The NeXus 10 MK3 is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/access professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MK3 is not intended for use in diagnosis, nor in critical and/or life supporting applications.The NeXus 10 MK3 is intended for use on humans.The NeXus 10 MK3 is intended to be used with approved NeXus 10 accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus 10 and may require interpretation by user or application software.
An electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy.