Chapter 4: Specifications
4-8 Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13
4.8 Guidance and manufacturer’s declaration for EMC
(IEC 60601-1-2)
The information refers to the requirements of IEC 60601-1-2:2007.
4.8.1 Electromagnetic emissions
4.8.2 Electromagnetic immunity
Guidance and manufacturer’s declaration - Electromagnetic emissions
The hemodialysis device is ready for use in an environment as described below. The customer or the user of the
hemodialysis device should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guideline
RF emissions CISPR 11 Group 1 The hemodialysis device uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class B The hemodialysis device 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.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
Guidelines and manufacturer's declaration – Electromagnetic immunity
The hemodialysis device is intended for use in the electromagnetic environment specified below. The customer
or the user of the hemodialysis device should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment –
guideline
Discharge of static
electricity (DSE)
according to
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Electrical fast
transient / burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/output
lines
±2 kV for power
supply lines
Not applicable
Mains power quality should be that of a
typical commercial and / or hospital
environment.
Surge according to
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV common mode
Mains power quality should be that of a
typical commercial and / or hospital
environment.
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