Integra CUSA Clarity - Electromagnetic Immunity Guidance

CUSA
®
Clarity Ultrasonic Surgical Aspirator System Operator’s Manual
A-8
Voluntary Standards
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The CUSA Clarity system is intended for use in the electromagnetic environment specied below. The
customer or the user of the CUSA Clarity system should assure that it is used in such an environment.
IMMUNITY Test
IEC 60601-1-2
Test Level
Compliance Level
Electromagnetic Environment
- Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact (3
rd
ed.)
± 8 kV contact (4
th
ed.)
± 8 kV air (3
rd
ed.)
± 15 kV contact (4
th
ed.)
± 8 kV contact
± 15 kV air
Floors should be wood, concrete
or ceramic tile. If oors 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
± 2 kV for power
supply lines
± 1 kV for input /
output lines
Mains power quality should be
that of a typical 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
Mains power quality should be
that of a typical 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
< 40 % U
T
(> 60% dip in U
T
)
for 5 cycles
< 70 % U
T
(> 30% dip in U
T
)
for 25 cycles
< 5% U
T
(> 95% dip in U
T
)
for 5 s
< 5% U
T
(> 95% dip in U
T
)
for 0,5 cycle
< 40% U
T
(> 60% dip in U
T
)
for 5 cycles
<70% U
T
(> 30% dip in U
T
)
for 25 cycles
< 5% U
T
(> 95% dip in U
T
)
for 5 s
Mains power quality should be
that of a typical hospital
environment. If the user of the
CUSA Clarity system requires
continued operation during
power mains interruptions, it is
recommended that the CUSA
Clarity system be powered from
an uninterruptible power supply.
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
3 A/m (3
rd
ed.)
30 A/m (4
th
ed.)
30 A/m
Power frequency magnetic elds
should be at levels characteristic
of a typical location in a typical
hospital environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.