NC Thermometer (Gen 3) ISO 80601-2-56 Validation

Status Completed

Clinical Trial Summary

The purpose of this clinical validation is to evaluate the the clinical bias, the limits of agreement, and the clinical repeatability of measuring oral temperature using a new thermometer, NC° Thermometer (Gen 3), compared to a reference clinical thermometer.

Clinical Trial Description

The purpose of this clinical study is to validate the clinical accuracy of the NC° Thermometer (Gen 3) according to the requirements of ISO 80601-2-56:2017. The NC° Thermometer (Gen 3) (the device under study (DUT)) is a predictive thermometer that operates in adjusted mode. The Welch Allyn oral thermometer (Welch Allyn Spot Vital Signs 420 SureTemp temperature module, Welch Allyn, San Diego, CA) with a measurement accuracy of ± 0.1 °C in monitor mode will be used the reference clinical thermometer (RCT). During the clinical study, subjects will be asked to perform three consecutive oral measurements with the DUT, and one oral measurement with the RCT. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05721131
Study type	Observational
Source	Natural Cycles
Contact
Status	Completed
Phase
Start date	January 10, 2023
Completion date	April 27, 2023

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