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For Medical Staff
Table 1 – Guidance and manufacturer’s declaration – electromagnetic emissions –
for all EQUIPMENT and SYSTEMS (see 5.2.2.1 c))
Guidance and manufacturer’s declaration – electromagnetic emissions
The TERUFUSION Infusion Pump Type LF3 is intended for use in the electromagnetic environment specified below.
The customer or the user of the TERUFUSION Infusion Pump Type LF3 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1
The TERUFUSION Infusion Pump Type LF3 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 Infusion Pump Type LF3 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 2 – Guidance and manufacturer’s declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS (see 5.2.2.1 f))
Guidance and manufacturer’s declaration – electromagnetic immunity
The TERUFUSION Infusion Pump Type LF3 is intended for use in the electromagnetic environment specified below.
The customer or the user of the TERUFUSION Infusion Pump Type LF3 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
±8 kV contact
±15 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 TERUFUSION Infusion
Pump Type LF3 requires continued
operation during power mains
interruptions, it is recommended
that the TERUFUSION Infusion
Pump Type LF3 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 Infusion Pump Type LF3 complies with the more stringent levels of IEC 60601-2-24:2012 (EN 60601-2-
24:2015).
