Requirements

This project is based on a design control framework to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. The team has identified 13 requirements that the device must satisfy.

1. The device dimensions must be less than that of a standard NICU incubator interior.
2. Device has to be removable by hand from the incubator.
3. The device must support the weight of an average newborn baby.
4. The device must meet electrical safety standards IPX1 and IEC 60601.
5. The device must produce thermal energy to heat the surface of the device to incubator ambient temperature.
6. The device surface material must have similar material properties to human skin.
7. The surface of the device must rise and fall.
8. The device must withstand incubator temperatures and humidity conditions.
9. The device must produce heartbeat sounds at its surface.
10. The device must produce guardian voices at its surface.
11. The prototype must fit within the project funding given by TCNJ and ethical considerations.
12. The device must operate for a long period of time and be rechargeable.
13. The device must be cleanable.