Gebrauchsanweisung Untersuchungseinheit cubeONE,
directions for use, refraction unit cubeONE
34
Wagner & Guder Medical GmbH
issue September 2020
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
Ausgangsleitungen
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.
