Guidance And Manufacturer's Declaration - Electromagnetic Immunity - Mectron Piezosurgery touch Manual De Uso

Guidance and manufacturer's declaration - Electromagnetic immunity

The PIEZOSURGERY® touch is intended for use in the electromagnetic environment specified
below. The customer or user of the PIEZOSURGERY® touch should ensure that it is used in
such an environment.
Immunity
EN
test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
N.B.: U is the AC mains voltage prior to application of the test level.
T
26
Test level
IEC 60601
±6 kV contact
±8 kV air
±2 kV for power supply
lines
±1 kV for input/output
lines
±1 kV differential
mode
±2 kV common mode
<5 % U (>95 % dip
T
) for 0,5 cycles
in U
T
40 % U
(60 % dip
T
) for 5 cycles
in U
T
70 % U
(30 % dip
T
) for 25 cycles
in U
T
<5 % U
T
(>95 % dip in U )
T
for 5 s
3 A/m
Compliance
level
The device continues
to work regularly and
in safety
The device continues
to work regularly and
in safety
The device continues
to work regularly and
in safety
The device can vary
from the required
levels of immunity
with a duration of
<5% / >95% / 5 s as
long as the device
remains in safety, no
malfunctions have
been dected and can
be restored to
pre-test status with
the intervention of
the operator
The device continues
to work regularly and
in safety
Electromagnetic
environment - Guidance
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Mains power quality
should be that of a
typical commercial or
hospital environment.
Mains power quality
should be that of a
typical commercial or
hospital environment.
Mains power quality
should be that of a
typical commercial or
hospital environment.
Power frequency
magnetic fields should
be at levels characteristic
of a typical location in a
commercial or hospital
environment.