Important Safety Information

Find important safety information about MED-EL's implant systems. Just select your country and your implant system using the menu below.

Cochlear and Auditory Brainstem Implant System
Albania

Cochlear and Auditory Brainstem Implant System

English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Albania

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Albania

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Albania

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Algeria

Cochlear and Auditory Brainstem Implant System

العربية

الإجراءات الطبية الخاصة بأنظمة غرسات MED‑EL

ManualMRI ChecklistMRI Safety Status Overview
Français

Procédures médicales pour les systèmes d'implant MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Algeria

Bone Conduction Implant - BCI 601

Français

Implants à conduction osseuse - BCI 601

Interférences avec d'autres équipements

  • Diathermie chirurgicale : Les instruments électrochirurgicaux peuvent produire des rayonnements haute fréquence pouvant induire des effets de couplage direct entre l'instrument et l'implant. Ne pas utiliser d'instruments électrochirurgicaux monopolaires à proximité de l'implant. Les courants induits peuvent endommager l'implant ou les capacités auditives du patient.
  • Thérapie par rayonnement ionisant : La thérapie par rayonnement ionisant n'a pas d'effet dommageable sur l'implant. Il est recommandé de ne pas porter l’audio processeur durant l'irradiation.
  • Rayons X, scanner, traitement au cobalt, scanner TEP, diagnostic aux ultrasons : Aucune restriction dans la limite des expositions cliniquement utiles.
  • Bistouri électrique monopolaire, ultrasons thérapeutiques, stimulation magnétique transcrânienne, thérapie électroconvulsive : Ne jamais appliquer directement sur l'implant, ces procédures pouvant l'endommager.
  • Imagerie par résonance magnétique (IRM) : Examen par IRM jusqu'à 1,5 T possible avec le Bonebridge. Conditions à prendre en compte:
    • Ne pas porter l’audio processeur, mais possibilité d'interférences auditives.
    • Présence d'un artefact de 15 cm autour de l'implant sur les images.
    • Examen IRM avec >1,5 T : implant endommagé, situation à éviter.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Algeria

Middle Ear Implant - VORP 502

Français

Implants d'Oreille Moyenne - VORP 502

Interférences avec d'autres équipements

  • Electrochirurgie : Les instruments électrochirurgicaux sont susceptibles de produire des ondes de radiofréquence pouvant directement coupler l’extrémité de l’instrument et l’implant. Les instruments chirurgicaux monopolaires ne doivent pas être utilisés à proximité de l’implant en raison des courants induits qui peuvent endommager l’implant ou diminuer le seuil auditif du patient.
  • Diathermie : Ne procédez jamais à une diathermie sur l’implant dans la mesure où les courants élevés induits dans l’implant risquent de d’endommager ou d’aggraver la surdité du patient.
  • Electrochoc : Ne procédez jamais un électrochoc sur un patient qui porte un SOUNDBRIDGE car ceci pourrait endommager l’implant ou diminuer le seuil auditif du patient.
  • Thérapie par rayonnement ionisant : La thérapie par rayonnement ionisant doit être envisagée avec prudence et le risque de dommage à l’implant VORP doit être considéré par rapport au gain médical potentiel de cette thérapie.
  • Imagerie par résonance magnétique (I.R.M.) : les patients porteurs du VIBRANT SOUNDBRIDGE (VORP 502x) ne doivent pas être exposés à des I.R.M. et ne doivent pas pénétrer dans une salle d’I.R.M. ni se tenir à proximité de champs magnétiques puissants.
  • Cardioversion : L’énergie induite en cours de la cardioversion risque d’endommager l’implant. Aucune défibrillation ne doit être appliquée sur ou à proximité de l’implant.
  • Divers : Les effets du traitement au cobalt, de la tomographie d’émission de positons (PET scan), de l’échographie transcranienne et des techniques d’accélération linéaire sur l’implant sont inconnus. L’utilisation de ces techniques proches de l’implant doit être évitée.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Algeria

Middle Ear Implant - VORP 503

Français

Implants d'Oreille Moyenne - VORP 503

Interférences avec les autres équipements

  • Électrochirurgie : Les instruments électrochirurgicaux peuvent produire des tensions de radio fréquence qui peuvent donner lieu à un couplage entre l'instrument et l'implant. Des instruments électrochirurgicaux monopolaires ne doivent pas être utilisés à proximité de l'implant. Les courants induits entraînent des dommages à l'implant ou au niveau de l'audition du patient.
  • Diathermie chirurgicale : Une diathermie ne doit jamais être appliquée au-dessus de l'implant car les courants élevés induits dans l'implant peuvent entraîner des dommages à l'implant ou au niveau de l'audition du patient.
  • Rayonnements ionisants : Une radiothérapie jusqu'à une dose totale d'ionisation de 100 Gray ainsi que des procédures de diagnostic médical utilisant des rayonnements ionisants, telles que les radiographies, TDM et TEP, ne sont pas nocives pour l'implant. Il est recommandé toutefois de ne pas porter l'audio processeur durant une irradiation.
  • Échographie : Les expositions à une échographie diagnostique utile sur le plan clinique ne causent aucun dommage à l'implant.
  • Cardioversion: L'énergie induite au cours d'une cardioversion peut endommager l'implant. Il ne faut pas pratiquer de défibrillation au-dessus ou près du dispositif.
  • Électrocautérisation monopolaire, échographie thérapeutique, stimulation magnétique transcrânienne, thérapie par électrochocs : Ne doivent jamais être appliquées au-dessus de l'implant car ces procédures peuvent endommager l'implant.
  • Imagerie par résonance magnétique (IRM) : L'examen IRM avec le VORP 503 n'est autorisé que dans le cas d'une utilisation de scanners IRM à ouverture fermée de 1,5 Tesla (T). Il est nécessaire de tenir compte des conditions suivantes :
    • Le scanner IRM doit être limité au « Mode opératoire normal » ; le « Mode opératoire de premier niveau » doit être évité.
    • Les bobines RF de transmission locale ne doivent pas être utilisées dans la région du cou et de la tête. L'utilisation des bobines réceptrices locales n'est pas restreinte.
    • Avant que le patient entre dans la pièce de l'appareil IRM, l'audio processeur doit être retiré de la tête. Une interférence audible peut se produire pendant la procédure suppress. Les patients doivent être conseillés d'indiquer toute gêne éventuelle pouvant se faire ressentir et de demander à ce que la procédure IRM soit interrompue si nécessaire. Après l'examen IRM, le patient ne doit remettre l'audio processeur qu'une fois sorti de la pièce de l'appareil IRM.
    • Au cours de l'examen IRM, il est requis que la tête soit maintenue droite.
    • Un artéfact d'environ 14 cm autour de l'implant sera présent sur les images.
    • Un examen IRM à > 1,5 T endommagera l'implant et doit être évité.
    • Si un examen IRM est nécessaire avant la première activation du système Vibrant Soundbridge, les mesures de sécurité doivent être prises en compte pour prévenir toute complication de la cicatrisation de la plaie due à l'éventuel mouvement de l'implant sous l'influence d'un fort champ magnétique RM.
    • Lorsque les membres inférieurs doivent être examinés, il est recommandé, mais pas exigé, que les jambes du patient soient introduites en premier dans le l'IRM.
  • Systèmes antivol et de détection de métal : Les systèmes de détection antivol et les détecteurs de métaux produisent de forts champs électromagnétiques. Les patients portant un implant doivent être informés que le passage à travers des portiques détecteurs de métaux peut activer l'alarme du détecteur. C'est pour cette raison qu'il est recommandé aux patients de porter sur eux en permanence leur carte d'identification d'utilisateur du système Vibrant Soundbridge.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Argentina

Cochlear and Auditory Brainstem Implant System

Español

Procedimientos médicos para Sistemas de implante MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Argentina

Bone Conduction Implant - BCI 601

Español

Implantes de Conducción Ósea - BCI 601

Interferencias con otros dispositivos

  • Diatermia quirúrgica: El instrumental de electrocirugía puede producir voltajes de radiofrecuencia, que pueden resultar en el acoplamiento directo entre el instrumento y el implante. Queda prohibido emplear instrumental electroquirúrgico monopolar cerca del implante. Las corrientes inducidas podrían causar daños en el implante o en la audición del paciente.
  • Terapia de radiación ionizante: La radioterapia no daña el implante. Se recomienda no portar un procesador de audio durante la irradiación.
  • Rayos X, tomografía computarizada, tratamiento con cobalto, escáner PET, ultrasonido diagnóstico: No existen restricciones dentro de las exposiciones con fines clínicos.
  • Electrocauterio monopolar, ultrasonido terapéutico, estimulación magnética transcraneal, terapia electroconvulsiva: Queda prohibido aplicar directamente estos procedimientos sobre el implante, ya que podrían causar daños en el mismo.
  • Imagen por Resonancia Magnética (IRM): La evaluación por medio de IRM está permitida hasta 1,5 T con el Bonebridge. Tenga en cuenta las siguientes exigencias:
  • No se debe portar el procesador de audio. Aún así, es posible que surjan interferencias audibles.
  • Los escáneres presentarán un artefacto de 15 cm alrededor del implante.
  • Evite una evaluación con IRM >1,5 T, ya que dañaría el implante.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL.MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Argentina

Middle Ear Implant - VORP 502

Español

Implantes de Oído Medio - VORP 502

Interferencias con otros dispositivos

  • Electrocirugía: Los instrumentos electroquirúrgicos pueden producir voltajes de radiofrecuencia que son capaces de acoplar el extremo del instrumento y el implante. Los instrumentos de cirugía monopolar no deben ser usados en el área próxima al implante debido a que inducen corrientes que pueden dañar el implante o la audición del paciente.
  • Diatermia: La diatermia no debe ser nunca aplicada sobre el implante debido a que las grandes corrientes que se inducen en el mismo lo pueden dañar o dañar la audición del paciente.
  • Terapia Electroconvulsiva: La terapia electroconvulsiva no debe ser usada nunca en un paciente con un Soundbridge debido a que puede dañar el implante o la audición del paciente.
  • Terapia de Radiación Ionizante: La terapia de radiación ionizante debe ser considerada cuidadosamente ante el riesgo de dañar el implante VORP. Debe ser sopesado el riesgo frente al beneficio médico de dicha terapia.
  • Resonancia Magnética (RMN): Los pacientes implantados con el VIBRANT SOUNDBRIDGE (VORP 502x) no deben ser sometidos a RMN y no deben entrar a una cabina de RMN o estar en las proximidades de otras fuentes de campos magnéticos potentes.
  • Cardioversión: La energía inducida durante la cardioversión puede dañar el implante. La desfibrilación no debe ser aplicada en o cerca del dispositivo.
  • Miscelánea: Los efectos del tratamiento de cobalto, PET, diagnóstico y terapia ultrasónica y técnicas de aceleración lineal en las proximidades del implante son desconocidas. Su uso en las zonas próximas al implante debe ser evitado.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Argentina

Middle Ear Implant - VORP 503

Español

Implantes de Oído Medio - VORP 503

Interferencias con otros equipos

  • Electrocirugía: los instrumentos electroquirúrgicos pueden producir frecuencias de radio que pueden causar el acoplamiento entre el instrumento y el implante. No se deben utilizar instrumentos quirúrgicos monopolares en las proximidades del implante. La corriente de inducción podría dañar el implante y/o la audición del paciente.
  • Diatermia quirúrgica: nunca se debe aplicar diatermia sobre el implante porque la corriente inducida podría causar daños en el implante o en la audición del paciente.
  • Radiación ionizante: la terapia con radiación ionizante hasta una dosis de ionización total de 100 Gy, así como los procedimientos médicos diagnósticos que utilizan radiación ionizante, como los rayos X, TC y PET, no dañan el implante. No se recomienda llevar el procesador auditivo durante la radiación.
  • Ultrasonidos: la exposición a ultrasonidos de utilidad diagnóstica no causa daños en el implante.
  • Cardioversión: la energía inducida durante la cardioversión podría dañar el implante. No se debe aplicar desfibrilación sobre el dispositivo ni en sus proximidades.
  • Electrocauterización monopolar, ultrasonidos terapéuticos, estimulación magnética transcraneal, tratamiento electroconvulsivo: nunca deben aplicarse directamente sobre el implante porque pueden dañarlo.
  • Imágenes por resonancia magnética (IRM): el examen por IRM con VORP 503 solo se permite con escáneres IRM cerrados de 1,5 teslas (T). Deben tenerse en cuenta las siguientes condiciones:
    • El escáner MRI debe estar limitado a modo de operación normal; evite el modo de operación de primer nivel.
    • No utilice bobinas de RF de transmisión local en la región craneal o cervical. No se limita el uso de bobinas de recepción local.
    • Antes de que el paciente entre en la sala de IRM, el procesador auditivo debe retirarse de la cabeza. Durante el escáner pueden producirse interferencias audibles. Los pacientes deben estar informados de que tienen que comunicar cualquier posible molestia y solicitar que se interrumpa la prueba si es necesario. Después de la prueba, el paciente no se pondrá el procesador auditivo hasta salir de la sala de IRM.
    • Durante el examen con IRM, la cabeza debe mantenerse en posición recta.
    • Las imágenes mostrarán un artefacto de aproximadamente 14 cm alrededor del implante.
    • Los exámenes con IRM de más de 1,5 T causan daños en el implante y deben evitarse.
    • Si necesita un examen IRM antes de la primera activación de Vibrant Soundbridge, deberán tomarse medidas de seguridad para evitar complicaciones en la curación de la herida por posibles movimientos del implante dentro del potente campo de RM.
    • Para examinar las extremidades inferiores se recomienda, aunque no es imprescindible, que las piernas entren primero en el escáner.
  • Sistemas antirrobo y detectores de metales: los sistemas comerciales antirrobo y detectores de metales generan potentes campos electromagnéticos. Los pacientes que utilicen implantes deben saber que pueden activar la alarma al pasar por los detectores de metales de seguridad. Por eso se recomienda a los pacientes llevar encima la tarjeta de identificación de usuario de Vibrant Soundbridge en todo momento.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Armenia

Cochlear and Auditory Brainstem Implant System

Русский

Проведение медицинских процедур у пользователей систем имплантации MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Armenia

Bone Conduction Implant - BCI 601

Русский

Импланты костной проводимости - BCI 601

Взаимодействие с другими устройствами

  • Хирургическая диатермия: Генерируемые электрохирургическими инструментами высокочастотные токи могут привести к замыканию между инструментом и имплантом. Монополярные электрохирургические инструменты не должны применяться вблизи импланта, так как индуцируемые ими токи могут повредить имплант или слух пациента.
  • Лучевая терапия: Лучевая терапия не повреждает имплант. Рекомендуется снять аудиопроцессор с головы и отложить егов сторону во время облучения.
  • Рентген, компьютерная томография, лечение кобальтом, позитронно-эмиссионная томография, диагностический ультразвук: При клиническом использовании ограничения отсутствуют.
  • Монополярная электрокоагуляция, терапевтический ультразвук, транскраниальная магнитная стимуляция, электрошоковая терапия: Никогда нельзя использовать непосредственно вблизи импланта, так как это может его повредить.
  • Магнитно-резонансная томография (МРТ): Пациентам, имплантированным системой Bonebridge разрешены MРТ-обследования до 1,5 T. Следует соблюдать следующие условия:
    • Аудиопроцессор должен быть снят с головы, но даже после этого могут появляться слуховые ощущения.
    • На полученных изображениях будет наблюдаться артефакт 15 см вокруг импланта.
    • MРТ-обследования с величиной магнитной индукции >1,5 T повреждают имплант и их следует избегать.
Изделия, способы применения и эксплуатационные характеристики подлежат утверждению компетентными государственными органами; некоторые функциональные возможности могут быть недоступны в текущий момент или не продаваться компанией MED-EL в вашем регионе. Для получения дополнительной информации обратитесь к представителю MED-EL в своем регионе. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Armenia

Middle Ear Implant - VORP 502

Русский

Импланты среднего уха - VORP 502

Взаимодействие с другими устройствами

  • Электрохирургия: Электрохирургические инструменты способны производить радиочастотные токи, которые могут вызвать замыкание между инструментом и имплантом. Монополярные электрохирургические инструменты не должны использоваться вблизи от импланта, так как индуцируемый ими ток может повредить имплант или слух пациента.
  • Диатермия: Диатермия не должна применяться к пациентам, носящим имплант, потому что индуцируемый ей ток может повредить имплант или слух пациента.
  • Электрошоковая терапия: Электрошоковая терапия не должна применяться к пациентам, использующим SOUNDBRIDGE так как она может вызвать повреждение импланта или нарушение слуха пациента.
  • Ионизирующая радиационная терапия: При назначении ионизирующей радиационной терапии необходимо тщательно взвесить возможный риск повреждения импланта и потенциальный медицинский эффект от такой терапии.
  • Магнитно-резонансная томография (МРТ, MRI): Пациентам, имплантированным системой VIBRANT SOUNDBRIDGE (VORP 502x), исследование МРТ должно быть заменено на другое. Нельзя также находиться в комнате, где проводится исследование, вблизи самого МР томографа или других источников сильных магнитных полей.
  • Кардиостимуляция: Энергия, производимая во время кардиостимуляции, может вызвать повреждение импланта. Дефибрилляция не должна проводиться вблизи импланта
  • Другое: Эффекты, оказываемые на имплант кобальтовой терапией, PET сканированием, транскраниальной ультразвуковой диагностикой, техникой линейного ускорения, пока не изучены. Рекомендуется следовать инструкциям хирурга относительно размещения ложа импланта и соединительного кабеля. Не рекомендуется применение вышеперечисленных методик в области импланта.
Изделия, способы применения и эксплуатационные характеристики подлежат утверждению компетентными государственными органами; некоторые функциональные возможности могут быть недоступны в текущий момент или не продаваться компанией MED-EL в вашем регионе. Для получения дополнительной информации обратитесь к представителю MED-EL в своем регионе. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Armenia

Middle Ear Implant - VORP 503

Русский

Импланты среднего уха - VORP 503

Взаимодействие с другими устройствами

  • Электрохирургия: Генерируемые электрохирургическими инструментами высокочастотные напряжения могут привести к прямому соединению между инструментом и имплантом. Монополярные электрохирургические инструменты не должны применяться в непосредственной близости от импланта. Индуцируемые ими токи могут привести к повреждению импланта или слуха пациента.
  • Хирургическая диатермия: Диатермию никогда нельзя применять поверх импланта, поскольку индуцированные в импланте сильные токи могут привести к повреждению импланта или слуха пациента.
  • Ионизирующее излучение: Лучевая терапия до суммарной ионизационной дозы 100 Грей, а также медицинские диагностические процедуры с использованием источников ионизирующего излучения, такие как рентгенография, КТ и ПЭТ, не наносят вреда импланту. Рекомендуется не надевать аудиопроцессор во время облучения.
  • Ультразвук: Воздействие клинически применимого диагностического ультразвука не вызывает каких-либо повреждений импланта.
  • Кардиостимуляция: Энергия, индуцируемая во время кардиостимуляции, может вызвать повреждение импланта. Дефибрилляцию не следует применять на устройстве или в непосредственной близости от него.
  • Монополярная электрокоагуляция, терапевтический ультразвук, транскраниальная магнитная стимуляция, электрошоковая терапия: Никогда не следует применять непосредственно поверх импланта, так как эти процедуры могут повредить имплант.
  • Магнитно-резонансная томография (МРТ): МРТ-обследование при наличии VORP 503 допустимо только в закрытом (туннельном) МРТ-сканере с 1,5 Тесла (T). Необходимо учитывать следующие условия:
    • МРТ-сканер следует ограничить режимом «Нормальный рабочий режим». Режима «Рабочий режим первого уровня» нужно избегать.
    • Локальные передающие РЧ-катушки нельзя использовать в области головы и шеи. Локальные приемные катушки не ограничены в использовании.
    • Прежде чем пациент войдет в кабинет МРТ, ему следует снять с головы аудиопроцессор. Во время сканирования могут возникать звуковые помехи. Пациента нужно предупредить о том, что он должен сигнализировать о каком-либо могущем возникнуть дискомфорте и, если необходимо, попросить о прекращении МРТ. По окончании МРТ-обследования пациент может снова надеть аудиопроцессор только после того, как покинет кабинет МРТ.
    • Во время МРТ-обследования голову следует держать прямо.
    • На изображениях вокруг имплантата на расстоянии прибл. 14 см будут присутствовать артефакты.
    • MРТ-обследования с величиной магнитной индукции >1,5 T повреждают имплант; их следует избегать.
    • Если некое МРТ-обследование необходимо до первого включения Vibrant Soundbridge, следует предпринять меры безопасности с тем, чтобы предотвратить осложнения с заживлением раны из-за возможного смещения импланта в сильном поле МР.
    • Если необходимо произвести обследование нижних конечностей, рекомендуется (но не требуется) в первую очередь поместить в сканер голени пациента.
       
  • Системы сигнализации и металлодетекторы: Коммерческие охранные системы и металлодетекторы производят сильные электромагнитные поля. Пациенты с имплантами должны быть предупреждены, что прохождение через охранные металлодетекторы может активировать сигнал тревоги. Из этих соображений пациентам рекомендуется постоянно носить при себе идентификационную карту пользователя Vibrant Soundbridge.
Изделия, способы применения и эксплуатационные характеристики подлежат утверждению компетентными государственными органами; некоторые функциональные возможности могут быть недоступны в текущий момент или не продаваться компанией MED-EL в вашем регионе. Для получения дополнительной информации обратитесь к представителю MED-EL в своем регионе. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Aruba

Cochlear and Auditory Brainstem Implant System

Nederlands

Medische procedures voor MED‑EL-implantaatsystemen

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Aruba

Bone Conduction Implant - BCI 601

Nederlands

Beengeleidingsimplantaat - BCI 601

Wisselwerking met andere apparaten

  • Chirurgische diathermie: Door elektrochirurgische instrumenten gegenereerde hoogfrequente spanningen kunnen leiden tot een rechtstreekse koppeling tussen het instrument en het implantaat. Monopolaire elektrochirurgische instrumenten mogen niet worden gebruikt in de nabijheid van het implantaat. De geïnduceerde stromen kunnen het implantaat of het hoorvermogen van de patiënt beschadigen.
  • Radiotherapie: Radiotherapie is niet schadelijk voor het implantaat. Het verdient aanbeveling de audioprocessor tijdens de bestraling af te doen.
  • Röntgen, CT, kobaltbehandeling, PET-scan, diagnostisch ultrasoon onderzoek: Geen beperking bij klinische bestralingen.
  • Monopolaire elektrocauterisatie, therapeutische ultrasoontherapie, transcraniële magnetische stimulatie, elektroshocktherapie: Mag nooit direct boven het implantaat worden gebruikt, omdat het implantaat hierdoor beschadigd kan raken.
  • Magnetic Resonance Imaging (MRI): MRI-onderzoeken tot maximaal 1,5 T zijn bij de Bonebridge toegestaan. De volgende voorwaarden moeten in acht worden genomen:
    • De audioprocessor mag niet gedragen worden, hoorbare interferentie blijft echter mogelijk.
    • Op de beelden zal een artefact van 15 cm rondom het implantaat zichtbaar zijn.
    • MRI-onderzoeken met >1,5 T beschadigen het implantaat en dienen te worden vermeden.
De producten, toepassingen en prestatiekarakteristiekenmoeten worden goedgekeurd door de nationale bevoegde autoriteiten. Sommige functies zijn momenteel mogelijk niet beschikbaar of worden niet door MED-EL in uw regio verkocht. Neem contact op met uw lokale MED-EL-vertegenwoordiger voor meer informatie. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Aruba

Middle Ear Implant - VORP 502

Nederlands

Middenoorimplantaten - VORP 502

Wisselwerking met andere apparaten

  • Electrochirurgie: Electrochirurgische instrumenten kunnen een elektrische veldsterkte opwekken waardoor de tip van het instrument direct kan worden gekoppeld met het implantaat. Monopolaire electrochirurgische instrumenten mogen niet worden gebruikt in de nabijheid van het implantaat, omdat de geïnduceerde stroom schade kan veroorzaken aan het implantaat of aan het gehoor van de patiënt.
  • Diathermie: Diathermie mag nooit worden toegepast ter hoogte van het implantaat omdat de hoge stroomsterktes die het implantaat in kunnen lopen het implantaat of het gehoor van de patiënt kunnen beschadigen.
  • Electroconvulsietherapie: Electroconvulsietherapie mag niet worden toegepast bij een patiënt met een SOUNDBRIDGE omdat dit het implantaat of het gehoor van de patiënt kan beschadigen.
  • Ioniserende bestralingstherapie: Ioniserende bestralingstherapie dient zorgvuldig te worden overwogen en het risico op schade aan het implantaat dient te worden afgezet tegen de medische baten van deze therapie.
  • Magnetic Resonance Imaging (MRI): Patiënten met een VIBRANT SOUNDBRIDGE (VORP 502x) mogen niet worden onderzocht m.b.v. MRI en niet de onderzoeksruimte van de MRI-scan betreden of in de nabijheid komen van andere bronnen met sterke magnetische velden.
  • Cardioversie: de energie die wordt opgewekt tijdens cardioversie kan schade berokkenen aan het implantaat. Defibrilatie mag niet worden toegepast op of bij het implantaat.
  • Overige: De effecten van kobaltbehandeling, PET scans, diagnostische ultrasound en lineaire versnellingstechnieken in de nabijheid van het implantaat zijn niet bekend. Het gebruik hiervan in de nabijheid van het implantaat dient daarom te worden vermeden.
De producten, toepassingen en prestatiekarakteristiekenmoeten worden goedgekeurd door de nationale bevoegde autoriteiten. Sommige functies zijn momenteel mogelijk niet beschikbaar of worden niet door MED-EL in uw regio verkocht. Neem contact op met uw lokale MED-EL-vertegenwoordiger voor meer informatie. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Aruba

Middle Ear Implant - VORP 503

Nederlands

Middenoorimplantaten - VORP 503

Interferentie van andere apparatuur

  • Elektrochirurgie: Elektrochirurgische instrumenten kunnen hoogfreqente spanningen voortbrengen die direct van het instrument kunnen overspringen op het implantaat. Monopolaire elektrochirurgische instrumenten mogen niet in de directe omgeving van het implantaat worden gebruikt. De geïnduceerde elektrische stromen zouden het implantaat of het gehoor van de patiënt kunnen beschadigen.
  • Chirurgische diathermie: Er mag in geen geval diathermie op het implantaat worden toegepast, omdat de hoge, in het implantaat geïnduceerde, stroomsterktes het implantaat of het gehoor van de patiënt zouden kunnen beschadigen.
  • Ioniserende straling: Radiotherapie tot een totale ionisatiedosis van 100 Gray, evenals medisch-diagnostisch onderzoek waarbij gebruik wordt gemaakt van ioniserende straling zoals röntgen, CT en PET, veroorzaakt geen schade aan het implantaat. Aanbevolen wordt om tijdens bestraling de audioprocessor niet te dragen.
  • Echografie: Echografie is niet schadelijk voor het implantaat.
  • Cardioversie: De energie die tijdens een cardioversie wordt geïnduceerd, kan het implantaat beschadigen.
    Op of in de nabijheid van het implantaat mag geen defibrillatie worden toegepast.
  • Monopolaire elektrochirurgie, therapeutische ultrasoonbehandeling, transcraniële magnetische stimulatie, elektroconvulsieve therapie: Deze behandelingen mogen in geen geval rechtstreeks boven het implantaat worden toegepast omdat daardoor het implantaat kan worden beschadigd.
  • Magnetic Resonance Imaging (MRI): Een MRI-onderzoek met de VORP 503 is uitsluitend toegestaan in 1,5 Tesla (T) MRI-scanners met een gesloten buis. Er dient rekening te worden gehouden met de volgende voorwaarden:
    • De MRI-scanner mag uitsluitend in de "Normale bedrijfsmodus" worden gebruikt, de "Eerste niveau bedrijfsmodus" dient te worden vermeden.
    • Lokaal zendende RF-spoelen mogen niet in het hoofd-nekgebied worden gebruikt. Er is geen beperking voor locale ontvangstspoelen.
    • Voordat de patiënten de MRI-ruimte binnengaan moet de audioprocessor van het hoofd worden genomen. Tijdens de scan kan hoorbare interferentie optreden. De patiënt moet worden geïnstrueerd om enig mogelijk ongemak te melden en indien nodig te vragen of de MRI kan worden afgebroken. Na het MRI-onderzoek mag de patiënt de audioprocessor pas na het verlaten van de MRI-ruimte weer opzetten.
    • Tijdens de MRI-scan moet het hoofd zo recht mogelijk worden gehouden.
    • Op de afbeelding is een artefact van ongeveer 14 cm rondom het implantaat zichtbaar.
    • Een MRI-onderzoek van >1,5 T beschadigt het implantaat en moet worden vermeden.
    • Is voorafgaande aan de eerste activering van de Vibrant Soundbridge een MRI-onderzoek noodzakelijk, dan moeten er veiligheidsmaatregelen worden genomen om complicaties bij de wondgenezing, als gevolg van mogelijke verplaatsing van het implantaat door het sterke MR-veld, te voorkomen.
    • Moeten er ook onderste ledematen worden onderzocht, dan wordt geadviseerd, maar dat is niet verplicht, dat de benen van de patiënt als eerste de scanner ingaan.
       
