Appendix
Page E-8
Operator’s Manual PiCCO
2
Version 3.1
Table 2
–
Guidance and manufacturer´s declaration
–
electromagnetic immunity
(EN 60601-1-2:2007; 5.2.2.1 f)
Guidance and manufacturer's declaration - electromagnetic immunity
The PiCCO
2
is intended for use in the electromagnetic environment specified below. The customer or the user of the
PiCCO
2
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 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
± 1 kV for input / output
lines
± 2 kV for power supply
lines
± 1 kV for input / output
lines
Mains 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
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
< 5% U
T
(>95 % dip in U
T
)
for 0,5 cycle
< 5% U
T
(>95 % dip in U
T
)
for 0,5 cycle
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the PiCCO
2
requires
continued Operation during
power mains interruptions, it is
recommended that the PiCCO
2
is powered from an
uninterruptible power supply or
a battery.
40% U
T
(60 % dip in U
T
)
for 5 cycles
40% U
T
(60 % dip in U
T
)
for 5 cycles
70% U
T
(30 % dip in U
T
)
for 25 cycles
70% U
T
(30 % dip in U
T
)
for 25 cycles
< 5% U
T
(> 95% dip in U
T
)
for 5 s
< 5% U
T
(> 95% dip in U
T
)
for 5 s
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.