Xltek®EMU40EX™ User and Service Manual
6
Product Intended Use
The XLTEK EMU40EX EEG Headbox is an electroencephalograph that works in conjunction with XLTEK
NeuroWorks software.
The XLTEK EMU40EX EEG Headbox is used to acquire, digitize, store and transmit physiological signals
(such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.
The XLTEK EMU40EX EEG Headbox requires competent user input, and its output must be reviewed
and interpreted by trained medical professionals who will exercise professional judgement in using this
information.
System Components
The EMU40EX amplifier system is provided with optional system components. Computers are intended
to run the NeuroWorks software exclusively. Cameras are intended to acquire synchronized video of the
patient during long-term monitoring. Isolation transformers are intended to provide power for all system
components while ensuring the safety of operators and patients. Carts are intended to support and
facilitate the use of the EMU40EX amplifier while keeping the system mobile. Patient Event Switches are
handheld pushbutton switches used by the patient (or nearby attendant) to signal a significant clinical
event (e.g. an aura or the beginning of a seizure).
Essential Peformance
Essential performances of the EMU40EX amplifer are 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 defitions 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 Peformance 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 behaviour.
If any of the above are observed or if unusual system behaviour is observed contact Natus Technical
support.
