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2014
Journal Article
Title
Pelvic intraoperative neurophysiologic monitoring
Title Supplement
Development and realization as medical device
Abstract
We present an intraoperative neuromonitoring system for the preservation of autonomous nerves in the pelvic region. The development of such a system as medical device is a complex task. High quality standards need to be considered to insure safety for the patient and the user; these include special electric design requirements as well as stringent specifications on a fail-safe user interface. Especially if a new methodology has to be established, unpredictable challenges can arise. Many years of experience are needed to pre-estimate the customers' needs in order to develop a system that is able to support rather than to challenge the surgeon and his team in the operation room during a possible stressful situation. In this case the commonly known method of intraoperative neurophysiological monitoring was transferred to a new technique and its application in the pelvic region.