Boston Scientific LithoVue Manuel D'utilisation page 43

table 9�1 Acceptable environment for operation of the System Workstation
Emissions test
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/Flicker
Emissions IEC 61000-3-3
9�2 GUIdAncE And MAnUFActUrEr'S dEcLArAtIon – IMMUnIty ALL EQUIPMEnt And SyStEMS
The LithoVue System is intended for use in the electromagnetic environment specified below (Table 9.2). You
should ensure the operating environment meets these requirements before using the System Workstation.
table 9�2 Acceptable environment for operation of the System Workstation
IEc 60601
Immunity test
test Level
Electrostatic discharge
± 6 kV contact
(ESD)
± 8 kV air
IEC 61000-4-2
± 2 kV for power
Electrical fast transient
supply lines
/ burst
± 1 kV for input/
IEC 61000-4-4
output lines
± 1 kV line(s) to line(s)
Surge
IEC 61000-4-5
± 2 kV line(s) to earth
< 5 % U
(> 95% dip in U
for 0.5 cycle
40% U
Voltage dips, short
(60% dip in U
interruptions and
for 5 cycles
voltage variations on
70% U
power supply input lines
(30% dip in U
IEC 61000-4-11
for 25 cycles
< 5% U
(> 95% dip in U
for 5 sec
User's Manual
compliance Electromagnetic Environment—Guidance
The LithoVue™ System uses radio frequency (RF)
energy only for its internal function. Therefore, its RF
Group 1
emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
Class A
The LithoVue System is suitable for use in all establishments
other than domestic and those directly connected to the
Class A
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Complies
compliance
Level
± 6 kV contact
± 8 kV air
± 2 kV for power
supplylines
± 1 kV for input/output
lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
< 5 % U
T
T
)
(> 95% dip in U
T
for 0.5 cycle
40% U
T
T
) (60% dip in U
T
for 5 cycles
70% U
T
T
)
(30% dip in U
T
for 25 cycles
< 5% U
T
T
(> 95% dip in U
)
T
for 5 sec
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 commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
)
T
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
)
T of the LithoVue System requires
continued operation during
power mains interruptions, it is
recommended that the LithoVue
)
T
System Workstation be powered
from an uninterruptible power
supply or battery.
)
T
43
Black (K) ∆E ≤5.0