Boston Scientific Neuromodulation PSC5210W Precision SCS System Remote Control User Manual II Patient Handbook

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Document Description	Patient Handbook
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Date Submitted	2004-08-26 00:00:00
Date Available	2004-12-13 00:00:00
Creation Date	2004-06-04 20:42:09
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MP9055184 Rev A
Federal law restricts this device to sale, distribution and use by or on the order of a physician.
CAUTION:
Patient System Handbook
DRAFT
ii
Velcro® is a registered mark of Velcro Industries, Manchester, New Hampshire. Other brands and
their products are trademarks or registered trademarks of their respective holders and should be
noted as such.
Registered Trademarks
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.
Guarantees
©2004 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.
Copyright
Patient System Handbook
Safety Information ............................................................7
System Description ...........................................................3
Buttons and Basic Operation ................................................ 27
Stimulation On and Off ........................................................ 30
The Level Screen .................................................................. 30
Stimulation Level Control ....................................................... 33
Selecting Areas for Level Control ........................................... 34
Programs ............................................................................. 35
Selecting and Activating Programs ........................................ 36
The Remote Control .......................................................27
Indications for Use ................................................................. 7
Precision System Clinical Summary .......................................... 7
Contraindications ................................................................. 16
Warnings ............................................................................ 16
Precautions .......................................................................... 19
Adverse Effects ..................................................................... 23
Introduction .......................................................................1
Table of Contents
iii
Table of Contents
iv
Saving Program Changes ..................................................... 37
Options ............................................................................... 40
Understanding Battery Status Messages ................................ 46
Battery Replacement ............................................................. 50
Index..................................................................................75
Glossary ...........................................................................71
Implanted Pulse Generator .................................................... 65
Externals .............................................................................. 67
Limited Warranty ...........................................................65
Stimulation ........................................................................... 59
Remote Control Display Messages ........................................ 61
Accessories ......................................................................... 64
Contacting Advanced Bionics ............................................... 64
Help ..................................................................................59
Getting Started .................................................................... 53
Charging Your Implant ......................................................... 54
Charging the Implant .....................................................51
Patient System Handbook
Introduction
Before receiving your new implant, you had the
opportunity to test stimulation therapy and
decide if it would work for you. By choosing to
have a stimulator surgically implanted, you
The Advanced Bionics® Precision™ SCS (Spinal
Cord Stimulation) system is prescribed for the
management of chronic pain. The system
electrically stimulates the spinal cord to alter the
perception of pain signals that move along the
nerve pathways on either side of the spine.
Paresthesia is the term that describes the light,
tingling sensation—the “feeling”—of spinal
cord stimulation.
2
Advanced Bionics is an organization dedicated to helping you manage your pain. We will
help you make the most of this therapy for an improved quality of life.
confirmed that paresthesia is capable of providing you with good to excellent pain relief. As
you go forward with this therapy, your health professionals will work with you to find the
most comfortable level of paresthesia to cover the painful areas by adjusting your implant’s
settings. Although you may have pain areas that cannot be reached by spinal cord
stimulation, the goal is to bring you the most effective pain relief possible. The more you
help and work with your health professionals, the more likely you are to achieve the best
outcome possible from your new Precision system.
Patient System Handbook
System Description
The Remote Control, the heart of the Precision system, is a powerful yet easy to use tool for
managing every aspect of your pain treatment—from controlling the level, or strength, of
stimulation to accessing special treatment programs and program options.
The Precision system includes both implanted and external components: During your
surgery, one or more wires called leads were placed along your spinal cord where pain
signals to the brain can be intercepted. The lead was then attached to an implantable pulse
generator (IPG), also referred to as an implant. The IPG is commonly placed in the
abdomen, upper buttock, or subclavicular area. The implant sends a small electrical current
to a series of stimulating contacts, called electrodes, at the end of the lead. The batterypowered implant is controlled by a hand-held programmer or Remote Control, and is
periodically recharged using a separate Charging System.
4
These subjects are covered on the following pages, and we encourage you to read this
manual entirely. If you have any questions, or need clarification of anything contained in
this manual, feel free to contact our Customer Service Department at (866) 360-4747.
3. how to recharge the implant.
2. how to use the Remote Control, and
1. what to be aware of for safety,
To make the most of your Precision system, it’s important to learn:
Patient System Handbook
Remote Control
Charger
Charger Base Station
Power Supply
Remote Control Cover
Velcro® Charging Belt
Charger Adhesives (52 pieces)
Remote Control Batteries (3)
Carrying Case
(1)
(1)
(1)
(1)
(1)
(1)
(1)
(1)
(1)
Permanent Patient Identification Card
Back
Front
Before reading more about the Precision System, first check that all of the following items
were included in your Patient Kit. (And check to be sure you have your Temporary Patient
Identification Card; keep it with you until you receive your permanent card.) If any item is
missing, please call our Customer Service department for a replacement.
