Precision Spectra System Implantable Pulse Generator
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- Laura Lombardi Pereira
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1 Precision Spectra System Implantable Pulse Generator CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician. Directions for Use SC-1132 Implantable Pulse Generator en es fr de it nl sv fi no da pt ptbr REV D
2 Implantable Pulse Generator en Copyright 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. These documents are the property of Boston Scientific Corporation and shall not be reproduced, distributed, disclosed, or used for manufacture or sale of device without the express written consent of Boston Scientific Corporation. Guarantees Boston Scientific 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. Trademarks Precision Spectra, Infinion, and Artisan are trademarks of Boston Scientific. Other brands and their products are trademarks or registered trademarks of their respective holders and should be noted as such. Industry Canada Equipment Certification Number IC: 9773A-SC1132 Implantable Pulse Generator REV D 1 of 168
3 Table of Contents Table of Contents Description...4 Package Contents...4 IPG Kit...4 Maximum Current Amplitude per Electrode Versus Impedance...5 Specifications and Technical Data...6 Materials...6 Radiopaque Identification Tag...6 Registration Information...6 Instructions for Use...7 IPG Handling and Storage...7 Pre-Op Instructions...7 IPG Implantation...7 Tunneling the Lead or Lead Extension...8 Connecting the Lead, Extension, Splitter, or Connector to the IPG...10 IPG Explant or Replacement...12 Rechargeable Stimulator System...12 Charging Steps...13 IPG Battery Status...14 en Product Model Number SC-1132 Implantable Pulse Generator Refer to the Indications for Use for indications and related information. Refer to the appropriate Information for Prescribers manual for contraindications, warnings, precautions, adverse events summary, physician instructions, sterilization, component disposal, and contact information for Boston Scientific. Refer to the Labeling Symbols Addendum for an explanation of labeling symbols. Refer to the following Directions for Use (DFU) for device specific instructions not included in this manual: Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra System Clinician Remote Control DFU, Clinician Trial Manual, Precision Spectra System Programming Manual, and Programming Wand DFU. Refer to the Limited Warranty for warranty information. For information regarding the Patient Identification Card, FCC rules and for clinical studies supporting the clinical use of the neurostimulation system, refer to the Information for Prescribers manual. Implantable Pulse Generator REV D 2 of 168
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5 Description Description The Precision Spectra 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 flexibility in conjunction with ease of programming. A rechargeable battery increases IPG longevity and output capability while reducing size and device replacement surgeries. The IPG is controlled by a handheld Remote Control, and can be engaged by a clinician programmer using proprietary programming software. Periodically, the IPG battery requires replenishing with an external RF charging device. en Package Contents IPG Kit (1) Precision Spectra Implantable Pulse Generator (1) Hex Wrench (1) Tunneling Tool Assembly (1) IPG Pocket Template (4) Port Plugs (1) Device Registration Form and Temporary Patient Identification Card Implantable Pulse Generator REV D 4 of 168
6 Implantable Pulse Generator en Maximum Current Amplitude per Electrode Versus Impedance Programmable up to 25.5 ma Programmable up to 21.1 ma Programmable up to 15.8 ma Programmable up to 12.7 ma Pulse Width: Impedance (Ω) Note: Maximum output capacity is frequency independent Implantable Pulse Generator REV D 5 of 168 Current (ma)
