Boston Scientific Neuromodulation SC-1100 SCS Implant System Implantable Pulse Generator User Manual SCS Dr Covers

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Physician Implant Manual
9055100-001 Rev D
Physician Implant Manual
CAUTION. Investigational device. Limited by federal law to
investigational use.
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 be serviced only by
Advanced Bionics. Do not attempt to open or repair any of the
components. Unauthorized opening of or attempts to repair
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
BionicNavigator™ and Precision™ are registered trademarks of
Advanced Bionics Corporation. 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
©2003 by Advanced Bionics Corporation. All Rights Reserved.
Table of Contents
Table of Contents
Introduction ............................................... 1
Manual Overview ........................................................... 1
Device Description .......................................................... 1
Features ........................................................................ 1
Indications for Use ........................................................... 2
Patient Selection .............................................................. 2
Contraindications ............................................................ 2
Safety Instructions ...................................... 3
Warnings ...................................................................... 3
Precautions .................................................................... 4
Adverse Effects ............................................................... 5
Instructions for the Physician ............................................... 6
Package Contents ........................................................... 7
Patient Identification ......................................................... 7
Sterilization .................................................................... 7
Handling ....................................................................... 8
Storage ......................................................................... 8
Guidelines for Permanent Implantation ...... 9
Percutaneous Lead/Extension Removal ................................ 9
Option A. Temporary Lead Removal ............................. 9
Option B. Extension Removal ....................................... 9
IPG Implantation ........................................................... 11
Tool Assembly .............................................................. 12
Tunneling The Lead ........................................................ 12
Connecting To the IPG ................................................... 16
Dual Lead Connection .............................................. 16
Single Lead Connection ............................................ 16
iii
Physician Implant Manual
IPG Explant or Replacement ..................... 19
Rechargable Implant System .................... 20
IPG Battery Status .......................................................... 20
Charging Steps ............................................................ 21
Patient Remote Control ............................. 24
Basic Operation ........................................................... 24
Basic Programming ....................................................... 25
Stimulation On/Off ................................................. 25
Stimulation Amplitude ............................................... 25
Coverage Area Selection .......................................... 25
Program Selection ................................................... 25
Options ................................................................. 26
Physician Mode ............................................................ 27
Entering Physician Mode .......................................... 27
Device Links and Resets .................................................. 28
Change Link (same patient use only) ........................... 28
Change Patient ....................................................... 29
Changing Links and Resets ........................................ 29
Reading Lead Impedances .............................................. 30
Stimulation Set Up (Programming) ..................................... 30
Electrode Configuration ............................................ 31
Parameters ............................................................. 32
Exiting Clinician’s Programming Screen ....................... 32
Programmer Communication ........................................... 32
Specifications and Technical Data ............. 33
IPG (SC-1100) ............................................................. 33
Registration Information .......................... 34
Registering the Implant ................................................... 34
iv
Table of Contents
Technical Service ...................................... 35
Limited Warranty ..................................... 36
Physician Implant Manual
vi
Introduction
Introduction
Manual Overview
This manual provides basic information for the implantation and
operation of the Precision™ Implantable Pulse Generator (IPG),
SC Model 1100. This information includes an overview of accessories
for programming and powering the IPG, clinical and surgical considerations, storage and handling requirements, and relevant precautions
concerning an implanted neurostimulator. Additional information on
system components and operation can be found in the Precision Physician Systems Handbook.
Device Description
The Advanced Bionics® Precision implantable pulse generator system
is intended to treat chronic pain by electrically stimulating the spinal
cord. The multi-channel, multi-electrode device capability provides
flexibility in conjunction with ease of programming. A rechargeable
battery increases IPG longevity and output capability while reducing
size and device replacement surgeries. The implant is controlled by a
handheld Remote Control, and can be engaged by a clinician computer using proprietary BionicNavigator™software. Periodically, the
implant battery requires replenishing with an RF charging device provided in the Patient Take Home Kit SC-6000.
Features
•
•
•
•
•
•
•
Stimulation electrode field navigation
Sixteen independent current-controlled electrodes
Four programmable stimulation areas per program; four
possible programs
Long-life operation
High-range parameter capability
Small size
Two-foot programming range
Physician Implant Manual
Indications for Use
The Precision is indicated for the management of chronic intractable
pain of the trunk and limbs utilizing spinal cord stimulation.
