Boston Scientific Neuromodulation PSC5210W Precision SCS Remote Control User Manual II PSH RC3 CHGR2 US

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Patient System Handbook
CAUTION:
Federal law restricts this device to sale, distribution and use by or on the order of a physician.
Part No. 9055520-001 Rev A
Patient System Handbook
Copyright
©2006 by Advanced Bionics Corporation. All Rights Reserved. Any copying, reproduction or
translation of all or part of the contents of this document without the express written permission of
Advanced Bionics Corporation is strictly forbidden by the provisions of the law of March 11th,
1957.
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.
Registered Trademarks
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.
ii
Table of Contents
Table of Contents
1 Introduction .......................................................................1
2 System Description ...........................................................3
3 Safety Information ............................................................7
Indications for Use ................................................................. 7
Precision System Clinical Summary .......................................... 7
Contraindications ................................................................. 16
Warnings ............................................................................ 18
Precautions .......................................................................... 21
Adverse Effects ..................................................................... 26
4 The Remote Control .......................................................27
Buttons and Basic Operation ................................................ 27
Communicating with the Stimulator ........................................ 31
Stimulation On and Off ......................................................... 32
Signal Strength .................................................................... 32
The Level Screen .................................................................. 34
Stimulation Level Control ....................................................... 34
Selecting Areas for Level Control ........................................... 38
iii
Patient System Handbook
Programs ............................................................................. 39
Selecting and Activating Programs ........................................ 40
Saving Program Changes ..................................................... 42
Options ............................................................................... 45
Understanding Battery Messages .......................................... 51
5 Charging the Stimulator ................................................55
Getting Started .................................................................... 57
Charging Your Stimulator ..................................................... 60
6 Help ..................................................................................65
Stimulation ........................................................................... 65
Remote Control Display Messages ........................................ 68
Accessories ......................................................................... 72
Contacting Advanced Bionics ............................................... 72
7 Limited Warranty ...........................................................73
Implanted Pulse Generator .................................................... 73
Externals .............................................................................. 75
Glossary ...........................................................................79
Index..................................................................................83
iv
1
Introduction
The Advanced Bionics PrecisionTM 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.
Before receiving your new Stimulator, 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
Patient System Handbook
confirmed that paresthesia is capable of providing you with good to excellent pain relief. As
you go forward with this therapy, your healthcare professionals will work with you to find
the most comfortable level of paresthesia to cover the painful areas by adjusting your
Stimulator’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 healthcare professionals, the more likely you are to achieve the
best outcome possible from your new Precision system.
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.
2
System Description
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 or Stimulator), also referred to as an implant, or Stimulator. The Stimulator
is commonly placed in the abdomen, upper buttock, or subclavicular area. The Stimulator
sends a small electrical current to a series of stimulating contacts, or electrodes, at the end
of the lead. The battery-powered Stimulator is controlled by a hand-held programmer or
Remote Control, and is periodically recharged using a separate Charging System.
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.
Patient System Handbook
To make the most of your Precision system, it is important to learn:
1. what to be aware of for safety,
2. how to use the Remote Control, and
3. how to recharge the Stimulator.
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.
System Description
Before reading more about the Precision System, first check that you have received all of
the following items. (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.
(1)
(1)
(1)
(1)
(1)
(1)
(1)
(1)
Remote Control
Charger
Charger Base Station
Power Supply
Remote Control Case
Charging Belt
Charger Adhesives (52 pieces)
Remote Control Batteries (3)
Front
Back
Note: Use only accessories supplied by Advanced
Bionics.
Permanent Patient Identification Card
Patient System Handbook
Find a convenient electrical outlet, one
that will not 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.
For now, that is all you need to do to get
started. For more information on the
Charging System and its use, see
“Charging the Stimulator” on page 55.
1. Indicator Light
2. Charger
3. Power Supply
4. Power Button
5. Base Station
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
Patient System Handbook
the treatment chronic intractable pain of the trunk and/or limbs, including unilateral or
bilateral pain associated with the following: failed back surgery syndrome, intractable low
back and leg pain.
