Natus® Brain Monitor &
Embla Dx Series™
User and Service Manual
6
System Components
The Amplifier system is provided with several optional system components. Computers are intended to
run the NeuroWorks / SleepWorks software exclusively. Cameras are intended to acquire synchronized
video of the patient during EEG or Sleep studies. Isolation transformers are intended to provide power for
all system components while ensuring the safety of the operators and the patients. Carts are intended to
support and facilitate the use of the Brain Monitor & Embla Dx Series Amplifiers while keeping the system
mobile.
Essential Performance
Essential performances of the Natus Brain Monitor is identified in the standard IEC 60601-2-26:2012.
Essential performance relates to the quality of the signal recorded from the amplifier. Specific essential
performances are (1) accuracy of signal reproduction, (2) dynamic range and differential offset voltage,
(3) input noise level, (4) frequency response, and (5) common mode rejection. The definitions of these
essential performances can be found in the standard.
The standard ISO 80601-2-61 also applies as the amplifier is considered pulse oximeter equipment
without an alarm system. The additional essential performance required of the amplifier as laid out in this
standard includes SpO2 and pulse rate accuracy, to be verified by an electronic patient simulator; and
indication of abnormal operation, including notification of signal inadequacy and probe faults. Evidence of
SpO2 accuracy by controlled desaturation study to be covered by the manufacturer of the pulse oximeter
probe or sensor used.
Essential Performance Degradation
Professional healthcare trained personnel will observe essential performance degradation which includes
but are not limited to:
Loss of EEG signal/data
Amplifier saturation indication on the computer monitor,
Intermittent bursts of noise on random EEG leads.
Loss of communications from the computer to the Natus base
Pinbox disconnected events. (Quantum)
Interruptions in signal transmission resulting from external electromagnetic events. (Ex:
Electrocautery, Operation of wireless equipment in close proximity to the amplifier, etc.)
Any form or random or intermittent system behavior.
If any of the above are observed or if unusual system behavior is observed contact Natus Technical
support.
Operating Principle of the Amplifier
The Natus Brain Monitor & Embla Dx Series amplifiers are comprised of a base unit and a breakout box.
The variation of the amplifier and feature subset is defined by the model of breakout that is connected to
the base unit. It is part of a system that is made up of a personal computer, a photic stimulator, an
isolation transformer, video and audio equipment, networking equipment, and mechanical supports.
Electrophysiological signals, from electrodes, sensors, and other accessories such as pulse oximeters
can be acquired by the amplifier. These signals are digitized and transmitted to the personal computer
running the Natus NeuroWorks/SleepWorks software. The signals are displayed on the personal
computer and can be recorded to the computer's local storage or to remote networked storage for later
review.