  • Diefstal- en metaaldetectiesystemen: Commerciële diefstaldetectiesystemen en metaaldetectors wekken sterke elektromagnetische velden op. Patiënten met een implantaat moeten erover worden geïnformeerd dat bij het passeren van een veiligheidsmetaaldetector het detectoralarm kan afgaan. Daarom is het raadzaam dat patiënten altijd hun Vibrant Soundbridge gebruikersidentificatiekaart bij zich hebben.
De producten, toepassingen en prestatiekarakteristiekenmoeten worden goedgekeurd door de nationale bevoegde autoriteiten. Sommige functies zijn momenteel mogelijk niet beschikbaar of worden niet door MED-EL in uw regio verkocht. Neem contact op met uw lokale MED-EL-vertegenwoordiger voor meer informatie. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Australia

Cochlear and Auditory Brainstem Implant System

English - AU

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Australia

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Australia

Middle Ear Implant - VORP 502

English - AUS

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region.
Middle Ear Implant - VORP 503
Australia

Middle Ear Implant - VORP 503

English - AUS

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI Checklist
Cochlear and Auditory Brainstem Implant System
Austria

Cochlear and Auditory Brainstem Implant System

Deutsch

Medizinische Behandlungen bei MED‑EL Implantatsystemen

ManualMRI ChecklistMRT Sicherheitsstatus im Überblick
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Austria

Bone Conduction Implant - BCI 601

Deutsch

Knochenleitungsimplantat - BCI 601

Wechselwirkung mit anderen Geräten

  • Chirurgische Diathermie: Durch elektrochirurgische Instrumente erzeugte hochfrequente Spannungen können zu einer direkten Kopplung zwischen Instrument und Implantat führen. Monopolare elektrochirurgische Instrumente dürfen in der Nähe des Implantats nicht verwendet werden. Die induzierten Ströme könnten das Implantat oder das Hörvermögen des Patienten schädigen.
  • Strahlentherapie: Strahlentherapie schädigt das Implantat nicht. Es wird empfohlen, den Audioprozessor während der Bestrahlung abzulegen.
  • Röntgen, CT, Kobaltbehandlung, PET-Scan, diagnostischer Ultraschall: Keine Einschränkung bei klinischen Bestrahlungen.
  • Monopolare Elektrokauterisation, therapeutischer Ultraschall, transkranielle Magnetstimulation, Elektroschocktherapie: Darf nie direkt über dem Implantat eingesetzt werden, da dies das Implantat schädigen könnte.
  • Magnetresonanztomographie (MRT): MRT-Untersuchungen bis zu 1,5 T sind bei der Bonebridge erlaubt. Folgende Bedingungen sind zu beachten:
    • Der Audioprozessor soll nicht getragen werden, trotzdem kann es zu Hörempfindungen kommen.
    • Ein Artefakt von 15 cm rund um das Implantat wird auf den Bildern zu sehen sein.
    • MRT-Untersuchungen mit >1,5 T schädigen das Implantat und sind zu vermeiden.
Die Produkte, Anwendungen und Leistungscharakteristiken unterliegen der Zulassung der zuständigen nationalen Behörden; manche Bestandteile stehen derzeit möglicherweise in Ihrem Land nicht zur Verfügung oder werden von MED-EL nicht in Ihrem Land zum Verkauf angeboten. Bitte kontaktieren Sie Ihren persönlichen MED-EL Ansprechpartner für weitere Informationen. MRI Info SheetMRI ChecklistMRT Sicherheitsstatus im Überblick
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Austria

Middle Ear Implant - VORP 502

Deutsch

Mittelohrimplantate - VORP 502

Wechselwirkung mit anderen Geräten

  • Elektrochirurgie: Elektrochirurgische Instrumente können hochfrequente Spannungen erzeugen, die von der Spitze des Instruments direkt auf das Implantat überspringen können. In der Nähe des Implantats dürfen monopolare elektrochirurgische Instrumente nicht verwendet werden, da der von ihnen erzeugte Strom das Implantat beschädigen und das Gehör des Patienten beeinträchtigen kann.
  • Diathermie: Diathermie darf niemals über dem Implantat durchgeführt werden, da der starke, in das Implantat induzierte Strom das Implantat beschädigen und das Gehör des Patienten beeinträchtigen kann.
  • Elektroschocktherapie: Elektroschocktherapie darf an Patienten mit einer VIBRANT SOUNDBRIDGE nicht durchgeführt werden, da dadurch das Implantat beschädigt und das Gehör des Patienten beeinträchtigt werden kann.
  • Therapie mit ionisierender Strahlung: Notwendige Therapien mit ionisierender Strahlung sind genau zu prüfen und das Risiko einer Beschädigung des VORP Implantats sorgfältig gegen den Nutzen einer solchen Behandlung abzuwägen.
  • Magnetresonanztomographie (MRT): Patienten mit einer VIBRANT SOUNDBRIDGE (VORP 502x) sollten nicht mit MRT untersucht werden und sollten keinen MRT-Raum betreten oder sich in der Nähe anderer Quellen mit starken magnetischen Feldern aufhalten.
  • Kardioversion: Die während der Kardioversion erzeugte Energie kann Schäden am Implantat hervorrufen. Am oder in der Nähe des Implantats sollte keine Defibrillierung vorgenommen werden.
  • Sonstiges: Die Auswirkungen von Kobaltbehandlungen, PET Scans, diagnostischem und therapeutischem Ultraschall und Linearbeschleunigerverfahren in der Nähe des Implantats sind nicht bekannt. Solche Behandlungen sollten in der Nähe des Implantats vermieden werden.
Die Produkte, Anwendungen und Leistungscharakteristiken unterliegen der Zulassung der zuständigen nationalen Behörden; manche Bestandteile stehen derzeit möglicherweise in Ihrem Land nicht zur Verfügung oder werden von MED-EL nicht in Ihrem Land zum Verkauf angeboten. Bitte kontaktieren Sie Ihren persönlichen MED-EL Ansprechpartner für weitere Informationen. MRT Sicherheitsstatus im Überblick
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Austria

Middle Ear Implant - VORP 503

Deutsch

Mittelohrimplantate - VORP 503

Beeinflussung durch andere Geräte

  • Elektrochirurgie: Elektrochirurgische Instrumente können hochfrequente Spannungen erzeugen, die von dem Instrument direkt auf das Implantat überspringen können. In der Nähe des Implantats dürfen monopolare elektrochirurgische Instrumente nicht verwendet werden. Die induzierten Ströme könnten das Implantat oder das Hörvermögen des Patienten schädigen.
  • Chirurgische Diathermie: Diathermie darf niemals über dem Implantat durchgeführt werden, da der starke, in das Implantat induzierte Strom das Implantat beschädigen und das Gehör des Patienten beeinträchtigen kann.
  • Ionisierende Strahlung: Strahlentherapie bis zu einer Gesamtstrahlendosis von 100 Gray sowie medizinische Diagnoseverfahren mithilfe von ionisierender Strahlung (wie Röntgen, CT und PET) schädigen das Implantat nicht. Es wird empfohlen, den Audioprozessor während einer Bestrahlung abzulegen.
  • Ultraschall: Einwirkungen von klinischem Diagnoseultraschall beschädigen nicht das Implantat.
  • Kardioversion: Die während einer Kardioversion erzeugte Energie könnte Schäden am Implantat hervorrufen. Am oder in der Nähe des Gerätes sollte keine Defibrillierung vorgenommen werden.
  • Monopolare Elektrokauterisation, therapeutischer Ultraschall, transkranielle magnetische Stimulation, elektrokonvulsive Therapie: Darf nie direkt über dem Implantat eingesetzt werden, da dies das Implantat schädigen könnte.
  • Magnetresonanztomographie (MRT): Eine MRT-Untersuchung bei einem Träger des VORP 503 ist nur mit einem geschlossenen MRT-Scanner bei 1,5 Tesla (T) zulässig. Folgende Bedingungen müssen beachtet werden:
    • Der MRT-Scanner muss auf den normalen Betriebsmodus beschränkt werden. Der Betriebsmodus der Stufe 1 muss vermieden werden.
    • Lokale übertragende HF-Spulen dürfen nicht in der Kopf- oder Nackenregion verwendet werden. Lokale Empfängerspulen können ohne Einschränkung verwendet werden.
    • Patienten müssen den Audioprozessor vom Kopf abnehmen, bevor sie einen MRT-Raum betreten. Während des Scans können hörbare Interferenzen entstehen. Patienten müssen angewiesen werden, jegliches Unwohlsein sofort zu melden, um das MRT gegebenenfalls zu beenden. Nach der MRT-Untersuchung darf der Patient den Audioprozessor erst anlegen, wenn er den MRT-Raum verlassen hat.
    • Während der MRT-Untersuchung muss der Kopf gerade gehalten werden.
    • Auf den Bildern wird ein Artefakt von etwa 14 cm um das Implantat zu sehen sein.
    • Eine MRT-Untersuchung mit mehr als 1,5 T beschädigt das Implantat und muss vermieden werden.
    • Falls vor der ersten Aktivierung der Vibrant Soundbridge eine MRT-Untersuchung notwendig ist, müssen Sicherheitsmaßnahmen getroffen werden, um Komplikationen bei der Wundheilung aufgrund der möglichen Bewegung des Implantats im starken MR-Feld zu vermeiden.
    • Wenn die unteren Extremitäten untersucht werden, wird empfohlen, dass die Beine des Patienten zuerst in den Scanner geschoben werden.
  • Diebstahlsicherung und Metalldetektoren: Kommerzielle Diebstahlsicherungen und Metalldetektoren erzeugen starke elektromagnetische Felder. Patienten mit einem Implantat müssen darauf hingewiesen werden, dass beim Passieren eines Sicherheitsmetalldetektors der Alarm ausgelöst werden könnte. Aus diesem Grund wird empfohlen, dass Patienten immer ihre Vibrant Soundbridge Benutzer-Identifikationskarte mit sich führen. 
Die Produkte, Anwendungen und Leistungscharakteristiken unterliegen der Zulassung der zuständigen nationalen Behörden; manche Bestandteile stehen derzeit möglicherweise in Ihrem Land nicht zur Verfügung oder werden von MED-EL nicht in Ihrem Land zum Verkauf angeboten. Bitte kontaktieren Sie Ihren persönlichen MED-EL Ansprechpartner für weitere Informationen. MRI Info SheetMRI ChecklisteMRT Sicherheitsstatus im Überblick
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Azerbaijan

Cochlear and Auditory Brainstem Implant System

Русский

Проведение медицинских процедур у пользователей систем имплантации MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Azerbaijan

Bone Conduction Implant - BCI 601

Русский

Импланты костной проводимости - BCI 601

Взаимодействие с другими устройствами

  • Хирургическая диатермия: Генерируемые электрохирургическими инструментами высокочастотные токи могут привести к замыканию между инструментом и имплантом. Монополярные электрохирургические инструменты не должны применяться вблизи импланта, так как индуцируемые ими токи могут повредить имплант или слух пациента.
  • Лучевая терапия: Лучевая терапия не повреждает имплант. Рекомендуется снять аудиопроцессор с головы и отложить егов сторону во время облучения.
  • Рентген, компьютерная томография, лечение кобальтом, позитронно-эмиссионная томография, диагностический ультразвук: При клиническом использовании ограничения отсутствуют.
  • Монополярная электрокоагуляция, терапевтический ультразвук, транскраниальная магнитная стимуляция, электрошоковая терапия: Никогда нельзя использовать непосредственно вблизи импланта, так как это может его повредить.
  • Магнитно-резонансная томография (МРТ): Пациентам, имплантированным системой Bonebridge разрешены MРТ-обследования до 1,5 T. Следует соблюдать следующие условия:
    • Аудиопроцессор должен быть снят с головы, но даже после этого могут появляться слуховые ощущения.
    • На полученных изображениях будет наблюдаться артефакт 15 см вокруг импланта.
    • MРТ-обследования с величиной магнитной индукции >1,5 T повреждают имплант и их следует избегать.
Изделия, способы применения и эксплуатационные характеристики подлежат утверждению компетентными государственными органами; некоторые функциональные возможности могут быть недоступны в текущий момент или не продаваться компанией MED-EL в вашем регионе. Для получения дополнительной информации обратитесь к представителю MED-EL в своем регионе. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Azerbaijan

Middle Ear Implant - VORP 502

Русский

Импланты среднего уха - VORP 502

Взаимодействие с другими устройствами

  • Электрохирургия: Электрохирургические инструменты способны производить радиочастотные токи, которые могут вызвать замыкание между инструментом и имплантом. Монополярные электрохирургические инструменты не должны использоваться вблизи от импланта, так как индуцируемый ими ток может повредить имплант или слух пациента.
  • Диатермия: Диатермия не должна применяться к пациентам, носящим имплант, потому что индуцируемый ей ток может повредить имплант или слух пациента.
  • Электрошоковая терапия: Электрошоковая терапия не должна применяться к пациентам, использующим SOUNDBRIDGE так как она может вызвать повреждение импланта или нарушение слуха пациента.
  • Ионизирующая радиационная терапия: При назначении ионизирующей радиационной терапии необходимо тщательно взвесить возможный риск повреждения импланта и потенциальный медицинский эффект от такой терапии.
  • Магнитно-резонансная томография (МРТ, MRI): Пациентам, имплантированным системой VIBRANT SOUNDBRIDGE (VORP 502x), исследование МРТ должно быть заменено на другое. Нельзя также находиться в комнате, где проводится исследование, вблизи самого МР томографа или других источников сильных магнитных полей.
  • Кардиостимуляция: Энергия, производимая во время кардиостимуляции, может вызвать повреждение импланта. Дефибрилляция не должна проводиться вблизи импланта
  • Другое: Эффекты, оказываемые на имплант кобальтовой терапией, PET сканированием, транскраниальной ультразвуковой диагностикой, техникой линейного ускорения, пока не изучены. Рекомендуется следовать инструкциям хирурга относительно размещения ложа импланта и соединительного кабеля. Не рекомендуется применение вышеперечисленных методик в области импланта.
Изделия, способы применения и эксплуатационные характеристики подлежат утверждению компетентными государственными органами; некоторые функциональные возможности могут быть недоступны в текущий момент или не продаваться компанией MED-EL в вашем регионе. Для получения дополнительной информации обратитесь к представителю MED-EL в своем регионе. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Azerbaijan

Middle Ear Implant - VORP 503

Русский

Импланты среднего уха - VORP 503

Взаимодействие с другими устройствами

  • Электрохирургия: Генерируемые электрохирургическими инструментами высокочастотные напряжения могут привести к прямому соединению между инструментом и имплантом. Монополярные электрохирургические инструменты не должны применяться в непосредственной близости от импланта. Индуцируемые ими токи могут привести к повреждению импланта или слуха пациента.
  • Хирургическая диатермия: Диатермию никогда нельзя применять поверх импланта, поскольку индуцированные в импланте сильные токи могут привести к повреждению импланта или слуха пациента.
  • Ионизирующее излучение: Лучевая терапия до суммарной ионизационной дозы 100 Грей, а также медицинские диагностические процедуры с использованием источников ионизирующего излучения, такие как рентгенография, КТ и ПЭТ, не наносят вреда импланту. Рекомендуется не надевать аудиопроцессор во время облучения.
  • Ультразвук: Воздействие клинически применимого диагностического ультразвука не вызывает каких-либо повреждений импланта.
  • Кардиостимуляция: Энергия, индуцируемая во время кардиостимуляции, может вызвать повреждение импланта. Дефибрилляцию не следует применять на устройстве или в непосредственной близости от него.
  • Монополярная электрокоагуляция, терапевтический ультразвук, транскраниальная магнитная стимуляция, электрошоковая терапия: Никогда не следует применять непосредственно поверх импланта, так как эти процедуры могут повредить имплант.
  • Магнитно-резонансная томография (МРТ): МРТ-обследование при наличии VORP 503 допустимо только в закрытом (туннельном) МРТ-сканере с 1,5 Тесла (T). Необходимо учитывать следующие условия:
    • МРТ-сканер следует ограничить режимом «Нормальный рабочий режим». Режима «Рабочий режим первого уровня» нужно избегать.
    • Локальные передающие РЧ-катушки нельзя использовать в области головы и шеи. Локальные приемные катушки не ограничены в использовании.
    • Прежде чем пациент войдет в кабинет МРТ, ему следует снять с головы аудиопроцессор. Во время сканирования могут возникать звуковые помехи. Пациента нужно предупредить о том, что он должен сигнализировать о каком-либо могущем возникнуть дискомфорте и, если необходимо, попросить о прекращении МРТ. По окончании МРТ-обследования пациент может снова надеть аудиопроцессор только после того, как покинет кабинет МРТ.
    • Во время МРТ-обследования голову следует держать прямо.
    • На изображениях вокруг имплантата на расстоянии прибл. 14 см будут присутствовать артефакты.
    • MРТ-обследования с величиной магнитной индукции >1,5 T повреждают имплант; их следует избегать.
    • Если некое МРТ-обследование необходимо до первого включения Vibrant Soundbridge, следует предпринять меры безопасности с тем, чтобы предотвратить осложнения с заживлением раны из-за возможного смещения импланта в сильном поле МР.
    • Если необходимо произвести обследование нижних конечностей, рекомендуется (но не требуется) в первую очередь поместить в сканер голени пациента.
       
  • Системы сигнализации и металлодетекторы: Коммерческие охранные системы и металлодетекторы производят сильные электромагнитные поля. Пациенты с имплантами должны быть предупреждены, что прохождение через охранные металлодетекторы может активировать сигнал тревоги. Из этих соображений пациентам рекомендуется постоянно носить при себе идентификационную карту пользователя Vibrant Soundbridge.
Изделия, способы применения и эксплуатационные характеристики подлежат утверждению компетентными государственными органами; некоторые функциональные возможности могут быть недоступны в текущий момент или не продаваться компанией MED-EL в вашем регионе. Для получения дополнительной информации обратитесь к представителю MED-EL в своем регионе. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Bahamas

Cochlear and Auditory Brainstem Implant System

English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Bahamas

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Bahamas

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Bahamas

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Bahrain

Cochlear and Auditory Brainstem Implant System

العربية

الإجراءات الطبية الخاصة بأنظمة غرسات MED‑EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Bahrain

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Bahrain

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Bahrain

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Bangladesh

Cochlear and Auditory Brainstem Implant System

English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Bangladesh

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Bangladesh

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Bangladesh

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Belarus

Cochlear and Auditory Brainstem Implant System

Русский

Проведение медицинских процедур у пользователей систем имплантации MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Belarus

Bone Conduction Implant - BCI 601

Русский

Импланты костной проводимости - BCI 601

Взаимодействие с другими устройствами

  • Хирургическая диатермия: Генерируемые электрохирургическими инструментами высокочастотные токи могут привести к замыканию между инструментом и имплантом. Монополярные электрохирургические инструменты не должны применяться вблизи импланта, так как индуцируемые ими токи могут повредить имплант или слух пациента.
  • Лучевая терапия: Лучевая терапия не повреждает имплант. Рекомендуется снять аудиопроцессор с головы и отложить егов сторону во время облучения.
  • Рентген, компьютерная томография, лечение кобальтом, позитронно-эмиссионная томография, диагностический ультразвук: При клиническом использовании ограничения отсутствуют.
  • Монополярная электрокоагуляция, терапевтический ультразвук, транскраниальная магнитная стимуляция, электрошоковая терапия: Никогда нельзя использовать непосредственно вблизи импланта, так как это может его повредить.
  • Магнитно-резонансная томография (МРТ): Пациентам, имплантированным системой Bonebridge разрешены MРТ-обследования до 1,5 T. Следует соблюдать следующие условия:
    • Аудиопроцессор должен быть снят с головы, но даже после этого могут появляться слуховые ощущения.
    • На полученных изображениях будет наблюдаться артефакт 15 см вокруг импланта.
    • MРТ-обследования с величиной магнитной индукции >1,5 T повреждают имплант и их следует избегать.
Изделия, способы применения и эксплуатационные характеристики подлежат утверждению компетентными государственными органами; некоторые функциональные возможности могут быть недоступны в текущий момент или не продаваться компанией MED-EL в вашем регионе. Для получения дополнительной информации обратитесь к представителю MED-EL в своем регионе. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Belarus

Middle Ear Implant - VORP 502

Русский

Импланты среднего уха - VORP 502

Взаимодействие с другими устройствами

  • Электрохирургия: Электрохирургические инструменты способны производить радиочастотные токи, которые могут вызвать замыкание между инструментом и имплантом. Монополярные электрохирургические инструменты не должны использоваться вблизи от импланта, так как индуцируемый ими ток может повредить имплант или слух пациента.
  • Диатермия: Диатермия не должна применяться к пациентам, носящим имплант, потому что индуцируемый ей ток может повредить имплант или слух пациента.
  • Электрошоковая терапия: Электрошоковая терапия не должна применяться к пациентам, использующим SOUNDBRIDGE так как она может вызвать повреждение импланта или нарушение слуха пациента.
  • Ионизирующая радиационная терапия: При назначении ионизирующей радиационной терапии необходимо тщательно взвесить возможный риск повреждения импланта и потенциальный медицинский эффект от такой терапии.
  • Магнитно-резонансная томография (МРТ, MRI): Пациентам, имплантированным системой VIBRANT SOUNDBRIDGE (VORP 502x), исследование МРТ должно быть заменено на другое. Нельзя также находиться в комнате, где проводится исследование, вблизи самого МР томографа или других источников сильных магнитных полей.
  • Кардиостимуляция: Энергия, производимая во время кардиостимуляции, может вызвать повреждение импланта. Дефибрилляция не должна проводиться вблизи импланта
  • Другое: Эффекты, оказываемые на имплант кобальтовой терапией, PET сканированием, транскраниальной ультразвуковой диагностикой, техникой линейного ускорения, пока не изучены. Рекомендуется следовать инструкциям хирурга относительно размещения ложа импланта и соединительного кабеля. Не рекомендуется применение вышеперечисленных методик в области импланта.
Изделия, способы применения и эксплуатационные характеристики подлежат утверждению компетентными государственными органами; некоторые функциональные возможности могут быть недоступны в текущий момент или не продаваться компанией MED-EL в вашем регионе. Для получения дополнительной информации обратитесь к представителю MED-EL в своем регионе. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Belarus

Middle Ear Implant - VORP 503

Русский

Импланты среднего уха - VORP 503

Взаимодействие с другими устройствами

  • Электрохирургия: Генерируемые электрохирургическими инструментами высокочастотные напряжения могут привести к прямому соединению между инструментом и имплантом. Монополярные электрохирургические инструменты не должны применяться в непосредственной близости от импланта. Индуцируемые ими токи могут привести к повреждению импланта или слуха пациента.
  • Хирургическая диатермия: Диатермию никогда нельзя применять поверх импланта, поскольку индуцированные в импланте сильные токи могут привести к повреждению импланта или слуха пациента.
  • Ионизирующее излучение: Лучевая терапия до суммарной ионизационной дозы 100 Грей, а также медицинские диагностические процедуры с использованием источников ионизирующего излучения, такие как рентгенография, КТ и ПЭТ, не наносят вреда импланту. Рекомендуется не надевать аудиопроцессор во время облучения.
  • Ультразвук: Воздействие клинически применимого диагностического ультразвука не вызывает каких-либо повреждений импланта.
  • Кардиостимуляция: Энергия, индуцируемая во время кардиостимуляции, может вызвать повреждение импланта. Дефибрилляцию не следует применять на устройстве или в непосредственной близости от него.
  • Монополярная электрокоагуляция, терапевтический ультразвук, транскраниальная магнитная стимуляция, электрошоковая терапия: Никогда не следует применять непосредственно поверх импланта, так как эти процедуры могут повредить имплант.
  • Магнитно-резонансная томография (МРТ): МРТ-обследование при наличии VORP 503 допустимо только в закрытом (туннельном) МРТ-сканере с 1,5 Тесла (T). Необходимо учитывать следующие условия:
    • МРТ-сканер следует ограничить режимом «Нормальный рабочий режим». Режима «Рабочий режим первого уровня» нужно избегать.
    • Локальные передающие РЧ-катушки нельзя использовать в области головы и шеи. Локальные приемные катушки не ограничены в использовании.
    • Прежде чем пациент войдет в кабинет МРТ, ему следует снять с головы аудиопроцессор. Во время сканирования могут возникать звуковые помехи. Пациента нужно предупредить о том, что он должен сигнализировать о каком-либо могущем возникнуть дискомфорте и, если необходимо, попросить о прекращении МРТ. По окончании МРТ-обследования пациент может снова надеть аудиопроцессор только после того, как покинет кабинет МРТ.
    • Во время МРТ-обследования голову следует держать прямо.
    • На изображениях вокруг имплантата на расстоянии прибл. 14 см будут присутствовать артефакты.
    • MРТ-обследования с величиной магнитной индукции >1,5 T повреждают имплант; их следует избегать.
    • Если некое МРТ-обследование необходимо до первого включения Vibrant Soundbridge, следует предпринять меры безопасности с тем, чтобы предотвратить осложнения с заживлением раны из-за возможного смещения импланта в сильном поле МР.
    • Если необходимо произвести обследование нижних конечностей, рекомендуется (но не требуется) в первую очередь поместить в сканер голени пациента.
       
  • Системы сигнализации и металлодетекторы: Коммерческие охранные системы и металлодетекторы производят сильные электромагнитные поля. Пациенты с имплантами должны быть предупреждены, что прохождение через охранные металлодетекторы может активировать сигнал тревоги. Из этих соображений пациентам рекомендуется постоянно носить при себе идентификационную карту пользователя Vibrant Soundbridge.
Изделия, способы применения и эксплуатационные характеристики подлежат утверждению компетентными государственными органами; некоторые функциональные возможности могут быть недоступны в текущий момент или не продаваться компанией MED-EL в вашем регионе. Для получения дополнительной информации обратитесь к представителю MED-EL в своем регионе. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Belgium

Cochlear and Auditory Brainstem Implant System

Deutsch / Français / Nederlands

Medizinische Behandlungen bei MED-EL Implantatsystemen

ManualMRI ChecklistMRT Sicherheitsstatus im Überblick
Deutsch / Français / Nederlands

Procédures médicales pour les systèmes d'implant MED-EL

ManualMRI ChecklistMRT Sicherheitsstatus im Überblick
Deutsch / Français / Nederlands

Medische procedures voor MED-EL-implantaatsystemen

Manual MRI ChecklistMRT Sicherheitsstatus im Überblick
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Belgium

Bone Conduction Implant - BCI 601

Deutsch

Knochenleitungsimplantat - BCI 601

Wechselwirkung mit anderen Geräten

  • Chirurgische Diathermie: Durch elektrochirurgische Instrumente erzeugte hochfrequente Spannungen können zu einer direkten Kopplung zwischen Instrument und Implantat führen. Monopolare elektrochirurgische Instrumente dürfen in der Nähe des Implantats nicht verwendet werden. Die induzierten Ströme könnten das Implantat oder das Hörvermögen des Patienten schädigen.
  • Strahlentherapie: Strahlentherapie schädigt das Implantat nicht. Es wird empfohlen, den Audioprozessor während der Bestrahlung abzulegen.
  • Röntgen, CT, Kobaltbehandlung, PET-Scan, diagnostischer Ultraschall: Keine Einschränkung bei klinischen Bestrahlungen.
  • Monopolare Elektrokauterisation, therapeutischer Ultraschall, transkranielle Magnetstimulation, Elektroschocktherapie: Darf nie direkt über dem Implantat eingesetzt werden, da dies das Implantat schädigen könnte.
  • Magnetresonanztomographie (MRT): MRT-Untersuchungen bis zu 1,5 T sind bei der Bonebridge erlaubt. Folgende Bedingungen sind zu beachten:
    • Der Audioprozessor soll nicht getragen werden, trotzdem kann es zu Hörempfindungen kommen.
    • Ein Artefakt von 15 cm rund um das Implantat wird auf den Bildern zu sehen sein.
    • MRT-Untersuchungen mit >1,5 T schädigen das Implantat und sind zu vermeiden.
Die Produkte, Anwendungen und Leistungscharakteristiken unterliegen der Zulassung der zuständigen nationalen Behörden; manche Bestandteile stehen derzeit möglicherweise in Ihrem Land nicht zur Verfügung oder werden von MED-EL nicht in Ihrem Land zum Verkauf angeboten. Bitte kontaktieren Sie Ihren persönlichen MED-EL Ansprechpartner für weitere Informationen. MRI Info SheetMRI ChecklistMRT Sicherheitsstatus im Überblick
Français

Implants à conduction osseuse - BCI 601

Interférences avec d'autres équipements

  • Diathermie chirurgicale : Les instruments électrochirurgicaux peuvent produire des rayonnements haute fréquence pouvant induire des effets de couplage direct entre l'instrument et l'implant. Ne pas utiliser d'instruments électrochirurgicaux monopolaires à proximité de l'implant. Les courants induits peuvent endommager l'implant ou les capacités auditives du patient.
  • Thérapie par rayonnement ionisant : La thérapie par rayonnement ionisant n'a pas d'effet dommageable sur l'implant. Il est recommandé de ne pas porter l’audio processeur durant l'irradiation.
  • Rayons X, scanner, traitement au cobalt, scanner TEP, diagnostic aux ultrasons : Aucune restriction dans la limite des expositions cliniquement utiles.
  • Bistouri électrique monopolaire, ultrasons thérapeutiques, stimulation magnétique transcrânienne, thérapie électroconvulsive : Ne jamais appliquer directement sur l'implant, ces procédures pouvant l'endommager.
  • Imagerie par résonance magnétique (IRM) : Examen par IRM jusqu'à 1,5 T possible avec le Bonebridge. Conditions à prendre en compte:
    • Ne pas porter l’audio processeur, mais possibilité d'interférences auditives.
    • Présence d'un artefact de 15 cm autour de l'implant sur les images.
    • Examen IRM avec >1,5 T : implant endommagé, situation à éviter.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Nederlands

