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Usability of a Patch-Type Ultrasound System for Non-Invasive Hemodynamic Monitoring: A Simulation Study in
Soyeon Noh1, Hyungmin Kim1, Hyeonkyeong Choi1
1Department of Medical Device Engineering and Management, Yonsei University College of Medicine, Seoul 06229, Republic of Korea.
Healthcare (Basel, Switzerland)
|April 14, 2026
Summary
This study found a novel patch-type ultrasound system for hemodynamic monitoring demonstrated good usability in simulated operating room scenarios. The system showed consistent performance across anesthesiologists with varying experience levels.
Area of Science:
- Medical Devices
- Biomedical Engineering
- Anesthesiology
Background:
- Developing non-invasive hemodynamic monitoring is crucial for clinical decisions and reducing invasive procedure risks.
- Usability evaluation is vital for ensuring the safety and effectiveness of medical devices before market release.
- This study focuses on the usability of a new patch-type ultrasound system (CW10) for continuous perioperative monitoring.
Purpose of the Study:
- To evaluate the usability of the novel patch-type ultrasound-based system (CW10) in simulated perioperative settings.
- To assess the system's safety and effectiveness through user performance and satisfaction.
- To identify potential usability issues and variations across different levels of clinical experience.
Main Methods:
- A summative usability evaluation was performed following IEC 62366-1 standards with 15 anesthesiologists.
- Potential hazards were identified using the FDA MAUDE database (Code: DQK) to create realistic test scenarios.
- Participants performed 49 tasks across 9 clinical scenarios in a simulated operating room, with metrics including task success rates, subjective satisfaction, and the System Usability Scale (SUS).
Main Results:
- The CW10 system achieved an overall task success rate of 98.2%.
- No statistically significant differences in performance, subjective ratings, or SUS scores were found across anesthesiologist experience groups (p > 0.05).
- The mean SUS score was 78.5, indicating "Good" usability, with minor use errors attributed to prior device experience rather than interface design.
Conclusions:
- The CW10 system exhibits acceptable usability and consistent operational performance across varying levels of user experience.
- Integrated automated features and the patch design appear to minimize inter-user variability in continuous monitoring.
- This usability evidence can guide the development of future non-invasive hemodynamic monitoring technologies.
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