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The device PNEUMOCLEAR™ is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimal invasive surgery.

The PNEUMOCLEAR™ is a microprocessor controlled CO2 insufflator that consists of the following major components and features: (1) a casing, (2) a world power supply, (3) pressure reducers, (4) pressure sensors, (4) venting systems, (5) various safety valves. (6) a suction pump. (7) a fluid sensor and (8) a software controlled graphical user interface (GUI) touch screen with various setting keys and display elements. The proposed device offers six operating modes (i.e. Standard, High Flow/Bariatric, Pediatric, Advanced Flow, Vessel Harvest, and TAMIS. The PNEUMOCLEAR™is not intended to enter the sterile field, and cannot be sterilized. It is to be used with specially designed single-use insufflation tube sets that are delivered sterile. Specifically, five different tube sets may be used with the proposed device: (1) insufflation tube set with integrated filter, (2) insufflation tube set with integrated filter and heating wire; (3) insufflation tube set with integrated filter, heating wire and humidification media; (4) insufflation and smoke evacuation tube set with integrated filter, heating wire, and humidification media; and insufflation and smoke evacuation tube set with integrated filter. When used with a smoke evacuation tube set the PNEUMOCLEAR™ allows for removal and filtration of CO2 and surgical smoke from the abdomen, rectum or colon during laparoscopic and transanal minimally invasive procedures and at the end of a procedure.

The device Insufflator 50L FM134 is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, Pediatric and Bariatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.

The Insufflator 50L FM134 is a microprocessor controlled CO2 insufflator that consists of the following major components and features: a casing, a world power supply, pressure reducers, a venting system, redundant pressure measurement, a fluid sensor, a gas heater, a software controlled graphical user interface (GUI) touch screen and various setting keys and display elements. The Insufflator 50L FM134 is not intended to enter the sterile field, and cannot be sterilized. The device is to be used with specially designed single-use tube sets that are delivered sterile. Specifically, the proposed device is to be used with a single-use tube set with heating wire and integrated filter or with a single-use tube set with integrated filter but without heating wire.