Human Factoring Validation of Pulsenmore ES Device

Inclusion criteria

for participants:

• The participant has voluntarily provided and signed the informed consent form (ICF)
• The participant has voluntarily provided authorization and signed the Videography and Photography Release form
• The participant is able to speak, read, write and comprehend US English and resides in the United States of America
• The participant to have adequate communications skills
• Pregnant women > 18 years of age
• A singleton gestation
• Gestational age between 14 to 38 weeks with a prior scan demonstrating fetal viability and confirming dates
• Maximum BMI of 40
• Willing and able to participate in a 60-75 min video and is willing to be audio recorded for the post-procedure interview

Inclusion criteria

for HCP:

• The HCP has voluntarily provided and signed the HCP consent information sheet (CIS)
• The HCP has voluntarily provided authorization and signed the HCP Videography and photography Release form
• The HCP is able to speak, read, write and comprehend US English and resides in the United States of America.
• The HCP has adequate communications skills
• The HCP is willing and able to participate in one 60 min video call and is willing to be audio recorded during the interview.

Exclusion criteria

for participants:

• Multiple gestation
• Skin problem(s) in the abdominal area (such as wounds, cuts in the skin and skin rash)
• The participant has a visual or hearing impairment, and/or a condition that affects her motor and/or cognitive skills, that would prevent her from independently performing a fetal ultrasound scan at home
• The participant has a language barrier that can affect the communication and compliance to the usability study requirement
• Uncontrolled and untreated psychiatric conditions for a minimum of 6 months prior to screening,
• Alcohol or drug dependence with current symptoms
• Previous Pulsenmore ES trials and have previously used the Pulsenmore ES device
• Known fetal and genetic anomalies.

Exclusion criteria

for clinicians:

• The HCP has a visual or hearing impairment, that would prevent him or her from independently directing a fetal ultrasound scan
• The HCP has a language barrier and/or in the opinion of the recruiting interviewer provides any reason to believe that compliance with the study requirements will not be achievable
• The HCP has participated in in previous Pulsenmore trials and have previously used the Pulsenmore ES device