Efficacy Evaluation
Three (3) clinical literature studies were used to support the effectiveness of the
PRECISION System (Ohnmeiss et al. 1996, Villavincencio et al. 2000, Hassenbach SJ et al.
1995). The studies included a total of 116 patients that were implanted with an SCS system.
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
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
Patient System Handbook
implanted with a SCS system. In this study, 27/41 patients, 66%, had permanent implants.
All patients were examined after 6 weeks. Pain measurements were assessed at 3-6 month
intervals for the first year and annually thereafter. The median long-term follow-up was 34
months. A total of 24/27 (89%), reported greater than 50% reduction in pain. Since the
majority of the patients were treated for FBSS, this article supports the use of SCS for the
treatment of FBSS.
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 Stimulator 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 opioids. 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
10
Safety Information
internalized. A retrospective analysis of patients with unilateral leg and/or buttock pain
treated initially with SCS and bilateral leg or mainly low back pain treated initially with
spinal infusions of opioids was then done.
In this study, 42 patients were screened; 26 (62%) patients received spinal stimulation; 16
(38%) received opioids via a spinal infusion pump. 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.
11
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
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 Stimulator and RF systems. The clinical experience reported in the
literature on RF systems is relevant to determining the safety of totally implantable
Stimulator systems.
Table 1: Summary of Risks Identified in the Retrospective Clinical Studies
12
Risks
# Patients
With
Adverse
Event
Intent-toTreat 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%
Seroma
0%
0%
Hematoma
0.1%
0.1%
Safety Information
Paralysis
0%
0%
CSF Leak
0.5%
0.6%
Over/Under Stimulation, Ineffective Pain
Control
46
4.4%
5.2%
Intermittent Stimulation
0%
0%
Pain Over Implant
16
1.5%
1.8%
Allergic Reaction
0.6%
0.7%
Skin Erosion
0%
0%
Lead Breakage
35
3.3%
4.0%
Hardware Malfunction
22
2.1%
2.5%
Loose Connection
0%
0%
Battery Failure
0.2%
0.2%
Other
45
4.3%
5.1%
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Patient System Handbook
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. 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
Type
Number of Patients
Resolution
Lead Migration
Lead repositioning
and subsequent
replacement
Output malfunction
Device replaced
Infection
Infection treated
Pain
Lead explanted
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.
14
Safety Information
References
Burchiel, K.J., V.C. Anderson, F.D. Brown, R.G. Fessler, W.A. Friedman, S. Pelofsky, R.L. Weiner, J. Oakley,
and D. Shatin. “Prospective, Multicenter Study of Spinal Cord Stimulation for Relief of Chronic Back
and Extremity Pain.” Spine, 21:2786-2793, 1996.
Hassenbusch, S.J., M. Stanton-Hicks, E.C. Covington. “Spinal cord stimulation verses spinal infusion for low
back and leg pain”. Acta Neurochirgica, 64:109-115, 1995.
Kemler, M.A., G.A.M. Barendse, M. Van Kleef, H.C.W. 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 PainSome 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.
15
Patient System Handbook
Rainov, N.G., V. Heidecke, and W. Burkert. “Short Test-Period Spinal Cord Stimulation for Failed Back
Surgery Syndrome.” Minim Invasive Neurosurg, 39(2):41-44, 1996.
Segal, R., B. Stacey, T. Rudy, S. Basser, J. Markham. “Spinal Cord Stimulation Revisited.” Neurological
Research, 20:391-396, 1998.
Spieglemann, R. and W.A. Friedman. “Spinal Cord Stimulation: A Contemporary Series.” Neurosurg 28:6571, 1991.
Villavicencio, A.T., J.C. Leveque, L. Rubin, K. Bulsara, and J.P. Gorecki. “Laminectomy versus percutaneous
electrode placement for spinal cord stimulation.” Neurosurgery, 46:399-406, 2000.
