This regulation is applicable to the initial verification, subsequent verification and in-service inspection of digital electroencephalogram mapping & brain electric activity mapping.
This regulation is also applicable to the initial verification, subsequent verification and in-service inspection of digital electroencephalogram mapping & brain electric activity mapping that take electroencephalograph as pre-amplifier. For such verified equipment, the electroencephalograph used as pre-amplifier is considered as a part of equipment and verified integrally.
2 Overview
Digital electroencephalogram mapping is to convert the biological analog electronic signals generated from brain tissue activities into digital values via input circuit, amplifier, data collector and analog-digital converter, etc. and to store the digital values. After analyzing and processing the stored digital values, time domain electroencephalogram is replayed or printed.
As for brain electric activity mapping, frequency domain analysis function for brain electric signals is added in digital electroencephalogram mapping, the analysis result is displayed or printed in the form of power spectrum mapping, brain electric activity mapping and the like.
In this regulation, digital electroencephalogram mapping & brain electric activity mapping are referred to as verified instrument.