NH2S Solution - Patient data recorder, long-term, electrocardiograph

Intended purpose

The NH2S System is an integrated digital cardiovascular monitoring platform intended for the acquisition, recording, storage, transmission, analysis and review of electrocardiographic (ECG) and ambulatory blood pressure (ABP) data to assist qualified healthcare professionals in the diagnosis, assessment, monitoring and management of cardiovascular conditions. The system is intended for use in adult patients where ambulatory or resting cardiovascular assessment is clinically indicated. NH2S System comprises ambulatory ECG recorders (including Holter recorders), resting 12-lead ECG recorders, ambulatory blood pressure monitors, a mobile application and an analysis software platform. These components operate together to enable the secure acquisition, transmission, storage, processing and review of physiological data collected in hospitals, outpatient clinics, primary healthcare facilities, community healthcare services and remote healthcare environments. The analysis software platform processes ECG and ambulatory blood pressure data using automated analytical functions, including ECG waveform analysis, event detection, heart rhythm analysis, blood pressure trend analysis and report generation. The software presents clinically relevant information to assist healthcare professionals in reviewing patient data and identifying findings that may require further clinical assessment. The mobile application supports secure communication between the monitoring devices and the analysis platform to facilitate timely access to patient information. NH2S System is intended for use by trained healthcare professionals, including physicians, cardiologists, nurses, cardiac technicians and other authorised healthcare practitioners. It supports both clinic-based and remote patient monitoring by enabling physiological data to be securely transferred for review, interpretation and reporting, thereby facilitating continuity of care and timely clinical management. NH2S System is designed to provide objective physiological measurements and automated analytical tools that support clinical assessment and decision-making. The system is not intended to replace the independent clinical judgement of a qualified healthcare professional or to provide a definitive diagnosis. All diagnostic, treatment and patient management decisions must be based on the healthcare professional's assessment of the patient together with the patient's medical history, presenting symptoms and all other relevant clinical information. NH2S System is intended to improve the efficiency of cardiovascular assessment, support earlier identification of clinically significant abnormalities and enhance the delivery of cardiovascular care through integrated digital monitoring and analysis.