16
Safety Information
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
17
Patient System Handbook
Warnings
Do not charge while sleeping. This may result in a burn. While
charging, the Charger may become warm. It should be handled with care. Failure to use the
Charger with either the Charging Belt or an adhesive patch, as shown, may result in a burn.
If you experience pain or discomfort, cease charging and contact Advanced Bionics.
Heat Due to Charging.
You should not be exposed to Magnetic Resonance
Imaging (MRI). Exposure to this diagnostic technology may result in dislodgement of your
Stimulator or lead(s), 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.
Magnetic Resonance Imaging (MRI).
The safety and effectiveness of spinal cord stimulation has not been
established for pediatric use.
Pediatric Use.
As an SCS patient, you should not have any form of diathermy 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 Stimulator, whether
it is turned on or off, may be damaged.
Diathermy.
18
Safety Information
Spinal cord stimulators may interfere with the operation of
implanted sensing stimulators, such as pacemakers and implantable cardiac defibrillators
(ICDs). Be sure your physicians are aware of your spinal cord stimulator before going
forward with other implantable device therapies so that medical decisions can be made and
appropriate safety measures taken.
Cardiac Pacemakers.
Stimulator 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.
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.
Posture.
Strong electromagnetic fields can potentially turn the
stimulator off, or cause uncomfortable or jolting stimulation. Avoid or exercise care around:
Electromagnetic Interference.
• 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
19
Patient System Handbook
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 welders
• 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
Stimulator. If the Stimulator suddenly turns off by itself, first move away from the area.
Next, check the Stimulator status with the Remote Control by pressing the Stimulation On/
Off button and observing the screen. The Stimulator may need to be recharged before
stimulation can be restarted. (See “Charging the Stimulator” on page 55 for additional
information.)
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.
20
Safety Information
Precautions
Physician training is required.
The following medical therapies or procedures may turn
stimulation off or may cause permanent damage to the Stimulator, particularly if used in
close proximity to the device:
Medical Devices/Therapies.
•
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
21
Patient System Handbook
•
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.
Do not operate an automobile, other motorized
vehicle, or any potentially dangerous machinery/equipment with therapeutic stimulation
switched on. Turn off stimulation first. Sudden stimulation changes, if they occur, may
distract you from attentive operation of the vehicle or equipment.
Automobiles and Other Equipment.
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:
Post Operative.
•
Do not lift objects of more than five pounds.
•
Do not engage in rigorous physical activity such as twisting, bending, or climbing.
•
If new leads were implanted, do not raise your arms above your head.
22
Safety Information
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.
If you notice excessive redness around the wound areas during this time, contact your
physician to check for infection and administer proper treatment. In rare cases, adverse
tissue reaction to implanted materials can occur during this period.
Be sure to consult your physician before making lifestyle changes due to decreases in pain.
Never attempt to change the orientation or “flip” the Stimulator. Do
not “finger” or play with the Stimulator. If the Stimulator 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.
Stimulator Location.
In some cases, the skin over your Stimulator may become very thin over time. If this occurs,
contact your physician.
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 Stimulator in the clinic or
repositioning the lead during another operation.
Lead Location.
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Patient System Handbook
Stimulators 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.
Device Failure.
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. For proper operation, do not use the Charger if
the ambient temperature is above 35°C (95°F).
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 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 73.)
24
Safety Information
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 for information.
The components can be cleaned using
alcohol or a mild detergent applied with a cloth or tissue. Residue from soapy detergents
should be removed with a damp cloth. Do not use abrasive cleansers for cleaning.
Remote Control, Charging System Cleaning.
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.
Cell Phones.
25
Patient System Handbook
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 undesirable changes in stimulation and subsequent reduction in pain relief.
•
System failure, which can occur at any time due to random failure(s) of the components
or the battery. 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.
•
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 Stimulator 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
26
Safety Information
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 Stimulator or the leads; may distort or destroy the image needed for diagnosis; and
may produce enough electromagnetic interference (EMI) to erase the Stimulator
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 Stimulator may move from its original position.
27
Patient System Handbook
•
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.
