ZOLL AED Pro Rev J User Manual

Page 102

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PPENDIX

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S

PECIFICATIONS

A–14 www.zoll.com

9650-0350-01 Rev. J

Successful defibrillation with Rectilinear Biphasic shocks was achieved with 58% less
delivered current than with monophasic shocks (14±1 amperes versus 33±7 amperes,
p=0.0001).

The difference in efficacy between the Rectilinear Biphasic and the monophasic shocks was
greater in patients with high transthoracic impedance (greater than 90 ohms). The first shock,
first induction efficacy of biphasic shocks was 100% versus 63% for monophasic shocks for
patients with high impedance (p=0.02, 95% confidence interval of the difference of –0.0217%
to 0.759% and 90% confidence interval of the difference of 0.037% to 0.706%).

A single patient required a second biphasic shock at 150 joules to achieve 100% efficacy versus
six patients for whom monophasic shocks of up to 360 joules were required for 100% total
defibrillation efficacy.

Conclusion: The data demonstrate the equivalent efficacy of low energy Rectilinear Biphasic
shocks compared to standard high energy monophasic shocks for transthoracic defibrillation for
all patients at the 95% confidence level. The data also demonstrate the superior efficacy of low
energy Rectilinear Biphasic shocks compared to standard high energy monophasic shocks in
patients with high transthoracic impedance at the 90% confidence level. There were no unsafe
outcomes or adverse events due to the use of Rectilinear Biphasic waveform.

Monophasic

Biphasic

First shock efficacy
(high impedance patients)

63%

100%

p-value

0.02

95% confidence interval

–0.0217% to 0.759%

90% confidence interval

0.037% to 0.706%

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