Device Dossier
Single-patient physiologic monitoring system
Device Dossier for Single-patient physiologic monitoring system (Single-patient physiologic monitoring system, Class IIb, sponsor Frontline Medical…
- GMDN category: Single-patient physiologic monitoring system
Intended purpose
The purpose and function of Clarity Medical’s series of patient monitors (Spectra Smart+, Spectra Slim+, Spectra Gold, Radiant+, Recobro Vigile) is to monitor the vital parameters of a patient in general and intensive healthcare settings. The vital parameters that the patient monitors are able to acquire and process are: electrocardiograph (ECG), heart rate (HR), non-invasive blood pressure (NIBP) – systolic, diastolic, and mean arterial pressures, functional arterial oxygen saturation (SpO2), respiratory rate (RR), end tidal carbon dioxide (etCO2) and temperature (Temp). All of the above-mentioned parameters are measured simultaneously and could be displayed on a single monitor as well as a central monitoring station. The patient monitors are intended for use by trained healthcare professionals. The monitors can be used to monitor adult, and pediatric populations in all hospital and/or clinic areas and/or hospital-like facilities, such as operation theatre(s) (OTs), General patient wards etc. The patient monitors may also be used in non-hospital like settings such as monitoring of the patient in home, in hospice care settings etc.