Boston Scientific SC-5213 Manual

Precision™ SCS
System with MultiWave
Technology
Physician Trial Kit
SC-5112 External Trial Stimulator
SC-5213 Remote Control
Directions for Use 2
Instrucciones de uso 9
Mode d’emploi 16
Gebrauchsanweisung 23
Istruzioni per l’uso 30
Gebruiksaanwijzing 37
Bruksanvisning 44
Käyttöohjeet 51
Bruksanvisning 58
Brugsanvisning 64
Instruções de Utilização 70
Instruções de uso 78
CAUTION:
Federal law restricts this device to sale, distribution and
use by or on the order of a physician.
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Storage, Handling, and Transport:
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ENGLISH
Precision™ SCS
System with
MultiWave Technology
Physician Trial Kit
SC-5112 External Trial Stimulator
SC-5213 Remote Control
Caution: Federal Law restricts this device to
sale, distribution, and use by or on the order
of a physician.
The Precision SCS System with MultiWave
Technology Trial Stimulator is intended to
be used during a screening trial to assess
the efcacy of spinal cord stimulation in the
treatment of patients with chronic pain. The
Trial Stimulator communicates with, and is
controlled by, both a patient programmer (the
Remote Control) and a clinician programmer
via a wireless link.
The Precision SCS System with MultiWave
Technology Remote Control unit is a hand-
held device for patient control of both the
external Trial Stimulator and the permanent,
implantable pulse generator (IPG) models of
the Precision SCS System with MultiWave
Technology device.
Following set up of the Remote Control by
the clinician, the Trial Stimulator is able to
respond to patient control of:
• stimulation on/off functions
• stimulation amplitude and other (optional)
parameters
• stimulation delivery areas
• individualized stimulation therapy
programs.
Patient use instructions are outlined in the
Patient Trial Handbook for Precision SCS
System with MultiWave Technology.
Storage, Handling, and
Transport:
• To avoid unexpected stimulation results,
never make connections while the Trial
Stimulator is on.
• The battery used in the Trial Stimulator
may present a risk of re or chemical burn
if mistreated. Do not disassemble, heat
above 100 ºC (212 ºF), or incinerate.
• Handle the devices with care. Although
durability testing has been performed
to ensure quality manufacturing and
performance, dropping the devices
on hard surfaces or in water, or other
destructive handling, can cause
permanent damage.
• Avoid all sources of water that can come
into contact with the devices.
• Do not expose the devices to extreme
temperatures.
• Store between -20 and 60 °C (-4 and
140 °F).
• Do not dispose of the devices in re.
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Trial Stimulator
1. 2-R
2. 1-L
3. Indicator Light
4. Stimulation On/Off
General Instructions
1. Ensure that the Trial Stimulator is
equipped with a new 6-volt battery before
conducting intraoperative stimulation
testing, and for each new trial. (A battery
is included in the Patient Trial Kit.)
2. Before connecting the OR Cable for
intraoperative testing, ensure that the
Trial Stimulator is off (no indicator light).
Turn the Stimulator on for testing, then
return it to off before disconnecting the
test cables.
3. When tting the patient with the Trial
Stimulator, ensure that the OR Cables are
properly connected and labeled. Superior
(upper or left) leads connect to socket
1-L. Inferior (lower or right) leads connect
to socket 2-R. If only a single lead is
being used, connect it to 1-L.
4. Before releasing the patient, ensure that
he/she understands:
• Basic control of the Trial Stimulator using
the Remote Control, and that stimulation
may be turned on and off with the &or !
button on either unit.
• How to disconnect and reconnect the OR
Cable(s) with the power off.
• How to replace the Trial Stimulator
battery. (See illustration below.)
Remote Control
Battery Information
The Remote Control uses three AAA
batteries. The Remote Control issues a
warning when:
• its batteries are low.
• the implant needs recharging.
• the Trial Stimulator battery needs
replacement.
Instruct patients to pay close attention to all
battery messages.
Battery Replacement
NOTE:
• Following a battery replacement, the
Remote Control will reload information
from the implanted or external Stimulator.
• The Remote Control must be within
communication range (approximately two
feet) of the Stimulator during this period.
• It will take about 30 seconds for the
Remote Control to reconnect with the
Stimulator.
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General Instructions
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Battery removal is recommended if the
Remote Control is not going to be used for an
extended period of time.
1. On the rear of
the Remote
Control, push
in slightly and
slide the battery
compartment
cover down.
2. Remove the old
batteries.
3. Place the new batteries in the slots by
matching the positive (+) and negative (–)
battery ends with the + / – markings in the
compartment.
4. Align the cover on the case and slide the
cover into position until it snaps closed.
