Product requirements

  • Functional requirements: The multipurpose protecting kit is designed for manufacture in the point of care using local materials. The kit consists of an enhanced face mask, an enhanced face shield and a portable UV light sterilizer with improved adaptability and ergonomics. It is cost-affordable and makes use of an eco-friendly production and supply chain.
  • Usability requirements: All components involved in the kit can be used by healthcare professionals and there is no need for special training to use these components. A fit testing might be required to check for proper fit of the components.
  • Safety requirements: Shield itself would be a Class I device and the sterilizer is Class IIa so, according to device classification, the whole kit would be a Class IIa system. Testing should be performed to analyze the sterilization potential of UV following medical device sterilization standards and specific standards for UV lighting systems. Additional details are found in device classification and regulation checklist sections.
  • Interaction requirements: Design will take into consideration standards from minimizing risk and promoting usability. The masks / shield of the "Covid auxikit" should be as ergonomic as possible, with adjusting options for dealing with different epidemic diseases. The sterilizing chambers should be designed considering their mutual interaction with