Device Dossier

SiSU Health Station - Patient monitor module, multifunction

Device Dossier for SiSU Health Station - Patient monitor module, multifunction (Patient monitor module, multifunction, Class IIa, sponsor Sisu Wellness).…

Intended purpose

The SiSU Health Station is intended to be used by the general population as a non-invasive, multifunctional means to measure cardiovascular and metabolic biometrics, such as blood pressure, heart rate, height, weight, body mass index (BMI) and body composition. The Health Station presents a series of questions based on existing health questionnaires to quantify factors that may contribute to the overall health and well-being of individuals, such as the risk of developing diabetes, assessing lifestyle habits or measuring psychological distress. The SiSU Health Station is not intended to diagnose any medical conditions, the information presented to the user is designed for them to consider lifestyle factors or to use when consulting healthcare professionals. The SiSU Health Station is intended to be fully unattended and placed within public environments such as supermarkets, pharmacies or corporate environments.

TGA Public Summary