Patient data recorder, long-term, electrocardiograph

Intended purpose

The Wireless dynamic multi-parameter holter is a small digital ambulatory ECG recorder. It is intended to record, store, display, transfer ECG data, receive and display blood oxygen (SpO2) and PR (pulse rate) data from the Pulse oximeter (SpO2 Probe); For routine checkups and/or self-monitoring of patients in the clinical setting and/or home settings under professional (e.g. doctor, nurse, family doctor) supervision. Clinical setting is only applicable to the general medical clinical setting, not for ICU, Emergency, Intensive care, Surgery, and the clinical setting that must be specifically alarmed and analyzed. The Wireless dynamic multi-parameter holter does not include analysis and diagnosis functions, does not include monitoring function. Data are given to the doctor or the user. The device 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 data are used as a base to establish a doctors' diagnosis, but the data cannot replace the diagnosis result given by a doctor.