Physiol. Meas. 18 (1997) 215225.

Printed in the UK

PII: S0967-3334(97)80900-8

An assessment of infrared tympanic thermometers for body temperature measurement

Vittorio Betta, Furio Cascetta and Davide Sepe
DETEC Dipartimento di Energetica, Termouidodinamica Applicata e Condizionamenti Ambientali, University of Naples Federico II, Italy Received 9 January 1997, in nal form 28 April 1997 Abstract. This article provides an experimental assessment of three commercially available clinical thermometers, using different thermal infrared sensors. This kind of thermometer measures body temperature by detecting infrared radiation from the tympanic membrane. These thermometers are growing in popularity thanks to their simplicity of use, rapid response and minimal distress to the patient. The purpose of the laboratory tests presented here was to assess the effect of varying ambient temperature and varying simulated patient temperature on the performance of the three infrared tympanic thermometers. Keywords: tympanic thermometer, infrared radiation thermometry, medical thermometry

1. Introduction Several clinical thermometers that measure the infrared emissions from the auditory canal and tympanic membrane have been introduced over the past few years. The attraction of these infrared tympanic thermometers (ITTs) lies in their ability to make temperature measurements rapidly, with minimal distress to the patient (Kenney et al 1990, Rhoads and Grandner 1990, Johnson et al 1991). Core body temperature (or the temperature of the blood perfusing the thermoregulatory receptors in the hypothalamus) is measured by the use of sensors (typically thermistors) placed in suitable deep-tissue sites (such as the pulmonary, brain or coronary arteries). In daily practice, however, all these deep-tissue measurement sites are inaccessible. Therefore, a variety of practical alternative body sites (such as the rectum, the armpit and the mouth) have been used clinically to monitor body temperature in adults and children. The tympanic membrane shares the same vascular supply that perfuses the hypothalamus, and therefore is an excellent accessible site for the detection of a temperature that, since it corresponds very closely to pulmonary artery temperature, can be considered a reliable indication of the core body temperature (Benzinger T H 1969, Benzinger M 1969). Although traditional contact-type probes (i.e., thermocouples or electronic thermometers) provide accurate measurements of the tympanic membrane temperature, patient discomfort and complications (such as perforation of the tympanic membrane) have restricted their use (Wallace et al 1974). Recently, infrared tympanic thermometers, which offer a painless and instantaneous reading without membrane contact, have been developed and introduced onto the market (Shinozaki et al 1988, Stewart et al 1992, Ros 1989, Schuman 1991, Brogan et al 1993). Obviously, axillary/oral/rectal and tympanic temperature readings are not coincident. A
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number of clinical studies have been carried out in order to determine the equivalence, or the correlation factors, between the tympanic temperature reading and the axillary/oral/rectal temperature readings (Freed and Fraley 1992, Yetman et al 1993, Petersen-Smith et al 1994, Chamberlain et al 1991, Brown et al 1992). The use of the term equivalence, although useful to provide users with familiar scales for interpreting aural temperature readings (i.e., for prediction of fever or hypothermia), may contribute to a certain misunderstanding or mislead, since the aural temperature is likely to be different from the temperatures measured in other traditional body sites (mouth, rectum and armpit) (McKenzie 1995, Pransky 1991). Since ITTs are growing in popularity and some of them are successfully sold, both for hospital (particularly pediatrics, anaesthesia and emergency department) and home use, it is important for clinicians to understand the advantages and limitations of auditory canal thermometry (Terndrup and Milewski 1991, Muma et al 1991, Weiss 1991, Green et al 1989, Shenep et al 1991). This article will address the reader to an experimental, metrological evaluation of three commercially available ITTs, using different thermal infrared sensors.

Figure 1. A simplied scheme of an ITT.

