Physio Control LIFEPAK 15, Operating Instructions Manual

Page: 254 / 284

Overview of the Shock Advisory System
254
LIFEPAK 15 Monitor/Defibrillator Operating Instructions
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 shockable 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 45 LIFEPAK 15 Monitor/Defibrillator Overall SAS Performnce
SAS OVERALL PERFORMANCE
Sensitivity >90%
Specificity >95%
Positive Predictive Value >90%
False Positive Rate <5%