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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
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
