ONAVITAL
The smart new way to take care of the health of those who need it most
OnaVital
ONAVITAL allows the accurate monitoring of several parameters in a non-invasive device, improving and simplifying the current healthcare system.
ONAVITAL allows you to monitor…
Blood Pressure
Oxygen saturation
Heart rate
Skin temperature
ONAVITAL Certifications:
- A PORTABLE and TRANSIT OPERABLE medical device as per IEC 60601-1-11:
- No skin sensitization according to ISO 10993-10:2021.
- Radioelectric disturbance emission compliance according to EN 60601-1-2:2015+A1:2021.
- Immunity tests to electrostatic discharges according to EN 61000 – 4 – 2.
- Immunity tests to electromagnetic fields according to EN 61000 – 4 – 3.
- IP65 degree of protection provided by enclosures according to EN 60529:201.
- Degree of protection against shock according to EN 60068-2-27:2008.
- Degree of protection against drops according to IEC 60601-1-11:2015.
- Degree of protection against vibration according to EN 60068-2-64:2008
ISO 13485: is an internationally recognized quality management system (QMS) standard specifically designed for the medical device industry. It outlines the requirements for a comprehensive system to ensure the design, development, production, installation, and servicing of medical devices consistently meet customer and regulatory requirements.
AEMPS Medical Device Manufacturer License: The manufacturing license granted by the Spanish Agency of Medicines and Medical Devices (AEMPS) is an essential requirement for any company wishing to manufacture medicines or medical devices in Spain. This license ensures that the manufacturer complies with the necessary regulations and standards to guarantee the quality, safety, and efficacy of the products.
What makes ONAVITAL different?
Non-invasive technology
We measure vital signs with optical technology
Big Data
We are able to extract more data thanks to continuous monitoring.
Certified medical equipment
Technology validated in Hospital environment. In process of FDA & CE Class IIB medical certification.
Real time
We offer all monitored data in the ONAVITAL App. We also have an external & integrable platform for the supervision of doctors.
What are the advantages of using ONAVITAL?
It allows the patient to be independent of hospital equipment thanks to the remote monitoring of vital signs.
The supervising doctor will be able to monitor your health with the precision of a hospital team.
Thanks to a customizable alert system, the doctor and the patient will be able to detect any unwanted variability of the parameters.
Integrable platform to facilitate interoperability
Data management through a cloud platform
Compatible with iOS and Android systems
All connected with the ONAVITAL App
Direct connectivity to any type of platform via API
Freedom of movement
IP65
Reliable measurement
Our physical sensors, properly validated in a clinical environment, allow the reliable measurement of multiple parameters in contact with the skin.
Strategic partners
