imagine, what is your pain now?” 16/26 patients
(62%) had greater than 50% pain relief with SCS. In this study, 2/16 (13%) had greater than
50% pain relief with opioids. Mean follow-up was 2.1 + 0.3 years. This analysis supports
the use of SCS for intractable low back and leg pain.
In this study, 7 (17%) patients suffered complications after implantation of the device; 5
(12%) patients required repositioning of catheter type electrodes and 2 patients required
revision of the stimulator generator.
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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. It should be noted that
citations cover both IPG and RF Systems. The clinical experience reported in the literature
on RF systems is relevant to determining the safety of totally implantable IPG systems.
Table 1: Summary of Risks Identified in the Retrospective Clinical Studies
Risks
# Patients
With
Adverse
Event
Intent-to-
Treat Basis
N = 1056
Implanted
Patient
Basis
N = 880
Lead Migration 175 16.6% 19.9%
Infection 39 3.7% 4.4%
Epidural Hemorrhage 0 0% 0%
Seroma 0 0% 0%
Hematoma 1 0.1% 0.1%
Paralysis 0 0% 0%
Safety Information
15
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
CSF Leak 5 0.5% 0.6%
Over/Under Stimula-
tion, Ineffective Pain
Control
46 4.4% 5.2%
Intermittent Stimula-
tion
00%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%
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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.
Table 2: Clinical Experience Safety
Other minor adverse events reported by at least one patient included: receiver malfunction,
skin irritation, unpleasant stimulation, CSF leak, infection at implant site, lead migration,
and OR cable malfunction. Two of the subjects reported multiple events.
Type Number of Patients Resolution
Lead Migration 1 Lead repositioning
and subsequent
replacement
Output malfunction 1 Device replaced
Infection 1 Infection treated
Pain 1 Lead explanted
Safety Information
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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. De Vet, C.P.M. Rijks, C.A. Furnee and F.A.J.M. Van
den Wilderberg. “Spinal Cord Stimulation in Patients with Chronic Reflex Sympathetic Dystrophy.”
New England J of Medicine, 343: 618-24, 2000.
Kim S. H., R.R. Tasker, and M.Y. Oh. “Spinal Cord Stimulation for Nonspecific Limb Pain versus Neuropathic
Pain and Spontaneous versus Evoked Pain.” Neurosurgery, 48(5): 1056-1064, 2001.
Kumar, K., C. Toth, R. Nath, and P. Lang. “Epidural Spinal Cord Stimulation for Treatment of Chronic Pain-
Some Predictors of Success. A 15 year experience.” Surg Neurol, 50: 110-120, 1998.
Lang, P. “The Treatment of Chronic Pain by Epidural Spinal Cord Stimulation.” AXON, 18(4): 71-73, 1997.
Ohnmeiss, D., R. Rashbaum, M. Bogdanffy. Prospective Outcome Evaluation of Spinal Cord Stimulation in
Patients With Intractable Leg Pain. Spine, 21:1344-1351, 1996.
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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 28:65-
71, 1991.
Villavicencio, A.T., J.C. Leveque, L. Rubin, K. Bulsara, and J.P. Gorecki. “Laminectomy versus percutaneous
electrode placement for spinal cord stimulation.” Neurosurgery, 46:399-406, 2000.
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
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19
Warnings
Heat Due to Charging. 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.
Magnetic Resonance Imaging (MRI). You should not be exposed to Magnetic Resonance
Imaging (MRI). Exposure to this diagnostic technology may result in dislodgement of your
Stimulator or leads, heating of the Stimulator, severe damage to the Stimulator electronics
and/or increased voltage through the leads or Stimulator which can cause an uncomfortable
or “jolting” sensation.
Pediatric Use. The safety and effectiveness of spinal cord stimulation has not been
established for pediatric use.
Diathermy. As an SCS patient, you should not have any form of diathermy as either
treatment for a medical condition or as part of a surgical procedure. The high energy and
heat generated by diathermy can be transferred through the leads, causing tissue damage at
the lead site and, possibly, severe injury or death. The Stimulator, whether it is turned on or
off, may be damaged.
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Cardiac Pacemakers. 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.
Implant Damage. Burns may result if the pulse generator case is ruptured or pierced and
patient tissue is exposed to battery chemicals. Do not implant the device if the case is
damaged.
Posture. Changes in posture or abrupt movements may cause decreases, or uncomfortable
or painful increases in the perceived stimulation level. Keep the Remote Control with you at
all times, and turn the stimulation down or off before making posture changes. If unpleasant
sensations occur, the stimulation should be turned off immediately.
