Electroencephalograph

Intended purpose

Intended Use (NeuroWorks) •Natus NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography who will exercise professional judgment in using the information. •The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals. •The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. •The Spike Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. •aEEG, Burst Suppression, Envelope, Alpha variability, Spectral Edge and Spectral Entropy trending functionalities included in NeuroWorks are intended to assist the user while monitoring the state of the brain. The automated event marking function of NeuroWorks is not applicable to these analysis features. •NeuroWorks also includes the display of a quantitative EEG plot, Density Spectral Array (DSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of NeuroWorks is not applicable to DSA. •This device does not provide any diagnostic conclusion about the patient’s condition to the user. Intended Use – SleepWorks The SleepWorks software is intended for polysomnography studies. The software allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders. The SleepWorks allows: • Automated analysis of physiological signals that is intended for use only in adults. • An optional audio / visual alert for user-defined threshold on calibrated DC input. These alerts are not intended for use as life support, such as vital signs monitoring or continuous medical surveillance in intensive care units. • Sleep report templates are provided that summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values, as well as data ranges for trended values. SleepWorks software does not provide any diagnostic conclusion about the patient’s condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.