Patient Selection
The therapy is generally most effective in patients who suffer neuropathic pain. Careful patient selection, therefore, is an important factor
in achieving efficacious outcomes. It is recommended that patients be
screened for psychological factors that could reduce the likelihood of
therapeutic success. (Specific information regarding patient selection
is included in the Physician Systems Handbook.) Most successful outcomes occur with the following:
•
Identifiable pathology
•
Pain of neuropathic origin
•
Psychological screening
•
Patient understanding of risks, benefits and limitations,
and a commitment to a successful therapy
•
Successful externalized stimulation trial prior to acceptance of permanent IPG implantation
Contraindications
Patients contraindicated for permanent SCS therapy are those who:
•
do not meet psychological selection criteria
•
have failed trial stimulation
•
are poor surgical risks
•
are pregnant
Safety Instructions
Safety Instructions
Warnings
Pregnancy. The safety and/or effectiveness of neurostimulation during pregnancy has not been established.
Diathermy. Shortwave, microwave and/or therapeutic ultrasound
diathermy are categorically contraindicated for SCS patients. The
energy generated by diathermy can be transferred through the stimulator system, causing tissue damage at the lead site and resulting in
severe injury or death.
Implanted Stimulation Devices. Spinal cord stimulators may
interfere with the operation of implanted sensing stimulators such as
pacemakers or cardioverter defibrillators. The effects of implanted
stimulation devices on neurostimulators is unknown.
Implant Damage. Burns may result if the pulse generator case is
ruptured or pierced and patient tissue is exposed to battery chemicals.
Do not implant the device if the case is damaged.
Postural Changes. Patients should be advised that changes in pos-
ture or abrupt movements may cause decreases, or uncomfortable or
painful increases in the perceived stimulation level.
Electromagnetic Interference. Strong electromagnetic fields can
potentially turn the stimulator off, or cause uncomfortable or jolting
stimulation. Patients should be counseled to avoid or exercise care
around:
•
Theft detectors or security screeners
•
Power lines or power generators
•
Electric steel furnaces and arc welders
•
Large, magnetized stereo speakers
Physician Implant Manual
Precautions
MRI. Patients implanted with the Precision SCS system should not be
subjected to MRI. MRI exposure may result in dislodgement of
implanted components, heating of the neurostimulator, damage to the
device electronics and/or voltage induction through the leads and
stimulator causing 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 defibrillation
•
radiation therapy
•
ultrasonic scanning
•
high-output ultrasound
If any of the above is required by medical necessity, refer to “Instructions for the Physician” on page 6. Ultimately, however, the device
may require explantation as a result of damage to the device.
Automobiles and Other Equipment. Patients should not operate
automobiles, other motorized vehicles, or potentially dangerous
machinery/equipment with therapeutic stimulation switched on. Stimulation must be turned off first. Sudden stimulation changes, if they
occur, may distract patients from attentive operation of the vehicle or
equipment.
Safety Instructions
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.
Physician Implant Manual
Instructions for the Physician
Implanted Stimulation Devices. If such implanted devices are
indicated for the patient, careful screening is required to determine if
safe results can be achieved before permanently implementing concurrent electrical therapies.
Postural Changes. Depending on the activity level of the patient,
postural changes may affect stimulation intensity. Instruct patients to
keep the Remote Control at hand at all times, and ensure that they
understand how to adjust stimulation levels.
Medical Devices/Therapies. If the patient is required to undergo
lithotripsy, electrocautery, external defibrillation, radiation therapy,
ultrasonic scanning, or high-output ultrasound:
•
Adjust stimulation to its lowest level before the procedure or application, then turn off IPG.
•
All equipment, including ground plates and paddles,
must be used as far away from the IPG as possible.
•
Every effort should be taken to keep fields, including
current, radiation, or high-output ultrasonic beams,
away from the IPG.
•
Equipment should be set to the lowest energy setting
clinically indicated.
•
Instruct patients to confirm IPG functionality following
treatment by turning on the IPG and gradually increasing stimulation to the desired level.
