What is VidaApp Sensor Band?
The VidaAppTM Sensor Band is composed of a neoprene fabric material that integrates electrodes and a 36mm diameter miniature electronic equipment designed for monitoring people who want to improve their mental and musculoskeletal health. This device is placed on the forehead, and uses non-invasive electronic technology to perform biometric readings of people.
SCHEMATIC OF VIDA APP SENSOR BAND
The main vital signs measured by the VidaAppTM Sensor Band are:
1. Electroencephalogram (EEG) of up to 8 electrodes, which allows to obtain the electrical signal of the brain.
2. Electromyogram (EMG) with possibility of multiple electromyography of several muscles.
3. Touch-less body temperature using an infrared sensor with an accuracy of 0.03°C.
4. Reflective Pulse Oximety, with the ability to determine on the forehead, blood oxygen content and heart rate.
On the other hand, it has GPS and accelerometer to monitor the physical activity of the user (steps and km traveled), GPS geolocation and anatomical position (standing, sitting, lying down).
Who is it for?
Persons requiring a record of brain bioelectrical activity, during wakefulness or sleep, indicated for all kinds of cerebral dysfunction, especially in the symptomatic phase such as epilepsy, dementia, neurodegenerative diseases, cerebrovascular diseases, etc.
Electro partial encephalograms, for real-time alarm emission when detecting the onset of epilepsy seizures.
Safe driving control for drivers, pilots and operators of dangerous machinery, determining the moment of occurrence of the initial phases of sleep through the detection of REM sleep phases and the blinking speed alerting the drivers, operators and transport companies.
Electromyography for corrections of maxillofacial muscle abnormalities during the sleep process. Electromyography of specific muscle zones in real time (removal of dental splints).
System to improve the memory in normal people and Alzheimer's syndrome, using brain wave analysis in combination with external stimuli in real time. (Application under study).
Applications related to sports medicine.
How does it work?
VidaAppTM Sensor Band 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 SENSOR BAND REMOTE MONITORING SYSTEM
For interior scenarios, such as a residence or a medical center, the VidaAppTM Sensor Band can dispense with the user's mobile phone to send the events and use the VidaAppTM Solar Node which acts as a collection node for several bands and displays a GSM / GPRS and low-energy Bluetooth gateway to connect to the Medical Control Center.
VIDA APP SENSOR BANDS WITH VIDA APP SOLAR NODE
In a mobility scenario, the VidaAppTM Sensor Band 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.
Mobile Application (doctor and patient user profile):
- Vital Signs Panel.
- Map with the position of the user.
- Summary sheet of user data.
Triggering of medical alarms:
- High oxygen saturation: hyperventilation, anxiety.
- Low oxygen saturation: chronic lung diseases, decompensation or asthma crisis, heart disease.
Control of medicines.
Training plan (physical activity).
Interoperability with clinical records (ISO 13606 / HL7).Medical control center
Follow up, control and monitoring reports.
EEG and EMG Holter service informed.
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.
The VidaAppTM Sensor Band PCB shown in the photographs includes a (5.) 32b high performance microcontroller with real time clock and perpetual calendar. This MCU allows pre-diagnostics of biomedical signals and their comparative analysis to perform early mental health alarms. This is possible by means of a system integrated in the same MCU that allows to make comparative recognition of biomedical patterns in real time. This system allows the generation of early alarms of parameters of EEG, EMG, blood oxygen, body temperature, mobility, as well as autonomous recognition of REM phases, among other important parameters. The VidaAppTM Sensor Band also includes the following circuits:
6. 3-axis accelerometer that detects body mobility, verticality, permanent use pedometer for obesity control, fall detection and unconsciousness.
7. GNSS type GPS with antenna integrated in the same PCB for geo location of people, including Geofencing. Determine the steps and kilometers traveled in combination with the pedometer.
8. Low energy Bluetooth 4.0 communication with integrated antenna. This system allows communication with mobile phones equipped with an APP and serves as a collecting node for other wireless biometric sensors that can be installed in people, such as blood pressure monitors, spirometers and additional remote auscultation sensors for monitoring COPD processes.
9. Internal management of a real-time clock (RTC) for issuing alarms for medication reminders, and the broadcasting of voice messages in any language.
10. Non-volatile 2Mb EEPROM memory (250,000 characters), for the storage of biomedical data in holster mode, programming, biometric behavior patterns, voice messages, among others. This report may also be used to keep the complete medical records of the persons as well as the legal and general information of the same.
11. Man-machine interface with 4 LED indicators: 2 for instrument and 2 for battery (on load and full charge).
12. Intelligent LIPO battery charging circuit integrated in the PCB.
13. It is IP67 which implies that it can be used under the shower and is dust resistant.
VidaAppTM is a registered trademark of Integrated Systems Design and Development S.L. and the product VidaAppTM Sensor Band 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.
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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.