Human Factors Engineering and testing for a wearable, long duration ultrasound system self-applied by an end user.

One of the major challenges in the design of a new class of medical device is ensuring that the device will have a safe and effective user interface for the intended users. Human Factors Engineering addresses these concerns through direct study of how a user interacts with newly designed devices with unique features. In this study, a novel long duration, low intensity therapeutic ultrasound device is tested by 20 end users representative of the intended user population. Over 90% of users were able to operate the device successfully. The therapeutic ultrasound device was found to be reasonably safe and effective for the intended users, uses, and use environments.