Important Safety Information
Middle Ear Implants - VORP 502x
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.