Abstract
In the last decade there has been an increase in the use of medical devices in the home environment. These devices are commonly the same as those used in hospitals by healthcare professionals. The use of these these devices by lay users outside of a clinical environment may become unsafe. This study presents a methodology that allows decision makers to identify potential risk situations that may arise when lay users operate healthcare medical devices at home. Through a usability study based on the Grounded Theory methodology, we create a conceptual model in which we identified problems and errors related to the use of a multi-parameter monitor in a home environment by a group of lay users. The conceptual model is reified as a graphical representation, which allows stakeholders to identify (i) the weaknesses of the device, (ii) unsafe operation modes, and (iii) the most suitable device for a specific user.