37
VER: A001 202203
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.
3V rms
At 0.15-80 MHz
6V rms
At ISM & Radio Amateur Freq.
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
communications
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.
