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9.
Tec
hnical Specifications
ECG Algorithm
The ECG arrhythmia analysis performance has been evaluated by using several databases of real-life ECG
recordings, including MIT-BIH A (Massachusetts Institute of Technology-Beth Israel Hospital, Arrhythmia), MIT-BIH
MVA (Massachusetts Institute of Technology-Beth Israel Hospital, Malignant Ventricular Arrhythmia), MIT-BIH SVA
(Massachusetts Institute of Technology-Beth Israel Hospital, Supraventricular Arrhythmia), CU VT (Creighton University,
Ventricular Tachyarrhythmia), AHA (American Heart Association, Ventricular Arrhythmia), and Defibtech’s internal
library of real-life and electronically-manipulated ECG recordings. The Defibtech AEDs meet the recommendations
of the AHA12 and IEC 60601-2-4 for performance goals of arrhythmia analysis algorithms. The performance of the
arrhythmia analysis algorithm is summarized in the following table. Note that the same ECG arrhythmia analysis
algorithm is used in all Defibtech AEDs.
Defibtech AED Patient Analysis System Performance (typical)
Rhythm Class
ECG Test
Sample
1
Size
Algorithm Performance
1
Specifications
Performance
2
90% Lower
Confidence Limit
2
Shockable Rhythm –
Ventricular Fibrillation
227
>97%
>95%
Meets or exceeds IEC-60601-2-4
requirements; meets the AAMI DF80
requirement and the AHA recommendation
2
of Sensitivity > 90%
Shockable Rhythm
– Ventricular
Tachycardia
101
>98%
>95%
Meets or exceeds IEC-60601-2-4
requirements; meets the AAMI DF80
requirement and the AHA recommendation
2
of Sensitivity > 75%
Non-Shockable
Rhythm – Normal
Sinus Rhythm
213
100%
100%
Meets or exceeds IEC-60601-2-4
requirements; meets the AAMI DF80
requirement of Specificity >95% and the
AHA recommendation
2
of Specificity > 99%
Non-Shockable
Rhythm – Asystole
113
100%
100%
Meets or exceeds IEC-60601-2-4
requirements; meets the AAMI DF80
requirement and the AHA recommendation
2
of Specificity > 95%
Non-Shockable
Rhythm – All other
non-shockable
rhythms
3
248
>99%
>98%
Meets or exceeds IEC-60601-2-4
requirements; meets the AAMI DF80
requirement and the AHA recommendation
2
of Specificity > 95%
Intermediate Rhythm
– Fine Ventricular
Fibrillation
31
>90%
N/A
Report only
2
Intermediate Rhythm
– Other Ventricular
Tachycardia
Sinusoidal
17
>40%
N/A
Report only
2
Intermediate Rhythm
– Other Ventricular
Tachycardia
Horizontal
9
>65%
N/A
Report only
2
1. From Defibtech ECG Rhythm Databases.
2. Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety.
American Heart Association (AHA) Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation, 1997;95:1677-1682.
3. Other Non-Shockable Rhythms include A-Fib (AF), A-Flutter (AFL), Heart Block (HB), Premature Ventricular Contractions (PVC), Sinus Bradycardia (SB), Supra-Ventricular Tachycardia (SVT), and idioventricular rhythms.
Defibtech DDU-2000 Series AED (continued)
DAC-U2510EN-BF rev H
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