System Description
6
For now, that’s all you need to do to get
started. For more information on the
Charging System and its use, see
“Charging the Implant” on page 51.
Find a convenient electrical outlet, one
that won’t expose the Charging System
parts to water or direct heat, and plug in
the Base Station Power Supply. Next,
connect the Power Supply to the Base
Station, and locate the Base Station on a
flat surface. Finally, place the Charger in
the Base Station with the stimulation on/
off button facing up.
Patient System Handbook
Safety Information
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
Indications for Use
The Advanced Bionics Precision™ 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.
8
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
included the VAS, pain drawings, medication use, SIP (Sickness Impact Profile), isometric
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 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.
Patient System Handbook
9
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
implanted with a SCS system. In this study, 27/41 patients, 66%, had permanent implants.
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.
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.
Safety Information
10
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
internalized. A retrospective analysis of patients with unilateral leg and/or buttock pain
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.
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.
Patient System Handbook
Safety Evaluation
Eleven studies were identified based on the detailed inclusion/exclusion criteria to
demonstrate the safety of the PRECISION System. The studies included a total of 1056
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.
11
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.
treated initially with SCS and bilateral leg or mainly low back pain treated initially with
spinal infusions of opioids was then done.
Safety Information
12
# Patients
With
Adverse
Event
175
39
Risks
Lead Migration
Infection
Epidural Hemorrhage
Seroma
Hematoma
Paralysis
CSF Leak
0.5%
0%
0.1%
0%
0%
3.7%
16.6%
Intent-toTreat Basis
N = 1056
0.6%
0%
0.1%
0%
0%
4.4%
19.9%
Implanted
Patient
Basis
N = 880
Table 1: Summary of Risks Identified in the Retrospective Clinical Studies
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.
Patient System Handbook
0
16
35
22
45
Intermittent Stimulation
Pain Over Implant
Allergic Reaction
Skin Erosion
Lead Breakage
Hardware Malfunction
Loose Connection
Battery Failure
Other
4.3%
0.2%
0%
2.1%
3.3%
0%
0.6%
1.5%
0%
4.4%
5.1%
0.2%
0%
2.5%
4.0%
0%
0.7%
1.8%
0%
5.2%
13
Clinical Experience-Safety
Clinical data has been collected during a clinical study of the PRECISION™ System. As of
January 15, 2004, 35 subjects were enrolled in the study at multiple sites and 26 subjects had
a successful trial stimulation period and were implanted with the PRECISION™ System.
46
Over/Under Stimulation, Ineffective Pain
Control
Safety Information
1
Lead Migration
Output malfunction
Infection
Pain
Lead explanted
Infection treated
Device replaced
Lead repositioning
and subsequent
replacement
Resolution
14
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.
References
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.
Number of Patients
Type
Table 2: Clinical Experience Safety
The follow-up period for the 26 implanted patients ranged from two weeks to six months.
The following major adverse events were reported.
Patient System Handbook
Segal, R., B. Stacey, T. Rudy, S. Basser, J. Markham. “Spinal Cord Stimulation Revisited.” Neurological
Research, 20:391-396, 1998.
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.
Ohnmeiss, D., R. Rashbaum, M. Bogdanffy. Prospective Outcome Evaluation of Spinal Cord Stimulation in
Patients With Intractable Leg Pain. Spine, 21:1344-1351, 1996.
15
Lang, P. “The Treatment of Chronic Pain by Epidural Spinal Cord Stimulation.” AXON, 18(4): 71-73, 1997.
Kumar, K., C. Toth, R. Nath, and P. Lang. “Epidural Spinal Cord Stimulation for Treatment of Chronic PainSome Predictors of Success. A 15 year experience.” Surg Neurol, 50: 110-120, 1998.
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.
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.
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.
Safety Information
are unable to operate the SCS system
have failed trial stimulation by failing to receive effective pain relief
are poor surgical risks
are pregnant
16
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
IPG or lead(s), heating of the IPG, severe damage to the IPG electronics and/or increased
voltage through the leads or IPG which can cause an uncomfortable or “jolting” sensation.
Warnings
•
•
•
•
Contraindications
Patients contraindicated for permanent SCS therapy are those who:
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.
Spieglemann, R. and W.A. Friedman. “Spinal Cord Stimulation: A Contemporary Series.” Neurosurg 28:6571, 1991.
Patient System Handbook
Posture.
17
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
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.
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.
Diathermy.
As an SCS patient, you should not have any form of diathermy as either as
treatment for a medical condition or as part of a surgical procedure. The high energy and
heat generated by diathermy can be transferred through your stimulator system, causing
tissue damage at the lead site and, possibly, severe injury or death. The IPG, whether it is
turned on or off, may be damaged.
Pediatric Use.
The safety and effectiveness of spinal cord stimulation has not been
established for pediatric use.
