Nivolis-Meto

This app is used to connect via iPhone to the data collected by Nivolis devices and stored on a server accessible via nivolis.pro website. These are devices to collect respiratory data from specific approved medical data at home for homecare providers.
The access is granted for registered users who own a Nivolis-Anton device.
The data shown in the app is also visible for registered users on the nivolis.pro website. The data shown in the app is not intended for medical diagnosis or therapy adjustment.
The app is a mirror of the data shown on nivolis.pro website

The intended purpose of Nivolis-Anton™ is to collect, store and transmit physiological values collected from an external third party transcutaneous blood gas monitor. Nivolis-Anton is intended for use at home, long term care or in hospital environment, with the exception of acute care units.
Data transmitted by Nivolis-Anton are the measurements and calculations done by the external transcutaneous blood gas monitor as per to its manufacturer recommendations.
Data transmitted from the monitor through Nivolis-Anton for patient assessment must be used by qualified health practitioners in conjunction with clinical signs and symptoms according to the intended use of the external transcutaneous monitor.
data collected by Nivolis-Anton and stored on nivolis.pro may not be considered as personal data when taken separately from the care-provider processing system and do not require RGPD compliance.

Nivolis-Anton is neither qualified as a Medical Device nor as a Medical Device Accessory per European Medical Device Regulation 2017/745.
The data in the app is the assessement of the recording quality. The recordings themselves may only be downloaded from the nivolis.pro website.