Boston Scientific Neuromodulation SC-1100 SCS Implant System Implantable Pulse Generator User Manual SCS Patient Cvrs

Boston Scientific Neuromodulation Corporation SCS Implant System Implantable Pulse Generator SCS Patient Cvrs

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Patient Trial Handbook

CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.

9055078-001 Rev C

Patient Trial Handbook

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and (2) This device must accept any interference

received including interference that may cause undesired operation.

The Precision System components should only be serviced by Advanced Bionics. Do not attempt to open or

repair any of the components. Unauthorized opening of or attempts to repair the components will void the

warranty.

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

What is Spinal Cord Stimulation? .................................................. 1

Caretaking During the Trial ........................................................... 2

How to Use This Manual During the Trial ....................................... 5

Overview: The Trial Journal ............................ 6

Pain Profile ................................................................................... 6

The Journal ................................................................................... 6

Using the Medical Equipment ......................... 8

The Trial Stimulator System ............................................................ 8

Taking Care of Your Trial Equipment ............................................. 9

The Trial Stimulator ..................................................................... 10

The Remote Control ................................................................... 11

Basic Operation ......................................................................... 12

Stimulation On and Off ............................................................... 13

Stimulation Level Control ............................................................. 14

Selecting Areas (for Stimulation Control) ...................................... 15

Selecting Programs (for Stimulation Control) ................................. 16

Battery Information ..................................................................... 18

Patient Trial Handbook

Safety Instructions ........................................ 22

Warnings ................................................................................. 22

Precautions ................................................................................. 23

Adverse Effects ............................................. 25

Help ............................................................. 26

Stimulation ................................................................................. 26

Remote Control Display ............................................................... 27

Accessories ................................................................................ 28

Contacting Advanced Bionics ..................................................... 29

Introduction

Welcome to the “Trial Phase” of the Advanced Bionics® Precision™ pain management program.

You’re about to test a pain treatment therapy that could result in a dramatic change in your life and

your lifestyle. The trial you’ve agreed to participate in is intended to give you and your physician a

chance to evaluate spinal cord stimulation (SCS) as an appropriate and effective long-term therapy

option for your chronic pain.

At the end of the trial period (approximately one week) you and your physician will meet to discuss

your experience with spinal cord stimulation. The doctor will also want to explore your feelings

about a permanent SCS implant so that, together, both of you can determine whether long-term

treatment with spinal cord stimulation is an appropriate option for you. To prepare yourself for this

important decision, you may want to spend at least some of the trial period carefully evaluating

spinal cord stimulation.

Contraindications: Patients who fail to receive pain relief during stimulation, do not meet

psychological selection criteria, are poor surgical risks or are pregnant cannot be implanted

with the permanent device.

What is Spinal Cord Stimulation?

Most pain signals travel from the source problem or injury area to nerve pathways to the spine, then

up the spine and to the brain. SCS uses electrical stimulation of the spinal cord to block the

Patient Trial Handbook

perception of those signals. To apply the stimulation, a small electrical pulse generator is connected

to one or two wires, called leads, which are placed along your spinal cord. The stimulator, internal or

external, sends pulses of a low electrical current to a series of metal contacts, called electrodes,

located at the end of the lead(s). The “feeling” produced by this stimulation is a light sensation called

paresthesia. Thousands of SCS patients consider paresthesia not only a pleasant substitute feeling,

but also an effective and welcome relief from pain.

It’s important to understand that spinal cord stimulation cannot cure pain or eliminate its cause. It

does, however, provide control of and relief from certain types of pain over the area where the

paresthesia is felt. Spinal cord stimulation is a treatment choice designed to provide you with the

most effective pain relief over the widest pain area possible. When that goal is reached with the

Precision™ system, you should experience good to excellent relief from chronic pain.

Caretaking During the Trial

To speed-up your recovery following the surgery, your physician might require bed rest for the first

several hours after the surgery; administer antibiotics; schedule a mid-trial follow-up visit; and limit

your physical activity, including driving.

If your doctor approves of you driving during the trial, always turn off the external Trial Stimulator before getting

behind the wheel. Please ask for specific instructions about what you may do and should not do during the trial, and

follow all instructions carefully!

