Electromagnetic Compatibility
A-2 Efficia CM Series Rack and Modules Instructions for Use
• Is the interference due to misplaced or poorly applied electrodes or sensors? If so, re-
apply electrodes and 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
technical support team.
Restrictions for Use
Artifact on ECG and other 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 Efficia CM patient monitors are designed and evaluated to comply with the
emissions and immunity requirements of international and national EMC standards. For
detailed information regarding declaration and guidance, see Table A-1 through Table A-
3.
The EMC standards state that manufacturers of patient-coupled equipment must specify
immunity levels for their systems. See Table A-2 to Table A-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.
To Next Page
Loading...
