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Appendix E: Electromagnetic Compatibility
Manual 41018v0800
SIGMA Spectrum Infusion System
Revision B
Operator’s Manual
Immunity – ESD, transient/burst, voltage disparity and
magnetic field
Note1: For levels 2, 3 and 4, a clearable alarm will occur with interruption of flow.
NOTE:
The Pump was tested to the requirements of IEC 60601-1-2:2001/A1:2004,
Ed 2 and IEC 60601-2-24:1998.
Guidance and manufacturer’s declaration – electromagnetic immunity –
for all equipment and systems
The SIGMA Spectrum Infusion System is intended for use in the electromagnetic environment specified below. The
customer or user of the Pump 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
±2 kV contact
±6 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%. See Note 1.
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
Not applicable
Supply power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
±1 kV differential
mode
Not applicable
Supply 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% 120 VAC
(>95% dip in 120
VAC) or 0.5 cycle
40% 120 VAC
(60% dip in 120
VAC) for 5 cycles
70% 120 VAC
(30% dip in 120
VAC) for 25 cycles
<5% 120 VAC
(>95% dip in 120
VAC) for 5 sec
<5% 120 VAC
(>95% dip in 120
VAC) or 0.5 cycle
40% 120 VAC
(60% dip in 120
VAC) for 5 cycles
70% 120 VAC
(30% dip in 120
VAC) for 25 cycles
<5% 120 VAC
(>95% dip in 120
VAC) for 5 sec
Supply power quality should be that of a typical
commercial or hospital environment. If the user
of the SIGMA Spectrum Infusion System
requires continued operation during power
interruption, it is recommended that the Pump
be powered from an uninterrupted power
supply or the internal battery be fully charged
to provide unit power as specified in this
operator’s manual.
Power frequency
(50/60Hz) magnetic
field
IEC 61000-4-8
3 A/m
400 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical commercial or
hospital environment.