Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00025

Inclusion criteria

• Subject is 18-50 years of age.
• Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
• Hemoglobin value is greater than or equal to 11 g/dL.
• Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.
• Carbon monoxide (CO) value less than or equal to 2.0% fractional carboxyhemoglobin (FCOHb).
• Subject has a physical status of ASA I or II (American Society of Anesthesiology Class 1; Healthy subjects without any systemic disease at all. American Society of Anesthesiology Class II; subjects with mild systemic disease) as it applies to the systemic disease portion of the classification.
• Blood Pressure: (Systolic BP ≤ 140 mmHg and ≥ 90 mmHg, Diastolic BP ≤ 90 mmHg and ≥50 mmHg), and if blood pressure is lower than 100/60 subject passes an orthostatic blood pressure test
• Subject is able to read and communicate in English and understands the study and risks involved.

Exclusion criteria

(*= Per physician discretion)

• Subject is pregnant.
• Subject has a BMI > 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
• Subject has a history of fainting (vasovagal), blacking out or losing consciousness during or after a blood draw, or has a fear of blood draws.
• Subject smokes one pack of cigarettes or more in one week, and/or the equivalent of e-cigarette liquid, and smokers are not being recruited as indicated in the CSRF.
• Subject has open wounds, inflamed tattoos or piercings and/or any visible healing wounds that a medical professional renders them at an increased risk for participation.*
• Subject has known drug or alcohol abuse or uses recreational drugs.
• Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound.
• Subject has experienced a concussion or head injury with loss of consciousness within the past 12 months.
• Subject has any history of a stroke, myocardial infarction, seizures or heart attack.
• Subject who has taken anticoagulant medications within the last 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDS).
• Subject has donated blood within the past 4 weeks.
• Subject has any chronic bleeding disorder (i.e. hemophilia)
• Subject has any symptomatic cardiac dysrhythmia (i.e. atrial fibrillation) and has not received clearance from their physician to participate.
• Subject has Wolff-Parkinson-White Syndrome or Stokes - Adams syndrome.
• Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subjects' level of consciousness.
• Subject has taken opioid pain medication within 24 hours of start of study.
• Subject has any type of infectious disease (i.e. Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles, etc.).
• Subject is taking medications known to treat any type of infectious disease.*
• Subject has either signs or history of peripheral ischemia or carpal tunnel syndrome.
• Subject has had invasive surgery within the past year- including but not limited to major dental surgery*, appendix*, plastic surgery*.
• Subject has had invasive surgery within the past year- including but not limited to gallbladder, major fracture repairs (involving plates/ screws), jaw surgery, urinary tract surgery, major ENT surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery.
• Subject has symptoms of congestion, head cold, flu or other illnesses.
• Subject is claustrophobic and/or has generalized anxiety disorder.
• Subject has been in severe car accident(s) or a similar type of accident(s) requiring hospitalization within the past 12 months.
• Subject has any cancer or history of cancer (not including skin cancer).*
• Subject has chronic unresolved asthma, lung disease (including COPD) and/or respiratory disease.
• Subject is allergic to lidocaine, latex, adhesives, or plastic.
• Subject has a heart condition, insulin-dependent Diabetes, or uncontrolled hypertension.
• Subject has delivered vaginally, has had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the past 6 months.
• Subject intends to participate in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle, tennis) or exercise (working out, riding a bike, riding a skate board etc.), or any activity that will put additional stress on the wrist within 24 hours following a study that involved an arterial line.
• Subject has any medical condition which in the judgement of the investigator and/or medical staff, renders them ineligible for participation in this study (Discretion of investigator/study staff).