Safety Information
18
• 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 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 IPG. If
the IPG suddenly turns off by itself, first move away from the area. Next, check the implant
status with the Remote Control by pressing the Stimulation On/Off button and observing the
Electromagnetic Interference.
Strong electromagnetic fields can potentially turn the
stimulator off, or cause uncomfortable or jolting stimulation. Avoid or exercise care around:
all times, and turn the stimulation down or off before making posture changes. If unpleasant
sensations occur, the stimulation should be turned off immediately.
Patient System Handbook
•
•
•
•
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
Medical Devices/Therapies.
19
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:
Physician training is required.
Precautions
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.
screen. The IPG may need to be recharged before stimulation can be re-started. (See
“Charging the Implant” on page 51 for additional information.)
Safety Information
20
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:
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.
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
Before having procedures, medical therapies, or diagnostics, have your healthcare
professional call our Customer Service department at (866) 360-4747 for proper
instructions.
•
Patient System Handbook
Lead Location.
21
In some instances a lead can move from its original location, and
stimulation at the intended pain site can be lost. If this occurs, consult your physician who
may able to restore stimulation by reprogramming the implant in the clinic or repositioning
the lead during another operation.
In some cases, the skin over your implant may become very thin over time. If this occurs,
contact your physician.
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.
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.
Do not exercise or attempt to move heavy objects, and avoid deep bending and stretching.
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.
Safety Information
22
in these devices can explode in fire. Dispose of used batteries in accordance with local
Component Disposal. Do not dispose of the Remote Control or Charger in fire. The battery
Handling.
Handle the system components and accessories with care. Do not drop them or
submerge them in water. Avoid all sources of water that can come into contact with the
devices. 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. (See “Limited Warranty” on page 65.)
Storage.
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).
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
charging (up to four hours), turn off stimulation and contact your physician so that the
system can be evaluated.
Patient System Handbook
•
•
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,
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:
Cell Phones.
23
While we don’t anticipate any interference with cell phones, the full effects of
interaction with cell phones are unknown at this time.
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.
regulations. The IPG should be explanted in the case of cremation, and returned to
Advanced Bionics.
Safety Information
24
•
•
•
•
•
electrical shorts or open circuits and lead insulation breaches, can result in
ineffective pain control.
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
Patient System Handbook
•
•
•
•
•
25
the implant programming, destroy the leads, or cause the leads to move from
their intended location.
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 IPG or lead site.
Safety Information
26
Patient System Handbook
The Remote Control
Buttons and Basic Operation
To use most Remote Control functions, you will simply
press a button as you would on a TV remote control.
Other functions require a “long press,” which is described
in “Selecting Options” on page 41.
Each button on the Remote Control activates one or more
of the stimulation functions which are described in detail
on the following pages of this section.
Up/Activate
Area Button
Stimulation On/Off Button
27
Down/Save
Program Button
28
When it is not being used, the Remote Control sets
itself in a “sleep” or idle mode and the display screen
is blank. When you press any button except E
(stimulation on/off) during this sleep mode, the
Remote Control will “wake up” and display the
screen shown on the right. After you unlock the
buttons by pressing D, the remote will immediately
look for your implant 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 will return to
the sleep mode within a minute or so.
Patient System Handbook
Keys Locked
Press P To
Unlock
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: If there is a problem communicating with the
implant, the message “No Response” will appear
on the Remote Control screen. See “Help” on
page 59 for more information.
Good communication between your implant and the
Remote Control is very important. For that reason,
you will sometimes see the message “Connecting...”
while you are using the Remote Control because it is
always checking for the implant.
29
The Remote Control
30
The Level Screen
Whenever stimulation is turned on, or after the
Remote Control is awakened from sleep/idle mode,
the remote display defaults to the Level screen.
When you press the S or T button from this display,
you’re able to increase or decrease the stimulation
strength, or level, of all of your pain areas at once (if
your implant was programmed to treat more than one
Stimulation On and Off
The Remote Control uses a “dedicated” stimulation
on/off switch.You may press E at any time—even
during the remote’s sleep or idle mode—to turn
stimulation on or off. The remote will briefly display
a message notifying you of the on or off status.
Patient System Handbook
The Level screen also displays a bar graphic in the
upper right corner to indicate the battery charge level
of your implant. The graphic is very easy to
understand: Three filled-in bars means that your IPG
has a fully-charged battery. As the battery strength
wears down, depending on your stimulation settings
and usage, the bars will “empty” accordingly. For
complete information on maintaining your implant’s
battery for uninterrupted delivery of the therapy
prescribed for you, see “Charging the Implant” on
page 51.
Low
OK
Full
area). To learn about adjusting the stimulation of individual areas, please see “Selecting
Areas for Level Control” on page 34.
31
The Remote Control
32
• 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 health professional to
determine what is possible.
Note: • Remember, the Level screen will remain on the display for approximately one minute if you
don’t press a button to perform an action with the Remote Control. After a minute, the
remote will go into idle mode and the display will go blank.