Electromagnetic Interference. Strong electromagnetic fields can potentially turn the
Stimulator off, or cause uncomfortable or jolting stimulation. Avoid or exercise care around:
• Theft detectors or security screeners, such as those used at entrances/exits of
department stores, libraries, and other public establishments, and/or airport
security screening devices. It is recommended that you request assistance to
Safety Information
21
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. 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. Next, check the stimulation status with the Remote Control by pressing the power
button and observing the screen.
Always be aware of your surroundings, particularly near theft detectors/security screeners.
Ask for assistance to go around these devices if you feel at all uncomfortable.
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Precautions
Physician training is required.
Medical Devices/Therapies. The following medical therapies or procedures may turn
stimulation off or may cause permanent damage to the implant, particularly if used in close
proximity to the device:
• lithotripsy — high-output sound or shock waves often used to treat gall stones
and kidney stones
• electrocautery — the use of a heated electric probe to stop bleeding during
surgery
• external defibrillation — the use of electrically charged paddles to restart the
heart in an emergency
• radiation therapy — ionizing energy commonly used to treat cancer
• ultrasonic scanning — very high frequency sound waves used to produce images
of internal organs or tissue for diagnostic purposes
• 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
Safety Information
23
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. Sudden stimulation changes, if they occur, may
distract you from attentive operation of the vehicle or equipment.
Post Operative. During the two weeks following surgery, it is important to use extreme
care so that appropriate healing will secure the implanted components and close the surgical
incisions:
• Do not lift objects of more than five pounds.
• Do not engage in rigorous physical activity such as twisting, bending, or
climbing.
• Do not raise your arms above your head.
• Do not pull or jiggle the leads.
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.
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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.
Implant Location. Never attempt to change the orientation or “flip” the implant. Do not
“finger” or play with the implant. If the implant flips over in your body it cannot be charged.
If you know that the device has turned, or if stimulation cannot be turned on after charging,
contact your physician to arrange an evaluation of the system.
In some cases, the skin over your implant may become very thin over time. If this occurs,
contact your physician.
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 be able to restore stimulation by reprogramming the implant in the clinic or
repositioning the lead during another operation.
Device Failure. Implants 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
Safety Information
25
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. If the Remote Control or the Charging System
is to be stored for a period of time, be careful that the storage temperature does not exceed -
20–60 °C (-4–140 °F).
Handle the system components and accessories with care. Do not drop them or submerge
them in water. Avoid all sources of water which can come into contact with the Trial
Stimulator and the Remote Control. Although reliability testing has been performed to
ensure quality manufacturing and performance, dropping the devices on hard surfaces or in
water, or other rough handling, can permanently damage the components.
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.
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26
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.
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.
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 undesireable changes in stimulation and subsequent
reduction in pain relief.
• System failure, which can occur at any time due to random failure(s) of the
components or the battery. These events, which may include battery leakage,
device failure, lead breakage, hardware malfunctions, loose connections,
electrical shorts or open circuits and lead insulation breaches, can result in
ineffective pain control.
Safety Information
27
• 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. However, since the leads are placed in the fluid surrounding
your spinal cord, there is a small risk that spinal fluid may leak from the lead
insertion site following 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. Exposure to magnetic resonance imaging (MRI) can result in noticeable
heat near the implant or the leads; may distort or destroy the image needed for
diagnosis; and may produce enough electromagnetic interference (EMI) to erase
the implant programming, destroy the leads, or cause the leads to move from
their intended location.
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• 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.
• 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.
29
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 4. Velcro® Belt
2. Cable 5. Lead
3. Trial Stimulator
42)!,%15)0-%.4
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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.
•For the Trial Stimulator, use only the Patient Trial Belt supplied by Advanced Bionics.
Using the Trial Equipment
31
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.
• Never submerge the Trial Stimulator or the
Remote Control in water, or leave them
outside in the rain, extreme heat, or
extreme cold. Avoid all sources of water
that can come into contact with the Remote Control and the Trial Stimulator.
• Always turn off the Trial Stimulator, remove it from the belt pocket, and disconnect and
secure the leads before taking a sponge bath.
2EMOTE#ONTROL
4RIAL3TIMULATOR
Patient Trial Handbook
32
• 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.
CAUTION: Always turn the Stimulator off before connecting
or disconnecting your lead(s).
Table 4: Stimulator Connection
1. 2-R 4. Indicator Light
2. 1-L 5. Stimulation On/Off
3. Patch (optional)
Using the Trial Equipment
33
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.
Note: • If you were given a patch electrode for stimulation, an extra one is provided in case the
adhesive wears out. When connecting a new patch electrode, be sure to plug it into the con-
nector securely.
