Restrictions for Use
B-2 EarlyVue VS30 Instructions for Use
Reducing Electromagnetic Interference
The monitor and associated accessories can be susceptible to interference from other RF
energy sources and continuous, repetitive, power line bursts. Examples of other sources
of RF interference are other medical electrical devices, cellular products, information
technology equipment, and radio/television transmission. If interference is encountered,
as demonstrated by dramatic variations in physiological parameter measurement values,
attempt to locate the source. Assess the following:
• Is the interference due to misplaced or poorly applied sensors? If so, reapply sensors
correctly according to directions in the product’s Instructions for Use.
• Is the interference intermittent or constant?
• Does the interference occur only in certain locations?
• Does the interference occur only when in close proximity to certain medical electrical
equipment?
• Do parameter measurement values change dramatically when the AC line cord is
unplugged?
Once the source is located, attempt to attenuate the interference by distancing the
product from the source as much as possible. If assistance is needed, contact your local
Philips service representative.
Restrictions for Use
Artifact on physiological waveforms caused by electromagnetic interference should be
evaluated by a physician or physician authorized personnel to determine if it will
negatively impact patient diagnosis or treatment.
Emissions and Immunity
The monitor is designed and evaluated to comply with the emissions and immunity
requirements of international and national EMC standards. See Table B-1 through
Table B-6 for detailed information regarding declaration and guidance.
The EMC standards state that manufacturers of patient-coupled equipment must specify
immunity levels for their systems. See Table B-2 through Table B-6 for this detailed
immunity information.
Immunity is defined in the standard as the ability of a system to perform without
degradation in the presence of an electromagnetic disturbance. Degradation in system
performance is a qualitative assessment which can be subjective.
Caution should, therefore, be taken in comparing immunity levels of different devices.
The criteria used for degradation is not specified by the standard and can vary with the
manufacturer.
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