E-SOUM-PLUS Rev E
5
Guidance And Manufacturer’s Declaration – Electromagnetic Immunity
(Table 202)
The SonicOne CLINIC SYSTEM is intended for use in the electromagnetic environment specified below. The customer or the
user of the SonicOne CLINIC 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
±2kV, ±5kV, ±8kV,
±15 kV air
o
±8 kV contact
o
±2kV, ±5kV, ±8kV,
o
±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
±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.
Surge
IEC 61000-4-5
o
±1 kV differential
mode
o
±2 kV common mode
o
±1 kV differential
mode
o
±2 kV common
mode
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short in-
terruptions 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 SonicOne CLINIC 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.
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
Footswitch cable
14 ft. | 4.3 m
shielded 2-conductor
Table 1.3 List of cables
