Advanced Bionics Precision SCS User manual

Patient System Handbook
CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.
9055072-001 Rev C

Patient System Handbook
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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.
Copyright
©2003 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.
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.

Table of Contents
iii
Table of Contents
Introduction .................................................... 1
System Description ......................................... 2
Safety Instructions .......................................... 5
Warnings .................................................................................... 5
Precautions ................................................................................... 7
Adverse Effects ............................................. 11
The Remote Control ....................................... 12
Basic Operation ......................................................................... 14
Stimulation On and Off ............................................................... 15
Stimulation Level Control ............................................................ 16
Selecting Areas (for Stimulation Control) ...................................... 17
Selecting Programs (for Stimulation Control) ................................. 18
Options ..................................................................................... 21
Remote Control Battery Replacement .......................................... 25
Charging the Implant .................................... 27

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Getting Started ........................................................................... 28
Charging Your Implant ................................................................ 29
Help ............................................................. 33
Stimulation ................................................................................. 33
Remote Control Display ............................................................... 34
Accessories ................................................................................ 35
Contacting Advanced Bionics ..................................................... 36
Limited Warranty .......................................... 37
Implanted Pulse Generator .......................................................... 37
Externals .................................................................................... 39

Introduction
1
Introduction
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 percep-
tion 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 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 confirmed that
paresthesia is capable of providing you with good to excellent pain relief. Going forward with this
therapy, your health professionals will work with you to find the most comfortable level of
paresthesia to cover the painful areas through adjusting the 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.
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.

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System Description
The Precision system includes both implanted and external components: 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 implanted pulse generator (IPG), referred to as an implant. The implant
sends a small electrical current to a series of stimulating contacts, called electrodes, at the end of the
lead. The battery-powered implant 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.
For your Precision system, it’s important to learn 1) what to be aware of for safety, 2) how to use the
Remote Control, and 3) how to re-charge the implant. 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 here, feel free to contact our Customer Service department at
[phone].

System Description
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Before you continue, however, first check to be sure that all of the following items were included in
your Patient Kit. (And check to be sure you have your Temporary Patient Identification Card; be sure
to keep it with you until you receive your permanent card.) If any item is missing, please call our
Customer Service department at [phone].
(1) Remote Control
(1) (IPG) Charger
(1) Charger Base Station
(1) Transformer
(1) Belt Clip Holster
(1) Velcro®Charging Belt
(1) Charger Adhesives (52 pieces)
(1) Remote Control Battery
(1) Carrying Case

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Find a convenient electrical outlet, one that
won’t expose the parts to water or direct heat,
and plug in the transformer. Next, connect the
transformer to the Charger Base Station and
locate the Base Station on a flat surface.
Finally, place the Charger in the Base Station
with the blue power button facing up.
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 27.

Safety Instructions
5
Safety Instructions
Warnings
Pregnancy. The safety considerations of totally implanted SCS devices for use during pregnancy are
unknown. If you become pregnant, turn off the device when you become aware of your condition
and consult your physician.
Diathermy. As an SCS patient, you must 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.
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.
Posture. Some changes in posture may cause decreased or uncomfortable increased stimulation
levels. Keep the Remote Control with you at all times in order to be ready to adjust stimulation for
unexpected changes.

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Electromagnetic Interference. Avoid or exercise care around electromagnetic fields generated by:
• Theft detectors and security screeners (usually located at stores, airports, libraries, and
government buildings)
• Power lines and power generators
• Electric steel furnaces, arc welders, and other heavy duty industrial electric equipment
• 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 power button and observing the screen. The IPG may need to be recharged
before stimulation can be re-started. (See “Charging the Implant” on page 27 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.

Safety Instructions
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Precautions
MRI. You must 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.
Medical Devices/Therapies. The following medical therapies or procedures may turn stimulation
off or may cause permanent damage to the implant, particularly if used in close proximity to the
device:
• lithotripsy
• electrocautery
• external defribrillation
• radiation therapy
• ultrasonic scanning
• high-output ultrasound
Before having procedures, medical therapies, or diagnostics, have your healthcare professional call
our Customer Service department at [phone] for proper instructions.

