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The Dophi Electroporation System is intended for surgical ablation of soft tissue by irreversible electroporation.

The Electroporation System consists of Electroporation Power Generator, Electroporation Trigger Probe, Electroporation Standard Probe, Electroporation Fixator support and Foot Switch. The single-use Electroporation Trigger Probe with EO sterilization is the same as Electroporation Standard Probe and Electroporation Fixator support. The Electroporation Power Generator and Foot Switch are non-sterile and reusable. With the Electroporation System, a voltage applied between pairs of probes in a series of pulses. The waveform of the voltage is adjustable as determined by clinician-chosen parameters. These parameters include volts, pulse width, pulse frequency and the distance between probes. Up to six probes may be placed in an array within the tissue. The probes of the array are matched as pairs by the system. When probes are activated via a foot switch, the scheduled voltage is delivered to tissue between subsequent pairs of probes. Soft tissue between the probes is ablated.

The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity, so as to generate and maintain pneumoperitoneum, expand the surgical field and keep sufficient space during diagnostic and therapeutic laparoscopic procedures.

The subject device is composed of Gas Insufflator Unit (Model GVS100) and accessories Highpressure Gas Pipe, Insufflation Tubing Set (Model GI-S001), and power adapter). The Insufflation Tubing Set is provided sterile and disposable. The Gas Insufflator Unit is nonsterile, reusable, and AC-powered (100 - 240 VAC, 50/60 Hz, 200 W). The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity to generate and maintain pneumoperitoneum during laparoscopic diagnosis and/or surgical treatment. The Gas Insufflator controls gas pressure and flow rate by the solenoid valve. The touchscreen displays the gas pressure and flow output. The Gas Insufflator is insufflate CO2 to a body cavity up to 30 mmHg/40 LPM for Adult mode and 15 mmHg/15 LPM for Child mode. The Gas Insufflator is for professional healthcare environment use.

The Ultrasonic Scalpel System is intended to transect, dissect, and coagulate tissue. The instruments are indicated for use in open and endoscopic general surgical procedures where bleeding control and minimal thermal injury to tissue are desired. The instruments allow for the coagulation of vessels (veins and arteries) up to 5 mm in diameter while using the power level 1. Device have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.

The Ultrasonic Scalpel System is an ultrasonic dissection and coagulation system composed of four components: the single use Ultrasonic Scalpel including four shaft lengths; a multiple use transducer; a generator and a foot switch. The single-use Ultrasonic Scalpel with EO sterilization contains the waveguide, shaft, jaws, trigger and activation button. Trigger activation opens and closes the jaws against the distal tip of the waveguide where the tissue is clamped. The Ultrasonic Generator provides AC electrical energy to drive the Ultrasonic Transducer. The Ultrasonic Transducer converts the electrical energy into mechanical vibrations, making the Ultrasonic Scalpel waveguide tip keep vibrating with amplitude between 50μm-100μm at frequency about 55.5kHz. When the vibrating Ultrasonic Scalpel waveguide tip contacts with soft tissues, the hydrogen bond in proteins of the soft tissues is broken apart. The proteins become viscous and coagulate so as to stop bleeding and reduce damage to soft tissues in cutting. The single-use Ultrasonic Scalpel with EO sterilization, the Ultrasonic Generator and Ultrasonic Transducer are of non-sterile package, the transducer has to be sterilized by users before being used in surgery. This device is intended to be used in the hospital environment, such as surgical operation room and imaging intervention room.

The Energy generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The Energy generator is equipped with monopolar and bipolar outputs.

The Energy Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulation of tissue. The generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications. The three models ES300, ES200 and ES100 have the same hardware. They have different software on the control board and has different electrosurgical power limit.

The Video Endoscopy System & 3D Video Endoscopy System are intended to be used to provide illumination and visualization of surgical field in a wide variety of diagnostic abdominal and thoracic minimally invasive procedures, including female reproductive organs (gynecology) and urological anatomy.

