Patient data recorder, long-term, electrocardiograph

Intended purpose

The Dynamic ECG recorder is intended to measure, review and store adults’ECG data at home or in healthcare environment. The device continuously records and stores ECG and activity data for at least 7 days at a time. The device does no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system (AI-ECG Tracker) which will analyze the recorded data. The device data and the data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis. The device does not include analysis and diagnosis functions. The device has not been tested and it is not intended for pediatric use.