2. Short background of clinical tympanic thermometry All the ITTs have a common design conguration (gure 1). It consists of three basic elements: (i) the probe (containing the optical system), which must be inserted into the auditory canal (a wave-guide, or barrel, located in the probe of the thermometer, directs the infrared radiation from the thermal target, i.e., the tympanic membrane, towards the IR sensor); (ii) the sensor unit, where the infrared radiation detector which receives the thermal radiation and converts it into an electric signal is located; (iii) the electronic unit (or signal-processing facility), which processes the electric signal and shows on the display the temperature reading. Normally, units (i) and (iii) (i.e., the probe and the electronic unit) of an ITT are essentially similar; the basic component of any tympanic thermometer is the radiation

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detector. According to the operation principle of the radiation detector (thermopile or pyroelectric detector), the sensor unit (ii) contains the components required for the correct working of the thermometer. In 1986, Intelligent Medical Systems (Carlsbad, CA) introduced into the US hospital market the rst commercially available ITT for taking temperatures from the auditory canal (and therefore appropriately named the FirstTemp thermometer) (Fraden 1991). It consists of three units: (i) a hand-held probe attached by a cable to (ii) a desktop unit (which contains a calibration system, microprocessor, AD converter, power supply, display, and other components), and (iii) a charger. The hand-held probe contains a thermopile sensor with a preamplier, heater, controller, indicators, and switches. Immediately before each temperature measurement, the probe is placed on the desktop unit where the sensor is warmed to approximately 36.7 C. This preliminary calibration of FirstTemp probably represents its major limitation, since the patient measurement must be performed within about 15 s from calibration to assure good accuracy (OHara and Phillips 1986). The probe, covered by a disposable tip (or cover), is inserted into the ear canal opening. When activated, it records the highest temperature detected in a 12 s interval. The processor enables the measured temperature to be displayed directly, using the calibration mode (cal). Alternatively, the user can cause an estimated oral, rectal, or core temperature to be displayed by selecting the appropriate setting. These equivalent temperatures are determined by an algorithm that adds xed offsets of 0.4, 0.8, and 0.9 C respectively. The FirstTemp requires approximately 20 s for the sensor to be rewarmed before another measurement can be obtained. Other apparent disadvantages are the relatively high power consumption, weight of the instrument, and high cost. The FirstTemp became popular, particularly in pediatricians ofces, where its ease of use and ability to measure temperature rapidly are considered an asset. In 1991, Intelligent Medical Systems introduced a new ITT, called Genius, that combines an ergonomic one-piece design with a sensor (which remains a thermopile) that operates at ambient temperature, thus avoiding the preliminary calibration procedure. After a recent commercial merger between two companies (Intelligent Medical Systems and Sherwood Medical), this thermometer is now sold with the name of FirstTemp Genius (model 3000A). In this new version, the FirstTemp Genius consists of a probe with a disposable cover and a base (or desktop) unit that serves only as a storage site for additional disposable covers and for the probe when it is not in use. When the scan button is pushed, the instrument converts the amount of received energy into a temperature reading, that is digitally displayed in different operation modes (i.e., calibration, oral-equivalent, rectal-equivalent, etc). The thermopile used as the thermal sensor shows good accuracy, speed of response, reliability, low noise, and predictable response. However, the thermopile has serious limitations such as a low level of the output signal, non-linearity and, most of all, high cost. In the same year (1991), Thermoscan (San Diego, CA) introduced two new ITTs, one for professional use (PRO-1) and the other one for home use (HM-1), which operate at ambient temperature, and which utilize a pyroelectric element as an infrared thermal sensor (Fraden 1989). These instruments combine an ergonomic design (they consist of a handheld unit containing sensor, AD converter, microprocessor, and other components) with a technology which provides the advantages of a pyroelectric sensor (its simplicity, lower cost, and ease of operation). The conventional pyroelectric sensor is a heat ow detector, and it only measures a change in temperature, rather than an absolute temperature. Therefore, an ITT using a pyroelectric detector requires both a mechanical shutter and an internal temperature reference sensor (usually a thermistor) for the detection of the ambient temperature (i.e.,

