CS-3000 RF Generator Unit Operator Manual
LBL-2123 Rev. E
nContact Surgical, Inc.
Page 5/ 79
Guidance & Manufacturer’s Declaration– Electromagnetic Immunity
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment -Guidance
Electrostatic Discharge
(ESD) IEC 61000-4-2
+/- 6kV Contact for conductive parts
+/- 8kV air Discharge for insulated parts
6 kV CD
8 kV AD
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
+/- 2kV for Power
Supply Lines
+/- 1kV for Input/Output Lines
+/- 2kV for Power
Supply Lines
+/- 1kV for Input/Output Lines
Mains power quality should be that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-4
+/- 1kV line(s) to line(s)
+/- 2kV
line(s) to earth
+/- 1 kV DM
+/- 2 kV CM
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% V
t
(>95% dip in V
t
for .5 cycle)
40% V
t
(60% dip in V
t
for 5 cycles)
70% V
t
(30% dip in V
t
for 25 cycles)
<5% V
t
(95% dip in V
t
for 5 sec)
<5% V
t
(>95% dip in V
t
for .5 cycle)
40% V
t
(60% dip in V
t
for 5 cycles)
70% V
t
(30% dip in V
t
for 25 cycles)
<5% V
t
(95% dip in V
t
for 5 sec)
Mains power quality should be that of a typical commercial or
hospital environment. If the user of the CS-3000 RF Generator
requires continued operation during power mains interruptions, it is
recommended that the CS-3000 RF Generator 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: V
t
is the ac mains voltage prior to application of the test level.
Portable and mobile RF communications equipment should be used no closer to
any part of the CS-3000 RF Generator including cables, than the recommended
separation distance calculated from the equation applicable to the frequency of
the transmitter.
Recommended Separation Distance (d):
Conducted RF
IEC 61000-4-6
3 V
rms
3 V
rms
d = 1.2√P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
d = 1.2√P - 80 MHz to 800 MHz
d = 2.3√P - 800MHz to 2.5 GHz where ‘
P’
is the maximum output power rating of
the transmitter in watts (W) according to the Transmitter Manufacturer and
‘d’
is
the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic
site survey
a
, should be less than the compliance
level in each frequency range
b
Interference may occur in the vicinity of equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and
people.
a.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters,
an electromagnetic site survey should be considered. If the measured field strength in the location in which the CS-3000 RF Generator is used exceeds the
applicable RF compliance level above, the CS-3000 RF Generator should be observed to verify normal operation. If abnormal performance is observed,
additional measure may be necessary, such as re-orienting or relocating the CS-3000, RF Generator.
b.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