7 Specifications and Technical Data Specifications and Technical Data Parameter Range Default Areas (Channels) 4 Amplitude ma 0 ma Rate pps a 40 pps Width μsec b 210 μsec Cycle 1 sec 90 min, OFF OFF Ramp ON 1 10 secs 3 secs Contacts 1 32, case: +100% to -100%, OFF 1 32, case: OFF en a. Only one Area is available if the rate is > 130 pps. b. Amplitude Width 12.7 µc. Materials Case Header Strain Relief Size/Volume Titanium Epoxy Silicone 55.0 mm x 46.0 mm x 10.8 mm / 21.2 cm 3 (including header) Radiopaque Identification Tag The IPG contains a radiopaque identification tag BSC IPG. The identification 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 Scientific 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 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 Boston Scientific, keep one copy for patient records, provide one copy to the patient, and one copy to the physician. Boston Scientific Neuromodulation Rye Canyon Loop Valencia, California 91355, USA Attention: Customer Service Department Implantable Pulse Generator REV D 6 of 168
8 Implantable Pulse Generator en 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 on a hard surface. 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 Scientific Neuromodulation. 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. Ensure that the IPG is fully charged prior to the permanent implant procedure. The approximate location of the IPG is marked on the IPG kit. Turn on the Charger and place it over the IPG to begin charging. Refer to Charging Steps in this manual for additional instructions. 2. Check that the sterile package is intact. (See Sterilization in the Information for Prescribers manual.) 3. 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 at a depth of up to 2.0 cm from the surface. Implant charging could become ineffective at depths shallower than 0.5 cm or greater than 2.0 cm. 5. Tunnel the lead(s) to the IPG site. Implantable Pulse Generator REV D 7 of 168
9 Instructions for Use Note: Using the IPG template will help guide the correct pocket sizing. It is important to keep the pocket small to reduce the chances of patient manipulation and IPG flipping. Select an IPG site several inches away from the previously externalized trial lead site to reduce risk of infection. en Tunneling the Lead or Lead Extension 1. If not already assembled, attach the tunneling tool handle to the shaft by turning the locking mechanism clockwise. Tool Handle Locking Mechanism 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. Implantable Pulse Generator REV D 8 of 168
10 Implantable Pulse Generator en 5. Make a small incision at the desired exit site. 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. Implantable Pulse Generator REV D 9 of 168
11 Instructions for Use 11. Wipe the proximal end(s) clean. CAUTION: Do not tunnel 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 Scientific tunneling tool: REF (36 cm); REF (55 cm); REF (65 cm) Note: When using a Codman Disposable Catheter Passer, tunnel from the midline incision to the IPG pocket using the standard technique. en Connecting the Lead, Extension, Splitter, or Connector to the IPG IPG ports are labeled as follows: For convenience, connect leads or splitter tails to the IPG ports corresponding to their locations, superior versus inferior or left versus right lead placements. For example: Superior leads to upper IPG ports A or B. Inferior leads to IPG ports C or D. For the Infinion 16, connect the splitter tail with laser etched bands (contacts 1-8 of the Infinion 16 lead) to the left ports A or C and the unmarked splitter tail (contacts 9-16 of the Infinion 16 lead) to the right ports B or D. For the Artisan 2x8 surgical lead, connect the left side to the left ports A or C. Connect the right side (the laser-etched tail), contacts 9-16, to the right ports B or D. Implantable Pulse Generator REV D 10 of 168
12 Implantable Pulse Generator en 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 difficulty when inserting the lead, lead extension, splitter, connector, or port plug, use the hex wrench to loosen (counterclockwise) the set screw and/or gently rotate the lead to help advance the proximal end. Note: To confirm 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 hex 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. Implantable Pulse Generator REV D 11 of 168
