Thermoteknix FevIR Scan2

Skin temperature screening and face mask detection technology

The miniature, discreet and ultra-portable FevIR Scan 2 skin temperature measurement system provides high-speed accurate skin temperature measurement.

FevIR Scan 2 skin temperature measurement system is an adjunctive screening system which is used for triage, serving in many countries around the world.

FevIR Scan 2 skin temperature measurement system is easily installed, operated and relocated with a minimum of setup time and following practical operator training.

The system is password-protected to prevent unauthorised changes while the flexible configuration software allows the user to select Thermal and Visible imaging on Operator and Viewer independent displays with Side-by-Side, or Picture-in-Picture formats.

Audible, visible and electronic alerts can be set based on absence of face masks as well as temperature thresholds.

FevIR Scan 2 skin temperature measurement system should be operated in controlled environmental conditions and are not intended, nor designed, to diagnose or detect medical conditions including, but not limited to viruses or other illnesses.

While thermal imaging is not an effective diagnostic device for COVID-19, when used properly it can determine if someone has an elevated temperature, which can be an important risk management tool during a pandemic.

Important Limitations and Disclaimers

Human skin temperature is affected by a wide number of environmental and physiological factors. An elevated facial skin temperature may signify a raised body core temperature; correspondingly, an elevated core temperature may not be accompanied by a raised facial skin temperature.

FevIR Scan 2 skin temperature measurement systems are accurate scientific systems that must be operated strictly in accordance with the manufacturer’s User Guide.

FevIR Scan 2 skin temperature measurement systems are not intended, nor designed, to diagnose or detect medical conditions including, but not limited to, viruses or other illnesses.

Absence of an elevated skin temperature does not exclude a fever.

1. FevIR Scan 2 skin temperature measurement system is not FDA-cleared or approved and its usage should be wholly in accordance with the enforcement policy for telethermographic systems.
   Skin temperature measurement from the FevIR Scan
2. Skin temperature measurement system should not be solely or primarily relied upon to diagnose or exclude a diagnosis of COVID-19, or any other disease.
3. Elevated body temperature in the context of use should be confirmed with secondary evaluation methods (e.g. a non-contact infrared thermometer (NCIT) or clinical grade contact thermometer).
4. Public health officials, through their experience with the device in the particular environment of use, should determine the significance of any fever or elevated temperature based on the skin telethermographic temperature measurement.
5. The technology should only be used to view and measure the temperature of one person at a time directly facing the camera.
6. Visible thermal patterns are only intended for locating the points from which to extract the thermal measurement.
7. For use instructions, device performance specifications and the methodology, and frequency of any calibration needed to maintain the labelled specifications please refer to the documentation and labelling supplied with the system.
8. The equipment should be used with the Blackbody reference source supplied with the system. This is used to compensate for thermal drift and is vital to obtain an accurate temperature measurement.
9. Automatic face detection software will identify the region of interest for temperature measurement (typically the inner canthus (inner angle of the eye socket)). Software compensation is available to correlate with oral temperature.
10. The system should be set up in accordance with the directions provided in the system User Guide with particular regard to environmental factors such as screening background, ambient temperature and humidity, airflow, camera and temperature reference location within the field of view.
11. It is important that subjects are provided with sufficient time to equilibrate to the environment where scanning is performed, particularly following entry from external extremes of environmental temperature.
12. FevIR Scan 2 skin temperature measurement system must be operated in accordance with ISO/TR 13154: 2017: Medical electrical equipment — Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph.