Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

This is a prospective, non-randomized data collection study to evaluate the performance of the Masimo INVSENSOR00063 in obtaining temperature measurements.

Individual sites are only representative of a subset of the overall population, per ISO 80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement), and therefore clinical bias and limits of agreement should not be evaluated for the subsets. Publication of results should include repeatability from individual sites and the combined clinical bias and limits of agreement (NCT05787782, NCT05674344 and NCT05779397).

Inclusion Criteria:

• Participant age ≥ 1 year
• Afebrile or febrile at time of enrollment: For febrile subjects, ≥ 99.5 F/ 37.5 C for sublingual temperature reference; ≥ 100.4 F/ 38 C for temporal artery temperature reference.
• English-or Spanish-speaking patient or parent/Legal Guardian

Exclusion Criteria:

• Participants deemed not suitable for the study at the discretion of the investigator