Boston Scientific precision spectra Quick setup guide

Precision Spectra™
Spinal Cord
Stimulator System
Information for Prescribers
90970880-04 REV A
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Information for Prescribers
Información para médicos
Informations destinées aux médecins
Informationen für verordnende Personen
Informazioni per i medici prescrittori
Informatie voor voorschrijvers
Information för remitterande personal
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Informação para Médicos
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Информация для лиц,
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Guarantees
Boston Scientic Corporation reserves the right to modify, without prior notice, information
relating to its products in order to improve their reliability or operating capacity.
Trademarks
All trademarks are the property of their respective owners.
Additional Information
For Indications and related information, see the Indications DFU. For other device-specic
information not included in this manual, labeling symbols, and warranty information, refer to the
appropriate DFU for your SCS System as listed on your Reference Guide.

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Table of Contents
Device and Product Description .............................................................................................. 1
Contraindications......................................................................................................................1
Safety Information.....................................................................................................................1
Instructions for the Patient..................................................................................................1
Instructions for the Physician..............................................................................................7
Sterilization .........................................................................................................................8
EN 60601-1-2 Classication Information ............................................................................9
Technical Service..............................................................................................................10
End of Programmed Service............................................................................................. 10
IPG Battery Life ................................................................................................................10

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Device and Product Description
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Device and Product Description
The Precision Spectra Spinal Cord Stimulator System consists of an Implantable Pulse
Generator (IPG), temporary and permanent Percutaneous Leads, Surgical Paddle Leads,
Lead Extensions, OR Cables, Trial Stimulator, Remote Control, Clinician Programmer, and
Programming Wand, each packaged as a separate kit. Single use accessories and disposable
tools are also included in these kits.
Features of the Precision Spectra System include:
• Stimulation electrode eld navigation
• Thirty-two independent current-controlled electrodes
• Four programmable stimulation areas per program; sixteen possible programs
• Long-life operation
• High-range parameter capability
• Small size
• Two-foot programming range
• This product contains no detectable latex
Contraindications
Patients contraindicated for permanent Spinal Cord Stimulator (SCS) therapy are those who:
• are unable to operate the SCS system
• have failed trial stimulation by failing to receive effective pain relief
• are poor surgical risks
• are pregnant
Safety Information
WARNING: Unauthorized modication to the medical devices is prohibited. System integrity
could be compromised and harm or injury to the patient could occur if the medical devices are
subjected to unauthorized modication.
Instructions for the Patient
Warnings
Heat Due to Charging. Patients should not charge while sleeping. This may result in a burn.
While charging, the Charger may become warm. It should be handled with care. Failure to
use the Charger with either the Charging Belt or an adhesive patch, as shown, may result
in a burn. If patients experience pain or discomfort, they should cease charging and contact
Boston Scientic.

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Magnetic Resonance Imaging (MRI).
• MRI Transmit or Transmit/Receive RF Body Coil: Patients implanted with the Precision
Spectra System should not be subjected to a MRI transmit or transmit/receive RF body coil.
RF body coil exposure may result in signicant heating and/or tissue damage, especially
near the proximal and distal portions of the implant. RF body coil exposure can damage the
IPG electronics, potentially requiring device replacement. RF body coil exposure may also
cause voltage induction through the leads and stimulator causing unintended stimulation,
which the patient could experience as a tingling, shocking, or jolting sensation.
• MRI Transmit/Receive RF Head Coil: The Precision Spectra Spinal Cord Stimulator (SCS)
System is “MR Conditional”. An MRI examination of the head only (no other part of the body)
can be conducted safely using only a 1.5 Tesla horizontal closed-bore whole-body MRI system
that is congured to use its 1.5T transmit/receive radio frequency (RF) head coil for the MRI
scan when all instructions in the supplemental manual “ImageReady™ MRI Guidelines for
Precision Spectra Spinal Cord Stimulator System” are followed. It is important to read the
information in this supplemental manual in its entirety before conducting or recommending
an MRI examination on a patient with a Precision Spectra SCS System. The “ImageReady™
MRI Guidelines for Precision Spectra Spinal Cord Stimulator System” manual appears on the
Boston Scientic websites (www.bostonscientic.com and www.controlyourpain.com/dfu).
MRI examinations performed on patients with the Precision Spectra System using open-
sided MRI systems, or other types of MRI systems operating at other static magnetic eld
strengths (higher or lower) have not been assessed and, as such, should not be performed.
• External Devices: Precision Spectra external components (i.e., External Trial Stimulator,
Remote Control, Battery Charger) are MR Unsafe. They must not be taken into any MR
environment such as the MRI scanner.
Pediatric Use. The safety and effectiveness of spinal cord stimulation has not been established
for pediatric use.
Diathermy. Shortwave, microwave and/ or therapeutic ultrasound diathermy should not be
used on 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. The IPG, whether it is turned on or off, may be damaged.
Implanted Stimulation Devices. Spinal cord stimulators may interfere with the operation of
implanted sensing stimulators such as pacemakers or cardioverter debrillators. The effects of
implanted stimulation devices on neurostimulators is unknown.
Stimulator 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.

