| Calibrated Accuracy Limits |
Calibrated Accuracy Limits (after Recalibration*) |
Displayed Temperature Measurement Range |
| Ambient Temperature Target Temperature Accuracy: |
Ambient Temperature Target Temperature Accuracy: |
Temperature Range depends on Site Mode as follows: |
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Ear |
| 16°C to 33°C ± 0.3°C |
16°C to 33°C ± 0.3°C |
33.0°C to 42.0°C |
| 33°C to 42°C ± 0.3°C |
33°C to 42°C ± 0.3°C |
(91.4°F to 107.6°F) |
| (60.8°F to 91.4°F) (± 0.5°F) |
(60.8°F to 91.4°F) (± 0.5°F) |
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| (91.4°F to 107.6°F) (± 0.5°F) |
(91.4°F to 107.6°F) (± 0.5°F) |
Oral |
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33.0°C to 41.9°C |
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*Post recalibration accuracy using the Genius Checker/Calibrator may not necessarily be equivalent to factory calibration. |
(91.4°F to 107.4°F) |
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Rectal |
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33.6°C to 42.0°C |
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(92.4°F to 107.6°F) |
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| Ambient Temperature Range |
Temperature Resolution |
Ambient Air Pressure |
| 16°C to 33°C |
0.1°C |
Operating atmospheric pressure range from 70kPA to 106kPA |
| (60.8°F to 91.4°F) |
0.1°F |
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| 15% to 90% RH |
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| non condensing |
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| Degree of Protection Against Electrical Shock |
Weight |
Transport and Storage Temperature Range |
| Type BF |
Thermometer w/ batteries 160 grams |
-25°C to 55°C |
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Base — 100 grams |
(-13°F to 131°F) |
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up to 95% RH non-condensing |
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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 |
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| Clinical Repeatability |
Degree of Protection Against Ingress of Fluids |
Device and Safety Standards |
| Clinical repeatability in compliance with ISO 80601-2-56 is as follows: |
Drip Proof – IP22 |
The Genius 3 Tympanic Thermometer and Base meets: |
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| The following equivalence modes are available on the Genius 3 Tympanic Thermometer and Base. Data is available from Cardinal Health on request. |
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ISO 80601-2-56:2017 |
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IEC 60601-1:2005/AMD1:2012 |
| Ear: |
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IEC 60601-1-2:2014. |
| 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. |
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The device meets ISO 80601-2-56:2017 subject to the following conditions: |
| Oral: In oral (ORL) mode, the ear temperature is adjusted to display the oral temperature equivalent. |
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| Oral Mode = Ear Mode -0.09 °C |
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The software was modified during testing to increase the precision of the measurements taken from one significant digit to two significant digits. |
| Clinical Bias = 0.09 °C |
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The increased precision numbers were then averaged to account for the known variance in measurements taken due to human factors. |
| Limits of Agreement = (+/-) 0.64 °C |
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| Clinical Repeatability = 0.13 °C |
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| Reference Body Site = Oral Cavity |
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| Measuring Body Site = EAR |
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| Rectal: In rectal (REC) mode, the ear temperature is adjusted to display the rectal temperature equivalent. |
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| Rectal Mode = Ear Mode +0.56 °C |
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| Clinical Bias: = 0.5 °C |
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| Limits of Agreement: = -0.47 / +1.66 °C |
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| Clinical Repeatability: = 0.231 °C |
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| Reference Body Site: = Rectum |
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| Measuring Body Site: = EAR” |
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