Usability Evaluation of the Orthopedic Navigation System OrthoPilot®Elite
We validate the suitability for use of medical devices
When computer-based navigation systems are used in surgical orthopedics, safe and user-friendly handling is crucial. In this context, USE-Ing. supported the developers at Aesculap AG in the summative User Interface validation of their medical technology product, OrthoPilot®Elite.
Intuitive operation through evaluation of human-machine interactions
The orthopedic navigation system OrthoPilot®Elite provides the surgeon with precise feedback on the position of the instrument and implant during the procedure, enabling them to make the right decisions based on an even more solid information base. The intuitive operation of this exceptional medical product was ensured by evaluating the versatile Human-Machine Interfaces (User Interfaces).
How do you validate the safe and usable operation of medical products?
IEC 62366-1 mandates the summative evaluation of usability in the form of a so-called Usability Test. By recruiting medical professionals (surgeons and surgical assistants), realistic usage scenarios with real users could be simulated in the Usability Lab, and important questions about the Human-Machine Interaction of the surgery system could be clarified. The result was a successful usability validation, certifying safe and effective handling.
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