Integra CUSA Clarity System Service And Maintenance Manual page 93

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
CUSA® Clarity System Service and Maintenance Manual
IEC 60601-1-2
Compliance Level
Test Level
± 6 kV contact (3 rd ed.)
± 8 kV contact (4 ed.)
th
± 8 kV air (3 rd ed.)
± 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) ± 1 kV line(s) to line(s)
± 2 kV line(s) to earth ± 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 rd ed.)
30 A/m (4 th ed.)
Electromagnetic Environment
± 8 kV contact
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
± 15 kV air
± 2 kV for power
supply lines
Mains power quality should be that of a typical
hospital environment.
± 1 kV for input /
output lines
Mains power quality should be that of a typical
hospital environment.
< 5% U
T
(> 95% dip in U
)
T
for 0,5 cycle
Mains power quality should be that of a typical
< 40% U
T
hospital environment.
(> 60% dip in U )
T
for 5 cycles
If the user of the CUSA Clarity system requires
continued operation during power mains
<70% U
interruptions, it is recommended that the
T
(> 30% dip in U
)
CUSA Clarity system be powered from an
T
for 25 cycles
uninterruptible power supply.
< 5% U
T
(> 95% dip in U )
T
for 5 s
Power frequency magnetic fields should be at
30 A/m levels characteristic of a typical location in a
typical hospital environment.
Page 93 of 117
- Guidance
0645403-2-EN