Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Intended purpose

The Multifunctional Operational Dissectors (electrosurgical pencils) are sterile, single-use, hand-held monopolar electrosurgical pencils 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. Cutting (CUT) and coagulation (COAG) functions are selected using a hand-controlled switch on the handle. A range of tip shapes and handle configurations is offered across the model series, and selected models incorporate a suction channel that allows blood, tissue debris and surgical smoke to be removed from the operative field during use. 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. Output power should be set as low as practicable to achieve the intended clinical effect. The device is contraindicated for use in patients with cardiac pacemakers or other active electronic implants without prior consultation with an appropriately qualified professional. It is intended for transient, intra-operative use and is not implanted.