A - 15
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 (
Δ
cb)
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
Summary of Contents for VS 8A
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