Physio-Control LIFEPAK 15 - Manual (Page 267)

APPENDIX
C
©2007-2013 Physio-Control, Inc. LIFEPAK 15 Monitor/Defibrillator Operating Instructions
C-3
1 Each sample is run 10 times asynchronously.
2 Association for the Advancement of Medical Instrumentation. DF80: 2003 Medical electrical equipment-Part2-4, Section
6.8.3 aa) 3) essential performance data of the rhythm recognition detector. 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 Association (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
Operator Control of Shock Therapy
The Shock Advisory System causes the AED to charge automatically when it detects the presence of
a shockable rhythm. When a shock is advised, the operator presses the SHOCK button to deliver the
energy to the patient.
Continuous Patient Surveillance System
The Continuous Patient Surveillance System (CPSS) automatically monitors the patient's ECG
rhythm for a potentially shockable rhythm while the electrodes are attached and the AED is turned
on. CPSS is not active during ECG analysis or when the AED is in a CPR cycle.
Table C-2 LIFEPAK 15 Monitor/Defibrillator SAS Performance by Rhythm Category
RHYTHM CLASS
ECG TEST 1
SAMPLE
SIZE
PERFORMANCE
GOAL
OBSERVED PERFORMANCE
Shockable:
Coarse VF
168 >90% sensitivity
LIFEPAK 15 monitor/defibrillator meets the
AAMI
2 DF80 requirements and AHA 3
recommendations.
Shockable: VT 65 >75% sensitivity
LIFEPAK 15 monitor/defibrillator meets the
AAMI DF80 requirements and AHA
recommendations.
Nonshockable:
NSR
144
>99% specificity
for NSR (AHA)
LIFEPAK 15 monitor/defibrillator meets the
AHA recommendations.
Nonshockable:
asystole
43 >95% specificity
LIFEPAK 15 monitor/defibrillator meets the
AAMI DF80 requirements and AHA
recommendations.
Nonshockable:
all other rhythms
531 >95% specificity
LIFEPAK 15 monitor/defibrillator meets the
AAMI DF80 requirements and AHA
recommendations.
Intermediate:
fine VF
29 Report only >75% sensitivity