Emi/Emc/Rf Safety Information - GE MAC 600 Operator's Manual

EMI/EMC/RF Safety Information

Users should consider RF sources, such as radio or TV stations and hand-held or mobile two-way
radios, when installing and operating a medical device or system.
Operating the system near radio frequency (RF) and electromagnetic interference (EMI) above the
conditions defined in the EMC Standard EN60601-1-2 for Radiated Immunity (field strengths above
3 volts per meter) may cause waveform distortions.
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in the accompanying service
manual. Portable and mobile RF communications equipment can affect medical electrical
equipment.
The use of accessories, transducers, and cables other than those specified, with the exception of
transducers and cables sold by the manufacturer of the system as replacement parts for internal
components, may result in increased emissions or decreased immunity of the system.
The system should not be used adjacent to or stacked with other equipment and, that if it is
necessary to use this system adjacent to or stacked with other equipment, the system should be
observed to verify normal operation in the configuration in which it will be used. Review the AAMI
Committee Technical Information Report (TIR) 18, "Guidance on Electromagnetic Compatibility of
Medical Devices for Clinical/Biomedical Engineers". This guidance document provides a means
to evaluate and manage the EMI environment in the hospital.
The following actions can be taken to reduce the risk of medical device EMI and achieve EMC:
Assess the EMC environment of the healthcare facility (for example, identify radio transmitters in
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and around the facility) and identify areas where critical medical devices are used (for example,
ER, ICU, CCU, NICU).
Increase the distance between sources of EMI and susceptible devices.
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Remove the devices that are highly susceptible to EMI.
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Lower the power transmitted from electrical and electronic equipment (EMI sources) under
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hospital control (for example, paging systems).
2047426-001K MAC™ 600
Introduction
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