Beengeleidingsimplantaat - BCI 601

Wisselwerking met andere apparaten

  • Chirurgische diathermie: Door elektrochirurgische instrumenten gegenereerde hoogfrequente spanningen kunnen leiden tot een rechtstreekse koppeling tussen het instrument en het implantaat. Monopolaire elektrochirurgische instrumenten mogen niet worden gebruikt in de nabijheid van het implantaat. De geïnduceerde stromen kunnen het implantaat of het hoorvermogen van de patiënt beschadigen.
  • Radiotherapie: Radiotherapie is niet schadelijk voor het implantaat. Het verdient aanbeveling de audioprocessor tijdens de bestraling af te doen.
  • Röntgen, CT, kobaltbehandeling, PET-scan, diagnostisch ultrasoon onderzoek: Geen beperking bij klinische bestralingen.
  • Monopolaire elektrocauterisatie, therapeutische ultrasoontherapie, transcraniële magnetische stimulatie, elektroshocktherapie: Mag nooit direct boven het implantaat worden gebruikt, omdat het implantaat hierdoor beschadigd kan raken.
  • Magnetic Resonance Imaging (MRI): MRI-onderzoeken tot maximaal 1,5 T zijn bij de Bonebridge toegestaan. De volgende voorwaarden moeten in acht worden genomen:
    • De audioprocessor mag niet gedragen worden, hoorbare interferentie blijft echter mogelijk.
    • Op de beelden zal een artefact van 15 cm rondom het implantaat zichtbaar zijn.
    • MRI-onderzoeken met >1,5 T beschadigen het implantaat en dienen te worden vermeden.
De producten, toepassingen en prestatiekarakteristiekenmoeten worden goedgekeurd door de nationale bevoegde autoriteiten. Sommige functies zijn momenteel mogelijk niet beschikbaar of worden niet door MED-EL in uw regio verkocht. Neem contact op met uw lokale MED-EL-vertegenwoordiger voor meer informatie. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Belgium

Middle Ear Implant - VORP 502

Deutsch

Mittelohrimplantate - VORP 502

Wechselwirkung mit anderen Geräten

  • Elektrochirurgie: Elektrochirurgische Instrumente können hochfrequente Spannungen erzeugen, die von der Spitze des Instruments direkt auf das Implantat überspringen können. In der Nähe des Implantats dürfen monopolare elektrochirurgische Instrumente nicht verwendet werden, da der von ihnen erzeugte Strom das Implantat beschädigen und das Gehör des Patienten beeinträchtigen kann.
  • Diathermie: Diathermie darf niemals über dem Implantat durchgeführt werden, da der starke, in das Implantat induzierte Strom das Implantat beschädigen und das Gehör des Patienten beeinträchtigen kann.
  • Elektroschocktherapie: Elektroschocktherapie darf an Patienten mit einer VIBRANT SOUNDBRIDGE nicht durchgeführt werden, da dadurch das Implantat beschädigt und das Gehör des Patienten beeinträchtigt werden kann.
  • Therapie mit ionisierender Strahlung: Notwendige Therapien mit ionisierender Strahlung sind genau zu prüfen und das Risiko einer Beschädigung des VORP Implantats sorgfältig gegen den Nutzen einer solchen Behandlung abzuwägen.
  • Magnetresonanztomographie (MRT): Patienten mit einer VIBRANT SOUNDBRIDGE (VORP 502x) sollten nicht mit MRT untersucht werden und sollten keinen MRT-Raum betreten oder sich in der Nähe anderer Quellen mit starken magnetischen Feldern aufhalten.
  • Kardioversion: Die während der Kardioversion erzeugte Energie kann Schäden am Implantat hervorrufen. Am oder in der Nähe des Implantats sollte keine Defibrillierung vorgenommen werden.
  • Sonstiges: Die Auswirkungen von Kobaltbehandlungen, PET Scans, diagnostischem und therapeutischem Ultraschall und Linearbeschleunigerverfahren in der Nähe des Implantats sind nicht bekannt. Solche Behandlungen sollten in der Nähe des Implantats vermieden werden.
Die Produkte, Anwendungen und Leistungscharakteristiken unterliegen der Zulassung der zuständigen nationalen Behörden; manche Bestandteile stehen derzeit möglicherweise in Ihrem Land nicht zur Verfügung oder werden von MED-EL nicht in Ihrem Land zum Verkauf angeboten. Bitte kontaktieren Sie Ihren persönlichen MED-EL Ansprechpartner für weitere Informationen. MRT Sicherheitsstatus im Überblick
Français

Implants d'Oreille Moyenne - VORP 502

Interférences avec d'autres équipements

  • Electrochirurgie : Les instruments électrochirurgicaux sont susceptibles de produire des ondes de radiofréquence pouvant directement coupler l’extrémité de l’instrument et l’implant. Les instruments chirurgicaux monopolaires ne doivent pas être utilisés à proximité de l’implant en raison des courants induits qui peuvent endommager l’implant ou diminuer le seuil auditif du patient.
  • Diathermie : Ne procédez jamais à une diathermie sur l’implant dans la mesure où les courants élevés induits dans l’implant risquent de d’endommager ou d’aggraver la surdité du patient.
  • Electrochoc : Ne procédez jamais un électrochoc sur un patient qui porte un SOUNDBRIDGE car ceci pourrait endommager l’implant ou diminuer le seuil auditif du patient.
  • Thérapie par rayonnement ionisant : La thérapie par rayonnement ionisant doit être envisagée avec prudence et le risque de dommage à l’implant VORP doit être considéré par rapport au gain médical potentiel de cette thérapie.
  • Imagerie par résonance magnétique (I.R.M.) : les patients porteurs du VIBRANT SOUNDBRIDGE (VORP 502x) ne doivent pas être exposés à des I.R.M. et ne doivent pas pénétrer dans une salle d’I.R.M. ni se tenir à proximité de champs magnétiques puissants.
  • Cardioversion : L’énergie induite en cours de la cardioversion risque d’endommager l’implant. Aucune défibrillation ne doit être appliquée sur ou à proximité de l’implant.
  • Divers : Les effets du traitement au cobalt, de la tomographie d’émission de positons (PET scan), de l’échographie transcranienne et des techniques d’accélération linéaire sur l’implant sont inconnus. L’utilisation de ces techniques proches de l’implant doit être évitée.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Safety Status Overview
Nederlands

Middenoorimplantaten - VORP 502

Wisselwerking met andere apparaten

  • Electrochirurgie: Electrochirurgische instrumenten kunnen een elektrische veldsterkte opwekken waardoor de tip van het instrument direct kan worden gekoppeld met het implantaat. Monopolaire electrochirurgische instrumenten mogen niet worden gebruikt in de nabijheid van het implantaat, omdat de geïnduceerde stroom schade kan veroorzaken aan het implantaat of aan het gehoor van de patiënt.
  • Diathermie: Diathermie mag nooit worden toegepast ter hoogte van het implantaat omdat de hoge stroomsterktes die het implantaat in kunnen lopen het implantaat of het gehoor van de patiënt kunnen beschadigen.
  • Electroconvulsietherapie: Electroconvulsietherapie mag niet worden toegepast bij een patiënt met een SOUNDBRIDGE omdat dit het implantaat of het gehoor van de patiënt kan beschadigen.
  • Ioniserende bestralingstherapie: Ioniserende bestralingstherapie dient zorgvuldig te worden overwogen en het risico op schade aan het implantaat dient te worden afgezet tegen de medische baten van deze therapie.
  • Magnetic Resonance Imaging (MRI): Patiënten met een VIBRANT SOUNDBRIDGE (VORP 502x) mogen niet worden onderzocht m.b.v. MRI en niet de onderzoeksruimte van de MRI-scan betreden of in de nabijheid komen van andere bronnen met sterke magnetische velden.
  • Cardioversie: de energie die wordt opgewekt tijdens cardioversie kan schade berokkenen aan het implantaat. Defibrilatie mag niet worden toegepast op of bij het implantaat.
  • Overige: De effecten van kobaltbehandeling, PET scans, diagnostische ultrasound en lineaire versnellingstechnieken in de nabijheid van het implantaat zijn niet bekend. Het gebruik hiervan in de nabijheid van het implantaat dient daarom te worden vermeden.
De producten, toepassingen en prestatiekarakteristiekenmoeten worden goedgekeurd door de nationale bevoegde autoriteiten. Sommige functies zijn momenteel mogelijk niet beschikbaar of worden niet door MED-EL in uw regio verkocht. Neem contact op met uw lokale MED-EL-vertegenwoordiger voor meer informatie. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Belgium

Middle Ear Implant - VORP 503

Deutsch

Mittelohrimplantate - VORP 503

Beeinflussung durch andere Geräte

  • Elektrochirurgie: Elektrochirurgische Instrumente können hochfrequente Spannungen erzeugen, die von dem Instrument direkt auf das Implantat überspringen können. In der Nähe des Implantats dürfen monopolare elektrochirurgische Instrumente nicht verwendet werden. Die induzierten Ströme könnten das Implantat oder das Hörvermögen des Patienten schädigen.
  • Chirurgische Diathermie: Diathermie darf niemals über dem Implantat durchgeführt werden, da der starke, in das Implantat induzierte Strom das Implantat beschädigen und das Gehör des Patienten beeinträchtigen kann.
  • Ionisierende Strahlung: Strahlentherapie bis zu einer Gesamtstrahlendosis von 100 Gray sowie medizinische Diagnoseverfahren mithilfe von ionisierender Strahlung (wie Röntgen, CT und PET) schädigen das Implantat nicht. Es wird empfohlen, den Audioprozessor während einer Bestrahlung abzulegen.
  • Ultraschall: Einwirkungen von klinischem Diagnoseultraschall beschädigen nicht das Implantat.
  • Kardioversion: Die während einer Kardioversion erzeugte Energie könnte Schäden am Implantat hervorrufen. Am oder in der Nähe des Gerätes sollte keine Defibrillierung vorgenommen werden.
  • Monopolare Elektrokauterisation, therapeutischer Ultraschall, transkranielle magnetische Stimulation, elektrokonvulsive Therapie: Darf nie direkt über dem Implantat eingesetzt werden, da dies das Implantat schädigen könnte.
  • Magnetresonanztomographie (MRT): Eine MRT-Untersuchung bei einem Träger des VORP 503 ist nur mit einem geschlossenen MRT-Scanner bei 1,5 Tesla (T) zulässig. Folgende Bedingungen müssen beachtet werden:
    • Der MRT-Scanner muss auf den normalen Betriebsmodus beschränkt werden. Der Betriebsmodus der Stufe 1 muss vermieden werden.
    • Lokale übertragende HF-Spulen dürfen nicht in der Kopf- oder Nackenregion verwendet werden. Lokale Empfängerspulen können ohne Einschränkung verwendet werden.
    • Patienten müssen den Audioprozessor vom Kopf abnehmen, bevor sie einen MRT-Raum betreten. Während des Scans können hörbare Interferenzen entstehen. Patienten müssen angewiesen werden, jegliches Unwohlsein sofort zu melden, um das MRT gegebenenfalls zu beenden. Nach der MRT-Untersuchung darf der Patient den Audioprozessor erst anlegen, wenn er den MRT-Raum verlassen hat.
    • Während der MRT-Untersuchung muss der Kopf gerade gehalten werden.
    • Auf den Bildern wird ein Artefakt von etwa 14 cm um das Implantat zu sehen sein.
    • Eine MRT-Untersuchung mit mehr als 1,5 T beschädigt das Implantat und muss vermieden werden.
    • Falls vor der ersten Aktivierung der Vibrant Soundbridge eine MRT-Untersuchung notwendig ist, müssen Sicherheitsmaßnahmen getroffen werden, um Komplikationen bei der Wundheilung aufgrund der möglichen Bewegung des Implantats im starken MR-Feld zu vermeiden.
    • Wenn die unteren Extremitäten untersucht werden, wird empfohlen, dass die Beine des Patienten zuerst in den Scanner geschoben werden.
  • Diebstahlsicherung und Metalldetektoren: Kommerzielle Diebstahlsicherungen und Metalldetektoren erzeugen starke elektromagnetische Felder. Patienten mit einem Implantat müssen darauf hingewiesen werden, dass beim Passieren eines Sicherheitsmetalldetektors der Alarm ausgelöst werden könnte. Aus diesem Grund wird empfohlen, dass Patienten immer ihre Vibrant Soundbridge Benutzer-Identifikationskarte mit sich führen. 
Die Produkte, Anwendungen und Leistungscharakteristiken unterliegen der Zulassung der zuständigen nationalen Behörden; manche Bestandteile stehen derzeit möglicherweise in Ihrem Land nicht zur Verfügung oder werden von MED-EL nicht in Ihrem Land zum Verkauf angeboten. Bitte kontaktieren Sie Ihren persönlichen MED-EL Ansprechpartner für weitere Informationen. MRI Info SheetMRI ChecklisteMRT Sicherheitsstatus im Überblick
Français

Implants d'Oreille Moyenne - VORP 503

Interférences avec les autres équipements

  • Électrochirurgie : Les instruments électrochirurgicaux peuvent produire des tensions de radio fréquence qui peuvent donner lieu à un couplage entre l'instrument et l'implant. Des instruments électrochirurgicaux monopolaires ne doivent pas être utilisés à proximité de l'implant. Les courants induits entraînent des dommages à l'implant ou au niveau de l'audition du patient.
  • Diathermie chirurgicale : Une diathermie ne doit jamais être appliquée au-dessus de l'implant car les courants élevés induits dans l'implant peuvent entraîner des dommages à l'implant ou au niveau de l'audition du patient.
  • Rayonnements ionisants : Une radiothérapie jusqu'à une dose totale d'ionisation de 100 Gray ainsi que des procédures de diagnostic médical utilisant des rayonnements ionisants, telles que les radiographies, TDM et TEP, ne sont pas nocives pour l'implant. Il est recommandé toutefois de ne pas porter l'audio processeur durant une irradiation.
  • Échographie : Les expositions à une échographie diagnostique utile sur le plan clinique ne causent aucun dommage à l'implant.
  • Cardioversion: L'énergie induite au cours d'une cardioversion peut endommager l'implant. Il ne faut pas pratiquer de défibrillation au-dessus ou près du dispositif.
  • Électrocautérisation monopolaire, échographie thérapeutique, stimulation magnétique transcrânienne, thérapie par électrochocs : Ne doivent jamais être appliquées au-dessus de l'implant car ces procédures peuvent endommager l'implant.
  • Imagerie par résonance magnétique (IRM) : L'examen IRM avec le VORP 503 n'est autorisé que dans le cas d'une utilisation de scanners IRM à ouverture fermée de 1,5 Tesla (T). Il est nécessaire de tenir compte des conditions suivantes :
    • Le scanner IRM doit être limité au « Mode opératoire normal » ; le « Mode opératoire de premier niveau » doit être évité.
    • Les bobines RF de transmission locale ne doivent pas être utilisées dans la région du cou et de la tête. L'utilisation des bobines réceptrices locales n'est pas restreinte.
    • Avant que le patient entre dans la pièce de l'appareil IRM, l'audio processeur doit être retiré de la tête. Une interférence audible peut se produire pendant la procédure suppress. Les patients doivent être conseillés d'indiquer toute gêne éventuelle pouvant se faire ressentir et de demander à ce que la procédure IRM soit interrompue si nécessaire. Après l'examen IRM, le patient ne doit remettre l'audio processeur qu'une fois sorti de la pièce de l'appareil IRM.
    • Au cours de l'examen IRM, il est requis que la tête soit maintenue droite.
    • Un artéfact d'environ 14 cm autour de l'implant sera présent sur les images.
    • Un examen IRM à > 1,5 T endommagera l'implant et doit être évité.
    • Si un examen IRM est nécessaire avant la première activation du système Vibrant Soundbridge, les mesures de sécurité doivent être prises en compte pour prévenir toute complication de la cicatrisation de la plaie due à l'éventuel mouvement de l'implant sous l'influence d'un fort champ magnétique RM.
    • Lorsque les membres inférieurs doivent être examinés, il est recommandé, mais pas exigé, que les jambes du patient soient introduites en premier dans le l'IRM.
  • Systèmes antivol et de détection de métal : Les systèmes de détection antivol et les détecteurs de métaux produisent de forts champs électromagnétiques. Les patients portant un implant doivent être informés que le passage à travers des portiques détecteurs de métaux peut activer l'alarme du détecteur. C'est pour cette raison qu'il est recommandé aux patients de porter sur eux en permanence leur carte d'identification d'utilisateur du système Vibrant Soundbridge.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Nederlands

Middenoorimplantaten - VORP 503

Interferentie van andere apparatuur

  • Elektrochirurgie: Elektrochirurgische instrumenten kunnen hoogfreqente spanningen voortbrengen die direct van het instrument kunnen overspringen op het implantaat. Monopolaire elektrochirurgische instrumenten mogen niet in de directe omgeving van het implantaat worden gebruikt. De geïnduceerde elektrische stromen zouden het implantaat of het gehoor van de patiënt kunnen beschadigen.
  • Chirurgische diathermie: Er mag in geen geval diathermie op het implantaat worden toegepast, omdat de hoge, in het implantaat geïnduceerde, stroomsterktes het implantaat of het gehoor van de patiënt zouden kunnen beschadigen.
  • Ioniserende straling: Radiotherapie tot een totale ionisatiedosis van 100 Gray, evenals medisch-diagnostisch onderzoek waarbij gebruik wordt gemaakt van ioniserende straling zoals röntgen, CT en PET, veroorzaakt geen schade aan het implantaat. Aanbevolen wordt om tijdens bestraling de audioprocessor niet te dragen.
  • Echografie: Echografie is niet schadelijk voor het implantaat.
  • Cardioversie: De energie die tijdens een cardioversie wordt geïnduceerd, kan het implantaat beschadigen.
    Op of in de nabijheid van het implantaat mag geen defibrillatie worden toegepast.
  • Monopolaire elektrochirurgie, therapeutische ultrasoonbehandeling, transcraniële magnetische stimulatie, elektroconvulsieve therapie: Deze behandelingen mogen in geen geval rechtstreeks boven het implantaat worden toegepast omdat daardoor het implantaat kan worden beschadigd.
  • Magnetic Resonance Imaging (MRI): Een MRI-onderzoek met de VORP 503 is uitsluitend toegestaan in 1,5 Tesla (T) MRI-scanners met een gesloten buis. Er dient rekening te worden gehouden met de volgende voorwaarden:
    • De MRI-scanner mag uitsluitend in de "Normale bedrijfsmodus" worden gebruikt, de "Eerste niveau bedrijfsmodus" dient te worden vermeden.
    • Lokaal zendende RF-spoelen mogen niet in het hoofd-nekgebied worden gebruikt. Er is geen beperking voor locale ontvangstspoelen.
    • Voordat de patiënten de MRI-ruimte binnengaan moet de audioprocessor van het hoofd worden genomen. Tijdens de scan kan hoorbare interferentie optreden. De patiënt moet worden geïnstrueerd om enig mogelijk ongemak te melden en indien nodig te vragen of de MRI kan worden afgebroken. Na het MRI-onderzoek mag de patiënt de audioprocessor pas na het verlaten van de MRI-ruimte weer opzetten.
    • Tijdens de MRI-scan moet het hoofd zo recht mogelijk worden gehouden.
    • Op de afbeelding is een artefact van ongeveer 14 cm rondom het implantaat zichtbaar.
    • Een MRI-onderzoek van >1,5 T beschadigt het implantaat en moet worden vermeden.
    • Is voorafgaande aan de eerste activering van de Vibrant Soundbridge een MRI-onderzoek noodzakelijk, dan moeten er veiligheidsmaatregelen worden genomen om complicaties bij de wondgenezing, als gevolg van mogelijke verplaatsing van het implantaat door het sterke MR-veld, te voorkomen.
    • Moeten er ook onderste ledematen worden onderzocht, dan wordt geadviseerd, maar dat is niet verplicht, dat de benen van de patiënt als eerste de scanner ingaan.
       
  • Diefstal- en metaaldetectiesystemen: Commerciële diefstaldetectiesystemen en metaaldetectors wekken sterke elektromagnetische velden op. Patiënten met een implantaat moeten erover worden geïnformeerd dat bij het passeren van een veiligheidsmetaaldetector het detectoralarm kan afgaan. Daarom is het raadzaam dat patiënten altijd hun Vibrant Soundbridge gebruikersidentificatiekaart bij zich hebben.
De producten, toepassingen en prestatiekarakteristiekenmoeten worden goedgekeurd door de nationale bevoegde autoriteiten. Sommige functies zijn momenteel mogelijk niet beschikbaar of worden niet door MED-EL in uw regio verkocht. Neem contact op met uw lokale MED-EL-vertegenwoordiger voor meer informatie. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Benin

Cochlear and Auditory Brainstem Implant System

Français

Procédures médicales pour les systèmes d'implant MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Benin

Bone Conduction Implant - BCI 601

Français

Implants à conduction osseuse - BCI 601

Interférences avec d'autres équipements

  • Diathermie chirurgicale : Les instruments électrochirurgicaux peuvent produire des rayonnements haute fréquence pouvant induire des effets de couplage direct entre l'instrument et l'implant. Ne pas utiliser d'instruments électrochirurgicaux monopolaires à proximité de l'implant. Les courants induits peuvent endommager l'implant ou les capacités auditives du patient.
  • Thérapie par rayonnement ionisant : La thérapie par rayonnement ionisant n'a pas d'effet dommageable sur l'implant. Il est recommandé de ne pas porter l’audio processeur durant l'irradiation.
  • Rayons X, scanner, traitement au cobalt, scanner TEP, diagnostic aux ultrasons : Aucune restriction dans la limite des expositions cliniquement utiles.
  • Bistouri électrique monopolaire, ultrasons thérapeutiques, stimulation magnétique transcrânienne, thérapie électroconvulsive : Ne jamais appliquer directement sur l'implant, ces procédures pouvant l'endommager.
  • Imagerie par résonance magnétique (IRM) : Examen par IRM jusqu'à 1,5 T possible avec le Bonebridge. Conditions à prendre en compte:
    • Ne pas porter l’audio processeur, mais possibilité d'interférences auditives.
    • Présence d'un artefact de 15 cm autour de l'implant sur les images.
    • Examen IRM avec >1,5 T : implant endommagé, situation à éviter.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Benin

Middle Ear Implant - VORP 502

Français

Implants d'Oreille Moyenne - VORP 502

Interférences avec d'autres équipements

  • Electrochirurgie : Les instruments électrochirurgicaux sont susceptibles de produire des ondes de radiofréquence pouvant directement coupler l’extrémité de l’instrument et l’implant. Les instruments chirurgicaux monopolaires ne doivent pas être utilisés à proximité de l’implant en raison des courants induits qui peuvent endommager l’implant ou diminuer le seuil auditif du patient.
  • Diathermie : Ne procédez jamais à une diathermie sur l’implant dans la mesure où les courants élevés induits dans l’implant risquent de d’endommager ou d’aggraver la surdité du patient.
  • Electrochoc : Ne procédez jamais un électrochoc sur un patient qui porte un SOUNDBRIDGE car ceci pourrait endommager l’implant ou diminuer le seuil auditif du patient.
  • Thérapie par rayonnement ionisant : La thérapie par rayonnement ionisant doit être envisagée avec prudence et le risque de dommage à l’implant VORP doit être considéré par rapport au gain médical potentiel de cette thérapie.
  • Imagerie par résonance magnétique (I.R.M.) : les patients porteurs du VIBRANT SOUNDBRIDGE (VORP 502x) ne doivent pas être exposés à des I.R.M. et ne doivent pas pénétrer dans une salle d’I.R.M. ni se tenir à proximité de champs magnétiques puissants.
  • Cardioversion : L’énergie induite en cours de la cardioversion risque d’endommager l’implant. Aucune défibrillation ne doit être appliquée sur ou à proximité de l’implant.
  • Divers : Les effets du traitement au cobalt, de la tomographie d’émission de positons (PET scan), de l’échographie transcranienne et des techniques d’accélération linéaire sur l’implant sont inconnus. L’utilisation de ces techniques proches de l’implant doit être évitée.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Benin

Middle Ear Implant - VORP 503

Français

Implants d'Oreille Moyenne - VORP 503

Interférences avec les autres équipements

  • Électrochirurgie : Les instruments électrochirurgicaux peuvent produire des tensions de radio fréquence qui peuvent donner lieu à un couplage entre l'instrument et l'implant. Des instruments électrochirurgicaux monopolaires ne doivent pas être utilisés à proximité de l'implant. Les courants induits entraînent des dommages à l'implant ou au niveau de l'audition du patient.
  • Diathermie chirurgicale : Une diathermie ne doit jamais être appliquée au-dessus de l'implant car les courants élevés induits dans l'implant peuvent entraîner des dommages à l'implant ou au niveau de l'audition du patient.
  • Rayonnements ionisants : Une radiothérapie jusqu'à une dose totale d'ionisation de 100 Gray ainsi que des procédures de diagnostic médical utilisant des rayonnements ionisants, telles que les radiographies, TDM et TEP, ne sont pas nocives pour l'implant. Il est recommandé toutefois de ne pas porter l'audio processeur durant une irradiation.
  • Échographie : Les expositions à une échographie diagnostique utile sur le plan clinique ne causent aucun dommage à l'implant.
  • Cardioversion: L'énergie induite au cours d'une cardioversion peut endommager l'implant. Il ne faut pas pratiquer de défibrillation au-dessus ou près du dispositif.
  • Électrocautérisation monopolaire, échographie thérapeutique, stimulation magnétique transcrânienne, thérapie par électrochocs : Ne doivent jamais être appliquées au-dessus de l'implant car ces procédures peuvent endommager l'implant.
  • Imagerie par résonance magnétique (IRM) : L'examen IRM avec le VORP 503 n'est autorisé que dans le cas d'une utilisation de scanners IRM à ouverture fermée de 1,5 Tesla (T). Il est nécessaire de tenir compte des conditions suivantes :
    • Le scanner IRM doit être limité au « Mode opératoire normal » ; le « Mode opératoire de premier niveau » doit être évité.
    • Les bobines RF de transmission locale ne doivent pas être utilisées dans la région du cou et de la tête. L'utilisation des bobines réceptrices locales n'est pas restreinte.
    • Avant que le patient entre dans la pièce de l'appareil IRM, l'audio processeur doit être retiré de la tête. Une interférence audible peut se produire pendant la procédure suppress. Les patients doivent être conseillés d'indiquer toute gêne éventuelle pouvant se faire ressentir et de demander à ce que la procédure IRM soit interrompue si nécessaire. Après l'examen IRM, le patient ne doit remettre l'audio processeur qu'une fois sorti de la pièce de l'appareil IRM.
    • Au cours de l'examen IRM, il est requis que la tête soit maintenue droite.
    • Un artéfact d'environ 14 cm autour de l'implant sera présent sur les images.
    • Un examen IRM à > 1,5 T endommagera l'implant et doit être évité.
    • Si un examen IRM est nécessaire avant la première activation du système Vibrant Soundbridge, les mesures de sécurité doivent être prises en compte pour prévenir toute complication de la cicatrisation de la plaie due à l'éventuel mouvement de l'implant sous l'influence d'un fort champ magnétique RM.
    • Lorsque les membres inférieurs doivent être examinés, il est recommandé, mais pas exigé, que les jambes du patient soient introduites en premier dans le l'IRM.
  • Systèmes antivol et de détection de métal : Les systèmes de détection antivol et les détecteurs de métaux produisent de forts champs électromagnétiques. Les patients portant un implant doivent être informés que le passage à travers des portiques détecteurs de métaux peut activer l'alarme du détecteur. C'est pour cette raison qu'il est recommandé aux patients de porter sur eux en permanence leur carte d'identification d'utilisateur du système Vibrant Soundbridge.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Bolivia

Cochlear and Auditory Brainstem Implant System

Español

Procedimientos médicos para Sistemas de implante MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Bolivia

Bone Conduction Implant - BCI 601

Español

Implantes de Conducción Ósea - BCI 601

Interferencias con otros dispositivos

  • Diatermia quirúrgica: El instrumental de electrocirugía puede producir voltajes de radiofrecuencia, que pueden resultar en el acoplamiento directo entre el instrumento y el implante. Queda prohibido emplear instrumental electroquirúrgico monopolar cerca del implante. Las corrientes inducidas podrían causar daños en el implante o en la audición del paciente.
  • Terapia de radiación ionizante: La radioterapia no daña el implante. Se recomienda no portar un procesador de audio durante la irradiación.
  • Rayos X, tomografía computarizada, tratamiento con cobalto, escáner PET, ultrasonido diagnóstico: No existen restricciones dentro de las exposiciones con fines clínicos.
  • Electrocauterio monopolar, ultrasonido terapéutico, estimulación magnética transcraneal, terapia electroconvulsiva: Queda prohibido aplicar directamente estos procedimientos sobre el implante, ya que podrían causar daños en el mismo.
  • Imagen por Resonancia Magnética (IRM): La evaluación por medio de IRM está permitida hasta 1,5 T con el Bonebridge. Tenga en cuenta las siguientes exigencias:
  • No se debe portar el procesador de audio. Aún así, es posible que surjan interferencias audibles.
  • Los escáneres presentarán un artefacto de 15 cm alrededor del implante.
  • Evite una evaluación con IRM >1,5 T, ya que dañaría el implante.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL.MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Bolivia

