Publicidad
Idiomas disponibles
Idiomas disponibles
12. Electromagnetic Compatibility (EMC)
This appliance conforms to the following standards:
IEC 60601-1-11 Medical electrical equipment – Part 1-11: General requirements for basic
sfety and essential performance – Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment and
complies with the requirements of IEC 60601-1-2(EMC), IEC 60601-1(Safety) standards.
And the manufacturer is ISO 13485 certified.
Guidance and manufacturer's declaration – electromagnetic emissions
This breast pump is intended for use in the electromagnetic environment
specified below. The customer or the user of the breast pump should assure
that it is used in such an environment .
Emission tests
Compliance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
IEC 61000-3-3
Warning
:
This breast pump should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, this breast pump should be
observed to verify normal operation in the configuration in which it will be used.
34
Electromagnetic
environment – guidance
The breast pump uses RF
Group 1
energy only for its internal
function. Therefore, its RF
emissions are very low and
are not likely to cause any
interference in nearby
electronic equipment .
Class B
The breast pump is suitable
for use in all establishments,
including domestic
establishments and those directly
connected to the public
Class A
low-voltage power supply
network that supplies
buildings used for domestic
purposes.
Complies
12. Electromagnetic Compatibility (EMC)
Guidance and manufacturer's declaration – electromagnetic immunity
This breast pump is intended for use in the electromagnetic environment
specified below. The customer or the user of the breast pump should assure
that it is used in such an environment.
Compliance
Immunity test
IEC 60601
level
test level
± 8 kV contact
± 8 kV contact
Electrostatic
discharge
discharge
discharge
± 2 kV, ± 4 kV,
± 2 kV, ± 4 kV,
(ESD)
± 8 kV, ± 15 kV
± 8 kV, ± 15 kV
IEC 61000-4-2
air discharge
air discharge
± 2 kV, 100 kHz
Electrical fast
± 2 kV, 100 kHz
repetition
transient/burst
repetition
frequency
IEC 61000-4-4
frequency
Surge
± 0.5 kV, ± 1 kV
± 0.5 kV, ± 1 kV
IEC 61000-4-5
Line-to-lin e
Line-to-lin e
Voltage dips,
0 % UT ; 0.5
0 % UT ; 0.5
short
cycle
cycle
At 0°, 45°, 90°,
At 0°, 45°, 90°,
interruptions
.
135°,
135°,
and voltage
180°, 225°, 270°,
180°, 225°, 270°,
variations on
and
and
power supply
315°
315°
input lines
0% UT;1 cycle
0% UT;1 cycle
IEC
At 0°
At 0°
61000-4-1 1
70% UT; 25
70% UT; 25
cycles
cycles
At 0°
At 0°
0% UT; 250
0% UT; 250
cycles
cycles
Electromagnetic
environment – guidance
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material,
the relative humidity
should be at least 30%.
Mains power quality
should be that of a
typical commercial
or hospital environment.
Mains power quality
should be that of a
typical commercial or
hospital environment
Mains power quality
should be that of a
typical commercial or
hospital environment.
If the user of the
breast pump requires
continued operation
during power mains
interruptions, it is
recommended that
the breast pump be
powered from an
uninterruptible power
supply or a battery.
35
Publicidad
