scholarly journals Verification of User Interface Software: The Example of Use-Related Safety Requirements and Programmable Medical Devices

2017 ◽  
Vol 47 (6) ◽  
pp. 834-846 ◽  
Author(s):  
Michael D. Harrison ◽  
Paolo Masci ◽  
Jose Creissac Campos ◽  
Paul Curzon
2021 ◽  
Author(s):  
Michael Wiklund ◽  
Erin Davis ◽  
Alexandria Trombley ◽  
Jacqueline Edwards

Author(s):  
Michael D. Harrison ◽  
Paolo Masci ◽  
Jose Creissac Campos ◽  
Paul Curzon

2020 ◽  
Vol 2 (1) ◽  
pp. 174-182
Author(s):  
Agata Kielesińska

AbstractThe purpose of the paper is to present the issues of ensuring the safety of machinery and equipment in accordance with the requirements of the Machinery Directive 2006/42/EC of May 17, 2006 on the essential requirements for machines, with regard to the sphere of their import and distribution. This issue is related to the dynamically developing trade in cheaper new machines, mainly from countries outside the EEA (including China) and is a priority for ensuring safety and protecting the health and life of users of this type of equipment in accordance with EU regulations. The use of a variety of machines in industry, in addition to general safety requirements, which may also include quality criteria, care for the environment and industry-specific safety management requirements (e.g. food, automotive, medical devices).


10.2196/15581 ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e15581
Author(s):  
Stephan Wegner ◽  
Quentin Lohmeyer ◽  
Dimitri Wahlen ◽  
Sandra Neumann ◽  
Jean-Claude Groebli ◽  
...  

Background In order to give a wide range of people the opportunity to ensure and support home care, one approach is to develop medical devices that are as user-friendly as possible. This allows nonexperts to use medical devices that were originally too complicated to use. For a user-centric development of such medical devices, it is essential to understand which user interface design best supports patients, caregivers, and health care professionals. Objective Using the benefits of mobile eye tracking, this work aims to gain a deeper understanding of the challenges of user cognition. As a consequence, its goal is to identify the obstacles to the usability of the features of two different designs of a single medical device user interface. The medical device is a patient assistance device for home use in peritoneal dialysis therapy. Methods A total of 16 participants, with a subset of seniors (8/16, mean age 73.7 years) and young adults (8/16, mean age 25.0 years), were recruited and participated in this study. The handling cycle consisted of seven main tasks. Data analysis started with the analysis of task effectiveness for searching for error-related tasks. Subsequently, the in-depth gaze data analysis focused on these identified critical tasks. In order to understand the challenges of user cognition in critical tasks, gaze data were analyzed with respect to individual user interface features of the medical device system. Therefore, it focused on the two dimensions of dwell time and fixation duration of the gaze. Results In total, 97% of the handling steps for design 1 and 96% for design 2 were performed correctly, with the main challenges being task 1 insert, task 2 connect, and task 6 disconnect for both designs. In order to understand the two analyzed dimensions of the physiological measurements simultaneously, the authors propose a new graphical representation. It distinguishes four different patterns to compare the eye movements associated with the two designs. The patterns identified for the critical tasks are consistent with the results of the task performance. Conclusions This study showed that mobile eye tracking provides insights into information processing in intensive handling tasks related to individual user interface features. The evaluation of each feature of the user interface promises an optimal design by combining the best found features. In this way, manufacturers are able to develop products that can be used by untrained people without prior knowledge. This would allow home care to be provided not only by highly qualified nurses and caregivers, but also by patients themselves, partners, children, or neighbors.


Author(s):  
Julia Benzko ◽  
Lisa Krause ◽  
Armin Janß ◽  
Björn Marschollek ◽  
Paul Merz ◽  
...  

AbstractSevere bottlenecks in usability and human technology interaction (HTI) of existing surgical workplaces and operating room (OR) equipment can occur today: lack of space, cable as trip hazard, communication problems between sterile and non-sterile staff, and operating errors in the handling of the medical devices. In fact, risks that are caused by poor usability can be critical, and studies show that most are preventable. This issue gets even more challenging in the context of open-OR networks regarding consistent and usable integration of user interfaces (UIs) of independently designed systems in one integrated surgical work system. In this work, a concept of generic UI profiles for the modular integration of a UI has been developed and first prototypes have been implemented. The concept is essentially based on the approach of device profiles developed in the context of the Bundesministerium für Bildung und Forschung project OR.NET (


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