Nicolet Cortical Stimulator
1-10
Revised 8/27/13
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.
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
Summary of Contents for Nicolet SCU
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Page 9: ...Revised 8 27 13 1 1 1 General Information...
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Page 21: ...Revised 8 27 13 2 1 2 Nicolet Cortical Stimulator Overview...
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Page 37: ...Revised 8 27 13 3 1 3 Performing a Cortical Stimulation Study...
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Page 55: ...Revised 8 27 13 4 1 4 Electromagnetic Compatibility EMC...
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Page 63: ...Revised 8 27 13 5 1 5 Error Codes...
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