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Statistical Results of Clinical Investigation Data
A.6.4.2 Specifications of the Genius™ 3 Tethered Tympanic Thermometer
A.6.4.3 Specifications of the Exergen TemporalScanner™ Thermometer
A.6.4.4 Specifications of the HeTaiDa Infrared Thermometer
Resolution 0.1 °C
Minimum measurement
time for accurate readings
Monitor mode: <60 s
Predictive mode: <20 s (typical test:< 12 s)
Alarm limit Range Step
Temp High (low limit +1) °C to 44 °C 0.1 °C
Temp Low 25 °C to (high limit -1) °C
Clinical BIAS (Δcb)
Limits of Agreement
(LA)
Clinical
Repeatability (σr)
Oral 0.02 0.33 0.1
Axilla 0.06 0.38 0.13
Rectum -0.05 0.48 0.14
Operating mode Adjusted mode
Measurement range 33.0 °C to 42.0 °C (91.4 °F to 107.6 °F)
Accuracy ±0.3 °C
Measurement range 16.0°C to 43.0 °C
Measurement accuracy ± 0.2 °C
Resolution 0.1 °C
Battery Specifications
Type Alkaline battery
Voltage 9V
Run time Approximately one hour continuous use or 15000 readings
Measurement range 34.0°C to 42.9 °C
Measurement accuracy 34.0°C to 34.9°C: ±0.3°C
35.0°C to 42.0°C: ±0.2°C
42.1°C to 42.9°C: ±0.3°C
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