Device Dossier

Patient monitor, multiparameter, transportable

Device Dossier for Patient monitor, multiparameter, transportable (Multiple vital physiological parameter monitoring system, clinical, Class IIa, sponsor…

Intended purpose

The Starling SV with NIBP and SpO2 functionalities is a portable, hemodynamic non-invasive Cardiac Output device that measures and displays a patient’s Cardiac Output (CO) in Ltr/Min with a Non-Invasive Blood Pressure (NIBP) function that non-invasively measures and displays blood pressure (diastolic, systolic and mean arterial pressure) and heart rate and with a SpO2 function that non-invasively measures and displays blood oxygen saturation (SpO2). The device displays associated hemodynamic parameters based on measurements or calculations of measurements already incorporated into the Starling SV. The monitor is not used to monitor vital physiological parameters of a patient.

TGA Public Summary