20
EMC Declaration
Immunity
Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic
Environment
–
Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHZ
3 V/m
80 MHz to 2.5
Ghz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the blood pressure monitor,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance:
d=1.2
√
P
d=1.2
√
P 80MHz to 800MHz
d=2.3
√
P 800MHz to 2.5Ghz
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 metres (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 fallowing
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 broadcasts and TV
broadcasts 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
blood pressure monitor is used exceeds the applicable RF compliance level above, the
blood pressure monitor should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or
relocating the blood pressure monitor.
b.
Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than [V1]
V/m.
