natus Nicolet Viking EDX, Руководство пользователя

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Nicolet EDX
1-4 January 30, 2020
Nicolet EDX amplifier and system essential performance
The Nicolet EDX amplifier and system is designed to function under a wide
range of environmental conditions without any compromise in performance
specifications.
In the event that an environmental artifact (e.g. ESD, line voltage fluctuations,
etc.) is of sufficient intensity and/or duration to adversely affect system
performance, the system is designed to detect this condition and send a message
notifying the operator that an adverse event has occurred. Once the operator has
cleared this message, the system will indicate that acquisition can resume with
the settings restored to the previous state.
If this type of condition causes persistent messages, please contact your local
service representative.
Protective and equipment classifications
1. This system is intended for continuous operation and has an IEC 60601-1
protective classification of Class I, Type BF and Type B applied parts,
ordinary equipment, not suitable for use in the presence of flammable
anesthetics.
2. The MDD equipment classification is IIb.
Intended operator
The Nicolet EDX with Synergy / Viking software is intended to be used by a
qualified healthcare provider.
Intended use
See the Indications for use as listed in the beginning of this guide. The system is
expected to typically be in use for 8-10 hours per day. It would be expected that
while in use (patient connected, the system would be interacted with by qualified
healthcare personnel performing the various studies listed in the indications for
use.