USER
MANUAL
39
51335-006
EEG System
Guidance and Manufacturer’s Declaration
Electromagnetic Emissions
IEC 60601-1-2 / EN 60601-1-2
The R40 is intended for use in the electromagnetic environment specified below. The customer or user of the R40
should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment Guidance
RF emissions
CISPR11/EN55011
Group 1
The R40 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 equipment.
RF emissions
CISPR11/EN55011
Class B
The R40 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.
Note: Only the recommended or supplied PC must be used in the
system to ensure compliance.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/Flicker
emissions IEC 61000-3-3
Complies
Electromagnetic Immunity
IEC 60601-1-2 / EN 60601-1-2
The R40 is intended for use in the electromagnetic environment specified below. The customer or user of the R40
should assure that it is used in such an environment.
Immunity Test
EN 60601-1-2
Test Level
Compliance
Level
Electromagnetic Environment Guidance
Electrostatic discharges
(ESD)
IEC 61000-4-2
+/- 8 kV: Contact
+/- 15kV: Air
+/- 8 kV: Contact
+/- 8kV :Air
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should
be at least 30%.
While in use, the patient should be stationery and not touch
the R40 amplifier
Electrical fast Transients/
burst
IEC 61000-4-4
Compliance is
provided by the
recommended PC
equipment.
Compliance is
provided by the
recommended PC
equipment.
Mains power should be that of a typical commercial and/or
hospital environment
Surge
IEC 61000-4-5
Compliance is
provided by the
recommended PC
equipment.
Compliance is
provided by the
recommended PC
equipment.
Mains power should be that of a typical commercial and/or
hospital environment
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
Compliance is
provided by the
recommended PC
equipment.
Compliance is
provided by the
recommended PC
equipment.
Mains power should be that of a typical commercial and/or
hospital environment. If the user of the R40 system requires
continued operation during power mains interruptions, it
is recommended that the R40 system be powered from an
uninterruptible power supply or a battery
Appendix 6
Summary of Contents for neuro R40
Page 1: ...USER MANUAL EEG System ...
