Using New Model-Based Techniques for the User Interface Design of Medical Devices and Systems

Janß, Armin; Lauer, Wolfgang; Pekam, Fabrice Chuembou; Radermacher, Klaus

doi:10.4018/978-1-60960-177-5.ch010

Cited by 6 publications

(3 citation statements)

References 7 publications

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“…Current approaches regarding integrated OR-systems focus, amongst others, on centralized man-machine interfaces (MMI) [1,2,3]. In this context, one important question is how to integrate differing user interfaces into a central control station in a way that ergonomic deficiencies and resulting risks can be avoided.…”

Section: Introductionmentioning

confidence: 99%

Ergonomie und Patientensicherheit (1)

2011

Biomedizinische Technik/Biomedical Engineering

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Section: Introductionmentioning

confidence: 99%

Ergonomie und Patientensicherheit (1)

2011

Biomedizinische Technik/Biomedical Engineering

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“…zum Nutzungsprozess die Gefahr, ein defizitäres Bedieninterface zu entwickeln. Der neue Ansatz ermöglicht eine effiziente, softwaregestützte und modellbasierte Gebrauchstauglichkeitsprüfung sowie eine nutzungsorientierte Risikoanalyse, die in einer -sowohl für das Risikomanagement als auch im Usability-Engineering geforderten -normgerechten Dokumentation mündet[38].Bei der HiFEM-Modellierung eines Nutzungsprozesses für ein bereits vorhandenes System bzw. eine vorhandene Bedienschnittstelle tritt nach den bisherigen Erfahrungen ein interessanter und produktiver Nebeneffekt auf: Um hier eine IST-Zustands-Modellierung des Nutzungsprozesses aufzustellen, entwickeln die Anwender mit dem zu überprü-fenden System ein exploratives Testverhalten.…”

unclassified

Usability First

Janß

Radermacher²

2014

Bundesgesundheitsbl.

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Due to increasing automation, the number and complexity of technical components have increased in the medical context (e.g., in the clinic or in the home care sector) in recent years. Besides new effective and efficient therapeutic and diagnostic options, these devices entail a wide range of functions and very complex (often computer-based) user interfaces that may lead to human-induced risk potential. A systematic and early human risk analysis and a usability evaluation allow medical device manufacturers to identify and control risks within the human-machine interaction very efficiently. At the Department of Medical Engineering in the Helmholtz Institute for Biomedical Engineering at the RWTH Aachen University, a formal-analytical methodology and a corresponding software tool for prospective human-risk analysis and model-based usability evaluation has been developed. Based on a twofold approach, user interactive process sequences and their potential impacts on the overall process are identified and the resulting use-related risks are assessed. For this, the tasks are categorized (in system and user tasks) and modeled and temporally related within the framework of a high-level task analysis. Within a subsequent cognitive low-level task analysis, potentially critical parallel process sequences are then tested in order to detect a potential resource overload of the user. The subsequent corresponding human-risk analysis is developed according to a knowledge base (checklist) of taxonomies related to human error. The HiFEM (human-function effect modeling) methodology is universally applicable and can be used for the evaluation of human-computer interfaces as well as for the analysis of purely mechanical control interfaces and simple hand-held instruments (such as a scalpel and implant). In a comparative study, the HiFEM method clearly outperforms the classic FMEA (failure modes and effects analysis) process with regard to effectiveness, efficiency, learnability, and user satisfaction. Especially small and medium-sized enterprises that constitute the medical device industry can be supported by the new methodology in the context of risk management according to ISO 14971 as well as usability engineering in accordance with IEC 62366 and IEC 60601-1-6 as well as EN ISO 9241.

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“…In addition to the evaluation of the usability, the risk analysis method mAIXuse (Janß et al 2011) and the risk management software CARAD from SurgiTAIX AG, Aachen were applied to evaluate the patient's safety.…”

Section: Methodsmentioning

confidence: 99%

A New Approach in High Precision Bone Surgery: Semi-Automatic Alignment of an Application-Specific Instrument Guide Adjusted by a Smart Screwdriver

Theisgen¹,

Jeromin²,

Vossel³

et al.

EPiC Series in Health Sciences

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Robotic surgical systems reduce the cognitive workload of the surgeon by assisting in guidance and operational tasks. As a result, higher precision and a decreased surgery time are achieved, while human errors are minimised. However, most of robotic systems are expensive, bulky and limited to specific applications.In this paper a novel semi-automatic robotic system is evaluated that offers the high accuracies of robotic surgery while remaining small, universally applicable and easy to use. The system is composed of a universally applicable handheld device, called Smart Screwdriver (SSD) and an application specific kinematic chain serving as a tool guide. The guide mechanism is equipped with motion screws. By inserting the SSD into a screw head, the screw is identified automatically and the required number of revolutions is executed to achieve the desired pose of the tool guide.The usability of the system was evaluated according to IEC 60601-1-6 using pedicle screw implementation as an example. The achieved positioning accuracies of the drill sleeve were comparable to those of SpineAssist from Mazor Robotics Ltd., Caesarea (IL) with -0.54 ± 0.93 mm (max: 2.08 mm) in medial/lateral-direction and 0.17 ± 0.51 mm (max: 1.39 mm) in cranial/caudal-direction in the pedicle isthmus. Additionally, the system is cost-efficient, safe, easy to integrate in the surgical workflow and universally applicable to applications in which a static position in one or more DOF is to be adjusted.

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Using New Model-Based Techniques for the User Interface Design of Medical Devices and Systems

Cited by 6 publications

References 7 publications

Ergonomie und Patientensicherheit (1)

Ergonomie und Patientensicherheit (1)

Usability First

A New Approach in High Precision Bone Surgery: Semi-Automatic Alignment of an Application-Specific Instrument Guide Adjusted by a Smart Screwdriver

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