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The KIRWAN MODEL 28 1000 Generator is a general purpose solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.

A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- Swatts, full scale (@ 100 ohms). A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation. The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply. Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines. IF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) ipolar coagulators.

This document describes the Kirwan 28 1000 Coagulator, specifically a 510(k) premarket notification for a predicate device. It does not contain information about acceptance criteria or a study proving a device meets those criteria.

Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a medical device, not a performance study.

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