Device Dossier

Open-surgery electrosurgical electrode, monopolar, single-use

Device Dossier for Open-surgery electrosurgical electrode, monopolar, single-use (Open-surgery electrosurgical electrode, monopolar, single-use, Class…

Intended purpose

The Disposable Electrodes (model series SY-03M, SY-03S, SY-03W and SY-03D) are sterile, single-use, monopolar electrosurgical electrodes intended to be connected to a compatible high-frequency (HF) electrosurgical generator. They are used by trained surgeons during open surgical procedures to cut tissue and to coagulate tissue for haemostasis, by conducting high-frequency current from the generator to the surgical site through the electrode tip. As monopolar devices, they operate in conjunction with a patient return (neutral / dispersive) electrode, which must be correctly applied to the patient before use so that current returns safely to the generator. The electrodes are supplied in a range of tip shapes and sizes across the model series to suit different cutting and coagulation requirements. The working part that contacts tissue is stainless steel; the device also comprises an insulating layer and a plastic handle, and is used with a connecting cable. A protective sheath and holster are available as accessories. The device is supplied sterile (ethylene oxide) and is intended for single use only; it must not be reprocessed or reused. It is compatible with HF electrosurgical generators from a range of manufacturers and provides cutting (CUT) and coagulation (COAG) modes. Output power should be set as low as practicable to achieve the intended clinical effect. The device is intended for transient, intra-operative use and is not implanted.