3
Infrared Tympanic Electronic Thermometer
The Infrared Tympanic Electronic Thermometer is a reliable and accurate temperature-taking device. The reason
for the accuracy of the Infrared Tympanic Electronic Thermometer is the design, controlled calibration methods
and stringent manufacturing controls. One of the most critical functional parts of a thermometer is the probe
cover. The Infrared Tympanic Electronic Thermometer probe cover, when placed on a Infrared Tympanic Electronic
Thermometer, serves as an infection control barrier between the patient and the device and the medium for
heat transmission from the patient to the thermometer. The functionality of the Infrared Tympanic Electronic
Thermometer probe cover is extremely important for preventing device contamination and also for allowing
accurate patient temperature measurements.
The reason the Infrared Tympanic Electronic Thermometer and probe covers have satisfied our customers’
expectations is due to the integration of these two parts during the manufacturing process. The Infrared Tympanic
Electronic Thermometer probe cover molding process parameters are tightly controlled to minimize variation and
produce consistent and reliable products. The special grades of thermoplastic materials are also tightly controlled
and are specifically chosen to deliver consistent temperature measurements with Infrared Tympanic Electronic
Thermometers. The factory calibration and final determination of an acceptable Infrared Tympanic Electronic
Thermometer is dependent on the use of acceptable probe covers. The use of generic probe covers or other probe
covers not produced by PSS World Medical, Inc. is not supported or sanctioned. The use of unauthorized Infrared
Tympanic Electronic Thermometer probe covers could jeopardize the accuracy of the Infrared Tympanic Electronic
Thermometer. Check your probe cover carton for the Lumeon
TM
logo to be certain that your thermometer will
deliver an accurate temperature every time it is utilized.
Section V — Instructions for Use
Peak Select System
™
The Infrared Tympanic Electronic Thermometer uses the patented Peak Select System. This system is different
than what is found in other similar thermometers in that it reduces technique errors by taking multiple readings
and automatically selects the most accurate temperature for display. Whereas other systems only use 32 readings,
the Peak Select System uses 100 readings for the Infrared Tympanic Electronic Thermometer.
Equivalence Modes
The Infrared Tympanic Electronic Thermometer is an ear canal thermometer for neonates**, newborns,
children, and adults.
Prior to the introduction of tympanic thermometry, patient temperatures were measured in the mouth (oral), in the
rectum (rectal), under the arm (axillary), or in special cases with an indwelling Swan-Ganz™* catheter (core). If a
patient’s temperature was measured simultaneously with each of these methods, different absolute temperatures
would be obtained. The Infrared Tympanic Electronic Thermometer compensates for the average difference in
temperature at each of these sites by adjusting the displayed temperature.
A field calibration checker is available for this device. The device should be checked if it is dropped or if it is stored
at less than -25°C or above 55°C.
“ASTM laboratory accuracy requirements in the display range of 37 to 39°C (98 to 102°F) for Infrared
thermometers is ± 0.2°C (± 0.4°F), whereas for mercury-in-glass and electronic thermometers, the requirement
per ASTM Standards E 667-86 and E 1112-86 is ± 0.1°C (± 0.2°F).”
The following equivalence modes are available on the Infrared Tympanic Electronic Infrared Tympanic
Electronic Thermometer. Data is available from Kendall on request.