Misonix neXus - Page 7

Instructions For Use – neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A p 6
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (Table 202)
The neXus Ultrasonic Surgical Aspirator System is intended for use in the electromagnetic environment specified below. The
customer or the user of the neXus Ultrasonic Surgical Aspirator 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
o ±8 kV contact
o ±2 kV, ±4 kV, ±8 kV,
±15 kV air
o ±8 kV contact
o ±2 kV, ±4 kV, ±8 kV, ±15 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
o ±2 kV for power
supply lines
o ±1 kV for
input/output lines
o ±2 kV for power
supply lines
o ±1 kV for input/output
lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
o ±0.5 kV, ±1 kV
line to line
o ±0.5 kV, ±1 kV, ±2 kV
line to ground
o ±0.5 kV, ±1 kV line to
line
o ±0.5 kV, ±1 kV, ±2 kV
line 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
0 % U
T
(100 % dip in U
T
for 0,5 cycle
70 % U
T
(30 % dip in U
T
)
for 25 cycles
0 % U
T
(100 % dip in U
T
)
for 1 cycles
0 % U
T
(100 % dip in U
T
)
for 5 sec
0 % U
T
(100 % dip in U
T
) for
0,5 cycle
70 % U
T
(30 % dip in U
T
) for 25
cycles
0 % U
T
(100 % dip in U
T
) for 1
cycles
0 % U
T
(100 % dip in U
T
) for 5
sec
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the neXus
Ultrasonic Surgical Aspirator System
requires continued operation during
power mains interruptions, it is
recommended that the powered from
an uninterruptible power supply.
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
30 A/m
30 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 AC mains voltage prior to application of the test level.
NOTE If a fault notification on the GUI occurs, press the “X” button to exit the screen and initiate system reset.
Table 1.2 Guidance & manufacturer’s declaration on electromagnetic immunity (EN table 202)
List of Cables
Item
Cable Length
Type
Handpiece cable
15 ft | 4.6 m
shielded 2-conductor
Power cord
10 ft | 3.0 m
unshielded 3-conducter
Monopolar Hand Switch Cable
15.5 ft | 4.7 m
unshielded 3-conducter
Table 1.3 List of cables