Essential Performance Determinations
Essential performance of the Efficia DFM100 defibrillator/monitor derived from the product's
Safety Risk Assessment:
The ability to deliver defibrillation therapy (manual, AED and Synchronized Cardioversion).
The ability to deliver pacing therapy (fixed and demand).
This includes ancillary functions, such as ECG, which affect the ability to deliver defibrillation or
All other functions are considered nonessential performance but were monitored for EMC.
Restrictions for Use
Artifact on the ECG and parameter waveforms caused by electromagnetic disturbances 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 DFM100 is designed and tested to comply with the radiated and conducted emissions
requirements of international and national standards. See
information regarding declaration and guidance.
WARNING: The use of accessories, transducers and cables other than those specified might result in increased
emissions or decreased immunity of the Efficia DFM100.
The list of cables, transducers, and other accessories with which Philips claims compliance with the
emissions and immunity requirements listed in "Supplies and Accessories" on page 195.
The EMC standards state that manufacturers of patient-coupled equipment must specify immunity
levels for their systems. See
communications equipment and the Efficia DFM100.
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 could 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 might vary with the manufacturer.
for recommended minimum separation distances between portable and mobile
for this detailed immunity information. See