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Thermal Imaging Cameras – FDA Recommendations

As discussed further below, scientific studies support that certain telethermographic systems, also known as thermal imaging systems, may be used to measure surface skin temperature. These systems include an infrared thermal camera and may have a temperature reference source. In this document, they are referred to as thermal imaging systems.

Thermal imaging systems and non-contact infrared thermometers (NCITs) use different forms of infrared technology to measure temperature. For information about NCITs, please refer to the fact sheet on Non-contact Infrared Thermometers.

Thermal Imaging Systems and COVID-19

  • When used correctly, thermal imaging systems generally have been shown to accurately measure someone’s surface skin temperature without being physically close to the person being evaluated. Thermal imaging systems offer certain benefits in that other methods need a closer proximity or contact to measure temperature (for example, non-contact infrared thermometers or oral thermometers).
  • Temperature-based screening, such as thermal imaging, is not effective at determining if someone definitively has COVID-19 because, among other things, a person with COVID-19 may not have a fever. A diagnostic test must be performed to determine if someone has COVID-19.
  • Thermal imaging systems have not been shown to be accurate when used to take the temperature of multiple people at the same time. The accuracy of these systems depends on careful set-up and operation, as well as proper preparation of the person being evaluated.
  • Thermal imaging systems have been used by several countries during epidemics, although information about their effectiveness as part of efforts to reduce the spread of disease has been mixed.
  • The FDA issued the Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency guidance to help expand the availability of thermal imaging systems and mitigate thermometer shortages during the public health emergency. The guidance sets forth an enforcement policy that is intended to apply to all thermal imaging systems that are intended for medical purposes for the duration of the public health emergency related to COVID-19, and provides recommendations regarding performance and labeling of such systems.
Figure one: A picture of an infrared thermal camera pointed at a woman standing by herself in a public space. The camera displays her thermal image on the camera screen. Her face is shown on the screen in a reddish orange color indicating her skin has a higher surface temperature than her clothing displayed as yellow and the distant background displayed as gray. The temperature displayed on the screen as 31.7o Celsius.

Figure 1 demonstrates the proper thermal imaging setup for processing of individual people in a public area.

Benefits of Thermal Imaging Systems

  • The person who handles the thermal imaging system is not required to be physically close to the person being evaluated. In fact, the person who handles the thermal imaging system could be in a different area or room.
  • The thermal imaging system may measure surface skin temperature faster than the typical forehead or oral (mouth) thermometer that requires a close distance or physical contact with the person being evaluated.
  • Scientific studies show that, when used correctly, thermal imaging systems generally measure surface skin temperature accurately.

Limitations of Thermal Imaging Systems

  • Although these systems may be in use for initial temperature assessment to triage individuals in high throughput areas (for example, airports, businesses and sporting events), the systems have not been shown to be effective when used to take the temperature of multiple people at the same time. They should not be used for “mass fever screening.”
  • 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.
  • These systems work effectively only when all the following are true:
    • 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.

Proper Use of Thermal Imaging Systems

The person who handles the system should follow all manufacturer instructions to make sure the system is set up properly and located where it can measure surface skin temperature accurately.

The person who handles the system should be trained to properly prepare both the location where the system will be used, and the person being evaluated, to increase accuracy. For details, see the standards and scientific papers listed under References below.

Preparing the Area where You will Use a Thermal Imaging System

  • Room temperature should be 68-76 °F (20-24 °C) and relative humidity 10-50 percent.
  • Try to control other items that could impact the temperature measurement:
    • 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).
An illustration of a person standing at a fixed distance directly facing an infrared thermal camera. Behind the person is a low reflective background and calibrated black body at the person’s head height. The camera is connected to a laptop.

Figure 2 demonstrates the proper thermal imaging room setup.

Preparing the Thermal Imaging System

  • Some systems require the use of a calibrated blackbody (a tool for checking the calibration of an infrared temperature sensor) during evaluation to make sure measurements are accurate. Check the manufacturer’s instructions to determine if a calibrated blackbody is needed. Some devices do not require one.
  • Turn on the entire system 30 minutes before use to warm it up.

