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Abstract:
Usability testing is a technique that can be used to identify problems users have with a device. If usability testing is employed early in the development cycle it can identify potential use-related problems and hazards so that they can be addressed early in the design and/or development process. The FDA's Center for Devices and Radiological Health has published a document that provides guidance on medical device use-safety and describes the benefits of usability testing to identify potential hazards. This paper describes the application of usability testing to the design development and use of a functional neuromuscular (cough) stimulator and the accompanying documentation. The purpose of the user testing has to observe participants using a device in a realistic situation. Iterative design and user testing is an effective way to (1) reduce or eliminate use-related hazards, (2) make an interface intuitive, (3) alert users to errors and (4) provide aids for safe operation.
| Pages: |
4 |
| Report Date: |
25 OCT 2001 |
| Report Number: |
A943904 |
Report Unavailable |
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