Iridex PASCAL Synthesis - Page 128

PASCAL
®
Synthesis Ophthalmic Scanning Laser Systems Page 128 of 141
88292-EN, Rev D
Guidance and manufacturer's declaration - electromagnetic immunity
The PASCAL Synthesis Ophthalmic Scanning Laser System is intended for use in the electromagnetic
environment specified below. The customer or the user of the PASCAL Synthesis Ophthalmic Scanning
Laser System should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic
environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
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
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for
input/output lines
Repetition frequency
100kHz
± 2 kV for power
supply lines
± 1 kV for
input/output lines
Repetition frequency
100kHz
Main power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV
line(s) to line(s)
± 2 kV
line(s) to earth
± 1 kV
line(s) to line(s)
± 2 kV
line(s) to earth
Main power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
Voltage variations
on power supply
input lines
IEC 61000-4-11
<5% U
t
(>95% dip in U
t
)
for 0.5 cycle
(with phase angle 0°,
45°, 90°, 135°, 180°,
225°, 270° and 315°)
<5% U
t
(>95% dip in U
t
)
for 1 cycle
70% U
t
(30% dip in U
t
)
for 25/30 cycles
<5% U
t
(>95% dip in U
t
)
for 5 sec
<5% U
t
(>95% dip in U
t
)
for 0.5 cycle
(with phase angle 0°,
45°, 90°, 135°, 180°,
225°, 270° and 315°)
<5% U
t
(>95% dip in U
t
)
for 1 cycle
70% U
t
(30% dip in U
t
)
for 25/30 cycles
<5% U
t
(>95% dip in U
t
)
for 5 sec
Main power quality should be that
of a typical commercial or hospital
environment. If the user of the
PASCAL Synthesis Ophthalmic
Scanning Laser System requires
continued operation during main
power interruptions, it is
recommended that the SL-
PASCAL Synthesis Ophthalmic
Scanning Laser System be
powered from an uninterruptible
power supply or battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
NOTE U
t
is the a.c. main voltage prior to application of the test level.