InMode System with BodyFX Handpiece Operator's Manual page 40

Guidance and manufacturer's declaration – electromagnetic emissions
The InMode is intended for use in the electromagnetic environment specified below. The customer or the user of
the InMode should assure that it is used in such an environment.
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic immunity
The InMode is intended for use in the electromagnetic environment specified below. The customer or the user of
the InMode should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Electrostatic ± 6 kV contact
discharge (ESD) IEC ± 8 kV air
61000-4-2
Electrical fast ± 2 kV for power supply
transient/burst lines ± 1 kV for
IEC 61000-4-4 input/output lines
Surge IEC 61000-4-5 ± 1 kV differential mode
± 2 kV common mode
Voltage dips, short <5 % U
interruptions and U
voltage variations on
power supply input 40 % U
lines IEC 61000-4-11 for 5 cycles
70 % U
for 25 cycles
<5 % U
U
Power frequency 3 A/m
(50/60 Hz) magnetic
field IEC 61000-4-8
NOTE - U is the AC mains voltage prior to application of the test level.
T
InMode BodyFX Operator Manual
Compliance
Group 1
Class B
Not Applicable
Complies
(>95 % dip in
T
) for 0,5 cycle
T
(60 % dip in U )
T T
(30 % dip in U )
T T
(>95 % dip in
T
) for 5 sec
T
Electromagnetic environment – guidance
The InMode uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
The InMode 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.
Compliance level Electromagnetic environment
– guidance
± 6 kV contact Floors should be wood, concrete
± 8 kV air or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
± 2 kV for power
supply lines
± 1 kV differential Mains power quality should be
mode ± 2 kV common that of a typical commercial or
mode hospital environment.
>95 % dip for 10 ms Mains power quality should be
that of a typical commercial or
hospital environment. If the user
60 % dip for 100 ms of the InMode requires continued
operation during power mains
interruptions, it is recommended
30 % dip for 500 ms that the InMode be powered
from an uninterruptible power
supply.
95 % dip for 5000 ms
3 A/m Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
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