D.2 Electromagnetic Immunity
Guidance and manufacturer’s declaration: electromagnetic immunity
The
PBSV4.1 bladder scanner
is intended for use in the electromagnetic environment specified
below.
The customer or the user of the
PBSV4.1 bladder scanner
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 made of 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
±2 kV for power
supply lines
Main power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Main power quality should be that
of a typical commercial or hospital
environment.
Voltage
dips,
short
interruptions
and
l
<5 % UT
(>95 % dip in
UT)
for 0,5 cycle
40 % UT
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
Main power quality should be that
of a typical commercial or hospital
environment. If the user of the
PBSV4.1 bladder scanner requires
continued operation during an
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency of magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
NOTE: UT is the a.c. main voltage prior to application of the test level.
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