Boston Scientific Precision Novi IPG Series Manual

90930910-07 REV A
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Directions for Use
Instrucciones de uso
Mode d’emploi
Gebrauchsanweisung
Istruzioni per l’uso
Gebruiksaanwijzing
Bruksanvisning
Käyttöohje
Bruksanvisning
Brugsanvisning
Instruções de Utilização
Instruções de uso
Kullanım Talimatları
Указания по использованию

Οδηγίες χρήσης
Návod k použití
Návod na použitie
Instrukcja obsługi
Használati utasítások
Precision Novi™
Implantable
PulseGenerator
Directions for Use
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
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Trademarks
All trademarks are the property of their respective owners.
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.
Drawings are for illustration purposes only.
Additional Information
For Indications and related information, see the Indications DFU. For contraindications,
warnings, precautions, adverse events summary, physician instructions, sterilization,
component disposal, and contact information for Boston Scientic, refer to the Information for
Prescribers DFU for your spinal cord stimulator system. 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.
Product Model Numbers
Model Number Description
SC-1140 Precision Novi™ Implantable Pulse Generator Kit
SC-1042A Precision Novi™ Implantable Pulse Generator and Freelink™ RC Kit
Industry Canada Equipment Certication Number
IC: 9773A-SC1132
Precision Novi™ Implantable Pulse Generator Directions for Use
90930910-07 REV A ii of iv
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
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Table of Contents
Description......................................................................................................................1
Compatible Leads...........................................................................................................1
Package Contents ..........................................................................................................2
2
Maximum Current Amplitude per Electrode Versus Impedance................................3
Maximum Amplitude Based on Frequency and Pulse Width .....................................3
................................................................................4
Materials..........................................................................................................................4
 ......................................................................................4
Registration Information................................................................................................4
Instructions for Use........................................................................................................5
5
5
5
6
8
10
IPG Battery Life.............................................................................................................10
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Description
The Precision Novi implantable pulse generator (IPG) system is intended to treat chronic pain
by electrically stimulating the spinal cord. The multi-channel, multi-electrode device capability
provides exibility in conjunction with ease of programming. A non-rechargeable battery
provides output capability while eliminating the need to charge. The IPG is controlled by a
hand-held Remote Control, and can be engaged by a clinician programmer using proprietary
programming software. As a non-rechargeable IPG, the IPG battery will eventually become
depleted.
The Precision Novi System supports a total of 16 active contacts: two 8-contact percutaneous
leads, one 16-contact percutaneous lead, or one 16-contact (2x8) surgical lead.
Compatible Leads
The following leads are compatible with the Precision Novi System:
Innion™ 16 xxcm 16 Contact Lead
Innion CX xxcm 16 Contact Lead
Linear™ xxcm 8 Contact Lead
Linear ST xxcm 8 Contact Lead
Linear 3-4 xxcm 8 Contact Lead
Linear 3-6 xxcm 8 Contact Lead
Artisan™ 2x8 Surgical Lead
8 Contact Extensions
2x4 Splitters
2x8 Splitters
Note: xx denotes length (cm)
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Package Contents
Precision Novi IPG Kit
(1) Implantable Pulse Generator
(1) Torque Wrench
(1) Tunneling Tool Assembly
(1) IPG Pocket Template
(2) Port Plugs
Product Literature
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Maximum Current Amplitude per Electrode Versus Impedance
AMP (mA)
Impedance (Ω)
Pulse Width:
20 μsec
100 μsec
200 μsec
300 μsec
400 μsec
600 μsec
800 μsec
1000 μsec
Maximum Amplitude Based on Frequency and Pulse Width
Current (mA)
Frequency (Hz)
Pulse Width:
20 μsec
100 μsec
200 μsec
300 μsec
400 μsec
600 μsec
800 μsec
1000 μsec
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Specications and Technical Data
Parameter Range Default
Areas (Channels) 4 —
Amplitude 0 – 25.5 mA 0 mA
Rate 2 – 1200 ppsa40 pps
Width 20 – 1000 μsecb210 μsec
Cycle 1 sec – 90 min, OFF OFF
Ramp ON 1 – 10 sec 3 sec
Contacts 1 – 16, case: +100% to -100%, OFF 1 – 16, case: OFF
a. Only one Area is available if the rate is >130 pps.
b. Amplitude × Width ≤ 12.7 µC.
