Terumo TERUFUSION TE-SS830P, Instruction Manual

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157
For Medical Staff
Table 201 – Guidance and manufacturer’s declaration – electromagnetic emissions – for IEC 60601-1-2:2007 (EN 60601-1-2:2007)
for all EQUIPMENT and SYSTEMS (see 5.2.2.1 c)
Guidance and manufacturer’s declaration – electromagnetic emissions
The TERUFUSION Syringe Pump Type SS3 OTCI is intended for use in the electromagnetic environment specified below.
The customer or the user of the TERUFUSION Syringe Pump Type SS3 OTCI should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1 The TERUFUSION Syringe Pump Type SS3 OTCI 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.
RF emissions
CISPR 11
Class [B] The TERUFUSION Syringe Pump Type SS3 OTCI is suitable for use
in all establishments, including domestic establishments and those
directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class [A]
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Table 202 – Guidance and manufacturer’s declaration – electromagnetic immunity – for IEC 60601-1-2:2007 (EN 60601-1-2:2007)
for all EQUIPMENT and SYSTEMS (see 5.2.2.1 f)
Guidance and manufacturer’s declaration – electromagnetic immunity
The TERUFUSION Syringe Pump Type SS3 OTCI is intended for use in the electromagnetic environment specified below.
The customer or the user of the TERUFUSION Syringe Pump Type SS3 OTCI 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
±6kV contact
±8kV air
±8kV contact
±15kV 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 TERUFUSION Syringe Pump
Type SS3 OTCI requires continued
operation during power mains
interruptions, it is recommended that
the TERUFUSION Syringe Pump
Type SS3 OTCI 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 levels.
* The TERUFUSION Syringe Pump Type SS3 OTCI complies with the more stringent levels of IEC 60601-2-24:2012 (EN 60601-2-
24:2015).