Preparing the Person Being Evaluated

The person handling the system should make sure the person being evaluated:

  • Does not have any face obstructions before measurement (such as a mask, glasses, hat, headband, or scarf), the person’s hair is pulled away from the face, and the person’s face is clean and dry.
  • Does not have a higher or lower face temperature from wearing excessive clothing or head covers (for example, headbands, bandanas) or from using facial cleansing products (for example, cosmetic wipes).
  • Has waited at least 15 minutes in the measurement room or 30 minutes after exercising, strenuous physical activity, bathing, or using hot or cold compresses on the face.
Picture of the infrared thermal image of a man standing in front of a plain wall with a small square blackbody background on the wall. His face is shown in a dark red color indicating a higher skin surface temperature than his clothing that is shown in blue and yellow. The blackbody background is shown in very dark brown indicating minimized reflection of infrared radiation. A temperature range scale bar to the right of the picture shows a color range from dark brown through the color spectrum to dark blue.

Figure 3 demonstrates the proper thermal imaging setup for processing of individual people using a calibrated blackbody background.

Using the Thermal Imaging System

  • Measure only one person’s surface skin temperature at a time.
  • Position the person at a fixed distance (follow the manufacturer’s instructions for use) from the thermal imaging system, directly facing the camera.
  • The image area should include the person’s whole face and the calibrated blackbody, if using one.
  • If an increased temperature is seen using the thermal imaging system, you should use a different method to confirm a fever. Public health officials can help you determine if the fever is a sign of infection.

Questions about Using Thermal Imaging Systems during COVID-19

Q: Are thermal imaging systems effective for screening people for fevers in places like nursing homes, airports, and hospital emergency rooms?

A: When using a thermal imaging system, it is important to assess whether the system will provide the intended results in high throughput areas. We understand that these devices are being used for initial temperature assessment and triage of individuals for elevated temperatures in medical and non-medical environments. They should not be used for measuring temperatures of many people at the same time in crowded areas, in other words “mass fever screening” is not recommended.

Based on where the system will be used, there may be more appropriate methods to initially assess and triage people, especially if there is a risk that infected people would not be identified right away. For example:

  • In a nursing home, inaccurate temperature measurement or a missed contagious person without a fever could spread infection among nursing home residents. So, in this case, other assessment options and following infection control practices may be more effective.
  • In airports, workplaces, grocery stores, concert venues, or other areas where you are trying to screen large groups of people for mass fever screening, diagnostic testing may be too difficult because of the time and costs needed to screen and get results. These systems will likely miss most individuals with COVID-19 who are contagious. Thermal imaging systems could be considered as one method for initial temperature assessment in these types of settings when used as part of a larger approach to risk management.
  • In a hospital emergency room, a thermal imaging system may help to quickly assess temperature and triage patients to determine who needs more evaluation or isolation.

Q: Are thermal imaging systems effective as the sole means of diagnosing COVID-19?

A: No. A fever or higher body temperature is only one possible symptom of a COVID-19 infection. Thermal imaging systems generally detect a high body temperature accurately when used appropriately. They do not detect any other infection symptoms, and many people with COVID-19 can be contagious without a fever. Also, a high body temperature does not necessarily mean a person has a COVID-19 infection.

All fevers measured by thermal imaging systems should be confirmed by another method and followed by more diagnostic evaluations for other symptoms, as appropriate.

Q: How can thermal imaging systems help with the COVID-19 response?

A: To help address urgent public health concerns raised by shortages of temperature measurement products and expand the availability of telethermographic systems used for initial body temperature for triage use during this COVID-19 public health emergency, the FDA is applying regulatory flexibility for certain telethermographic systems as outlined in its enforcement policy.

When a high body temperature is identified by thermal imaging, an additional evaluation should follow (for example, doctor evaluations or interview, laboratory testing and patient observation).

