Clinical validation of the Caregiver non-contact thermometer model PRO-TF200/ PRO-TF300 in febrile and afebrile patients of all ages
Background. The CAREGIVER® Model PRO-TF200 and PRO-TF300 (Thermomedics, Miami, FL) are non-contact clinical professional thermometers used to read human body temperature in children and adults through the determination of infrared energy from the middle of the forehead. Both models function identically, thus they will be referred to hereafter as 'CAREGIVER'. The purpose of this paper is to describe the methods and findings of the CAREGIVER'S validation for clinical use.
Methods. Fully consented/assented, febrile and afebrile participants in this prospective study included adults (n=135) and children (n=160). Readings were compared to a reference thermometer (SureTemp Plus® 690, Welch-Allyn®, Skaneateles Falls, NY) to derive agreement (clinical accuracy) and repeatability.
Results. Agreement in the adult group was -0.2°F (-O.rC) with a standard deviation of 0.50°F (0.28°C). In the pediatric group, agreement was 0.14°F(0.07°C) with a standard deviation of 0.42°F (0.22°C). Repeatability was 0.17°F in adults and 0.19°F in children.
Conclusions. The CAREGIVER thermometer is designed to measure clinical body temperature from the center of the forehead without contact with the skin. Device agreement and repeatability both fall within current standards for clinical infrared thermometers.
Introduction
Clinical thermometers are validated against international standards to assure users of their suitability for the determination of clinical temperature in patients for whom the devices are intended. CAREGIVER is a non-invasive clinical professional thermometer that reads human body temperature without touch in children and adults by detecting the body's infrared energy. It does so without the need for probe covers and with a fast and simple one-button operation that minimizes cross-contamination.
Our objective was to re-validate the CAREGIVER in a larger sample against current laboratory and clinical standards for thermometry.
Laboratory accuracy
Prior to use in the clinical accuracy and repeatability tests, the laboratory accuracy of the CAREGIVER thermometer was validated in various operating environments from 60°F to 104°F and relative humidities ranging from less than 50% to 85% as called for in the ASTM E1965-98(2009) standard (1). Blackbody temperatures of 95°F, 98.6°F and 105.8°F were tested. The maximum laboratory bias for each of the blackbody temperatures and environmental conditions was found to be 0.2F°. This is better than the ±0.4F° requirement as specified in the ASTM standard and compliant with the ±0.2C° in the ISO 80601-2-56 standard.
Methods
In this prospective study, with patients acting as their own controls, temperature measurements were obtained with SureTemp 690 oral electronic thermometers as reference (in predictive mode) and CAREGIVER (in 'BODY' mode) as test devices. Data were collected in Family Medicine (clinic, hospital and home care) and Pediatrics (outpatient, sick baby room, and hospital ward) departments at China Medical University Hospital (Taichung, Taiwan) between September, 2012 and August, 2013. The study was approved by the hospital's institutional review board (IRB) and all participants and/or parents signed informed consent/ assent to participate. The projected sample is described in Table 1.
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