Ascblue (8010)

The Electrosurgical Generator 8010 is indicated for cutting and coagulation of tissue in general surgery procedures via monopolar and bipolar modes. It is intended for use with monopolar handpieces and dispersive electrodes, or with bipolar handpieces and footswitches.

The Electrosurgical Generator 8010 is indicated for cutting and coagulation of tissue in general surgery procedures via monopolar and bipolar modes. It is intended for use with monopolar handpieces and dispersive electrodes, or with bipolar handpieces and footswitches.

The subject device of this submission is the Ascblue 8010 Electrosurgical Generator. The Electrosurgical Generator 8010 is indicated for use in general electrosurgical procedures for monopolar cutting, monopolar coagulation, and bipolar coagulation of tissue. It is intended to be used with monopolar handpieces and dispersive electrodes, or with bipolar handpieces and footswitches. Electrosurgery is the application of high-frequency (radio-frequency, RF) alternating current to biological tissue in order to cut, coagulate, desiccate, or fulgurate tissue. The RF current produces heating of the tissue through intracellular oscillation of ionized molecules, which leads to an elevation of intracellular temperature. The benefits of electrosurgery include the ability to perform precise surgical cutting with effective hemostasis and limited blood loss. Electrosurgical devices are widely used in both inpatient operating rooms and outpatient surgical procedures to facilitate tissue dissection and minimize intraoperative bleeding. The device is an advanced microprocessor-controlled electrosurgical generator providing: 4 Monopolar cutting modes / 4 Monopolar coagulation modes / 4 Bipolar modes, and Return Safety Monitor (RSM) for dispersive electrode quality check. The device includes an internal USB port that is physically present on the hardware. This USB port is intended solely for manufacturing, service, and testing purposes. The port is sealed prior to distribution and is not user-accessible, not visible, and not intended for clinical use in the marketed configuration. The device does not support user-accessible data transfer, networking, or external communication functions.