Pivot Breath Sensor Human Factors and Usability Study

Pivot Breath Sensor Human Factors and Usability Study

Prospective, observational open label, single center study enrolling up to 15 subjects to evaluate human factors and usability of the Pivot Breath Sensor.

The objectives of this Human Factors/Usability study are to:

• Ensure that representative intended users are able to operate the Pivot Breath Sensor independently
• Validate appropriate mitigations of use related hazards identified in risk management documentation
• Uncover previously unforeseen use errors

This human factors and usability testing is conducted to demonstrate that the Pivot Breath Sensor can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions.

Inclusion Criteria:

• 18-80 years of age
• English speaking
• Owns and uses a smartphone
• Willing to sign the Informed Consent Form

Exclusion Criteria:

• Prior experience with a study sponsored by Carrot Inc
• Pregnancy