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Postural Changes. Patients should be advised that changes in posture or abrupt movements
may cause decreases, or uncomfortable or painful increases in the perceived stimulation
level. Patients should be advised to turn down the amplitude or turn off the IPG before making
posture changes.
Important: If unpleasant sensations occur, the IPG should be turned off immediately.
Electromagnetic Interference. Strong electromagnetic elds can potentially turn the
Stimulator off, or cause uncomfortable or jolting stimulation or affect wireless communication.
Patients should be counseled to avoid or exercise care around:
• Theft detectors or security screeners such as those used at entrances/exits of department
stores, libraries, and other public establishments, and/or airport security screening devices.
It is recommended that patients request assistance to bypass the device. If they must
proceed through the device, the patient should turn off the Stimulator and proceed with
caution, moving through the center of the screener as quickly as possible.
• Power lines or power generators
• Electric steel furnaces and arc welders
• Large, magnetized stereo speakers
• Tag deactivators such as those found in retail stores and libraries
If the patient is near these devices, he may become aware of changing stimulation levels. In
rare instances, if the stimulation is on, the patient could experience an increase in stimulation
level to the point that the sensation is uncomfortably strong or possibly “jolting.” If this happens,
the patient should turn off the Stimulator. If the Stimulator suddenly turns off by itself, the patient
should rst move away from the area. Next, check the stimulation status with the Remote
Control by pressing the Unlock button and observing the screen. The implant may need to be
recharged before stimulation can be restarted. The patient can refer to the Charging Handbook
for further information.
The patient should be counseled to always be aware of his surroundings, particularly near theft
detectors/security screeners. He should ask for assistance to go around these devices if he
feels at all uncomfortable.

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Precautions
Physician training is required.
Medical Devices/Therapies. The following medical therapies or procedures may turn
stimulation off or may cause permanent damage to the Stimulator, particularly if used in close
proximity to the device:
• lithotripsy
• electrocautery (See “Instructions for the Physician” on page 7)
• external debrillation
• radiation therapy (Any damage to the device by radiation may not be immediately
detectable.)
• ultrasonic scanning
• high-output ultrasound
X-ray and CT scans may damage the Stimulator if stimulation is on. X-Ray and CT Scans are
unlikely to damage the Stimulator if stimulation is turned off.
If any of the above is required by medical necessity, refer to “Instructions for the Physician” on
page 7. 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 rst. Sudden stimulation changes, if they occur,
may distract patients from attentive operation of the vehicle or equipment.
Post Operative. During the two weeks following surgery, it is important that patients use
extreme care so that appropriate healing will secure the implanted components and close the
surgical incisions:
• Patients should not lift objects of more than ve pounds.
• Patients should not engage in rigorous physical activity such as twisting, bending, or
climbing.
• If new leads were implanted, patients should not raise their arms above their head.
Temporarily, there may be some pain in the area of the implant as the incisions heal. Patients
should be instructed that if discomfort continues beyond two weeks, they should contact their
physician.
If patients notice excessive redness around the wound areas during this time, they should
contact their physician to check for infection and administer proper treatment. In rare cases,
adverse tissue reaction to implanted materials can occur during this period.
Patients should consult their physician before making lifestyle changes due to decreases in pain.

