Physio-Control LIFEPAK 15 - Manual (Page 266)

C-2
LIFEPAK 15 Monitor/Defibrillator Operating Instructions
Shock Advisory System
complexes, and normal sinus rhythms. These rhythms are specifically mentioned in the AHA
recommendations. The SAS does not continue analyzing the ECG after a SHOCK ADVISED decision is
reached.
Shock Advisory System Performance
ECG analysis by the Shock Advisory System (SAS) in the LIFEPAK 15 monitor/defibrillator was
tested by playing ECG waveforms from the Physio-Control database through the electrode
connector. For each test ECG, the decision SHOCK or NO SHOCK of the SAS was recorded and
compared to the rhythm classification and treatment recommendation by clinical experts. A report
of test results is available on request.
SAS Test Set
The SAS Test Set consists of 989 ECG samples recorded during pre-hospital use of the LIFEPAK 5
defibrillator. The ECG was recorded using cassette tape recorders connected to the LIFEPAK 5
defibrillator. Selected ECG segments were sampled and the ECG rhythm was classified by clinical
experts. The SAS Test Set contains the following ECG samples:
• 168 each coarse ventricular fibrillation (VF) (
200 μV peak-to-peak amplitude)
• 29 each fine ventricular fibrillation (<200 and
80 μV peak-to-peak amplitude)
• 65 each shockable ventricular tachycardia (VT) (HR >120 bpm, QRS duration
160 ms, no
apparent P waves, patient reported to be pulseless by the paramedics)
• 43 each asystole (<80 μV peak-to-peak amplitude)
• 144 each normal sinus rhythm (NSR) (sinus rhythm, heart rate 60-100 bpm)
• 531 each other organized rhythm (includes all rhythms except those in other listed categories)
• 2 each transitional (transition occurs within the sample from nonshockable to nonshockable or
vice versa)
• 5 each shockable rhythms with pacemaker artifact (the pacemaker artifact is spread over time
by the filtering in the LIFEPAK 5 defibrillator)
• 2 each nonshockable rhythms with pacemaker artifact (the pacemaker artifact is spread over
time by the filtering in the LIFEPAK 5 defibrillator)
Table C-1 LIFEPAK 15 Monitor/Defibrillator Overall SAS Performance
SAS OVERALL PERFORMANCE
Sensitivity >90%
Specificity >95%
Positive Predictive Value >90%
False Positive Rate <5%