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the temperature of the thermometer itself). This type of ITT calculates the temperature of the object (i.e., the tympanic membrane and surrounding tissues) from the difference between the temperature detected by the pyroelectric sensor upon opening the shutter and the ambient temperature (Cascetta 1995b). The shutter (or chopper) is positioned between the thermal source (auditory canal) and the pyroelectric sensor, and it acts as a gate which controls infrared heat ow. The shutter is actuated to an open position by depression of the pushbutton and remains in the open position for sufcient time to permit the pyroelectric sensor to generate the electric signal in response to the shutter opening. Therefore, an obvious disadvantage of this kind of thermometer lies in the necessity to employ moving components (i.e., the shutter or chopper mechanism). When the activation button is pushed the thermometer measures the infrared energy which is naturally emitted from the eardrum and surrounding tissue, calculates the core temperature, converts it to an oral or rectal equivalent, and displays it on the digital display after 12 s from the beginning of the measurement cycle. Another temperature reading can be taken in about 10 s. In 1991 several other manufacturers began marketing their own ITTs (Diatek, San Diego, CA, introduced Diatek 9000 and Ivac, San Diego, CA, introduced the CoreCheck) (Schuman 1993). In 1992 Omron Corporation introduced the Omron MC 500, which uses an active sensor to detect thermal radiation from the ear canal (Cascetta 1995a). Finally in 1994, Safe Design (Israel) introduced on the market the E-Z Therm (model 518). This type of ITT also measures tympanic membrane temperature by means of a pyroelectric sensor. The basic difference between this ITT and the previous one (manufactured by Thermoscan) lies in the fact that in this case the necessary chopper mechanism (driven by a quartz timepiece movement) allows the detector (i.e., the pyroelectric element) to be exposed intermittently to the heat ow from the ear canal. In operation, when the pushbutton is pressed, over a period of 3 s, the thermometer takes a series of six consecutive readings, showing on the LCD the average of these multiple measurements (Gal et al 1993). 3. Experimental method and results The purpose of the laboratory tests presented here was to assess the effect of varying ambient temperature and varying simulated patient temperature (also called target, reference, or true temperature in the following text) on the performance of three infrared tympanic thermometers (Zehner and Terndrup 1991, Weiss et al 1991). The metrological analysis was carried out in order to evaluate the deviation (i.e., the error) and the repeatability of the tested ITTs. Deviation is dened as the difference between the average of multiple measurements (usually ten readings for each xed target temperature) and the reference value (the conventional true value). The test facility is made up of a simulated ear canal realized by means of a copper cylinder with black-painted internal surfaces, surrounded by a sealed water jacket. The target is the bottom of the copper cylinder (i.e., a circle of 8 mm diameter), which represents the tympanic membrane at the end of the auditory canal. The circulating water is carefully temperature regulated. The temperature of the target (i.e., the simulated patient temperature) has been measured by means of a platinum resistance thermometer (Pt100) embedded just a few millimetres below the visible surface, in the centre of the target (Cascetta 1995b). The Pt100 thermometer had been previously calibrated by means of a high-precision standard resistance thermometer (Pt25.5). The Pt100 thermometer was found

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to be accurate within 0.025 C over the temperature range 34.042.0 C, at the beginning and end of the experimental tests. It is worth pointing out that the test facility employed is quite different from the real ear canal, since most ear canals have slight bends which can prevent the thermometer from having a clear aim toward the eardrum. Therefore, before using an ITT, it is important to perform the ear canal straightening technique. The results here reported refer only to a laboratory (or in vitro) testing. The human (or hospital) testing (which requires an anaesthetized patient) allows an estimate to be made of some other factors of inuence, such as the presence of cerumen inside the auditory canal. Obviously, the manufacturers calibrate their own instruments by means of laboratory tests. For the calibration procedure, the tested ITTs were installed in a custom-designed support: this allowed the thermometer to be used inside a small, sealed, temperaturecontrolled chamber. A calibrated thermistor was placed inside the chamber to measure the temperature of the environment surrounding the thermometer (called ambient temperature, Tamb ).

Figure 2. A simplied block diagram of a thermopile ITT (thermometer A).

