16-4 EMC Guidance and Manufacturer’s Declaration
TABLE 3
GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC IMMUNITY
The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
IMMUNITY
TEST
IEC 60601 TEST
LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT-GUIDANCE
Conduced RF
IEC 61000-4-6
3 Vrms
0,15 MHz – 80
MHz
6 Vrms in ISM and
amateur
radio bands
between
0,15 MHz and 80
MHz
3 Vrms
0,15 MHz – 80
MHz
6 Vrms in ISM
and amateur
radio bands
between
0,15 MHz and
80 MHz
Portable and mobile RF
communications equipment should
be used no closer to any part of
system, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter. Recommended
separation distance
d = 1.2 x
d = 1.2 x
80 MHz to 800 MHz
d = 2.3 x
800 MHz to 2.7GHz
Where, P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, should
be less than the compliance level in
each frequency range.
Interference may occur in the
vicinity of equipment marked with
the following symbol:
Radiated RF
IEC 61000-4-3
10 V/m
80MHz - 2.7GHz
10 V/m
80MHz -
2.7GHz
Proximity fields
from RF
wireless
communications
equipment
IEC 61000-4-3
27 V/m
380–390 MHz
27 V/m
430–470 MHz,
800–960 MHz,
1700–1990 MHz,
2400–2570 MHz
28 V/m
704–787 MHz,
5100–5800 MHz
9 V/m
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.
Field strengths 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
system is used exceeds the applicable RF compliance level above, system should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the system.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
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