User Manual

Shock Advisory System
E-2 LIFEPAK 20e Defibrillator/Monitor Operating Instructions
were selected to be a representative sample of rhythms seen during treatment of cardiac arrest.
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)
1
Each sample is run 10 times asynchronously.
2
Association for the Advancement of Medical Instrumentation. DF80: 2003 Medical electrical equipment-Part 2-4.
Arlington, VA: AAMI, 2004
3 Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting
Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety. American Heart Associa-
tion (AHA) Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation. 1997: Vol.
95: 1677-1682.
VF = ventricular fibrillation; VT = ventricular tachycardia; NSR = normal sinus rhythm
Table E-1 LIFEPAK 20e Series Overall SAS Performance
SAS Overall Performance
Sensitivity >90%
Specificity >95%
Positive Predictive Value >90%
False Positive Rate <5%
Table E-2 LIFEPAK 20e Series SAS Performance by Rhythm Category
Rhythm Class
ECG Test
1
Sample Size
Performance
Goal
Observed Performance
Shockable: Coarse VF 168 >90% sensitivity
LIFEPAK 20e meets the AAMI
2
DF80
requirements, EN60601-2-4:2003
requirements, and AHA
3
recommendations
Shockable: VT 65 >75% sensitivity
LIFEPAK 20e meets the AAMI DF80
requirements, EN60601-2-4:2003
requirements, and AHA recommendations
Nonshockable: NSR 144 >99% specificity
LIFEPAK 20e meets the AHA
recommendations
Nonshockable: asystole 43 >95% specificity
LIFEPAK 20e meets the AAMI DF80
requirements, EN60601-2-4:2003
requirements, and AHA recommendations
Nonshockable: all other
rhythms
531 >95% specificity
LIFEPAK 20e meets the AAMI DF80
requirements, EN60601-2-4:2003
requirements, and AHA recommendations
Intermediate: fine VF 29 Report only >75% sensitivity