Indications for Use
PMcardio OMI AI ECG Model
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.
PMcardio Core AI ECG Model
Core AI ECG Model is designed to assist qualified healthcare professionals in interpreting 12-lead resting ECGs in subjects over 18 years of age. Core Diagnostics AI Mode is intended for use by healthcare professionals trained in ECG interpretation in a professional healthcare environment such as hospitals, emergency medical services and other healthcare facilities.
Indications for use include patients presenting with common cardiovascular symptoms, such as Chest pain, Palpitations, Shortness of breath, Syncope. Additionally, Core AI ECG Model can be used in all situations when an ECG exam is performed or gathered by the intended users including routine examinations, pre-operative testing, sport exams and vitals testing in the urgent care setting.
Core 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. The device is designed to be integrated into medical devices or other IT healthcare solutions by a healthcare solution operator to build web, mobile or other types of applications.
Note: PMcardio modules are CE-marked as class IIb medical device under EU MDR and only certified for marketing in the European Union and the United Kingdom. PMcardio technology has not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA. Not all modules of the PMcardio platform may be available in your region.
Prior to use, reference the Instructions for Use, for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
