Indications for Use
The OMI AI ECG Model is designed to assist qualified healthcare professionals in interpreting 12-lead resting ECGs. The OMI AI ECG Model is intended for use by healthcare professionals trained in ECG interpretation in a professional healthcare environment such as a pre-hospital or in-hospital environment. The indications for use focus on the assessment of ECGs of adult patients presenting with symptoms of acute coronary syndrome for the presence of occlusion myocardial infarction (OMI). The OMI AI ECG Model interpretation results are not intended to be the sole means of diagnosis. The device’s output is to be considered advice only and to be interpreted in conjunction with the health care professional’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.