Medela Vario Mode D'emploi page 346

I Technical documentation
WARNINGS
Do not use other accessories than those specified or sold by the manufacturer as
replacement parts for internal components as it may result in increased emissions or
decreased immunity of the Vario pump.
HF (high-frequency) surgical equipment, radio networks or the like can influence the
operation of the device and may not be operated in combination with the system.
EMC
Vario is EMC-tested in conformity with the requirements of IEC 60601-1-2:2007 and IEC
60601-1-2:2014 4th Edition according to clause 7 and 8.9. Vario is suitable for use in home
and clinical environments. Vario is a medical device that requires special safety precautions
and must be installed and placed in operation in accordance with the attached EMC informa-
tion.
Electromagnetic Compatibility (EMC, IEC 60601-1-2:2007, 3rd Edition and IEC60601-1-2
4th Edition, Table 1)
Electromagnetic Emissions
Vario is intended for use in the electromagnetic environment specified below. The
customer or the user of Vario should assure that they are used in such environment.
Emission Tests
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctutions /
flicker emissions
IEC 61000-3-3
WARNINGS
Vario should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, Vario should be observed to verify normal operation in the
configuration in which it will be used.
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Technical documentation
Compliance Electromagnetic environment – guidance
Group 1 Vario uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any interference
with nearby electronic equipment.
Class B Vario is suitable for use in all establishments,
including domestic establishments and those
directly connected to the public low-voltage
Class A
power supply network that supplies buildings
used for domestic purposes.
Not applicable