The tested ITTs show the following characteristics: (i) the thermometer called A uses a thermopile as the radiation detector (gure 2); the stated patient and ambient temperature ranges are respectively 15.643.3 C and 15.5 40.0 C; (ii) the thermometer called B uses a pyroelectric detector equipped with a shutter control mechanism of conventional design (gure 3); the stated patient and ambient temperature ranges are respectively 34.041.1 C and 15.040.0 C; (iii) the thermometer called C uses a pyroelectric detector equipped with a shutter driven in reciprocating motion by a crystal-controlled timepiece movement (gure 4), such as that commonly employed in watches. Such a movement is characterized by use of a very small amount of electrical power; its volume is very small and the chopping frequency achieved from this device is both stable and precise. The stated patient and ambient temperature ranges are respectively 34.042.0 C and 11.036.0 C. The experimental tests have been carried out at three representative ambient temperatures: 19 1 C, 24 1 C and 29 1 C. The target temperature (i.e., the true temperature) has been ranged from 34.0 to 42.0 C, in 0.5 C increments.
Sherwood IMS FirstTemp Genius model 3000A. Thermoscan model HM-1. E-Z Therm model 518.

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Figure 3. A simplied block diagram of a pyroelectric ITT with a shutter control mechanism of conventional design (thermometer B).

Figure 4. A simplied block diagram of a pyroelectric ITT with a shutter driven by a crystalcontrolled timepiece movement (thermometer C).

The probe was carefully inserted into the simulated auditory canal, after the pushbutton was depressed, as recommended by the manufacturer. Ambient and target temperatures were simultaneously detected; for each value of target temperature, ten readings of each ITT were recorded, with 90 s intervals between two consecutive measurements. In gures 57 the deviations of the three tested ITTs versus the target temperature, for the three xed ambient temperatures (Tamb = 19, 24, and 29 C) are reported. 4. Discussion The tested ITTs show metrological performances which are only partially in accordance with medical requirements: commonly the allowable errors of clinical thermometers must be within a band of 0.10 C in the patient range 3739 C, whereas in the patient ranges 3637 and 3941 C the allowable errors must be within the band of 0.20 C.

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Figure 5. The deviation (error) of the infrared tympanic thermometer A.

Figure 6. The deviation (error) of the infrared tympanic thermometer B.

The main experimental results referred to each tested tympanic thermometer are reported in the following.

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Figure 7. The deviation (error) of the infrared tympanic thermometer C.

4.1. Infrared tympanic thermometer A (i) Accuracy. At Tamb = 19 C all the ITT readings are outside the allowable limits. The smallest deviation (0.29 C) occurs when Ttarget = 34.09 C, while the greatest one (0.45 C) occurs when Ttarget = 39.59 C. At Tamb = 24 C the measurements are satisfactory within the limits only when the target temperature is below 36 C, while in the range 3642 C the results are outside the allowable limits. The smallest and the greatest deviation occur respectively when Ttarget = 34.06 C (0.16 C) and when Ttarget = 39.59 C (0.39 C). At Tamb = 29 C the ITT readings are well within the above-mentioned limits only when Ttarget < 38 C; in the patient temperature range 3841 C most of the results are in the band 0.3 C. The smallest deviation (0.04 C) occurs when Ttarget = 34.24 C while the greatest one (0.32 C) occurs when Ttarget = 41.59 C. (ii) Repeatability. This type of ITT shows a very good repeatability (i.e., the readings of the tympanic thermometer are very close to each other) for each value of the ambient temperature; the widest spread in a series of ten consecutive measurements is 0.1 C. 4.2. Infrared tympanic thermometer B (i) Accuracy. At Tamb = 19 C, the thermometer shows sufcient accuracy: the only readings just outside the allowable limits occur in the range 3739 C (see gure 5). The smallest (0.05 C) and the greatest (0.14 C) experimental deviation occur respectively when Ttarget = 39.55 C and when Ttarget = 37.09 C. At Tamb = 24 C in the patient temperature range 3739 C (highly important from a medical point of view) the readings are outside the limits. The smallest deviation (0.06) occurs when Ttarget = 34.06 C, while the greatest deviation (0.24 C) occurs when Ttarget = 41.04 C. At Tamb = 29 C in the temperature range 3741 C the readings are outside the allowable limits; the greatest

