Shock Advisory System
B-4 LIFEPAK 1000 Defibrillator Operating Instructions
The Shock Advisory System 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 the
following table.
Table 3 SAS Performance for Pediatric Patients
The Shock Advisory System was also tested using paced rhythms recorded at high-fidelity from
patients 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.
Ta b l e 4 SAS Performance with Active Pacemakers
CONTROL OF SHOCK THERAPY
The Shock Advisory System causes the defibrillator to charge automatically when it detects the
presence of a shockable rhythm. When a shockable rhythm is detected, the defibrillator
instructs the user to deliver the shock by pressing the shock button.
Note: If the shock button is not pressed within 15 seconds, the system disarms and repeats
the analysis. The system also disarms if the patient impedance decreases suddenly or the
patient impedance goes outside the acceptable range for analysis. If none of these occur,
the shockable rhythm decision is not revised during charging or prior to shock.
Rhythm Category Performance Goal Sample Size Tested Test Result (Goal)
Shockable (Sensitivity)
Coarse VF >90% 63 Met
Nonshockable (Specificity)
Normal Sinus Rhythm
Other QRS
Asystole
>95%
>99%
>95%
>95%
69
507
60
Met
Met
Met
Met
Intermediate
Fine VF Report Only 1 >20% shocked
Rhythm Category Performance Goal Sample Size Tested Test Result
Shockable (Sensitivity)
Coarse VF >90% 35 Met
Nonshockable (Specificity) >95% 35 Met
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