Welch Allyn AED 10 User Manual page 87

78 Specifications
Conclusion
The MRL Orbital Biphasic waveform was as effective as the 2kV Biphasic waveform in
this model of a higher impedance patient. When these devices are compared on the basis
of peak current, the MRL Orbital Biphasic required less peak current than the 2kV
Biphasic waveform.
Rationale for Animal Studies
Electrical waveforms for transthoracic ventricular defibrillation have been well studied for
nearly 50 years. These studies led to the development of monophasic waveforms such as
the Edmark, Lown, and truncated exponential waveforms that have now been used in
humans for over 30 years. Starting in the early 1980s, biphasic waveforms have been
extensively studied in animal models of transthoracic ventricular defibrillation. These
studies have shown that a wide variety of biphasic waveforms exhibited superior
defibrillation effectiveness to these conventional monophasic waveforms. In many cases,
the waveform comparisons performed in animals were repeated in clinical trials involving
humans. These studies have conclusively demonstrated that well-designed animal studies
can and do predict the results that will be observed in humans.
The reasons for conducting animal trials (as opposed to additional human clinical studies)
are:
1. Animal studies can use a much larger sample size (more shocks per subject), and
thus, result in far more accurate comparisons.
2. Animal studies do not place human subjects at risk from additional (and clinically
unneeded) shocks.
3. The animal hearts can be inspected for damage after the defibrillation studies.
Waveform Safety & Effectiveness Conclusions:
These scientific studies have demonstrated that:
• The data suggests that the MRL Orbital Biphasic waveform in the Welch Allyn AED 10
is at least as effective as, and may be more effective than either of the two tested
monophasic waveforms, appearing to allow termination of fibrillation episodes using
lower energies.
• The MRL Orbital Biphasic waveform in the Welch Allyn AED 10 is as effective as the
2kV biphasic truncated exponential waveform in another commercially available
defibrillator.
• The MRL Orbital Biphasic waveform in the Welch Allyn AED 10 requires less peak
current to achieve defibrillation effectiveness than either of the two monophasic
waveforms or the 2kV biphasic truncated exponential waveform that is used in
another commercially available defibrillator.
Welch Allyn AED 10 Automatic External Defibrillator