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Werner Korb, Dirk Engel, Robert Boesecke, Georg Eggers, Bibiana Kotrikova, Rüdiger Marmulla, Noel O`Sullivan, Jörg Raczkowsky, Stefan Hassfeld
Surgical Robot for Craniotomies – Risk Analysis and First Patient Trial
Within the framework of the Collaborative Research Centre (SFB 414) — Information Technology in Medicine: Computer and Sensor Aided Surgery — the surgical robot system RobaCKa was developed. It is dedicated for maxillofacial surgery, i. e. milling of the bony skull. Since surgical robots are complex mechatronic systems, it is important to apply systematic approaches for fault-free design, error detection and quality assurance. In universities and research centers it is often not possible to apply the same measures for software design and error analysis as it is demanded for suppliers of medical products. Nevertheless it makes sense to apply quality management already in the very beginning of a project. This is necessary for clinical investigations and it might be easier, to transfer the ideas into a commercial product later. The development and quality management includes besides risk analysis and proper design methods also the tests on phantoms to evaluate the accuracy of the system. After all these preparations in April 2003 the first patient was treated with the system. The results are discussed in this paper.
at – Automatisierungstechnik, Oldenbourg Wissenschaftsverlag
Print ISSN: 0178-2312
Volume: 52, 06/2004
Pages: 288 - 295