Customer Support Response Study

The SCOUT DS device is not yet approved by the FDA for sale in the United States, but
currently is being marketed in Canada and other countries. Customers who are using the
device have contacted the sponsor with questions about testing conditions which might affect
the reproducibility of measurements.

The objective is to obtain information to allow the Sponsor to address these issues. The
concerns fall into three broad categories:

• Factors affecting the interface between the skin and the test sensor

These would include the effects of skin care products applied to the forearm, subject
activity that changes perfusion to the skin and subject movement during the test procedure.

- General operating conditions Issues such as ambient temperature, lighting, and height
of the table on which the SCOUT DS device rests have been questioned as possible
factors influencing accuracy.

- Rare subject disorders

Included here would be subject skin abnormalities or physiologic changes which occur so
infrequently that they were not well represented in previous data sets. Examples of such
rare conditions would include scleroderma, capillary angiomata, and Raynaud phenomenon.

Inclusion Criteria:

- Males and/or females greater than or equal to 18 years of age

Exclusion Criteria:

- Have received investigational treatments in the past 14 days

- Have psychosocial issues that interfere with an ability to follow study procedures

- Are known to be pregnant

- Have scars, tattoos, rashes or other disruption/discoloration on the left volar
forearm.

- Have been treated on the past month with oral steroid therapy or topical steroids
applied to the left forearm. Inhaled steroid therapy is not a basis for exclusion

- Are receiving medications that fluoresce (A list of excluded medications is located
in Appendix H)

- Are known to have, or at risk for, photosensitivity reactions (e.g., sensitive to
ultraviolet light, or taking medication known to cause photosensitivity)