The goal of this study is to conduct human factors validation testing with the Pulsenmore ES home Ultrasound device in the video-guided mode of operation (participants) and the clinician-guided mode of operation (participants and healthcare professionals (HCP)) to evaluate whether the device/user interface can be used by the intended users without any serious issues or errors under that intended use and actual use conditions. The intended users will be qualitatively assessed via observation and cognitive debrief and usability testing methodology. Participants will be remotely observed during the video-guided fetal scanning actual process and participants and HCPs will be remotely observed during the clinician-guided fetal scanning actual process.
Study Type
OBSERVATIONAL
Enrollment
57
Fetal Ultrasound scanning using Pulsenmore ES device followed with an interview by a human factoring researched
Center for Fetal Medicine and Women Ultrasound
Los Angeles, California, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Safety issues while using Pulsenmore ES device
Any safety issue, either serious that could cause serious injury or death to the user, or non serious
Time frame: One day
User error while using Pulsenmore ES device
Any user interface issues reported by study participants and HCPs that can cause delay in diagnosis or treatment
Time frame: One day
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