Q: Are thermal imaging systems used for body temperature assessment considered medical devices?

A: As discussed in the enforcement policy, telethermographic systems are devices when they are intended for a medical purpose. To determine if these products are intended for a medical purpose, FDA will consider whether:

  1. They are labeled or otherwise intended for use by a health care professional;
  2. They are labeled or otherwise for use in a health care facility or environment; and
  3. They are labeled for an intended use that meets the definition of a device, for example, body temperature measurement for diagnostic purposes, including in non-medical environments.

Q: How does a thermal imaging system differ from a thermometer?

A: Both thermal imaging systems and non-contact infrared thermometers (NCIT) can measure surface temperatures without contact. An NCIT measures surface temperature in a single location, whereas a thermal imaging system can measure temperature differences across multiple locations, creating a relative temperature map of a region of the body. The enforcement policy in the guidance applies to use of thermal imaging systems to determine initial body temperature measurements.

There is a separate enforcement policy that applies to certain NCITs and other clinical electronic thermometers: Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.

References

Note, this information is applicable to thermal imaging systems that are intended for a medical purpose. This means that the system is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease and, therefore, meets the definition of “device” set forth in Section 201(h) of the Federal Food, Drug, and Cosmetic Act.

For more information on FDA’s policies for these devices, and recommendations on their design, labeling, and use during the COVID-19 Public Health Emergency, please review the following:

Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff

Additional information on these devices can be found at:

IEC 80601-2-59: Medical electrical equipment – Part 2-59: Particular requirements for basic safety and essential performance of screening thermoghraphs for human febrile temperature screening. 2017, International Electrotechnical Commission & International Organization for Standardization.

ISO/TR 13154: Medical electrical equipment — Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph. 2017, International Organization for Standardization.

Ghassemi, P., et al. (2018). “Best practices for standardized performance testing of infrared thermographs intended for fever screening.” PLoS ONE 13(9): e0203302External Link Disclaimer.

Comparing Temperature Sensor Devices

  • Industrial infrared temperature sensors are inexpensive and used everywhere in home and industrial. Your microwave for example.  They read surface temperature if aimed properly and clean and calibrated (all sensors require cleaning and calibration)
    • The Heimann sensor is the first we encountered. The HPTA32x32 (64 pixel) “thermopile array”.
    • Melexis makes several models (all TO-39)
    • Mitsubishi, Elo and many others make these.
    • They have been adapted for reading temperatures of foreheads basically and are at the low end of the accuracy scale.
    • None of these are FDA approved or submitted.
  • Thermal Imaging Cameras
    • These are a whole magnitude higher weight-class.  Several of them are specifically designed for supplemental elevated body temperature.  They do this by zooming and focusing on specific areas of the face like tearducts.  IR Arrays have limited spatial resolution and must average many regions and samples in order to provide a general value.
    • FLIR is the manufacturer most used.  They have several which certified by FDA and others submitted.
    • Another option is ICI though there are some questions on FDA 510 (we cannot locate them) as well as some components used.

 
Temperature Related More Reading

Temperature Kiosk Commentary

As government and corporate America develop post-COVID-19 action plans for responsibly reopening the country, some businesses are scrambling to keep up with the demand for thermal cameras, which many believe can help identify novel coronavirus cases via elevated temperature detection.

We see many RFPs from governmental agencies for temperature and thermal sensing devices.  Federal such FEMA and the Veterans Administration among them.

