Usability of a Patch-Type Ultrasound System for Non-Invasive Hemodynamic Monitoring: A Simulation Study in...

Background/Objectives: Non-invasive hemodynamic monitoring technologies are being developed to support clinical decisions while reducing risks from invasive procedures. Usability evaluation is essential to assess safety and effectiveness before commercial release. This study examined the usability of a novel patch-type ultrasound-based system (CW10) designed for continuous monitoring in perioperative settings. Methods: A summative evaluation was conducted following IEC 62366-1 with 15 anesthesiologists. Potential hazards were identified via the FDA MAUDE database (Code: DQK) to inform test scenarios. Participants were stratified by clinical experience (1-<5, 5-<10, and ≥10 years) to observe potential variations in operation. In a simulated operating room, users performed 9 clinical scenarios (49 tasks). Metrics included task success rates, subjective satisfaction (5-point Likert scale), and the System Usability Scale (SUS). Results: The overall task success rate was 98.2%. No statistically significant differences were observed across groups in performance, subjective ratings, or SUS scores (p > 0.05). The mean SUS score was 78.5, corresponding to a "Good" usability level. While some use errors occurred in tasks like probe orientation, root cause analysis suggested these were likely due to negative transfer from prior device experience rather than interface complexity. Conclusions: The results suggest the system demonstrates acceptable usability and consistent operation across experience levels. Integrated automated features and the patch design may contribute to reducing inter-user variability for continuous monitoring. This study provides usability evidence that may inform the development of similar non-invasive technologies.