Boston Scientific Rotablator - Appendix D - Electronic and Electromagnetic Guidance

7
An adapter fitting is available for the Rotablator™ Console. This fitting has a
female quick-connect on one end and .6 cm (¼”) MNPT threads on the other.
The .6 cm (¼”) MNPT end is a standard .6 cm (¼”) pipe male fitting and will
readily fit most gas handling equipment or connectors on the house lines. The
quick-connect mates directly to the connector on the end of the supply hose
which normally would attach to a regulator.
Appendix D - Electronic and
Electromagnetic Guidance
Guidance and manufacturer’s declaration - electronic emissions
The Rotablator System is intended for use in the electromagnetic environment specified below. The customer or the user of the Rotablator System should assure that it
is used in such an environment.
Emission Test Compliance Electromagnetic Environment - Guidance
RF emissions
CISPR 11
Group 1 The Rotablator System uses RF energy only for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A The Rotablator System is suitable for use in all establishments other than domestic and those
directly connected to the public low-voltage power supply network that supplies buildings used
for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations / flicker emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration - electromagnetic immunity
The Rotablator System is intended for use in the electromagnetic environment specified below. The customer or the user of the Rotablator System should assure that it
is used in such an environment.
Immunity Test IEC 60601
Test Level
Compliance Level Electromagnetic Environment - Guidance
Electrostatic discharge (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
+ 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 commercial or
hospital environment.
Surge
IEC 61000-4-5
+
1 kV differential mode
+ 2 kV common mode
+
1 kV differential mode
+ 2 kV common mode
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% 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 seconds
<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 seconds
Mains power quality should be that of a typical commercial or
hospital environment. If the user of the Rotablator System requires
continued operation during power mains interruptions, it is
recommended that the Rotablator System be powered from an
uninterruptible power supply or a battery.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m 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 a.c. mains voltage prior to application of the test level.