Revised 11/21/18 4-5
Electromagnetic Compatibility (EMC)
Declaration of compliance for IEC 60601-1-2: Ed. 4.0 (2014)
The Nicolet Cortical Stimulator is intended for use in the electromagnetic environment specified below. The
customer or the user of the Nicolet Cortical Stimulator should assure that it is used in such an environment.
Table 1 - Electromagnetic emissions
Table 4 - Immunity Test Levels - Enclosure Port
Emissions Test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The Nicolet Cortical Stimulator uses RF energy only
for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic environment.
RF emissions
CISPR 11
Class A
The Nicolet Cortical Stimulator is suitable for use in
all establishments, including domestic establishments
and those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes, provided the following warning is
heeded:
This equipment/system is intended for
use by healthcare professionals only. This equipment/
system may cause radio interference or may disrupt
the operation of nearby equipment. It may be
necessary to take mitigation measures, such as
reorienting or relocating the equipment or shielding
the location.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
Phenomenon
Basic EMC Standard
or Test Method
Immunity Test Levels - Professional Healthcare
Facility Environment
Electrostatic Discharge IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiated RF EM Fields IEC 61000-4-3
3 V/m
80 MHz – 2,7 GHz
80% AM at 1 kHz
Proximity Fields from RF Wireless
Communications Equipment
IEC 61000-4-3
See “Table 9 - Enclosure Port Immunity to RF
Wireless Communications Equipment” below
Rated Power Frequency Magnetic
Fields
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
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