Properties | Details |
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SFDA Classification | Class IIb |
Purpose of Use | During surgery, tissues and blood vessels are cut, causing bleeding. To prevent too much blood loss and to keep the surgical area free from excess blood, electrosurgical units are used, different operating modes can be set. CUT is a combination of cutting and coagulation. This operating mode is used for cutting and at the same time reducing bleeding (coagulation) and is indicated by the color yellow. 'COAGULATION' is used for maximum coagulation, and 'drying' is used for tissue destruction and is indicated by blue. It also has two forms of conduction: The monopolar mode is used for cutting and coagulation, and the bipolar mode is used mainly for desiccation (tissue destruction). |
Work Location & End-User | Work Location: operating room End User: Doctors trained on the device |
Parts & Accessories | • High Frequency Generator • Relays • Handpiece • foot switch • User Interface Module • Dissipation pad / return electrode |
Operation | An electric current of about 500 kHz is used to cut and coagulate tissue. This process involves applying an RF (radio frequency) spark between the probe and the tissue. The electric current through the tissue heats the tissue and the water in the cell evaporates and destroys it. This achieves special surgical effects such as cutting, coagulation and dehydration. The voltage on the electrode ranges between 1000 - 10000 volts. It works in two modes. In the unipolar mode, the active electrode focuses the current to the surgical site and the dispersing (return) electrode directs the current away from the patient. In the bipolar mode, the active and return electrode are located at the site of surgery. |
Common Problems | • Burns, usually under the electrode of the ECG device, or on different parts of the body that may be in contact with the device's alternating current return path • Fires occur when flammable liquids come into contact with sparks from the appliance's alternating current in the presence of an oxidizer. • Electric shock, accidentally coming into contact with the fist directly or indirectly through a metal part attached |
Manufacturers | • Covidien • ERBE • Valleylab • Heal Force • Medtronic • Integra |
Sources | • Saudi Food and Drug Authority • ScienceDirect • ATL Technology |