The objective of this clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
180
Masimo INVSENSOR00048 will be used to collect temperature measurements.
Children's Hospital of Orange County
Orange, California, United States
Clinical Performance of Masimo INVSENSOR00048
The outcome measure is determination of the Masimo INVSENSOR00048 temperature performance by comparing the Clinical Bias and Limits of Agreement (LOA) between the corresponding adjustment mode temperature of the INVSENSOR00048 and reference thermometer in degrees celsius. Clincal Bias is defined as mean difference between output temperatires of a clinical thermometer and a reference clinical thermometer for the intended reference body site with specified limitis of agreement when measured from selected group of subjects . Limits of agreement is defined as the magnitude of a potential disagreement between outputs of two clinical thermometers equal to double the standard deviation of output temperate differences when used on the same human subject .
Time frame: Approximately 90 minutes
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