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Automobiles and Other Equipment. Do not operate an automobile, other motorized vehicle, or any
potentially dangerous machinery/equipment with therapeutic stimulation switched on. Turn off
stimulation first. Sudden stimulation changes, if they occur, may distract you from attentive
operation of the vehicle or equipment.
Post Operative. During the two weeks following surgery, it is important to use extreme care so that
appropriate healing will secure the implanted components and close the surgical incisions:
Do not 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.
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.
Implant Location. Never attempt to change the orientation or “flip” the implant. Do not “finger” or
play with the implant. If the implant flips over in your body it cannot be charged. If you know that
the device has turned, or if stimulation cannot be turned on after charging, contact your physician to
arrange an evaluation of the system.
In some cases, skin erosion at the implant location can occur over time. If this occurs, contact your
physician.

Safety Instructions
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Lead Location. In some instances a lead can move from its original location, and stimulation at the
intended pain site can be lost. If this occurs, consult your physician who may able to restore
stimulation by reprogramming the implant in the clinic or repositioning the lead during another
operation.
Device Failure. Implants can fail at any time due to random component failure, loss of battery
functionality, or lead breakage. If the device stops working even after complete charging (up to four
hours), turn off the implant and contact your physician so that the system can be evaluated.
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).
Handling. Handle the system components and accessories with care. Do not drop them or submerge
them in water. 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 37.)
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.

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Remote Control Battery. Do not try to use a AA (1.5-volt) battery in the Remote Control unit. The
control will only operate with the special 3.6-volt battery available from Advanced Bionics.
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.

Adverse Effects
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Adverse Effects
Potential risks are involved with any surgery. The possible risks of implanting a pulse generator as
part of a system to deliver spinal cord stimulation include:
• Lead migration, resulting in undesirable changes in stimulation and subsequent
reduction in pain relief.
• System failure, which can occur at any time due to random failure(s) of the components
or the battery. These events, which may include device failure, lead breakage, hardware
malfunctions, loose connections, electrical shorts or open circuits and lead insulation
breaches, can result in ineffective pain control.
• Tissue reaction to implanted materials can occur.
• Skin erosion at the IPG site can occur over time.
• Possible surgical procedural risks are: temporary pain at the implant site, infection,
cerebrospinal fluid (CSF) leakage and, although rare, epidural hemorrhage, seroma,
hematoma and paralysis.
• External sources of electromagnetic interference may cause the device to malfunction
and affect stimulation.
• Exposure to MRI can result in heating of tissue, image artifacts, induced voltages in the
neurostimulator and/or leads, lead dislodgement.

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The Remote Control
The Remote Control unit is your direct link to choices available for tailoring spinal cord stimulation
to suit your comfort and convenience requirements. Keep the Remote Control with you at all times,
in a pocket, purse, or in your immediate vicinity.

The Remote Control
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The Remote Control is used to:
• Turn stimulation On and Off
• Change stimulation levels
• Activate or save new programs
• Change stimulation options (If enabled by the clinician. See “Stimulation Level
Control” on page 16.)
Each button function label shown on the screen is related to the control button below it. As you move
through the screen, the function labels for the buttons will change accordingly.

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Basic Operation
When it is not being used, the Remote Control is in a “sleep” mode. Press any button and the Remote
Control will wake up and look for the implant. Once connected, you can make adjustments. When
you are done, the Remote Control will go to sleep after 60 seconds.
Good communication between the implant and the Remote Control is very important. This is the
reason you’ll often see the message “Connecting...” while you are adjusting the stimulation. This is
normal because the Remote Control continually checks for the implant.
Note: If you have trouble communicating with the implant, the message “No Response” will appear
on the Remote Control screen. See “Help” on page 33 for more information.

The Remote Control
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Stimulation On and Off
The Remote Control uses a “dedicated”
stimulation on/off switch.You may press the
stimulation power button at any time to turn
stimulation on or off. You don’t have to be
concerned about whether or not the Remote
Control is awake.