MOBOTIX thermal solution complies with the strict specifications of the U.S. Food and Drug Administration (FDA)

Langmeil, February 2021 - MOBOTIX AG has developed the M16 EST Thermal Camera as a special thermal solution for the for zero-contact detection of temperature fluctuations of the body surface (EST: Elevated Surface Temperature). The M16 EST thermal camera complies with the specifications of the U.S. Food and Drug Administration (FDA), which enables and enforces its use and distribution in the United States.

 

The thermal solution precisely satisfies the requirements of the COVID-19 Emergency Use Authorization (EUA) by the FDA's enforcement policy for tele-thermographic systems. This means that the MOBOTIX M16 EST solution can be utilized by following FDA regulations for determining body temperature within the duration of the public health emergency that was declared by the Secretary of Health and Human Services (HHS).  Examples of suitable locations for this solution include, but are not limited to: healthcare facilities, schools, government institutions and retail environments.

 

Proof of quality and appeal to other markets

Meeting FDA requirements under the emergency order is an essential step for MOBOTIX sales in the growing US market. However, utilization of the MOBOTIX M16 EST solution within the healthcare sector in countries outside the US may require further product releases and approvals to satisfy the specific needs of various national laws.  Regardless, with all FDA specifications met, the highly-esteemed German manufacturing quality within this professional thermal solution will undoubtedly extend into other countries and markets.

 

A special solution to contain the COVID-19 pandemic

The measurement system, which complies with FDA specifications, consists of two components, the MOBOTIX M16 EST thermal camera, and a black body radiator. The black body radiator is used to create an area with a reference temperature for the MOBOTIX M16 EST thermal camera. Non-contact temperature detection is used primarily by healthcare professionals to screen and potentially identify (COVID-19) infected people. The thermal camera solution can be used in healthcare facilities or non-medical areas, such as airports or building access gates.

Recording body temperature with the MOBOTIX M16 EST thermal camera is an effective tool for risk detection. Of course, the MOBOTIX solution should not be used exclusively or primarily for diagnosing or ruling out COVID-19 as well as any other disease. Elevated body temperatures associated with the use of this solution should always be confirmed with secondary evaluation methods such as non-contact infrared thermometer (NCIT) or clinical grade contact thermometer.

 

 

Defined structure and procedure

The MOBOTIX M16 EST thermal camera should only be used to record a single person's temperature at a time. The distance between the person and the camera must be the same as the distance between the person and the blackbody radiator. The MOBOTIX M16 EST thermal camera measures the difference between the reference temperature of the calibrated blackbody radiator and the temperature of the hottest point within the measuring range of the uncovered face of a person. Usually, this is the inner canthus (tear duct) of the eye.