Section Iv Instructions For Use; Peak Select System; Equivalence Modes; Probe Covers - Covidien Genius 3 Manual De Instrucciones

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Section IV — Instructions for Use

Peak Select System

The Genius 3 Tympanic Thermometer and Base uses the patented Peak Select System. It takes multiple readings and selects the
highest temperature for display.

Equivalence Modes

Genius 3 Tympanic Thermometer and Base is an ear canal thermometer for infants, children, and adults.
Prior to the introduction of tympanic thermometry, patient temperatures were measured in the mouth (oral), or in the rectum
(rectal). If a patient's temperature was measured at the same time with each of these methods, different temperatures would
result. The Genius 3 Tympanic Thermometer and Base accounts for the average difference at each of these sites by adjusting the
displayed temperature.
The following equivalence modes are available on the Genius 3 Tympanic Thermometer and Base. Data is available from
Covidien on request.
Ear: In ear (EAR) mode, the display will indicate the absolute temperature without adjustment. The EAR mode is also the
UNADJUSTED MODE or DIRECT MODE of temperature acquisition.
Oral: In oral (ORL) mode, the ear temperature is adjusted to display the oral temperature equivalent.
Oral Mode = Ear Mode -0.09 °C
Clinical Bias = 0.09 °C
Limits of Agreement = (+/-) 0.64 °C
Clinical Repeatability = 0.13 °C
Reference Body Site = Oral Cavity
Measuring Body Site = EAR
Rectal: In rectal (REC) mode, the ear temperature is adjusted to display the rectal temperature equivalent.
Rectal Mode = Ear Mode +0.56 °C
Clinical Bias: = 0.5 °C
Limits of Agreement: = -0.47 / +1.66 °C
Clinical Repeatability: = 0.231 °C
Reference Body Site: = Rectum
Measuring Body Site: = EAR

Probe Covers

The Genius 3 Tympanic Thermometer and Base uses single use probe covers. The use of non-Covidien probe covers will cause
incorrect readings.
The probe covers are held in a cassette stored in the thermometer base. To load a probe cover on the thermometer, firmly push
the probe tip into the probe cover. When installed on the thermometer, the probe cover film should be smooth with no holes,
tears, or wrinkles. After the reading has been taken, eject the probe cover by pressing the eject button. Probe covers should
be disposed of properly after use. In order to help prevent and control infection, always use a new probe cover before taking
a reading.
Tympanic Thermometer and Base
4
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