Sigma sigmaspectrum 35700ABB - APPENDIX E - Electromagnetic Compatibility: Immunity; Immunity - ESD, Transient;Burst, Voltage Disparity, Magnetic; APPENDIX F - Low Battery Tutorial: Very Low Battery; Very Low Battery Tutorial

84 APPENDIX E - Electromagnetic Compatibility
SIGMA Manual Number 41018
Revision AR
Immunity – ESD, transient/burst, voltage disparity, magnetic
Note1: For levels 2, 3 & 4 a clearable alarm will occur with interruption of flow.
Guidance and manufacturer’s declaration – electromagnetic immunity
The SIGMA Model Spectrum Infusion pump is intended for use in the electromagnetic environment specified
below. The customer or user of the Spectrum should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic environment -
guidance
Electrostatic dis-
charge (ESD)
IEC 61000-4-2
±8 kV contact
± 15 kV air
±2 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%. See Note 1.
Electrical fast tran-
sient/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 environ-
ment.
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 environ-
ment.
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 environ-
ment. If the user of the Spectrum
requires continued operation during
power interruption, it is recommended
that the Spectrum be powered from an
uninterruptible power supply or the
internal battery be fully charged to pro-
vide unit power as specified in this oper-
ator’s manual.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
400 A/m 400 A/m Power frequency magnetic fields should
be at levels characteristic of a typical
commercial or hospital environment.