20
Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
Table 3. Electromagnetic Interference Resistance
Guidance and Manufacturer’s Declaration — Electromagnetic Immunity
The GreenLight XPS™ Laser System is intended for use in the electromagnetic environment specified below. The customer or user of the GreenLight
XPS Laser System should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment — Guidance
ElectrostaticDischarge
(ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or ceramic tile. If floors 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
± 2 kV for power
supply lines
Mains power quality should be that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line to line
±2 kV line(s) to ground
± 1 kV line(s) to line(s)
±2 kV line(s) to ground
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
< 5 % U
T
(>95%dipinU
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%dipinU
T
for
5 sec)
< 5 % U
T
(>95%dipinU
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
Mains power quality should be that of a typical commercial
or hospital environment. If the user of the GreenLight XPS
Laser System requires continued operation during power
mains interruptions, it is recommended that the GreenLight
XPS Laser System be powered from an uninterruptible power
supply or a battery.
PowerFrequency(50/60Hz)
Magnetic Field
IEC 61000-4-8
N/A N/A Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
Note: U
T
is the AC mains voltage prior to application of the test level.