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Stimulator Location. Patients should never attempt to change the orientation or “ip” (rotate
or spin) the Stimulator. Patients should not “nger” or play with the Stimulator. If the Stimulator
ips over in the Patient’s body, it cannot be charged. If the Patient knows that the device has
turned, or if stimulation cannot be turned on after charging, the Patient should contact his or her
physician to arrange an evaluation of the system. In some cases, the skin over the Stimulator
may become very thin over time. If this occurs, Patients should contact their physicians.
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, Patients should consult their physician who
may able to restore stimulation by reprogramming the Stimulator in the clinic or repositioning
the lead during another operation.
Device Failure. Stimulators 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), Patients should turn off the Stimulator and contact their physician so that the
system can be evaluated.
Operating Temperature. The operating temperature of the Trial Stimulator, Remote Control,
and Programming Wand is 10–40 °C (50–104 °F). For proper operation, do not use the
Charger if the ambient temperature is above 35 °C (95 °F).
Storage, Handling and Transport. 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 without
batteries, the storage temperature should not exceed -20 to 60 °C (-4 to 140 °F).
Handle the system external 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 these components. (See “Limited Warranty - IPG”.)
Upon completion of the Patient Trial, remove the batteries from the Trial Stimulator.
Component Disposal. Do not dispose of the Remote Control or Charger in re. The battery
in these devices can explode in re. Dispose of used batteries in accordance with local
regulations. The IPG should be explanted in the case of cremation, and returned to Boston
Scientic. External devices to be disposed of per local regulatory requirements. Please contact
your healthcare professional.

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Remote Control, Charging System, External Trial Stimulator and Wand Cleaning. The
charging system components can be cleaned using alcohol or a mild detergent applied with a
cloth or tissue. The Remote Control, External Trial Stimulator and Programming Wand can be
cleaned using a mild detergent applied with a lightly dampened cloth or tissue. Residue from
soapy detergents should be removed with a cloth lightly dampened with water. Do not use
abrasive cleansers for cleaning.
Cell Phones. While we do not anticipate any interference with cell phones, the full effects
of interaction with cell phones are unknown at this time. If there is a concern or a problem is
encountered, the patients should contact their physician.
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. In some cases, the formation of reactive
tissue around the lead in the epidural space can result in delayed onset of spinal cord
compression and neurological/sensory decit, including paralysis. Time to onset is variable,
possibly ranging from weeks to years after implant.
• Skin erosion at the IPG site can occur over time.
• Possible surgical procedural risks are: temporary pain at the implant site, infection,
cerebrospinal uid (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.
• Undesirable stimulation may occur over time due to cellular changes in tissue around the
electrodes, changes in electrode position, loose electrical connections and/or lead failure.
• The patient may experience painful electrical stimulation of the chest wall as a result of
stimulation of certain nerve roots several weeks after surgery.
• Over time, the Stimulator may move from its original position.
• Weakness, clumsiness, numbness or pain below the level of implantation.
• Persistent pain at the IPG or lead site.
In any event, instruct the patient to contact their physician to inform him/her.

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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 on hand at all times, and
ensure that they understand how to adjust stimulation levels. Refer to Postural Changes in the
Instructions for Patients section of this manual, page 3, for additional information.
Medical Devices/Therapies. If the patient is required to undergo lithotripsy, electrocautery,
external debrillation, radiation therapy, ultrasonic scanning, or high-output ultrasound, X-ray or
CT scan:
• Turn off stimulation at least ve minutes before the procedure or application.
• 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 elds, 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 conrm IPG functionality following treatment by turning on the IPG and
gradually increasing stimulation to the desired level.

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Sterilization
All Precision Spectra System implantable and surgical components are sterilized with ethylene
oxide.
Inspect the condition of the sterile package before opening the package and using the contents.
Do not use the contents if the package is broken or torn, or if contamination is suspected
because of a defective sterile package seal.
• Do not use any component that shows signs of damage.
• Do not resterilize the package or the contents. Obtain a sterile package from Boston
Scientic.
• Do not use if the product is past the labeled expiration date.
• All components are for single use only. Do not reuse.
• Do not use if package is opened or damaged.
• Do not use if labeling is incomplete or illegible.
WARNING: Contents supplied STERILE using an ethylene oxide (EO) process. Do not use
if sterile barrier is damaged. If damage is found, call your Boston Scientic representative.
For Single Use Only.
Do Not Reuse.
Do Not Resterilize.
Do not use if package is damaged.
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead to device
failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or
resterilization may also create a risk of contamination of the device and/or cause patient
infection or crossinfection, including, but not limited to, the transmission of infectious disease(s)
from one patient to another. Contamination of the device may lead to injury, illness or death of
the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or
local government policy.

