Xinetix performed extensive testing on the Levitate Air Frame for susceptibility to radiated electrical emissions. It was essential to recreate the operating room environment, simulating Air Frame use in the presence of electrosurgical cutting and coagulation electromagnetic radiation. Xinetix drew upon more than twenty years of experience in the design and manufacturing of commercial electrosurgical equipment to develop test protocols and environments to challenge the Air Frame design.
Xinetix delivered conclusive reports and documentation supporting the safety of Air Frame use in the operating room. This evidence was sufficient to support the company's FDA 510(k) submission.