•If you believe cables have come loose from your Trial Stimulator, turn stimulation off and
contact your healthcare professional. Do not attempt to reinsert the cables yourself.
Improper technique may result in overstimulation.
Patient Trial Handbook
34
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
Each button on the Remote Control activates one of the stimulation functions which are
described on the following pages. If you have a successful trial and later receive the
permanent Precision Stimulator, you will learn about additional Remote Control features
that are not described here.
1. Area Button 4. Program Button
2. Up/Activate 5. Stimulation On/Off
3. Down/Save
Using the Trial Equipment
35
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 will immediately look for your Stimulator
and then connect with it, allowing you to make
adjustments to your stimulation.
When you are finished using it (no buttons are being
pressed), the Remote Control will return to the sleep
mode within a minute or so.
Patient Trial Handbook
36
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 Pto retry, or
press to cancel. See “Help” on page 55 for more
information.
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.
Using the Trial Equipment
37
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.
Signal Strength
The Remote Control indicates the signal strength
between the unit and the Stimulator in the upper right
corner of the display:
• If there are no signal bars, move the Remote
Control closer and tilt it. If no signal bars appear, communication may still be
achieved, however, it is at a very weak level.
• If there are 1 or 2 signal bars, there is adequate communication between the
Remote Control and the Stimulator.
Patient Trial Handbook
38
• 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
39
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). To learn about adjusting
the stimulation of individual areas, please see
“Selecting Areas for Level Control” on page 43.
The Level screen also displays a bar graphic near the top center to indicate the battery
charge level of your Stimulator.
Note: This is the battery level of your stimulator, not your Remote Control.
Patient Trial Handbook
40
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.
The Remote Control unit is your direct link to choices available
for tailoring spinal cord stimulation to suit your comfort and
convenience requirements. Keep the Remote Control with you at
all times.
Note: Remember, the Level screen will remain on the display for
approximately one minute if you do not press a button to perform
an action with the Remote Control. After a minute, the Remote
Control will go into idle mode and the display will go blank.
&ULL
/+
,OW
Using the Trial Equipment
41
•Multiple area control is available only if your
system has been programmed to deliver stimula-
tion to separate areas. If you do not have sepa-
rate area control (for example, left leg vs. right
leg) but feel that separate control might improve
your therapy, contact your healthcare profes-
sional to determine what is possible.
Patient Trial Handbook
42
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. The bar replacing
the down arrow means that you have reached the
minimum level and can only increase the stimulation
setting.
Using the Trial Equipment
43
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. From the main Level screen, press the Cbutton
as many times as necessary to cycle through your
programmed area Level screens.
Note: Button presses will move from one area to the next and will eventually return you to the Level
screen.
2. When the named or numbered area that you want to adjust is shown on the screen, press
S (increase) or T (decrease) to change the stimulation level for that area.
The screen will go blank and the Remote Control will go to “sleep” after one minute of
inactivity.
Patient Trial Handbook
44
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. You may have been encouraged to try using specific
programs for different circumstances, or different body positions, or different times in your
daily routine. Programs and their flexibility give you and your healthcare professional a way
to continually “fine tune” your therapy.
Using the Trial Equipment
45
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.
Pressto 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. Pressingfrom program 1
also returns you to the Level screen.
Patient Trial Handbook
46
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 acti-
vated or saved (see below).
Using the Trial Equipment
47
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.
Saving Program Changes
If you do make a stimulation level adjustment and
decide that you prefer it to the original setting, you
can save the new level (or any other change) and
make it a permanent part of the program:
Patient Trial Handbook
48
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
49
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. After saving the new program, the
Remote Control will return to the Level screen.
Patient Trial Handbook
50
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.” Do not
ignore the message to replace the batteries!
When you press P from the Remote Battery Low screen, the Remote Control will make a
check of the Trial Stimulator’s battery status also.
If the Trial Stimulator’s battery is full/OK, the Remote Control will return to the Level
screen without displaying a message.
Using the Trial Equipment
51
• 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
52
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
53
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
54
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.
Note: It is recommended that you remove the batteries if the Remote Control is not going to be used
for an extended period of time.
55
5Help
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. When the indicator light is blinking and you still
do not feel stimulation:
Patient Trial Handbook
56
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. When the indicator light is not blinking and you do not feel stimulation, replace the Trial
Stimulator battery.
4. Call your physician’s office 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 Coverage is in a Different Area Than at the Doctor’s Office
1. If stimulation moves, and you did not activate a different program, you should call your
doctor. It is possible that the leads may have moved.