Middle Ear Implant - VORP 502

Español

Implantes de Oído Medio - VORP 502

Interferencias con otros dispositivos

  • Electrocirugía: Los instrumentos electroquirúrgicos pueden producir voltajes de radiofrecuencia que son capaces de acoplar el extremo del instrumento y el implante. Los instrumentos de cirugía monopolar no deben ser usados en el área próxima al implante debido a que inducen corrientes que pueden dañar el implante o la audición del paciente.
  • Diatermia: La diatermia no debe ser nunca aplicada sobre el implante debido a que las grandes corrientes que se inducen en el mismo lo pueden dañar o dañar la audición del paciente.
  • Terapia Electroconvulsiva: La terapia electroconvulsiva no debe ser usada nunca en un paciente con un Soundbridge debido a que puede dañar el implante o la audición del paciente.
  • Terapia de Radiación Ionizante: La terapia de radiación ionizante debe ser considerada cuidadosamente ante el riesgo de dañar el implante VORP. Debe ser sopesado el riesgo frente al beneficio médico de dicha terapia.
  • Resonancia Magnética (RMN): Los pacientes implantados con el VIBRANT SOUNDBRIDGE (VORP 502x) no deben ser sometidos a RMN y no deben entrar a una cabina de RMN o estar en las proximidades de otras fuentes de campos magnéticos potentes.
  • Cardioversión: La energía inducida durante la cardioversión puede dañar el implante. La desfibrilación no debe ser aplicada en o cerca del dispositivo.
  • Miscelánea: Los efectos del tratamiento de cobalto, PET, diagnóstico y terapia ultrasónica y técnicas de aceleración lineal en las proximidades del implante son desconocidas. Su uso en las zonas próximas al implante debe ser evitado.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Bolivia

Middle Ear Implant - VORP 503

Español

Implantes de Oído Medio - VORP 503

Interferencias con otros equipos

  • Electrocirugía: los instrumentos electroquirúrgicos pueden producir frecuencias de radio que pueden causar el acoplamiento entre el instrumento y el implante. No se deben utilizar instrumentos quirúrgicos monopolares en las proximidades del implante. La corriente de inducción podría dañar el implante y/o la audición del paciente.
  • Diatermia quirúrgica: nunca se debe aplicar diatermia sobre el implante porque la corriente inducida podría causar daños en el implante o en la audición del paciente.
  • Radiación ionizante: la terapia con radiación ionizante hasta una dosis de ionización total de 100 Gy, así como los procedimientos médicos diagnósticos que utilizan radiación ionizante, como los rayos X, TC y PET, no dañan el implante. No se recomienda llevar el procesador auditivo durante la radiación.
  • Ultrasonidos: la exposición a ultrasonidos de utilidad diagnóstica no causa daños en el implante.
  • Cardioversión: la energía inducida durante la cardioversión podría dañar el implante. No se debe aplicar desfibrilación sobre el dispositivo ni en sus proximidades.
  • Electrocauterización monopolar, ultrasonidos terapéuticos, estimulación magnética transcraneal, tratamiento electroconvulsivo: nunca deben aplicarse directamente sobre el implante porque pueden dañarlo.
  • Imágenes por resonancia magnética (IRM): el examen por IRM con VORP 503 solo se permite con escáneres IRM cerrados de 1,5 teslas (T). Deben tenerse en cuenta las siguientes condiciones:
    • El escáner MRI debe estar limitado a modo de operación normal; evite el modo de operación de primer nivel.
    • No utilice bobinas de RF de transmisión local en la región craneal o cervical. No se limita el uso de bobinas de recepción local.
    • Antes de que el paciente entre en la sala de IRM, el procesador auditivo debe retirarse de la cabeza. Durante el escáner pueden producirse interferencias audibles. Los pacientes deben estar informados de que tienen que comunicar cualquier posible molestia y solicitar que se interrumpa la prueba si es necesario. Después de la prueba, el paciente no se pondrá el procesador auditivo hasta salir de la sala de IRM.
    • Durante el examen con IRM, la cabeza debe mantenerse en posición recta.
    • Las imágenes mostrarán un artefacto de aproximadamente 14 cm alrededor del implante.
    • Los exámenes con IRM de más de 1,5 T causan daños en el implante y deben evitarse.
    • Si necesita un examen IRM antes de la primera activación de Vibrant Soundbridge, deberán tomarse medidas de seguridad para evitar complicaciones en la curación de la herida por posibles movimientos del implante dentro del potente campo de RM.
    • Para examinar las extremidades inferiores se recomienda, aunque no es imprescindible, que las piernas entren primero en el escáner.
  • Sistemas antirrobo y detectores de metales: los sistemas comerciales antirrobo y detectores de metales generan potentes campos electromagnéticos. Los pacientes que utilicen implantes deben saber que pueden activar la alarma al pasar por los detectores de metales de seguridad. Por eso se recomienda a los pacientes llevar encima la tarjeta de identificación de usuario de Vibrant Soundbridge en todo momento.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Bosnia

Cochlear and Auditory Brainstem Implant System

Hrvatski

Medicinski postupci za implantacijske sustave MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Bosnia

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Bosnia

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Bosnia

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Brazil

Cochlear and Auditory Brainstem Implant System

Português

Procedimentos médicos para os sistemas de implante MED‑EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Brazil

Bone Conduction Implant - BCI 601

Português

Implantes de Condução Óssea - BCI 601

Interferência com outro eqiupamento

  • Diatermia cirúrgica: Os instrumentos eletrocirúrgicos podem produzir tensões de frequência rádio que poderão resultar em interferência direta entre o instrumento e o implante. Os instrumentos eletrocirúrgicos monopolares não devem ser utilizados perto do implante. As correntes induzidas podem danificar o implante ou a audição do paciente.
  • Terapia de radiação ionizante: A terapia de radiação não prejudica o implante. Recomenda-se que não utilize um processador áudio durante a irradiação.
  • Raios-X, TAC, tratamento com cobalto, tomografias de emissão positrónica, ecografia de diagnóstico: Nenhuma restrição com exposições clinicamente úteis.
  • Eletrocauteria monopolar, ecografia terapêutica, estimulação magnética transcraniana, terapia eletroconvulsiva: Nunca devem ser aplicadas diretamente sobre o implante, pois esses procedimentos poderão danificá-lo.
  • Ressonância magnética: A ressonância magnética até 1,5 T com o Bonebridge é permitida. Devem ser consideradas as seguintes condições:
  • O processador áudio não deve ser usado, mas pode continuar a ocorrer interferência audível.
  • Estará presente nas imagens um artefacto de 15 cm em redor do implante.
  • Os exames de ressonância magnética superiores a 1,5 T irão danificar o implante e devem ser evitados.
Os produtos, aplicativos e características de desempenho estão sujeitas à aprovação pelos órgãos nacionais competentes; alguns recursos podem estar indisponíveis ou não estão à venda no momento em sua região. Entre em contato com seu representante local da MED-EL para mais informações. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Brazil

Middle Ear Implant - VORP 502

Português

Implantes de Ouvido Médio - VORP 502

Interferência com outro eqiupamento

  • Electro-cirurgia: O instrumentário electro-cirúrgico pode produzir voltagens de radiofrequência que poderiam resultar na união directa do instrumento ao implante. Não deve ser utilizado instrumentário cirúrgico monopolar perto do implante, uma vez que as correntes induzidas podem danificar o implante ou a capacidade auditiva do paciente.
  • Não deve ser aplicada diatermia sobre o implante, uma vez que as correntes de alta voltagem induzidas podem danificar o implante ou a capacidade auditiva do paciente.
  • Tratamento Electroconvulsivo: O tratamento electroconvulsivo nunca deve ser utilizado num paciente com um SOUNDBRIDGE, porque pode danificar o implante ou a capacidade auditiva do paciente.
  • Terapia de Radiação Ionizante: A terapia de radiação ionizante deve ser considerada cuidadosamente ante o risco de danificar o implante VORP. Deve ser pesado o risco frente ao benefício médico de tal terapia.
  • Ressonância Magnética (RM): Os pacientes implantados com o VIBRANT SOUNDBRIDGE (VORP 502x) não devem submeter-se a RM, nem entrar em salas onde se realizem RM ou aproximar-se de quaisquer fontes de intensos campos magnéticos.
  • Cardioversão: A energia induzida durante a cardioversão poderia danificar o implante. Não se deverá aplicar desfibrilhação sobre ou próximo do dispositivo.
  • Vários: Desconhecem-se os efeitos das técnicas de cobaltoterapia, PET scans, diagnóstico com ultra-sons e técnicas lineares de aceleração sobre o implante. Deverá evitar-se o seu uso próximo do implante.
Os produtos, aplicativos e características de desempenho estão sujeitas à aprovação pelos órgãos nacionais competentes; alguns recursos podem estar indisponíveis ou não estão à venda no momento em sua região. Entre em contato com seu representante local da MED-EL para mais informações. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Brazil

Middle Ear Implant - VORP 503

Português

Implantes de Ouvido Médio - VORP 503

Interferência com outro equipamento

  • Eletrocirurgia: instrumentos eletrocirúrgicos podem produzir tensões de radiofrequência que podem resultar num acoplamento direto entre o instrumento e o implante. Os instrumentos eletrocirúrgicos monopolares não devem ser utilizados nas proximidades do implante. As correntes induzidas podem causar danos no implante ou na audição do paciente.
  • Diatermia cirúrgica: nunca deve ser aplicada diatermia sobre o implante, porque as altas tensões induzidas sobre o implante podem danificar o implante ou a audição do paciente.
  • Radiação Ionizante: radioterapia com uma dose de ionização total de até 100 Gray, bem como procedimentos de diagnóstico médico que utilizem radiação, tais como raio-X, TC e TEP, não danificam o implante. Recomenda-se não utilizar o processador de áudio durante a radiação.
  • Ultrassom: exposições a ultrassons de diagnóstico de utilidade clínica não causam danos ao implante.
  • Cardioversão: a energia induzida durante a cardioversão pode danificar o implante. Não deve ser aplicada desfibrilação no dispositivo nem perto dele.
  • Eletrocautério monopolar, ultrassom terapêutico, estimulação magnética transcraniana, terapia eletroconvulsiva: nunca podem ser aplicados diretamente sobre o implante porque tais procedimentos podem danificar o implante.
  • Ressonância magnética (RM): o exame de RM com o VORP 503 apenas é permitido com scanners de ressonância magnética fechada de 1,5 Tesla (T). As seguintes condições têm de ser levadas em consideração:
    • O scanner de ressonância magnética tem de estar limitado ao "Modo de Operação Normal"; o "Modo de Operação de Primeiro Nível" deve ser evitado.
    • Não podem ser utilizadas bobinas de radiofrequência de transmissão local na região da cabeça e do pescoço. Não existe restrição de utilização de bobinas receptoras locais.
    • O processador de áudio deve ser removido da cabeça do paciente antes de entrar em qualquer sala de RM. Pode ocorrer uma interferência audível durante a ressonância. Os pacientes devem ser aconselhados a indicar qualquer possível desconforto que possa surgir e a pedir que a RM seja interrompida, se necessário. Após o exame de RM, o paciente apenas pode voltar a colocar o processador de áudio quando abandonar a sala de RM.
    • Durante o exame de RM, é necessário manter a cabeça reta.
    • Nas imagens será visível um objeto de aproximadamente 14 cm à volta do implante.
    • Exames de RM com >1,5 T irão danificar o implante e devem ser evitados.
    • Se for necessário um exame de RM antes da primeira ativação do Vibrant Soundbridge, devem ser tomadas medidas de segurança para evitar complicações da cicatrização da incisão devido a um possível movimento do implante causado pelo forte campo de RM.
    • Quando forem examinadas extremidades inferiores, recomenda-se, mas não é essencial, que as pernas do paciente entrem primeiro no scanner.
  • Sistemas antifurto e detectores de metal: os sistemas antifurto comerciais e os detectores de metais produzem fortes campos eletromagnéticos. Os pacientes com um implante devem estar cientes de que poderão ativar o alarme do detector de metais de segurança quando passarem pelo mesmo. Por este motivo, aconselha-se que os pacientes andem sempre com o seu cartão de identificação de usuário Vibrant Soundbridge.
Os produtos, aplicativos e características de desempenho estão sujeitas à aprovação pelos órgãos nacionais competentes; alguns recursos podem estar indisponíveis ou não estão à venda no momento em sua região. Entre em contato com seu representante local da MED-EL para mais informações. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Bulgaria

Cochlear and Auditory Brainstem Implant System

български

Медицински процедури за имплантни системи MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Bulgaria

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Bulgaria

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Bulgaria

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Cameroon

Cochlear and Auditory Brainstem Implant System

Français

Procédures médicales pour les systèmes d'implant MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Cameroon

Bone Conduction Implant - BCI 601

Français

Implants à conduction osseuse - BCI 601

Interférences avec d'autres équipements

  • Diathermie chirurgicale : Les instruments électrochirurgicaux peuvent produire des rayonnements haute fréquence pouvant induire des effets de couplage direct entre l'instrument et l'implant. Ne pas utiliser d'instruments électrochirurgicaux monopolaires à proximité de l'implant. Les courants induits peuvent endommager l'implant ou les capacités auditives du patient.
  • Thérapie par rayonnement ionisant : La thérapie par rayonnement ionisant n'a pas d'effet dommageable sur l'implant. Il est recommandé de ne pas porter l’audio processeur durant l'irradiation.
  • Rayons X, scanner, traitement au cobalt, scanner TEP, diagnostic aux ultrasons : Aucune restriction dans la limite des expositions cliniquement utiles.
  • Bistouri électrique monopolaire, ultrasons thérapeutiques, stimulation magnétique transcrânienne, thérapie électroconvulsive : Ne jamais appliquer directement sur l'implant, ces procédures pouvant l'endommager.
  • Imagerie par résonance magnétique (IRM) : Examen par IRM jusqu'à 1,5 T possible avec le Bonebridge. Conditions à prendre en compte:
    • Ne pas porter l’audio processeur, mais possibilité d'interférences auditives.
    • Présence d'un artefact de 15 cm autour de l'implant sur les images.
    • Examen IRM avec >1,5 T : implant endommagé, situation à éviter.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Cameroon

Middle Ear Implant - VORP 502

Français

Implants d'Oreille Moyenne - VORP 502

Interférences avec d'autres équipements

  • Electrochirurgie : Les instruments électrochirurgicaux sont susceptibles de produire des ondes de radiofréquence pouvant directement coupler l’extrémité de l’instrument et l’implant. Les instruments chirurgicaux monopolaires ne doivent pas être utilisés à proximité de l’implant en raison des courants induits qui peuvent endommager l’implant ou diminuer le seuil auditif du patient.
  • Diathermie : Ne procédez jamais à une diathermie sur l’implant dans la mesure où les courants élevés induits dans l’implant risquent de d’endommager ou d’aggraver la surdité du patient.
  • Electrochoc : Ne procédez jamais un électrochoc sur un patient qui porte un SOUNDBRIDGE car ceci pourrait endommager l’implant ou diminuer le seuil auditif du patient.
  • Thérapie par rayonnement ionisant : La thérapie par rayonnement ionisant doit être envisagée avec prudence et le risque de dommage à l’implant VORP doit être considéré par rapport au gain médical potentiel de cette thérapie.
  • Imagerie par résonance magnétique (I.R.M.) : les patients porteurs du VIBRANT SOUNDBRIDGE (VORP 502x) ne doivent pas être exposés à des I.R.M. et ne doivent pas pénétrer dans une salle d’I.R.M. ni se tenir à proximité de champs magnétiques puissants.
  • Cardioversion : L’énergie induite en cours de la cardioversion risque d’endommager l’implant. Aucune défibrillation ne doit être appliquée sur ou à proximité de l’implant.
  • Divers : Les effets du traitement au cobalt, de la tomographie d’émission de positons (PET scan), de l’échographie transcranienne et des techniques d’accélération linéaire sur l’implant sont inconnus. L’utilisation de ces techniques proches de l’implant doit être évitée.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Cameroon

Middle Ear Implant - VORP 503

Français

Implants d'Oreille Moyenne - VORP 503

Interférences avec les autres équipements

  • Électrochirurgie : Les instruments électrochirurgicaux peuvent produire des tensions de radio fréquence qui peuvent donner lieu à un couplage entre l'instrument et l'implant. Des instruments électrochirurgicaux monopolaires ne doivent pas être utilisés à proximité de l'implant. Les courants induits entraînent des dommages à l'implant ou au niveau de l'audition du patient.
  • Diathermie chirurgicale : Une diathermie ne doit jamais être appliquée au-dessus de l'implant car les courants élevés induits dans l'implant peuvent entraîner des dommages à l'implant ou au niveau de l'audition du patient.
  • Rayonnements ionisants : Une radiothérapie jusqu'à une dose totale d'ionisation de 100 Gray ainsi que des procédures de diagnostic médical utilisant des rayonnements ionisants, telles que les radiographies, TDM et TEP, ne sont pas nocives pour l'implant. Il est recommandé toutefois de ne pas porter l'audio processeur durant une irradiation.
  • Échographie : Les expositions à une échographie diagnostique utile sur le plan clinique ne causent aucun dommage à l'implant.
  • Cardioversion: L'énergie induite au cours d'une cardioversion peut endommager l'implant. Il ne faut pas pratiquer de défibrillation au-dessus ou près du dispositif.
  • Électrocautérisation monopolaire, échographie thérapeutique, stimulation magnétique transcrânienne, thérapie par électrochocs : Ne doivent jamais être appliquées au-dessus de l'implant car ces procédures peuvent endommager l'implant.
  • Imagerie par résonance magnétique (IRM) : L'examen IRM avec le VORP 503 n'est autorisé que dans le cas d'une utilisation de scanners IRM à ouverture fermée de 1,5 Tesla (T). Il est nécessaire de tenir compte des conditions suivantes :
    • Le scanner IRM doit être limité au « Mode opératoire normal » ; le « Mode opératoire de premier niveau » doit être évité.
    • Les bobines RF de transmission locale ne doivent pas être utilisées dans la région du cou et de la tête. L'utilisation des bobines réceptrices locales n'est pas restreinte.
    • Avant que le patient entre dans la pièce de l'appareil IRM, l'audio processeur doit être retiré de la tête. Une interférence audible peut se produire pendant la procédure suppress. Les patients doivent être conseillés d'indiquer toute gêne éventuelle pouvant se faire ressentir et de demander à ce que la procédure IRM soit interrompue si nécessaire. Après l'examen IRM, le patient ne doit remettre l'audio processeur qu'une fois sorti de la pièce de l'appareil IRM.
    • Au cours de l'examen IRM, il est requis que la tête soit maintenue droite.
    • Un artéfact d'environ 14 cm autour de l'implant sera présent sur les images.
    • Un examen IRM à > 1,5 T endommagera l'implant et doit être évité.
    • Si un examen IRM est nécessaire avant la première activation du système Vibrant Soundbridge, les mesures de sécurité doivent être prises en compte pour prévenir toute complication de la cicatrisation de la plaie due à l'éventuel mouvement de l'implant sous l'influence d'un fort champ magnétique RM.
    • Lorsque les membres inférieurs doivent être examinés, il est recommandé, mais pas exigé, que les jambes du patient soient introduites en premier dans le l'IRM.
  • Systèmes antivol et de détection de métal : Les systèmes de détection antivol et les détecteurs de métaux produisent de forts champs électromagnétiques. Les patients portant un implant doivent être informés que le passage à travers des portiques détecteurs de métaux peut activer l'alarme du détecteur. C'est pour cette raison qu'il est recommandé aux patients de porter sur eux en permanence leur carte d'identification d'utilisateur du système Vibrant Soundbridge.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Canada

Cochlear and Auditory Brainstem Implant System

English - CA

Medical Procedures for MED-EL Implant Systems

ManualMRI Checklist
Français - CA

Procédures médicales pour les systèmes d’implant MED‑EL

ManualMRI Checklist
Bone Conduction Implant - BCI 601
Canada

Bone Conduction Implant - BCI 601

English - CA

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI Checklist
Français - CA

Implants à conduction osseuse - BCI 601

Interférences avec d'autres équipements

  • Diathermie chirurgicale : Les instruments électrochirurgicaux peuvent produire des rayonnements haute fréquence pouvant induire des effets de couplage direct entre l'instrument et l'implant. Ne pas utiliser d'instruments électrochirurgicaux monopolaires à proximité de l'implant. Les courants induits peuvent endommager l'implant ou les capacités auditives du patient.
  • Thérapie par rayonnement ionisant : La thérapie par rayonnement ionisant n'a pas d'effet dommageable sur l'implant. Il est recommandé de ne pas porter l’audio processeur durant l'irradiation.
  • Rayons X, scanner, traitement au cobalt, scanner TEP, diagnostic aux ultrasons : Aucune restriction dans la limite des expositions cliniquement utiles.
  • Bistouri électrique monopolaire, ultrasons thérapeutiques, stimulation magnétique transcrânienne, thérapie électroconvulsive : Ne jamais appliquer directement sur l'implant, ces procédures pouvant l'endommager.
  • Imagerie par résonance magnétique (IRM) : Examen par IRM jusqu'à 1,5 T possible avec le Bonebridge. Conditions à prendre en compte:
    • Ne pas porter l’audio processeur, mais possibilité d'interférences auditives.
    • Présence d'un artefact de 15 cm autour de l'implant sur les images.
    • Examen IRM avec >1,5 T : implant endommagé, situation à éviter.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL.MRI Info SheetMRI Checklist
Middle Ear Implant - VORP 502
Canada

Middle Ear Implant - VORP 502

English - CA

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region.
Français - CA

Implants d'Oreille Moyenne - VORP 502

Interférences avec d'autres équipements

  • Electrochirurgie : Les instruments électrochirurgicaux sont susceptibles de produire des ondes de radiofréquence pouvant directement coupler l’extrémité de l’instrument et l’implant. Les instruments chirurgicaux monopolaires ne doivent pas être utilisés à proximité de l’implant en raison des courants induits qui peuvent endommager l’implant ou diminuer le seuil auditif du patient.
  • Diathermie : Ne procédez jamais à une diathermie sur l’implant dans la mesure où les courants élevés induits dans l’implant risquent de d’endommager ou d’aggraver la surdité du patient.
  • Electrochoc : Ne procédez jamais un électrochoc sur un patient qui porte un SOUNDBRIDGE car ceci pourrait endommager l’implant ou diminuer le seuil auditif du patient.
  • Thérapie par rayonnement ionisant : La thérapie par rayonnement ionisant doit être envisagée avec prudence et le risque de dommage à l’implant VORP doit être considéré par rapport au gain médical potentiel de cette thérapie.
  • Imagerie par résonance magnétique (I.R.M.) : les patients porteurs du VIBRANT SOUNDBRIDGE (VORP 502x) ne doivent pas être exposés à des I.R.M. et ne doivent pas pénétrer dans une salle d’I.R.M. ni se tenir à proximité de champs magnétiques puissants.
  • Cardioversion : L’énergie induite en cours de la cardioversion risque d’endommager l’implant. Aucune défibrillation ne doit être appliquée sur ou à proximité de l’implant.
  • Divers : Les effets du traitement au cobalt, de la tomographie d’émission de positons (PET scan), de l’échographie transcranienne et des techniques d’accélération linéaire sur l’implant sont inconnus. L’utilisation de ces techniques proches de l’implant doit être évitée.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL.
Middle Ear Implant - VORP 503
Canada

Middle Ear Implant - VORP 503

English - CA

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info Sheet MRI Checklist 
Français - CA

Implants d'Oreille Moyenne - VORP 503

Interférences avec les autres équipements

  • Électrochirurgie : Les instruments électrochirurgicaux peuvent produire des tensions de radio fréquence qui peuvent donner lieu à un couplage entre l'instrument et l'implant. Des instruments électrochirurgicaux monopolaires ne doivent pas être utilisés à proximité de l'implant. Les courants induits entraînent des dommages à l'implant ou au niveau de l'audition du patient.
  • Diathermie chirurgicale : Une diathermie ne doit jamais être appliquée au-dessus de l'implant car les courants élevés induits dans l'implant peuvent entraîner des dommages à l'implant ou au niveau de l'audition du patient.
  • Rayonnements ionisants : Une radiothérapie jusqu'à une dose totale d'ionisation de 100 Gray ainsi que des procédures de diagnostic médical utilisant des rayonnements ionisants, telles que les radiographies, TDM et TEP, ne sont pas nocives pour l'implant. Il est recommandé toutefois de ne pas porter l'audio processeur durant une irradiation.
  • Échographie : Les expositions à une échographie diagnostique utile sur le plan clinique ne causent aucun dommage à l'implant.
  • Cardioversion: L'énergie induite au cours d'une cardioversion peut endommager l'implant. Il ne faut pas pratiquer de défibrillation au-dessus ou près du dispositif.
  • Électrocautérisation monopolaire, échographie thérapeutique, stimulation magnétique transcrânienne, thérapie par électrochocs : Ne doivent jamais être appliquées au-dessus de l'implant car ces procédures peuvent endommager l'implant.
  • Imagerie par résonance magnétique (IRM) : L'examen IRM avec le VORP 503 n'est autorisé que dans le cas d'une utilisation de scanners IRM à ouverture fermée de 1,5 Tesla (T). Il est nécessaire de tenir compte des conditions suivantes :
    • Le scanner IRM doit être limité au « Mode opératoire normal » ; le « Mode opératoire de premier niveau » doit être évité.
    • Les bobines RF de transmission locale ne doivent pas être utilisées dans la région du cou et de la tête. L'utilisation des bobines réceptrices locales n'est pas restreinte.
    • Avant que le patient entre dans la pièce de l'appareil IRM, l'audio processeur doit être retiré de la tête. Une interférence audible peut se produire pendant la procédure suppress. Les patients doivent être conseillés d'indiquer toute gêne éventuelle pouvant se faire ressentir et de demander à ce que la procédure IRM soit interrompue si nécessaire. Après l'examen IRM, le patient ne doit remettre l'audio processeur qu'une fois sorti de la pièce de l'appareil IRM.
    • Au cours de l'examen IRM, il est requis que la tête soit maintenue droite.
    • Un artéfact d'environ 14 cm autour de l'implant sera présent sur les images.
    • Un examen IRM à > 1,5 T endommagera l'implant et doit être évité.
    • Si un examen IRM est nécessaire avant la première activation du système Vibrant Soundbridge, les mesures de sécurité doivent être prises en compte pour prévenir toute complication de la cicatrisation de la plaie due à l'éventuel mouvement de l'implant sous l'influence d'un fort champ magnétique RM.
    • Lorsque les membres inférieurs doivent être examinés, il est recommandé, mais pas exigé, que les jambes du patient soient introduites en premier dans le l'IRM.
       
