Timmy3 Module Clinical Accuracy ISO 80601-2-56:2017 + A1 2018

Exclusion Criteria

• •Study subjects (person who is having their temperature taken) are excluded if they meet any of the below criteria. Any subject that withdraws from the study will be replaced.
• •* The study subject has anatomical abnormalities that would affect temperature.
• •* The study subject has any known contraindication to oral, axillary, or rectal temperature measurements.
• •* The subject is not alert or unable to follow simple commands such as closing one's mouth completely around the probe if an oral reference temperature is being taken.
• •* The study subject has consumed food or drink, or smoked, within the last 20 minutes. The subject may be included if they wait 20 minutes prior to taking oral temperature.
• •* The study subject has engaged in strenuous or semi-strenuous activity within the last twenty minutes (i.e., running, weightlifting, etc.).
• •* Subject has taken antipyretics (Aspirin, acetaminophen, ibuprofen) in the preceding 120 minutes.
• •* Subjects has medical conditions such as inflammation at the MEASURING SITE (Barbiturates, thyroid preparations, antipsychotics, recent immunizations).
• •* Neutropenic immunocompromised patients, in whom rectal manipulation may seed the blood with bacteria.
• •Note: The study subject will be excluded if the reference temperature does not stabilize after the 3 -5 minute monitoring time.