Mindray BeneHeart S1 Fully Automatic - B.2 Mindray Shockable Rhythm Analysis Algorithm Performance

B - 2
B.2 Mindray Shockable Rhythm Analysis Algorithm Performance
Test results on the performance of the equipment configured with Mindray shockable rhythm analysis algorithm
meet IEC 60601-2-4 requirements
b
and AHA recommendations
a
.
Test results on IEC 60601-2-4 requirements are shown below.
Test results on AHA recommendations are shown below.
a
. Kerber RE, et al, “Automatic External Defibrillators for Public Access Defibrillation: Recommendations for
Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and
Enhancing Safety: A Statement for Health Professionals from the American Heart Association Task Force on
Automatic External Defibrillation”, Subcommittee on AED Safety and Efficacy. Circulation, 1997: Vol. 95: 1677-
1682.
b
. Clause 201.7.9.3.103 “Essential Performance data of the Rhythm Recognition Detector” and clause 201.107
“Requirements for Rhythm Recognition Detector,” International Electrotechnical Association, IEC 60601-2-4,
Medical Electrical Equipment – Part 2-4: Particular Requirements for the Basic Safety and Essential Performance
of Cardiac Defibrillators: 2010.
Rhythm category Requirement Test result
Shockable (sensitivity):
Coarse VF
Rapid VT
>90%
>75%
Met
Met
Nonshockable (specificity) >95% Met
Positive predictive value Report only >98%
False positive rate Report only <2%
Rhythm category Minimum sample
size (cases)
Performance
goal
Sample size
tested (cases)
Test result
Shockable (sensitivity):
Coarse VF
Rapid VT
200
50
>90%
>75%
205
80
Met
Met
Nonshockable (specificity):
Normal sinus rhythm
Asystole
Other nonshockable
rhythms
300
100
100
30
>99%
>95%
>95%
171
180
385
Met
Met
Met
Intermediate:
Fine VF
Other VT
25
25
Report only
Report only
27
42
66.67% shockable
76.19%
nonshockable