Boston Scientific SC-5213 User manual

Precision™ SCS
System with MultiWave
Technology Remote
Control
Model SC-5213
CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.
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Battery Information
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Precision™ SCS
System with
MultiWave Technology
Remote Control
Model SC-5213
Caution: Federal Law restricts this device to
sale, distribution, and use by or on the order
of a physician.
1. Area Button
2. Up/Activate
3. Down/Save
4. Program
Button
5. Stimulation
On/Off
Button
The Precision SCS System with MultiWave
Technology Remote Control is a hand-held
programmer for controlling the Precision
SCS System with MultiWave Technology
implantable and external pulse generators.
Following set up of the Remote Control by the
clinician, the device gives patient access to:
• stimulation on/off functions
• stimulation delivery areas
• individualized stimulation therapy
programs
• amplitude and other (optional)
parameters
For complete use instructions, refer to the
Patient System Handbook for Precision SCS
System with MultiWave Technology
Storage, Handling, and Transport:
• Do not expose the Remote Control to
extreme temperatures. Do not leave it in a
vehicle or out-of-doors.
• Handle the Remote Control carefully.
Although it has been durability-tested
to ensure quality manufacturing and
performance, dropping it on hard surfaces
or in water, or other destructive handling,
can permanently damage the Remote
Control.
• Avoid all sources of water that can come
into contact with the Remote Control.
• Do not dispose of the Remote Control in
re.
• Dispose of used batteries in accordance
with any local regulations.
• Use the Remote Control between
temperatures of 5 and 40 °C (41 and
104 °F).
• Store between -20 and 60 °C (-4 and
140°F).
• External devices to be disposed of per
local regulatory requirements. Please
contact your healthcare professional for
information.
Battery Information
The Remote Control uses three AAA
batteries. The Remote Control displays a
warning when:
• its batteries are low.
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Precision™ SCS System with MultiWave Technology Remote Control
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• the implant needs recharging.
• the Trial Stimulator battery needs
replacement.
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 (two feet) of the
Stimulator during this period.
• It will take about 30 seconds for the
Remote Control to reconnect with the
Stimulator.
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:
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General Instructions
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• To reactivate (unlock) the Remote Control,
press and hold Puntil the following
screen appears.
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 your 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.
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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 your Stimulator is
programmed to operate at frequencies
of 1,200Hz or below and your
healthcare provider has made options
available to you.
Pulse Width (If provided by physician)
1. Press and hold "from the Level screen to
access 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 Area 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.
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Maintenance
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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 Remote Control may be cleaned with a
cloth lightly dampened with water or a mild
household cleaner. Do not use abrasive
cleansers.
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],
[phone]
• 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.
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Limited Warranty
BostonScienticCorporation(referredto
asBostonScientic)warrantstothepatient
that the Remote Control Device and Charger
System (Charger and/or Charger Base
Station) are free from defects in workmanship
and materials for a period of one year from
the date of purchase.
If a Remote Control Device 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 Boston
Scientic’sproperty.
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;
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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Limited Warranty
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Control remoto del
sistema de estimulación
de la médula espinal
(EME) Precision™ con
tecnología MultiWave
Modelo SC-5213
Precaución: las leyes federales de los
Estados Unidos sólo permiten la venta, la
distribución y el uso de este dispositivo bajo
prescripción facultativa.
1. Botón de
área
2. Arriba/
Activar
3. Abajo/
Guardar
4. Botón de
programa
5. Botón de
activación/
desacti-
vación de la
estimulación
El control remoto del sistema de EME
Precision con tecnología MultiWave es
un programador de mano para el control
de los generadores de impulsos externos
e implantables del sistema de EME Precision
con tecnología MultiWave. Una vez que el
personalclínicohaconguradoelcontrol
remoto, el dispositivo permite al paciente
acceder a:
• funciones de activación y desactivación
de la estimulación
• áreas de administración de estimulación
• programas de terapia de estimulación
individualizados
• amplitud y otros parámetros (opcionales)
Las instrucciones de uso completas se
indican en el Manual del sistema para el
paciente del sistema de EME Precision con
tecnología MultiWave.
Almacenamiento, manipulación y
transporte:
• No exponga el control remoto a
temperaturas extremas. No lo deje en un
vehículo ni a la intemperie.
• Manipule el control remoto con cuidado.
Aunque ha sido sometido a pruebas de
durabilidad para garantizar su calidad de
fabricación y funcionamiento, el control
remoto puede sufrir daños irreparables si
se golpea, se sumerge o recibe otro tipo
de tratamiento destructivo.
• No deje que el control remoto entre en
contacto con líquidos.
• No arroje el control remoto al fuego.
• Deseche las pilas usadas de conformidad
con la regulación vigente.
• Utilice el control remoto a temperaturas
comprendidas entre 5 y 40 °C (41 y
104 °F).
• Almacénelo a temperaturas
comprendidas entre -20 y 60 °C (-4 y
140 °F).
• Los dispositivos externos deben
eliminarse de conformidad con la
regulación vigente. Póngase en contacto
con un profesional sanitario para obtener
más información.
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Información sobre las
pilas
El control remoto utiliza tres pilas AAA. El
control remoto muestra una advertencia
cuando:
• Las pilas tienen poca carga.
• Es necesario recargar el implante.
• Es necesario cambiar la pila del
estimulador de prueba.
Preste mucha atención a todos los mensajes
referentes a las pilas.
Cambio de pilas:
NOTA:
• Tras un cambio de pilas, el control remoto
debe recargar información del estimulador
implantado o externo.
• Durante este proceso, el control remoto
debe hallarse dentro del radio de
comunicación con el estimulador (60 cm).
• El control remoto tarda unos 30 segundos
en volverse a conectar con el estimulador.
Es conveniente quitar las pilas cuando no se
vaya a utilizar el control remoto durante un
largo período de tiempo.
1. En la parte trasera del control remoto,
presione ligeramente y deslice la tapa del
compartimento de pilas hacia abajo.
2. Retire las pilas viejas.
3. Coloque las pilas nuevas en las ranuras
haciendo coincidir sus polos positivos (+)
y negativos (–) con las marcas + / – del
compartimiento.
4. Alinee la tapa sobre el compartimiento y
deslícela hasta que quede bien cerrada.
Instrucciones generales
1. Para activar o desactivar la estimulación,
pulse el botón !.
NOTA:
• Si el control remoto no se utiliza durante
un minuto aproximadamente, entra
automáticamente en modo de reposo o
inactivo y la pantalla se queda en blanco.
En ese momento, se bloquean las teclas.
Al pulsar cualquier botón excepto el
botón !, el control remoto mostrará el
siguiente mensaje:
Control remoto Precision™
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Control remoto del sistema de estimulación de la médula espinal (EME) Precision™
con tecnología MultiWave