Appendix E: Electromagnetic Compatibility 153
SIGMA Spectrum Infusion System Pump Operating Software Version 8.00
Operator’s Manual For Use With MDL Version 8.0
NOTE: The essential performance of the Pump is volumetric accuracy.
WARNING Magnetic Fields.
The SIGMA Spectrum Infusion System is not designed to be MRI-
compatible nor is it intended to be used in this manner. Strong
magnetic fields (those beyond the level tested) may cause the device
to operate improperly.
Do not expose the Pump to strong magnetic fields such as is
common with MRI equipment or in close proximity 60.9 cm (2 ft) of a
cathode ray tube (CRT) monitor. Doing so may cause injury to the
patient and/or damage to the equipment.
WARNING Adjacent or Stacked Use.
The Pump should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the Pump should
be observed to verify normal operation in the configuration in which it
will be used.
NOTE: The SIGMA Spectrum Infusion System has been tested to
operate normally when used stacked or adjacent to other
SIGMA Spectrum Infusion Systems.
CAUTION ECG Artifacts Related to the Use of the SIGMA Spectrum
Infusion System.
Peristaltic infusion pumps may produce what is known as
piezoelectric artifact on ECG monitors and similar types of monitoring
instruments. The SIGMA Spectrum Infusion System may produce this
effect when the Pump is running at rates in the higher ranges of
operation, this may be in the frequency range tracked by the ECG
monitor. The appearance of the artifact may be affected by set up
and/or connection of electrodes, leads or equipment. See the ECG
monitoring system documentation for recommendations on proper set
up including electrode connections, site preparation, monitor system
set up and electrode placement.
CAUTION Static Sensitive Equipment.
Wherever possible, eliminate any electro-static producing
materials or conditions (dry, low humidity, synthetic materials such
as blankets, carpeting, drapes, and so forth).
The Pump is ESD sensitive when the Battery Module is removed.
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