There are also several pitfalls and challenges with this technology when it comes to detecting somebody with an elevated body temperature. Things that can affect the accuracy of the measurement are:

  • Makeup
  • Physiological Stress
  • Sweating
  • Insufficient Camera Resolution
  • Measuring the wrong location on the face
  • Not using a reference black body for calibration
  • Using the wrong camera
  • Subject motion

Some observations:

  • The fact that the key measurement is temperature would seem to imply that the manufacturer has a superior device or at least a documented device. Does your supplier describe the sensor for you, or do they provide specifications?
  • Some solutions utilizing non-FDA-approved devices in the cause of health condition check have been withdrawn due to potential liability issues the device manufacturer might be subjected to.
  • Does the camera support a black body calibration?
  • Cameras have a NETD factor which is basically the noise floor it will factor and then read the signal. Almost like squelch discrimminators in RF radios. Being able to filter noise out from the measurement is crucial. What is the factor and spec?
  • ADA and height can be a factor — Some solutions provide AI which automatically detects the face and focuses. Others will not.
  • Reflected light impacts the measurement. In junior high I entered the Science Fair and for my project I demonstrated Albedo.  A black man or a hispanic or a white person can all measure differently.
  • Are you reading body temperature or facial temperature.

In conclusion, the most important questions to ask a potential supplier are:

  • What is the spatial resolution?
  • How long has your solution/camera been on the market?
  • Has your solution been used successfully during the SARS outbreak?
  • What is the ideal distance to subject during screening?
  • Does your camera have a 510k approval?
  • How many pixels?

Temperature Sensor Device Examples

  • Industrial infrared temperature sensors are inexpensive and used everywhere in home and industrial. Your microwave for example.  They read surface temperature if aimed properly and clean and calibrated (all sensors require cleaning and calibration)
    • The Heimann sensor is the first we encountered. The HPTA32x32 (64 pixel) “thermopile array”.
    • Melexis makes several models (all TO-39)
    • Mitsubishi, Elo and many others make these.
    • They have been adapted for reading temperatures of foreheads basically and are at the low end of the accuracy scale.
    • None of these are FDA approved or submitted.
  • Thermal Imaging Cameras
    • These are a whole magnitude higher weight-class.  Several of them are specifically designed for reading elevated body temperature.
    • FLIR is the manufacturer most used.  They have several which certified by FDA and others submitted.
    • Another option is ICI though there are some questions on FDA 510 (we cannot locate them) as well as some components used.

Temperature Screening Kiosk KMA Public Service Announcement

From KMA Global Jun2020

Temperature Kiosks Advisory and Caution – Public Service Announcement

By KMA Manager | June 29, 2020

As government and corporate America develop post-COVID-19 action plans for responsibly reopening the country, some businesses are scrambling to keep up with the demand for thermal cameras, which many believe can help identify novel coronavirus cases via elevated temperature detection.

We see many RFPs from governmental agencies for temperature and thermal sensing devices.  Federal such FEMA and the Veterans Administration among them.

There are also several pitfalls and challenges with this technology when it comes to detecting somebody with an elevated body temperature. Things that can affect the accuracy of the measurement are:

  • Makeup
  • Physiological Stress
  • Sweating
  • Insufficient Camera Resolution
  • Measuring the wrong location on the face
  • Not using a reference black body for calibration
  • Using the wrong camera
  • Subject motion

Some observations:

  • The fact that the key measurement is temperature would seem to imply that the manufacturer has a superior device or at least a documented device. Does your supplier describe the sensor for you, or do they provide specifications?
  • Some solutions utilizing non-FDA-approved devices in the cause of health condition check have been withdrawn due to potential liability issues the device manufacturer might be subjected to.
  • Does the camera support a black body calibration?
  • Cameras have a NETD factor which is basically the noise floor it will factor and then read the signal. Almost like squelch discrimminators in RF radios. Being able to filter noise out from the measurement is crucial. What is the factor and spec?
  • ADA and height can be a factor — Some solutions provide AI which automatically detects the face and focuses. Others will not.
  • Reflected light impacts the measurement. In junior high I entered the Science Fair and for my project I demonstrated Albedo.  A black man or a hispanic or a white person can all measure differently.
  • Are you reading body temperature or facial temperature.

In conclusion, the most important questions to ask a potential supplier are:

  • What is the spatial resolution?
  • How long has your solution/camera been on the market?
  • Has your solution been used successfully during the SARS outbreak?
  • What is the ideal distance to subject during screening?
  • Does your camera have a 510k approval?