28
4
The Remote Control
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.
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 47.
1. Area Button
2. Up/Activate
3. Down/Save
4. Program Button
5. Stimulation On/Off
29
Patient System Handbook
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.
30
The Remote Control
Communicating with the Stimulator
Good communication between your Stimulator and
the Remote Control is very important. For that
reason, you will sometimes see the following icon on
your screen. This indicates that the Remote Control
is checking for the Stimulator.
Note: If there is a problem communicating with the
Stimulator, the message “No Response” will appear
on the Remote Control screen. Press to retry, or
press  to cancel. See “Help” on page 65 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.
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Patient System Handbook
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 there are no signal bars, 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.
32
The Remote Control
•
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.
33
Patient System Handbook
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 38.
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.
34
The Remote Control
The graphic is easy to understand: Three filled-in
bars means that the Stimulator 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 Stimulator’s battery
for uninterrupted delivery of the therapy prescribed
for you, see “Charging the Stimulator” on page 55.
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.
&ULL
/+
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.
,OW
35
Patient System Handbook
• Multiple area control is available only if your
system has been programmed to deliver stimulation to separate areas. If you do not have separate area control (for example, left leg vs. right
leg) but feel that separate control might improve
your therapy, contact your healthcare professional to determine what is possible.
36
The Remote Control
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.
37
Patient System Handbook
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 or T 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.
38
The Remote Control
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.
39
Patient System Handbook
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.
40
The Remote Control
2. Press P or to move until the program you
want is highlighted, then press S to activate the
program.
Note: You might not have four programs saved in your
Remote Control. Empty program slots will have a
blank box with no program number. If you try to
activate an empty program, nothing will happen.
• An underline (_ ) beneath a program number
means that program was the most recently activated or saved (see below).
41
Patient System Handbook
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:
42
The Remote Control
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.
43
Patient System Handbook
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 by pressing 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.
44
The Remote Control
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.
If you have been told about program options and instructed in how to use them, you may
realize that you probably will not “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 47 to make adjustments.
45
Patient System Handbook
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:
•
Pulse Width, or how long each stimulation pulse
lasts, and
•
Rate, or how many times-per-second your
Stimulator sends a stimulation pulse.
Note: Restore is available to all patients. However, Pulse Width and/or Rate may not be available
to you. Their availability would have been discussed with you at your first programming
session.
46
The Remote Control
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
particular option screen is displayed. The action you take next depends on which option you
want to adjust. Follow the appropriate instructions below:
To Adjust Stimulation Pulse Width:
1. From the Level screen, press and hold Cuntil
you see the Width Area 1 screen. If this is the
area you want to adjust, press either S or T to
increase or decrease the Pulse Width.
2. To move to another area, press Cbriefly (a
“normal” press) to cycle through your
programmed areas until you find the Width Area
screen (2, 3 or 4) that you want.
3. Press either S or T to increase or decrease the
Pulse Width.
47
Patient System Handbook
Note: The Remote Control will beep to notify you if you reach a preset limit while increasing or
decreasing the Pulse Width.
To return to the Level screen from any Pulse Width screen, press and hold Cuntil Rate
Area 1 is displayed, then press and hold Cagain to see the Level screen. If you do not have
access to the Rate option, the Level screen will appear right away.
To Adjust Stimulation Rate
1. From the Level screen make a long Cbutton
press to Pulse Width Area 1.
Note: If you do not have access to the Pulse Width
option, the long press will take you directly to the
Rate Area 1 screen.
2. If the Pulse Width Area 1 screen is displayed,
make another long Cbutton press to Rate Area 1.
If this is the area you want to adjust, press either
S or T to increase or decrease the Rate.
48
The Remote Control
3. 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.
4. Press either S or T to increase or decrease the Rate.
Note: • You may also find Rate Area 1 by making a long Cbutton press from any Pulse Width
screen.
• The Remote Control will beep to notify you if you reach a preset limit while increasing or
decreasing the Rate.
To return to the Level screen from any Rate screen, press and hold C.
