User and Service Manual
EMU40EX™
7
Essential Performance
Essential performances of the EMU40EX amplifier 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 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
•
Interruptions in signal transmission resulting from external electromagnetic events. (Ex: Operation of wireless
equipment near 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.
Any serious incident that has occurred in relation to the device should be reported to
Natus Medical Incorporated and the competent authority of the Member State in which the user and/or patient is established.
Instructions to access the eIFU
A copy of the Instructions for Use in PDF format is in:
https://neuro.natus.com/neuro-support
Search for “EMU40EX User and Service manual” and choose the version for your local language for the Instructions For Use.
The files can be printed, saved, or searched using Adobe Reader. A copy of Adobe Reader can be downloaded directly from
Adobe Systems (
). To request a paper copy in English or available translations, contact Natus Customer
Support.
Содержание Xltek EMU40EX
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