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    Automated Actuator Active Bag Ventilator

     

     

     

    We are a multi-sectorial coalition organized to design and manufacture an automated resuscitator to fight COVID 19 pandemic in Puerto Rico

  • ABOUT US

    • The utmost goal of the team is to manufacture an FDA EAU approved mechanical ventilator with parts easily available in PR and the continental US.
    • Our team is following the MIT open source project E-VENT (Emergency Ventilator) design guidelines.
    • The multi-sectorial coalition is represented by the PR Government, academia, and the private sector.

    Press below for detailed MIT project information and specifications

  • A3B Vent Design

    Prototype for FDA Submission

    The A3B Vent. is not meant to replace conventional ventilators, but provides ventilator functionality in emergencies when no other options are available. The equipment allows hospitals to expand their capacity to care for patients needing invasive mechanical ventilation and reallocate conventional ventilators for patients with more sophisticated needs. It is being developed following MIT E-Vent design with the intent to be included in Apendix B and receive FDA Emergency Use Authorization (EUA) during the COVID-19 public health emergency. This unit is not FDA cleared or approved yet.

  • GENERAL SPECS

  • OVERALL DESIGN APPROACH

    The main design goal was to choose components known and available in Puerto Rico and the USA to expedite the prototype's manufacturing, testing, validation, and eventual FDA approval.

    MECHANICAL

    The mechanical design intends to safely ventilate a COVID-19 patient by automatically actuating a manual resuscitator. The A3B is compatible with existing manual resuscitators.

    ELECTRICAL

    • Designed with industrial automation components mostly used in the life-science industry. 
    • Monitor critical parameters of operations in order not to cause harm to patients.

    COMPLIANCE STRATEGY

    • The A3B is classified as a Class II Medical Device with no requirement for clinical testing.
    • The ventilators and the resuscitators are already approved and included in the FDA Emergency Use Authorization (EUA). 
    • A 510(k) requires a demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicated.  
    • The A3B submittal strategy is based on demonstrating that our ventilator is equivalent to MIT's approved E-Vent design ventilators such as the Spiro Wave and the Spanish OxyGen versions.
  • Puerto Rico Statistics

    Find out daily available ventilators in P.R.

  • COLLABORATORS

  • Your Next Move in Automation

    Risk-based quality management software for the Life Sciences Industry

    Making Technology Work

    La Nasa Boricua

    Industry-University Research Center

    Confidence Beyond Compliance

    Listen.Think.Solve

    RUM

    Colegio Universitario de Mayaguez

    Driven by Innovation and Results

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