Operating instructions
A-2 LIFEPAK 500 Automated External Defibrillator Operating Instructions
Shock Advisory System
The LIFEPAK 500 defibrillator was also tested using ECGs acquired from hospitalized pediatric patients
ranging in age from < 1 day old to 17 years old. The results are summarized in Table A-2.
Table A-2 LIFEPAK 500 AED SAS Performance Table for Pediatric ECGs
Intermediate:
fine VF
29 Report only 86.2% [74.3%] sensitivity
1.
From Medtronic 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
1
Sample Size
1.
From Medtronic ECG database.
Performance Goal
2
2.
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.
Observed Performance
Sensitivity or Specificity [LCL]
3
3.
LCL = 90% exact one-sided lower confidence limit.
Shockable:
coarse VF
90 >90% sensitivity 98.9% [95.7%]
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%]
Nonshockable:
all other rhythms
433 >95% specificity 98.8% [97.9%]
Intermediate:
fine VF
4 Report only 100.0% [56.2%] sensitivity
Intermediate:
other VT
7 Report only 42.9% [17.0%] specificity
Table A-1 LIFEPAK 500 AED SAS Performance Table for Adult ECGs
Rhythm Class
ECG Test
1
Sample Size
Performance Goal
2,
3
Observed Performance
Sensitivity or Specificity [LCL]
4