Operating instructions

5-18 LIFEPAK 500 Automated External Defibrillator Operating Instructions
Maintenance
Table 5-5 LIFEPAK 500 AED Battery Charger Specifications
CLINICAL SUMMARY: DEFIBRILLATION OF VENTRICULAR FIBRILLATION AND
VENTRICULAR TACHYCARDIA
Background
Physio-Control conducted a multi-centered, prospective, randomized and blinded clinical trial of
biphasic truncated exponential (BTE) shocks and conventional monophasic damped sine wave (MDS)
shocks.
1
Specifically, the equivalence of 200J and 130J BTE shocks to 200J MDS shocks was tested.
Methods
Ventricular fibrillation (VF) was induced in 115 patients during evaluation of implantable cardioverter
defibrillator function and 39 patients during electrophysiologic evaluation of ventricular arrhythmias.
After 19±10 seconds of VF, a customized defibrillator delivered an automatically randomized shock.
Efficacy was based on success of this shock. To demonstrate equivalence of test shocks to control
shocks, the 95% upper confidence limit of the difference in efficacy (95UCLD), control minus test, was
required to be less than 10%.
Results
Ventricular Fibrillation
The efficacy of the 200J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200J
MDS shocks (95UCLD=2%). The difference is success rates of 200J MDS minus 200J BTE shocks
was -10% (exact 95% confidence interval from -27% to 4%). The 130J BTE shocks were not
demonstrated equivalent to 200J MDS shocks (95UCLD=22%). However, neither was their efficacy
significantly lower than that of the 200J MDS shocks (statistical power limited by small sample sizes).
For all shock types, hemodynamic parameters (oxygen saturation and systolic and diastolic blood
pressure) were at or near their pre-induction levels by 30 seconds after successful shocks.
GENERAL
Safety Classification
Class II (double insulation), IEC 60601/EN 60601, 5.1
Input 100–240V 0.7–0.4A 50/60 Hz
Output 9.9Vdc for 10 hours, 9.2V trickle charge thereafter
Output Protection Current limited, short circuit protected
ENVIRONMENTAL
Operating Temperature 15°–35°C (50°–95°F)
Water Resistance IEC 60529/EN 60529 IPX0 (Indoor Use Only)
1
S.L. Higgins et al., “A comparison of biphasic and monophasic shocks for external defibrillation.”
Prehospital Emergency
Care,
2000; 4(4): 305-13.
Shock
Ventricular Fibrillation
1st Shock Success
Exact 95% Confidence Interval
200J MDS 61/68 (90%) 80–96%
200J BTE 39/39 (100%) 91–100%
130J BTE 39/47 (83%) 69–92%