Immunity Requirements - Input And Output Through The Device's Cover - Nonny BM-03 Instrucciones De Uso

EN | Baby breathing monitor
14.2

IMMUNITY REQUIREMENTS - INPUT AND OUTPUT THROUGH THE DEVICE'S COVER

Phenomenon
Electrostatic discharge
RF EM fi elds propagated by
a)
radiation
Near fi elds from RF wireless
communication devices
Magnetic fi eld of specifi ed
d) e)
mains frequencies
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.
22
MXA51105
Basic standard for EMC or
test method
IEC 61000-4-2
IEC 61000-4-3
IEC 61000-4-3
IEC 61000-4-8
Immunity test levels
Professional medical
facilities
±8 kV or contact charge
±2 kV, ±4 kV, ±8 kV, ± 15 kV for air discharge
f)
3 V/m
b)
80 MHz – 2.7 GHz
c)
80% AM at 1 kHz
see 8.10.
30 A/m
50Hz or 60 Hz
Home health care
f)
10 V/m
b)
80 MHz – 2.7 GHz
c)
80% AM at 1 kHz
g)