USER
MANUAL
40
51335-006
EEG System
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment Guidance
Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
3 A/m, 30A/m
3 A/m
See Note e.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical com-mercial
and/or hospital environment.
Conducted RF
IEC 61000-4-6
Radiated RF
Electromagnetic Fields
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
6V in ISM Bands
3 V/m
80 MHz to 2.5 GHz
10V/m (Home
Environment)
3 Vrms
3 V/m
See Note f.
Portable and mobile RF communications equipment should
be used no closer to any part of the R40, including cables
than the recommended separation distance calculated from
the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = [3.5/E]
√
P = 1.2
√
P
d = [3.5/E]
√
P : 80 MHz to 800 MHz = 1.17
√
P
d = [7/E]
√
P : 800 MHz to 2.5 GHz = 2.33
√
P
Note: using unshielded input leads
Where P is the maximum output power rating of the
transmitter in watts (W) according to the manufacturer and d
is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey
a
, should be less than the
compliance level in each frequency range
b
.
Interference may occur in the vicinity
of equipment marked with the
following symbol:
NOTE 1. At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the R40 is used exceeds the applicable RF compliance level above, the R40 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the R40.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
c The immunity levels for conducted RF are for unscreened input electrode leads 1 m in length and worse-case coupling, including any
resonances across the frequency band. The interference is less when the coupling plane of the interference source is not in the same
plane as the electrode leads.
d The immunity levels for radiated RF are for unscreened input electrode leads 1 m in length and worse-case coupling, including any
resonances across the frequency band. The interference is less when the polarisation plane of the interference source is not in the same
plane as the electrode leads.
e The R40 does not contain magnetic components and is not susceptible to power frequency magnetic field interference.
f The conditions of intended use justify lower immunity test levels. The hazards and risk analysis associated with these lower limits have
been documented in the Risk Management file
Appendix 6
Summary of Contents for neuro R40
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