Nellcor™ Abbreviated Sensor Additional Data Collection

The purpose of this study is to collect data on the Nellcor™ Pulse Oximetry device when paired with a variety of Nellcor™ Market Released sensors under invasive, controlled desaturation conditions, to verify Pulse Rate and SpO2 accuracy in a diverse participant population over a specified saturation range.

Inclusion criteria

• Male or female participants ≥ 18 years of age, and < 51 years of age.
• Participant is willing and able to comply with study procedures and duration.
• Participant is willing to sign an ICF.
• Participant weighs > 40kg (88.2 lb).
• Participant is a non-smoker or has not smoked within 36 hours prior to the study.
• Cleared same day health assessment form and health screening
• Successful perfusion index ulnar/ulnar+radial ratio test (Assessed via the Allen's Test) showing adequate collateral blood flow.

Exclusion criteria

• Participant is considered as being morbidly obese (defined as BMI >39.5).
• Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized)
• Participants of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study.
• Subjects with COHb levels >3% as assessed by CO-Oximetry during the procedure
• tHb < 10 g/dl as assessed by CO-Oximetry during the procedure
• MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
• Participants with known respiratory conditions such as:

• uncontrolled / severe asthma
• flu or influenza type infection
• pneumonia / bronchitis
• shortness of breath / respiratory distress
• unresolved respiratory or lung surgery
• emphysema, COPD, lung disease
• recent COVID (last 2 months)
• Participants with known heart or cardiovascular conditions such as:

• Uncontrolled hypertension (systolic pressure >140mmHg, or diastolic pressure >90mmHg on 3 consecutive readings day of screening)
• previous cardiovascular surgery
• chest pain (angina)
• heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
• previous heart attack
• blocked artery
• unexplained shortness of breath
• congestive heart failure (CHF)
• history of stroke and/or transient ischemic attack
• carotid artery disease
• myocardial ischemia
• myocardial infarction
• cardiomyopathy
• implantable active medical device such as pacemaker or automatic defibrillator
• Self-reported health conditions as identified in the Health Assessment Form:

• Diabetes
• uncontrolled thyroid disease
• kidney disease / chronic renal impairment
• history of seizures (except childhood febrile seizures)
• epilepsy
• history of unexplained syncope
• recent history of frequent migraine headaches (within the last 2 months)
• recent symptomatic head injury (within the last 2 months)
• cancer requiring chemotherapy, radiation, or current treatment
• participants with known clotting disorders
• history of bleeding disorders or personal history of prolonged bleeding from injury
• history of blood clots
• hemophilia
• sickle cell trait or disease
• current use of blood thinner: prescription or daily use of aspirin
• participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors
• participants with severe allergy to iodine (only applicable if iodine is used)
• participants with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin
• arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right)
• history of clinically significant complications from previous arterial cannulation
• unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits
• other known health condition, upon disclosure in Health Assessment form
• Failure of the Allen's Test.