  • Systèmes antivol et de détection de métal : Les systèmes de détection antivol et les détecteurs de métaux produisent de forts champs électromagnétiques. Les patients portant un implant doivent être informés que le passage à travers des portiques détecteurs de métaux peut activer l'alarme du détecteur. C'est pour cette raison qu'il est recommandé aux patients de porter sur eux en permanence leur carte d'identification d'utilisateur du système Vibrant Soundbridge.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Info SheetMRI Checklist
Cochlear and Auditory Brainstem Implant System
Chile

Cochlear and Auditory Brainstem Implant System

Español

Procedimientos médicos para Sistemas de implante MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Chile

Bone Conduction Implant - BCI 601

Español

Implantes de Conducción Ósea - BCI 601

Interferencias con otros dispositivos

  • Diatermia quirúrgica: El instrumental de electrocirugía puede producir voltajes de radiofrecuencia, que pueden resultar en el acoplamiento directo entre el instrumento y el implante. Queda prohibido emplear instrumental electroquirúrgico monopolar cerca del implante. Las corrientes inducidas podrían causar daños en el implante o en la audición del paciente.
  • Terapia de radiación ionizante: La radioterapia no daña el implante. Se recomienda no portar un procesador de audio durante la irradiación.
  • Rayos X, tomografía computarizada, tratamiento con cobalto, escáner PET, ultrasonido diagnóstico: No existen restricciones dentro de las exposiciones con fines clínicos.
  • Electrocauterio monopolar, ultrasonido terapéutico, estimulación magnética transcraneal, terapia electroconvulsiva: Queda prohibido aplicar directamente estos procedimientos sobre el implante, ya que podrían causar daños en el mismo.
  • Imagen por Resonancia Magnética (IRM): La evaluación por medio de IRM está permitida hasta 1,5 T con el Bonebridge. Tenga en cuenta las siguientes exigencias:
  • No se debe portar el procesador de audio. Aún así, es posible que surjan interferencias audibles.
  • Los escáneres presentarán un artefacto de 15 cm alrededor del implante.
  • Evite una evaluación con IRM >1,5 T, ya que dañaría el implante.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL.MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Chile

Middle Ear Implant - VORP 502

Español

Implantes de Oído Medio - VORP 502

Interferencias con otros dispositivos

  • Electrocirugía: Los instrumentos electroquirúrgicos pueden producir voltajes de radiofrecuencia que son capaces de acoplar el extremo del instrumento y el implante. Los instrumentos de cirugía monopolar no deben ser usados en el área próxima al implante debido a que inducen corrientes que pueden dañar el implante o la audición del paciente.
  • Diatermia: La diatermia no debe ser nunca aplicada sobre el implante debido a que las grandes corrientes que se inducen en el mismo lo pueden dañar o dañar la audición del paciente.
  • Terapia Electroconvulsiva: La terapia electroconvulsiva no debe ser usada nunca en un paciente con un Soundbridge debido a que puede dañar el implante o la audición del paciente.
  • Terapia de Radiación Ionizante: La terapia de radiación ionizante debe ser considerada cuidadosamente ante el riesgo de dañar el implante VORP. Debe ser sopesado el riesgo frente al beneficio médico de dicha terapia.
  • Resonancia Magnética (RMN): Los pacientes implantados con el VIBRANT SOUNDBRIDGE (VORP 502x) no deben ser sometidos a RMN y no deben entrar a una cabina de RMN o estar en las proximidades de otras fuentes de campos magnéticos potentes.
  • Cardioversión: La energía inducida durante la cardioversión puede dañar el implante. La desfibrilación no debe ser aplicada en o cerca del dispositivo.
  • Miscelánea: Los efectos del tratamiento de cobalto, PET, diagnóstico y terapia ultrasónica y técnicas de aceleración lineal en las proximidades del implante son desconocidas. Su uso en las zonas próximas al implante debe ser evitado.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Chile

Middle Ear Implant - VORP 503

Español

Implantes de Oído Medio - VORP 503

Interferencias con otros equipos

  • Electrocirugía: los instrumentos electroquirúrgicos pueden producir frecuencias de radio que pueden causar el acoplamiento entre el instrumento y el implante. No se deben utilizar instrumentos quirúrgicos monopolares en las proximidades del implante. La corriente de inducción podría dañar el implante y/o la audición del paciente.
  • Diatermia quirúrgica: nunca se debe aplicar diatermia sobre el implante porque la corriente inducida podría causar daños en el implante o en la audición del paciente.
  • Radiación ionizante: la terapia con radiación ionizante hasta una dosis de ionización total de 100 Gy, así como los procedimientos médicos diagnósticos que utilizan radiación ionizante, como los rayos X, TC y PET, no dañan el implante. No se recomienda llevar el procesador auditivo durante la radiación.
  • Ultrasonidos: la exposición a ultrasonidos de utilidad diagnóstica no causa daños en el implante.
  • Cardioversión: la energía inducida durante la cardioversión podría dañar el implante. No se debe aplicar desfibrilación sobre el dispositivo ni en sus proximidades.
  • Electrocauterización monopolar, ultrasonidos terapéuticos, estimulación magnética transcraneal, tratamiento electroconvulsivo: nunca deben aplicarse directamente sobre el implante porque pueden dañarlo.
  • Imágenes por resonancia magnética (IRM): el examen por IRM con VORP 503 solo se permite con escáneres IRM cerrados de 1,5 teslas (T). Deben tenerse en cuenta las siguientes condiciones:
    • El escáner MRI debe estar limitado a modo de operación normal; evite el modo de operación de primer nivel.
    • No utilice bobinas de RF de transmisión local en la región craneal o cervical. No se limita el uso de bobinas de recepción local.
    • Antes de que el paciente entre en la sala de IRM, el procesador auditivo debe retirarse de la cabeza. Durante el escáner pueden producirse interferencias audibles. Los pacientes deben estar informados de que tienen que comunicar cualquier posible molestia y solicitar que se interrumpa la prueba si es necesario. Después de la prueba, el paciente no se pondrá el procesador auditivo hasta salir de la sala de IRM.
    • Durante el examen con IRM, la cabeza debe mantenerse en posición recta.
    • Las imágenes mostrarán un artefacto de aproximadamente 14 cm alrededor del implante.
    • Los exámenes con IRM de más de 1,5 T causan daños en el implante y deben evitarse.
    • Si necesita un examen IRM antes de la primera activación de Vibrant Soundbridge, deberán tomarse medidas de seguridad para evitar complicaciones en la curación de la herida por posibles movimientos del implante dentro del potente campo de RM.
    • Para examinar las extremidades inferiores se recomienda, aunque no es imprescindible, que las piernas entren primero en el escáner.
  • Sistemas antirrobo y detectores de metales: los sistemas comerciales antirrobo y detectores de metales generan potentes campos electromagnéticos. Los pacientes que utilicen implantes deben saber que pueden activar la alarma al pasar por los detectores de metales de seguridad. Por eso se recomienda a los pacientes llevar encima la tarjeta de identificación de usuario de Vibrant Soundbridge en todo momento.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
China

Cochlear and Auditory Brainstem Implant System

中文-中国

医疗程序 MED‑EL 植入系统

ManualMRI Checklist
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
China

Bone Conduction Implant - BCI 601

中文-中国

BONEBRIDGE BCI 601

其他设备的干扰

  • 外科透热疗法:电外科器械可能产生射频电压,从而可能导致上述器械与植入体的直接耦合。不能在植入体附近使用单极电外科器械。感应电流可能导致植入体或患者听力遭受损伤。

  • 电离放射治疗:放射治疗不会损坏植入体。建议在进行放射治疗时摘下声音处理器。

  • X-线、CT检查、钴治疗、PET扫描、超声诊断临床常规使用范围内没有限制。

  • 单极电烙术、超声治疗、经颅磁刺激、电惊厥疗法绝对不可直接在植入体之上应用,因为这些操作可能对其造成损坏。

  • 磁共振成像MRI):在中国地区,该设备尚未批准用于核磁检查。

产品、应用和性能特点需经国家主管部门核准;某些功能目前可能不可用或无法由您所在地区的 MED-EL 提供。请联系您当地的 MED-EL 代理处,以了解更多信息。
English - CN

BONEBRIDGE BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): Not approved for MRI in China.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region
Middle Ear Implant - VORP 502
China

Middle Ear Implant - VORP 502

中文-中国

中耳植入 - VORP 502

Interference with other equipment

  • 电外科:电外科设备能够产生射频电压,会直接耦合设备的尖端和植入体。在植入体的附近不得使用单极的电外科设备,因为诱导电流会导致植入体或患者听力的损伤。
  • 透热疗法:在植入体上不能使用透热疗法,因为进入植入体的高强电流会导致植入体或患者听力的损伤。
  • 电惊厥治疗:不得对Soundbridge使用者使用电惊厥治疗,因为可能导致植入体或患者听力的损伤。
  • 放射治疗:放射治疗需谨慎考虑,放射治疗有可能损坏植入体VORP。
  • 核磁共振成像(MRI):对植入Vibrant Soundbridge (VORP 502x)的患者不应进行MRI,并且不应使其进入MRI室或过于接近强磁场源。
  • 电复律:在电复律过程中产生的能量会导致植入体的损坏。不得在设备上或其附近进行除颤操作。
  • 其他:钴治疗、PET扫描、诊断性超声波和直线加速度技术在植入体附近的影响还不明确。应避免在植入体附近使用。
产品、应用和性能特点需经国家主管部门核准;某些功能目前可能不可用或无法由您所在地区的 MED-EL 提供。请联系您当地的 MED-EL 代理处,以了解更多信息。
English - CN

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region.
Middle Ear Implant - VORP 503
China

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Colombia

Cochlear and Auditory Brainstem Implant System

Español

Procedimientos médicos para Sistemas de implante MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Colombia

Bone Conduction Implant - BCI 601

Español

Implantes de Conducción Ósea - BCI 601

Interferencias con otros dispositivos

  • Diatermia quirúrgica: El instrumental de electrocirugía puede producir voltajes de radiofrecuencia, que pueden resultar en el acoplamiento directo entre el instrumento y el implante. Queda prohibido emplear instrumental electroquirúrgico monopolar cerca del implante. Las corrientes inducidas podrían causar daños en el implante o en la audición del paciente.
  • Terapia de radiación ionizante: La radioterapia no daña el implante. Se recomienda no portar un procesador de audio durante la irradiación.
  • Rayos X, tomografía computarizada, tratamiento con cobalto, escáner PET, ultrasonido diagnóstico: No existen restricciones dentro de las exposiciones con fines clínicos.
  • Electrocauterio monopolar, ultrasonido terapéutico, estimulación magnética transcraneal, terapia electroconvulsiva: Queda prohibido aplicar directamente estos procedimientos sobre el implante, ya que podrían causar daños en el mismo.
  • Imagen por Resonancia Magnética (IRM): La evaluación por medio de IRM está permitida hasta 1,5 T con el Bonebridge. Tenga en cuenta las siguientes exigencias:
  • No se debe portar el procesador de audio. Aún así, es posible que surjan interferencias audibles.
  • Los escáneres presentarán un artefacto de 15 cm alrededor del implante.
  • Evite una evaluación con IRM >1,5 T, ya que dañaría el implante.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL.MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Colombia

Middle Ear Implant - VORP 502

Español

Implantes de Oído Medio - VORP 502

Interferencias con otros dispositivos

  • Electrocirugía: Los instrumentos electroquirúrgicos pueden producir voltajes de radiofrecuencia que son capaces de acoplar el extremo del instrumento y el implante. Los instrumentos de cirugía monopolar no deben ser usados en el área próxima al implante debido a que inducen corrientes que pueden dañar el implante o la audición del paciente.
  • Diatermia: La diatermia no debe ser nunca aplicada sobre el implante debido a que las grandes corrientes que se inducen en el mismo lo pueden dañar o dañar la audición del paciente.
  • Terapia Electroconvulsiva: La terapia electroconvulsiva no debe ser usada nunca en un paciente con un Soundbridge debido a que puede dañar el implante o la audición del paciente.
  • Terapia de Radiación Ionizante: La terapia de radiación ionizante debe ser considerada cuidadosamente ante el riesgo de dañar el implante VORP. Debe ser sopesado el riesgo frente al beneficio médico de dicha terapia.
  • Resonancia Magnética (RMN): Los pacientes implantados con el VIBRANT SOUNDBRIDGE (VORP 502x) no deben ser sometidos a RMN y no deben entrar a una cabina de RMN o estar en las proximidades de otras fuentes de campos magnéticos potentes.
  • Cardioversión: La energía inducida durante la cardioversión puede dañar el implante. La desfibrilación no debe ser aplicada en o cerca del dispositivo.
  • Miscelánea: Los efectos del tratamiento de cobalto, PET, diagnóstico y terapia ultrasónica y técnicas de aceleración lineal en las proximidades del implante son desconocidas. Su uso en las zonas próximas al implante debe ser evitado.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Colombia

Middle Ear Implant - VORP 503

Español

Implantes de Oído Medio - VORP 503

Interferencias con otros equipos

  • Electrocirugía: los instrumentos electroquirúrgicos pueden producir frecuencias de radio que pueden causar el acoplamiento entre el instrumento y el implante. No se deben utilizar instrumentos quirúrgicos monopolares en las proximidades del implante. La corriente de inducción podría dañar el implante y/o la audición del paciente.
  • Diatermia quirúrgica: nunca se debe aplicar diatermia sobre el implante porque la corriente inducida podría causar daños en el implante o en la audición del paciente.
  • Radiación ionizante: la terapia con radiación ionizante hasta una dosis de ionización total de 100 Gy, así como los procedimientos médicos diagnósticos que utilizan radiación ionizante, como los rayos X, TC y PET, no dañan el implante. No se recomienda llevar el procesador auditivo durante la radiación.
  • Ultrasonidos: la exposición a ultrasonidos de utilidad diagnóstica no causa daños en el implante.
  • Cardioversión: la energía inducida durante la cardioversión podría dañar el implante. No se debe aplicar desfibrilación sobre el dispositivo ni en sus proximidades.
  • Electrocauterización monopolar, ultrasonidos terapéuticos, estimulación magnética transcraneal, tratamiento electroconvulsivo: nunca deben aplicarse directamente sobre el implante porque pueden dañarlo.
  • Imágenes por resonancia magnética (IRM): el examen por IRM con VORP 503 solo se permite con escáneres IRM cerrados de 1,5 teslas (T). Deben tenerse en cuenta las siguientes condiciones:
    • El escáner MRI debe estar limitado a modo de operación normal; evite el modo de operación de primer nivel.
    • No utilice bobinas de RF de transmisión local en la región craneal o cervical. No se limita el uso de bobinas de recepción local.
    • Antes de que el paciente entre en la sala de IRM, el procesador auditivo debe retirarse de la cabeza. Durante el escáner pueden producirse interferencias audibles. Los pacientes deben estar informados de que tienen que comunicar cualquier posible molestia y solicitar que se interrumpa la prueba si es necesario. Después de la prueba, el paciente no se pondrá el procesador auditivo hasta salir de la sala de IRM.
    • Durante el examen con IRM, la cabeza debe mantenerse en posición recta.
    • Las imágenes mostrarán un artefacto de aproximadamente 14 cm alrededor del implante.
    • Los exámenes con IRM de más de 1,5 T causan daños en el implante y deben evitarse.
    • Si necesita un examen IRM antes de la primera activación de Vibrant Soundbridge, deberán tomarse medidas de seguridad para evitar complicaciones en la curación de la herida por posibles movimientos del implante dentro del potente campo de RM.
    • Para examinar las extremidades inferiores se recomienda, aunque no es imprescindible, que las piernas entren primero en el escáner.
  • Sistemas antirrobo y detectores de metales: los sistemas comerciales antirrobo y detectores de metales generan potentes campos electromagnéticos. Los pacientes que utilicen implantes deben saber que pueden activar la alarma al pasar por los detectores de metales de seguridad. Por eso se recomienda a los pacientes llevar encima la tarjeta de identificación de usuario de Vibrant Soundbridge en todo momento.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Costa Rica

Cochlear and Auditory Brainstem Implant System

Español

Procedimientos médicos para Sistemas de implante MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Costa Rica

Bone Conduction Implant - BCI 601

Español

Implantes de Conducción Ósea - BCI 601

Interferencias con otros dispositivos

  • Diatermia quirúrgica: El instrumental de electrocirugía puede producir voltajes de radiofrecuencia, que pueden resultar en el acoplamiento directo entre el instrumento y el implante. Queda prohibido emplear instrumental electroquirúrgico monopolar cerca del implante. Las corrientes inducidas podrían causar daños en el implante o en la audición del paciente.
  • Terapia de radiación ionizante: La radioterapia no daña el implante. Se recomienda no portar un procesador de audio durante la irradiación.
  • Rayos X, tomografía computarizada, tratamiento con cobalto, escáner PET, ultrasonido diagnóstico: No existen restricciones dentro de las exposiciones con fines clínicos.
  • Electrocauterio monopolar, ultrasonido terapéutico, estimulación magnética transcraneal, terapia electroconvulsiva: Queda prohibido aplicar directamente estos procedimientos sobre el implante, ya que podrían causar daños en el mismo.
  • Imagen por Resonancia Magnética (IRM): La evaluación por medio de IRM está permitida hasta 1,5 T con el Bonebridge. Tenga en cuenta las siguientes exigencias:
  • No se debe portar el procesador de audio. Aún así, es posible que surjan interferencias audibles.
  • Los escáneres presentarán un artefacto de 15 cm alrededor del implante.
  • Evite una evaluación con IRM >1,5 T, ya que dañaría el implante.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL.MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Costa Rica

Middle Ear Implant - VORP 502

Español

Implantes de Oído Medio - VORP 502

Interferencias con otros dispositivos

  • Electrocirugía: Los instrumentos electroquirúrgicos pueden producir voltajes de radiofrecuencia que son capaces de acoplar el extremo del instrumento y el implante. Los instrumentos de cirugía monopolar no deben ser usados en el área próxima al implante debido a que inducen corrientes que pueden dañar el implante o la audición del paciente.
  • Diatermia: La diatermia no debe ser nunca aplicada sobre el implante debido a que las grandes corrientes que se inducen en el mismo lo pueden dañar o dañar la audición del paciente.
  • Terapia Electroconvulsiva: La terapia electroconvulsiva no debe ser usada nunca en un paciente con un Soundbridge debido a que puede dañar el implante o la audición del paciente.
  • Terapia de Radiación Ionizante: La terapia de radiación ionizante debe ser considerada cuidadosamente ante el riesgo de dañar el implante VORP. Debe ser sopesado el riesgo frente al beneficio médico de dicha terapia.
  • Resonancia Magnética (RMN): Los pacientes implantados con el VIBRANT SOUNDBRIDGE (VORP 502x) no deben ser sometidos a RMN y no deben entrar a una cabina de RMN o estar en las proximidades de otras fuentes de campos magnéticos potentes.
  • Cardioversión: La energía inducida durante la cardioversión puede dañar el implante. La desfibrilación no debe ser aplicada en o cerca del dispositivo.
  • Miscelánea: Los efectos del tratamiento de cobalto, PET, diagnóstico y terapia ultrasónica y técnicas de aceleración lineal en las proximidades del implante son desconocidas. Su uso en las zonas próximas al implante debe ser evitado.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Costa Rica

Middle Ear Implant - VORP 503

Español

Implantes de Oído Medio - VORP 503

Interferencias con otros equipos

  • Electrocirugía: los instrumentos electroquirúrgicos pueden producir frecuencias de radio que pueden causar el acoplamiento entre el instrumento y el implante. No se deben utilizar instrumentos quirúrgicos monopolares en las proximidades del implante. La corriente de inducción podría dañar el implante y/o la audición del paciente.
  • Diatermia quirúrgica: nunca se debe aplicar diatermia sobre el implante porque la corriente inducida podría causar daños en el implante o en la audición del paciente.
  • Radiación ionizante: la terapia con radiación ionizante hasta una dosis de ionización total de 100 Gy, así como los procedimientos médicos diagnósticos que utilizan radiación ionizante, como los rayos X, TC y PET, no dañan el implante. No se recomienda llevar el procesador auditivo durante la radiación.
  • Ultrasonidos: la exposición a ultrasonidos de utilidad diagnóstica no causa daños en el implante.
  • Cardioversión: la energía inducida durante la cardioversión podría dañar el implante. No se debe aplicar desfibrilación sobre el dispositivo ni en sus proximidades.
  • Electrocauterización monopolar, ultrasonidos terapéuticos, estimulación magnética transcraneal, tratamiento electroconvulsivo: nunca deben aplicarse directamente sobre el implante porque pueden dañarlo.
  • Imágenes por resonancia magnética (IRM): el examen por IRM con VORP 503 solo se permite con escáneres IRM cerrados de 1,5 teslas (T). Deben tenerse en cuenta las siguientes condiciones:
    • El escáner MRI debe estar limitado a modo de operación normal; evite el modo de operación de primer nivel.
    • No utilice bobinas de RF de transmisión local en la región craneal o cervical. No se limita el uso de bobinas de recepción local.
    • Antes de que el paciente entre en la sala de IRM, el procesador auditivo debe retirarse de la cabeza. Durante el escáner pueden producirse interferencias audibles. Los pacientes deben estar informados de que tienen que comunicar cualquier posible molestia y solicitar que se interrumpa la prueba si es necesario. Después de la prueba, el paciente no se pondrá el procesador auditivo hasta salir de la sala de IRM.
    • Durante el examen con IRM, la cabeza debe mantenerse en posición recta.
    • Las imágenes mostrarán un artefacto de aproximadamente 14 cm alrededor del implante.
    • Los exámenes con IRM de más de 1,5 T causan daños en el implante y deben evitarse.
    • Si necesita un examen IRM antes de la primera activación de Vibrant Soundbridge, deberán tomarse medidas de seguridad para evitar complicaciones en la curación de la herida por posibles movimientos del implante dentro del potente campo de RM.
    • Para examinar las extremidades inferiores se recomienda, aunque no es imprescindible, que las piernas entren primero en el escáner.
  • Sistemas antirrobo y detectores de metales: los sistemas comerciales antirrobo y detectores de metales generan potentes campos electromagnéticos. Los pacientes que utilicen implantes deben saber que pueden activar la alarma al pasar por los detectores de metales de seguridad. Por eso se recomienda a los pacientes llevar encima la tarjeta de identificación de usuario de Vibrant Soundbridge en todo momento.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Croatia

Cochlear and Auditory Brainstem Implant System

Hrvatski

Medicinski postupci za implantacijske sustave MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Croatia

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Croatia

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Croatia

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Cyprus

Cochlear and Auditory Brainstem Implant System

Ελληνικά

Ιατρικές διαδικασίες για τα συστήματα εμφυτευμάτων MED‑EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Cyprus

Bone Conduction Implant - BCI 601

Ελληνικά

Εμφυτεύματα Οστικής Αγωγιμότητας - BCI 601

Παρεμβολές από άλλο εξοπλισμό

  • Χειρουργική διαθερμία: Τα όργανα ηλεκτροχειρουργικής μπορεί να παράγουν τάσεις ραδιοσυχνοτήτων, οι οποίες μπορεί να επιφέρουν απευθείας ζεύξη μεταξύ του οργάνου και του εμφυτεύματος. Τα μονοπολικά ηλεκτροχειρουργικά όργανα δεν πρέπει να χρησιμοποιούνται κοντά στο εμφύτευμα. Το προκαλούμενο ρεύμα μπορεί να επιφέρει ζημιά στο εμφύτευμα ή στην ακοή του ασθενή.
  • Θεραπεία ακτινοβολίας ιονισμού: Η θεραπεία ακτινοβολίας δεν προκαλεί ζημιές στο εμφύτευμα. Συστήνεται να μην φοράτε επεξεργαστή ήχου κατά τη διάρκεια της ακτινοβολίας.
  • Ακτινογραφία, αξονική τομογραφία, θεραπεία με κοβάλτιο, τομογραφία εκπομπής ποζιτρονίων (PET), διαγνωστικό υπερηχογράφημα: Κανένας περιορισμός σε ιατρικά ωφέλιμη έκθεση.
  • Μονοπολική ηλεκτροκαυτηρίαση, θεραπευτικό υπερηχογράφημα, ενδοκρανιακή μαγνητική διέγερση, ηλεκτροσπασμοθεραπεία: Δεν επιτρέπεται απευθείας εφαρμογή πάνω από το εμφύτευμα, διότι οι ανωτέρω διαδικασίες μπορεί να προκαλέσουν ζημιά.
  • Απεικόνιση μαγνητικού συντονισμού (MRI): Εξέταση MRI έως 1,5T με το Bonebridge επιτρέπεται. Πρέπει να ληφθούν υπόψη οι ακόλουθες συνθήκες:
    • Ο επεξεργαστής ήχου δεν θα φοριέται, ωστόσο μπορεί να συμβούν ακουστικές παρεμβολές.
    • Στις εικόνες γύρω από το εμφύτευμα θα είναι παρόν ένα ψευδές εύρημα 15 εκ.
    • Μια εξέταση MRI με >1,5Τ θα προκαλέσει ζημιά στο εμφύτευμα και πρέπει να αποφεύγεται.
Τα προϊόντα, οι εφαρμογές και τα χαρακτηριστικά απόδοσης αποτελούν αντικείμενο έγκρισης από τις εθνικές αρμόδιες αρχές. Μερικά στοιχεία πιθανώς να μην είναι διαθέσιμα προς το παρόν ή να μην διατίθενται προς πώληση στην περιοχή σας από την MED-EL. Παρακαλούμε να επικοινωνήσετε με τον τοπικό αντιπρόσωπο της MED-EL για περαιτέρω πληροφορίες. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Cyprus

Middle Ear Implant - VORP 502

Ελληνικά

Εμφυτεύματα Μέσου Ωτός - VORP 502

Παρεμβολές από άλλο εξοπλισμό

  • Ηλεκτροχειρουργική: Τα ηλεκτροχειρουργικά όργανα έχουν την ικανότητα παραγωγής τάσεων ραδιοσυχνότητας, οι οποίες μπορούν να συνδέουν απευθείας την ακμή οργάνου και το εμφύτευμα. Τα μονοπολικά ηλεκτροχειρουργικά όργανα δεν πρέπει να χρησιμοποιούνται κοντά στο εμφύτευμα διότι τα προκαλούμενα ρεύματα θα μπορούσαν να επιφέρουν βλάβη στο εμφύτευμα ή στην ακοή του ασθενή.
  • Διαθερμία: Δεν πρέπει ποτέ να εφαρμόζεται διαθερμία στο εμφύτευμα διότι τα υψηλά ρεύματα που προκαλούνται στο εμφύτευμα θα μπορούσαν να προκαλέσουν ζημιά στο εμφύτευμα ή στην ακοή του ασθενή.
  • Ηλεκτροσπασμοθεραπεία: Δεν πρέπει ποτέ να χρησιμοποιείται ηλεκτροσπασμοθεραπεία σε έναν ασθενή με Soundbridge διότι ενδέχεται να προκληθεί ζημιά στο εμφύτευμα ή στην ακοή του ασθενή.
  • Θεραπεία ιονίζουσας ακτινοβολίας: Η θεραπεία ιονίζουσας ακτινοβολίας πρέπει να εξετάζεται λεπτομερώς και να μελετάται προσεκτικά ο κίνδυνος βλάβης στο εμφύτευμα VORP σε σχέση με τα ιατρικά πλεονεκτήματα από μια τέτοια θεραπεία.
  • Απεικόνιση μαγνητικού συντονισμού (MRI): Ασθενείς με εμφυτευμένο VIBRANT SOUNDBRIDGE (VORP 502x) δεν πρέπει να υπόκεινται σε MRI, και δεν πρέπει να εισέρχονται σε αίθουσα MRI ή να προσεγγίζουν άλλες πηγές δυνατών μαγνητικών πεδίων.
  • Απινιδισμός: Η προκαλούμενη ενέργεια κατά τον απινιδισμό θα μπορούσε να προκαλέσει βλάβη στο εμφύτευμα. Δεν πρέπει να διεξάγεται απινιδισμός στη συσκευή ή κοντά σε αυτήν.
  • Διάφορα: Η επιπτώσεις της θεραπείας με κοβάλτιο, της θεραπείας εκπομπής ποζιτρονίων (ΡΕΤ), των διαγνωστικών και θεραπευτικών υπερηχογραφημάτων και των τεχνικών γραμμικής επιτάχυνσης κοντά στο εμφύτευμα είναι άγνωστες. Η χρήση τους κοντά στο εμφύτευμα πρέπει να αποφεύγεται.
Τα προϊόντα, οι εφαρμογές και τα χαρακτηριστικά απόδοσης αποτελούν αντικείμενο έγκρισης από τις εθνικές αρμόδιες αρχές. Μερικά στοιχεία πιθανώς να μην είναι διαθέσιμα προς το παρόν ή να μην διατίθενται προς πώληση στην περιοχή σας από την MED-EL. Παρακαλούμε να επικοινωνήσετε με τον τοπικό αντιπρόσωπο της MED-EL για περαιτέρω πληροφορίες. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Cyprus

Middle Ear Implant - VORP 503

Ελληνικά

Εμφυτεύματα Μέσου Ωτός - VORP 503

Παρεμβολές από άλλο εξοπλισμό

  • Ηλεκτροχειρουργική: Τα όργανα ηλεκτροχειρουργικής μπορεί να παράγουν τάσεις ραδιοσυχνοτήτων, οι οποίες μπορεί να επιφέρουν απευθείας ζεύξη μεταξύ του οργάνου και του εμφυτεύματος. Τα μονοπολικά ηλεκτροχειρουργικά όργανα δεν πρέπει να χρησιμοποιούνται κοντά στο εμφύτευμα. Το προκαλούμενο ρεύμα μπορεί να επιφέρει ζημιά στο εμφύτευμα ή στην ακοή του ασθενή.
  • Χειρουργική διαθερμία: Δεν πρέπει ποτέ να εφαρμόζεται διαθερμία στο εμφύτευμα διότι τα υψηλά ρεύματα που προκαλούνται στο εμφύτευμα θα μπορούσαν να προκαλέσουν ζημιά στο εμφύτευμα ή στην ακοή του ασθενή.
  • Ιονίζουσα ακτινοβολία: Η θεραπεία ακτινοβολίας μέχρι συνολική δόση ιονισμού 100 Gray καθώς και οι ιατρικές διαγνωστικές διαδικασίες που χρησιμοποιούν ακτινοβολία ιονισμού, όπως ακτινογραφία, αξονική τομογραφία και τομογραφία εκπομπής ποζιτρονίων δεν βλάπτουν το εμφύτευμα. Συστήνεται να μην φοράτε επεξεργαστή ήχου κατά τη διάρκεια της ακτινοβολίας.
  • Υπερηχογράφημα: Έκθεση σε κλινικά χρήσιμο διαγνωστικό υπέρηχο δεν προκαλεί ζημιά στο εμφύτευμα.
  • Απινιδισμός: Η προκαλούμενη ενέργεια κατά τον απινιδισμό θα μπορούσε να προκαλέσει βλάβη στο εμφύτευμα. Δεν πρέπει να διεξάγεται απινιδισμός στη συσκευή ή κοντά σε αυτήν.
  • Μονοπολική ηλεκτροκαυτηρίαση, θεραπευτικό υπερηχογράφημα, διακρανιακή μαγνητική διέγερση, ηλεκτροσπασμοθεραπεία: Δεν επιτρέπεται απευθείας εφαρμογή πάνω από το εμφύτευμα, διότι οι ανωτέρω διαδικασίες μπορεί να προκαλέσουν ζημιά σε αυτό.
  • Απεικόνιση μαγνητικού συντονισμού (MRI): Η εξέταση MRI με το VORP 503 επιτρέπεται μόνο σε σαρωτές MRI 1,5 Tesla (T) κλειστού τύπου. Πρέπει να ληφθούν υπόψη οι ακόλουθες συνθήκες:
    • Ο σαρωτής MRI πρέπει να περιορίζεται στην "Κανονική κατάσταση λειτουργίας". Η "Κατάσταση λειτουργίας πρώτου επιπέδου" πρέπει να αποφεύγεται.
    • Τα τοπικά πηνία RF (ραδιοσυχνοτήτων) μετάδοσης δεν πρέπει να χρησιμοποιούνται στον τομέα της κεφαλής και του αυχένα. Τα τοπικά πηνία δέκτη δεν έχουν περιορισμό στη χρήση.
    • Προτού εισέλθουν ασθενείς στην αίθουσα MRI, πρέπει να αφαιρεθεί ο επεξεργαστής ήχου από το κεφάλι. Κατά τη διάρκεια της σάρωσης μπορεί να προκύψουν ηχητικές παρεμβολές. Συνιστάται στους ασθενείς να αναφέρουν οποιαδήποτε δυσφορία που μπορεί να προκύψει και να ζητάνε διακοπή της σάρωσης MRI. Μετά την εξέταση MRI, ο ασθενής θα τοποθετήσει τον επεξεργαστή ήχου μόνο αφότου αποχωρήσει από την αίθουσα MRI.
    • Κατά τη διάρκεια της εξέτασης MRI, απαιτείται το κεφάλι να έχει ευθεία κατεύθυνση.
    • Στις εικόνες γύρω από το εμφύτευμα θα είναι παρόν ένα ψευδές εύρημα περίπου 14 εκ.
    • Μια εξέταση MRI με > 1,5Τ θα προκαλέσει ζημιά στο εμφύτευμα και πρέπει να αποφεύγεται.
    • Εάν απαιτείται εξέταση MRI πριν από την πρώτη ενεργοποίηση του Vibrant Soundbridge, πρέπει να ληφθούν υπόψη μέτρα για να εμποδιστούν επιπλοκές στην ίαση των πληγών λόγω της πιθανής κίνησης του εμφυτεύματος στο δυνατό πεδίο MRI.
    • Όταν πρέπει να εξεταστούν κάτω άκρα, συστήνεται, αλλά δεν είναι απαραίτητο, τα πόδια του ασθενή να τοποθετούνται πρώτα στον σαρωτή.
       
