Guidance And Manufacturer's Declaration On Emc - Fresenius Medical Care multiFiltrate Instructions For Use Manual

12.5.2 Guidance and manufacturer's declaration on EMC

Electromagnetic emissions

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
RF emissions according to
CISPR 11
RF emissions according to
CISPR 11
Harmonic current
emissions according to
IEC 61000-3-2
Emissions from voltage
fluctuations / flicker
according to
IEC 61000-3-3
Electromagnetic interference immunity

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
Electrostatic
discharge
(ESD)
according to
IEC 61000-4-2
Electrical fast
transient / burst
immunity according
to IEC 61000-4-4
Surge voltages
according to
IEC 61000-4-5
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
The information refers to the requirements of IEC 60601-1-2:2007.
Compliance
Group 1
Class B
Class A
Compliant
IEC 60601 test level Compliance level
±6 kV contact
discharge
±8 kV air discharge
±2 kV for power lines
±1 kV for input and
output lines
±1 kV differential
mode voltage
±2 kV common mode
voltage
Electromagnetic environment – guidelines
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.
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.
±6 kV contact
discharge
±8 kV air discharge
±2 kV for power lines
±1 kV for input and
output lines
Not applicable
±2 kV common mode
voltage
Chapter 12: Specifications
Electromagnetic environment –
guidelines
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%.
The quality of the supply voltage should
correspond to that of a typical commercial
and / or hospital environment.
The quality of the supply voltage should
correspond to that of a typical commercial
and / or hospital environment.
12-7