Table 2. Immunity Guidance
power supply input
lines
EN 61000-4-11
for 0,5 cycle
40% UT (>60% dip of
UT)
for 5 cycle
70% UT (>30% dip of
UT)
for 25 cycle
<5% UT (>95% dip of
UT)
for 5 seconds
for 0,5 cycle
40% UT (>60% dip of
UT)
for 5 cycle
70% UT (>30% dip of
UT)
for 25 cycle
<5% UT (>95% dip of
UT)
for 5 seconds
functioning during power supply interruptions,
it is recommended a backup power supply unit
(UPS) or battery.
Magnetic field at
power frequency EN
61000-4-8
3 A /m 3 A /m Power frequency magnetic fields should have
characteristic levels of a typical commercial or
clinical environment.
Table 3. Immunity Radio Frequency Guidance
The vision screener is manufactured to work in the electromagnetic environment specified below. The operator or user
should make sure it is used within those environmental conditions.
Immunity Test Test level EN
60601-1-2
Conformity Level Electromagnetic environment guide
Conducted RF
EN 61000-4-6
3 Veff from 150kHz to
80MHz
3 Veff from 150kHz to
80MHz
The portable and mobile devices with RF
communication should not be used near any
part of the device, including cables, except
when they follow the recommended safety
distance for separation, calculated with the
equation applicable to the frequency of the
transmitter. Recommended safety distance for
separation:
d= 1.2 x from 150kHz to 80MHz
d= 1.2 x from 80MHz to 800MHz
d= 1.2 x from 800MHz to 2,5GHz
where P is the nominal maximum power of the
transmitter output expressed in Watts (W) as
specified by the transmitter manufacturer andd
is the recommended separation distance
expressed in meters (m).
Radiated RF
EN 61000-4-3
3 V/m 80 MHz to 2.5
GHz
3 V/m 80 MHz to 2.5
GHz
Surge EN 61000-4-5
Differential mode: ±1
kV
Common mode: ±2kV
Differential mode: ±1
kV
Common mode: ±2kV
The field intensity of the fixed RF transmitters, as checked in an electromagnetic investigation of the locus, should be
less than the conformity level for each range of frequency.
It is possible to have interference near devices marked with the symbol:
Directions for use Specifications 49