Materials
Case Titanium
Header Epoxy
Strain Relief Silicone
Size/Volume 70.9 mm x 49.5 mm x 11.3 mm / 33 cm3 (including header)
Radiopaque Identication Tag
The IPG contains a radiopaque identication tag “BSC S1140”. The identication tag is visible
using standard x-ray procedures.
Registration Information
In accordance with international practice and regulatory legislation in some countries, a
registration form is packed with each Boston Scientic 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 specic device to gain quick access to
pertinent data from the manufacturer.
Boston Scientic Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia, California 91355, USA
Attention: Customer Service Department
Boston Scientific Confidential. Unauthorized use is prohibited.
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Instructions for Use
IPG Handling and Storage
• Handle the IPG and all components with care.
• Keep sharp instruments away from the components.
• Do not use the IPG if it has been dropped.
• 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 Boston Scientic
Neuromodulation Corporation. An explant kit is available.
• 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.
Pre-Op Instructions
1. Check that the sterile package is intact. (See “Sterilization” in the Information for Prescribers
manual.)
2. If intra-operative stimulation testing is desired, ensure that a Trial Stimulator is available for
use. Refer to the Clinician Trial Manual for additional instructions.
IPG Implantation
1. Ensure that the area surrounding the lead entry site is incised to a dimension that will
accommodate the tunneling tool.
2. Check that the lead is securely anchored.
3. Select and mark the intended IPG site, using the IPG template, and create an incision for
the IPG pocket.
4. Create a subcutaneous pocket no larger than the IPG outline. The IPG pocket can be made
as deep as is comfortable for the patient.
5. Tunnel the lead(s) to the IPG site.
Note: Using the IPG template will help guide the correct pocket sizing. Select an IPG site
several inches away from the previously externalized trial lead site to reduce risk of
infection.
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Tunneling the Lead or Lead Extension
Note: If using an Innion™ CX Lead(s), it is recommended to use the Long Tunneling Tool
(35 cm).
1. If not already assembled, attach the tunneling tool handle to the shaft by turning the locking
mechanism clockwise.
Locking Mechanism
Tool Handle
Shaft
2. Mark the desired route of the tunnel.
3. Administer the appropriate local anesthetic along the tunneling path.
4. OPTIONAL. If necessary, bend the tool shaft to conform to the patient’s body.
5. Make a small incision at the desired exit site.
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6. Create a subcutaneous tunnel between the lead(s) incision and the IPG pocket site until the
straw is visible and accessible at the exit point.
7. Unscrew and remove the tunneling tool handle.
8. Grasp the tip of the tool with one hand while holding the straw in place with the other hand.
Pull the tunneling tool shaft out through the straw.
9. Push the lead or extension through the straw, then withdraw the straw.
10. Pull the proximal end(s) out of the exit point.
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11. Wipe the proximal end(s) clean.
CAUTION: Do not tunnel the splitter.
Note: If using the 2x8 Splitter and performing a permanent trial, the splitter tails may be
tunneled to the exit site.
Note: The following Codman Disposable Catheter Passers may be used in place of the
Boston Scientic tunneling tool:
REF 82-1515 (36 cm); REF 82-1516 (55 cm); REF 82-1517 (65 cm)
Note: When using a Codman Disposable Catheter Passer, tunnel from the midline incision to
the IPG pocket using the standard technique.
Connecting the Lead, Extension, Splitter, or Connector to the IPG
IPG ports are labeled as follows:
Connecting to the IPG:
• Leads connect to IPG ports C or D.
• For the Innion 16, connect the splitter tail with laser-etched bands (contacts 1-8 of the
Innion 16 lead) to the left port C and the unmarked splitter tail (contacts 9-16 of the
Innion 16 lead) to the right port D.
• For the Innion CX Lead, connect the tail with the single marker band (contacts 1-8 of
the Innion CX Lead) to the left port C and the tail with two marker bands (contacts 9-16
of the Innion CX Lead) to the right port D.
• For the Artisan 2x8 surgical lead, connect the left side to the left port C. Connect the
right side (the laser-etched tail), contacts 9-16, to the right port D.
