Usability Study for SOBERLINK System

Forty (40) subjects identified as potential end users of the device will be recruited to the
study and screened according to the study inclusion and exclusion criteria. Subjects will be
asked to sign informed consent. The Soberlink Cellular device, in its original packaging,
along with the QuickStart guide will be provided to the patient in a simulated home-use
environment and Rx clinical setting. The patient labeling will be in the format intended for
distribution.

Ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink
Cellular device while an additional ten (10) Rx subjects will be provided instruction for use
in clinic for the Soberlink Cellular device and Sober Sky web portal. An additional ten (10)
simulated home use subjects will be provided instruction for use for the Soberlink Cellular
device while an additional ten (10) simulated home use subjects will be provided instruction
for use in clinic for the Soberlink Cellular device and Sober Sky web portal. All subjects
will be provided with a post-test questionnaire on how to operate the device.

The post-test questionnaire will collect information regarding device use. The device's use
will be compared with identified risks to determine if the percentage of failures is within
the study protocol success criteria. Additionally, measurable usability criteria for
specific, critical steps will be evaluated.

Inclusion Criteria:

- Male and female participants between the ages of 18-99 years old in a clinical setting
under the care of a healthcare provider.

- Male and female participants between the ages of 18-99 years old in an
over-the-counter setting (home use setting).

Exclusion Criteria:

- Participants with lung disease unable to exhale for 4 seconds.