Important Safety Information

Middle Ear Implants - 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: 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.
     
  • o 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.
     
     

MRI Info Sheet

"Magnetic Resonance Imaging with the SOUNDBRIDGE VORP 503"


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