13 Rechargeable Stimulator System 6. If desired, secure the IPG in the pocket by suturing through the holes in the IPG header. CAUTION: Do not suture through leads or splitter. en 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 10. Or, to terminate therapy, surgically remove the implanted lead system. 5. Notify Boston Scientific to document the reason for explant or replacement and to arrange for return of IPG and components. Rechargeable Stimulator System The Precision Spectra Stimulator is rechargeable. Boston Scientific recommends any recharge routine that fits the patient s schedule and lifestyle while maintaining sufficient charge to maintain stimulation. Developing a patient s recharge routine involves finding the right balance among the following: How much power is required for the patient to experience effective therapy. How often the patient wants to recharge. How long the patient wants to recharge. How the patient would like to manage their personal schedule. The Precision Spectra Clinician Programmer will estimate charging time based on 24 hours per day of stimulation at the programmed settings. To charge fully, wait until the Charger emits an end of charge beep signal or the Remote Control display indicates that the battery is charged. Refer to the Patient s Charger Handbook and the Clinician s Remote Control Directions for Use for additional information. The recharging process is simple, but important. Implantable Pulse Generator REV D 12 of 168
14 Implantable Pulse Generator en Charging Steps WARNINGS: Patient 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 Charger Belt or an adhesive patch, as shown, may result in a burn. If pain or discomfort is felt, cease charging and contact Boston Scientific. The Charger Base Station should be plugged in and the Charger placed in the Base Station when not in use. When the indicator light is green, the Charger is fully charged. When the indicator is amber, the Charger is partially charged, but is still able to deliver a charge to the Stimulator. 1. When the indicator light is green, remove the Charger from the Base Station. The indicator light will then turn off. 2. Press the power button. The indicator light will come on again, and the Charger will begin beeping as it searches for the Stimulator. 3. Place the Charger over the Stimulator. When the Charger is aligned with the Stimulator, the beeping will stop. Centering the Charger over the Stimulator will ensure the shortest charging time. Many patients are able to feel the implanted Stimulator and can place the Charger directly on top of it. Alternatively, centering the Charger within the alignment area (i.e., the area where the Charger does not beep) will also ensure that the Charger is aligned. 4. Secure the Charger over the Stimulator by using either an adhesive patch or the Charger Belt. Adhesive Patch: Remove the clear liner from the patch. Apply the white side with the blue stripe to the back of the Charger. Then remove the beige liner from the patch. Secure the Charger over the Stimulator by pressing the adhesive to the skin over the Stimulator. Charger Belt: Place the Charger into the pocket on the Charger Belt so that the Power button is visible through the mesh fabric. Secure the Charger over the Stimulator by adjusting the Charger Belt. Implantable Pulse Generator REV D 13 of 168
15 IPG Battery Status en Note: If you accidentally locate the patch in the wrong place, or if the Charger Belt moves out of alignment, the Charger will start beeping again. Use a new adhesive patch or readjust the belt to place the Charger back into position. 5. When the Charger emits a series of double beeps, the Stimulator is fully charged. Turn off the Charger, remove the Charger Belt or adhesive patch, and return the Charger to the Base Station. Do not confuse the end of charge signal (a series of double beeps) with the continuous beeps that indicate that the Charger is searching for the Stimulator. Note: The end of a charge signal is a distinct double beep, and the alignment indicator is a steady continuous signal. The Remote Control will not be able to communicate with the IPG when charging. Refer to IPG Battery Life in your Information for Prescribers manual for information on Stimulator battery life. IPG Battery Status The patient Remote Control displays the Stimulator battery status when communicating with the Stimulator. Refer to the Clinician s Remote Control Directions for Use for additional information. When the Remote Control indicates a low battery the Stimulator should be recharged as soon as possible. Failure to recharge may lead to loss of stimulation in less than 24 hours. After stimulation stops, communication with the Stimulator will also cease. Until a sufficient level of charge has been attained, the Stimulator may not communicate with the Remote Control. Implantable Pulse Generator REV D 14 of 168
