Device Dossier

Electrosurgical/ultrasonic surgical system generator

Device Dossier for Electrosurgical/ultrasonic surgical system generator (Electrosurgical/ultrasonic surgical system generator, Class IIb, sponsor…

Intended purpose

The electric signal from generator is applied to a transducer disposed within the Handpiece, which converts electric energy to mechanical vibration and results in longitudinal motion of the piezo-ceramic elements of the transducer. The ultrasound vibrations are amplified and transmitted to the surgical scalpel or blade to vibrate longitudinally at approximately 55.5kHz. It is intended to be used for soft tissue incisions when control of bleeding and minimal thermal injury are desired. It is capable of sealing 5mm vessels. Link with advanced coagulation shear to realize "advanced coagulation function". It is used in the operating room of the hospital and can be used by doctors to diagnose applicable patients.

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