Terumo CAPIOX EBS Circuit with X coating, Instructions For Use Manual

Page: 171 / 177

For Medical Staff
Table 2 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY –
for all ME EQUIPMENT and ME SYSTEMS (see 5.2.2.1 f)
Guidance and manufacturer’s declaration
–
electromagnetic immunity
The CAPIOX Centrifugal Pump Controller SP-200 is intended for use in the electromagnetic environment specified below. The
customer or the user of the CAPIOX Centrifugal Pump Controller SP-200 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
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 s
<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 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the CAPIOX
Centrifugal Pump Controller SP-200
requires continued operation during power
mains interruptions, it is recommended
that the CAPIOX Centrifugal Pump
Controller SP-200 be powered from an
uninterruptible power supply or a 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.
Note
• U
T
is the a.c. mains voltage prior to application of the test level.
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