Infrared Thermometry

Ambient Temperature Target Temperature Accuracy:

• 16°C to 33°C  ± 0.3°C  
• 33°C to 42°C ± 0.3°C
• (60.8°F to 91.4°F)  (± 0.5°F)
• (91.4°F to 107.6°F) (± 0.5°F)

Ambient Temperature Target Temperature Accuracy:

• 16°C to 33°C ± 0.3°C
• 33°C to 42°C ± 0.3°C
• (60.8°F to 91.4°F) (± 0.5°F)
• (91.4°F to 107.6°F) (± 0.5°F)

*Post recalibration accuracy using the Genius Checker/Calibrator may not necessarily be equivalent to factory calibration.

Temperature Range depends on Site Mode as follows:

• Ear
  • 33.0°C to 42.0°C
  • (91.4°F to 107.6°F)
• Oral
  • 33.0°C to 41.9°C
  • (91.4°F to 107.4°F)
• Rectal
  • 33.6°C to 42.0°C
  • (92.4°F to 107.6°F)

• 0.1°C
• 0.1°F

• Operating atmospheric pressure range from 70kPA to 106kPA

• Type BF

• Thermometer w/ batteries 160 grams
• Base — 100 grams

• -25°C to 55°C
• (-13°F to 131°F)
• up to 95% RH non-condensing

If the unit is stored at extreme temperature, it is recommended that the unit be checked on the field calibration checker or at the factory before returning to service

Clinical repeatability in compliance to ISO 80601-2-56 is as follow:

The following equivalence modes are available on the Genius 3 Tympanic Thermometer and Base. Data is available from Cardinal Health 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”

• Drip Proof – IP22

The Genius 3 Tympanic Thermometer and Base meets:

• ISO 80601-2-56:2017
• IEC 60601-1:2005/AMD1:2012
• IEC 60601-1-2:2014.

The device meets ISO 80601-2-56:2017 subject to the following conditions:

1. The software was modified during testing to increase the precision of the measurements taken from one significant digit to two significant digits.
2. The increased precision numbers were then averaged to account for the known variance in measurements taken due to human factors.