62
MXA51005
EN | Baby breathing monitor
14.2
IMMUNITY REQUIREMENTS - INPUT AND OUTPUT THROUGH THE DEVICE’S COVER
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.
Phenomenon
Basic standard for EMC or
test method
Immunity test levels
Professional medical
facilities
Home health care
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
f)
80 MHz – 2.7 GHz
b)
80% AM at 1 kHz
c)
10 V/m
f)
80 MHz – 2.7 GHz
b)
80% AM at 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
g)
50Hz or 60 Hz