Device Dossier
Patient monitor module, oximeter, pulse
Device Dossier for Patient monitor module, oximeter, pulse (Patient monitor module, oximeter, pulse, Class IIb, sponsor Draeger). ARTG record, intended…
- GMDN category: Patient monitor module, oximeter, pulse
Intended purpose
Infinity MCable Masimo SET / Infinity MCable Masimo Rainbow SET: The Infinity MCable Masimo SET and the Infinity MCable Masimo Rainbow SET are intended to be used with the Draeger Infinity M540 Patient Monitor to provide continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), perfusion index (PI) and pulse rate (measured by a Masimo sensor) for neonatal, pediatric, and adult populations in healthcare environments where patient care is provided by licensed healthcare professionals. The Infinity MCable Masimo SET and the Infinity MCable Masimo Rainbow SET accessories are indicated for use during both motion and non-motion conditions, and for patients who are well or poorly perfused in hospitals and hospital type facilities. Infinity MCable Nellcor OxiMax: The Infinity MCable Nellcor OxiMax is intended for use with the Draeger Infinity M540 patient monitor to provide continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an OEM OxiMax sensor) for adult, pediatric, and neonatal patients in healthcare environments where patient care is provided by licensed Healthcare Professionals.