16 Generador de impulsos implantable es Copyright 2012 Boston Scientific Corporation o sus empresas afiliadas. Reservados todos los derechos. La presente documentación es propiedad de Boston Scientific Corporation y no está permitida su reproducción, distribución, exposición o uso para la fabricación o venta de dispositivo alguno sin el consentimiento expreso y por escrito de Boston Scientific Corporation. Garantías Boston Scientific Corporation se reserva el derecho de modificar, sin aviso previo, la información relativa a estos productos con el objetivo de mejorar su fiabilidad y capacidad operativa. Las imágenes son meramente ilustrativas. Marcas comerciales Precision Spectra, Infinion y Artisan son marcas comerciales de Boston Scientific. Las demás marcas y sus productos son marcas comerciales o marcas registradas de sus respectivos titulares y deben citarse como tales. Número de certificación de equipos de Industry Canada IC: 9773A-SC1132 Generador de impulsos implantable REV D 15 de 168
17 Índice Índice Descripción...18 Contenido del envase...18 Kit del GII...18 Máxima amplitud de corriente por electrodo frente a impedancia...19 Especificaciones y datos técnicos...20 Materiales...20 Etiqueta de identificación radiopaca...20 Información de registro...20 Instrucciones de uso...21 Manipulación y almacenamiento del GII...21 Instrucciones preoperatorias...21 Implante del GII...21 Tunelización del electrodo o extensión del electrodo...22 Conexión del electrodo, la extensión, la extensión bifurcada o el conector al GII...24 Explante o sustitución del GII...26 Sistema de estimulación recargable...26 Procedimiento de recarga...27 Estado de la batería del GII...28 es Número de modelo del producto Generador de impulsos implantable SC-1132 Consulte la sección de Indicaciones de uso para obtener instrucciones e información relacionada. Consulte el manual de Información para médicos para obtener información acerca de las contraindicaciones, advertencias, precauciones, resumen de efectos adversos, instrucciones para médicos, esterilización, eliminación de los componentes y datos de contacto de Boston Scientific. Para obtener una descripción de los símbolos de etiquetado, consulte el Anexo de símbolos de etiquetado. Consulte las siguientes instrucciones de uso para ver las instrucciones específicas del dispositivo no incluidas en este manual: Instrucciones de uso de los electrodos quirúrgicos, Indicaciones de uso para electrodos percutáneos, las del control remoto del médico del sistema Precision Spectra, el Manual de prueba para el médico, el Manual de programación del sistema Precision Spectra y las instrucciones de uso de la varilla de programación. Consulte la Garantía limitada para obtener más información. Para consultar información sobre la Tarjeta de identificación del paciente, las normas FCC y los estudios clínicos que respaldan el uso clínico del sistema de neuroestimulación, consulte el manual de Información para médicos. Generador de impulsos implantable REV D 16 de 168
18 Generador de impulsos implantable es Esta página se ha dejado en blanco a propósito. Generador de impulsos implantable REV D 17 de 168
19 Descripción Descripción El sistema generador de impulsos implantable (GII) Precision Spectra está diseñado para el tratamiento del dolor crónico mediante la estimulación eléctrica de la médula espinal. La capacidad multicanal y multipolo del dispositivo proporciona flexibilidad combinada con una programación sencilla. La batería recargable prolonga la duración y la capacidad de salida del GII, a la vez que reduce su tamaño y las intervenciones quirúrgicas de sustitución del dispositivo. El GII se controla mediante un control remoto y puede ponerse en marcha desde el programador médico a través del software de programación patentado. La batería del GII debe recargarse periódicamente con un dispositivo de recarga de RF externo. es Contenido del envase Kit del GII (1) Generador de impulsos implantable Precision Spectra (1) Llave hexagonal (1) Conjunto de herramientas de tunelización (1) Plantilla para el bolsillo del GII (4) Tapones de puerto (1) Formulario de registro del dispositivo y tarjeta temporal de identificación del paciente Generador de impulsos implantable REV D 18 de 168