Safety Instructions
Package Contents
(1) Precision Pulse Generator
(1) Hex Wrench
(1) Tunneling Tool
(1) Tunneling Tool Extension
(1) IPG Pocket Template
(1) Skin Marker
(2) Connector Plugs
(1) Device Registration Form
(1) Temporary Patient Identification Card
(1) Manual
Patient Identification
Please ensure that the patient receives a completed temporary identification card following surgery. Permanent cards will be mailed directly
to the patient following patient registration.
Sterilization
•
Before implanting the IPG, inspect the condition of the
sterilization indicator and the sterile package before
opening the package and using the contents. Do not use
the contents if the indicator lines are not red, if the package is broken or torn, or if contamination is suspected
because of a defective sterile package seal.
•
Do not resterilize the IPG. If resterilization is required,
obtain a sterile device for implantation.
•
The IPG is for single use only. Do not reuse.
Physician Implant Manual
Handling
Handle the IPG and implanted accessories with care.
•
Keep sharp instruments away from the components.
•
Do not use the IPG if it has been dropped on a hard surface from a height of more than one foot.
•
Do not incinerate an IPG. Improper disposal of the
device could result in an explosion. Devices should be
explanted in the case of cremation, and returned to
Advanced Bionics Corporation.
Storage
•
Store the IPG between 0° C and 45° C (32° F and
113° F). Devices should always be kept in temperature
regulated areas within the acceptable temperature range.
IPG damage can occur at temperatures outside of this
range.
Guidelines for Permanent Implantation
Guidelines for Permanent Implantation
This section details the procedures for
•
tunneling the lead/extension as part of an IPG implant,
and
•
connection of lead/extension to the IPG.
The Tunneling Tool Assembly used in this procedure is provided with
the Precision device as part of the IPG Kit.
Percutaneous Lead/Extension Removal
Before revising a trial system for chronic stimulation, the nonsterile
portion of the lead or extension must be removed. The method chosen
from the choices below will depend upon how the patient was prepared for the trial phase.
Remove bandages and properly cleanse the exit site.
Option A. Temporary Lead Removal
Remove the lead(s) completely and discard them.
Option B. Extension Removal
1.
Open the midline incision to expose the lead and connector.
Physician Implant Manual
2.
Cut the lead extension at the connector.
3.
Pull the lead extension through the tunnel and away from body at
the externalized site.
4.
Loosen the connector setscrew using the torque wrench provided.
Disconnect and discard the connector.
Note: Connect a new lead extension, if necessary, to reach the
selected IPG site.
10
Guidelines for Permanent Implantation
IPG Implantation
1.
Ensure that the area surrounding the lead entry site is incised to a
dimension that will accommodate the tunneling tool. Check that
the lead is securely sutured with the suture sleeve.
2.
Select and mark the intended IPG site several inches away from
the previously externalized leads, and create an incision at the top
of the implant site. (Common sites are the abdomen, upper buttock, or subclavicular area.)
3.
Create a subcutaneous pocket no larger than the IPG outline at a
depth less than 3/4 inch (2.0 cm) from the surface.
Note: • Using the template will help guide the correct pocket sizing.
It is important to keep the pocket small to reduce the
chances of patient twiddling and IPG flipping afforded by
larger pockets.
• Implant charging frequency or time will increase with
pocket depths greater than 3/4 inch (2.0 cm), and could
become ineffective at greater depths.
11
Physician Implant Manual
Tool Assembly
The tunneling tool provided with the IPG includes a shaft extender to
be used for up to two leads.
1.
Attach the handle to the tunneling tool shaft by turning the locking mechanism clockwise.
Note: For more length, attach the shaft extension to the handle, and
then attach the carrier shaft.
2.
Thread the tip cover onto the tunneling tool and tighten by turning clockwise.
Tunneling The Lead
1.
Mark the desired route of the tunnel.
2.
Administer the appropriate local anesthetic along the tunneling
path.
12
Guidelines for Permanent Implantation
Note: Check that the tunneling tool tip is securely threaded onto the
carrier.
3.
OPTIONAL. If necessary, bend the tool shaft to conform to the
patient’s body.
Do not bend locking joints.
4.
