Appendix 2_ Ecg Analysis Algorithm Accuracy - Saadat SHOOKA User Manual

Appendix 2_ ECG Analysis Algorithm Accuracy

This appendix describes the basic function of the Shock Algorithm (SA).
Overview
Shock Algorithm (SA) is an ECG analysis program in the SHOOKA automatic external
defibrillator that recommends whether or not a patient should be given a defibrillation shock.
This algorithm makes it possible for individuals who are not trained to interpret ECG rhythms
to provide potentially life-saving therapy to victims of ventricular fibrillation (VF) or pulseless
ventricular tachycardia (VT). The Shock Algorithm is used to analyze the ECG rhythm during
the first rhythm analysis after the electrode pads have been placed on the patient when CPR is
not being performed. It is also used during subsequent rhythm analyses when the user has been
instructed to stop CPR.
Automated Interpretation of the ECG
The SHOOKA automatic external defibrillator recommends a shock if either of the following
rhythms is detected:
• Ventricular fibrillation
• Rapid ventricular tachycardia (Rate >150 bpm, patient should be pulseless)
The SHOOKA automatic external defibrillator recommends no shock for non-shockable ECG
rhythms as indicated in the Shock Algorithm Performance Report in this appendix.
The SHOOKA automatic external defibrillator is designed to detect and remove pacemaker
pulses from the ECG so that an accurate decision can be reached while a pacemaker is
functioning.
Shock Algorithm
The Shock Algorithm (SA) in the SHOOKA automatic external defibrillator was verified by
inputting specific ECG waveform segments from databases through the electrode connector
and recording the SA decision of 'shock' or 'no shock.' The 'shock' or 'no shock' decision made
by the SA for each ECG waveform segment was compared to the databases reference
annotations or treatment recommendation by similar device.
The main ECG database used to verify the performance of the SHOOKA automatic external
defibrillator for SA is named the PhysioNet Test Set. In addition, the ECG database named
Simulator Test Set was used to provide shockable and Non-shockable ECG segments for
verification purposes. The following information about the test sets and the Summary
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