Too often we see these days a rush to market by vendors all over the world all touting their thermal imagers without specifications.

It is worth noting that the FDA issued wide guidance when antibody test kits were being offered. Rather than test them they went the open market test route which resulted in many thousands of people being misdiagnosed and localities and countries (UK e.g.) spending millions of dollars and getting the wrong results.

Additional questions relating to FDA should be asked:

  1. Y or N — Is it tested and labeled 80601?
  2. Y or N – do you have test results of alternative performance criteria currently allowed by FDA
  3. Y or N – is there prominent labeling that this device cannot be used as sole measurement?
  4. Y or N – is there a clear indicator that the device is NOT approved by FDA?
  5. Y or N – is there a clear description of the main device along with its specifications and calibration procedures?

More Temperature Kiosk Resources

  • Non-contact Infrared Thermometers
  • Thermal Imaging Systems (Infrared Thermographic Systems / Thermal Imaging Cameras)
  • From FDA 2020 — Measuring a person’s temperature can be done in several ways. One method to measure a person’s surface temperature is with the use of non-contact infrared thermometers (NCITs). NCITs may be used to reduce cross-contamination risk and minimize the risk of spreading disease. While typically 98.6°F (37.0°C) is considered a “normal” temperature, some studies have shown that “normal” body temperature can be within a wide range, from 97°F (36.1°C) to 99°F (37.2°C). Before NCITs are used, it is important to understand the benefits, limitations, and proper use of these thermometers. Improper use of NCITs may lead to inaccurate measurements of temperature.
  • From FDA — The FDA issued the Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency guidance to help expand the availability of thermal imaging systems and mitigate thermometer shortages during the public health emergency. The guidance sets forth an enforcement policy that is intended to apply to all thermal imaging systems that are intended for medical purposes for the duration of the public health emergency related to COVID-19, and provides recommendations regarding performance and labeling of such systems.

This is the letter from the FDA in April 2020 on Enforcement Policy that companies might try and use.

FDA recommends that the device:

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);

b) The system includes an accurate blackbody temperature reference source; 10

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

d) The device risk assessment addresses all potential safety issues, including: i) Electrical safety; ii) Electromagnetic compatibility; iii) Mechanical safety; iv) Excessive temperatures and other hazards; v) Accuracy of controls, instruments, and information display; vi) Considerations for software associated with Programmable Electrical Medical Systems including network connections;11 and vii)Usability.

In addition, FDA recommends that the devices described above use labeling that helps users better understand the device, such as:

1) The labeling includes a prominent notice that the measurement should not be solely or primarily relied upon to diagnose or exclude a diagnosis of COVID-19, or any other disease;

2) The labeling includes a clear statement that: a) Elevated body temperature in the context of use should be confirmed with secondary evaluation methods (e.g., an NCIT or clinical grade contact thermometer);12

10 This is usually a blackbody (idealized physical body that absorbs all incident electromagnetic radiation) with known temperature and emissivity that can be used for thermal drift compensation.

11 For more information on this recommendation, see Clause 201.14 of IEC 80601-2-59: 2017. 12 This labeling recommendation is consistent with IEC 80601-2-59: 2017. Contains Nonbinding Recommendations 6 b) 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; c) The technology should be used to measure only one subject’s temperature at a time; and d) Visible thermal patterns are only intended for locating the points from which to extract the thermal measurement.

