natus Nicolet, User Manual

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Revised 11/21/18
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General Information
Environmental considerations (operating)
Environmental considerations (non-operating)
Regulatory standards
The Nicolet Cortical Stimulator meets the following safety standards set by
domestic and international regulatory agencies for Medical Electrical Equipment.
Type BF applied device.
Note: If the SUPPLY MAINS is interrupted when power is restored:
The Cortical Stimulator Control Unit will power back up normally to the “NO
STIM” state and can be used normally. If the EEG monitoring system was in use
(SSU mode), this system will also power back up normally and can be used
normally.
Temperature 15.6°C to 32.2°C (60°F to 90°F)
Relative Humidity 20% - 80% (non-condensing)
Altitude 0-3 km (0-10,000 ft)
Temperature -17.7°C to 55°C (0°F to 132°F)
Relative Humidity 10% - 90% (non-condensing)
Altitude 0-12 km (0-40,000 ft)
UL 60601-1 Medical Electrical Safety Standard (USA)
CAN/CSA-C22.2 no.
601.1-M90 Medical Electrical Safety Standard (Canada)
EN/IEC 60601-1 Medical Electrical Safety of Medical Equipment
(International and Europe)
IEC 60601-2-26 Particular safety of electroencephalographs equipment
IEC 60601-2-40 Particular safety of electromyography and evoked response
equipment
EN 60601-1-2 Collateral safety standard for EMC
CE Mark