To Restore a Clinician 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.
49
Patient System Handbook
1. From the Level screen, press and hold P to reach
the Restore screen. Program 1 will be
highlighted.
Note: The highlighted program is the current selection;
an underline (_ ) indicates the last program
restored; a [] indicates an empty program slot.
2. If necessary, press P to 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.
50
The Remote Control
Understanding Battery Messages
About the Remote Control Batteries
As an SCS patient, it is 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
paresthesia. Always pay close attention to the battery
status messages described in this section.
When the Remote Control batteries are at a low power level, the battery 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 the P button from this screen, the Remote Control will make a check of
your Stimulator’s battery status also.
51
Patient System Handbook
If the Stimulator battery is full or OK, the Remote Control will return to the Level screen. To
learn about the messages you will see when the Stimulator’s battery is less than full, see
page 53.
If you do not 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.
Next, you would see the more urgent message shown
opposite. You must respond immediately! When you
press P, the Remote Control will make another
check of your Stimulator battery and may display
one of the messages shown on the following page.
Note: Make a habit of replacing the Remote Control
batteries when you first see the Remote Battery
Low message. See “Battery Replacement” on
page 54.
52
The Remote Control
About Your Stimulator Battery
When the Remote Control checks the condition of
your Stimulator battery, you may see one or more of
the following messages depending on the battery’s
charge level:
•
If the Stimulator battery is low, the Remote
Control will display the message shown at right.
Press P to return to the Level screen.
•
If the Stimulator battery is very low, the Remote
Control will display this notice to recharge the
stimulator battery immediately. Stimulation has
most likely been turned off automatically.
Note: The Remote Control will continue to display this
message until the stimulator is recharged.
53
Patient System Handbook
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 battery compartment cover on the case
and slide the cover into position until it snaps closed.
The Remote Control will connect to the 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.
54
5
Charging the Stimulator
Your Precision Stimulator uses a rechargeable battery to provide stimulation. The Precision
System’s programming software gives your healthcare provider a conservative
recommendation for how often to charge. This estimate is based on 24 hours per day/7 days
a week at the maximum energy output level. While you may want to follow these
recommendations, you can also develop a charge routine that fits best into your own
lifestyle. Developing a recharge schedule involves finding the right balance between four
things:
•
How much power you need in order to have effective therapy.
•
How often you want to recharge.
•
How long you want to recharge.
•
How you would like to manage your personal schedule.
55
Patient System Handbook
In most cases, the Stimulator will need to be recharged at intervals ranging from once a
week to once a month. The Remote Control provides an easy-view Stimulator 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 53.
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 Stimulator before it reaches the very low “hibernation” condition, stimulation
will eventually stop until you charge again. Developing a charging routine you are
comfortable with will help to prevent you from losing stimulation due to a low battery.
56
Charging the Stimulator
Getting Started
WARNINGS:
•
Do not charge while sleeping. This may result in a burn.
•
While charging, the Charger may become warm. It should be handled with care.
•
Failure to use the Charger with either the Charging Belt or an adhesive patch, as shown,
may result in a burn. If you experience pain or discomfort, cease charging and contact
Advanced Bionics.
The Charging System for your Stimulator consists of the Charger unit, a Base Station, and a
Power Supply. 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.
1. Find a convenient place with a flat, clear surface to keep the Base Station plugged in.
2. Plug the Power Supply into a standard AC wall outlet, and then plug the other end into
the Base Station connector.
57
Patient System Handbook
3. Place the Charger in the Base Station.
When charging, you must use the Charger with either the Charging Belt or an adhesive
patch to hold the Charger over the Stimulator. Before using the Charging Belt, you may cut
it to a more convenient size, but be careful not to cut too much. The adhesive patches are
made of non-reactive material suitable for most sensitive skin types.
Note: Advanced Bionics recommends the use of the Charging Belt for charging.