20 Generador de impulsos implantable Máxima amplitud de corriente por electrodo frente a impedancia Programable hasta 25,5 ma Programable hasta 21,1 ma Programable hasta 15,8 ma Programable hasta 12,7 ma Impedancia (Ω) Nota: La capacidad de salida máxima es independiente de la frecuencia. es Ancho de impulso: Generador de impulsos implantable REV D 19 de 168 Intensidad (ma)
21 Especificaciones y datos técnicos Especificaciones y datos técnicos Parámetro Intervalo Valor predeterminado Áreas (canales) 4 Amplitud 0 25,5 ma 0 ma Frecuencia pps a 40 pps Anchura μs b 210 μs Ciclo 1 s 90 min, Desconectado Desconectado Rampa activada 1-10 s 3 s Contactos 1 32, carcasa: de +100 % a -100 %, desconectado 1 32, carcasa: Desconectado es a. Si la frecuencia es > 130 pps, solo hay un área disponible. b. Amplitud x anchura 12,7 µc. Materiales Carcasa Cabezal Protector contra tensión Tamaño/Volumen Titanio Epoxi Silicona 55,0 mm x 46,0 mm x 10.8 mm / 21,2 cm 3 (incluido cabezal) Etiqueta de identificación radiopaca El GII incluye una etiqueta de identificación radiopaca BSC IPG. La etiqueta de identificación 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 Scientific se incluye un formulario de registro. La finalidad 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. Rellene el formulario de registro que se incluye en el envase. Devuelva una copia a Boston Scientific, guarde otra con el expediente del paciente y proporcione también una copia al paciente y al médico. Boston Scientific Neuromodulation Rye Canyon Loop Valencia, California 91355, USA Atención: departamento del Servicio de atención al cliente Generador de impulsos implantable REV D 20 de 168
22 Generador de impulsos implantable Instrucciones de uso es Manipulación y almacenamiento del GII Manipule con cuidado el GII y todos sus componentes. Mantenga los instrumentos cortantes lejos de los componentes. No utilice el GII si se cae sobre una superficie dura. No queme el GII. Una eliminación incorrecta del dispositivo podría causar una explosión. En caso de cremación, el GII deberá explantarse y devolverse a Boston Scientific Neuromodulation. Dispone de un kit de explante. Almacene el GII a una temperatura de entre 0 ºC y 45 ºC (entre 32 ºF y 113 ºF). Los dispositivos deben mantenerse siempre dentro del intervalo de temperatura aceptable en zonas de temperatura controlada. El GII puede deteriorarse a temperaturas que se salgan de este intervalo. Instrucciones preoperatorias 1. Asegúrese de que el GII esté completamente cargado antes del procedimiento de implante permanente. La ubicación aproximada del GII está marcada en el kit de GII. Encienda el cargador y colóquelo sobre el GII para comenzar la recarga. Para obtener más instrucciones, consulte la sección "Procedimiento de recarga" en este manual. 2. Compruebe que el paquete estéril esté intacto. (Consulte la sección sobre la esterilización en el manual de información para prescriptores.) 3. Si desea una prueba de estimulación intraoperatoria, asegúrese de que el estimulador de prueba esté disponible para su uso. Para obtener más instrucciones, consulte el Manual de prueba para el médico. Implante del GII 1. Asegúrese de que la incisión en el área circundante del punto de entrada del electrodo tiene un espacio suficiente para reacomodar el tunelizador. 2. Compruebe que el electrodo esté bien anclado. 3. Seleccione y marque la ubicación deseada del GII mediante la plantilla del GII y realice una incisión para el bolsillo del GII. 4. Cree una bolsa subcutánea no más grande que el contorno del GII a menos de 2,0 cm de profundidad de la superficie. Es posible que la recarga de un implante colocado a menos de 0,5 cm o más de 2,0 cm de profundidad no se realice correctamente. 5. Avance los electrodos por los túneles hasta el punto del GII. Generador de impulsos implantable REV D 21 de 168
23 Instrucciones de uso Nota: La plantilla del GII le ayudará a trazar el tamaño correcto del bolsillo. Es importante que el bolsillo sea pequeño para reducir las probabilidades de que el paciente lo manipule y el GII se mueva. Seleccione una ubicación del GII a varios centímetros del punto del electrodo de prueba anteriormente externalizado para reducir el riesgo de infección. es Tunelización del electrodo o extensión del electrodo 1. Si no está ya ensamblado, conecte el mango del tunelizador al eje girando el mecanismo de bloqueo en el sentido de las agujas del reloj. Mango del tunelizador Mecanismo de bloqueo Eje 2. Marque el recorrido del túnel que desee. 3. Distribuya el anestésico local adecuado por toda la vía de tunelización. 4. OPCIONAL: si es preciso, curve el eje del instrumento para adaptarlo al cuerpo del paciente. Generador de impulsos implantable REV D 22 de 168
