Clinical Accuracy Validation of the Moni-Patch Temperature Monitoring Patch System

This study is conducted in accordance with ISO 80601-2-56:2017, which outlines definitions for temperature-measuring devices, age groups, required sample sizes, fever definitions, procedural flow, and statistical methods for clinical performance evaluation. All subjects undergo temperature measurement using the reference device(Tympanic) and the investigational device (Moni-Patch Temperature Monitoring Patch System). The Moni-Patch Sensor is applied to the neck and paired with the Receiver, while the tympanic probe is positioned and sealed in the ear canal. Each subject participates in a continuous 15-minute temperature monitoring session, during which both devices collect temperature values concurrently every 30 seconds. Environmental temperature and humidity are also recorded during the session.