SCHWIND Amaris 500E - Table 3: ELECTROMAGNETIC IMMUNITY (1)

USER MANUAL (Instruction for Use) SW 6.1
AppendiXes
Version 6.1.6 dated 2020-01-31 EN Page 196 of 201
Table 3: ELECTROMAGNETIC IMMUNITY (1)
Guidelines and declaration of conformity – electromagnetic immunity
The AMARIS excimer lasers are intended to be used in a PROFESSIONAL HEALTHCARE
FACILITY ENVIRONMENT. The electromagnetic environment is specified below. The
customer or the user of the AMARIS excimer laser should assure that it is used in such an
environment. The AMARIS excimer lasers are not intended to be used in exclusions, such as
hospitals with near active HF SURGICAL EQUIPMENT and RF shielded rooms of an ME
System for magnetic resonance imaging or other environments where the intensity of EM
DISTURBANCES is high.
Immunity test IEC 60601 test
level
Compliance level Electromagnetic
environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8kV contact
±2kV, ±4kV, ±8kV,
±15kV air
±8kV contact
±2kV, ±4kV, ±8kV,
±15kV air
Floor should be according to
the guidance “Room
Requirements”. If floor is
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
±1kV for input /
output lines
100kHz repetition
frequency
±2 kV for power
supply lines
±1kV for input /
output lines
100kHz repetition
frequency
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV line(s) to
line(s)
±2 kV line(s) to
earth
±1kV line(s) to
line(s)
±2 kV line(s) to earth
Mains 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
100% dip in U
T
for
0.5 cycle
at 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°.
100% dip in U
T
for
1 cycle
70% U
T
(30% dip in U
T
) for
25 cycles
100% dip in U
T
for
250 cycles
100% dip in U
T
for
0.5 cycle
at 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°.
100% dip in U
T
for 1
cycle
70% U
T
(30% dip in U
T
) for
25 cycles
100% dip in U
T
for
250 cycles
Mains power quality should
be that of a typical
commercial or hospital
environment.
If the user of the AMARIS
EXCIMER LASER requires
continued operation during
power mains interruptions,
it is recommended that the
AMARIS EXCIMER LASER
be powered from an
uninterruptible power
supply (UPS).