Search Results

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 CO2 gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a perioneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatic laparoscopic procedures. The Vessel Harvest 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 transanal minimally invasive surgery.

The PNEUMOCLEAR™ is a microprocessor controlled device that consists of the following major components and features: a casing, a world power supply, pressure reducers, pressure sensors, venting systems, various safety valves, a suction pump, a fluid sensor and a software controlled graphical user interface (GUI) touch screen with various setting keys and display elements. The proposed device offers six operating modes: 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 one of the following specially designed, single-use, sterile insufflation tube sets: (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 (5) insufflation and smoke evacuation tube set with integrated filter. When a smoke evacuation tube set is connected, 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 ARTHRO-Pump PA304 is an arthroscopic pump intended to provide fluid distension of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid aspiration during diagnostic and operative arthroscopic procedures.

The ARTHRO-Pump PA304 is a microprocessor controlled single roller pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend cavities and provides fluid aspiration for arthroscopic procedures. The pump consists of the following main components: a power supply, a power switch, a touch display, a connection for the suction function, a roller wheel, a pump head and a casing. The pump has to be used with the following tube sets: - . Standard Irrigation Tube Set (also referred to as "ST261") - . Suction Tube Set (one connection, "I"-shape; also referred to as "ST287") - Suction Tube Set (two connections, "Y"-shape; also referred to as "ST282") . - Vacuum Tube Set (also referred to as "ST291"). .

The GYN-Pump PH304 is a combined suction and irrigation pump for use in hysteroscopic and laparoscopic interventions. During diagnostic and operative hysteroscopy, the GYN-Pump PH304 is intended to provide liquid distension of the uterus and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. During diagnostic and therapeutic laparoscopic procedures, the GYN-Pump PH304 is intended to irrigate fluid into and remove fluid from the abdominal cavity.

The GYN-Pump PH304 is a microprocessor controlled single roller pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend the uterus and provides fluid deficit monitoring during operative hysteroscopy. It is also used to irrigate the abdominal cavity during laparoscopy and provides fluid aspiration. The pump consists of the following main components: a power supply, a power switch, a touch display, a connection for the suction function, a roller wheel, a pump head and a casing. The proposed pump is designed to be used with the Fluid Monitoring Unit PS304 in order to assist with fluid deficit monitoring. The Fluid Monitoring Unit PS304 is a component of the GYN-Pump PH304 and together they are a medical electrical system. The pump must be used with the following tube sets: Standard Irrigation Tube Set (also referred to as "ST261"), Suction Tube Set (one connection, "I"-shape; also referred to as "ST287"), Suction Tube Set (two connections, "Y"-shape; also referred to as "ST282"), Vacuum Tube Set (also referred to as "ST291").

The Aquilex® Fluid Control System AQL-100S is intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopy and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

The Aquilex® Fluid Control System AQL-100S is a modified version of the primary predicate device, Aquilex Fluid Control System H112 (K112642). The proposed device is a microprocessor-controlled device that consists of the following two main components: (1) an irrigation pump unit including suction pumps (AQL-110P) and (2) and fluid monitoring unit (AQL-100CBS) that are to be placed on a roller stand. The irrigation pump unit (AQL-110P) of the Aquilex® Fluid Control System AQL-100S is a microprocessor-controlled device that functions according to the peristaltic principle and consists of the following components: (1) a casing. (2) a power switch, (3) a power supply, (4) mains cable, (5) a roller wheel, (6) a pump head, (7) suction pumps, (8) various setting keys and (9) display elements. The irrigation pump unit (AQL-110P) is to be used with specially designed single use irrigation and outflow tube sets that are delivered sterile (AQL-110 and AQL-111). In addition, the suction pumps of the irrigation pump unit are to be used with specially designed non-sterile vacuum tube sets (AQL-114). The fluid monitoring unit (AQL-100CBS) consists of the following main components: (1) two scale units, (2), a bag holder, (4) a bag deflector, (5) a container holder, and (6) a roller wheel base. The irrigation pump unit of the proposed device is only operational in conjunction with the fluid monitoring unit.

The LAP-Pump PP110 is a suction and irrigation pump intended for use during diagnostic and or therapeutic laparoscopic procedures to irrigate fluid into and remove fluid from the abdominal cavity.

The LAP-Pump PP110 is a suction and irrigation pump for use during laparoscopic procedures. The irrigation and suction functions are used to facilitate the removal of debris and fluids during laparoscopy. The pump consists of the following main components: : (1) a power supply, (2) a power switch, (3), a START/STOP button for the irrigation function, (4), a START/STOP button for the suction function, (5) a roller wheel, (6) a pump head, (7) suction pump and (8) a casing. The pump is a microprocessor controlled single roller pump that functions according to the peristaltic principle and is to be used with specially designed sterile, single use irrigation tube sets with or without hand piece, a sterile outflow tube set and a vacuum tube set. The pump is designed to be mounted on a pole/tripod, or can be placed in an equipment rack.

The HD-Camera HDC1000 is intended to be used during diagnostic and operative endoscopic procedures to provide illumination and visualization of body cavities, hollow organs and to allow for image recording and documentation. The HD-Camera HDC1000 is indicated for use with compatible rigid or flexible endoscopes and other video equipment and endoscopic accessories.

The HD-Camera HDC1000 is a video-management system that consists of a camera, an integrated light source and a capture module for storing and compressing video and still images. It is used in conjunction with an endoscope or microscope, a light cable and other endoscopic accessories to illuminate surgical sites and to view the surgical sites on video monitors during diagnostic and operative endoscopic procedures. The camera of the proposed device consists of a camera control unit (CCU), a coupler, and a camera head with an integral cable that connects to the camera control unit (CCU). The optical image is transferred from the surgical site to the camera head by compatible rigid and flexible endoscopes that are attached to the camera head using an optical coupler. The camera head including camera cable and the coupler are reusable devices and must be sterilized using the STERRAD ® advanced sterilization process or may be used with a sterile cover or sleeve. The camera control unit (CCU) is not intended to enter the sterile field, and cannot be sterilized.