Inspection and Testing of Electroencephalographs, Electromyographs, and Evoked Response Equipment
摘要
This chapter deals with the inspection of neurodiagnostic equipment for measurement of electrophysiological signals in order to detect eventual problems and prevent them from becoming serious safety risks. The first section of the text gives a brief description of the human neuromuscular system, followed by description and short historical overview of considered neurodiagnostic methods: electroencephalography (EEG) including evoked potentials (EP), electromyography (EMG) and nerve conduction study (NCS). Operating principle of a computer-controlled neurodiagnostic instrument is explained using a generic block diagram. The next sections discuss potential harms and hazards associated with the use of neurodiagnostic equipment as well as standards and regulations concerning basic safety and essential performance requirements. A dedicated section follows up with importance of evidence-based post-market surveillance (PMS), while inspection section describes testing and inspection procedures for periodic testing of modern computer-based neurodiagnostic instruments in the field. Following section is a review of recommendations, contraindications, and warnings for use, while the closing section provides a chapter summary.