58
Charging the Stimulator
The Charger is completely ready and able
to fully charge your Stimulator when the
indicator light is green. If the light is
amber-colored, the Charger can only
partially charge the Stimulator. It may be
used, but it may not be able to return your
Stimulator to a full charge (and you may
need to charge sooner than you normally
would).
Indicator Light Status:
•
Green – ready for full charge
•
Amber – partial charge
•
Off – not ready for charging
1. Indicator Light
2. Charger
3. Power Supply
4. Power Button
5. Base Station
59
Patient System Handbook
Charging Your Stimulator
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.)
2. Using the Adhesive Patch:
• Apply the adhesive patch to the backside of the Charger by peeling the clear liner
from the patch and applying the white side with the blue stripe to the rear of the
Charger, as shown. (See diagram below.)
• Remove the skin side beige liner from the adhesive (only good for one fixation.)
(See diagram below.)
OR
Using the Charging Belt:
• Place the Charger into the pocket on the Charging Belt with the power button
facing out. (See diagram below.)
60
Charging the Stimulator
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 Stimulator.
61
Patient System Handbook
4. Locate the Charger over the Stimulator. When
the Charger is aligned with the Stimulator, the
beeping will stop.
5. Secure the Charger over the Stimulator either by
pressing the adhesive to the skin over the
Stimulator, or by securing the Charging Belt.
Note: If you accidentally locate the patch in the wrong
place, or if the Charging 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.
62
Charging the Stimulator
6. When the Charger emits a distinct double
beep, the Stimulator is charged. Switch off
the Charger, remove the Charging Belt or
adhesive patch, and return the Charger to
the Base Station.
Do not confuse the end of charge signal (a
distinct double beep) with the steady,
continuous misalignment signal.
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Patient System Handbook
Note: • Depending on your program parameters, you may expect daily recharging times from as
low as 10 minutes up to four hours, or weekly recharging times from as low as one hour up
to four hours.
• The end of a charge signal is a distinct double beep, and the alignment indicator is a steady
continuous signal.
The rechargeable Stimulator battery should provide you with at least five years of service.
Over time and with repeated charging, the battery in your Stimulator will lose the ability to
recover its full capacity. As a result, you may need to recharge your Stimulator for longer
periods and/or more often. Your Stimulator will need replacement when stimulation can no
longer be maintained with routine daily charging.
64
6
Help
Stimulation
No Stimulation
1. Toggle the Remote Control stimulation on/off
button to make sure that stimulation is ON. If the
Remote Control receives confirmation from the
Stimulator, it will flash “Stimulation On.”
2. Turn up the level of stimulation from the main
screen or area screens.
3. Charge the Stimulator. When the charge is
complete, try turning the stimulation on.
65
Patient System Handbook
4. Call our Customer Service Department at (866) 360-4747 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 Shuts Off
1. When the Stimulator 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 Stimulator regularly stops stimulating before you charge, you can charge
more often.
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
Stimulator.
66
Help
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 Stimulator.
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Patient System Handbook
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 “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 “Battery Replacement” on page 54).
68
Help
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.
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Patient System Handbook
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 P button.
Call our Customer Service Department at (866) 360-4747 if the problem continues.
70
Help
“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, wait a few
seconds, move the Remote Control closer 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 is pressed, or to idle mode if is not
pressed within one minute.
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Patient System Handbook
Accessories
Washing the Charging Belt
Wash the Charging 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:
72
Advanced Bionics Corporation
Pain Management Division
Mann Biomedical Park
25129 Rye Canyon Loop
Valencia, CA 91355
7
Limited Warranty
Implanted Pulse Generator
Advanced Bionics® Corporation (referred to as Bionics) warrants to the patient who
receives a Precision® Implantable Pulse Generator (referred to as the IPG) that the IPG will
be free from defects in workmanship and materials for a period of (5) five years from the
date of surgical implant of the IPG. This warranty applies only to the patient who has the
IPG implanted and no other person or entity. This warranty does not apply to the leads,
extensions, or surgical accessories used with the IPG.