Create a subcutaneous tunnel from the IPG site to the midline
incision.
Note: Deep tunneling is not recommended.
13
Physician Implant Manual
5.
Once the tunneling tip is completely exposed at midline, press it
toward the shaft and turn it counterclockwise to remove it for
access to the carrier.
Note: You may feel the tip slide back before the cover begins to
unscrew.
14
Guidelines for Permanent Implantation
6.
Carefully position each lead or extension into the carrier shaft
and press the lead/extension into the groove.
Note: If necessary, swivel the carrier by pulling it away from the
handle and turning it to get better access to the cavities.
7.
Gently pull the tunneling tool back through the tunnel.
15
Physician Implant Manual
8.
Gently lift the lead(s) out of the locking groove(s).
9.
Wipe off any fluids from the proximal end of the lead(s).
Connecting To the IPG
Dual Lead Connection
•
Superior (upper or left) leads connect to IPG port 1-L.
•
Inferior (lower or right) leads connect to IPG port 2-R.
Single Lead Connection
16
•
Connect a single lead to IPG port 1-L.
•
Plug port 2-R with the connector plug supplied in the
IPG Kit.
Guidelines for Permanent Implantation
1.
Fully insert the lead(s) into the IPG port(s). When the lead is
properly inserted, the lead will stop and the retention ring will be
located under the setscrew.
2.
Pass the torque wrench through the slit in the septum located on
the top of the IPG header and tighten both set screws, one at a
time, until the torque wrench “clicks,” indicating lock.
17
Physician Implant Manual
Note: • If the connector plug is used in port 2-R, it is still necessary
to tighten the setscrew as described.
• The wrench is torque-limited and cannot be overtightened.
• Ensure that the lead is fully inserted before tightening the
setscrew to prevent lead damage.
3.
Place the IPG in the subcutaneous pocket with “This Side Up”
facing anterior towards the skin.
4.
Coil excess lead or extension under the IPG.
Note: To confirm good connections, check impedances.
5.
Secure the IPG in the pocket by suturing through the holes in the
connector.
6.
Close and dress the wound(s).
18
IPG Explant or Replacement
IPG Explant or Replacement
1.
Turn off the IPG.
2.
Surgically open the IPG pocket and withdraw the device.
3.
Unscrew the connector setscrews to release the leads.
4.
For replacement, connect the new IPG following steps 1-6 of
“Connecting to the IPG,” preceding. Or, to terminate therapy, surgically remove the implanted lead system.
19
Physician Implant Manual
Rechargable Implant System
The Precision spinal cord stimulator is rechargeable. Depending on
stimulation power usage and programming, the majority of patients
will need to recharge the implant once per week. High power users
will require more frequent charging.
The clinician programmer will estimate charging time based on 24
hours per day of stimulation at the programmed settings. Patients
should be instructed to charge until the charger emits an end of charge
beep signal.
Estimated charge times for 1-4 stimulation areas set to stimulate at 40
pulses-per-second and 210 µs per area:
1 Area
2 Areas
4 Areas
Nominal
Power
Medium
Power
High Power
Total Current
< 4 mA
4-8 mA
> 8 mA
Per Week
1 hour 30 min.
4 hours
Per Day
15 min.
30 min.
1 hour
*Beginning of Life
IPG Battery Status
The patient Remote Control will display when the stimulator battery
is low and when the stimulator battery is empty. If the IPG is not
recharged before depletion, stimulation will automatically shut off
20
Rechargable Implant System
and the implant will need to be charged for approximately 2 hours
before reactivation.
Charging Steps
The Charger Base Station should be plugged in and the charger placed
in the cradle until the indicator light is green. If the indicator is not
green, the charger may not be able to fully charge the implant.
Users may wear the charger over the implant using a Velcro® belt or
adhesive patches. The patches are preferred to maintain proper alignment throughout charging.
1.
While the Charger is seated in the Base Station, check that the
indicator light is green.
2.
Remove the Charger from the Base Station. (The indicator light
will go out, regardless of the ready status.)
21
Physician Implant Manual
3.
Apply the adhesive to the backside of the Charger by peeling the
clear device side liner from the patch and applying the patch to
the device, as shown, and then remove the skin side beige liner
from the adhesive (only good for one fixation).