  • Αντικλεπτικά συστήματα και συστήματα ανίχνευσης μετάλλων: Τα αντικλεπτικά συστήματα του εμπορίου και οι ανιχνευτές μετάλλων παράγουν δυνατά ηλεκτρομαγνητικά πεδία. Ασθενείς με ένα εμφύτευμα πρέπει να ενημερώνονται ότι η διέλευση μέσα από ανιχνευτές μετάλλων ασφαλείας μπορεί να ενεργοποιήσει τον συναγερμό ανιχνευτή. Για το λόγο αυτό συστήνεται οι ασθενείς να έχουν πάντα μαζί την Κάρτα Ταυτοποίησης Χρήστη Vibrant Soundbridge.
Τα προϊόντα, οι εφαρμογές και τα χαρακτηριστικά απόδοσης αποτελούν αντικείμενο έγκρισης από τις εθνικές αρμόδιες αρχές. Μερικά στοιχεία πιθανώς να μην είναι διαθέσιμα προς το παρόν ή να μην διατίθενται προς πώληση στην περιοχή σας από την MED-EL. Παρακαλούμε να επικοινωνήσετε με τον τοπικό αντιπρόσωπο της MED-EL για περαιτέρω πληροφορίες. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Czech Republic

Cochlear and Auditory Brainstem Implant System

Česky

Lékařské postupy pro systémy implantátů společnosti MED‑EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Czech Republic

Bone Conduction Implant - BCI 601

Česky

Implantační systém pro přímé kostní vedení - BCI 601

Vzájemná kompatibilita s jinými zařízeními

  • Chirurgická diatermie: Vysokofrekvenční napětí, vytvořené elektrochirurgickými nástroji, může vést k přímému propojení mezi nástrojem a implantátem. Monopolární elektrochirurgické nástroje se nesmí užívat v blízkosti implantátu. Indukované proudy by mohly poškodit implantát nebo sluch pacienta.
  • Radioterapie: Radioterapie nepoškozuje implantát. Doporučuje se, během radioterapie audio procesor odložit.
  • Rentgen, CT, léčba kobaltem, PET, diagnostický ultrazvuk: Žádné omezení v klinické radioterapii.
  • Monopolární elektrokauterizace, léčebný ultrazvuk, transkraniální magnetická stimulace, léčba elektrickým šokem: Nesmí se aplikovat přímo nad implantátem, protože by mohlo dojít k poškození implantátu.
  • Magnetorezonanční tomografie (MRT): MRT vyšetření do 1,5 T jsou při Bonebridge povoleny. Třeba však dodržovat následující podmínky:
    • Audio procesor by se neměl nosit, přes to všechno to může vést k sluchovým vjemům.
    • Na snímcích je vidět v okolí implantátu artefakt o velikosti 15 cm.
    • MRT vyšetření s >1,5 T poškodí implantát, a proto se jim musí vyhýbat.
MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Czech Republic

Middle Ear Implant - VORP 502

Česky

Středoušní implantát - VORP 502

Vzájemná kompatibilita s jinými zařízením

  • Elektrochirurgie: Elektrochirurgické nástroje mohou vytvářet vysokofrekvenční napětí, která mohou přeskakovat ze špičky nástroje přímo na implantát. V blízkosti implantátu se nesmí používat monopolární elektrochirurgické nástroje, protože nimi vytvořený proud by mohl poškodit implantát a mohl by ovlivnit sluch pacienta.
  • Diatermie: V žádném případě se nesmí nad implantátem provést diatermie, protože do implantátu silně indukovaný proud by mohl implantát poškodit a ovlivnit sluch pacienta.
  • Elektrošoková terapie: U pacientů s implantátem VIBRANT SOUNDBRIDGE se nikdy nesmí použít elektrošoková terapie, protože by mohla poškodit implantát a ovlivnit sluch pacienta.
  • Terapie ionizujícím zářením: Potřebné léčby s ionizujícím zářením se musí přesně prověřit a musí se pečlivě zvážit riziko poškození implantátu VORP vzhledem k prospěchu takové léčby.
  • Tomografie magnetickou rezonancí (MRT): Pacienti s implantátem VIBRANT SOUNDBRIDGE (VORP 502x) by se neměli podstoupit vyšetření MRT a také by neměli vstupovat do prostoru MRT anebo se zdržovat v blízkosti zdrojů se silným magnetickým polem.
  • Kardioverze: Energie, vytvořená v průběhu kardioverze může způsobit poškození implantátu. Nad implantátem nebo v jeho blízkosti by se neměla provádět defibrilace.
  • Jiné: Účinky léčby kobaltem, vyšetřením PET Scans, diagnostickým a léčebným ultrazvukem a léčby ineárním urychlovačem v blizkosti implantátu nejsou známé. V blízkosti implantátu by se mělo upustit od takového způsobu léčby.
MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Czech Republic

Middle Ear Implant - VORP 503

Česky

Středoušní implantát - VORP 503

Vzájemná interakce s jinými zařízeními

  • Elektrochirurgie: Elektrochirurgické nástroje mohou vytvářet vysokofrekvenční napětí, která mohou přeskakovat z nástroje přímo na implantát. Monopolární elektrochirurgické nástroje se nesmí užívat v blízkosti implantátu. Indukované proudy by mohly poškodit implantát nebo sluch pacienta.
  • Chirurgická diatermie: V žádném případě se nesmí nad implantátem provést diatermie, protože do implantátu silně indukovaný proud by mohl implantát poškodit a ovlivnit sluch pacienta.
  • Ionizující záření: Léčba ozařováním až do celkové radiační dávky 100 Gray a lékařská diagnostika pomocí ionizujícího záření (jako je rentgen, CT a PET), nepoškodí implantát. Doporučuje se odložit audio procesor během ozařování.
  • Ultrazvuk: Účinky klinického diagnostického ultrazvuku nepoškodí implantát.
  • Kardioverze: Energie, vytvořená v průběhu kardioverze může způsobit poškození implantátu. Nad implantátem nebo v jeho blízkosti by se neměla provádět defibrilace.
  • Monopolární elektrokauterizace, léčebný ultrazvuk, transkraniální magnetická stimulace, elektrokonvulzivní terapie: Nesmí se aplikovat přímo nad implantátem, protože by mohlo dojít k poškození implantátu.
  • Magnetická rezonanční tomografie (MRT): Vyšetření MR u VORP 503 je přípustné pouze s uzavřeným MRI skenerem při 1,5 Tesla (T). Musí být dodrženy následující podmínky:
    • MRI skener musí být omezen na normální provozní režim. Je nutné se vyhnout provoznímu režimu stupně 1.
    • Lokální vysílací radiofrekvenční cívky se nesmí používat v oblasti hlavy a krku. Lokální cívky přijímače mohou být použity bez omezení.
    • Pacienti musí odstranit audio procesor z hlavy před tím, než vstoupí do místnosti s MRT. Při skenování mohou vzniknout slyšitelné interference. Pacienti by měli být poučeni, aby okamžitě hlásili jakékoliv nepohodlí, aby se v případě potřeby mohlo MR vyšetření ukončit. Po vyšetření MR si smí pacient audio procesor přiložit pouze tehdy, až když opustil místnost s MRT.
    • Při vyšetření MR je nutné hlavu držet rovně.
    • Na snímcích je viditelný artefakt cca 14 cm kolem implantátu.
    • MR vyšetření s >1,5 T poškodí implantát, a je proto nutné se mu vyhnout.
    • Pokud je před první aktivací Vibrant Soundbridge nutné vyšetření MR, musí se učinit bezpečnostní opatření, aby se zabránilo komplikacím při hojení rány z důvodu možného pohybu implantátu v silném poli MR.
    • Pokud jsou vyšetřovány dolní končetiny, doporučuje se, aby si pacient lehl do skeneru nohama dopředu.
       
  • Bezpečnostní ochranné systémy proti krádeži a detektory kovů: Komerční bezpečnostní ochranné systémy proti krádeži a detektory kovů vytvářejí silná elektromagnetická pole. Pacienti s implantátem musí být upozorněni na to, že při průchodu bezpečnostním detektorem kovů by se mohl spustit alarm. Z toho důvodu se doporučuje, aby pacienti měli vždy u sebe svou identifikační kartu uživatele Vibrant Soundbridge.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Denmark

Cochlear and Auditory Brainstem Implant System

Dansk

Medicinske procedurer for MED‑EL-implantatsystemer

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Denmark

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Denmark

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Denmark

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Ecuador

Cochlear and Auditory Brainstem Implant System

Español

Procedimientos médicos para Sistemas de implante MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Ecuador

Bone Conduction Implant - BCI 601

Español

Implantes de Conducción Ósea - BCI 601

Interferencias con otros dispositivos

  • Diatermia quirúrgica: El instrumental de electrocirugía puede producir voltajes de radiofrecuencia, que pueden resultar en el acoplamiento directo entre el instrumento y el implante. Queda prohibido emplear instrumental electroquirúrgico monopolar cerca del implante. Las corrientes inducidas podrían causar daños en el implante o en la audición del paciente.
  • Terapia de radiación ionizante: La radioterapia no daña el implante. Se recomienda no portar un procesador de audio durante la irradiación.
  • Rayos X, tomografía computarizada, tratamiento con cobalto, escáner PET, ultrasonido diagnóstico: No existen restricciones dentro de las exposiciones con fines clínicos.
  • Electrocauterio monopolar, ultrasonido terapéutico, estimulación magnética transcraneal, terapia electroconvulsiva: Queda prohibido aplicar directamente estos procedimientos sobre el implante, ya que podrían causar daños en el mismo.
  • Imagen por Resonancia Magnética (IRM): La evaluación por medio de IRM está permitida hasta 1,5 T con el Bonebridge. Tenga en cuenta las siguientes exigencias:
  • No se debe portar el procesador de audio. Aún así, es posible que surjan interferencias audibles.
  • Los escáneres presentarán un artefacto de 15 cm alrededor del implante.
  • Evite una evaluación con IRM >1,5 T, ya que dañaría el implante.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL.MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Ecuador

Middle Ear Implant - VORP 502

Español

Implantes de Oído Medio - VORP 502

Interferencias con otros dispositivos

  • Electrocirugía: Los instrumentos electroquirúrgicos pueden producir voltajes de radiofrecuencia que son capaces de acoplar el extremo del instrumento y el implante. Los instrumentos de cirugía monopolar no deben ser usados en el área próxima al implante debido a que inducen corrientes que pueden dañar el implante o la audición del paciente.
  • Diatermia: La diatermia no debe ser nunca aplicada sobre el implante debido a que las grandes corrientes que se inducen en el mismo lo pueden dañar o dañar la audición del paciente.
  • Terapia Electroconvulsiva: La terapia electroconvulsiva no debe ser usada nunca en un paciente con un Soundbridge debido a que puede dañar el implante o la audición del paciente.
  • Terapia de Radiación Ionizante: La terapia de radiación ionizante debe ser considerada cuidadosamente ante el riesgo de dañar el implante VORP. Debe ser sopesado el riesgo frente al beneficio médico de dicha terapia.
  • Resonancia Magnética (RMN): Los pacientes implantados con el VIBRANT SOUNDBRIDGE (VORP 502x) no deben ser sometidos a RMN y no deben entrar a una cabina de RMN o estar en las proximidades de otras fuentes de campos magnéticos potentes.
  • Cardioversión: La energía inducida durante la cardioversión puede dañar el implante. La desfibrilación no debe ser aplicada en o cerca del dispositivo.
  • Miscelánea: Los efectos del tratamiento de cobalto, PET, diagnóstico y terapia ultrasónica y técnicas de aceleración lineal en las proximidades del implante son desconocidas. Su uso en las zonas próximas al implante debe ser evitado.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Ecuador

Middle Ear Implant - VORP 503

Español

Implantes de Oído Medio - VORP 503

Interferencias con otros equipos

  • Electrocirugía: los instrumentos electroquirúrgicos pueden producir frecuencias de radio que pueden causar el acoplamiento entre el instrumento y el implante. No se deben utilizar instrumentos quirúrgicos monopolares en las proximidades del implante. La corriente de inducción podría dañar el implante y/o la audición del paciente.
  • Diatermia quirúrgica: nunca se debe aplicar diatermia sobre el implante porque la corriente inducida podría causar daños en el implante o en la audición del paciente.
  • Radiación ionizante: la terapia con radiación ionizante hasta una dosis de ionización total de 100 Gy, así como los procedimientos médicos diagnósticos que utilizan radiación ionizante, como los rayos X, TC y PET, no dañan el implante. No se recomienda llevar el procesador auditivo durante la radiación.
  • Ultrasonidos: la exposición a ultrasonidos de utilidad diagnóstica no causa daños en el implante.
  • Cardioversión: la energía inducida durante la cardioversión podría dañar el implante. No se debe aplicar desfibrilación sobre el dispositivo ni en sus proximidades.
  • Electrocauterización monopolar, ultrasonidos terapéuticos, estimulación magnética transcraneal, tratamiento electroconvulsivo: nunca deben aplicarse directamente sobre el implante porque pueden dañarlo.
  • Imágenes por resonancia magnética (IRM): el examen por IRM con VORP 503 solo se permite con escáneres IRM cerrados de 1,5 teslas (T). Deben tenerse en cuenta las siguientes condiciones:
    • El escáner MRI debe estar limitado a modo de operación normal; evite el modo de operación de primer nivel.
    • No utilice bobinas de RF de transmisión local en la región craneal o cervical. No se limita el uso de bobinas de recepción local.
    • Antes de que el paciente entre en la sala de IRM, el procesador auditivo debe retirarse de la cabeza. Durante el escáner pueden producirse interferencias audibles. Los pacientes deben estar informados de que tienen que comunicar cualquier posible molestia y solicitar que se interrumpa la prueba si es necesario. Después de la prueba, el paciente no se pondrá el procesador auditivo hasta salir de la sala de IRM.
    • Durante el examen con IRM, la cabeza debe mantenerse en posición recta.
    • Las imágenes mostrarán un artefacto de aproximadamente 14 cm alrededor del implante.
    • Los exámenes con IRM de más de 1,5 T causan daños en el implante y deben evitarse.
    • Si necesita un examen IRM antes de la primera activación de Vibrant Soundbridge, deberán tomarse medidas de seguridad para evitar complicaciones en la curación de la herida por posibles movimientos del implante dentro del potente campo de RM.
    • Para examinar las extremidades inferiores se recomienda, aunque no es imprescindible, que las piernas entren primero en el escáner.
  • Sistemas antirrobo y detectores de metales: los sistemas comerciales antirrobo y detectores de metales generan potentes campos electromagnéticos. Los pacientes que utilicen implantes deben saber que pueden activar la alarma al pasar por los detectores de metales de seguridad. Por eso se recomienda a los pacientes llevar encima la tarjeta de identificación de usuario de Vibrant Soundbridge en todo momento.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Egypt

Cochlear and Auditory Brainstem Implant System

العربية

الإجراءات الطبية الخاصة بأنظمة غرسات MED‑EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Egypt

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Egypt

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Egypt

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Estonia

Cochlear and Auditory Brainstem Implant System

Lietuvos

Meditsiinilised protseduurid ja MED‑EL-i implantaadisüsteemid

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Estonia

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Estonia

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Estonia

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Ethiopia

Cochlear and Auditory Brainstem Implant System

English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Ethiopia

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Ethiopia

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Ethiopia

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Finland

Cochlear and Auditory Brainstem Implant System

Suomi

Medicinska förfaranden för MED‑EL implantatsystem

ManualMRI ChecklistMRI Safety Status Overview
Svenska

Medicinska förfaranden för MED‑EL implantatsystem

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Finland

Bone Conduction Implant - BCI 601

Suomi

Luujohtoistute - BCI 601

Muiden laitteiden häirintä

  • Kirurginen diatermia: Sähkökirurgiset instrumentit voivat tuottaa radiotaajuusjännitteitä, joista saattaa seurata suora kytkentä instrumentin ja implantin välillä. Implantin läheisyydessä ei saa käyttää monopolaarisia sähkökirurgisia instrumentteja. Syntyneet virrat voivat vahingoittaa implanttia tai potilaan kuuloa.
  • Sädehoito: Sädehoito ei vahingoita implanttia. Säteilytyksen aikana ei suositella audioprosessorin käyttöä.
  • Röntgen, tietokonetomografia, kobolttihoitojen, PET-kuvaus, diagnostinen ultraääni: Ei rajoitusta kliinisesti hyödyllisissä altistuksissa.
  • Monopolaarinen sähkökauterointi, terapeuttinen ultraääni, transkraniaalinen magneettistimulaatio, sähköšokkihoito: Ei saa milloinkaan kohdistaa suoraan implanttiin, koska nämä toimenpiteet voivat vahingoittaa sitä.
  • Magneettiresonanssikuvaus (MRI): MRI-tutkimus on sallittu Bonebridgea käyttävällä potilaalla enintään 1,5 T:n teholla. Seuraavat olosuhteet on otettava huomioon:
    • Audioprosessoria ei saa käyttää, mutta silti voi tapahtua kuuluvaa häiriötä.
    • Kuvissa on 15 cm artefakti implantin ympärillä.
    • MRI-tutkimus > 1,5 T:n teholla vahingoittaa implanttia, ja sitä on vältettävä.
Toimivaltaisten kansallisten viranomaisten on hyväksyttävä tuotteet, sovellukset ja ominaisuudet. Jotkin ominaisuudet eivät ehkä ole tällä hetkellä saatavilla, tai MED-EL ei tarjoa niitä myyntiin alueellasi. Saat lisätietoja ottamalla yhteyttä paikalliseen MED-EL-edustajaan. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Svenska

Benledningsimplantatet - BCI 601

Påverkan av annan utrustning

  • Kirurgisk diatermi: Elektrokirurgiska instrument kan ge upphov till radiofrekvensspänningar som kan göra så att instrumentet kopplas direkt till implantatet. Monopolära elektrokirurgiska instrument får inte användas i närheten av implantatet. De strömstyrkor som genereras kan skada implantatet eller patientens hörsel.
  • Behandling med joniserande strålning: Strålbehandling skadar inte implantatet. Vi rekommenderar att patienten inte har ljudprocessorn på sig under själva strålningen.
  • Röntgen, CT, koboltbehandling, PET-skanning, diagnostiskt ultraljud: Inga restriktioner vid normal klinisk användning.
  • Monopolär elektrokauterisation, terapeutiskt ultraljud, transkranial magnetisk stimulans, elektrokonvulsiv behandling: Får aldrig göras direkt över implantatet, eftersom det kan skadas av dessa behandlingar.
  • Magnetisk resonanstomografi (MRT): MRT-undersökningar med högst 1,5 T tillåts med Bonebridge. Man måste ta hänsyn till följande villkor:
    • Ljudprocessorn ska inte bäras, men störande ljud kan ändå förekomma.
    • En 15 cm stor artefakt kommer att synas runt implantatet på bilderna.
    • MRT-undersökningar med >1,5 T skadar implantatet och måste undvikas.
Produkterna, applikationer och egenskaper är beroende av godkännande av de nationella myndigheterna; vissa egenskaper kan för närvarande vara inte tillgängliga, eller inte erbjudas till försäljning från MED-EL i din region. Kontakta ditt lokala MED-EL kontor eller representant för ytterligare information. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Finland

Middle Ear Implant - VORP 502

Suomi

Välikorvaistute - VORP 502

Muiden laitteiden häirintä

  • Sähkökirurgia: Sähkökirurgiset instrumentit voivat tuottaa radiotaajuusjännitteitä, jotka voivat muodostaa suoran kytkennän instrumentin kärkeen ja implanttiin. Implantin läheisyydessä ei saa käyttää monopolaarisia sähkökirurgisia instrumentteja, sillä indusoituneet virrat voivat vahingoittaa implanttia tai potilaan kuuloa.
  • Diatermia: Implantin yllä ei koskaan saa käyttää diatermiaa, sillä implanttiin indusoituvat korkeat virrat voivat vahingoittaa implanttia tai potilaan kuuloa.
  • Sähköšokkihoito: Sähköšokkihoitoa ei koskaan saa käyttää potilaalle, jolla on SOUNDBRIDGE, koska se saattaa vahingoittaa implanttia tai potilaan kuuloa.
  • Ionisoiva sädehoito: Ionisoivan sädehoidon antamista on harkittava tarkkaan ja VORP-implantin vahingoittumisen riskiä on verrattava huolellisesti tällaisesta hoidosta saatavaan lääketieteelliseen hyötyyn.
  • Magneettiresonanssikuvaus (MRI): Potilaita, joille on implantoitu VIBRANT SOUNDBRIDGE (VORP 502x), ei saa altistaa magneettiresonanssikuvaukselle, eivätkä potilaat saa siirtyä MRI-huoneeseen tai olla muiden voimakkaiden magneettikenttien läheisyydessä.
  • Kardioversio: Kardioversion aikana indusoitunut energia saattaa vahingoittaa implanttia. Defibrillaatiota ei saa antaa laitteen päällä tai lähellä.
  • Sekalaista: Kobolttihoidon, PET-kuvausten, diagnostisen ja terapeuttisen ultraäänen ja lineaaristen kiihdytystekniikoiden vaikutuksia implantin läheisyydessä ei tunneta. Niiden käyttämistä implantin läheisyydessä on vältettävä.
Toimivaltaisten kansallisten viranomaisten on hyväksyttävä tuotteet, sovellukset ja ominaisuudet. Jotkin ominaisuudet eivät ehkä ole tällä hetkellä saatavilla, tai MED-EL ei tarjoa niitä myyntiin alueellasi. Saat lisätietoja ottamalla yhteyttä paikalliseen MED-EL-edustajaan. MRI Safety Status Overview
Svenska

Mellanörat Implantat - VORP 502

Påverkan av annan utrustning

  • Elektrokirurgi: Elektrokirurgiska instrument är kapabla att producera radio-frekventa spänningar som kan överföras direkt från instruments spets till implantatet. Monopolära elektrokirurgiska instrument skall inte användas i implantatets omedelbara närhet därför att de inducerade strömmarna kan skada implantatet eller patientens hörsel.
  • Diatermi: Diatermi skall aldrig anbringas över implantatet därför att starka strömmar inducerade in i implantatet kan skada implantatet eller patientens hörsel.
  • Elektrokonvulsiv terapi: Elektrokonvulsiv terapi skall aldrig användas på en patient med VIBRANT SOUNDBRIDGE därför att denna terapi kan skada implantatet eller patientens hörsel.
  • Joniserande strålningsterapi: Joniserande strålningsterapi skall noga övervägas, och risken för skada på VORP implantatet skall noga vägas mot den medicinska nytta av en sådan terapi.
  • Magnetisk Resonans Diagnostik (MRI): Patienter implanterade med VIBRANT SOUNDBRIDGE (VORP 502x) skall inte undergå MRI, och skall inte beträda en MRI sal eller komma i omedelbar närhet av andra källor till starka magnetfält.
  • Kardioversion: Energin inducerad under kardioversion kan skada implantet. Defibrillation skall inte anbringas över, eller i närheten av devicet.
  • Diverse: Effekterna av kobolt-behandling, PET scan, diagnostiskt och terapeutiskt ultraljud, och linjära accelerations-tekniker i implantatets närhet är okända. Användande av dessa i implantatets närhet bör undvikas.
Produkterna, applikationer och egenskaper är beroende av godkännande av de nationella myndigheterna; vissa egenskaper kan för närvarande vara inte tillgängliga, eller inte erbjudas till försäljning från MED-EL i din region. Kontakta ditt lokala MED-EL kontor eller representant för ytterligare information. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Finland

Middle Ear Implant - VORP 503

Suomi

Välikorvaistute - VORP 503

Muiden laitteiden häirintä

  • Sähkökirurgia: Sähkökirurgiset instrumentit voivat tuottaa radiotaajuusjännitteitä, jotka saattavat aiheuttaa suoran kytkennän instrumentin ja implantin välillä. Implantin läheisyydessä ei saa käyttää monopolaarisia sähkökirurgisia instrumentteja. Indusoituneet virrat voivat vahingoittaa implanttia tai potilaan kuuloa.
  • Kirurginen diatermia: Implantin yllä ei koskaan saa käyttää diatermiaa, sillä implanttiin indusoituvat korkeat virrat voivat vahingoittaa implanttia tai potilaan kuuloa.
  • Ionisoiva säteily: Sädehoito, jossa kokonaisionisaatioannos on enintään 100 graytä, ja lääkinnälliset diagnostiikkatoimenpiteet, joissa käytetään ionisoivaa säteilyä, kuten röntgen, tietokonetomografia ja PET-kuvaus, eivät vahingoita implanttia. Säteilytyksen aikana ei suositella audioprosessorin käyttöä.
  • Ultraääni: Altistuminen kliinisesti hyödylliselle diagnostiselle ultraäänelle ei vahingoita implanttia.
  • Kardioversio: Kardioversion aikana indusoitunut energia saattaa vahingoittaa implanttia. Defibrillaatiota ei saa antaa laitteen päällä tai lähellä.
  • Monopolaarinen sähkökauterointi, terapeuttinen ultraääni, transkraniaalinen magneettistimulaatio, sähköšokkihoito: Ei saa milloinkaan kohdistaa suoraan implanttiin, koska nämä toimenpiteet voivat vahingoittaa implanttia.
  • Magneettiresonanssikuvaus (MRI): MRI-tutkimus yhdessä VORP 503 -implantin kanssa on sallittu vain 1,5 teslan (T) suljetulla putkella varustetuissa MRI-kuvauslaitteilla. Seuraavat olosuhteet on otettava huomioon:
    • MRI-kuvauslaite on rajoitettava “normaaliin käyttötilaan", ja "ensimmäisen tason käyttötilaa" on vältettävä.
    • Paikallisia lähettäviä radiotaajuuskeloja ei saa käyttää pään ja kaulan alueella. Paikallisten vastaanotinkelojen käyttöä ei ole rajoitettu.
    • Audioprosessori on poistettava päästä, ennen kuin potilaat menevät MRI-tutkimushuoneeseen. Kuvauksen aikana saattaa kuulua interferenssiä. Potilaita on neuvottava ilmoittamaan mahdollisesti aiheutuvasta epämukavuuden tunteesta ja pyytämään, että MRI keskeytetään tarvittaessa. MRI-tutkimuksen jälkeen potilaan on puettava audioprosessori vasta MRI-tutkimushuoneesta poistumisen jälkeen.
    • MRI-tutkimuksen aikana pään suuntauksen on oltava suora.
    • Kuvissa on noin 14 cm:n artefakti implantin ympärillä.
    • MRI-tutkimus >1,5 T:n teholla vahingoittaa implanttia, ja sitä on vältettävä.
    • Jos MRI-tutkimusta tarvitaan ennen Vibrant Soundbridgen ensimmäistä aktivointikertaa, on otettava huomioon turvatoimenpiteet implantin voimakkaassa MR-kentässä tapahtuvasta mahdollisesta liikkumisesta johtuvien haavan paranemiseen liittyvien komplikaatioiden ehkäisemiseksi.
    • Kun on tutkittava alaraajoja, on suositeltavaa mutta ei pakollista sijoittaa potilaan jalat ensin kuvauslaitteeseen.
       
