33
Fibrillation (VF) rhythms of varying amplitudes, Ventricular Tachycardia(VT) rhythms of
varying rates and QRS width, Normal Sinus Rhythms varying rates and amplitude and asystole.
These segments are given to the ZOLL AED Pro and we consider the result of this device
(shock/no shock) as a reference.
B. ECG Rhythm Types
The ECG rhythms were placed into the following categories:
Shockable
•
Coarse ventricular fibrillation (VF) (≥0.20 mV peak-to-peak amplitude)
•
Rapid ventricular tachycardia (VT) (Rate >150 bpm, patient should be pulseless)
Non-Shockable
•
Normal sinus rhythm (NSR)
•
Other Non-Shockable rhythms including atrial fibrillation/flutter, atrioventricular
block, idioventricular rhythms, sinus bradycardia, supraventricular tachycardia, and
premature ventricular contractions (PVC).
•
Asystole (<0.1 mV peak-to-peak amplitude)
Intermediate
•
Fine ventricular fibrillation (VF) (<0.20 and ≥0.1 mV peak-to-peak amplitude)
•
Other VT (ventricular tachycardia that does not meet criteria for VT in the shockable
rhythms category)
Also included rhythms with pacemaker pulses.
C. Shock Algorithm Performance Report
The results of tests with the Simulator and PhysioNet Test Sets in the SHOOKA automatic
external defibrillator are shown below in the context of requirements from IEC 60601-2-4 and
the recommendations from the American Heart Association.
Table 1
IEC 60601-2-4 Requirements and SA Performance
Rhythm Category
Requirement
Test Result
Shockable (Sensitivity)
Coarse VF
Rapid VT, pulseless
>90%
>75%
>90%
>89%
Non-Shockable (Specificity)
>95%
>96%
Positive Predictive Value
Report Only
>78%
False Positive Rate
Report Only
<4%
Table 2
AHA Recommendations and SA Performance
Rhythms
Performance Goal
Observed
Performance
Minimum Test
Sample Size
Sample Size
Tested
Shockable
Coarse VF
Rapid VT, pulseless
>90% (Sensitivity)
>75% (Sensitivity)
>90%
>89%
200
50
457
199