Patient System Handbook
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.
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:
33
The Remote Control
34
When you’ve finished making your change, the Remote Control will return to the Level
screen.
2. When the named or numbered area that you want to adjust is shown on the screen, press
S or T to change the stimulation level for that area.
Note: Button presses will move from one area to the next and will eventually return you to the Level
screen.
1. From the main Level screen, press the Cbutton
as many times as necessary to cycle through your
programmed area Level screens.
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:
Patient System Handbook
35
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.
The Remote Control
36
2. Press Duntil the program you want is
highlighted, then press S to activate the program.
Selecting and Activating Programs
1. Press the Dbutton from the Level screen to go to
the Program screen.
From the Program screen, each additional
Dbutton press cycles you through the program
numbers. The black highlight box shows where
you are in the cycle. Pressing Dfrom program 4
returns you to the Level screen.
Patient System Handbook
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:
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.
• An underline beneath a program number means
that program was the most recently activated,
saved (see below), or restored (see page 44) program.
Note: • You might not have four programs saved in your
Remote Control. Empty program slots will have
an X beside the program number. If you try to
activate an empty program, nothing will happen.
37
The Remote Control
38
If you confirm the change (Yes, or D), the program
will be updated and saved. If you decide not to make
a permanent change, pressing Cwill return you to
the Program screen.
The Remote Control will first ask you to confirm that
you want to “overwrite” the program; press the
appropriate button.
3. With the active program selected, press T to save
the change in the remote’s memory.
2. From the Program screen, press Das many times
as necessary to select the active program; that is,
the program that is currently running and the one
you’ve just changed.
1. After making a change to a program, press D
from any screen to return to the Program screen.
Patient System Handbook
39
You may also save a program change as a completely new program if an empty program slot
(X) is available: Simply select the empty slot using D and press T. After saving the new
program, the Remote Control will return to the Level screen.
The Remote Control
40
If you’ve been told about program options and instructed in how to use them, you may
realize that you probably won’t “exercise” your option settings very often. However, if your
Remote Control has been set up to access options, please follow the steps detailed in
“Selecting Options” on page 41 to make adjustments.
Options
Under some circumstances, and depending on your treatment prescription, your healthcare
provider may have given you therapy control beyond selectable programs by making special
options available to you. Program options make it possible for you to change certain preset
stimulation settings, and/or return changed programs to their original clinic settings. The
ability to go back to original settings allows you to change your mind... then change your
mind again... about how satisfied you are with your stimulation paresthesia.
Patient System Handbook
Rate, or how many times-per-second your
implant sends a stimulation pulse, and
Pulse Width, or how long each
stimulation pulse lasts.
41
Selecting Options
To access the options that may be available through your Remote Control, you will need to
use a “long” button press. This simply means that you will press and hold a button until a
Note: Restore is available to all patients. However, Rate and/or Pulse Width may not be available
to you. Their availability would have been discussed with you at your first programming
session.
•
•
There are three possible options. One of these,
Restore, is not a stimulation setting but is similar to
an “undo” feature. It returns a changed program
back to its original settings. The other two options
are stimulation settings that can affect the overall
feeling of the stimulation you receive:
The Remote Control
42
Note: The Remote Control will beep to notify you if you reach a preset limit while increasing or
decreasing the Rate.
3. Press either S or T to increase or decrease the
Rate.
2. To move to another area, press Cbriefly (a
“normal” press) to cycle through your
programmed areas until you find the Rate Area
screen (2, 3 or 4) that you want.
To Adjust Stimulation Rate:
1. From the Level screen, press and hold Cuntil
you see the Rate Area 1 screen. If this is the area
you want to adjust, press either S or T to
increase or decrease the Rate.
particular option screen is displayed. The action you take next depends on which option you
want to adjust. Follow the appropriate instructions below:
Patient System Handbook
43
3. To move to another area, press Cbriefly (a “normal” press) to cycle through your
programmed areas until you find the Pulse Width Area screen (2, 3 or 4) that you want.
2. If the Rate Area 1 screen is displayed, make
another long Cbutton press to Pulse Width Area
1. If this is the area you want to adjust, press
either S or T to increase or decrease the Pulse
Width.
Note: If you don’t have access to the Rate option, the long
press will take you directly to the Pulse Width Area
1 screen.
To Adjust Stimulation Pulse Width
1. From the Level screen make a long Cbutton
press to Rate Area 1.
To return to the Level screen from any Rate screen, press and hold Cuntil Pulse Width
Area 1 is displayed, then press and hold Cagain to see the Level screen. If you don’t have
access to the Pulse Width option, the Level screen will appear right away.
The Remote Control
44
To Restore a Clinic Program
Over time, you may have made changes to one or
more of the programs originally saved to your
Remote Control. The Restore option allows you to
return to those original stimulation settings if ever you become dissatisfied with a changed
program.
To return to the Level screen from any Pulse Width
screen, press and hold C.