  • Varkauden- ja metallinilmaisujärjestelmät: Kaupalliset varkaudenilmaisujärjestelmät ja metallinilmaisimet tuottavat voimakkaita sähkömagneettisia kenttiä. Implanttia käyttäville potilaille on ilmoitettava, että metallinilmaisinten läpi kulkeminen saattaa laukaista ilmaisimen hälyttimen. Tämän vuoksi potilaita kehotetaan pitämään Vibrant Soundbridge -käyttäjän tunnistekorttia aina mukanaan.
Toimivaltaisten kansallisten viranomaisten on hyväksyttävä tuotteet, sovellukset ja ominaisuudet. Jotkin ominaisuudet eivät ehkä ole tällä hetkellä saatavilla, tai MED-EL ei tarjoa niitä myyntiin alueellasi. Saat lisätietoja ottamalla yhteyttä paikalliseen MED-EL-edustajaan. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Svenska

Mellanörat Implantat - VORP 503

Interferens med annan utrustning

  • Elektrokirurgi: Elektrokirurgiska instrument kan generera radiofrekventa spänningar som kan leda till direktkoppling mellan instrumentet och implantatet. Monopolära elektrokirurgiska instrument får inte användas i närheten av implantatet. De frammanade spänningarna kan leda till skada på implantatet eller patientens hörsel.
  • Kirurgisk diatermi: Diatermi får aldrig tillämpas över implantatet eftersom de höga spänningar som går in i implantatet kan leda till skada på implantatet eller på patientens hörsel.
  • Joniserande strålning: Strålbehandling upp till en total joniseringsdos på 100 Gray och medicinska diagnostiska rutiner med joniserande strålning som t.ex. röntgen, CT och PET, skadar inte implantatet. Audioprocessor bör inte bäras vid strålning.
  • Ultraljud: Exponering för kliniskt praktisk ultraljudsdiagnostik utgör ingen risk för skada på implantatet.
  • Elkonvertering: Den energi som avges under elkonvertering kan skada implantatet. Defibrillering får inte tillämpas på eller i närheten av enheten.
  • Monopolär diatermi, terapeutiskt ultraljud, transkraniell magnetisk stimulering, elektrokonvulsiv behandling: Får aldrig tillämpas direkt över implantatet eftersom dessa behandlingar kan skada implantatet.
  • Magnetisk resonanstomografi (MRT): MRT-undersökning med VORP 503 tillåts endast med 1,5 Tesla (T) stängda MRT-skannrar. Följande tillstånd har övervägts:
    • MRT-skannern måste vara begränsad till "Normalt driftläge"; "Driftläge Första nivå" måste undvikas.
    • Lokalt sändande RF-spolar får inte användas i huvud- eller nackområde. Användning av lokala mottagarspolar är inte begränsad.
    • Innan patienter går in i ett MRT-rum måste audioprocessorn avlägsnas från huvudet. Hörbar störning kan inträffa under undersökningen. Patienter ska instrueras att informera om eventuella obehag som kan uppstå och begära att undersökningen avbryts vid behov. Efter MRT-undersökningen ska patienten sätta på sig audioprocessorn först efter han/hon har lämnat MRT-rummet.
    • Under MRT måste huvudet hållas rakt.
    • En artefakt på cirka 14 cm kommer att synas runt implantatet på bilderna.
    • MRT överstigande 1,5 T är skadlig för implantatet och måste undvikas.
    • Om MRT krävs innan Vibrant Soundbridge aktiveras för första gången ska säkerhetsåtgärder vidtas för att förebygga problem med läkningsprocessen på grund av möjlig rörelse av implantatet i ett starkt MR-fält.
    • När lägre extremiteter ska undersökas rekommenderas det att patientens ben går in i skannern först. Detta är dock inte obligatoriskt.
       
  • Stöld och metalldetektorsystem: Kommersiella och metalldetektorer avger starka elektromagnetiska fält som kan ge patienten ljudförnimelser via implantatet vid passage. Patienter med implantat ska vara medvetna om att larmet kan utlösas när de går igenom metalldetektorer. Av denna anledning ber vi patienten att alltid bära på sig sitt kort för användaridentifiering för Vibrant Soundbridge.
Produkterna, applikationer och egenskaper är beroende av godkännande av de nationella myndigheterna; vissa egenskaper kan för närvarande vara inte tillgängliga, eller inte erbjudas till försäljning från MED-EL i din region. Kontakta ditt lokala MED-EL kontor eller representant för ytterligare information. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
France

Cochlear and Auditory Brainstem Implant System

Français

Procédures médicales pour les systèmes d'implant MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
France

Bone Conduction Implant - BCI 601

Français

Implants à conduction osseuse - BCI 601

Interférences avec d'autres équipements

  • Diathermie chirurgicale : Les instruments électrochirurgicaux peuvent produire des rayonnements haute fréquence pouvant induire des effets de couplage direct entre l'instrument et l'implant. Ne pas utiliser d'instruments électrochirurgicaux monopolaires à proximité de l'implant. Les courants induits peuvent endommager l'implant ou les capacités auditives du patient.
  • Thérapie par rayonnement ionisant : La thérapie par rayonnement ionisant n'a pas d'effet dommageable sur l'implant. Il est recommandé de ne pas porter l’audio processeur durant l'irradiation.
  • Rayons X, scanner, traitement au cobalt, scanner TEP, diagnostic aux ultrasons : Aucune restriction dans la limite des expositions cliniquement utiles.
  • Bistouri électrique monopolaire, ultrasons thérapeutiques, stimulation magnétique transcrânienne, thérapie électroconvulsive : Ne jamais appliquer directement sur l'implant, ces procédures pouvant l'endommager.
  • Imagerie par résonance magnétique (IRM) : Examen par IRM jusqu'à 1,5 T possible avec le Bonebridge. Conditions à prendre en compte:
    • Ne pas porter l’audio processeur, mais possibilité d'interférences auditives.
    • Présence d'un artefact de 15 cm autour de l'implant sur les images.
    • Examen IRM avec >1,5 T : implant endommagé, situation à éviter.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
France

Middle Ear Implant - VORP 502

Français

Implants d'Oreille Moyenne - VORP 502

Interférences avec d'autres équipements

  • Electrochirurgie : Les instruments électrochirurgicaux sont susceptibles de produire des ondes de radiofréquence pouvant directement coupler l’extrémité de l’instrument et l’implant. Les instruments chirurgicaux monopolaires ne doivent pas être utilisés à proximité de l’implant en raison des courants induits qui peuvent endommager l’implant ou diminuer le seuil auditif du patient.
  • Diathermie : Ne procédez jamais à une diathermie sur l’implant dans la mesure où les courants élevés induits dans l’implant risquent de d’endommager ou d’aggraver la surdité du patient.
  • Electrochoc : Ne procédez jamais un électrochoc sur un patient qui porte un SOUNDBRIDGE car ceci pourrait endommager l’implant ou diminuer le seuil auditif du patient.
  • Thérapie par rayonnement ionisant : La thérapie par rayonnement ionisant doit être envisagée avec prudence et le risque de dommage à l’implant VORP doit être considéré par rapport au gain médical potentiel de cette thérapie.
  • Imagerie par résonance magnétique (I.R.M.) : les patients porteurs du VIBRANT SOUNDBRIDGE (VORP 502x) ne doivent pas être exposés à des I.R.M. et ne doivent pas pénétrer dans une salle d’I.R.M. ni se tenir à proximité de champs magnétiques puissants.
  • Cardioversion : L’énergie induite en cours de la cardioversion risque d’endommager l’implant. Aucune défibrillation ne doit être appliquée sur ou à proximité de l’implant.
  • Divers : Les effets du traitement au cobalt, de la tomographie d’émission de positons (PET scan), de l’échographie transcranienne et des techniques d’accélération linéaire sur l’implant sont inconnus. L’utilisation de ces techniques proches de l’implant doit être évitée.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
France

Middle Ear Implant - VORP 503

Français

Implants d'Oreille Moyenne - VORP 503

Interférences avec les autres équipements

  • Électrochirurgie : Les instruments électrochirurgicaux peuvent produire des tensions de radio fréquence qui peuvent donner lieu à un couplage entre l'instrument et l'implant. Des instruments électrochirurgicaux monopolaires ne doivent pas être utilisés à proximité de l'implant. Les courants induits entraînent des dommages à l'implant ou au niveau de l'audition du patient.
  • Diathermie chirurgicale : Une diathermie ne doit jamais être appliquée au-dessus de l'implant car les courants élevés induits dans l'implant peuvent entraîner des dommages à l'implant ou au niveau de l'audition du patient.
  • Rayonnements ionisants : Une radiothérapie jusqu'à une dose totale d'ionisation de 100 Gray ainsi que des procédures de diagnostic médical utilisant des rayonnements ionisants, telles que les radiographies, TDM et TEP, ne sont pas nocives pour l'implant. Il est recommandé toutefois de ne pas porter l'audio processeur durant une irradiation.
  • Échographie : Les expositions à une échographie diagnostique utile sur le plan clinique ne causent aucun dommage à l'implant.
  • Cardioversion: L'énergie induite au cours d'une cardioversion peut endommager l'implant. Il ne faut pas pratiquer de défibrillation au-dessus ou près du dispositif.
  • Électrocautérisation monopolaire, échographie thérapeutique, stimulation magnétique transcrânienne, thérapie par électrochocs : Ne doivent jamais être appliquées au-dessus de l'implant car ces procédures peuvent endommager l'implant.
  • Imagerie par résonance magnétique (IRM) : L'examen IRM avec le VORP 503 n'est autorisé que dans le cas d'une utilisation de scanners IRM à ouverture fermée de 1,5 Tesla (T). Il est nécessaire de tenir compte des conditions suivantes :
    • Le scanner IRM doit être limité au « Mode opératoire normal » ; le « Mode opératoire de premier niveau » doit être évité.
    • Les bobines RF de transmission locale ne doivent pas être utilisées dans la région du cou et de la tête. L'utilisation des bobines réceptrices locales n'est pas restreinte.
    • Avant que le patient entre dans la pièce de l'appareil IRM, l'audio processeur doit être retiré de la tête. Une interférence audible peut se produire pendant la procédure suppress. Les patients doivent être conseillés d'indiquer toute gêne éventuelle pouvant se faire ressentir et de demander à ce que la procédure IRM soit interrompue si nécessaire. Après l'examen IRM, le patient ne doit remettre l'audio processeur qu'une fois sorti de la pièce de l'appareil IRM.
    • Au cours de l'examen IRM, il est requis que la tête soit maintenue droite.
    • Un artéfact d'environ 14 cm autour de l'implant sera présent sur les images.
    • Un examen IRM à > 1,5 T endommagera l'implant et doit être évité.
    • Si un examen IRM est nécessaire avant la première activation du système Vibrant Soundbridge, les mesures de sécurité doivent être prises en compte pour prévenir toute complication de la cicatrisation de la plaie due à l'éventuel mouvement de l'implant sous l'influence d'un fort champ magnétique RM.
    • Lorsque les membres inférieurs doivent être examinés, il est recommandé, mais pas exigé, que les jambes du patient soient introduites en premier dans le l'IRM.
  • Systèmes antivol et de détection de métal : Les systèmes de détection antivol et les détecteurs de métaux produisent de forts champs électromagnétiques. Les patients portant un implant doivent être informés que le passage à travers des portiques détecteurs de métaux peut activer l'alarme du détecteur. C'est pour cette raison qu'il est recommandé aux patients de porter sur eux en permanence leur carte d'identification d'utilisateur du système Vibrant Soundbridge.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Gaboon

Cochlear and Auditory Brainstem Implant System

Français

Procédures médicales pour les systèmes d'implant MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Gaboon

Bone Conduction Implant - BCI 601

Français

Implants à conduction osseuse - BCI 601

Interférences avec d'autres équipements

  • Diathermie chirurgicale : Les instruments électrochirurgicaux peuvent produire des rayonnements haute fréquence pouvant induire des effets de couplage direct entre l'instrument et l'implant. Ne pas utiliser d'instruments électrochirurgicaux monopolaires à proximité de l'implant. Les courants induits peuvent endommager l'implant ou les capacités auditives du patient.
  • Thérapie par rayonnement ionisant : La thérapie par rayonnement ionisant n'a pas d'effet dommageable sur l'implant. Il est recommandé de ne pas porter l’audio processeur durant l'irradiation.
  • Rayons X, scanner, traitement au cobalt, scanner TEP, diagnostic aux ultrasons : Aucune restriction dans la limite des expositions cliniquement utiles.
  • Bistouri électrique monopolaire, ultrasons thérapeutiques, stimulation magnétique transcrânienne, thérapie électroconvulsive : Ne jamais appliquer directement sur l'implant, ces procédures pouvant l'endommager.
  • Imagerie par résonance magnétique (IRM) : Examen par IRM jusqu'à 1,5 T possible avec le Bonebridge. Conditions à prendre en compte:
    • Ne pas porter l’audio processeur, mais possibilité d'interférences auditives.
    • Présence d'un artefact de 15 cm autour de l'implant sur les images.
    • Examen IRM avec >1,5 T : implant endommagé, situation à éviter.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Gaboon

Middle Ear Implant - VORP 502

Français

Implants d'Oreille Moyenne - VORP 502

Interférences avec d'autres équipements

  • Electrochirurgie : Les instruments électrochirurgicaux sont susceptibles de produire des ondes de radiofréquence pouvant directement coupler l’extrémité de l’instrument et l’implant. Les instruments chirurgicaux monopolaires ne doivent pas être utilisés à proximité de l’implant en raison des courants induits qui peuvent endommager l’implant ou diminuer le seuil auditif du patient.
  • Diathermie : Ne procédez jamais à une diathermie sur l’implant dans la mesure où les courants élevés induits dans l’implant risquent de d’endommager ou d’aggraver la surdité du patient.
  • Electrochoc : Ne procédez jamais un électrochoc sur un patient qui porte un SOUNDBRIDGE car ceci pourrait endommager l’implant ou diminuer le seuil auditif du patient.
  • Thérapie par rayonnement ionisant : La thérapie par rayonnement ionisant doit être envisagée avec prudence et le risque de dommage à l’implant VORP doit être considéré par rapport au gain médical potentiel de cette thérapie.
  • Imagerie par résonance magnétique (I.R.M.) : les patients porteurs du VIBRANT SOUNDBRIDGE (VORP 502x) ne doivent pas être exposés à des I.R.M. et ne doivent pas pénétrer dans une salle d’I.R.M. ni se tenir à proximité de champs magnétiques puissants.
  • Cardioversion : L’énergie induite en cours de la cardioversion risque d’endommager l’implant. Aucune défibrillation ne doit être appliquée sur ou à proximité de l’implant.
  • Divers : Les effets du traitement au cobalt, de la tomographie d’émission de positons (PET scan), de l’échographie transcranienne et des techniques d’accélération linéaire sur l’implant sont inconnus. L’utilisation de ces techniques proches de l’implant doit être évitée.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Gaboon

Middle Ear Implant - VORP 503

Français

Implants d'Oreille Moyenne - VORP 503

Interférences avec les autres équipements

  • Électrochirurgie : Les instruments électrochirurgicaux peuvent produire des tensions de radio fréquence qui peuvent donner lieu à un couplage entre l'instrument et l'implant. Des instruments électrochirurgicaux monopolaires ne doivent pas être utilisés à proximité de l'implant. Les courants induits entraînent des dommages à l'implant ou au niveau de l'audition du patient.
  • Diathermie chirurgicale : Une diathermie ne doit jamais être appliquée au-dessus de l'implant car les courants élevés induits dans l'implant peuvent entraîner des dommages à l'implant ou au niveau de l'audition du patient.
  • Rayonnements ionisants : Une radiothérapie jusqu'à une dose totale d'ionisation de 100 Gray ainsi que des procédures de diagnostic médical utilisant des rayonnements ionisants, telles que les radiographies, TDM et TEP, ne sont pas nocives pour l'implant. Il est recommandé toutefois de ne pas porter l'audio processeur durant une irradiation.
  • Échographie : Les expositions à une échographie diagnostique utile sur le plan clinique ne causent aucun dommage à l'implant.
  • Cardioversion: L'énergie induite au cours d'une cardioversion peut endommager l'implant. Il ne faut pas pratiquer de défibrillation au-dessus ou près du dispositif.
  • Électrocautérisation monopolaire, échographie thérapeutique, stimulation magnétique transcrânienne, thérapie par électrochocs : Ne doivent jamais être appliquées au-dessus de l'implant car ces procédures peuvent endommager l'implant.
  • Imagerie par résonance magnétique (IRM) : L'examen IRM avec le VORP 503 n'est autorisé que dans le cas d'une utilisation de scanners IRM à ouverture fermée de 1,5 Tesla (T). Il est nécessaire de tenir compte des conditions suivantes :
    • Le scanner IRM doit être limité au « Mode opératoire normal » ; le « Mode opératoire de premier niveau » doit être évité.
    • Les bobines RF de transmission locale ne doivent pas être utilisées dans la région du cou et de la tête. L'utilisation des bobines réceptrices locales n'est pas restreinte.
    • Avant que le patient entre dans la pièce de l'appareil IRM, l'audio processeur doit être retiré de la tête. Une interférence audible peut se produire pendant la procédure suppress. Les patients doivent être conseillés d'indiquer toute gêne éventuelle pouvant se faire ressentir et de demander à ce que la procédure IRM soit interrompue si nécessaire. Après l'examen IRM, le patient ne doit remettre l'audio processeur qu'une fois sorti de la pièce de l'appareil IRM.
    • Au cours de l'examen IRM, il est requis que la tête soit maintenue droite.
    • Un artéfact d'environ 14 cm autour de l'implant sera présent sur les images.
    • Un examen IRM à > 1,5 T endommagera l'implant et doit être évité.
    • Si un examen IRM est nécessaire avant la première activation du système Vibrant Soundbridge, les mesures de sécurité doivent être prises en compte pour prévenir toute complication de la cicatrisation de la plaie due à l'éventuel mouvement de l'implant sous l'influence d'un fort champ magnétique RM.
    • Lorsque les membres inférieurs doivent être examinés, il est recommandé, mais pas exigé, que les jambes du patient soient introduites en premier dans le l'IRM.
  • Systèmes antivol et de détection de métal : Les systèmes de détection antivol et les détecteurs de métaux produisent de forts champs électromagnétiques. Les patients portant un implant doivent être informés que le passage à travers des portiques détecteurs de métaux peut activer l'alarme du détecteur. C'est pour cette raison qu'il est recommandé aux patients de porter sur eux en permanence leur carte d'identification d'utilisateur du système Vibrant Soundbridge.
Les produits, les applications et les caractéristiques en matière de rendement sont sous réserve de l’approbation des autorités nationales compétentes. Dans votre région, certaines fonctionnalités peuvent ne pas être actuellement disponibles ou ne sont pas offertes en vente par MED-EL. Pour de plus amples renseignements, veuillez communiquer avec le représentant local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Georgia

Cochlear and Auditory Brainstem Implant System

English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Georgia

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Georgia

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Georgia

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Germany

Cochlear and Auditory Brainstem Implant System

Deutsch

Medizinische Behandlungen bei MED‑EL Implantatsystemen

ManualMRI ChecklistMRT Sicherheitsstatus im Überblick
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Germany

Bone Conduction Implant - BCI 601

Deutsch

Knochenleitungsimplantat - BCI 601

Wechselwirkung mit anderen Geräten

  • Chirurgische Diathermie: Durch elektrochirurgische Instrumente erzeugte hochfrequente Spannungen können zu einer direkten Kopplung zwischen Instrument und Implantat führen. Monopolare elektrochirurgische Instrumente dürfen in der Nähe des Implantats nicht verwendet werden. Die induzierten Ströme könnten das Implantat oder das Hörvermögen des Patienten schädigen.
  • Strahlentherapie: Strahlentherapie schädigt das Implantat nicht. Es wird empfohlen, den Audioprozessor während der Bestrahlung abzulegen.
  • Röntgen, CT, Kobaltbehandlung, PET-Scan, diagnostischer Ultraschall: Keine Einschränkung bei klinischen Bestrahlungen.
  • Monopolare Elektrokauterisation, therapeutischer Ultraschall, transkranielle Magnetstimulation, Elektroschocktherapie: Darf nie direkt über dem Implantat eingesetzt werden, da dies das Implantat schädigen könnte.
  • Magnetresonanztomographie (MRT): MRT-Untersuchungen bis zu 1,5 T sind bei der Bonebridge erlaubt. Folgende Bedingungen sind zu beachten:
    • Der Audioprozessor soll nicht getragen werden, trotzdem kann es zu Hörempfindungen kommen.
    • Ein Artefakt von 15 cm rund um das Implantat wird auf den Bildern zu sehen sein.
    • MRT-Untersuchungen mit >1,5 T schädigen das Implantat und sind zu vermeiden.
Die Produkte, Anwendungen und Leistungscharakteristiken unterliegen der Zulassung der zuständigen nationalen Behörden; manche Bestandteile stehen derzeit möglicherweise in Ihrem Land nicht zur Verfügung oder werden von MED-EL nicht in Ihrem Land zum Verkauf angeboten. Bitte kontaktieren Sie Ihren persönlichen MED-EL Ansprechpartner für weitere Informationen. MRI Info SheetMRI ChecklistMRT Sicherheitsstatus im Überblick
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Germany

Middle Ear Implant - VORP 502

Deutsch

Mittelohrimplantate - VORP 502

Wechselwirkung mit anderen Geräten

  • Elektrochirurgie: Elektrochirurgische Instrumente können hochfrequente Spannungen erzeugen, die von der Spitze des Instruments direkt auf das Implantat überspringen können. In der Nähe des Implantats dürfen monopolare elektrochirurgische Instrumente nicht verwendet werden, da der von ihnen erzeugte Strom das Implantat beschädigen und das Gehör des Patienten beeinträchtigen kann.
  • Diathermie: Diathermie darf niemals über dem Implantat durchgeführt werden, da der starke, in das Implantat induzierte Strom das Implantat beschädigen und das Gehör des Patienten beeinträchtigen kann.
  • Elektroschocktherapie: Elektroschocktherapie darf an Patienten mit einer VIBRANT SOUNDBRIDGE nicht durchgeführt werden, da dadurch das Implantat beschädigt und das Gehör des Patienten beeinträchtigt werden kann.
  • Therapie mit ionisierender Strahlung: Notwendige Therapien mit ionisierender Strahlung sind genau zu prüfen und das Risiko einer Beschädigung des VORP Implantats sorgfältig gegen den Nutzen einer solchen Behandlung abzuwägen.
  • Magnetresonanztomographie (MRT): Patienten mit einer VIBRANT SOUNDBRIDGE (VORP 502x) sollten nicht mit MRT untersucht werden und sollten keinen MRT-Raum betreten oder sich in der Nähe anderer Quellen mit starken magnetischen Feldern aufhalten.
  • Kardioversion: Die während der Kardioversion erzeugte Energie kann Schäden am Implantat hervorrufen. Am oder in der Nähe des Implantats sollte keine Defibrillierung vorgenommen werden.
  • Sonstiges: Die Auswirkungen von Kobaltbehandlungen, PET Scans, diagnostischem und therapeutischem Ultraschall und Linearbeschleunigerverfahren in der Nähe des Implantats sind nicht bekannt. Solche Behandlungen sollten in der Nähe des Implantats vermieden werden.
Die Produkte, Anwendungen und Leistungscharakteristiken unterliegen der Zulassung der zuständigen nationalen Behörden; manche Bestandteile stehen derzeit möglicherweise in Ihrem Land nicht zur Verfügung oder werden von MED-EL nicht in Ihrem Land zum Verkauf angeboten. Bitte kontaktieren Sie Ihren persönlichen MED-EL Ansprechpartner für weitere Informationen. MRT Sicherheitsstatus im Überblick
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Germany

Middle Ear Implant - VORP 503

Deutsch

Mittelohrimplantate - VORP 503

Beeinflussung durch andere Geräte

  • Elektrochirurgie: Elektrochirurgische Instrumente können hochfrequente Spannungen erzeugen, die von dem Instrument direkt auf das Implantat überspringen können. In der Nähe des Implantats dürfen monopolare elektrochirurgische Instrumente nicht verwendet werden. Die induzierten Ströme könnten das Implantat oder das Hörvermögen des Patienten schädigen.
  • Chirurgische Diathermie: Diathermie darf niemals über dem Implantat durchgeführt werden, da der starke, in das Implantat induzierte Strom das Implantat beschädigen und das Gehör des Patienten beeinträchtigen kann.
  • Ionisierende Strahlung: Strahlentherapie bis zu einer Gesamtstrahlendosis von 100 Gray sowie medizinische Diagnoseverfahren mithilfe von ionisierender Strahlung (wie Röntgen, CT und PET) schädigen das Implantat nicht. Es wird empfohlen, den Audioprozessor während einer Bestrahlung abzulegen.
  • Ultraschall: Einwirkungen von klinischem Diagnoseultraschall beschädigen nicht das Implantat.
  • Kardioversion: Die während einer Kardioversion erzeugte Energie könnte Schäden am Implantat hervorrufen. Am oder in der Nähe des Gerätes sollte keine Defibrillierung vorgenommen werden.
  • Monopolare Elektrokauterisation, therapeutischer Ultraschall, transkranielle magnetische Stimulation, elektrokonvulsive Therapie: Darf nie direkt über dem Implantat eingesetzt werden, da dies das Implantat schädigen könnte.
  • Magnetresonanztomographie (MRT): Eine MRT-Untersuchung bei einem Träger des VORP 503 ist nur mit einem geschlossenen MRT-Scanner bei 1,5 Tesla (T) zulässig. Folgende Bedingungen müssen beachtet werden:
    • Der MRT-Scanner muss auf den normalen Betriebsmodus beschränkt werden. Der Betriebsmodus der Stufe 1 muss vermieden werden.
    • Lokale übertragende HF-Spulen dürfen nicht in der Kopf- oder Nackenregion verwendet werden. Lokale Empfängerspulen können ohne Einschränkung verwendet werden.
    • Patienten müssen den Audioprozessor vom Kopf abnehmen, bevor sie einen MRT-Raum betreten. Während des Scans können hörbare Interferenzen entstehen. Patienten müssen angewiesen werden, jegliches Unwohlsein sofort zu melden, um das MRT gegebenenfalls zu beenden. Nach der MRT-Untersuchung darf der Patient den Audioprozessor erst anlegen, wenn er den MRT-Raum verlassen hat.
    • Während der MRT-Untersuchung muss der Kopf gerade gehalten werden.
    • Auf den Bildern wird ein Artefakt von etwa 14 cm um das Implantat zu sehen sein.
    • Eine MRT-Untersuchung mit mehr als 1,5 T beschädigt das Implantat und muss vermieden werden.
    • Falls vor der ersten Aktivierung der Vibrant Soundbridge eine MRT-Untersuchung notwendig ist, müssen Sicherheitsmaßnahmen getroffen werden, um Komplikationen bei der Wundheilung aufgrund der möglichen Bewegung des Implantats im starken MR-Feld zu vermeiden.
    • Wenn die unteren Extremitäten untersucht werden, wird empfohlen, dass die Beine des Patienten zuerst in den Scanner geschoben werden.
  • Diebstahlsicherung und Metalldetektoren: Kommerzielle Diebstahlsicherungen und Metalldetektoren erzeugen starke elektromagnetische Felder. Patienten mit einem Implantat müssen darauf hingewiesen werden, dass beim Passieren eines Sicherheitsmetalldetektors der Alarm ausgelöst werden könnte. Aus diesem Grund wird empfohlen, dass Patienten immer ihre Vibrant Soundbridge Benutzer-Identifikationskarte mit sich führen. 
Die Produkte, Anwendungen und Leistungscharakteristiken unterliegen der Zulassung der zuständigen nationalen Behörden; manche Bestandteile stehen derzeit möglicherweise in Ihrem Land nicht zur Verfügung oder werden von MED-EL nicht in Ihrem Land zum Verkauf angeboten. Bitte kontaktieren Sie Ihren persönlichen MED-EL Ansprechpartner für weitere Informationen. MRI Info SheetMRI ChecklisteMRT Sicherheitsstatus im Überblick
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Ghana

Cochlear and Auditory Brainstem Implant System

English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Ghana

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Ghana

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Ghana

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Greece

Cochlear and Auditory Brainstem Implant System

Ελληνικά

Ιατρικές διαδικασίες για τα συστήματα εμφυτευμάτων MED‑EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Greece

Bone Conduction Implant - BCI 601

Ελληνικά

Εμφυτεύματα Οστικής Αγωγιμότητας - BCI 601

Παρεμβολές από άλλο εξοπλισμό

  • Χειρουργική διαθερμία: Τα όργανα ηλεκτροχειρουργικής μπορεί να παράγουν τάσεις ραδιοσυχνοτήτων, οι οποίες μπορεί να επιφέρουν απευθείας ζεύξη μεταξύ του οργάνου και του εμφυτεύματος. Τα μονοπολικά ηλεκτροχειρουργικά όργανα δεν πρέπει να χρησιμοποιούνται κοντά στο εμφύτευμα. Το προκαλούμενο ρεύμα μπορεί να επιφέρει ζημιά στο εμφύτευμα ή στην ακοή του ασθενή.
  • Θεραπεία ακτινοβολίας ιονισμού: Η θεραπεία ακτινοβολίας δεν προκαλεί ζημιές στο εμφύτευμα. Συστήνεται να μην φοράτε επεξεργαστή ήχου κατά τη διάρκεια της ακτινοβολίας.
  • Ακτινογραφία, αξονική τομογραφία, θεραπεία με κοβάλτιο, τομογραφία εκπομπής ποζιτρονίων (PET), διαγνωστικό υπερηχογράφημα: Κανένας περιορισμός σε ιατρικά ωφέλιμη έκθεση.
  • Μονοπολική ηλεκτροκαυτηρίαση, θεραπευτικό υπερηχογράφημα, ενδοκρανιακή μαγνητική διέγερση, ηλεκτροσπασμοθεραπεία: Δεν επιτρέπεται απευθείας εφαρμογή πάνω από το εμφύτευμα, διότι οι ανωτέρω διαδικασίες μπορεί να προκαλέσουν ζημιά.
  • Απεικόνιση μαγνητικού συντονισμού (MRI): Εξέταση MRI έως 1,5T με το Bonebridge επιτρέπεται. Πρέπει να ληφθούν υπόψη οι ακόλουθες συνθήκες:
    • Ο επεξεργαστής ήχου δεν θα φοριέται, ωστόσο μπορεί να συμβούν ακουστικές παρεμβολές.
    • Στις εικόνες γύρω από το εμφύτευμα θα είναι παρόν ένα ψευδές εύρημα 15 εκ.
    • Μια εξέταση MRI με >1,5Τ θα προκαλέσει ζημιά στο εμφύτευμα και πρέπει να αποφεύγεται.
Τα προϊόντα, οι εφαρμογές και τα χαρακτηριστικά απόδοσης αποτελούν αντικείμενο έγκρισης από τις εθνικές αρμόδιες αρχές. Μερικά στοιχεία πιθανώς να μην είναι διαθέσιμα προς το παρόν ή να μην διατίθενται προς πώληση στην περιοχή σας από την MED-EL. Παρακαλούμε να επικοινωνήσετε με τον τοπικό αντιπρόσωπο της MED-EL για περαιτέρω πληροφορίες. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Greece

