The following requirements have to be fulfilled by the device:
Functional requirements
- It is used for storing personal data and counting to help with contact tracing, which is obtained by creation of a software
- It must be used to take accurate temperatures without contact with a temperature range of 35°C to 45°C
- It must be affordable and marketable in different countries with a maximum selling price of $150
- It should be manufacturable with standard parts
- It should be easy to maintain
- The whole process should be quick and efficient to avoid long queues at the entrance with a maximum processing time of 30 seconds of the device (not including wait)
- It should have a maximum dimension of 20cm in length, 20cm in width and 30cm in height
Usability requirements:
- It should be easy to use even for first time users with simple instructions
- It should have a long lifespan for use in future epidemics
- It should be able to be used at most public spaces by adapting its size and features
- The interface should include English, French, Swahili and/or Arabic
Safety requirements:
- It should not have any particular risks as it is intended for use by everyone and is non-invasive and contactless
- Personal information collected should adhere to privacy standards and regulations in different countries such as non-disclosure of patient's identity and personal information
- All data collected should be safely stored in a database which can only be accessed by approved personnel
- It should adhere to EN ISO 14971 Medical devices. Application of risk management to medical devices