Appendix D: Electromagnetic Compatibility (Emc) - Medizintechnik EasyOne-CS 2001 Manual Del Usuario

2030434-002 Rev. B

20 Appendix D: Electromagnetic Compatibility (EMC)

Changes or modification to the EasyOne system not expressly approved by ndd could cause EMC is-
sues with this or other equipment. The EasyOne system is designed and tested to comply with applica-
ble regulation regarding EMC and needs to be installed and put into service according to the EMC in-
formation stated as follows.
WARNING
Use of portable phones or other radio frequency (RF) emitting equipment near the system may cause
unexpected or adverse operation.
WARNING
The equipment or system should not be used adjacent to, or stacked with, other equipment. If adja-
cent or stacked use is necessary, the equipment or system should be tested to verify normal operation
in the configuration in which it is being used.
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
The EasyOne is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to
ensure that the EasyOne is used in such an environment.
Emissions Test
RF emissions
EN 55011
RF emissions
EN 55011
Harmonic Emissions
EN 61000-3-2
Voltage fluctuations/Flicker
emissions
EN 61000-3-3
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The EasyOne is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to
ensure that the EasyOne is used in such an environment.
Immunity Test EN 60601 Test Level
Electrostatic dis- ± 6 kV contact
charge (ESD) ± 8 kV air
EN 61000-4-2
Electrical fast tran- ± 2 kV for power supply
sient/burst lines
EN 61000-4-4 ±1 kV for input/output
lines
Surge ± 1 kV differential mode
EN 61000-4-5 ± 2 kV common mode
Voltage dips, short <5% U
interruptions and 0.5 cycles
voltage variations 40% U
on power supply 5 cycles
input lines 70% U
EN 61000-4-11 25 cycles
<5% U
5 s
Power frequency 3 A/m
(50/60 Hz) magnetic
field
EN 61000-4-8
NOTE: U is the AC mains voltage prior to application of the test level.
t
Compliance
Group 1
Class B
Not applicable
Not applicable
Compliance Level
± 6 kV contact
± 8 kV air
The product has no power
supply lines.
The product has no input
or output lines that re-
quire testing.
The product has no power
supply lines.
(>95% dip in U ) for The product has no power
t t
supply lines
(60% dip in U ) for
t t
(30% dip in U ) for
t t
(>95% dip in U ) for
t t
3 A/m
Electromagnetic Environment – Guidance
The equipment 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.
The equipment is suitable for use in all establishments inclusively in domestic
and those directly connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Electromagnetic Environment – Guidance
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative humid-
ity should be at least 30%.
Power frequency magnetic fields should be at levels
characteristics of a typical location in a typical commer-
cial or hospital environment.
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