22
Wagner & Guder Medical GmbH
issue May 2021
Direction for use, cubeLITE
Guidance and manufacturer’s declaration – Electromagnetic immunity
This product is intended for use in the electromagnetic environment specified below. The
customer or the user of this product should assure that it is used in such an environment.
Immunity test
standard
EN 60601-
test level
Compliance level
Electromagnetic
environment - guidance
Electrostatic
Discharge (ESD)
according to
EN 61000-4-2
± 8 kV
contact
± 15 kV
air
fulfilled
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
according to
EN 61000-4-4
± 2 kV
Netzleitungen
± 1 kV
für Eingangs- und
Ausgangsleitunge
n
fulfilled
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge
according to
EN 61000-4-5
± 1 kV
Leiter-Leiter
± 2 kV
Leiter-Erde
fulfilled
Mains power quality should
be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
lines
According to
EN 61000-4-11
0% U
T
10ms
0% U
T
20ms
70% U
T
0,5s
fulfilled
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
this product requires
continued function even in
the event of interruptions in
the energy supply, this
product should be powered
from an un-interruptible
power supply or a battery.
Magnetic Field
Immunity
(50 or 60Hz)
EN 61000-4-8
30 A/m
fulfilled
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: U
T
= the AC mains voltage prior to application of the test level.