24 Generador de impulsos implantable 5. Practique una pequeña incisión en el punto de salida que desee. 6. Cree un túnel subcutáneo entre la incisión del electrodo y el punto del bolsillo del GII hasta que la cánula quede visible y accesible en el punto de salida. es 7. Desenrosque y quite el mango del tunelizador. 8. Sujete el extremo del instrumento con una mano mientras con la otra mantiene la cánula en su sitio. Tire del eje del tunelizador para sacarlo a través de la cánula. 9. Empuje el electrodo o la extensión a través de la cánula y, después, extráigala. 10. Tire de los extremos proximales hacia fuera del punto de salida. 11. Limpie con un paño los extremos proximales. Generador de impulsos implantable REV D 23 de 168
25 PRECAUCIÓN: No realice una tunelización en la extensión bifurcada. Instrucciones de uso Nota: Si utiliza la extensión bifurcada 2 x 8 y realiza una prueba permanente, es posible que las prolongaciones de la extensión bifurcada avancen hacia el punto de salida. Nota: Además del tunelizador de Boston Scientific, puede utilizar los siguientes pasadores de catéter desechables de Codman: REF (36 cm); REF (55 cm); REF (65 cm) Nota: Cuando utilice un pasador de catéter desechable de Codman, realice un túnel desde la incisión de la línea media hasta el bolsillo del GII mediante la técnica estándar. es Conexión del electrodo, la extensión, la extensión bifurcada o el conector al GII Los puertos del GII están etiquetados de este modo: Para su comodidad, conecte los electrodos o los extremos de la extensión bifurcada a los puertos del GII que correspondan a sus ubicaciones, en los puntos de electrodos de la parte superior frente a la inferior o la izquierda frente a la derecha. Por ejemplo: Electrodos superiores a los puertos A o B superiores del GII. Electrodos inferiores a los puertos C o D del GII. En el caso de Infinion 16, conecte el extremo con bandas grabadas con láser de la extensión bifurcada (contactos 1-8 del electrodo Infinion 16) a los puertos izquierdos A o C y el extremo sin marcar de la extensión bifurcada (contactos 9-16 del electrodo Infinion 16) a los puertos derechos B o D. En el caso del electrodo quirúrgico Artisan 2x8, conecte el lado izquierdo a los puertos izquierdos A o C. Conecte el lado derecho (el extremo con marcas de láser), contactos 9-16, a los puertos derechos B o D. Generador de impulsos implantable REV D 24 de 168
26 Generador de impulsos implantable 1. Inserte por completo los electrodos, las extensiones, las extensiones bifurcadas o los conectores en los puertos del GII, con cuidado para no aplicar tensión sobre el extremo proximal del electrodo ni doblarlo. Cuando el electrodo se haya introducido correctamente, se detendrá y el anillo de retención quedará bajo el tornillo fijador. es 2. Inserte por completo un tapón de puerto en los puertos del GII sin utilizar. Nota: Si experimenta alguna dificultad para insertar el electrodo, la extensión del electrodo, la extensión bifurcada, el conector o el tapón de puerto, afloje el tornillo fijador con la llave hexagonal (hacia la izquierda) o gire suavemente el electrodo para facilitar el avance del extremo proximal. Nota: Para confirmar que las conexiones sean correctas, compruebe las impedancias antes de apretar el tornillo fijador. El GII debe estar en contacto con el bolsillo subcutáneo para recibir las mediciones de impedancia precisas. 3. Introduzca la llave hexagonal a través del orificio del tabique que se encuentra en la parte frontal o posterior del cabezal del GII y apriete cada tornillo fijador hasta que la llave hexagonal haga "clic", lo que indica que se ha bloqueado. PRECAUCIÓN: Para no dañar el electrodo, asegúrese de que está totalmente introducido antes de apretar el tornillo fijador. Nota: Si utiliza un tapón de puerto, será igualmente necesario apretar el tornillo fijador en el tapón de puerto, como se ha descrito anteriormente. Nota: La llave hexagonal tiene un par de torsión limitado y no puede apretarse en exceso. Generador de impulsos implantable REV D 25 de 168
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