Device Dossier

Single-patient physiologic monitoring system

Device Dossier for Single-patient physiologic monitoring system (Single-patient physiologic monitoring system, Class IIb, sponsor Edwards Lifesciences).…

Intended purpose

The heart reference sensor is intended for use with a compatible BD noninvasive monitoring system -composed of compatible monitor, pressure source (pump), heart reference sensor, compatible BD finger cuff(s) and pressure controller - for noninvasive measurement of blood pressure and associated hemodynamic parameters.