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Table1 Guidance and manufacturer’s declaration – electromagnetic
emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
M102 Mesh Nebulizers are intended for use in the electromagnetic
environment specified below. The customer or the user of these
YUWELL Nebulizers should assure that it is used in such environment.
Emissions test
Compliance
Electromagnetic environment -
guidance
RF emissions
CISPR14-1
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
Class A
Complies
The Mesh Nebulizer is not suitable
for interconnection with other
equipment.
The Mesh Nebulizer 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
22 23
III. EMC instruction
With the increased number of electronic devices such as PC’s and
mobile (cellular) telephones, medical devices in use may be suscep-
tible to electromagnetic interference from other devices. Electro-
magnetic 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.
Medical devices manufactured by YUWELL conform to this
EN60601-1-2:2007 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 replace-
ment 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.