Laser Surgical Unit diomax
®
72
Revision 6
Guidance and manufacturer’s declaration – Electromagnetic immunity
The device is intended for use in an electromagnetic environment as specified below. The
user of the device must ensure that it is used in such an environment.
Immunity tests
IEC 60601
test level
Compliance level Electromagnetic
environment – Guidance
Electrostatic
discharge (ESD)
according to
IEC 61000-4-2
±8 kV contact
discharge
±15 kV air
discharge
±8 kV contact
discharge
±15 kV air
discharge
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Fast electrical
transients/bursts
according to
IEC 61000-4-4
±2 kV for mains
power lines
±1 kV for input
and output lines
±2 kV for mains
power lines
±1 kV for input
and output lines
The quality of the supply
voltage should be that of a
typical commercial or
hospital environment.
Surges according
to IEC 61000-4-5
±1 kV differential-
mode voltage
±2 kV common-
mode voltage
±1 kV differential-
mode voltage
±2 kV common-
mode voltage
The quality of the supply
voltage should be that of a
typical commercial or
hospital environment.
Voltage dips, short
power interruptions
and supply voltage
fluctuations
according to
IEC 61000-4-11
0% U
T
(100% dip in U
T
)
for ½ period at
0.45, 90, 135, 180,
225, 270 and
315 degrees
0% U
T
(100% dip in U
T
)
for 1 period
70% U
T
(30% dip in U
T
) for
25/30 periods,
single-phase at 0
degrees
0% U
T
(100% dip in U
T
)
for 250/300
periods
0% U
T
(100% dip in U
T
)
for ½ period at
0.45, 90, 135, 180,
225, 270 and
315 degrees
0% U
T
(100% dip in U
T
)
for 1 period
70% U
T
(30% dip in U
T
) for
25/30 periods,
single-phase at 0
degrees
0% U
T
(100% dip in U
T
)
for 250/300
periods
The quality of the supply
voltage should be that of a
typical commercial or
hospital environment. If
the user requires continued
operation during mains
power interruptions, it is
recommended to power the
device from an
uninterruptible power
supply.
Supply-frequency
(50/60 Hz)
magnetic field
according to
IEC 61000-4-8
30 A/m
30 A/m
Magnetic fields at mains
frequency should conform
to the typical values as
found in commercial or
hospital environments.
Note
U
T
is the AC mains voltage prior to application of the test levels.