Help
57
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
58
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. Then reposition the Remote Control until
it beeps. This indicates that communication has been
established.
Help
59
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.
Call our Customer Service Department at (866) 360-4747 if the problem continues.
Patient Trial Handbook
60
“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. If this does not work, please contact
our Customer Service Department.
Note: The Remote Control will go to the Level screen
when P is pressed, or to idle mode if Pis not
pressed within one minute.
Help
61
Accessories
Washing the Velcro® Belt
1. Wash the belt with mild soap and warm water.
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) 360-4747
• Customer Service Fax: (661) 362-1503
• Address: Advanced Bionics Corporation
Pain Management Division
Mann Biomedical Park
25129 Rye Canyon Loop
Valencia CA 91355
Patient Trial Handbook
62
Glossary
63
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.
A therapeutic procedure used
to heat body tissue by high-frequency
electromagnetic currents.
DISPLAY.
The Remote Control screen.
ELECTRICAL PULSE GENERATOR.
Also
called an implantable pulse generator
(IPG); 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.
EXTERNAL TRIAL STIMULATOR (ETS).
An electrical pulse generator used during
the Trial Phase of SCS therapy evaluation.
Patient System Handbook
64
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.
The movement of a
lead away from the spinal cord.
LEAD.
A surgical wire that sends electrical
stimulation pulses from a pulse generator
to the spinal cord.
LEVEL.
Term used on the Remote Control
screen to identify the amplitude or
strength of stimulation pulses.
MRI.
Magnetic Resonance Imaging; the use
of a nuclear magnetic resonance
spectrometer to produce electronic images
of tissues and organs.
PAIN PROFILE.
A record or documentation
of pain locations, occurrences, and
intensity. A pain "chart" for determining
therapy.
PARESTHESIA.
Sensation produced by
electrical stimulation.
Glossary
65
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.
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.
P
Program Button icon.
REMOTE CONTROL.
A battery powered
hand-held computer used to adjust
stimulation.
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. See
also Idle Mode.
SPINAL CORD STIMULATION (SCS).
A
method of applying electrical pulses to the
spinal cord to block/mask pain signals to
the brain.
II Patient Trial TC 3 US Glossary.fm Page 65 Friday, March 10, 2006 11:12 AM
Patient System Handbook
66
STIMULATION.
When used as a therapy for
pain, an artificially applied, low-level,
pulsating electrical "shock" felt as a
tingling or pulsating sensation in the area
of pain and perceived enough to reduce
the awareness of pain.
STIMULATION COVERAGE.
Area on the
body where stimulation occurs. (See
Area.)
E
or
Stimulation On/Off Button icon.
SYSTEM FAILURE.
Inability of stimulator
system to deliver stimulation therapy.
TRIAL SCREENING.
Temporary evaluation
of electrical stimulation of the spinal cord.
TRIAL JOURNAL.
Questionnaire, chart and
activity log used to record information
during the Trial Phase.
TRIAL STIMULATOR SYSTEM.
Precision
system components used during a limited
time to evaluate SCS therapy. The Trial
Stimulator System consists of an External
Trial Stimulator (ETS), temporary or
permanent lead(s), lead cable(s), the
Remote Control, and a Velcro® Belt.
VA S .
Visual Analog Scale. Numerical scale/
graph used to chart before-and-after pain
levels included in the Pain Profile.
WARNING.
Potential hazards that you must
be aware of to avoid serious situations that
may cause injury or death.
II Patient Trial TC 3 US Glossary.fm Page 66 Friday, March 10, 2006 11:22 AM
Index
67
Index
C
cable ............................................. 10, 54
D
diathermy ..................................... 43, 59
I
indicator ............................................. 12
L
label .................................................... 13
level .................................................... 22
M
MRI .................................................... 51
P
paresthesia ............................................2
Patient Identification card ..................12
T
Trial Journal .........................................7
V
VAS ..................................................7, 8
Patient Trial Handbook
68
The following is federal government communications regulation information about the Pre-
cision™ 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 oper-
ation.
The Precision™ System components should only be serviced by Advanced Bionics. Do not
attempt to open or repair any of the components. Unauthorized opening of or attempts to
repair the components will void the warranty.
Changes of modifications to this product not authorized by Advanced Bionics Corporation
could void the FCC Certification and negate your authority to operate this product.
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
PAIN MANAGEMENT DIVISION
Mann Biomedical Park
25129 Rye Canyon Loop, Valencia, CA 91355
(661) 362-1400, (661) 362-1500 Fax
9055426-001 Rev.A ©2006 Advanced Bionics Corp. All rights reserved.
Advanced Bionics®Corporation