VidaApp Spirometer

BLUETOOTH LOW ENERGY SPIROMETER.

What is VidaApp Spirometer?

The VidaAppTM Spirometer is a medical device used to measure the respiratory capacity of the lungs. This device is placed in the mouth and when blowing through the mouthpiece makes biometric readings of people's lung function.
The main vital signs measured by the VidaAppTM Spirometer are:
1. Forced Vital Capacity (FVC) is the maximum capacity to capture and expel air, under forced conditions.
2. Maximum expiratory volume in the first second (FEV1) is the amount of air expelled during the first second of maximal expiration, performed after a maximum inspiration.
 
Who is it for?
The product is indicated for people with chronic respiratory diseases such as COPD, asthma, apnea, smoking and pneumonia.

How does it work?
VidaAppTM Spirometer device senses the vital signs and performs a first analysis (pre-alarm) of variables out of range, according to the limits established by the Medical Control Center. In case of an event, it is connected through low-energy Bluetooth with the mobile of the user, which communicates through the mobile network with the Medical Center, including the alarm data and the geolocation of the user, to determine an appropriate course of action.
VIDA APP SPIROMETER SYSTEM
 
For interior scenarios, such as a residence or a medical center, the VidaAppTM Spirometer can dispense with the user's mobile phone to send the events and use the Solar Node VidaAppTM which acts as a collection node for several spirometers and displays a GSM / GPRS and low-energy Bluetooth gateway to connect to the Medical Control Center.
VIDA APP SPIROMETER SYSTEM IN INTERIOR SCENARIO
 
In a mobility scenario, the VidaAppTM Spirometer can be a satellite device of the VidaApp Vest. The spirometer connects via Bluetooth with the VidaAPP vest, which acts as a collection node to send the information to the Medical Control Center through a 3G modem integrated in the second PCB.
VIDA APP SPIROMETER SYSTEM IN MOBILITY SCENARIO
 
When using the VidaAppTM Spirometer in conjunction with the VidaAppTM Vest, the following variables of pulmonary activity are multiplied to be transmitted to pneumologists:

  • Spirometry: Forced Vital Capacity (FVC) and Maximum expiratory volume in the first second (FEV1).
  • Impedance pneumonography: senses the respiratory rate in number of ventilations per minute.
  • Pedometer to measure steps and km traveled.
  • GPS for geolocation of the user in case of exacerbations.
  • Pulse oximetry by reflection, with capacity to determine the oxygen content in blood and the heart pulse.
  • Panic button to alert emergency services in case of exacerbations.
  • Body temperature.
  • Therapeutic adherence: control of the medication through the app.
  • Remote auscultation. (Premium vest function requires second PCB).
  • Pre-recorded audio chips for medication reminder. (Premium vest function requires second PCB).
 
On the other hand, the VidaAppTM Blood Pressure Monitor can be paired to VidaAppTM Vest as a third device providing blood pressure measurement (systolic and diastolic in mmHg) for the monitoring of people with respiratory diseases.

VidaApp Neumo Mobile Application (doctor and patient profile):
Display of:
  • Panel of Vital Constants.
  • Map with the position of the user.
  • Summary sheet of user data.
Triggering of medical alarms:
  • Espirometry.
  • Breathing frequency.
  • Heart rate.
  • Temperature.
  • High oxygen saturation: hyperventilation, anxiety.
  • Low oxygen saturation: chronic lung diseases, decompensation or asthma crisis, heart disease.
  • Blood Pressure: systolic and diastolic.
Remote auscultation.
Medical orientation.
Control of medicines.
Training plan (physical activity).
Interoperability with clinical records (ISO 13606 / HL7).

Medical Control Center
Follow up, control and monitoring reports.
Holter service informed.
Personal support for anti-smoking program.
Configure alarms for the custom app.
Control and follow up of continuous monitoring.
Control and monitoring of physical activity.
Control of the medical history and treatment of the patient.