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deviation (0.26 C) occurs when Ttarget = 41.11 C, while the smallest one (0.04 C) occurs when Ttarget = 34.24 C. (ii) Repeatability. This type of ITT shows a very good repeatability for the three set ambient temperatures; the widest spread in a series of ten consecutive measurements is 0.1 C. 4.3. Infrared tympanic thermometer C (i) Accuracy. At Tamb = 19 C the thermometer readings are within the aforesaid limits only below 37 C. In the patient temperature range 3742 C the results are outside the requirements. The smallest experimental deviation (+0.09 C) occurs when Ttarget = 35.61 C, while the greatest deviation (+0.43 C) occurs when Ttarget = 41.53 C. At Tamb = 24 C, in the most important range from a clinical point of view (3741 C), the results are outside the allowable limits. The smallest (+0.10 C) and the greatest (+0.27 C) deviations occur respectively when Ttarget = 36.60 C and when Ttarget = 41.53 C. At Tamb = 29 C the ITT shows a satisfactory accuracy: the experimental data in the patient temperature range 3640 C are within the limits. The smallest experimental deviation (+0.05 C) occurs when Ttarget = 37.08 C; the greatest deviation (+0.21 C) occurs when Ttarget = 41.59 C. (ii) Repeatability. The thermometer shows a mediocre repeatability for the three set ambient temperatures; the widest spread in a series of ten consecutive readings is 0.3 C. 5. Summary and conclusions The ITT using a thermopile as thermal sensor (thermometer A) shows a trend to give underestimated readings in the whole temperature range investigated (i.e., the temperatures indicated by the thermometer are lower than the ones indicated by the reference thermometer). The analysis of gure 4 shows a signicant effect of ambient temperature on the ITT readings; the higher the ambient temperature, the smaller the experimental deviation. The experimental data are practically unaffected by the variation of the relative distance between the probe tip window and the target. As claimed by the manufacturer, the thermometer is able to take a measurement in both the stated patient and ambient temperature ranges. Such a kind of thermometer seems to be more suitable in applications where a good repeatability is required (i.e., in anaesthesia, in postcardiac surgey, for hypothermic patients, etc), rather than in applications where high accuracy is necessary. The ITT called thermometer B also shows a trend to give underestimated readings in the whole temperature range investigated. The accuracy of this type of ITT seems to be affected by the variations in ambient temperature: the higher Tamb , the greater the experimental deviation. The performance of the ITT is practically unaffected by the variation of the relative distance between the probe tip window and the target. It should be noted that the ITT does not measure temperatures lower than 34.0 C higher than 41.1 C. Moreover the thermometer is unable to take a reading if the ambient temperature is outside the range 1540 C, according to the manufacturers specications. In summary, thermometer B shows the best accuracy performance, since its readings at Tamb = 19 C are within the band 0.15 C (see gure 8). For this reason such a thermometer seems to be useful for fever prediction, in both adults and children. The ITT called C shows a trend to give overestimated readings in the whole temperature range investigated (i.e., the temperatures indicated by the thermometer are higher than

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Figure 8. A comparison of the performance of the three tested thermometers, at the most common ambient temperature (Tamb = 19 C).

the ones indicated by the reference thermometer). The accuracy of the thermometer is signicantly affected by the ambient temperature; the higher the ambient temperature, the lower the experimental deviation. The performance of the ITT is practically unaffected by the variation of the relative distance between the probe tip window and the target. It should be noted that the ITT does not measure temperatures lower than 34.0 C or higher than 42 C, as claimed by the manufacturer. Moreover the thermometer is unable to take a reading if the ambient temperature is outside the range 1136 C according to the stated technical specications. In conclusion, thermometer C shows the worst metrological performances (see gure 8), but, on the other hand, it is the cheapest among the tested ITTs.

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