CenterVue
COMPASS Operating Manual
Pag. 50 di 53
Guidance and manufacturers
’ declaration – electromagnetic immunity
Immunity Test
IEC60601 test level
Compliance Level
Electromagnetic
environment guidance
Electro-static
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±4 kV contact
±4 kV air
Note:
ESD levels in excess of
±4kV applied to the
sensor input connectors
can damage the
sensitive measurement
electronics.
Floors should be wood,
concrete or ceramic tile.
If floors are covered
with synthetic material,
the relative humidity
should be at least 30%.
Avoid touching the
exposed conductive
parts of connectors
when handling the
device or connecting
cables.
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
N/A for input/output
lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
±1 kV line(s) to line(s)
N/A for lines to earth
Mains power quality
should be that of a
typical commercial
hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC61000-4-11
<5% UT (>95% dip in UT)
for 0,5 cycle
40% UT (60% dip in UT)
for 5 cycles
70% UT (30% dip in UT)
for 25 cycles
<5% UT (>95% dip in UT)
for 5s
AC Power Port Dips of:
>95% for 0.5 cycle;
60% for 5 cycles;
30% for 25 cycles;
100% for 250 cycles of
Vnom repeated 10
times at 10 second
intervals.
Mains power quality
should be that of a
typical commercial or
hospital environment.
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
3A/m
3A/m
Power frequency
magnetic fields should
be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level
Table 2: Electromagnetic Immunity (ISO 60601-1-2:2007 5.2.2.1f)