Physio Control Lifepak 1000 - Page 63

Shock Advisory System
LIFEPAK 1000 Defibrillator Operating Instructions B-3
©2018 Physio-Control, Inc.
Intermediate
• Fine ventricular fibrillation (VF) (<0.20 and >
0.08 mV peak-to-peak amplitude)
• Other VT (ventricular tachycardia that does not meet criteria for VT in the shockable rhythms
category)
Also included are coarse VF with pacemaker pulses and nonshockable rhythms with pacemaker
pulses.
C. Summary Shock Advisory System Performance Report
The results of tests with the SAS and Physio-Control test sets in the LIFEPAK 1000 defibrillator
are shown below in the context of requirements from IEC 60601-2-4 and the recommendations
from the American Heart Association.
Ta b l e 1 IEC 60601-2-4 Requirements and SAS Performance for Adult and Pediatric Patients
Ta b l e 2 AHA Recommendations and SAS Performance for Adult Patients
Rhythm Category Requirement Test Result
Shockable (Sensitivity)
Coarse VF
Rapid VT, pulseless
>90%
>75%
Met
Met
Nonshockable (Specificity) >95% Met
Positive Predictive Value Report Only >90%
False Positive Rate Report Only <5%
Rhythm Category
Performance
Goal
Minimum
Sample Size
Sample Size
Tested
Test Result (Goal
and Sample Size)
Shockable (Sensitivity)
Coarse VF
Rapid VT, pulseless
>90%
>75%
200
50
206
65
Met
Met
Nonshockable (Specificity)
Normal Sinus Rhythm
Other QRS
Asystole
>95%
>99%
>95%
>95%
300
100
30
100
509
749
124
Met
Met
Met
Met
Intermediate
Fine VF
Other VT
Report Only
Report Only
25
25
32
27
>40% shocked
>20% shocked