Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults

Exclusion Criteria

• •1. Subject has history of allergy to acetaminophen or has been told by a health care provider they may not ingest acetaminophen
• •2. Subject reports history of liver cirrhosis or liver problems that a health care provider told them they should not use acetaminophen because of liver disorder.
• •3. Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) placement as assessed by a qualified individual.
• •4. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
• •5. Subject is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. (Please note participation in an observational study is acceptable.)
• •6. Subject is female of child-bearing potential and has a pregnancy screening test that is positive.
• •7. Subject is female of child-bearing potential and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator.
• •8. Subject is female and plans to become pregnant during the course of the study.
• •9. Subject is breast feeding.
• •10. Subject has a chronic heavy alcohol use as determined by investigator.
• •11. Subject has a history of a seizure disorder.
• •12. Subject has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents).
• •13. Subject has a history of adrenal insufficiency.
• •14. Subject is a member of the research staff involved with the study.