Temperature Change, Body
Conditions
Brief summary
A clinical study will be conducted on the Infrared Thermometers to verify whether its clinical accuracy (clinical bias, limits of agreement, and clinical repeatability) meets the standard requirements.
Interventions
DEVICEInfrared Thermometer
The test data are based on the data displayed by the infrared thermometer developed and manufactured by CONTEC Medical Systems Co., Ltd.
DEVICEElectronic Thermometer
The test data is based on the data displayed by the electronic thermometer developed and manufactured by joytech healthcare Co. Ltd.
Sponsors
Suzhou Care-Real Medical Technology Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Aged 0-1 year, 1-5 years, or \>5 years, regardless of gender; 2. The subject or/and their guardian consents and signs the Informed Consent Form.
Exclusion criteria
1. Premature infants with a gestational age of less than 37 weeks and low-birth-weight infants (birth weight less than 2.5kg); this item applies only to subjects aged 0-3 months; 2. Life-threatening acute infections; 3. Subjects who have taken a bath, sponge bath, applied hot/cold compresses, eaten, cried restlessly, or engaged in strenuous exercise within 30 minutes before the trial; 4. Subjects who have taken antipyretics within 180 minutes before the start of the measurement; 5. Other situations deemed inappropriate for participation in this study by the investigator, such as receiving immunization within 7 days before the test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical bias and limits of agreement | Baseline | Mean difference between OUTPUT TEMPERATURES of a CLINICAL THERMOMETER and a REFERENCE CLINICAL THERMOMETER for the intended REFERENCE BODY SITE with specified LIMITS OF AGREEMENT when measured from selected group of subjects. |
| Clinical repeatability | Baseline | Pooled standard deviation (over a selected group of subjects) of changes in multiple OUTPUT TEMPERATURES taken from the same subject at the same MEASURING SITE with the same CLINICAL THERMOMETER by the same OPERATOR within a relatively short time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device performance evaluation | Baseline | It is evaluated by the investigator using the test device, including operational satisfaction, working stability, and performance failures. |
| Device defects | Baseline | Device defects refer to unreasonable risks that may endanger human health and safety when medical devices are used normally during clinical trials, such as label errors, quality issues, and malfunctions. During the trial, closely observe the performance and safety of the test device, and monitor whether the test device has quality problems, malfunctions, or other defects, and whether these problems endanger the health or safety of the subjects. |
Countries
China
Outcome results
None listed