Clinical validation of the Caregiver non-contact thermometer model PRO-TF300 in febrile and afebrile patients age 0 to < 18

Background: The CAREGIVER Thermometer Model PRO-TF300 (Thermomedics Inc., Delray Beach, FL) is a non-contact clinical professional thermometer used to read human body temperature in children and adults through the determination of infrared energy from the middle of the forehead. The purpose of this paper is to describe the methods and findings of the CAREGIVER’S validation for clinical use in pediatric patients from newborns through adolescents.

Methods: Fully consented/assented, febrile and afebrile participants in this prospective study included children aged 0 to

Results: Overall agreement was 0.14°F (0.07°C) with a standard deviation of ±0.42°F (0.22°C). Overall repeatability was 0.19°F (0.1PC).

Conclusions: The CAREGIVER thermometer is designed to measure clinical body temperature in all age groups. This study included children ages 0 to

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 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 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 sample is described in Table 1.