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1. Fully insert the lead(s), extension(s), splitter(s), and/or connector(s) into the IPG port(s),
being careful not to stress or bend the proximal end of the lead. When the lead is properly
inserted, the lead will stop and the retention ring will be located under the set screw.
2. Fully insert a port plug into unused IPG ports.
Note: If you experience difculty when inserting the lead, lead extension, splitter, connector,
or port plug, use the torque wrench to loosen (counterclockwise) the set screw and/or
gently rotate the lead to help advance the proximal end.
Note: To conrm good connections, check impedances before tightening the set screw. The
IPG must be in contact with the subcutaneous pocket in order to receive accurate
impedance measurements.
3. Pass the hex wrench through the hole in the septum located on the front or back of the IPG
header and tighten each set screw until the hex wrench “clicks,” indicating lock.
CAUTION: Ensure that the lead is fully inserted before tightening the set screw to prevent
lead damage
Note: If a port plug is used, it is still necessary to tighten the set screw on the port plug as
described above.
Note: The torque wrench is torque-limited and cannot be over-tightened.
4. Place the IPG in the subcutaneous pocket with logo marking facing up towards the skin.
5. Coil excess lead, extension, splitter, or connector under the IPG.
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6. If desired, secure the IPG in the pocket by suturing through the holes in the IPG header.
CAUTION: Do not suture through the leads or the splitter.
7. Close and dress the wound(s).
IPG Explant or Replacement
1. Turn off the IPG.
2. Surgically open the IPG pocket and withdraw the device. Please try to preserve the integrity
of all components so that complete device assessment can be performed.
3. Loosen the connector set screws to release and remove the leads, extensions, or splitters.
4. For replacement, connect the new IPG following the instructions for “Connecting the Lead,
Extension, Splitter, or Connector to the IPG” on page 8. Or, to terminate therapy,
surgically remove the implanted lead system.
5. Notify Boston Scientic to document the reason for explant or replacement and to arrange
for return of IPG and components.
IPG Battery Life
For information on battery longevity, see the Information for Prescribers manual.
The clinician programmer and the patient remote control provide notice when the IPG battery
has entered Elective Replacement Mode and when the IPG battery has reached its end of
service (EOS). Refer to the Programming Manual and the Remote Control Directions for Use
for additional information.
Failure to replace the IPG may lead to reduced programming capabilities, limited
communication with the stimulator, and loss of stimulation.
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
Instrucciones de uso del Generador de impulsos implantable Precision Novi™
90930910-07 REV A 11 de 239
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Marcas comerciales
Todas las marcas comerciales pertenecen a sus respectivos propietarios.
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.
Las imágenes son meramente ilustrativas.
Información adicional
Para obtener instrucciones e información relacionada, consulte las Instrucciones de uso.
Para obtener información acerca de las contraindicaciones, advertencias, resumen de
efectos adversos, instrucciones para médicos, esterilización, eliminación de componentes e
información de contacto de Boston Scientic, consulte las Instrucciones de uso, Información
para médicos de su sistema de estimulación de la médula espinal. 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.
Números de modelo de los productos
Número del modelo Descripción
SC-1140 Kit del generador de impulsos implantable Precision Novi™
SC-1042A Kit del generador de impulsos implantable Precision Novi™ y control remoto
Freelink™
Número de certicación de equipos de Industry Canada
IC: 9773A-SC1132
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Generador de impulsos implantable Precision Novi™
Instrucciones de uso del Generador de impulsos implantable Precision Novi™
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Tabla de contenido
Descripción...................................................................................................................13
Electrodos compatibles...............................................................................................13
Contenidos del paquete...............................................................................................14
14
Máxima amplitud de corriente por electrodo frente a impedancia..........................15
Amplitud máxima basada en la frecuencia y la anchura de impulso......................15
 .............................................................................16
Materiales......................................................................................................................16
..........................................................................16
Información de registro ...............................................................................................16
Instrucciones de uso....................................................................................................17
17
17
17
18
20
22
Duración de la batería del GII......................................................................................22
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
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
Instrucciones de uso del Generador de impulsos implantable Precision Novi™
90930910-07 REV A 13 de 239
es
Descripción
El sistema generador de impulsos implantable (GII) Precision Novi está diseñado para el
tratamiento del dolor crónico mediante la estimulación eléctrica de la médula espinal. La
capacidad multicanal y multielectrodo del dispositivo proporciona exibilidad combinada con
una programación sencilla. Una batería no recargable proporciona alimentación al mismo
tiempo que elimina la necesidad de cargar el sistema. El GII se controla mediante un control
remoto y puede ponerse en marcha desde el programador clínico a través del software de
programación patentado. Ya que el GII es un sistema no recargable, su batería acabará
agotándose.