OR
Place the Charger into the Velcro® belt with the power button
facing out.
4.
22
Press the power button, the large blue center of the Charger, to
turn on the Charger. The indicator light will return to the status
position, and the Charger will begin beeping steadily to signal
that it is searching for the implant.
Rechargable Implant System
5.
Locate the Charger over the IPG. When the Charger is correctly
aligned with the IPG, the beeping will stop. Press the Charger
with the adhesive, or secure the Velcro® belt at this time.
Note: • If the Charger loses contact with the IPG during charging,
the steady alignment beep will sound. Readjust the belt or
reapply the adhesive.
6.
When the Charger emits a distinct double beep, the implant is
charged.
23
Physician Implant Manual
Patient Remote Control
Basic Operation
The Remote Control communicates with the implant through a radio
frequency (RF) telemetry link from a distance of up to two feet. The
Remote Control turns on automatically when any button is pressed.
During normal patient use, the Remote Control will turn off automatically after 60 seconds of non-use. Button functions are identified
above the buttons on the LCD screen. These function identifiers may
change depending upon the actions being performed.
Note: Electronic interference and poor orientation can result in a
lack of communication that will be displayed as “No
Response” on the device’s LCD screen. If this occurs, move the
remote closer to the IPG and try the previous action again.
24
Patient Remote Control
Basic Programming
Stimulation On/Off
The stimulation is turned on and off with a dedicated power switch on
the Remote Control keypad. Simply press the stimulation power button at any time to change the on/off state of the implant.
Stimulation Amplitude
Press the T or S button from the main screen to decrease or increase
amplitude.
Coverage Area Selection
Press the SEL 1 [SEL] button from the main screen to cycle to a specific stimulation coverage area. Press the T or S button to adjust the
amplitude of the selected area.
Program Selection
Press the SEL 2 [NEXT] button to display the program screen. Press
the SEL 1 [SEL] button to cycle through saved programs. Program
selections can be either activated (press T) or saved (press S) from
this screen.
25
Physician Implant Manual
Options
Press and hold the SEL 2 button for 3 seconds to access the Rate and
(Pulse) Width parameters and the program restore function. Use the
SEL 1 button to highlight the desired option, then press S [GO].
Note: Rate and Pulse Width are blocked from patient access by
default, but may be made available using the Clinician’s
Programmer.
26
Patient Remote Control
For Rate and Pulse Width: When the desired option screen is displayed, first use the SEL 1 button to find the desired area, then use the
T or S button to decrease or increase the parameter setting for that
area.
To restore a program: Press SEL 1 to highlight the desired program,
then press SEL 2 [RESTR]. The restore function returns a program to
the last clinic programmed settings.
Physician Mode
Patient-restricted physician screens provide access to these advanced
programming and interrogation functions:
•
Communication with the clinician programmer
•
Electrode and stimulation parameter programming
•
Electrode impedance monitoring
•
Remote Control and trial stimulator resetting/re-linking
Entering Physician Mode
1.
To access physicians screens, press SEL 1 and SEL 2 simultaneously.
2.
The Remote Control will request a code. (To obtain the code,
refer to the Physician Systems Handbook.) Use the S and T
buttons to scroll through the characters, and the SEL 1 [SEL] button to advance to the next entry. After entering the code, press
SEL 2 [ENTER].
Once the code is entered, the screen will appear as shown.
27
Physician Implant Manual
Device Links and Resets
A Remote Control can communicate with only one stimulator at a
time. This prevents the remote device from accidentally controlling
an unintended stimulator. To start a trial for a new patient, the remote
settings and programs must be reset or cleared.
Change Link (same patient use only)
Change the link when the remote is intended for continued use by the
same patient with a new stimulator. All programs set for the patient
will be maintained and can be used with the new stimulator. Change
the link when:
28
•
converting from a trial stimulator to a permanent IPG
•
replacing an IPG
Patient Remote Control
Change Patient
When a Remote Control is to be used with a different patient than was
previously using the remote, reset the system. This will clear all previously stored programs and will allow you the option of resetting a
trial stimulator when one is detected. Always reset the system when
using a remote with a different patient, such as when:
•
Programming an IPG or trial stimulator of a new or different patient
Changing Links and Resets
1.