• The Remote Control will beep to notify you if you
reach a preset limit while increasing or decreasing the Pulse Width.
Note: • You may also find Pulse Width Area 1 by making a long Cbutton press from any Rate
screen.
4. Press either S or T to increase or decrease the Pulse Width.
Patient System Handbook
2. If necessary, press Dto cycle through the
program numbers to select the program you want
to restore. When the desired program is
highlighted, press S. The Remote Control will
briefly flash a message confirming the
restoration.
Note: The highlighted program is the current selection;
an underline indicates the last program saved,
activated, or restored; an X indicates an empty
program slot.
1. From the Level screen, press and hold Dto reach
the Restore screen. Program 1 will be
highlighted.
45
The Remote Control
46
If the implant battery is full or OK, the Remote
Control will return to the Level screen. To learn
about the messages you will see when the implant’s
battery is less than full, see page 48.
When the Remote Control batteries are at a low
power level, the battery message shown here will be
displayed. When you press the Dbutton from this
screen, the remote will make a check of your
implant’s battery status also.
About the Remote Control Batteries
As an SCS patient, it’s essential that you appreciate the importance of battery power! The
replaceable batteries in your Remote Control and the rechargeable battery in your stimulator
work together to provide you with consistent, dependable parasthesia. Always pay close
attention to the battery status messages described in this section.
Understanding Battery Status Messages
Patient System Handbook
Note: Make a habit of replacing the Remote Control
batteries when you first see the Remote Battery
Low message. See “Battery Replacement” on
page 50.
Next, you’d see the more urgent message shown
opposite. You must respond immediately! When you
press D, the remote will make another check of your
implant battery and may display one of the messages
shown on the following page.
First, you'd see a message meaning that (because of
its low-power condition) the Remote Control can't
send stimulation changes to your implant. You will
only able to turn stimulation on or off.
If you don’t respond to the Remote Battery Low
message in a timely manner, the batteries will
eventually drain to the point of not having enough
power to manage your stimulator.
47
The Remote Control
48
If the implant battery is low, the Remote
Control will display the message shown
at right. Press Dto return to the Level
screen.
If the implant battery is very low, the
remote will display this notice to recharge
the stimulator battery immediately.
Stimulation has most likely been turned
off automatically. Pressing Dfrom this
screen will prompt the message explained
on the following page.
•
•
About Your Implant Battery
When the Remote Control checks the condition of
your implant battery, you may see one or more of the
following messages depending on the battery’s
charge level:
Patient System Handbook
The Must Recharge message means that your
implant has turned itself off and gone into a
“hibernation” mode. You may expect a three--four
hour charge period before you can resume your
therapy.
49
The Remote Control
50
The Remote Control will connect to the implant in approximately 30 seconds.
4. Align the battery compartment cover on the case
and slide the cover into position until it snaps
closed.
3. Place the three new AAA batteries in the slots,
matching the positive (+) and negative (-)
markings.
2. Remove the old batteries.
Battery Replacement
1. On the rear of the remote, push in slightly and
slide down the battery compartment cover.
Patient System Handbook
Charging the Implant
•
•
•
once a day
every other day
once or twice a week.
Based on your stimulation settings, you may charge:
51
The Remote Control provides an easy-view implant battery charge status graphic on the
Level screen as well as messages to inform you of the battery’s condition. These messages
are explained beginning on page 48.
Your Precision implant uses a rechargeable battery to provide stimulation. The Precision
System’s programming software gives your healthcare provider recommendations for
recharging your implant, and you should be given guidelines on when to charge.
52
If discontinuing stimulation for an extended period of time, the implant should first be fully
charged. Additionally, the implant should be fully charged every month if stimulation is not
used.
Note: If the implant is not recharged as recommended, stimulation will stop due to a low battery. If
this happens, the implant must be recharged within three days from loss of stimulation. If
stimulation stops and you have lost or cannot get to your charger within five days, contact
Customer Service immediately at (866) 360-4747 for a new charger.
Following the general recommendations made by your healthcare provider, you have the
freedom to establish the charging routine that suits you best. Keep in mind that if you do not
charge your implant before it reaches the very low/”hibernation” condition, stimulation will
eventually stop until you charge again. But charging the Precision is a such simple process,
requiring so little effort, that you should never have to experience an interruption of your
pain therapy.
Patient System Handbook
Note: Advanced Bionics recommends the use of the Velcro® belt for charging.
When charging, you can opt to use either a Velcro® belt or adhesive patches to hold the
Charger over the implant. Before using the Velcro® belt, you may cut it to a more
convenient size, but be careful not to cut too much. The patch adhesives are made of nonreactive material suitable for most sensitive skin types.
3. Place the Charger in the Base Station.
2. Plug the Power Supply into a standard AC wall outlet, then plug the other end into the
Base Station connector.
