The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to ISO 80601-2-56:2017 + A1 2018.
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Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Clinical Bias
Timeframe: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Clinical Bias
Timeframe: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Clinical Bias
Timeframe: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Clinical Bias
Timeframe: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Clinical Bias
Timeframe: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Clinical Bias
Timeframe: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Clinical Bias
Timeframe: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Limits of Agreement
Timeframe: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Limits of Agreement
Timeframe: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Limits of Agreement
Timeframe: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Limits of Agreement
Timeframe: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Limits of Agreement
Timeframe: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Limits of Agreement
Timeframe: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Limits of Agreement
Timeframe: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm - Clinical Repeatability
Timeframe: 20-30 minutes