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Accuracy Study for the Welch Allyn
®
Model 692/690 SureTemp
®
Plus
Oral, Adult Axillary, and Rectal Thermometer
Clinical accuracy studies were performed using the
SureTemp
®
Plus in the oral, adult axillary (18 years and
older), and rectal modes. Over 220 temperature
measurements were obtained from over 8 clinical sites. Thirty
percent of all data represent fevers. Temperatures ranged
from 93.7° F (34.27° C) to 105.0° F (40.55° C). Subjects
ranged in age from 7 months to 87 years. Accuracy results
for each site (oral, adult axillary, and rectal) are listed below.
For the combined data, the average error is -0.05° F (-0.027°
C) with a Standard Deviation of 0.355° F (0.197° C) (
Table 1).
Monitor Mode Temperature: Monitor mode is a
function of an electronic thermometer used to monitor a
temperature reading until it reaches the thermal steady
state. The thermal steady state for oral and rectal
temperatures is reached in approximately three minutes.
The thermal steady state for axillary temperatures is
reached in approximately five minutes.
Predicted Temperatures: Predicted temperatures are
from any thermometer that renders a temperature reading
before the steady state is achieved. Predictive
thermometers reduce the time required for measurement
by predicting what the temperature would be if the probe
were left in the site until steady state is reached.
Fever: For the purposes of this study, fever is defined as
any temperature equal to or greater than 100.0° F (37.77° C).
Data set: A data set is defined as a predicted
temperature followed by a three-minute (oral and rectal) or
a five-minute (axillary) monitor mode reference
temperature.
Normal body temperature in a healthy person is a
range that fluctuates throughout the day. Body
temperature can vary as much as 1° F to 2° F (0.5° C to 1.0°
C) over a twenty-four hour period. Body temperature is
lowest in the morning
(2-4 am) while resting and warmest in the afternoon
(4-6 pm) while active. Body temperature is regulated by
the hypothalamus, which continually adjusts
temperature to stay within a set range of normal in the
absence of illness (
Table 2). Fever is defined as a
temperature above an individual's range of normal.
Fever has always been recognized as an indication
of illness. Today, in every clinical setting, the primary
purpose for taking a patient's temperature is to screen
for fever and to follow its course. Timely, accurate
temperature measurement has always been an
essential part of patient assessment.
Thermometer technology has changed over recent
years. Temperature taking is FAST and clinicians must
rely on a thermometer’s accuracy to make important
and informed decisions for patient care.
The purpose of this clinical paper is to summarize
the studies performed to demonstrate the accuracy of
the Welch Allyn
®
SureTemp Plus thermometer in the
oral, adult axillary, and rectal predictive modes.
Six critical care nurses, trained on the use of the
SureTemp Plus, collected the data. All thermometers
and probes were tested for accuracy before and after
the study in a stirred water bath at three different
temperatures as per ASTM testing standards.
Over 220 data sets were collected, with 30% of all
data defined as febrile. For each subject, an initial oral,
adult axillary, or rectal temperature was taken in the
predict mode. Once the temperature was recorded, the
probe was left in place and the thermometer was
switched to the monitor mode for three minutes (oral
and rectal) or five minutes (adult axillary) to establish a
reference temperature. A direct comparison was then
made between each predicted temperature and the
corresponding reference temperature for each data set.
Data were analyzed by comparing each subject's
predicted temperature to the corresponding three or
five-minute monitor mode reference temperature.
Data Analysis:
Materials and Methods:
Overview:
Definitions:
Summary:
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