The proposed Video Endoscopy Systems include the Video Endoscopy System and 3D Video Endoscopy System, Video Endoscopy System supports 2D imaqe output, 3D Video Endoscopy System supports 2D/3D image output. Video Endoscopy System is composed of Video Endoscope (LPS21000/LPS21030) and Video Endoscopy processor (EVS100). The Video Endoscopy Processor is a video processor, which receives the electrical signals from the Video Endoscope and process it and output the final image to the monitor. Two models 2D Video Endoscope (LPS21000/LPS21030) are available, one image sensor is located at the distal of the endoscope (LPS21000/LPS21030), they are used in conjunction with Video Endoscopy Processor (EVS100) to output 2D images. 3D Video Endoscopy System is composed of Video Endoscope (LPS31000/LPS31030) and Video Endoscopy Processor (EVS200). The Video Endoscopy Processor is a video processor, which receives the electrical signals from the Video Endoscope and process it and output the final image to the monitor. Two models 3D Video Endoscope (LPS31000/LPS31030) are available, two image sensors are located at the distal of the endoscope (LPS31000/LPS31030), they are used in conjunction with Video Endoscopy Processor (EVS200) to output 2D/3D images. Video Endoscopy processor is non-sterile device. The Video Endoscope is terminallysterilized device. The Video Endoscope must be sterilized by users before being used in surgery.

The Microwave Ablation System is intended for coagulation (ablation) of soft tissue. It is not intended for use in cardiac procedures.

The Microwave Ablation System M150E is microwave-based system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablation) of a defined volume of that tissue. The Microwave Ablation System utilizes a 2450MHz generator to deliver power to single microwave ablation antenna or double microwave ablation antennas. The Microwave Ablation Generator provides for user setting of ablation time and ablation power. The proposed device consists of Microwave Ablation Generator, Microwave Ablation Electrode Kits, Temperature Probe and Foot Switch.

The Radio Frequecy Ablation System is intended for coagulation and ablation of soft tissue. It is not intended for use in cardiac procedures.

The proposed device consists of Radio Frequency Generator, Radio Frequency Electrode Kits, Temperature Probe and Foot Switch. Wherein, the radiofrequency generator integrated with cooling pump is capable of delivering up to 200W while monitoring tissue impedance, tissue temperature and electrode tip temperature during the delivery of the RF energy. The Radio Frequency Electrode Kits consists of Radio Frequency Electrode, introducer, inflow - outflow tubing sets and Return Pad to be used for puncturing the patient's lesion position during operation and also for outputting Radio Frequency energy to ablate the tumor tissue through connection with Radio Frequency Generator. The Temperature Probe is applied to monitor the temperature of the target location and to protect important organs and tissues in the periphery of the lesion from unexpected damage by Radio Frequency energy. The Radio Frequency generator supplies 470 kHz of radio frequency current, which enters into target tissue of patient, and builds a circuit loop with the Return Pad. The alternating current cause alternating motion of the positive ions in the tumor region. Because of the different size, mass and charge of each ion, the moving speeds of the ions are different, resulting in collision friction and thermal energy. When the temperature is above 50 °C, tumor tissue come into irreversible coagulation necrosis. lt supports three working modes: Auto Mode, POWER Mode and TEMP Mode. Auto Mode The Auto Mode allows the use of 1-3 RF ablation electrodes for ablation. When multiple RF Ablation electrodes are connected, the RF generator will switch between the electrodes for energy output. In Auto Mode, the system automatically adjusts the power output according to the built-in algorithm. Power mode In POWER Mode, the RF generator outputs according to the maximum power set by users. In this mode, only single RF electrode is allowed to be used. The RF Electrode is kept below 40°C by means of internal cooling with cooling-water delivers from a peristaltic pump. Temperature mode In TEMP Mode, the RF generator detects the temperature of the RF electrode automatically, and adjusts the power output according to the detected temperature. In this mode, "SET POWER(W)" is forbade to set. Single RF electrode is permitted to use. Once the temperature of RF electrode reaches 85℃, a beep sounds. Then users can pull the RF electrode out of patient at a rate of 1centimetre every 2 seconds. The Radio Frequency Generator is non-sterile, the return pad is non-sterile and for single use, while Radio Frequency Electrode and Temperature Probe are sterile and for single use. The device is software-driven and the software validation is provided in Section of Software.