El sistema Precision Novi admite un total de 16 contactos activos: Dos electrodos percutáneos
de 8 contactos, un electrodo percutáneo de 16 contactos o un electrodo quirúrgico de
16 contactos (2 x 8).
Electrodos compatibles
Los electrodos siguientes son compatibles con el sistema Precision Novi:
Electrodo de 16 contactos Innion™ 16 xx cm
Electrodo de 16 contactos Innion CX xxcm
Electrodo de 8 contactos Linear™ xx cm
Electrodo de 8 contactos Linear ST xx cm
Electrodo de 8 contactos Linear 3-4 xx cm
Electrodo de 8 contactos Linear 3-6 xx cm
Electrodo quirúrgico 2 x 8 Artisan™
Extensiones de 8 contactos
Extensiones bifurcadas 2 x 4
Extensiones bifurcadas 2 x 8
Nota: xx indica la longitud (cm)
Boston Scientific Confidential. Unauthorized use is prohibited.
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Generador de impulsos implantable Precision Novi™
Instrucciones de uso del Generador de impulsos implantable Precision Novi™
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Contenidos del paquete
Kit del GII Precision Novi
(1) Generador de impulsos implantable
(1) Llave dinamométrica
(1) Conjunto de tunelizadores
(1) Plantilla para el bolsillo del GII
(2) Conectores del puerto
Documentación del producto
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
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
Instrucciones de uso del Generador de impulsos implantable Precision Novi™
90930910-07 REV A 15 de 239
es
Máxima amplitud de corriente por electrodo frente a impedancia
AMP (mA)
Impedancia (Ω)
Anchura de impulso:
20 μs
100 μs
200 μs
300 μs
400 μs
600 μs
800 μs
1000 μs
Amplitud máxima basada en la frecuencia y la anchura de impulso
Intensidad (mA)
Frecuencia (Hz)
Anchura de impulso:
20 μs
100 μs
200 μs
300 μs
400 μs
600 μs
800 μs
1000 μs
Boston Scientific Confidential. Unauthorized use is prohibited.
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Generador de impulsos implantable Precision Novi™
Instrucciones de uso del Generador de impulsos implantable Precision Novi™
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es
Especicaciones y datos técnicos
Parámetro Intervalo Valor predeterminado
Áreas (canales) 4 —
Amplitud 0 – 25,5 mA 0 mA
Frecuencia 2 – 1.200 ppsa40 pps
Anchura 20 – 1.000 μsb210 μs
Ciclo 1 s – 90 min, Desactivado Desactivado
Rampa activada 1 – 10 s 3 s
Contactos 1 – 16, caja: de +100 % a -100 %, Desactivado 1 – 16, caja: Desactivado
a. Si la frecuencia es > 130 pps, solo hay un área disponible.
b. Amplitud x anchura ≤ 12,7 µC.
Materiales
Caja Titanio
Cabezal Epoxi
Protector contra tensión Silicona
Tamaño/Volumen 70,9 mm x 49,5 mm x 11,3 mm / 33 cm3 (incluido cabezal)
Etiqueta de identicación radiopaca
El GII incluye una etiqueta de identicación radiopaca “BSC S1140”. La etiqueta de
identicación es visible mediante procedimientos radiológicos estándar.
Información de registro
De conformidad con las prácticas internacionales y la legislación vigente en algunos países,
con cada neuroestimulador de Boston Scientic se incluye un formulario de registro. La
nalidad de este formulario es llevar un seguimiento de todos los productos y proteger los
derechos de garantía. Asimismo, posibilita el acceso rápido a los datos pertinentes del
fabricante por parte de la institución que interviene en la evaluación o sustitución de un
determinado dispositivo.
Boston Scientic Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia, California 91355, EE. UU.
A la atención de: Departamento de servicio al cliente
Boston Scientific Confidential. Unauthorized use is prohibited.
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