1. Find a convenient place with a flat, clear surface to keep the Base Station plugged in.
53
Getting Started
The Charging System for your implant consists of the Charger unit, a Base Station, and a
Power Supply. Power plug adaptors are also included for Charging System use in countries
other than U.S. The Base Station is designed to remain connected to a power outlet at all
times. When it is not being used, keep the Charger on the Base Station so that it is always
ready to deliver a charge.
Charging the Implant
Light Status:
Green – ready for full charge
Amber – partial charge
Off – not ready for charging
54
Charging Your Implant
1. When the indicator light is green, remove the Charger from the Base Station. (The
indicator will go off, regardless of the ready status of the Charger.)
Indicator
•
•
•
The Charger is completely ready and able
to fully charge your implant when the
indicator light is green. If the light is
amber-colored, the Charger can only
partially charge the implant. It may be
used, but it may not be able to return your
implant to a full charge (and you may
need to charge sooner than you normally
would).
Patient System Handbook
55
Place the Charger in the pocket with the power button facing out.
Using the Velcro® Belt:
3. Press the power button. The indicator light will come on again, and the Charger will
begin beeping steadily to signal that it is searching for the implant.
Apply the adhesive patch to the backside of the Charger
by peeling the clear liner from the patch. Remove the skin
side beige liner.
2. Using the Adhesive Patch:
Charging the Implant
56
Note: If you accidentally locate the patch in the wrong place, or if the Velcro® belt moves out of
alignment, the Charger will start beeping again. Use a new adhesive patch or readjust the
belt to place the Charger back into position.
Secure the Charger over the implant either by pressing the adhesive side of the patch to
the location, or by attaching the Velcro® belt.
4. Locate the Charger over the implant. When the Charger is aligned with the implant, the
beeping will stop.
Patient System Handbook
Do not confuse the end of charge signal
(a distinct double beep) with the steady,
continuous misalignment signal.
5. When the Charger emits a distinct
double beep, the implant is charged.
Switch off the Charger, remove the
adhesive patch or Velcro® belt, and
return the Charger to the Base Station.
57
Charging the Implant
58
The rechargable implant battery should provide you with at least five years of service. Over
time and with repeated charging, the battery in your implant will lose the ability to recover
its full capacity. As a result, you may need to recharge your implant for longer periods and/
or more often after five years of service. Your implant will need replacement when
stimulation can no longer be maintained with routine charging.
• The end of a charge signal is a distinct double beep, and the alignment indicator is a steady
continuous signal.
Note: • Depending on your program parameters, you may expect daily recharging times as low as
10 minutes up to four hours, or weekly recharging times from as low as one hour up to four
hours.
Patient System Handbook
Help
3. Charge the implant. When the charge is
complete, try turning the stimulation on.
2. Turn up the level of stimulation from the main
screen or area screens.
1. Toggle the Remote Control stimulation on/off
button to make sure that stimulation is ON. If the
Remote Control receives confirmation from the
implant, it will flash “Stimulation On.”
No Stimulation
Stimulation
59
60
3. Large magnetized speakers or large power lines that emit interference may also turn off
stimulation. If you cannot turn the stimulator back on with your Remote Control, you
may need to charge the implant.
2. Although unlikely, anti-theft screeners can turn stimulation off. If you cannot turn the
stimulator back on with your Remote Control, you may need to charge the implant.
1. When the implant battery needs to be recharged, it will stop stimulating. Check the
battery status with the Remote Control and recharge if necessary, then turn stimulation
back on. If the implant regularly stops stimulating before you charge, you can charge
more often.
Stimulation Shuts Off
2. Always keep the Remote Control with you, so that you can adjust your stimulation
levels as needed.
1. Stimulation can change depending on body position (lying down, standing or bending).
Stimulation Increases or Decreases on Its Own
4. Call our Customer Service Department at (866) 360-4747 if the above steps do not solve
the problem.
Patient System Handbook
Stimulation has stopped if you see this message. You
will probably need to recharge your implant for as
long as 3–4 hours before stimulation resumes.
“Recharge Stimulator Now” and “Must Recharge” on the
Display
Remote Control Display Messages
61
Help
62
When the Remote Control displays “No Response,”
there is a communication problem between the
remote and the implant probably caused by a weak
implant battery. Press the Dbutton. If the Remote
Control is still not able to communicate with your
implant, the “No Response” message will appear
again; press D again. If the remote connects with
your implant, you will be returned to the display you
“No Response” on the Display
The batteries in your Remote Control need to be
replaced with three fresh AAA batteries (refer to
“Battery Replacement” on page 50).
Remote Battery Low” on the Display
Patient System Handbook
Note: The remote will go to idle mode when D is pressed,
or within fifteen seconds if D is not pressed.
Please call our Customer Service Department at your
earliest convenience to report the error code.
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 D, wait a few
seconds, and try the action again.
“Action Failed” on the Display
Call our Customer Service Department at (866) 360-4747 if the problem continues.
