ZOLL R Series Service Manual page 542

A A S
PPENDIX PECIFICATIONS
Table A-5. Clinical Performance Results (Pediatric Patients)
Rhythms
Shockable
(49 patients)
Coarse VF
Rapid VT
Nonshockable
(155 patients)
NSR
AF, SB, SVT
heart block,
idioventricular, PVCs
Asystole
Intermediate
(16 patients)
Fine VF
Other VT
a. 161 of the 348 abnormal rhythm records were SVT (72 patients). The SVT heart rates ranged
from 152 to 302 beats per minute.
Arrhythmia performance is reported according to the article, Kerber RE, Becker LB,
Bourland JD, Cummins RO, Hallstrom AP, Michos MB, Nichol G, Ornato JP, Thies WH,
White RD, Zuckerman BD. "Automated External Defibrillators for Public Access
Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis
Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety," Circ J Am
Heart Assoc. 1997;95:1677-1682.
References
Young KD, Lewis RJ. "What is confidence? Part 2: Detailed definition and determination of
confidence intervals". Ann Emerg Med. September 1997;30:311-318.
Beyer WH. Percentage Points, F-Distribution Table. CRC Standard Mathematical Tables.
th
28 ed. Boca Raton, Fla: CRC Press; 1981:573.
A–30
Sample
Size
(9 second
records)
42
79
208
a
, 348
29
44
www.zoll.com
Performance Observed
Goals Performance
Sensitivity
>90% 100.0%
>75% 100.0%
Specificity
>99% 100.0%
>95%
>95%
0 Report only
Report only
90% One-sided
Lower
Confidence
Limit
93.1%
96.3%
98.6%
99.4% 98.2%
100% 90.2%
— —
84.1% 72.2%
9650-0912-01 Rev. N