Electromagnetic Emissions; Technical Documentation (Emc); Technische Dokumentation (Emv); Documentation Technique (Cem) - Medela Basic Instrucciones De Uso

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 Basic pump.
HF (high-frequency) surgical equipment, radio networks or the like can influence the oper-
ation of the device and may not be operated in combination with the Basic pump.
EMC (Electromagnetic Compatibility)
Basic has been 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 and can be used in the vicinity
of other EMC-tested devices that fulfill the requirements of the relevant IEC 60601-1-2 stand-
ard. Basic is a medical device that requires special safety precautions and must be installed
and placed in operation in accordance with the following EMC information.
Essential Performance
Medela has determined that the Basic suction pump does not have any functions, the failure
of which to work properly, could impact the safety of the system. As such, there is no essen-
tial performance as defined in the IEC 60601-1-2 standard. Nevertheless, the Basic was
tested in accordance with IEC 60601-1-2 ensuring that the pump could maintain the correct
vacuum during testing.
Electromagnetic Compatibility (EMC, IEC 60601-1-2, 3rd Edition and IEC60601-1-2 4th Edition,
Table 1)

Electromagnetic Emissions

Basic is intended for use in the electromagnetic environment specified below. The cus-
tomer or the user of Basic should assure that it is 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 60000-3-3
WARNINGS
Basic should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, Basic 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 Basic uses RF energy only for its internal func-
tion. Therefore, its RF emissions are very low
and are not likely to cause any interference with
nearby electronic equipment.
Class B Basic 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.
Complies