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SIGMA Manual Number 41018
Revision AR
APPENDIX E - ELECTROMAGNETIC
COMPATIBILITY
Emissions
WARNING:
The use of accessories or cables other than those specified by SIGMA
may result in increased Emissions or decreased Immunity of this medical
device.
Guidance and manufacturer ’s declaration – electromagnetic emissions
Th e SIGMA M odel Spectrum Infusion pump is intended for use in the electrom agnetic enviro nment speci-
fied b elow. The custo mer or user of the Spectrum should assure that it is used in su ch an environ ment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emission s
CISPR 11
Group 1
The Spectrum uses RF energy only for its internal
function. The refore, its RF e missions are very lo w
and are not likely to cause any interferen ce in
nearby electronic equipm ent.
RF emission s
CISPR 11
Class B
The Spectrum is suitable for use in all e stab lish -
m ents, including dom estic establishm ents an d
th ose d irectly conne cted 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
e missions
IEC 61000-3-3
Com plies