Introduction

Be aware that some changes in posture can cause a decrease or (at times) an uncomfortable increase

in the strength of the stimulation. Keep the Remote Control with you at all times so that you can

make adjustments quickly if necessary.

You can help the recovery process by:

• Keeping your incision dry. Be sure you

understand instructions about cleaning

the incision and sponge-bathing. You

must not bathe or shower during the

trial.

• Checking the wound occasionally for

signs of redness or the presence of

fluid.

• Notifying your physician’s office if you

develop a fever, or if you experience

increased pain at the incision site.

• Limiting most physical activity during the trial.

Patient Trial Handbook

During sleep, bathing or for comfort, turn off the Trial Stimulator, remove it from the pocket, and

disconnect the leads (see “The Trial Stimulator” on page 10 for information on disconnecting the

leads).

The position and stability of your leads is a vitally important part of the trial experience. Remember

that, when they were placed along your spine, the leads were specifically located according to where

you felt stimulation covering your pain. You want the leads to stay in place! So, to prevent them

from moving:

• Do not lift objects of more than 5 pounds.

• Do not engage in rigorous activity such as twisting, bending or climbing.

• Do not raise your arms above your head.

• Do not pull or jiggle the leads.

Again, call your doctor if you have any questions about an activity that you’re not sure is appropriate

for you during the trial.

Introduction

How to Use This Manual During the Trial

You will probably want to refer to this manual often during the trial period. For that reason, the

content is arranged in the order you are most likely to need it.

Overview: The Trial Journal. This section describes the SCS Trial Journal which is included at the

back of this manual. The journal is made up of a brief questionnaire, a simple chart, and a

stimulation activity log. Start your journal the first full day following surgery.

Using the Medical Equipment. Turn to this section when you’re ready to learn about the many ways

available for managing stimulation using the Remote Control unit to program the Trial Stimulator.

Depending upon the instructions you receive from your doctor you may not need all of the

information here. But it may help you in the future.

Safety Instructions. This section covers information you should be aware of (especially) if you are

under medical care for other conditions, or if your doctor does not restrict your activities outside the

home.

Questions and Answers. This section addresses typical questions that you and other SCS patients

have when first beginning therapy.

Patient Trial Handbook

Overview: The Trial Journal

All trials or tryouts require careful record keeping of times or scores, and your SCS trial is no

exception. In order for you and your doctor to decide to move on to the next step—a permanent

implant— you’ll both need a way to review the details of each of your SCS trial days. The easiest

way to do that is with the help of a journal. Your journal, which can be found at the back of this

manual, consists of the following:

Pain Profile

You may think of the Pain Profile as a way to make a starting point for this trial and for the journal.

The simple questions you answer here will establish a detailed, personal description of your pain

condition. The profile includes a simple graph called a Visual Analog Scale (VAS), commonly used

to measure the before-and-after pain levels of SCS trial patients. You may have completed a VAS

before in your doctor’s office or at a clinic. Once your VAS score is marked, it becomes an important

tool for determining your progress at the end of the trial.

The Journal

Seven log pages are included in your journal. We suggest that you begin keeping the log starting

with the first full day following your surgery. An explanation of the columns follows:

Overview: The Trial Journal

• Activity: Please name the activity whether it’s getting out of bed, washing the dishes, or

walking the dog.

• Time: Fill in the approximate time (starting, during or ending) of the activity.

• VAS: Use this column to enter a Visual Analog Scale pain score for what your pain level

was during the activity. The VAS score is a number between zero (0) and ten (10), where

10 is the worst pain imaginable and 0 is no pain. Rate the pain level you had while doing

the activity.

• STIM ON (Program No.) or STIM OFF: Indicate if stimulation was on or off during the

activity. If you know which program you were using, write the program number (1, 2, 3

or 4).

Patient Trial Handbook

Using the Medical Equipment

The Trial Stimulator System

The Trial Stimulator is a temporary external

spinal cord stimulator that is connected to the

lead(s) placed along the spinal cord. You will

use this external system to test how effective

stimulation is in relieving your pain.

