ICU Medical LifeCare PCA, Техническое и сервисное руководство, Страница: 142 / 148

APPENDIX
LifeCare PCA A - 2 Technical Service Manual
ELECTROMAGNETIC IMMUNITY
Table A-2
details guidance for the electromagnetic environment.
U
r
is the AC Mains voltage prior to application of the test level.
Compliance levels are tested to IEC 60601-2-24 requirements, which are more stringent
than IEC 61000-4-2 and IEC 61000-4-8.
Table A-2.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment
Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±8 kV Contact
±15 kV Air
±8 kV Contact
±15 kV Air
Floors should be
wood, concrete,
or ceramic tile
If floors are covered
with synthetic
material, 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 differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Voltage Dips,
Short Interruptions,
and Voltage
Variations on
Power Supply
Input Lines
IEC 61000-4-11
<5% U
r
(>95% dip in U
r
)
for 0.5 cycle
40% U
r
(60% dip in U
r
)
for 5 cycles
70% U
r
(30% dip in U
r
)
for 25 cycles
5% U
r
(>95% dip in U
r
)
for 5 seconds
<5% U
r
(>95% dip in U
r
)
for 0.5 cycle
40% U
r
(60% dip in U
r
)
for 5 cycles
70% U
r
(30% dip in U
r
)
for 25 cycles
5% U
r
(>95% dip in U
r
)
for 5 seconds
Mains power quality
should be that of a
typical commercial
or hospital
environment
If the user of the
infusion system
requires continued
operation during
power mains
interruptions,
it is recommended
that the infuser be
powered from an
uninterruptible AC
mains power supply
or the battery
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