Integra CUSA Clarity Operator's Manual page 135

Voluntary Standards
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The CUSA Clarity system is intended for use in the electromagnetic environment specified below. The
customer or the user of the CUSA Clarity system should assure that it is used in such an environment.
IMMUNITY Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines.
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: U is the a.c. mains voltage prior to application of the test level.
T
A-8
IEC 60601-1-2
Test Level
± 6 kV contact (3 ed.)
rd
± 8 kV contact (4 ed.)
th
± 8 kV air (3 ed.)
rd
± 15 kV contact (4 ed.)
th
± 2 kV for power
supply lines
± 1 kV for input /
output lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
< 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
3 A/m (3 ed.)
rd
30 A/m (4 ed.)
th
Compliance Level
± 8 kV contact
± 15 kV air
± 2 kV for power
supply lines
± 1 kV for input /
output lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
< 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
30 A/m
CUSA Clarity Ultrasonic Surgical Aspirator System Operator's Manual
®
Electromagnetic Environment
- Guidance
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Mains power quality should be
that of a typical hospital
environment.
Mains power quality should be
that of a typical hospital
environment.
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 magnetic fields
should be at levels characteristic
of a typical location in a typical
hospital environment.