SpO2 Hypoxia Accuracy Validation Study

The primary objective of this study is to evaluate the %SpO2 accuracy of a combined pulse
oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system
during non-motion conditions.

Inclusion Criteria:

- The subject is male or female

- The subject is of any racial or ethnic group

- The subject is ≥ 30 kg (≥ 66 pounds) in weight (self-reported)

- The subject has at least one finger height of 0.2 - 1.0 inch (based on measurement)

- The subject is between 18 years and 50 years of age (self-reported)

- The subject shows no evidence of medical problems as indicated by satisfactory
completion of the health assessment form

- The subject has given written informed consent to participate in the study

- The subject is both willing and able to comply with study procedures.

Exclusion Criteria:

- The subject has a BMI greater than 31 (based on weight and height)

- The subject has had any relevant injury at the sensor location site (self-reported)

- The subject has deformities or abnormalities that may prevent proper application of
the device under test (based on examination)

- The subject is current smoker (self-reported)

- The subject has a known respiratory condition (self-reported)

- The subject has a known heart or cardiovascular condition (self-reported)

- The subject is currently pregnant, is actively trying to get pregnant, or who has a
positive urine pregnancy test on the day of the study

- The subject has a clotting disorder (self-reported)

- The subject has Raynaud's Disease (self-reported)

- The subject is known to have a hemoglobinopathy (self-reported)

- The subject is on blood thinners or medication with aspirin (self-reported)

- The subject has unacceptable collateral circulation from the ulnar artery (based on
examination)

- The subject is unwilling or unable to provide written informed consent to participate
in the study

- The subject is unwilling or unable to comply with the study procedures

- The subject has another health condition which in the opinion of the principal
investigator makes him/her unsuitable for testing.