User Manual

B-2 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions
Shock Advisory System
The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators were also tested using paced rhythms
recorded at high-fidelity from victims with implanted pacemakers. The high-fidelity pacemaker spikes
were also added to samples of ventricular fibrillation to test the defibrillator’s ability to reach a shock
decision in the case of ventricular fibrillation with an implanted, active pacemaker. The results are
summarized in the following table.
Table B-2 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator SAS Performance with Active Pacemakers
The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators were also tested using ECGs acquired
from hospitalized pediatric victims ranging in age from < 1 day old to 17 years old. The results are
summarized in the following table.
Nonshockable:
all other rhythms
531 >95% specificity 95.9% [94.5%]
Intermediate:
fine VF
29 Report only 96.6% [87.2%] sensitivity
1
From Physio-Control ECG database. Each sample is run 10 times asynchronously.
2
Association for the Advancement of Medical Instrumentation. DF39-1993 Standard for Automatic External Defibrillators
and Remote-Control Defibrillators. Arlington, VA: AAMI;1993.
3
Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting
Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety. AHA Task Force on
Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation, 1997, Vol. 95, 1677-1682.
4
LCL = 90% exact one-sided lower confidence limit
VF = ventricular fibrillation
VT= ventricular tachycardia
NSR = normal sinus rhythm
Rhythm Class
ECG Test
Sample Size
Performance Goal Observed Performance
Shockable:
Coarse VF
35 >90% sensitivity 91.4% [81.9%]
Nonshockable:
Paced rhythms
35 >95% specificity 100.0% [93.6%]
Table B-3 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator SAS Performance Table for Pediatric ECGs
Rhythm Class
ECG Test
1
Sample Size
Performance Goal
2
Observed Performance
Sensitivity or Specificity [LCL]
3
Shockable:
coarse VF
90 >90% sensitivity 100.0% [97.5%]
Shockable:
shockable VT
11 >75% sensitivity 54.5% [31.8%]
Nonshockable:
NSR
424 >99% specificity 100.0% [99.5%]
Nonshockable:
asystole
95 >95% specificity 100.0% [97.6%]
Table B-1 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator SAS Performance Table for Adult ECGs (Continued)
Rhythm Class
ECG Test
1
Sample Size
Performance Goal
2, 3
Observed Performance
Sensitivity or Specificity [LCL]
4