Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients

Study Design: This study is a comparative, single-center study. This is a minimal risk study
(as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part
812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will
last approximately 1 hour.

Objective(s):

The primary objective of this study is to evaluate the two Fingertip Respiratory Rate (FTRR)
algorithms performance of Nonin's Onyx 3 by attempting to demonstrate a mean error for FTRR <
1.0 BPM during spontaneous breathing.

Inclusion Criteria:

- The subject is at least 18 years old;

- 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 history of or current atrial fibrillation;

- The subject has a documented history of frequent premature ventricular contractions
(PVCs), defined as >3 per 30 seconds;

- The subject has an implanted pacemaker;

- 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 currently or trying to get pregnant (self-reported); and/or

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