3M ESPE Paradigm DeepCure Mode D'emploi page 33

Guidance and manufacturer's declaration – electromagnetic immunity
The Paradigm DeepCure is intended for use in the electromagnetic environment specified below.
The customer or the user of the Paradigm DeepCure should assure that it is used in such an environment.
IEC 60601
Immunity test
test level
Electrostatic ± 6 kV contact
discharge (ESD)
± 8 kV air
IEC 61000-4-2
Electrostatic ± 2 kV for power
transient / burst supply lines
IEC 61000-4-4 ± 1 kV for input/output
lines
Surge ± 1 kV differential
mode
IEC 61000-4-5
± 2 kV common mode
Voltage dips, short < 5 % U
interruptions and (> 95 % dip in U
voltage variations for 0,5 cycle
on power supply
input lines 40 % U
(60 % dip in U
IEC 61000-4-11 for 5 cycles
70 % U
(30 % dip in U
for 25 cycles
< 5 % U
(>95 % dip in U
for 5 sec
Power frequency 3 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE U
32
T
)
T
T
)
T
T
)
T
T
)
T
is the a. c. mains voltage prior to application of the test level.
T
Compliance level
± 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
T
(> 95 % dip in U )
T
for 0,5 cycle
40 % U
T
(60 % dip in U )
T
for 5 cycles
70 % U
T
(30 % dip in U )
T
for 25 cycles
< 5 % U
T
(> 95 % dip in U )
T
for 5 sec
3 A/m
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. If the user
of the Paradigm DeepCure requires
continued operation during power
mains interruptions, it is recommended
that the Paradigm DeepCure be
powered fromnan uninterruptible power
supply or a battery.
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.