1. The device should not be solely or primarily relied upon to confirm an elevated skin temperature, or diagnose or exclude a diagnosis of COVID-19, or any other disease;
2. Skin temperature in the context of use should be confirmed with secondary evaluation methods (e.g., an NCIT or clinical grade contact thermometer);
3. The device should be used as the first line of screening and any abnormalities above the normal temperature readings should be tested by a secondary device to confirm an accurate temperature reading;
4. Public health officials, should determine the significance of any reading based on the skin telethermographic temperature measurement;
5. The technology should be used to measure only one subject's temperature at a time;
6. Visible thermal patterns are only intended for locating the points from which to extract the thermal measurement.
7. Preparing the area correctly for accurate use:
- Room temperature should be 68-76 °F (20-24 °C) and relative humidity 10-50 percent.
- Avoid reflective backgrounds (for example, glass, mirrors, metallic surfaces) to minimize reflected infrared radiation.
- Use in a room with no draft (movement of air), out of direct sunlight and away from radiant heat (for example, portable heaters, electrical sources).
- Avoid strong lighting (for example, incandescent, halogen and quartz tungsten halogen light bulbs).
8. These systems work effectively only when all the following are true:
- These systems measure surface skin temperature, which is usually lower than a temperature measured orally. Thermal imaging systems must be adjusted properly to correct for this difference in measurements.
- The systems are used in the right environment or location.
- The systems are set up and operated correctly.
- The person being assessed is prepared according to instructions.
- The person handling the thermal imaging system is properly trained.
(Reference - U.S Food and Drug Administration Guidelines)