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EN60601-1-2ClassicationInformation
• Internally Powered Equipment
• Continuous Operation
• Ordinary Equipment
• Class II
Table 1 – Guidance and Manufacturer’s Declaration – electromagnetic emissions –
for all ME Equipment and ME Systems
Guidance and Manufacturer’s Declaration - electromagnetic emissions
The Precision Spectra System intended for use in the electromagnetic environment specied
below. The customer or user of the IPG should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment Guide
RF emissions CISPR 11 Group 1 The Precision Spectra System uses
RF energy only for its internal function.
Therefore, its RF emissions are very low
and are not likely to cause any interference
in nearby electronic equipment.
RF emissions CISPR 11 Class B The Precision Spectra System is suitable
for use in all establishments. Including
domestic establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class B
Voltage uctuations /
Flicker emissions
IEC 61000-3-3
Complies
Hereby, Boston Scientic declares that the Precision Spectra System is in compliance with the essential requirements
and other relevant provisions of Directive 1999/5/EC.
NoticetotheUserPerIndustryCanadaRadioStandardsSpecications:
This device complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions:
1. this device may not cause interference, and
2. this device must accept any interference, including interference that may cause undesired
operation of the device.

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Technical Service
There are no user serviceable parts. If you have a specic question or issue, please contact
your Boston Scientic representative.
End of Programmed Service
The Precision Spectra System IPG software is programmed to end service after 12 years.
As the IPG nears the end of the programmed period, the Precision Spectra System Remote
Control and Precision Spectra System Clinician Programmer provide the following indicators to
inform the user that the end of the programmed period is approaching:
• Remote Control - Approximately six months before the end of programmed period, the
Remote Control displays a weekly message indicating the number of service days
remaining. Approximately one month before the end of the programmed period, the
message displays daily.
• Clinician Programmer - When less than six months of service remain, an indicator displays
on the Connect screen of the Clinician Programmer. When end of the programmed period
has been reached, a message displays when connecting to the Stimulator to indicate that
end of the programmed period has been reached and programming is not allowed.
Patients should contact their health care provider upon rst receiving a message regarding the
number of service days remaining.
IPG Battery Life
The rechargeable battery in the Precision Spectra System IPG should provide at least ve
years and up to 25 years or more of service.1The IPG recharge interval at typical settings
is at least 30 days.2 Over time, the IPG battery will need more frequent recharges. Like all
rechargeable batteries, use over time and repeated recharge cycles reduce the maximum
charge capacity of the IPG battery.
1 The expected years of battery operation are dened as the longer of either:
A. Typical case: the time at which therapy cannot be maintained with daily charging.
OR
B. High energy case: when the maximum recharge interval has decreased by more than 50 % from the initial recharge
interval.
2 This estimated recharge interval is based on the following assumptions:
• The Precision Spectra IPG is newly implanted and at the beginning of its charging life.
• The IPG has been programmed to the following settings: Current amplitude: 4 mA; Pulse Width: 300 μs; Pulse Rate:
50 Hz and Impedance: 750 Ohms.
NOTE: Your actual settings may vary, thus varying the number of days for your recharge interval.