Middle Ear Implant - VORP 502

Ελληνικά

Εμφυτεύματα Μέσου Ωτός - VORP 502

Παρεμβολές από άλλο εξοπλισμό

  • Ηλεκτροχειρουργική: Τα ηλεκτροχειρουργικά όργανα έχουν την ικανότητα παραγωγής τάσεων ραδιοσυχνότητας, οι οποίες μπορούν να συνδέουν απευθείας την ακμή οργάνου και το εμφύτευμα. Τα μονοπολικά ηλεκτροχειρουργικά όργανα δεν πρέπει να χρησιμοποιούνται κοντά στο εμφύτευμα διότι τα προκαλούμενα ρεύματα θα μπορούσαν να επιφέρουν βλάβη στο εμφύτευμα ή στην ακοή του ασθενή.
  • Διαθερμία: Δεν πρέπει ποτέ να εφαρμόζεται διαθερμία στο εμφύτευμα διότι τα υψηλά ρεύματα που προκαλούνται στο εμφύτευμα θα μπορούσαν να προκαλέσουν ζημιά στο εμφύτευμα ή στην ακοή του ασθενή.
  • Ηλεκτροσπασμοθεραπεία: Δεν πρέπει ποτέ να χρησιμοποιείται ηλεκτροσπασμοθεραπεία σε έναν ασθενή με Soundbridge διότι ενδέχεται να προκληθεί ζημιά στο εμφύτευμα ή στην ακοή του ασθενή.
  • Θεραπεία ιονίζουσας ακτινοβολίας: Η θεραπεία ιονίζουσας ακτινοβολίας πρέπει να εξετάζεται λεπτομερώς και να μελετάται προσεκτικά ο κίνδυνος βλάβης στο εμφύτευμα VORP σε σχέση με τα ιατρικά πλεονεκτήματα από μια τέτοια θεραπεία.
  • Απεικόνιση μαγνητικού συντονισμού (MRI): Ασθενείς με εμφυτευμένο VIBRANT SOUNDBRIDGE (VORP 502x) δεν πρέπει να υπόκεινται σε MRI, και δεν πρέπει να εισέρχονται σε αίθουσα MRI ή να προσεγγίζουν άλλες πηγές δυνατών μαγνητικών πεδίων.
  • Απινιδισμός: Η προκαλούμενη ενέργεια κατά τον απινιδισμό θα μπορούσε να προκαλέσει βλάβη στο εμφύτευμα. Δεν πρέπει να διεξάγεται απινιδισμός στη συσκευή ή κοντά σε αυτήν.
  • Διάφορα: Η επιπτώσεις της θεραπείας με κοβάλτιο, της θεραπείας εκπομπής ποζιτρονίων (ΡΕΤ), των διαγνωστικών και θεραπευτικών υπερηχογραφημάτων και των τεχνικών γραμμικής επιτάχυνσης κοντά στο εμφύτευμα είναι άγνωστες. Η χρήση τους κοντά στο εμφύτευμα πρέπει να αποφεύγεται.
Τα προϊόντα, οι εφαρμογές και τα χαρακτηριστικά απόδοσης αποτελούν αντικείμενο έγκρισης από τις εθνικές αρμόδιες αρχές. Μερικά στοιχεία πιθανώς να μην είναι διαθέσιμα προς το παρόν ή να μην διατίθενται προς πώληση στην περιοχή σας από την MED-EL. Παρακαλούμε να επικοινωνήσετε με τον τοπικό αντιπρόσωπο της MED-EL για περαιτέρω πληροφορίες. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Greece

Middle Ear Implant - VORP 503

Ελληνικά

Εμφυτεύματα Μέσου Ωτός - VORP 503

Παρεμβολές από άλλο εξοπλισμό

  • Ηλεκτροχειρουργική: Τα όργανα ηλεκτροχειρουργικής μπορεί να παράγουν τάσεις ραδιοσυχνοτήτων, οι οποίες μπορεί να επιφέρουν απευθείας ζεύξη μεταξύ του οργάνου και του εμφυτεύματος. Τα μονοπολικά ηλεκτροχειρουργικά όργανα δεν πρέπει να χρησιμοποιούνται κοντά στο εμφύτευμα. Το προκαλούμενο ρεύμα μπορεί να επιφέρει ζημιά στο εμφύτευμα ή στην ακοή του ασθενή.
  • Χειρουργική διαθερμία: Δεν πρέπει ποτέ να εφαρμόζεται διαθερμία στο εμφύτευμα διότι τα υψηλά ρεύματα που προκαλούνται στο εμφύτευμα θα μπορούσαν να προκαλέσουν ζημιά στο εμφύτευμα ή στην ακοή του ασθενή.
  • Ιονίζουσα ακτινοβολία: Η θεραπεία ακτινοβολίας μέχρι συνολική δόση ιονισμού 100 Gray καθώς και οι ιατρικές διαγνωστικές διαδικασίες που χρησιμοποιούν ακτινοβολία ιονισμού, όπως ακτινογραφία, αξονική τομογραφία και τομογραφία εκπομπής ποζιτρονίων δεν βλάπτουν το εμφύτευμα. Συστήνεται να μην φοράτε επεξεργαστή ήχου κατά τη διάρκεια της ακτινοβολίας.
  • Υπερηχογράφημα: Έκθεση σε κλινικά χρήσιμο διαγνωστικό υπέρηχο δεν προκαλεί ζημιά στο εμφύτευμα.
  • Απινιδισμός: Η προκαλούμενη ενέργεια κατά τον απινιδισμό θα μπορούσε να προκαλέσει βλάβη στο εμφύτευμα. Δεν πρέπει να διεξάγεται απινιδισμός στη συσκευή ή κοντά σε αυτήν.
  • Μονοπολική ηλεκτροκαυτηρίαση, θεραπευτικό υπερηχογράφημα, διακρανιακή μαγνητική διέγερση, ηλεκτροσπασμοθεραπεία: Δεν επιτρέπεται απευθείας εφαρμογή πάνω από το εμφύτευμα, διότι οι ανωτέρω διαδικασίες μπορεί να προκαλέσουν ζημιά σε αυτό.
  • Απεικόνιση μαγνητικού συντονισμού (MRI): Η εξέταση MRI με το VORP 503 επιτρέπεται μόνο σε σαρωτές MRI 1,5 Tesla (T) κλειστού τύπου. Πρέπει να ληφθούν υπόψη οι ακόλουθες συνθήκες:
    • Ο σαρωτής MRI πρέπει να περιορίζεται στην "Κανονική κατάσταση λειτουργίας". Η "Κατάσταση λειτουργίας πρώτου επιπέδου" πρέπει να αποφεύγεται.
    • Τα τοπικά πηνία RF (ραδιοσυχνοτήτων) μετάδοσης δεν πρέπει να χρησιμοποιούνται στον τομέα της κεφαλής και του αυχένα. Τα τοπικά πηνία δέκτη δεν έχουν περιορισμό στη χρήση.
    • Προτού εισέλθουν ασθενείς στην αίθουσα MRI, πρέπει να αφαιρεθεί ο επεξεργαστής ήχου από το κεφάλι. Κατά τη διάρκεια της σάρωσης μπορεί να προκύψουν ηχητικές παρεμβολές. Συνιστάται στους ασθενείς να αναφέρουν οποιαδήποτε δυσφορία που μπορεί να προκύψει και να ζητάνε διακοπή της σάρωσης MRI. Μετά την εξέταση MRI, ο ασθενής θα τοποθετήσει τον επεξεργαστή ήχου μόνο αφότου αποχωρήσει από την αίθουσα MRI.
    • Κατά τη διάρκεια της εξέτασης MRI, απαιτείται το κεφάλι να έχει ευθεία κατεύθυνση.
    • Στις εικόνες γύρω από το εμφύτευμα θα είναι παρόν ένα ψευδές εύρημα περίπου 14 εκ.
    • Μια εξέταση MRI με > 1,5Τ θα προκαλέσει ζημιά στο εμφύτευμα και πρέπει να αποφεύγεται.
    • Εάν απαιτείται εξέταση MRI πριν από την πρώτη ενεργοποίηση του Vibrant Soundbridge, πρέπει να ληφθούν υπόψη μέτρα για να εμποδιστούν επιπλοκές στην ίαση των πληγών λόγω της πιθανής κίνησης του εμφυτεύματος στο δυνατό πεδίο MRI.
    • Όταν πρέπει να εξεταστούν κάτω άκρα, συστήνεται, αλλά δεν είναι απαραίτητο, τα πόδια του ασθενή να τοποθετούνται πρώτα στον σαρωτή.
       
  • Αντικλεπτικά συστήματα και συστήματα ανίχνευσης μετάλλων: Τα αντικλεπτικά συστήματα του εμπορίου και οι ανιχνευτές μετάλλων παράγουν δυνατά ηλεκτρομαγνητικά πεδία. Ασθενείς με ένα εμφύτευμα πρέπει να ενημερώνονται ότι η διέλευση μέσα από ανιχνευτές μετάλλων ασφαλείας μπορεί να ενεργοποιήσει τον συναγερμό ανιχνευτή. Για το λόγο αυτό συστήνεται οι ασθενείς να έχουν πάντα μαζί την Κάρτα Ταυτοποίησης Χρήστη Vibrant Soundbridge.
Τα προϊόντα, οι εφαρμογές και τα χαρακτηριστικά απόδοσης αποτελούν αντικείμενο έγκρισης από τις εθνικές αρμόδιες αρχές. Μερικά στοιχεία πιθανώς να μην είναι διαθέσιμα προς το παρόν ή να μην διατίθενται προς πώληση στην περιοχή σας από την MED-EL. Παρακαλούμε να επικοινωνήσετε με τον τοπικό αντιπρόσωπο της MED-EL για περαιτέρω πληροφορίες. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Guatemala

Cochlear and Auditory Brainstem Implant System

Español

Procedimientos médicos para Sistemas de implante MED-EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Guatemala

Bone Conduction Implant - BCI 601

Español

Implantes de Conducción Ósea - BCI 601

Interferencias con otros dispositivos

  • Diatermia quirúrgica: El instrumental de electrocirugía puede producir voltajes de radiofrecuencia, que pueden resultar en el acoplamiento directo entre el instrumento y el implante. Queda prohibido emplear instrumental electroquirúrgico monopolar cerca del implante. Las corrientes inducidas podrían causar daños en el implante o en la audición del paciente.
  • Terapia de radiación ionizante: La radioterapia no daña el implante. Se recomienda no portar un procesador de audio durante la irradiación.
  • Rayos X, tomografía computarizada, tratamiento con cobalto, escáner PET, ultrasonido diagnóstico: No existen restricciones dentro de las exposiciones con fines clínicos.
  • Electrocauterio monopolar, ultrasonido terapéutico, estimulación magnética transcraneal, terapia electroconvulsiva: Queda prohibido aplicar directamente estos procedimientos sobre el implante, ya que podrían causar daños en el mismo.
  • Imagen por Resonancia Magnética (IRM): La evaluación por medio de IRM está permitida hasta 1,5 T con el Bonebridge. Tenga en cuenta las siguientes exigencias:
  • No se debe portar el procesador de audio. Aún así, es posible que surjan interferencias audibles.
  • Los escáneres presentarán un artefacto de 15 cm alrededor del implante.
  • Evite una evaluación con IRM >1,5 T, ya que dañaría el implante.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL.MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Guatemala

Middle Ear Implant - VORP 502

Español

Implantes de Oído Medio - VORP 502

Interferencias con otros dispositivos

  • Electrocirugía: Los instrumentos electroquirúrgicos pueden producir voltajes de radiofrecuencia que son capaces de acoplar el extremo del instrumento y el implante. Los instrumentos de cirugía monopolar no deben ser usados en el área próxima al implante debido a que inducen corrientes que pueden dañar el implante o la audición del paciente.
  • Diatermia: La diatermia no debe ser nunca aplicada sobre el implante debido a que las grandes corrientes que se inducen en el mismo lo pueden dañar o dañar la audición del paciente.
  • Terapia Electroconvulsiva: La terapia electroconvulsiva no debe ser usada nunca en un paciente con un Soundbridge debido a que puede dañar el implante o la audición del paciente.
  • Terapia de Radiación Ionizante: La terapia de radiación ionizante debe ser considerada cuidadosamente ante el riesgo de dañar el implante VORP. Debe ser sopesado el riesgo frente al beneficio médico de dicha terapia.
  • Resonancia Magnética (RMN): Los pacientes implantados con el VIBRANT SOUNDBRIDGE (VORP 502x) no deben ser sometidos a RMN y no deben entrar a una cabina de RMN o estar en las proximidades de otras fuentes de campos magnéticos potentes.
  • Cardioversión: La energía inducida durante la cardioversión puede dañar el implante. La desfibrilación no debe ser aplicada en o cerca del dispositivo.
  • Miscelánea: Los efectos del tratamiento de cobalto, PET, diagnóstico y terapia ultrasónica y técnicas de aceleración lineal en las proximidades del implante son desconocidas. Su uso en las zonas próximas al implante debe ser evitado.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Guatemala

Middle Ear Implant - VORP 503

Español

Implantes de Oído Medio - VORP 503

Interferencias con otros equipos

  • Electrocirugía: los instrumentos electroquirúrgicos pueden producir frecuencias de radio que pueden causar el acoplamiento entre el instrumento y el implante. No se deben utilizar instrumentos quirúrgicos monopolares en las proximidades del implante. La corriente de inducción podría dañar el implante y/o la audición del paciente.
  • Diatermia quirúrgica: nunca se debe aplicar diatermia sobre el implante porque la corriente inducida podría causar daños en el implante o en la audición del paciente.
  • Radiación ionizante: la terapia con radiación ionizante hasta una dosis de ionización total de 100 Gy, así como los procedimientos médicos diagnósticos que utilizan radiación ionizante, como los rayos X, TC y PET, no dañan el implante. No se recomienda llevar el procesador auditivo durante la radiación.
  • Ultrasonidos: la exposición a ultrasonidos de utilidad diagnóstica no causa daños en el implante.
  • Cardioversión: la energía inducida durante la cardioversión podría dañar el implante. No se debe aplicar desfibrilación sobre el dispositivo ni en sus proximidades.
  • Electrocauterización monopolar, ultrasonidos terapéuticos, estimulación magnética transcraneal, tratamiento electroconvulsivo: nunca deben aplicarse directamente sobre el implante porque pueden dañarlo.
  • Imágenes por resonancia magnética (IRM): el examen por IRM con VORP 503 solo se permite con escáneres IRM cerrados de 1,5 teslas (T). Deben tenerse en cuenta las siguientes condiciones:
    • El escáner MRI debe estar limitado a modo de operación normal; evite el modo de operación de primer nivel.
    • No utilice bobinas de RF de transmisión local en la región craneal o cervical. No se limita el uso de bobinas de recepción local.
    • Antes de que el paciente entre en la sala de IRM, el procesador auditivo debe retirarse de la cabeza. Durante el escáner pueden producirse interferencias audibles. Los pacientes deben estar informados de que tienen que comunicar cualquier posible molestia y solicitar que se interrumpa la prueba si es necesario. Después de la prueba, el paciente no se pondrá el procesador auditivo hasta salir de la sala de IRM.
    • Durante el examen con IRM, la cabeza debe mantenerse en posición recta.
    • Las imágenes mostrarán un artefacto de aproximadamente 14 cm alrededor del implante.
    • Los exámenes con IRM de más de 1,5 T causan daños en el implante y deben evitarse.
    • Si necesita un examen IRM antes de la primera activación de Vibrant Soundbridge, deberán tomarse medidas de seguridad para evitar complicaciones en la curación de la herida por posibles movimientos del implante dentro del potente campo de RM.
    • Para examinar las extremidades inferiores se recomienda, aunque no es imprescindible, que las piernas entren primero en el escáner.
  • Sistemas antirrobo y detectores de metales: los sistemas comerciales antirrobo y detectores de metales generan potentes campos electromagnéticos. Los pacientes que utilicen implantes deben saber que pueden activar la alarma al pasar por los detectores de metales de seguridad. Por eso se recomienda a los pacientes llevar encima la tarjeta de identificación de usuario de Vibrant Soundbridge en todo momento.
Los productos, aplicaciones y características de rendimiento están sujetos a la aprobación de las autoridades nacionales competentes; puede que algunas características no estén actualmente disponibles o que MED-EL no las tenga a la venta en su región. Para obtener más información, póngase en contacto con su representante local de MED-EL. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Hong Kong

Cochlear and Auditory Brainstem Implant System

Chinese traditional

醫療程式 MED‑EL 植入系統

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Hong Kong

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Hong Kong

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Hong Kong

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Hungary

Cochlear and Auditory Brainstem Implant System

Magyar

A MED‑EL implantátumrendszerek gyógyászati eljárásai

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Hungary

Bone Conduction Implant - BCI 601

Magyar

Csontvezetéses implantátumok - BCI 601

Kölcsönhatás más eszközökkel

  • Sebészeti diatermia: Az elektrosebészeti műszerek által keltett nagyfrekvenciás feszültségek a műszer és az implantátum közötti közvetlen csatoláshoz vezethetnek. Monopoláris elektrosebészeti eszközöket nem szabad az implantátum közelében alkalmazni. A keltett áramok károsíthatják az implantátumot vagy a páciens hallóképességét.
  • Sugárterápia: A sugárterápia nem károsítja az implantátumot. Javasolt az audioprocesszor levétele a besugárzás idejére.
  • Röntgen, CT, kobaltkezelés, PET-scan, diagnosztikai ultrahang: Nincs korlátozás klinikai besugárzásnál.
  • Monopoláris elektrokauterizáció, terápiás ultrahang, transzkraniális mágnetstimuláció, elektrosokk-terápia: Sohasem szabad közvetlenül az implantátum fölött végezni, mert károsíthatja az implantátumot.
  • Mágnesrezonanciás tomográfia (MRT): MRT-vizsgálatok 1,5 T értékig a Bonebridge mellett megengedettek. Az alábbi feltételeket kell figyelembe venni:
    • Az audioprocesszort ne viselje a páciens, ennek ellenére hangérzet alakulhat ki.
    • Az implantátum körül 15 cm-es művi elváltozás lesz látható a képeken.
    • A >1,5 T értékkel végzett MRT-vizsglatok károsítják az implantátumot, ezért kerülendők.
A termékekre, alkalmazásokra és teljesítményjellemzőkre az illetékes nemzeti hatóságok általi jóváhagyási kötelezettség vonatkozik; lehetséges, hogy egyes funkciók pillanatnyilag nem állnak rendelkezésre, vagy a MED-EL nem kínálja fel azokat értékesítésre az Ön országában. További információért kérjük, forduljon a helyi MED-EL képviselőjéhez. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Hungary

Middle Ear Implant - VORP 502

Magyar

Középfül-implantátumok - VORP 502

Kölcsönhatás más eszközökkel

  • Elektrochirurgie: Elektrochirurgické nástroje mohou vytvářet vysokofrekvenční napětí, která mohou přeskakovat ze špičky nástroje přímo na implantát. V blízkosti implantátu se nesmí používat monopolární elektrochirurgické nástroje, protože nimi vytvořený proud by mohl poškodit implantát a mohl by ovlivnit sluch pacienta.
  • Diatermie: V žádném případě se nesmí nad implantátem provést diatermie, protože do implantátu silně indukovaný proud by mohl implantát poškodit a ovlivnit sluch pacienta.
  • Elektrošoková terapie: U pacientů s implantátem VIBRANT SOUNDBRIDGE se nikdy nesmí použít elektrošoková terapie, protože by mohla poškodit implantát a ovlivnit sluch pacienta.
  • Terapie ionizujícím zářením: Potřebné léčby s ionizujícím zářením se musí přesně prověřit a musí se pečlivě zvážit riziko poškození implantátu VORP vzhledem k prospěchu takové léčby.
  • Tomografie magnetickou rezonancí (MRT): Pacienti s implantátem VIBRANT SOUNDBRIDGE (VORP 502x) by se neměli podstoupit vyšetření MRT a také by neměli vstupovat do prostoru MRT anebo se zdržovat v blízkosti zdrojů se silným magnetickým polem.
  • Kardioverze: Energie, vytvořená v průběhu kardioverze může způsobit poškození implantátu. Nad implantátem nebo v jeho blízkosti by se neměla provádět defibrilace.
  • Jiné: Účinky léčby kobaltem, vyšetřením PET Scans, diagnostickým a léčebným ultrazvukem a léčby ineárním urychlovačem v blizkosti implantátu nejsou známé. V blízkosti implantátu by se mělo upustit od takového způsobu léčby.
A termékekre, alkalmazásokra és teljesítményjellemzőkre az illetékes nemzeti hatóságok általi jóváhagyási kötelezettség vonatkozik; lehetséges, hogy egyes funkciók pillanatnyilag nem állnak rendelkezésre, vagy a MED-EL nem kínálja fel azokat értékesítésre az Ön országában. További információért kérjük, forduljon a helyi MED-EL képviselőjéhez. MRI Safety Status Overview
English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Hungary

Middle Ear Implant - VORP 503

Magyar

Középfül-implantátumok - VORP 503

Kölcsönhatás más eszközökkel

  • Elektrosebészet: Az elektrosebészeti műszerek által keltett nagyfrekvenciás feszültségek a műszer és az implantátum közötti közvetlen csatoláshoz vezethetnek. Monopoláris elektrosebészeti eszközöket nem szabad az implantátum közelében alkalmazni. A keltett áramok károsíthatják az implantátumot vagy a páciens hallóképességét.
  • Sebészeti diatermia: Diatermiát az implantátum felett semmiképpen sem szabad végezni, mivel az implantátumban indukált erős áram megrongálhatja az implantátumot és károsíthatja a páciens hallását.
  • Ionizáló sugárzás: A sugárterápia összesen 100 Gray sugárdózissal, valamint az ionizáló sugárzást (így röntgent, CT-t és PET-t) alkalmazó diagnosztikai eljárások nem károsítják az implantátumot. Javasolt az audioprocesszor levétele a besugárzás idejére.
  • Ultrahang: A klinikai diagnosztikai ultrahang hatása nem károsítja az implantátumot.
  • Kardioverzió: A kardioverzió közben generált energia megrongálhatja az implantátumot. Az eszközön vagy annak közelében nem ajánlott defibrilláció elvégzése.
  • Monopoláris elektrokauterizáció, terápiás ultrahang, transzkraniális mágneses stimuláció, elektrokonvulzív terápia: Sohasem szabad közvetlenül az implantátum fölött végezni, mert károsíthatja az implantátumot.
  • Mágnesrezonanciás tomográfia (MRI): Az MRI-vizsgálat VORP 503-at viselő személy esetén csak zárt MRI szkennerrel 1,5 Tesla (T) értékig megengedett. Az alábbi feltételeket kell figyelembe venni:
    • Az MRI szkennert normál üzemmódra kell korlátozni. Kerülni kell az 1. fokozat üzemmódját.
    • Helyi átvitelre szolgáló RF-tekercseket nem szabad a fej vagy a tarkó közelében alkalmazni. Helyi vevőtekercsek korlátozás nélkül használhatók fel.
    • A páciensnek le kell vennie fejéről az audioprocesszort, mielőtt belép az MRI-helyiségbe. A szkennelés közben hallható interferenciák keletkezhetnek. A pácienst utasítani kell arra, hogy bármilyen rosszullétet azonnal jelezzen az MRI befejezésére adott esetben. Az MRI-vizsgálat után a páciens az audioprocesszort csak akkor helyezheti el ismét, amikor elhagyta az MRI-helyiséget.
    • Az MRI-vizsgálat közben a fejet egyenesen kell tartani.
    • Egy kb. 14 cm-es művi elváltozás lesz látható a képeken az implantátum körül.
    • A >1,5 T értékkel végzett MRI-vizsgálatok károsítják az implantátumot, ezért kerülendők.
    • Amennyiben a Vibrant Soundbridge első aktiválása előtt MRI-vizsgálat szükséges, biztonsági intézkedéseket kell tenni a sebgyógyulás során fellépő, az implantátumnak az erős MR-térben való lehetséges mozgása miatti komplikációk elkerülésére.
    • Az alsó végtagok vizsgálata esetén ajánlott, hogy először a páciens lábát tolják be a szkennerbe.
       
  • Lopásvédelmi és fémdetektor rendszerek: a kereskedelmi lopásvédelmi rendszerek és a fémdetektorok erős elektromágneses teret generálnak. Az implantátumot viselő pácienst figyelmeztetni kell arra, hogy biztonsági fémdetektoron való áthaladásnál riasztás kioldása lehetséges. Ezért ajánlott, hogy a páciens mindig hordja magánál Vibrant Soundbridge felhasználói azonosító kártyáját.
A termékekre, alkalmazásokra és teljesítményjellemzőkre az illetékes nemzeti hatóságok általi jóváhagyási kötelezettség vonatkozik; lehetséges, hogy egyes funkciók pillanatnyilag nem állnak rendelkezésre, vagy a MED-EL nem kínálja fel azokat értékesítésre az Ön országában. További információért kérjük, forduljon a helyi MED-EL képviselőjéhez. MRI Info SheetMRI ChecklistMRI Safety Status Overview
English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Iceland

Cochlear and Auditory Brainstem Implant System

English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Iceland

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Iceland

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Iceland

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
India

Cochlear and Auditory Brainstem Implant System

English - IN

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
India

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
India

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
India

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector alarm. For this reason, it is advised that patients carry their Vibrant Soundbridge User Identification Card at all times.
The products, applications and performance characteristics are subject to approval by the national competent authorities, some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Cochlear and Auditory Brainstem Implant System
Indonesia

Cochlear and Auditory Brainstem Implant System

Bahasa

Prosedur Medis untuk Sistem Implan MED‑EL

ManualMRI ChecklistMRI Safety Status Overview
English

Medical Procedures for MED-EL Implant Systems

ManualMRI ChecklistMRI Safety Status Overview
Bone Conduction Implant - BCI 601
Indonesia

Bone Conduction Implant - BCI 601

English

Bone Conduction Implant - BCI 601

Interference with other equipment

  • Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage it.
  • Magnetic Resonance Imaging (MRI): MRI examination up to 1.5T with the Bonebridge is permissible. The following conditions have to be considered:
    • The audio processor shall not be worn, but still audible interference can occur.
    • An artifact of 15 cm around the implant will be present on the images.
    • MRI examination with >1.5T will damage the implant and must be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Info SheetMRI ChecklistMRI Safety Status Overview
Middle Ear Implant - VORP 502
Indonesia

Middle Ear Implant - VORP 502

English

Middle Ear Implant - VORP 502

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Electroconvulsive therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may cause damage to the implant or the patient’s hearing.
  • Ionizing radiation therapy: Ionizing radiation therapy should be carefully considered, and the risk of damage to the VORP implant should be carefully weighed against the medical benefit of such therapy.
  • Magnetic Resonance Imaging (MRI): Patients implanted with the Vibrant Soundbridge (VORP 502x) should not be subjected to MRI, and should not enter an MRI Suite or come into close proximity to other sources of strong magnetic fields.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Miscellaneous: The effects of cobalt treatment, PET scans, diagnostic and therapeutic ultrasound, and linear acceleration techniques in the vicinity of the implant are unknown. Their use in the vicinity of the implant should be avoided.
The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. MRI Safety Status Overview
Middle Ear Implant - VORP 503
Indonesia

Middle Ear Implant - VORP 503

English

Middle Ear Implant - VORP 503

Interference with other equipment

  • Electrosurgery: Electrosurgical instruments can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
  • Surgical Diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
  • Ionizing Radiation: Radiation therapy up to a total ionization dose of 100 Gray as well as medical diagnostic procedures using ionizing radiation, such as X-Ray, CT and PET, do not harm the implant. It is recommended not to wear an audio processor during irradiation.
  • Ultrasound: Exposures to clinically useful diagnostic ultrasound do not cause any damage to the implant.
  • Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
  • Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant.
  • Magnetic Resonance Imaging (MRI): MRI examination with the VORP 503 is only permissible in 1.5 Tesla (T) closed-bore MRI scanners. The following conditions have to be considered:
    • The MRI scanner has to be limited to “Normal Operating Mode”; “First Level Operating Mode” has to be avoided.
    • Local transmitting RF coils must not be used in the head and neck region. Local receiver coils are not restricted in use.
    • Before patients enter any MRI room, the audio processor must be removed from the head. Audible interference can occur during the scan. Patients shall be advised to indicate any possible discomfort that may arise and to request that the MRI be discontinued if needed. After the MRI examination, the patient shall put on the audio processor only after leaving the MRI room.
    • During MRI examination straight head orientation is required.
    • An artifact of approximately 14 cm around the implant will be present on the images.
    • MRI examination with >1.5 T will damage the implant and must be avoided.
    • If an MRI examination is needed prior to the first activation of the Vibrant Soundbridge, safety measures shall be taken into account to prevent wound healing complications due to the possible movement of the implant in the strong MR field.
    • When lower extremities are to be examined, it is recommended, but not required, that the patient’s legs are positioned in the scanner first.
  • Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may activate the detector