The use of infrared tympanic thermometers for monitoring patient health is widespread. However, studies into the performance of these thermometers have questioned their accuracy and repeatability. To give users confidence in these devices, and to provide credibility in the measurements, it is necessary for them to be tested using an accredited, standard blackbody source, with a calibration traceable to the International Temperature Scale of 1990 (ITS-90). To address this need the National Physical Laboratory (NPL), UK, has recently set up a primary ear thermometer calibration (PET-C) source for the evaluation and calibration of tympanic (ear) thermometers over the range from 15 °C to 45 °C. The overall uncertainty of the PET-C source is estimated to be ± 0.04 °C at k = 2.
The PET-C source meets the requirements of the European Standard EN 12470-5: 2003 Clinical thermometers. It consists of a high emissivity blackbody cavity immersed in a bath of stirred liquid. The temperature of the blackbody is determined using an ITS-90 calibrated platinum resistance thermometer inserted close to the rear of the cavity. The temperature stability and uniformity of the PET-C source was evaluated and its performance validated. This paper provides a description of the PET-C along with the results of the validation measurements.
To further confirm the performance of the PET-C source it was compared to the standard ear thermometer calibration sources of the National Metrology Institute of Japan (NMIJ), Japan and the Physikalisch-Technische Bundesanstalt (PTB), Germany. The results of this comparison will also be briefly discussed.
The PET-C source extends the capability for testing ear thermometers offered by the NPL body temperature fixed-point source, described previously. An update on the progress with the commercialisation of the fixed-point source will be given.
The use of infrared tympanic thermometers within the medical community (and more generically in the public domain) has recently grown rapidly, displacing more traditional forms of thermometry such as mercury-in-glass. Besides the obvious health concerns over mercury the increase in the use of tympanic thermometers is related to a number of factors such as their speed and relatively non-invasive method of operation. The calibration and testing of such devices is covered by a number of international standards (ASTM1, prEN2, JIS3) which specify the design of calibration blackbodies. However these calibration sources are impractical for day-to-day in-situ validation purposes. In addition several studies (e.g. Modell et al4, Craig et al5) have thrown doubt on the accuracy of tympanic thermometers in clinical use. With this in mind the NPL is developing a practical, portable and robust primary reference fixed point source for tympanic thermometer validation. The aim of this simple device is to give the clinician a rapid way of validating the performance of their tympanic thermometer, enabling the detection of mal-functioning thermometers and giving confidence in the measurement to the clinician (and patient!) at point of use. The reference fixed point operates at a temperature of 36.3 °C (97.3 °F) with a repeatability of approximately ± 20 mK. The fixed-point design has taken into consideration the optical characteristics of tympanic thermometers enabling wide-angled field of view devices to be successfully tested. The overall uncertainty of the device is estimated to be is less than 0.1°C. The paper gives a description of the fixed point, its design and construction as well as the results to date of validation tests.