Device typeAnaesthesia depth monitor: A mains electricity (AC-powered) device intended to be used to detect, process, and display the signals recorded from an unconscious patient (in a state of anaesthesia), showing the degree of consciousness. It is based upon the bispectral index (BIS) analysis of the electroencephalogram waveform and other features of this, enabling detection of, e.g., levels of sedation, loss of consciousness, and recall. It is used during anaesthesia administration and in trauma.
FDA categoryIndex-generating electroencephalograph software
Device ID10884521170254
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information