Occasionally, telemetry problems happen because the Remote Control cannot find the
implant because of orientation or interference. Move the remote closer and then press the
Dbutton.
63
were using before the problem began. If the problem cannot be corrected, the Remote
Control will go into sleep mode. Recharge the IPG and check to see if the problem is solved.
Help
64
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
•
•
•
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:
Wash the belt with mild soap and warm water.
Washing the Velcro® Belt
Accessories
Patient System Handbook
Limited Warranty
65
An IPG that fails to function within normal tolerances within (1) year from the date of
surgery is covered under this Limited Warranty. The liability of Advanced Bionics® under
this warranty shall be limited to: (a) replacement with a functionally equivalent IPG; or (b)
full credit equal to the original purchase price to be applied towards the purchase of a new
Advanced Bionics® Corporation (hereinafter referred to as Advanced Bionics®) warrants
to the patient who receives a Precision™ System that the implanted pulse generator
(hereinafter referred to as the IPG), Model SC-1110, is free from defects in workmanship
and materials for a period of one (1) year from the date of surgical implant of the IPG. This
warranty only applies to the patient (recipient, hereinafter referred to as the patient), and no
other individual.
Implanted Pulse Generator
66
This warranty does not include the leads, extensions or surgical accessories used with
the Precision™ IPG.
4. Failure of the IPG must be confirmed by Advanced Bionics®. This warranty specifically
excludes defects or malfunctions caused by: (a) fire, floods, lightning, natural disasters,
water damage and other calamities commonly defined as “Acts of God”; (b) accident,
misuse, abuse, negligence, or customer’s failure to operate the IPG in accordance with
manufacturer’s instructions; (c) unauthorized attempts to repair, maintain, or modify the
equipment by the customer or any unauthorized third party; or (d) attachment of any
equipment not supplied by Advanced Bionics® without prior approval.
3. The IPG must be implanted prior to the “use before” date.
2. The IPG must be returned to Advanced Bionics® (or authorized agent) within 30 days
of malfunction or discovery of defect, and shall be the property of Advanced Bionics®.
1. The product registration card must be completed and returned to Advanced Bionics®
within 30 days of surgery in order to obtain warranty rights.
IPG. Product claims under Advanced Bionics® Limited Warranty are subject to the
following conditions and limitations:
Patient System Handbook
67
A Remote Control device or Charger or Charger Base Station component that fails to
function within normal tolerances within one (1) year from the date of surgery or purchase is
covered under this Limited Warranty. The liability of Advanced Bionics® under this
warranty shall be limited to: (a) replacement with a functionally equivalent component; or
Externals
Advanced Bionics® warrants to the patient that the Remote Control device, Model
SC-5210, and Charger System (Charger, Model SC-5300, and/or Charger Base Station,
Model SC-5305) are free from defects in workmanship and materials for a period of one (1)
year from the date of purchase of a new Precision™ Patient Kit.
This warranty is in lieu of any other warranty, expressed or implied, including any warranty
of merchantability or fitness for intended use. Except as expressly provided by this Limited
Warranty, Advanced Bionics® shall not be responsible or liable for any direct,
consequential or incidental damages caused by device malfunction, failure or defect,
whether the claim is based on warranty, contract, tort or otherwise.
5. The decision as to product replacement or credit shall be made solely at the discretion of
Advanced Bionics®. For a replacement IPG, the warranty will run only to the end of the
warranty period for the original IPG that was replaced.
Limited Warranty
68
3. The component failure must be confirmed by Advanced Bionics®. This warranty
specifically excludes defects or malfunctions caused by: (a) fire, floods, lightning,
natural disasters, water damage and other calamities commonly defined as “Acts of
God”; (b) accident, misuse, abuse, negligence, or the customer’s failure to operate the
system and its components in accordance with manufacturer’s instructions; (c)
unauthorized attempts to repair, maintain, or modify the equipment by the customer or
any unauthorized third party; or (d) attachment of any equipment not supplied by
Advanced Bionics® without prior approval.
2. The component must be returned to Advanced Bionics® (or authorized agent) within 30
days of malfunction or discovery of defect.
1. The product registration card must be completed and returned to Advanced Bionics®
within 30 days of surgery or receipt of product in order to obtain warranty rights.
(b) full credit equal to the original purchase price to be applied towards the purchase of a
replacement device. Product claims under Advanced Bionics® Limited Warranty are
subject to the following conditions and limitations:
Patient System Handbook
69
This warranty is in lieu of any other warranty, expressed or implied, including any warranty
of merchantability or fitness for intended use. Except as expressly provided by this Limited
Warranty, Advanced Bionics® shall not be responsible or liable for any direct,
consequential or incidental damages caused by device malfunction, failure or defect,
whether the claim is based on warranty, contract, tort or otherwise.
4. The decision as to product replacement or credit shall be made solely at the discretion of
Advanced Bionics®. For a replacement component, the warranty will run only to the
end of the warranty period for the original component that was replaced.
