With the increased number of electronic devices such as PC's and mobile
(cellular) telephones, medical devices in use may be susceptible to
electromagnetic interference from other devices. Electromagnetic interference
may result in incorrect operation of the medical device and create a potentially
unsafe situation.
Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility)
with the aim to prevent unsafe product situations, the EN60601-1-2 standard has
been implemented. This standard defines the levels of immunity to
electromagnetic interferences as well as maximum levels of electromagnetic
emissions for medical devices.
III. EMC instruction
Medical devices manufactured by YUWELL conform to this EN60601-1-2:2014
standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
The use of accessories and cables other than those specified by YUWELL, with
the exception of cables sold by YUWELL as replacement parts for internal
components, may result in increased emission or decreased immunity of the
device.
The medical devices should not be used adjacent to or stacked with other
equipment. In case adjacent or stacked use is necessary, the medical device
should be observed to verify normal operation in the configuration in which it will
be used.
Refer to further guidance below regarding the EMC environment in which the
device should be used.
Table1 Guidance and manufacturer's declaration electromagnetic emissions
Guidance and manufacturer's declaration – electromagnetic emissions
Device is intended for use in the electromagnetic environment specified below. The
customer or the user of these YUWEII Nebulizers should assure that it is used in such
environment.
The involved model
is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings
used for domestic purposes
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Emissions test
Compliance
Complies
Class A
Complies
RF emissions
CISPR14-1
Harmonic emissions
IEC 61000-3-2
Electromagnetic environment - guidance
The involved model
with other equipment.
Guidance and manufacturer's declaration – electromagnetic immunity
Device is intended for use in the electromagnetic environment specified below. The customer
or the user of these YUWEII Nebulizers should assure that it is used in such environment.
Table 2 Guidance and manufacturer's declaration – electromagnetic immunity
Immunity test
IEC 60601
Test level
Electrostatic
discharge
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floor should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30% RH.
±2 kV for power
supply lines
±1 kV for
input/output lines
±2 kV for power
supply lines
±1 kV for
input/output lines
Mains power quality should be
that of a typical commercial
and/or hospital environment.
Surge
IEC 61000-4-5
±1 kV line to line
±2 kV
line to earth
±1 kV line to line
±2 kV
line to earth
Mains power quality should be
that of a typical commercial
and/or hospital environment.
Voltage dips,
short interruptions
and voltage
variations on
power supply
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(95 % dip in UT)
for 5 sec.
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(95 % dip in UT)
for 5 sec.
Mains power quality should be
that of a typical commercial
and/or hospital environment.
If the user of the nebulizer
involved in this manual
requires continued
interruption, it is
be powered from an
uninterruptible power supply
or battery.
Power frequency
(50/ 60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: UT is the A.C. mains voltage prior to application of the test level.
Electrical fast
transient/burst
IEC 61000-4-4
Compliance level
Electromagnetic environment
– guidance
is not suitable for
interconnection
operation
during power mains
recommended
that the involved model
10 11
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