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Pelvic intraoperative neurophysiologic monitoring

Development and realization as medical device
: Krueger, T.B.

Biomedizinische Technik 59 (2014), Nr. S1, S.S360-S363
ISSN: 0013-5585
ISSN: 1862-278X
Deutsche Gesellschaft für Biomedizinische Technik (DGBMT Jahrestagung) <48, 2014, Hannover>
Konferenzbeitrag, Zeitschriftenaufsatz
Fraunhofer IBMT ()

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.