Access the physician mode and enter the code.
2.
When the screen displays “CLINIC OPTIONS PC READY”
press S [RSET] to access the links and resets.
3.
Use SEL 1 to select “Link” or “Patient” from the following
screen, and press S [RSET].
29
Physician Implant Manual
The Remote Control will turn off after breaking the existing link and/
or clearing the programs. Press any button to turn on the remote and
re-establish the link.
Reading Lead Impedances
From the physician OPTIONS screen, press T [IMP] to check lead
electrode impedances. It will take a few seconds to display the
detected values.
Note: Failed electrodes that are not currently assigned will not be
displayed on the programming screen. Otherwise, failed
anodes will be displayed H+. Failed cathodes will be
displayed H-. You may wish to make note of problem contacts
from this screen to serve as a programming reference.
Stimulation Set Up (Programming)
Note: When using the Remote Control for a new or different patient,
be sure it has been reset. See “Change Patient” on page 29 for
instructions.
1.
Enter the physician mode (see “Entering Physician Mode” on
page 27) and press SEL 1 [CLIN] to access the programming
screen.
2.
The SEL 2 button toggles between the electrode configuration
and the parameters.
The screen displays the settings and configuration for one programmable area at a time. Up to four independent areas can be configured
for each of the four programs available with the IPG.
When there are separately controlled areas of stimulation, the
stimulation rates for the individual areas must be in descending
order or be equal. This means that Area 1 must have a rate
higher than or equal to Area 2, and Area 2 must have a rate
higher than or equal to Area 3, and so forth. (Coverage areas
are separate groups of electrodes, with independent
30
Patient Remote Control
programmable parameters, which are combined into a
program to achieve optimal pain coverage.)
Separately controlled areas within the same program cannot
share the same electrodes when the stimulation is monopolar,
utilizing the IPG or external patch electrode as the anode.
Electrode Configuration
1.
Electrodes are numbered 1-16 (8 per side), and displayed as
shown in the figure below. Use the T (down) and S(up) buttons
to cycle E1 through E16.
2.
When the desired electrode number is reached, configure the
polarity (+/ -/0) by pressing the SEL 1 button until the intended
polarity is shown on the respective electrode.
Note: When changing a configuration, the amplitude of the edited
area will be reduced to 0.0 and stimulation to all other areas
will be turned off.
3.
If you have changed a configuration, gradually increase the
amplitude of the edited area to a comfortable level.
4.
To restore stimulation at previous levels to all other areas, briefly
press the power button once, then press it a second time.
31
Physician Implant Manual
Parameters
1.
Use the SEL 1 button to cycle through various parameters including amplitude, rate, and pulse width, and to program or view
another area.
2.
Use the T (down) and S(up) buttons to adjust the selected
parameter.
Exiting Clinician’s Programming Screen
1.
2.
Upon completion, press SEL 1 and SEL 2 simultaneously. This
will advance to the PROGRAMS screen.
Select the program number you wish to save to by pressing
SEL 1. You can overwrite an existing program or save to an
empty program slot (*) if one is available.
3.
Press the up button (S) to save. You will return to the clinician
Options screen.
For more information on how to use the physician screen, see the
Physician Systems Handbook.
Programmer Communication
The clinician’s programmer can communicate with either an external
trial stimulator or an IPG. In order to begin a programming session,
the clinician programmer and the Remote Control infrared windows
must be aligned.
Arrange for the patient to be seated within two feet of the Remote
Control to ensure a complete communication link from the programmer to the stimulator.
For instructions on how to use the clinician’s programmer with the
BionicNavigator software to program the IPG and transfer programs
to the Remote Control, see the Physician Systems Handbook.
32
Specifications and Technical Data
Specifications and Technical Data
IPG (SC-1100)
Parameter
Range
Default
Areas (Channels)
—
Amplitude
0 – 20 mA
0 mA
Rate
0 – 1200 pps
40 pps
Width
0 – 1000 µsec
210 µsec
Cycle
0 – 90 min
OFF
Ramp ON
1 – 10 sec
2 sec
Contacts
1 – 16; +, -, OFF
1 – 16: OFF
Materials
Size
Case
Titanium
Header
Epoxy
Strain Relief
Silicone
Size
55mm x 45mm x 11mm
33
Physician Implant Manual
Registration Information
Registering the Implant
In accordance with international practice and regulatory legislation in
some countries, a registration form is packed with each Advanced
Bionics Corporation neurostimulator.
