Electromagnetic Compatibility
M4735A Heartstream XL Defibrillator/Monitor 13-27
13
Restrictions for Use
Artifact on the ECG 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.
Immunity Level
The EMC standards state that manufacturers of patient-coupled equipment must
specify immunity levels for their systems. It is recognized that the Heartstream XL
defibrillator/monitor is designed to receive and amplify low level signals in the same
bandwidth as the interference.
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 ECG
quality 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 may
vary with the manufacturer.
127( For additional information about compliance with the EMC standards, please
see the Declaration of Conformity Statement available at:
http://www.healthcare.agilent.com/mpg-reginfo/conformity.html.
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