Gebrauchsanweisung Untersuchungseinheit cubeONE,
directions for use, refraction unit cubeONE
35
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
Recommended distance
(c)
Conducted
disturbances
induced by RF
fields
EN 61000-4-6
Radiated RF EM
fields
EN 61000-4-3
3 Vrms
150kHz - 80MHz
6 Vrms
150kHz - 80MHz
3 V/m
80MHz - 2,7GHz
10 V/m
80MHz - 2,7GHz
80%@
1 kHz
AM Modulation
3 Vrms
6 Vrms
3V/m
80Mhz- 1 Ghz
10 V/m
80Mhz- 1 Ghz
80%@
1 kHz
AM Modulation
d=0,35
P
d=0,7
P
80MHz
– 800MHz
d=1,4
P
800MHz
– 2,7GHz
Proximity Field
from HF
transmitter
9 V/m to
28 V/m
fulfilled
Where
P
is the maximum output power rating of thet ransmitter in
watts
(W)
according to the transmitter manufacturer and
D
is the
recommended separation distance in metres
(m)
. Field strengths
from fi xed RF transmitters, as determined by an electromagnetic
site survey a, should be less than the compliance level in each
frequency range b Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1:
At 80 MHz and 800 MHz the higher frequency applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
