ZOLL AED Plus Fully Automatic Rev B User Manual

Page 52

Fully Automatic AED Plus Administrator’s Guide

Table 12: Clinical Performance Results (Pediatric Patients)

*155 of the 415 abnormal rhythm records were SVT (39 patients).

1. Arrhythmia Performance is reported according to the article, RE Kerber, LB Becker, JD Bourland,

RO Cummins, AP Hallstrom, MB Michos, G Nichol, JP Ornato, WH Thies, RD White, BD

Zuckerman, “Automated External Defibrillators for Public Access Defibrillation: Recommendations

for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporation New

Waveforms, and Enhancing Safety”, Circulation 1997, Vol 95, No 6, 1677-1681

References:

Young KD, Lewis RJ: “What is confidence? Part 2: Detailed definition and determination of confidence

intervals”. Annals of Emergency Medicine, September 1997; 30; 311-218

“CRC Standard Mathematical Tables 28

Edition”, William H. Beyer, Ph.D., CRC Press, Inc, Boca

Raton, FL., 1981, Percentage Points, F-Distribution Table, pg 573.

Rhythms

Sample
Size
(9 second
records)

Performance
Goals

Observed
Performance

90%

One-sided Lower

Confidence Limit

Shockable (23 Patients)

Coarse VF (1)

Rapid VT (2)

>90% sensitivity

>75% sensitivity

100% (42/42)

92.2% (47/51)

93.1%

82.9%

Non-shockable (121 Patients)

NSR (3)

AF, SB, SVT*, Heart block,

idioventricular, PVCs (4)

Asystole (5)

229

415

>99% specificity

>95% specificity

100% (229/229)

100% (415/415)

100% (14/14)

98.7%

99.3%

80.7%

Intermediate (15 Patients)

Fine VF (6)

Other VT (7)

Report only

77.3% (17/22)

---

58.0%