The Trial System includes:

•Lead—An implantable cable that

sends stimulation pulses to the

spinal cord.

•Remote Control—A small battery

powered computer used to adjust

stimulation.

•Cable(s)—Thin plastic cable(s) used to attach the Trial Stimulator to the lead.

•Velc ro® Belt—A belt used to hold the Trial Stimulator (optional).

Using the Medical Equipment

Taking Care of Your Trial Equipment

All of the items that were sent home with

you from the hospital are important to your

trial success. So please follow the

instructions listed.

• Handle the Trial Stimulator and the

Remote Control with care. These

items are well-designed, quality-

tested electronic components.

However, they can be damaged if

they’re dropped on a hard surface.

• Never submerge the Trial Stimulator

or the Remote Control in water, or leave them outside in the rain, extreme heat, or extreme cold.

• Always turn off the Trial Stimulator, remove it from the belt pocket, and disconnect and secure

the leads before taking a sponge bath.

• Carry your Temporary Patient Identification card (given to you by your healthcare provider)

throughout the trial.

Note: This information covers most of what you need to be aware of during the trial. For additional

precautionary information, see “Safety Instructions” on page 22. Please read the section

carefully.

Patient Trial Handbook

The Trial Stimulator

You may turn off the Trial Stimulator by pressing its

power on/off button, or by pressing the power button

on the Remote Control unit. When the stimulator is

on, the indicator light will blink

Always turn the stimulator off before connecting or

disconnecting your lead wires.

Disconnecting the Trial Stimulator

The Trial Stimulator has connectors for both left and

right leads, and a third connector for a patch

electrode. Whether you have one or two leads, your

doctor probably placed identifying labels on the lead

wires before connecting them to matching plugs on

the stimulator. These labels are intended to make it as

easy as possible for you to connect the wires properly.

Remember to check the label(s) each time you need to

reconnect the leads.

Note: If you were given a patch electrode for stimulation, an extra one is provided in case the

adhesive wears out. When connecting a new patch electrode, be sure to plug it securely into

the connector.

Using the Medical Equipment

The Remote Control

The Remote Control unit is your direct link to

choices available for tailoring spinal cord

stimulation to suit your comfort and

convenience requirements. Keep the Remote

Control with you at all times in a pocket, purse,

or in your immediate vicinity.

The Remote Control is used to:

• Turn stimulation ON and OFF

• Change stimulation levels

• Activate or save new programs

Each button function label shown on the screen

is related to the control button below it.

Patient Trial Handbook

Basic Operation

When it is not being used the Remote Control is in a “sleep” mode. Press any button and the Remote

Control will wake up and look for the stimulator. Once connected, you can make adjustments. When

you are done, the Remote Control will go to sleep after 60 seconds.

Good communication between the implant and the Remote Control is very important. This is the

reason you’ll often see the message “Connecting...” while you are adjusting the stimulation. This is

normal because the Remote Control continually checks for the stimulator.

Note: If you have trouble communicating with the stimulator, the message “No Response” will

appear on the Remote Control screen. See “Help” on page 26 for more information.

Using the Medical Equipment

Stimulation On and Off

The Remote Control uses a “dedicated”

stimulation on/off switch. You may press the

stimulation power button at any time to

immediately turn stimulation on or off. You

don’t have to be concerned about whether or

not the Remote Control is awake.

Patient Trial Handbook

Stimulation Level Control

A few seconds after stimulation is turned on, the

Remote Control displays the main screen. From here,

you may press the [down] or  [up] button to

adjust the stimulation level (or intensity) until you’re

comfortable. The main screen controls all stimulation,

whether you have one area of pain control... or more

than one.

Note: • In some cases, health professionals can give

you control over more than one stimulation

area.

•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 stimulation therapy,

speak to your health professional about this

at your next visit.

Using the Medical Equipment

Selecting Areas (for Stimulation Control)

1. From the main screen, press the SEL 1 button as

necessary to cycle through your programmed

areas. Each area is given a number (1 through 4)

or a name, for example LeftArm.

Note: If you only have one area of control, then that

one area will appear each time you press SEL 1.

2. When the named or numbered area that you want

to adjust is displayed, press  or  to change

the stimulation level for that area.

