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Appendix
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environments listed below, and should only
be used in such environments:
Immunity
test
IEC 60601 test level
Compliance
level
Electromagnetic environment
–
guidance
Conducted RF
IEC
61000-4-6
3V rms
At 0.15-80 MHz
6V rms
At ISM & Radio Amateur
Freq
Not Applicable
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Radiated RF
IEC
61000-4-3
Proximity
fields from RF
wireless
communicati
ons
equipment
IEC
61000-4-3
10 V/m at 80-2700 MHz
AM Modulation And
9-28V/m at
385-6000MHz,Pulse
Mode and other
Modulation. The system
shall be tested as
specified in
IEC60601-1-2 Table 9
for proximity fields from
RF wireless
communications
equipment using the
test methods specified
in IEC 61000-4-3
10 V/m at 80-2700
MHz
AM Modulation And
9-28V/m at
385-6000MHz,Pulse
Mode and other
Modulation. The
system shall be tested
as specified in
IEC60601-1-2 Table 9
for proximity fields
from RF wireless
communications
equipment using the
test methods specified
in IEC 61000-4-3
Recommended separation distance
Considering to reduce the minimum
separation distance, based on RISK
MANAGEMENT, and using higher IMMUNITY
TEST LEVELS that are appropriate for the
reduced minimum separation distance.
Minimum separation distances for higher
IMMUNITY TEST LEVELS shall be calculated
using the following equation:
E = 6/d
where
P
is the maximum power in W,
d
is
the minimum separation distance in m, and
E
is the IMMUNITY TEST LEVELS in V/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 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 the device is used
exceeds the applicable RF compliance level above, the device should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
the device.
b)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m