If the IPG fails to function within normal ranges within (5) five years after the date it is
implanted, Bionics will replace the IPG with a functionally equivalent IPG made by
Bionics. No other relief whatsoever is available under this limited warranty. The limited
warranty for a replacement IPG will last only for five years from the date of surgical implant
73
Patient System Handbook
of the original IPG. Claims under this limited warranty are subject to the following
additional conditions and limitations:
1. The product registration card must be completed and returned to Bionics within 30 days
of surgery.
2. The IPG must be purchased after January 1, 2005 and implanted before the “use before”
date.
3. Failure of the IPG must be confirmed by Bionics.
4. The IPG must be returned to Bionics (or Bionics’ authorized agent) within 30 days after
it fails to function within normal ranges. That IPG will be Bionics’ property.
5. This limited warranty does not include failures to function within normal ranges 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 IPG in
accordance with manufacturer's instructions;
74
Limited Warranty
(c) unauthorized attempts to repair, maintain, or modify the IPG by the patient or any
unauthorized third party; or
(d) attaching equipment to the IPG that is not supplied or expressly authorized by Bionics.
THIS LIMITED WARRANTY IS THE ONLY WARRANTY THAT APPLIES TO
THE IPG, AND BIONICS EXPRESSLY DISCLAIMS ANY OTHER WARRANTY,
EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
Under this limited warranty, Bionics will be responsible only for replacement of the IPG
with a functionally equivalent IPG made by Bionics and will not be liable for any damages
(whether direct, indirect, consequential, or incidental) caused by the IPG, whether the claim
is based on warranty, contract, tort or any other theory.
Externals
Advanced Bionics warrants to the patient that the Remote Control device and Charging
System (Charger and/or Charger Base Station) are free from defects in workmanship and
materials for a period of one (1) year from the date of purchase.
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Patient System Handbook
If a Remote Control Device or Charging System component fails to function within normal
ranges within one year after the date of purchase, Bionics will replace the device or
component with a functionally equivalent device or component made by Bionics. No other
relief whatsoever is available under this limited warranty. The limited warranty for a
replacement device or component will last only for one year after the date of purchase.
Claims under this limited warranty are subject to the following additional conditions and
limitations:
1. The product registration card must be completed and returned to Bionics within 30 days
of purchase.
2. Bionics must confirm the device or component failure.
3. The device or component must be returned to Bionics (or Bionics’ authorized agent)
within 30 days after it fails to function within normal ranges. That device or component
will be Bionics’ property.
4. This limited warranty does not include failures to function within normal ranges caused
by:
(a) fire, floods, lightning, natural disasters, water damage and other calamities commonly defined as “Acts of God”;
76
Limited Warranty
(b) accident, misuse, abuse, negligence, or the customer’s failure to operate the device or
component in accordance with manufacturer's instructions;
(c) unauthorized attempts to repair, maintain, or modify the device or component by the
patient or any unauthorized third party; or
(d) attaching equipment to the device or component that is not supplied or expressly
authorized by Bionics.
THIS LIMITED WARRANTY IS THE ONLY WARRANTY THAT APPLIES TO
THE DEVICE OR COMPONENT, AND BIONICS EXPRESSLY DISCLAIMS ANY
OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
Under this limited warranty, Bionics will be responsible only for replacement of the device
or component with a functionally equivalent device or component made by Bionics and will
not be liable for any damages (whether direct, indirect, consequential, or incidental) caused
by the device or component, whether the claim is based on warranty, contract, tort, or any
other theory.
77
Patient System Handbook
78
Glossary
Glossary
C Area Button icon. This figure respresents the
area button on the Remote Control.
ADHESIVE PATCH. Non-reactive skin patch
designed to temporarily attach the Charger
to the skin over the Stimulator site.
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.
CARDIAC PACEMAKER. A small
implantable device used to control the
rhythm of the heart.
CHARGER. A portable device used to
recharge the battery of the implanted
stimulator.
CHARGER BASE STATION. A holder/
power supply that supports the Charger and
keeps it in a ready state for recharging the
Stimulator.