Patient Trial Handbook

Selecting Programs (for Stimulation Control)

Your Remote Control can store up to four stimulation programs which may have been set up by your

healthcare professional. Each saved program will have certain differences in the settings. These

differences allow you to vary your stimulation in many ways. You may have been encouraged to try

and compare specific programs for different circumstances or times in your daily routine. This is

especially helpful during the trial period. Program flexibility gives you and your healthcare

professional a way to continually “fine-tune” your therapy.

To select and activate programs:

1. Press the SEL 2 [NEXT] button from the main screen to go to the program screen.

2. Press the SEL 1 [SEL] button as necessary to choose the program you want to activate.

Using the Medical Equipment

3. Once the desired program is highlighted,

press  [ACT] and that program will start

running after a couple of seconds.

Note: You might not have all four programs

saved in your Remote Control. Empty

program slots will have an * (asterisk)

symbol beside the program number. If

you try to activate an empty program,

nothing will happen.

Once you’ve selected and activated a program,

you can adjust its stimulation level using the 

and  buttons.

If you make a stimulation level adjustment and

decide that you prefer it, go back and select the

program again, then press  [SAVE]. The

program will be updated with the new level.

You may also save changes to any empty (*) program slot if one is available.

Patient Trial Handbook

Battery Information

Remote Control:

Following the low battery message you will only be

able to turn the implant on and off. If you try to use

any button except the power button, you will be

reminded “Replace Remote Battery ON/OFF ONLY.”

The battery for your Remote Control is a special 3.6-volt battery

available only from Advanced Bionics. Do not attempt to use a

1.5-volt AA battery in the Remote Control.

If you do not have an extra battery in your Trial Kit, call

Advanced Bionics Customer Service Department at (866) 566-

8913 to request a new battery.

Using the Medical Equipment

To replace the Remote Control battery

1. On the rear of the remote, slide the battery

compartment lock lever to the left to unlock

the cover.

2. Press down on the ridged area below the

lever using your thumb to release the cover.

3. Open the cover and remove the old battery.

4. Replace the new battery in the slot,

matching the positive and negative

markings.

5. Close the compartment by sliding the lock

lever to the right.

The Remote Control will connect and reload information from the stimulator in approximately 30

seconds.

Patient Trial Handbook

Trial Stimulator:

If the message “REPLACE STIMULATION BAT-

TERY” appears on the Remote Control screen accom-

panied by a three-beep alarm, press SEL2 [OK] to

acknowledge the message, then install a new battery

right away.

The battery for your Trial Stimulator is a 6-volt

battery (lithium Duracell 28L). This type of battery

can be purchased at most drug and convenience

stores.

Using the Medical Equipment

To replace the Trial Stimulator battery:

1. On the rear of the unit, press down on the

ridged area and slide to release the cover.

2. Open the cover and remove the old battery.

3. Replace the new battery in the slot,

matching the positive and negative

markings.

4. Close the compartment by sliding the cover

in the opposite direction.

Patient Trial Handbook

Safety Instructions

Warnings

Pregnancy. The safety considerations of SCS devices for use during pregnancy are unknown. If you

become pregnant, turn off the External Trial Simulator when you become aware of your condition

and consult your physician.

Diathermy. As an SCS patient, you must not have any form of diathermy either as treatment for a

medical condition or as part of a surgical procedure. The high energy and heat generated by

diathermy can be transferred through the leads, causing tissue damage at the lead site and, possibly,

severe injury or death.

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.

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

Safety Instructions

• Large magnetized stereo speakers.

As you approach these devices you may become aware of changing stimulation levels. In rare

instances, you could experience an increase in stimulation level to the point that the sensation is

uncomfortably strong or possibly “jolting.” If this happens, turn off the External Trial Stimulator. If

the stimulator suddenly turns off by itself, first move away from the area. Next, check the

stimulation status with the Remote Control by pressing the power button and observing the screen.

Always be aware of your surroundings, particularly near theft detectors/security screeners. Ask for

assistance to go around these devices if you feel at all uncomfortable.

