BIOSENer System® is a real time physiological welfare monitoring system that combines an ergonomic body-mounted module and a wireless communication network to provide control of the wearer’s physiological parameters without affecting its operability.
It is the only one device of its characteristics certify as medical product by the American Regulations (FDA) and European. The medical quality of this device allows its market.
BIOSENer equipment
BIOSENer allows knowing of an individual’s welfare through the measurement and process of the cardio-respiratory status and electrocardiogram (ECG), respiratory rate, temperature, and activity; this enables to determine the status of effort, stress, fatigue, heatstroke, position and general physical status, activating alerts and indicating the risk level.
- Information supplied
- Heart rate
- Two-channel electrocardiogram (ECG)
- Respiratory rate
- Temperature
- Position
- Movement
- Physical status (normal, warning, risk, no signal)
- Configurable alarms
- Stress and heatstroke
- Impact and drop (under development).
Display of an individual use
- Communication system
Every BIOSENer device records and transmits the information processed in real time wireless.
Storage:
- The data storage is done in a memory card, allowing loading the information into a computer so that the display program may reproduce the session, or sessions, that have been made. This allows having all the vital signs recorded while the user wore the system.
Real time:
- The device allows to see the information in real-time such as one or more user simultaneously from fixed or mobile monitoring points. The configuration of the communication network is flexible and broad coverage to meet the needs and infrastructure of the end-user, both military and civil or emergencies (WiFi, Tetra, GSM, etc).
Multiuser monitoring screen summary
- Monitoring
Monitoring can be done in various media: PC, mobile phone, PDA, etc.
Monitoring on mobile phone
The communications system enables the recording and real-time tracking of individual users simultaneously, allowing the diagnosis and monitoring of the user's status in real operations and training.
Multi-user network system
- Applications
BIOSENer is a versatile system which is highly useful for multiple applications because it is a diagnosis and monitoring medical system valid for testing and real operations. Noteworthy are:
Clinical use:
- Patients under home care
- Chronically ill
- Rehabilitation
- Field Hospitals and catastrophes
- Triage
- Emergency 112
- Seniors.
Electrode hold system for easy placement in case of emergency
Sports Medicine:
- Allows user to monitor as well as identify potential abnormalities, such as those that cause sudden death, which occur when exercise is performed, allowing the recording and real-time tracking of each user by the trainer.
Operation and training of professionals at risk:
- Army
- Pilots
- Fire, etc.
- Certifications
BIOSENer is currently a commercial product certified as a health device by European and American FDA standards:
- EU medical classification CE13485: Class IIb
- FDA medical classification: Class II
- Environmental protection IP67 – Shock protection: BF type.
Regulations:
- EN60601-1 (General Requirements for Safety)
- IEC60601-1-2 (Electromagnetic Compatibility)
- ISO 10993-1 (Evaluación y Pruebas de Dispositivos Médicos)
- ANSI/AAMI EC13:2002 (Heart Rate Meters) and ASTM E1112-00.
BIOSENer is a patented product system and trademark.
- Clients
BioSEN is the result of a contract subscribed by SENER and the Spanish Ministry of Defense to bestow the Future Warrior with a physiological sensor system integrated in the communication network of the Warrior.
Some of the clients of BIOSENer are the Armies of several countries, the Spanish one among them, Sport Technification Centers and Hospitals.
BIOSENer has been recently successfully verified by Real Madrid veterans at the charity match “Heart Classic Match 2010”, between Real Madrid and Milan, whose fundraisings are used in the sudden death investigation.
