| Eligibility |
Inclusion Criteria:
- Subject is 18 to 50 years of age.
- Subject weighs a minimum of 110 lbs.
- Hemoglobin value = 11 g/dL.
- Baseline heart rate = 45 bpm and = 85 bpm.
- Blood Pressure: Systolic BP = 140 mmHg and = 90 mmHg, Diastolic BP = 90 mmHg and = 50
mmHg, and if systolic BP is lower than 100 mmHg and/or diastolic BP is lower than 60
mmHg, subject passes an orthostatic blood pressure test.
- CO value = 3.0% FCOHb.
- Subject is able to read and communicate in English and understands the study and the
risks involved
Exclusion Criteria:
- Subject is pregnant.
- Subject has a BMI > 35.
- Subject is wearing nail polish that cannot be removed, gel nails, and/or acrylic nails
that can interfere with study device's placement is deemed ineligible at the
discretion of investigator/study staff. *
- Subject has a history of fainting (vasovagal syncope), blacking out or losing
consciousness during or after a blood draw, or has a fear of blood draws.
- Subject has open wounds, inflamed tattoos or piercings, and/or has any visible healing
wounds that a medical professional determines may place them at an increased risk for
participation. *
- Subject has known drug or alcohol abuse.
- Subject 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 (heart attack), and/or
seizures.
- Subject has any chronic bleeding disorder (e.g., hemophilia).
- Subject has taken anticoagulant medication within the past 30 days (excluding
nonsteroidal anti-inflammatory drugs (NSAIDS)).
- Subject has donated blood within the past 4 weeks.
- Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.
- Subject has any cardiac dysrhythmia (e.g., atrial fibrillation) and has not received
clearance from their physician to participate.
- Subject has a known neurological and/or psychiatric disorder (e.g., schizophrenia,
bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the
subject's level of consciousness. *
- Subject has taken opioid pain medication 24 hours before the study.
- Subject has any active signs and/or symptoms of infectious disease (e.g., 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, appendectomy, plastic surgery, jaw surgery, major ENT surgery,
major abdominal and/or pelvic surgery, heart surgery, or thoracic surgery. *
- Subject has symptoms of congestion, head cold, or other illnesses.
- Subject has been in a 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, chlorhexidine, 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 on participating in any heavy lifting, repetitive movement of their
wrist (including riding a motorcycle, tennis), exercise (working out, riding a bike,
riding a skateboard, etc.), or any activity that will put additional stress on the
wrist within 24 hours following a study that involves an arterial line.
- Subject has any medical condition which in the judgment of the investigator and/or
medical staff, renders them ineligible for participation in this study or subject is
deemed ineligible by the discretion of the investigator/study staff.
(*)Physician's discretion.
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