Precautions

MRI. You mu st not be exposed to Magnetic Resonance Imaging (MRI). Exposure to this diagnostic

technology may result in dislodgement of your lead(s) and/or increased voltage through the leads

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 Trial Stimulator, particularly if used in close proximity to

the device:

• lithotripsy

• electrocautery

Patient Trial Handbook

• external defribrillation

• radiation therapy

• ultrasonic scanning

• high-output ultrasound

Before having procedures, medical therapies, or diagnostics, have your healthcare professional call

our Customer Service department at (866) 566-8913 for proper instructions.

Automobiles and Other Equipment. Do not operate an automobile, other motorized vehicle, or

potentially dangerous machinery/equipment with stimulation turned on. Turn off stimulation first.

Sudden stimulation changes, if they occur, may distract you from attentive operation of the vehicle

or equipment.

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.

Patient Trial Handbook

Help

Stimulation

No Stimulation

1. When stimulating, the Trial Stimulator status light will blink. If it is not blinking, toggle the

power button on the Trial Stimulator or the Remote Control. When the Remote Control receives

confirmation from the Trial Stimulator, it will flash “Stimulation On.”

2. When the status light is blinking and you still do not feel stimulation:

a. Check to make sure the lead cable is properly connected to the stimulator. Turn the stim-

ulator “off” before adjusting the cables, and then turn it back “on.”

b. If you were provided a skin patch electrode, check that it is properly secured to your

skin. Make sure to turn the stimulation off first, and then back on.

c. Try turning up the level of the stimulation. If this does not bring on stimulation, turn it

back down.

3. When the status light will not blink and you do not feel stimulation, replace the Trial Stimulator

battery.

4. Call your physician’s office if the above steps do not solve the problem.

Help

Stimulation Increases or Decreases on Its Own

1. Stimulation can change depending on body position (lying down, standing or bending).

2. Always keep the Remote Control with you, so that you can adjust your stimulation levels as

needed.

Stimulation Coverage is in a Different Area Than at the Doctor’s Office

1. If stimulation is moved, and you did not activate a different program, you should call your

doctor. It is possible that the leads may have moved during the trial.

Remote Control Display

“Remote Battery Low” on the Display

1. The battery in your Remote Control needs to be replaced using the Advanced Bionics 3.6 Volt

battery. Do not use a AA battery. Call Advanced Bionics Customer Service department at (866)

566-8913 or your physician’s office to obtain a new battery.

“No Response” on the Display

1. When the Remote Control displays “No Response,” it cannot find the Trial Stimulator because

of orientation or interference. Move the remote closer and try again. Call our Customer Service

Department at (866) 566-8913 if the problem continues.

Patient Trial Handbook

“Action Unsuccessful” on the Display

1. When the Remote Control displays “Action Unsuccessful,” press [OK] and try the action again.

If pressing [OK] does not clear the message, call your physician’s office.

Accessories

Washing the Velcro® Belt

1. Wash the belt with mild soap and warm water.

Help

Contacting Advanced Bionics

If you have any other questions, or need to contact Advanced Bionics for any reason, you may do so

in any of the following ways:

• Customer Service Phone: (866) 566-8913

• Customer Service Fax: (661) 362-1503

• Address: Advanced Bionics® Corporation

Pain Management Division

Mann Biomedical Park

25129 Rye Canyon Loop

Valencia CA 91355

Patient Trial Handbook

CORPORATE HEADQUARTERS

Advanced Bionics®Corporation

12740 San Fernando Road, Sylmar, CA 91342

(800) 678-2575 in US and Canada

(818) 362-7588, (818) 362-5069 Fax

(800) 678-3575 TTY

www.advancedbionics.com

Email:info@advancedbionics.com

PAIN MANAGEMENT DIVISION

Advanced Bionics®Corporation

Mann Biomedical Park

25129 Rye Canyon Loop, Valencia, CA 91355

(661) 362-1400, (661) 1500 Fax

9055078 Rev C

IMAGINE the Possibilities®

Boston Scientific Neuromodulation SC-1100 SCS Implant System Implantable Pulse Generator User Manual SCS Patient Cvrs

Boston Scientific Neuromodulation Corporation SCS Implant System Implantable Pulse Generator SCS Patient Cvrs

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