Emc Tables - Terumo Advanced Perfusion System 1 Operator's Manual

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EMC Tables

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
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
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
®
environment.
Immunity test
Electrostatic
±6 kV contact
discharge (ESD)
±8 kV air
IEC 61000-4-2
Electrical fast transient/ ±2 kV for power
burst supply lines
IEC 61000-4-4 ±1 kV for input/output
lines
±1 kV differential
Surge
mode
IEC 61000-4-5
±2 kV common mode
<5 % U
Voltage dips, short
(> 95 % dip in U
interruptions and voltage
for 0,5 cycle
variations on mains
power supply lines
40 % U
IEC 61000-4-11 (60 % dip in U
for 5 cycles
70 % U
(30 % dip in U
for 25 cycles
<5 % U
(>95 % dip in U
for 5 sec
Mains power frequency
3 A/m
(50/60 Hz) magnetic
field
IEC 61000-4-8
U
NOTE is the a.c. mains voltage prior to application of the test level.
T
® Advanced Perfusion System 1 should assure that it is used
Compliance
Electromagnetic environment – guidance
The Terumo
energy only for its internal function. Therefore, its RF
Group 1
emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
Class [A]
The Terumo
suitable for use in all establishments, other than
domestic and those directly connected to the public
Class [A]
low-voltage power supply network that supplies
buildings used for domestic purposes.
Complies
Advanced Perfusion System 1 should assure that it is used in such an
IEC 60601
Compliance level
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
T
(> 95 % dip in U
)
T
for 0,5 cycle
40 % U
T
T
(60 % dip in U
)
T
T
for 5 cycles
70 % U
T
(30 % dip in U
T
)
T
T
for 25 cycles
<5 % U
T
T (>95 % dip in U
)
T
for 5 sec
10 A/m
11-12
Advanced Perfusion System 1 uses RF
®
Advanced Perfusion System 1 is
®
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
T
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.
)
T
Mains power frequency magnetic
fields should be at levels
characteristic of a typical location
in a typical commercial or hospital
environment.