Invasix InMode - Page 97

InMode Without Vasculaze Operator Manual
Section 14: System Specifications
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92 of 96
Guidance and manufacturer’s declaration – electromagnetic immunity
The System is intended for use in the electromagnetic environment specified below. The
customer or the user 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
Surge
IEC 61000-4-4
± 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
(>95 % dip
T
U<5 %
) for 0,5 cycle
T
Uin
(60 % dip
T
U40 %
) for 5 cycles
T
Uin
(30 % dip
T
U70 %
) for 25 cycles
T
Uin
(>95 % dip
T
U<5 %
) for 5sec
T
Uin
>95 % dip for
10 ms
60 % dip for
100 ms
30 % dip for
500 ms
95 % dip for
5000 ms
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the device
requires continued
operation during power
mains interruptions, it is
recommended that the
device be powered
from an uninterruptible
power supply.
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.
is the AC mains voltage prior to application of the test level.
T
U -NOTE