Limited Warranty
70
Patient System Handbook
CARDIAC PACEMAKER. A small
implantable device used to control the
rhythm of the heart.
AREA. A location on the body such as right
leg or left leg where stimulation will occur.
AMPLITUDE. The measure-of-strength of
delivered stimulation. (See Level.).
ADVERSE EFFECT. Undesirable result.
ADHESIVE PATCH. Non-reactive skin patch
designed to temporarily attach the Charger
to the skin over the IPG site.
C Area Button icon. This figure respresents the
area button on the Remote Control.
Glossary
71
DIATHERMY. A therapeutic procedure used
to heat body tissue by high-frequency
electromagnetic currents.
CONTROL BUTTONS. Buttons located on
the Remote Control; used for adjusting
stimulation settings.
CHARGING SYSTEM. The Charging
System consists of a Charger Base Station,
Charger, Power Supply, Velcro charging
belt and adhesive patches. The system is
used for recharging the implanted
stimulator.
CHARGER BASE STATION. A holder/
power supply that supports the Charger and
keeps it in a ready state for recharging the
implant.
CHARGER. A portable device used to
recharge the battery of the implanted
stimulator.
Glossary
72
IMPLANT. Small implantable electrical pulse
generator used to control stimulation.
IDLE MODE. A time-out period when the
Remote Control is not being used. Also
known as sleep mode.
ELECTROMAGNETIC INTERFERENCE
(EMI). Electromagnetic signals that
interfere with a variety of electrical signals
including spinal cord stimulation.
ELECTRICAL STIMULATION.The energy
created by a pulse generator.
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.
DISPLAY. The Remote Control screen.
Patient System Handbook
MRI. Magnetic Resonance Imaging; the use of
a nuclear magnetic resonance spectrometer
LONG BUTTON PRESS. To press and hold a
button for about 3 seconds.
LEVEL. Term used on the Remote Control
screen to identify the amplitude or strength
of stimulation pulses.
LEAD. A surgical wire that sends electrical
stimulation pulses from a pulse generator to
the spinal cord.
LEAD MIGRATION. The movement of a
lead away from the spinal cord.
IPG. Implantable Pulse Generator.
INDICATOR. A signal light used on the Trial
Stimulator and the IPG Charger.
INCISION. Small surgical cut or opening in
the skin.
PERMANENT IMPLANT. A stimulator
system, pulse generator and leads,
73
RATE. The number of times–per-second
(speed) at which stimulation pulses are
delivered to the spinal cord. An option
setting available from the Remote Control.
PATIENT IDENTIFICATION CARD. A
wallet size card that lists the patient and
physician names, and IPG model and serial
number.
PROGRAM. Combination of one or more
stimulation areas.
D Program Button icon. This symbol
represents the Program button on the
remote control.
PARESTHESIA. Sensation produced by
electrical stimulation.
PRECAUTION. Generally, situations that you
should be aware of in order to avoid
potentially uncomfortable stimulation
sensations and/or damage to your
stimulation system.
OPTIONS. Methods for adjusting stimulation
beyond amplitude, or level, using the
Remote Control. Your healthcare provider
may or may not provide you with all
available options.
PULSE WIDTH. The length of time each
stimulation "spark" lasts. An option setting
available from the Remote Control.
implanted in the body and maintained by a
pulse generator battery Charging System.
to produce electronic images of tissues and
organs.
Glossary
74
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.
SPINAL CORD STIMULATION (SCS). A
method of applying electrical pulses to the
spinal cord to block/mask pain signals to
the brain.
SLEEP MODE. A time-out period when the
Remote Control is not being used. Also
known as idle mode.
SAVE. The Remote Control button command
used to store a newly created or modified
stimulation program.
REMOTE CONTROL. A battery powered
hand-held computer used to adjust
stimulation.
Patient System Handbook
WIDTH. See Pulse Width.
WARNING. Potential hazards that you must be
aware of to avoid serious situations that
may cause injury or death.
SYSTEM FAILURE. Inability of spinal cord
stimulator system to deliver stimulation
therapy.
SUBCLAVICULAR. Under the collarbone.
STIMULATION COVERAGE. Area on the
body where stimulation occurs. (See Area.)
diathermy ..................................... 17, 71
control buttons ................................... 71
charge signal ...................................... 58
charge indicator ............................ 54, 55
battery .......................................... 23, 62
area ............................................... 71, 74
amplitude ............................... 71, 72, 73
Adhesive Patch ............................ 55, 71
Index
program ..............................................73
Power Supply ...................................5, 6
Patient Identification Card ..............5, 73
paresthesia ......................................1, 73
options ................................................73
MRI ..............................................18, 24
level ..............................................33, 72
indicator ........................................54, 72
75
Index
76
SAVE ................................................. 74
Patient System Handbook
77
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.
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.
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 following is federal government communications regulation information about the Precision™ System.
78
Patient System Handbook

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