CHARGING SYSTEM. The Charging System
consists of a Charger Base Station, Charger,
Power Supply, Charging Belt and adhesive
patches. The system is used for recharging
the implanted stimulator.
CONTROL BUTTONS. Buttons located on
the Remote Control; used for adjusting
stimulation settings.
DIATHERMY. A therapeutic procedure used
to heat body tissue by high-frequency
electromagnetic currents.
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Patient System Handbook
DISPLAY. The Remote Control screen.
ELECTRICAL PULSE GENERATOR. Also
called an implantable pulse generator (IPG
or Stimulator); 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.
IDLE MODE. A time-out period when the
Remote Control is not being used. Also
known as sleep mode.
INCISION. Small surgical cut or opening in the
skin.
80
INDICATOR. A signal light used on the Trial
Stimulator and the IPG Charger.
IPG. Implantable Pulse Generator.
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.
LEVEL. Term used on the Remote Control
screen to identify the amplitude or strength
of stimulation pulses.
LONG BUTTON PRESS. To press and hold a
button for about 3 seconds.
MRI. Magnetic Resonance Imaging; the use of
a nuclear magnetic resonance spectrometer
to produce electronic images of tissues and
organs.
Glossary
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.
P Program Button icon. This symbol
represents the Program button on the
remote control.
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.
PARESTHESIA. Sensation produced by
electrical stimulation.
PULSE WIDTH. The length of time each
stimulation "spark" lasts. An option setting
available from the Remote Control.
PATIENT IDENTIFICATION CARD. A
wallet size card that lists the patient name,
physician name, Stimulator model and
serial number.
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.
PERMANENT IMPLANT. A stimulator
system, pulse generator and leads,
implanted in the body and maintained by a
pulse generator battery Charging System.
REMOTE CONTROL. A battery powered
hand-held computer used to adjust
stimulation.
81
Patient System Handbook
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. Also
known as idle mode.
SPINAL CORD STIMULATION (SCS). A
method of applying electrical pulses to the
spinal cord to block/mask pain signals to
the brain.
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.)
82
STIMULATOR. Small implantable electrical
pulse generator used to control stimulation.
E or Stimulation On/Off Button icon.
SUBCLAVICULAR. Under the collarbone.
SYSTEM FAILURE. Inability of spinal cord
stimulator system to deliver stimulation
therapy.
WARNING. Potential hazards that you must be
aware of to avoid serious situations that
may cause injury or death.
WIDTH. See Pulse Width.
Index
Index
Adhesive Patch ............................ 57, 73
amplitude ............................... 73, 74, 75
area ............................................... 73, 76
battery .......................................... 23, 64
charge indicator ............................ 56, 58
charge signal ...................................... 60
control buttons ................................... 73
diathermy ..................................... 17, 73
indicator ........................................56, 74
level ..............................................34, 74
MRI ..............................................18, 25
options ................................................75
paresthesia ......................................1, 75
Patient Identification Card ..............5, 75
Power Supply ...................................5, 6
program ..............................................75
83
Patient System Handbook
SAVE ................................................. 76
84
The following is federal government communications regulation information about the Precision™ Spinal Cord Stimulation System.
This device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) This device
must accept any interference received including interference that may cause undesired operation.
The Precision System components should only be serviced by Advanced Bionics. Do not
attempt to open or repair any of the components. 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.
Patient System Handbook
CORPORATE HEADQUARTERS
PAIN MANAGEMENT DIVISION
Part No. 9055520-001 Rev A
©2006 Advanced Bionics Corp. All rights reserved.
Advanced Bionics® Corporation
12740 San Fernando Road, Sylmar, CA 91342
(800) 678-2575 in US and Canada
(818) 362-7588, (818) 362-5069 Fax
(800) 678-3575 TTY
www.advancedbionics.com
Email:info@advancedbionics.com
Advanced Bionics® Corporation
Mann Biomedical Park
25129 Rye Canyon Loop, Valencia, CA 91355
(661) 362-1400, (661) 362-1500 Fax

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