Device Dossier

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Device Dossier for Open-surgery electrosurgical handpiece/electrode, monopolar, single-use (Open-surgery electrosurgical handpiece/electrode, monopolar,…

Intended purpose

· The Medstar standard smoke evacuation pencil is designed to be used in conjunction with 70mm/100mm/120mm/152mm standard electrodes and Medstar integrated smoke evacuation leep electrodes . · The Medstar standard smoke evacuation pencil, when used with an effective smoke evacuation system, removes smoke plume from the surgical site. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. · Maximum voltage is not to exceed 6 kV peak.