We are no longer taking orders for FevIR Scan 2 systems in the USA
ALERT: Click here to download the operation manual and quick start guide that contain updated regulatory status of the FeviR Scan 2 telethermography system.
The documents have been clarified in accordance with the FDA’s 'Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency' which is available for download from the FDA’s official website.
The FDA’s 'Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency' no longer applies after November 7, 2023.
Thermoteknix is contacting all US customers of FevIR Scan 2 asking them to download the updated documentation using the link above.
Important Limitations and Disclaimers
- FevIR Scan 2 skin temperature measurement system lacks FDA clearance, approval or authorization.
- 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.
- 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).
- 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.
- The technology should only be used to view and measure the temperature of one person at a time directly facing the camera.
- Visible thermal patterns are only intended for locating the points from which to extract the thermal measurement.
- 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.
- 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.
- 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, otic, temple temperature.
- The system should be set up in accordance with the directions provided in this Manual with particular regard to environmental factors such as screening background, ambient temperature and humidity, and airflow and camera and blackbody temperature reference location within the field of view.
- 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.
- 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.
- 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.