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

ABP

Force exerted by blood against artery walls. Crucial for assessing cardiovascular health and detecting hypertension or hypotension, which can indicate health risks.

Oxygen saturation

SpO2

Percentage of hemoglobin in the blood that is saturated with oxygen. Important for assessing respiratory function and detecting possible oxygenation problems.

Heart rate

Number of heart beats per minute. Essential for assessing cardiac function and detecting arrhythmias or other cardiovascular problems.

Skin temperature

TEMP

Skin surface temperature. Important for detecting fever, hypothermia or other thermal imbalances that may indicate infection or other diseases.

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

Connectivity

Compatible with iOS and Android systems

All connected with the ONAVITAL App

Direct connectivity to any type of platform via API

Freedom of movement

Thanks to its design and reduced dimensions, it improves the quality of life of patients.

IP65

Water and dust resistant.

Reliable measurement

Our physical sensors, properly validated in a clinical environment, allow the reliable measurement of multiple parameters in contact with the skin.