Service Dynamics
These sensors emit data in continuous streaming and the information is stored and analyzed in real time. The development of a platform with a frontend adapted to the needs of the users, with a profile for the doctor that supervises and a profile for the patient is foreseen. A centralized database will be made up of patient information that will enable Big Data Analysis and reporting of mass behavior. An ANDROID and iOS operating system app is expected to be developed so patients can view relevant information, provide information about their illness, and schedule medication alarms to improve therapeutic adherence.

Through the whole system, it is proposed the design of a remote monitoring service for patients with respiratory diseases that allows:
● Transform the access of the health of patients with COPD through information and communication technologies to improve their quality of life.
● Promote active participation and self-management of the patient in the care of their health.
● Establish predictive algorithms based on biometric data and offer preventive medicine services. Grouping, analysis and dissemination of data to physicians, to achieve a true personalized treatment when necessary. Construction of predictive models with techniques such as linear regression, generalized linear models, logistic regression and classification trees.
● Design personalized health plans according to the needs of each patient focused on a precision medicine.
● Use Big Data to improve system efficiency and costs and to aid clinical decision making in real time.
● Proactively manage health care using accumulated information to predict future events.
● Improve therapeutic adherence.
● Improve adherence to home-based respiratory rehabilitation plans based on home aerobic training supervised by physiotherapists and pneumologists.

IMPORTANT NOTICE:

VidaAppTM is a registered trademark of Integrated Systems Design and Development S.L. and the product VidaAppTM Spirometer as well as the documentation contained in this fact-sheet is property of that company, with CIF/VAT Number B86208204 and registered address at Calle Los Pajaritos nº 23, 2ºB, 28007 Madrid, Spain, which is constituted at the notary D. Fernando Pérez Alcalá del Olmo on April 11, 2011 and is legally registered on 8/6/2011 in the Mercantile Registry of Madrid being its registration data the following: Volume 28913, Folio 69, Section 8, Sheet 520621.

Integrated Systems Design and Development S.L. and its subsidiaries (ISDD) reserve the right to make corrections, improvements or changes to the products and services described. Buyers must update the latest product information with ISDD to make the purchase decision. ISDD guarantees the operation of its products according to the conditions established in the terms and conditions of the sale of its telemedicine products and services. We use testing and other quality techniques to ensure the quality of our products to the extent we deem appropriate to support this guarantee. Unless required by law, testing of all parameters of each device is not necessarily performed.

ISDD assumes no responsibility for assisting the applications or the software and platforms design of the buyers who use their devices. Buyers are responsible for the services and applications they offer with them. To minimize the risks associated with the products and applications of the buyers, they must provide an adequate design and operational safeguard.

ISDD does not guarantee that the license of its products, whether express or implied, is granted under patent, trademark or intellectual property rights related to the use and combination of its technology. The information published by ISDD regarding products of third parties does not constitute a license to use such products or services or a guarantee thereof.

The buyer knows and agrees to be solely responsible for all legal, regulatory and safety requirements regarding the use of these products, without prejudice to the support that ISDD may offer.
The buyer acknowledges and agrees that he has the necessary experience to create and implement safeguards and preventive measures to anticipate dangerous consequences of monitoring failures and their consequences, to reduce the likelihood that they may cause harm and to take appropriate corrective measures. The buyer exonerates ISDD in its entirety for any damages that may occur due to the use of these products in critical security applications.

Conformity assessment to request the CE mark in the Spanish Agency of Medicines and Medical Devices.
Considering the potential risks that may arise from their use, medical devices are grouped into four classes: I, IIa, IIb and III, applying decision rules based on the vulnerability of the human body and requires:
A. The preparation of a Technical File, composed of:
1) Documentation corresponding to the design and validation of the medical device (identification of essential requirements and related harmonized standards, risk analysis ...).
2) Results of electrical safety tests and electromagnetic compatibility.
3) Clinical evaluation of the product.
B. The documentation and implementation of a Quality System, based on the harmonized standard ISO 13485 (Medical Devices. Quality management systems. Requirements for regulatory purposes).
This documentation is reviewed by an independent entity (Notified Body), which also audits the implementation of the quality system.

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