Device Dossier
Patient monitor, multiparameter
Device Dossier for Patient monitor, multiparameter (Single-patient physiologic monitoring system, Class IIb, sponsor Getinge). ARTG record, intended…
- GMDN category: Single-patient physiologic monitoring system
Intended purpose
PulsioFlex´s intended use is as a diagnostic aid for the minimally invasive measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables. Along with other bedside monitors and clinical evaluation, the PulsioFlex monitors patients at risk in a number of different settings. The PulsioFlex provides up to three technologies: 1. Arterial pulse contour analysis for the continuous determination of blood pressure, trend cardiac output, volume responsiveness and other derived parameters (ProAQT). 2. Fiberoptic reflective measurement for the determination of continuous measurement of oxygen saturation in the blood (CeVOX). 3. Pulse oximetry for continuous monitoring of the functional oxygen saturation of arterial haemoglobin (SpO2) and pulse densitometry for determination of the concentration of Indocyanine Green, a dye approved as a diagnostic drug (LiMON). The PulsioFlex is a multiparameter monitor intended for use in hospitals and hospital-like facilities and by trained health care professionals.