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The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers
Sponsor: Geon Corporation
Summary
Geon Corporation develops ear thermometers and forehead thermometers that use infrared measurement technology to measure human body temperature. This study verify the accuracy and repeatability of investigational devices. Efficacy verification is carried out by comparing with the referent medical devices. The main objectives of this study are: 1. To verify that the investigational devices and the reference medical devices have a reasonable deviation value. 2. To verify the consistency of repeated measurements of investigational devices.
Key Details
Gender
All
Age Range
Any - 80 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2022-08-12
Completion Date
2024-08-11
Last Updated
2024-04-09
Healthy Volunteers
Yes
Interventions
Infrared Forehead Thermometer (GE-TF03)
Infrared Forehead Thermometer (GE-TF03) is an investigational device intended to measure body temperature on the forehead. GE-TF03 took three measurements for each subject.
Infrared Ear Thermometer (GE-TE06)
Infrared Ear Thermometer (GE-TE06) is an investigational device intended to measure body temperature in the ear canal. GE-TF06 took three measurements for each subject.
Electronic Thermometer (MT-B321FB)
Electronic Thermometer (MT-B321FB) is an investigational device intended to measure body temperature on the temporal artery. MT-B321FB took three measurements for each subject.
Electronic Thermometer (MT-B231)
Electronic Thermometer (MT-B231) is a reference device that measured axillary temperature one time for each subject.
Locations (2)
Hsinchu MacKay Memorial Hospital
Hsinchu, Taiwan
HsinChu Municipal MacKay Memorial Hospital
Hsinchu, Taiwan