The Integrated Monopolar L-Hook (H/S)™ is a bifunctional device that combines proprietary visual field clearing and monopolar HF tissue and coagulation in a single device. The Integrated Monopolar L-Hook (H/S)™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The Integrated Monopolar L-Hook (H/S)™ provides two recessed smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of visual field clearing is electrostatic precipitation as per the predicate Ultravision system. When the tissue cutting is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision 2 generator user interface. Activation of the HF function of the Integrated Monopolar L-Hook (H/S)™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision 2 system. The Integrated Monopolar L-Hook (H/S)™ itself is incompatible with the connectors of third party electrosurgical generators. On demand visual field clearing only can also be applied by activation of a third grey button on the handle. This clearing field action is stopped immediately after release of the grey button.
A sterile device intended to be used during minimally-invasive surgery, in particular laparoscopic surgery, to filter surgical smoke (plume created by, e.g., electrosurgical diathermy, a laser or sonic scalpel) of potentially harmful agents (e.g., noxious chemicals, particulates, viruses, bacteria) without loss of pneumoperitoneum. It is typically a multi-layered filter pouch intended to be connected to a trocar stopcock; it is intended to help protect surgical staff from ambient exposure to potentially harmful agents. This is a single-use device.
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