Fresenius Medical Care multiFiltrate, Инструкция по эксплуатации

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Chapter 12: Specifications
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 12-7
12.5.2 Guidance and manufacturer's declaration on EMC
The information refers to the requirements of IEC 60601-1-2:2007.

Electromagnetic emissions

Electromagnetic interference immunity
Guidance and manufacturer's declaration on electromagnetic emissions
The multiFiltrate device is designed for operation in an electromagnetic environment as specified below. The
customer or operator of the multiFiltrate device should ensure that it is operated in such an environment.
Interference emission
measurements Compliance Electromagnetic environment – guidelines
RF emissions according to
CISPR 11 Group 1 The multiFiltrate uses RF energy exclusively for its internal
functions. As a result, its RF emissions are very low and it is
unlikely that it will interfere with neighboring electronic devices.
RF emissions according to
CISPR 11 Class B The multiFiltrate device is suitable for use in all establishments,
including private homes. These establishments must be directly
connected to a public power supply network which also supplies
power to buildings used for residential purposes.
Harmonic current
emissions according to
IEC 61000-3-2 Class A
Emissions from voltage
fluctuations / flicker
according to
IEC 61000-3-3 Compliant
Guidance and manufacturer's declaration on electromagnetic interference immunity
The multiFiltrate device is designed for operation in an electromagnetic environment as specified below. The
customer or operator of the multiFiltrate device should ensure that it is operated in such an environment.
Interference
immunity tests IEC 60601 test level Compliance level Electromagnetic environment –
guidelines
Electrostatic
discharge
(ESD)
according to
IEC 61000-4-2 ±6 kV contact
discharge
±8 kV air discharge ±6 kV contact
discharge
±8 kV air discharge Floors should be made of wood or concrete
or fitted with ceramic tiles. If the floor is
fitted with a synthetic material, the relative
humidity must be at least 30%.
Electrical fast
transient / burst
immunity according
to IEC 61000-4-4 ±2 kV for power lines
±1 kV for input and
output lines ±2 kV for power lines
±1 kV for input and
output lines The quality of the supply voltage should
correspond to that of a typical commercial
and / or hospital environment.
Surge voltages
according to
IEC 61000-4-5 ±1 kV differential
mode voltage
±2 kV common mode
voltage Not applicable
±2 kV common mode
voltage
The quality of the supply voltage should
correspond to that of a typical commercial
and / or hospital environment.