9
Service Manual
8
VNUS Radio Frequency Generator
Electromagnetic Compliance
Standards referenced in tables 4 and 5:
CISPR 11:2009 (Amended by A1:2010), Industrial, scientific and medical (ISM) radio-frequency
equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement
IEC 61000-3-2:2009, Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic
current emissions (equipment input current ≤ 16 A per phase)
IEC 61000-3-3:2008, Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage
fluctuations and flicker in low-voltage supply systems for equipment with rated current ≤ 16 A
IEC 61000-4-2:2008, Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement
techniques - Electrostatic discharge immunity test
IEC 61000-4-3:2008, Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement
techniques - Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-4:2004, Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement
techniques - Electrical fast transient/burst immunity test
IEC 61000-4-5:2005, Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement
techniques - Surge immunity test
IEC 61000-4-6:2008, Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement
techniques - Immunity to conducted disturbances, induced by radio-frequency fields .
IEC 61000-4-8:2009, Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement
techniques - Power frequency magnetic field immunity test
IEC 61000-4-11:2004, Electromagnetic compatibility (EMC) - Part 4-11: Testing and measuring
techniques - Voltage dips, short interruptions and voltage variations immunity tests
Table 4: Electromagnetic Emissions
Guidance and manufacturer’s declaration - electromagnetic emissions
The RF Generator is intended for use in the electromagnetic environment specified below . The
customer or the user of the RF Generator should assure that it is used in such an environment .
Emissions test
Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 2
The RFG2 must emit electro-magnetic energy in order
to perform its intended function . Nearby electronic
equipment may be affected .
RF emissions
CISPR 11
Class A
The RFG2 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
Table 5: Electromagnetic Immunity
Guidance and manufacturer’s declaration - electromagnetic immunity
The RF Generator is intended for use in the electromagnetic environment specified below .
The customer or the user of the RF Generator 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 shall 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
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment . If disruption in power
occurs, it may be necessary to reset
the unit by disconnecting and
reconnecting the catheter .
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
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 s
<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
Mains power quality should be that
of a typical commercial or hospital
environment . If the user of the
RFG2 requires continued operation
during power interruptions, it is
recommended that the RFG2 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 a levels characteristic
of a typical location in a typical
commercial or hospital environment .
