Terumo 801763, Operator'S Manual, Page: 307 / 359

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11-12
Table 202 – Guidance and manufacturer’s declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS (see 6.8.3.201 a) 6))
Guidance and manufacturer’s declaration – electromagnetic immunity
The Terumo
®
Advanced Perfusion System 1 is intended for use in the electromagnetic environment specified
below. The user of the Terumo
®
Advanced Perfusion System 1 should assure that it is used in such an
environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast transient/
burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on mains
power supply lines
IEC 61000-4-11
Mains power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
IEC 60601
test level
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for input/output
lines
±1 kV differential
mode
±2 kV common mode
<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 sec
3 A/m
Compliance level Electromagnetic environment –
guidance
Floors should be wood, concrete,
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user of
the Terumo
®
Advanced Perfusion
System 1 requires continued
operation during power mains
interruptions, it is recommended that
the Terumo
®
Advanced Perfusion
System 1 be powered from an
uninterruptible power supply or a
battery.
Mains 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.
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV differential
mode
±2 kV common mode
<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 sec
10 A/m
Table 201 – Guidance and manufacturer’s declaration – electromagnetic emissions –
for all EQUIPMENT and SYSTEMS (see 6.8.3.201 a) 3))
Guidance and manufacturer’s declaration – electromagnetic emissions
The Terumo ® Advanced Perfusion System 1 is intended for use in the electromagnetic environment
specified below. The user of the Terumo
® Advanced Perfusion System 1 should assure that it is used
in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Compliance
Group 1
Class [A]
Class [A]
Complies
Electromagnetic environment – guidance
The Terumo ® Advanced Perfusion System 1 uses RF
energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
The Terumo ® Advanced Perfusion System 1 is
suitable for use in all establishments, other than
domestic and those directly connected to the public
low-voltage power supply network that supplies
buildings used for domestic purposes.
EMC Tables