Key Topics
- Requirements
- Constraints
- Standards
The requirements, specifications, and justification for this device were created with the purpose of getting the team familiar with key engineering topics while also paving the road for possible design choices. The requirements included but were not limited to; must deliver therapeutic effect to the target area, must have safety based shut-off’s in place to protect the user and the device, and must run for the first couple hours of sleep as that is when RLS symptoms are most prevelent.
The constraints for this device were chosen based on categories such as global, economic, health and safety, ect. Constraints are important because they will not only influence the design of the device but they may alter some of the requirements chosen above. In this case, some requirements were added due to the constraints, but few were altered and/or deleted. Some constraints included the following; the device must be affordable (given insurance coverage), the device must produce minimal noise as to allow the user to fall asleep, and the device must be comfortable as it will be applied to the leg’s of users.
Standards can be gathered from organizations such as the FDA, OSHA, ASTM, and many others. Their purpose is to provide rules or methods for testing and safety practices during the design and construction phase of our device. As of now we have collected eight standards that we feel most appropriately applies to our device. Some of these include; IEC 60601 (Electrical Safety Standards), ASTM F3357-19 (Clean-ability of Reusable Medical Devices), and ISO 3272 / 10816 (Vibrational Severity).