FDA COVID System Recommendations

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FDA recommends that the device:

1. 1)  Is tested and labeled consistent with the following standard: IEC 80601-2-59:2017: Medical electrical equipment – Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening; OR
2.  Is tested using alternative performance specifications that provide similar results to IEC 80601-2-59:2017. This could include:  

a)  The laboratory temperature accuracy of a screening telethermographic system, including the measurement uncertainty, is less than or equal to ±0.5°C (±0.9°F) over the temperature range of at least 34-39°C (93.2-102.2°F); 10

b)  The system includes an accurate blackbody temperature reference source;

c)  Both stability and drift are less than 0.2°C (0.36°F) within a timeframe specified by the manufacturer

The Jogan Thermal Checkpoint meets and exceeds these system recommendations which address the inaccuracies that plague the majority of the systems flooding the market. Aside from measuring the interior canthi as called out by the IEC global standard, maintaining the temperature stability is critical to mitigate changes in the ambient temperature environment caused by air drafts from A/C, heat and doors opening and closing.

Choosing a system that meets the April 2020 COVID system recommendations as well as the global IEC 80601 and ISO standards is critical in providing a defensible position should legal or workers comp issues arise. 

Our patent pending temperature stabilized system is the only solution on the market that can meet section 2c of the FDA COVID System Recommendations specific to temperature stability and drift.