The purpose of this form is to maintain traceability of all products and
to secure warranty rights. It also allows the institution involved in the
evaluation or replacement of a specific implanted lead, accessory or
device to gain quick access to pertinent data from the manufacturer.
Fill out the registration form included in the package contents. Return
one copy to Advanced Bionics, keep one copy for patient records, and
provide one copy to the patient and physician.
Advanced Bionics Corporation
25129 Rye Canyon Loop
Valencia, California 91355
Attention: Customer Service Department
34
Technical Service
Technical Service
Advanced Bionics Corporation has highly trained service professionals located worldwide to assist you. The Technical Service Department is available to provide technical consultation 24 hours a day.
In North America, please call (866) 566-8913 to speak to a representative.
35
Physician Implant Manual
Limited Warranty
Advanced Bionics® Corporation (hereinafter referred to as Advanced
Bionics®) warrants to the patient who receives a Precision™ System
that the implanted pulse generator (hereinafter referred to as the IPG,
Model SC 1100, is free from defects in workmanship and materials
for a period of one (1) year from the date of surgical implant of the
IPG. This warranty only applies to the patient (recipient, hereinafter
referred to as the patient), and no other individual.
An IPG that fails to function within normal tolerances within (1) year
from the date of surgery is covered under this Limited Warranty. The
liability of Advanced Bionics® under this warranty shall be limited to:
(a) replacement with a functionally equivalent IPG; or (b) full credit
equal to the original purchase price to be applied towards the purchase
of a new IPG. Product claims under Advanced Bionics® Limited Warranty are subject to the following conditions and limitations:
1.
The product registration card must be completed and returned to
Advanced Bionics® within 30 days of surgery in order to obtain
warranty rights.
2.
The IPG must be returned to Advanced Bionics® (or authorized
agent) within 30 days of malfunction or discovery of defect, and
shall be the property of Advanced Bionics®.
3.
The IPG must be implanted prior to the “use before” date.
4.
Failure of the IPG must be confirmed by Advanced Bionics®.
This warranty specifically excludes defects or malfunctions
caused by: (a) fire, floods, lightning, natural disasters, water
damage and other calamities commonly defined as “Acts of
God”; (b) accident, misuse, abuse, negligence, or the customer’s
failure to operate the IPG in accordance with manufacturer's
instructions; (c) unauthorized attempts to repair, maintain, or
modify the equipment by the customer or any unauthorized third
party; or (d) attachment of any equipment not supplied by
Advanced Bionics® without prior approval.
36
Limited Warranty
a.
5.
This warranty does not include the leads, extensions or
surgical accessories used with the Precision™ IPG.
The decision as to product replacement or credit shall be made
solely at the discretion of Advanced Bionics®. For a replacement
IPG, the warranty will run only to the end of the warranty period
for the original IPG that was replaced.
This warranty is in lieu of any other warranty, expressed or implied,
including any warranty of merchantability or fitness for intended use.
Except as expressly provided by this Limited Warranty, Advanced
Bionics® shall not be responsible or liable for any direct, consequential or incidental damages caused by device malfunction, failure or
defect, whether the claim is based on warranty, contract, tort or otherwise.
37
IMAGINE the Possibilities
®
CORPORATE HEADQUARTERS
Advanced Bionics® Corporation
12740 San Fernando Road, Sylmar, CA 91342
(800) 678-2575 in US and Canada
(818) 362-7588, (818) 362-5069 Fax
(800) 678-3575 TTY
www.advancedbionics.com
Email:info@advancedbionics.com
PAIN MANAGEMENT DIVISION
Advanced Bionics® Corporation
Mann Biomedical Park
25129 Rye Canyon Loop, Valencia, CA 91355
(661) 362-1400, (661) 1500 Fax
JUN03-080620-P
9055100 Rev D
©2003 Advanced Bionics Corp. All rights reserved.

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