General Instructions
1. To turn stimulation on or off, press the !
button.
NOTE:
• When it has not been used for
approximately one minute, the Remote
Control sets itself in a sleep/idle mode
and the display screen is blank. At this
time, the keys become locked. When you
press any button except the !button, the
Remote Control will display the following
message:
• To reactivate (unlock) the Remote Control,
press and hold Puntil the following
screen appears.
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2. To increase or decrease the stimulation
level of all programmed therapy areas,
press either por qfrom the Level
screen.
3. To change the stimulation level of just
one area:
Note: Only applicable if the Stimulator is
programmed to treat more than one
area and to operate at frequencies of
1,200Hz or below.
a) From the Level screen, press "as
many times as necessary to nd the
desired area by name or number.
b) Press por qto make the change.
4. To activate a stimulation program:
a) Press Pfrom the Level screen.
b) From the Program screen press Pas
many times as necessary to highlight
the desired program.
c) Press pto activate the selected
program.
To save the new setting in a program,
return to the Program screen, select the
intended program number, and press q.
This will replace the existing program with
the new settings.
Accessing Patient Options
Note: Only applicable if the Stimulator is
programmed to operate at frequencies
of 1,200Hz or below and patient
options are made available.
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Maintenance
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Pulse Width (If provided by physician)
1. Press and hold "from the Level screen to
activate the Pulse Width Area 1 screen.
2. Press "(normal press) as necessary to
cycle to the area you want to adjust, then
press por qto increase or decrease
the Pulse Width.
3. From any Pulse Width screen, press and
hold "again to access the Rate 1 screen.
Rate (If provided by physician)
1. From the Pulse Width screen press and
hold "to access the Rate Area 1 screen.
2. Press "(normal press) as necessary to
cycle to the desired area.
3. Press por qto increase or decrease
Rate.
Saving Rate or Pulse Width Changes
1. Press Pfrom the Level screen.
2. From the Program screen, press P
as necessary to cycle to the active
underlined ( _ ) program.
3. With the program highlighted, press qto
save changes.
4. The Remote Control then prompts for a
conrmation to save the operation.
Restore Programs
1. From the Level screen, press and hold P
to access the Restore screen.
2. Press Pagain as necessary to highlight
the program you want to restore, then
press pto restore the program.
NOTE: This will restore the selected
programs to the most recent clinic
settings.
Maintenance
The Trial Stimulator and Remote Control may
be cleaned with a cloth lightly dampened with
water or a mild household cleaner. Do not
use abrasive cleansers on the devices, and
do not sterilize them.
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Customer Service - USA
In USA, to order replacement parts, or
for answers to any questions you might
have, please contact the Customer Service
Department:
• Phone: [phone], +1 (661)
949-4747
• Fax: [phone]
Corporate Headquarters:
Boston Scientic Neuromodulation
25155 Rye Canyon Loop
Valencia, CA 91355 USA
Customer Service - Outside
USA
For Physicians, if you have any other
questions or need to contact Boston
Scientic, choose your locality from the
contact list at the end of this document.
For Patients, if you have a specic question
or issue, please contact your healthcare
professional.
Limited Warranty
Boston Scientic Corporation warrants to
the patient that the Remote Control Device,
Charger System (Charger and/or Charger
Base Station) and Trial Stimulator are free
from defects in workmanship and materials
for a period of one year from the date of
purchase.
If a Remote Control Device or Trial Stimulator
fails to function within normal ranges
within one year after the date of purchase,
Boston Scientic will replace the device or
component with a functionally equivalent
device or component made by Boston
Scientic. 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 within 30 days of purchase and
returned to:
In USA: Boston Scientic
Outside USA: your healthcare
professional.
2. Boston Scientic must conrm the device
or component failure.
3. The device or component must be
returned within 30 days after it fails to
function within normal ranges. Return to:
In USA: Boston Scientic
Outside USA: your healthcare
professional.
4. That device or component will be the
property of Boston Scientic.
5. This limited warranty does not include
failures to function within normal ranges
caused by:
a) re, oods, lightning, natural disasters,
water damage and other calamities
commonly dened as “Acts of God”;
b) accident, misuse, abuse, negligence,
or the customer’s failure to operate
the device or component in
accordance with manufacturer’s
instructions;
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Limited Warranty
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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 Boston
Scientic.
This limited warranty is the only warranty
that applies to the device or component, and
Boston Scientic expressly disclaims any
other warranty, express or implied, including
any warranty of merchantability or tness for
a particular purpose.
Under this limited warranty, Boston Scientic
will be responsible only for replacement of
the device or component with a functionally
equivalent device or component made by
Boston Scientic 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.
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