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Argentina
T: [phone] F: [phone]
Australia / New Zealand
T: 1800 676 133 F: 1800 836 666
Austria
T: [phone] F: [phone]
Balkans
T: 0030 210 95 37 890 F: 0030 210 95 79 836
Belgium
T: 080094 494 F: 080093 343
Brazil
T: [phone] F: [phone]
Bulgaria
T: [phone] F: [phone]
Canada
T: [phone] F: [phone]
Chile
T: [phone] F: [phone]
China – Beijing
T: [phone] F: [phone]
China – Guangzhou
T: [phone] F: [phone]
China – Shanghai
T: [phone] F: [phone]
Colombia
T: [phone] F: [phone]
Czech Republic
T: [phone] F: [phone]
Denmark
T: 80 30 80 02 F: 80 30 80 05
Finland
T: 020 762 88 82 F: 020 762 88 83
France
T: [phone] F: [phone]
Germany
T: 0800 072 3301 F: 0800 072 3319
Greece
T: [phone] F: [phone]
Hong Kong
T: [phone] F: [phone]
Hungary
T: [phone] F: [phone]
India – Bangalore
T: [phone]/5 F: [phone]
India – Chennai
T: [phone] F: [phone]
India – Delhi
T: [phone]/6 F: [phone]
India – Mumbai
T: [phone] F: [phone]
Italy
T: [phone] F: [phone]
Korea
T: [phone] F: [phone]
Malaysia
T: [phone] F: [phone]
Mexico
T: [phone] F: [phone]
Middle East / Gulf / North Africa
T: [phone] F: [phone]
The Netherlands
T:[phone] F: [phone]
Norway
T: 800 104 04 F: 800 101 90
Philippines
T: [phone] F: [phone]
Poland
T: [phone] F: [phone]
Portugal
T: [phone] F: [phone]
Singapore
T: [phone] F: [phone]
South Africa
T: [phone] F: [phone]
Spain
T [phone] F [phone]
Sweden
T: 020 65 25 30 F: 020 55 25 35
Switzerland
T: 0800 826 786 F: 0800 826 787
Taiwan
T: [phone] F: [phone]
Thailand
T: [phone] F: [phone]
Turkey – Istanbul
T: [phone] F: [phone]
United States
T: [phone] Toll Free: [phone]
F: [phone]
Uruguay
T: [phone] F: [phone]
UK & Eire
T: [phone] F: [phone]
Venezuela
T: [phone] F: [phone]

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NOTE: Phone numbers and fax numbers
may change. For the most current
contact information, please refer
to our website at http://www.
bostonscientic-international.com/
or write to the following address:
BostonScienticNeuromodulation
25155 Rye Canyon Loop
Valencia, CA 91355, USA

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Garantías
Boston Scientic Corporation se reserva el derecho de modicar, sin aviso previo, la
información relativa a estos productos con el objetivo de mejorar su abilidad o capacidad
operativa.
Marcas comerciales
Todas las marcas comerciales pertenecen a sus respectivos propietarios.
Información adicional
Para obtener instrucciones e información relacionada, consulte las Instrucciones de uso. Para
obtener otra información especíca de los dispositivos que no se incluya en este manual, así
como los símbolos de etiquetado e información de garantía, consulte las instrucciones de uso
de su sistema de EME, tal como aparece en la Guía de referencia.

Información para médicos
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Tabla de contenido
Descripción del dispositivo y del producto..........................................................................15
Contraindicaciones .................................................................................................................15
Información de seguridad.......................................................................................................15
Instrucciones para el paciente..........................................................................................15
Instrucciones para el médico............................................................................................21
Esterilización.....................................................................................................................22
Información para la clasicación según la norma EN 60601-1-2 .....................................23
Servicio técnico.................................................................................................................24
Finalización del servicio programado ...............................................................................24
Duración de la batería del GII...........................................................................................24

