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EN | BM-03 Baby breathing monitor
MXA51006
(85956141BM03SJ)
15.2
IMMUNITY REQUIREMENTS - INPUT AND OUTPUT THROUGH THE DEVICE’S COVER
Phenomenon
Basic standard for EMC
or test method
Immunity test levels
Professional medical
facilities
Home health care
a)
Electrostatic discharge
IEC 61000-4-2
± 8 kV or contact charge
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV for air discharge
RF EM fi elds propagated
by radiation
a)
IEC 61000-4-3
3 V.m
-1 f)
80 MHz – 2,7 GHz
b)
80 % AM pri 1 kHz
c)
10 V.m
-1 f)
80 MHz – 2,7 GHz
b)
80 % AM pri 1 kHz
c)
Near fi elds from RF
wireless communication
devices
IEC 61000-4-3
see 8.10.
Magnetic fi eld of specifi ed
mains frequencies
d) e)
IEC 61000-4-8
30 A.m
-1 g)
50 Hz or 60 Hz
a) If an interface is used between the simulation of the patient‘s physiological signal and the ME device or ME
system, it must be located within 0.1 m of the vertical plane of the homogeneous fi eld area in one direction
with the ME device or ME system.
b) An ME device or ME system that intentionally receives RF electromagnetic energy for its operation must be
tested at the reception frequency. Testing may be performed at other modulation frequencies determined in
the risk management process. This test assesses the basic safety and necessary functionality of the intended
receiver when the ambient signal is in the passband. It is understood that the receiver may not achieve normal
reception during the test.
c) Testing may be performed at other modulation frequencies determined in the risk management process.
d) Valid only for ME devices and ME systems with magnetically sensitive components or circuits.
e) During the test, the ME instrument or ME system may be supplied with any nominal input voltage, but at the
same frequency as the test signal.
f) Before using modulation.
g) This test level assumes a minimum distance of at least 15 cm between the ME device or ME system and the
source of the mains frequency magnetic fi eld. If the risk analysis shows that the ME instrument or ME system
will be used closer than 15 cm from the source of the mains frequency magnetic fi eld, the immunity test level
must be set as is appropriate for the minimum expected distance.
Содержание BM-03
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