Vscan Access R2 Feasibility Evaluation

Evaluation of Feasibility and Accuracy of Assisted Fetal Heart Rate (FHR) Feature of the GE Vscan Access R2 Ultrasound System

This study is being done to evaluate if the Vscan Access R2 Ultrasound System can measure Fetal Heart Rate (FHR) in humans when compared against a reference device (GE Corometrics 170 Series Fetal Monitor), and to gather feedback from device operators on the usability of the device.

This study is being done to evaluate whether the Vscan Access R2 Ultrasound System Assisted FHR phantom testing conclusions can be extrapolated onto human fetal heart rate measurements, where CTG (GE Corometrics 170 Series Fetal Monitor) is to provide a reference value. It should be noted that the Vscan Access R2 Ultrasound System with Assisted FHR has a different intended use than CTG (momentary FHR value versus continuous monitoring of FHR patterns and trends) and this aspect is out of scope of this research.

Usability data will be gathered for further user experience optimization.

Inclusion Criteria:

1. Women aged 18 years or older at the time of consent;
2. By self-report, are in the 2nd or 3rd trimester of pregnancy;
3. Able and willing to provide written informed consent for participation;
4. Provide a completed Healthcare Verification Form which confirms the subject has received at least one diagnostic ultrasound during this pregnancy and has an uncomplicated pregnancy.

Exclusion Criteria:

1. Are direct employees/contractors of General Electric (GE);
2. Are potentially put at additional risk by participating, in the opinion of study staff;
3. Twin pregnancies identified in patient medical history.