Clinical Performance of Masimo INVSENSOR00048 (DALI0001)

Clinical Performance of Masimo INVSENSOR00048

This clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.

Inclusion Criteria:

• Febrile subjects aged 18 years and older who meet the following criteria for screening temperature:

  • sublingual temperature ≥ 37.5°C (99.5°F),
  • or axillary temperature ≥ 37.2°C (99.0°F)

Exclusion Criteria:

• Subjects with medical conditions such as inflammation at the measuring site or taking medications which might skew clinical accuracy validation results (e.g. barbiturates, thyroid preparations, antipsychotics or immunization within prior 7 days) or per the investigator's judgement
• Subjects with conditions at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown that would prevent monitoring of physiological parameters during the study
• Subjects with known allergies to adhesive material used in medical equipment
• Subjects with medical conditions which, in the judgment of the investigator, renders them inappropriate for participation in this study
• Excluded at the Principal Investigator's discretion