The study performed to demonstrate a reasonable assurance of safety and effectiveness of the Heart Guardian HR-501 when used in an out-of-hospital environment.
The defibrillation study was conducted by analyzing the logs of Heart Guardian HR-501 with Radian ECG Viewer. The product analysis was studied whether the device was operated normally in ECG analysis and electric shocks.
Study Type
OBSERVATIONAL
Enrollment
19
Arm one offers ECG data and electric shocks recorded during AED operation.
Radianqbio
Seoul, South Korea
Identification ECG from patients
The AED identifies if ECG is VF or normal
Time frame: during operating, approximately 2 hours
Survival patients by electric shock
Ratio of patients were survived after electric shock delivered
Time frame: 24 hours
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