Descripción del dispositivo y del producto
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Descripción del dispositivo y del producto
El sistema de estimulación de médula espinal Precision Spectra consta de un generador de
pulsos implantable (GII), electrodos percutáneos temporales o permanentes, electrodos planos
quirúrgicos, extensiones de electrodo, cables de estimulación intraoperatoria, estimulador de
prueba, control remoto, programador clínico y varilla de programación, cada uno embalado
como un kit aparte. Estos kits también incluyen accesorios de un solo uso y herramientas
desechables.
El sistema Precision Spectra ofrece las siguientes características:
• Navegación a través del campo de electrodos de estimulación
• Treinta y dos polos independientes de corriente controlada
• Cuatro áreas de estimulación programables por programa, dieciséis programas posibles
• Funcionamiento de larga duración:
• Función de parámetros de largo alcance
• Pequeño tamaño
• Intervalo de programación Two-foot
• Este producto no contiene látex detectable
Contraindicaciones
La terapia de estimulación de la médula espinal (EME) permanente está contraindicada en los
pacientes:
• Que no pueden manejar el sistema de EME
• Que no han superado la estimulación de prueba porque no notaron un alivio ecaz del dolor
• Cuyo sometimiento a procedimientos quirúrgicos implica un riesgo elevado
• Mujeres embarazadas
Información de seguridad
ADVERTENCIA: Queda prohibida la modicación no autorizada de los dispositivos médicos.
Se podría poner en peligro la integridad del sistema y causar daños o lesiones al paciente si
los dispositivos médicos se ven sometidos a modicaciones no autorizadas.
Instrucciones para el paciente
Advertencias
Calentamiento durante la recarga. No recargue el dispositivo mientras duerme, ya que
podría sufrir quemaduras. Durante la recarga, es posible que el cargador se caliente. Se debe
manipular con cuidado. Si no se utiliza el cargador con el cinturón para cargar o con un parche
adhesivo, tal como se muestra, podría provocar quemaduras. Si nota algún dolor o malestar,
deje de cargarlo y póngase en contacto con Boston Scientic.

Información para médicos
Información para médicos del sistema Precision Spectra™
90970880-04 REV A 16 de 279
es
Imágenes por resonancia magnética (IRM).
• Bobina cefálica de RF para la transmisión de IRM o transmisión/recepción de IRM:
Los pacientes que tengan implantado un sistema Precision Spectra no deben someterse
a una bobina cefálica de RF para la transmisión de IRM o transmisión/recepción de IRM.
La exposición a la bobina cefálica de RF puede resultar en un calentamiento signicativo
y/o daños tisulares, especialmente cerca de las porciones proximal y distal del implante.
La exposición a la bobina cefálica de RF puede dañar la electrónica, lo que podría dar
como resultado la sustitución del dispositivo. La exposición a la bobina cefálica de RF
también puede causar una inducción de voltaje a través de los electrodos y el estimulador
y puede producir una estimulación no intencionada, que el paciente puede experimentar
como una sensación de hormigueo, descarga o tirón.
• Bobina cefálica de RF para la transmisión/recepción de IRM: El sistema de
estimulación de la médula espinal Precision Spectra es de uso condicional con RM. Una
resonancia magnética de la cabeza (no otra parte del cuerpo) pueden llevarse a cabo con
seguridad utilizando solamente un sistema de IRM cerrado de cuerpo entero horizontal de
1,5 Tesla que está congurado para utilizar su bobina cefálica de transmisión/recepción por
radiofrecuencia de 1,5 T para el estudio de RM, cuando se siguen todas las instrucciones
indicadas en el manual complementario de "Directrices de IRM ImageReady™ para el
sistema de estimulación de la médula espinal Precision Spectra". Es importante leer toda
la información antes de llevar a cabo o recomendar un examen de IRM a un paciente con
un sistema de EME Precision Spectra. El "Manual complementario de Directrices de
IRM"ImageReady™ para el sistema de estimulación de la médula espinal Precision
Spectra" está disponible en los sitios web de Boston Scientic (www.bostonscientic.com
y www.controlyourpain.com/dfu). Las exploraciones por IRM realizadas en pacientes con
el sistema Precision Spectra que utiliza sistemas de IRM abiertos, u otros tipos de
sistemas de IRM que utilizan otras intensidades de campo magnético estático (superiores
o inferiores), todavía no se han evaluado, por lo que no se deben practicar.
• Dispositivos externos: Los componentes externos del sistema Precisio Spectra
(estimulador de prueba externo, control remoto, cargador de batería) están calicados
como no seguros con RM. Estos componentes no deben llevarse a un entorno de RM,
por ejemplo un escáner de RM.
Uso pediátrico. No se ha determinado la seguridad ni la ecacia de la estimulación de la
médula espinal en el uso pediátrico.
Diatermia. No debe utilizarse onda corta, microondas ni diatermia ultrasónica terapéutica
en los pacientes que reciben estimulación de la médula espinal. La energía generada por
la diatermia puede transferirse a través del estimulador y producir daños tisulares en las
ubicaciones de los electrodos, lo que podría producir daños graves o la muerte. El GII puede
estropearse, esté encendido o apagado.