3) The labeling includes a clear description of:

a) Device performance specifications and the methodology and frequency of any calibration needed to maintain the labeled specifications;12

b) How to use the thermal image to make a temperature measurement to within the stated device accuracy;

c) A description and purpose of the blackbody reference source (used for thermal drift compensation) and its importance in obtaining an accurate temperature assessment;

d) The reference body site used for temperature estimation, including any calibration or correction needed to estimate the temperature at that location, and the accuracy of the measurement at the reference site (e.g., oral, tympanic membrane);

e) How different environmental and system setup factors can affect the measurement, including the body site chosen for measurement, the condition of the screening site (e.g., screening background, ambient temperature and humidity, airflow);13

f) Different factors to consider in the design of the facility protocol (e.g., installation, viewing angle, blackbody temperature reference source); 14

g) The installation procedures and qualification testing that should be performed during installation or when imaging equipment is being relocated;15 and

h) The appropriate imaging distance based on the spatial resolution and performance of the camera. 16

4) The labeling references and is consistent with the guidelines in ISO/TR 13154: 2017: Medical electrical equipment — Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph; and

5) The labeling highlights the differences in design, indications, or functions, as applicable, compared to the unmodified, FDA-cleared version of the product or includes a clear identification that the device is not FDA-cleared or approved. For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. 17

For more information regarding use of consensus standards in regulatory submissions, refer to FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”

If you would like to understand more about the models and options that are available KMA is happy to provide information on any and all advertised solutions. As always we recommend beginning with members of the KMA who understand and observe standard regulations such ADA, FDA, EMV, PCI, HIPAA and UL.


Proper Use of NCITs

The person using the device should strictly follow the manufacturer’s guidelines and instructions for use for the specific NCIT being used. The manufacturer’s instructions for use typically include the following information and recommendations for proper use:

Preparing the Environment and NCIT:

The use environment may impact the performance of the NCIT. Instructions will typically include recommendations for optimal use, such as the following:

  • Use in a draft-free space and out of direct sun or near radiant heat sources.
  • Determine if conditions are optimal for use. Typically, the environmental temperature should be between 60.8-104 ºF (16-40 ºC) and relative humidity below 85 percent.
  • Place the NCIT in the testing environment or room for 10-30 minutes prior to use to allow the NCIT to adjust to the environment.

Cleaning Between Uses:

For cleaning NCITs between uses, follow the instructions in the Cleaning and Disinfecting section of the product instructions. Most NCITs should never be immersed in water or other liquids.

Preparing the Person being Evaluated:

In preparation for taking a temperature measurement with an NCIT, the person using the NCIT should typically ensure that

  • The test area of the forehead is clean, dry and not blocked during measurement.
  • The person’s body temperature or temperature at the forehead test area has not been increased or decreased by wearing excessive clothing or head covers (for example headbands, bandanas), or by using facial cleansing products (for example cosmetic wipes).

Using the NCIT:

As previously noted, the person using the device should strictly follow the manufacturer’s guidelines and instructions for use for the specific NCIT being used. In particular, the following are typical instructions for NCIT usage.

  • Hold the NCIT sensing area perpendicular to the forehead and instruct the person to remain stationary during measurement(s). (See Figure 1)
  • The distance between the NCIT and forehead is specific to each NCIT. Consult the manufacturer’s instructions for correct measurement distances.
  • Do not touch the sensing area of the NCIT and keep the sensor clean and dry.

Figure 1: Correct Use – Forehead unobstructed, and NCIT perpendicular to forehead & used at distance identified in manufacturer’s instructions

Figure 1: Correct Use – Forehead unobstructed, and NCIT perpendicular to forehead and used at distance identified in manufacturer’s instructions.


Figure 2: Incorrect Use – Not perpendicular to forehead

Figure 2: Incorrect Use – Not perpendicular to forehead


Figure 3: Incorrect Use –Forehead exposed to direct sunlight outdoors

Figure 3: Incorrect Use – Forehead exposed to direct sunlight outdoors


References

Note, this information is applicable to NCITs which are intended for a medical purpose which means that the NCIT is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease and, therefore, meets the definition of “device” set forth in Section 201(h) of the Federal Food, Drug and Cosmetic Act.

Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers

U.S. National Library of Medicine: MedlinePlus. (2019 February). Body Temperature Norms. https://medlineplus.gov/ency/article/001982.htm

ASTM E1965-98(2016),Standard Specification for Infrared Thermometers for Intermittent Determination of Patient TemperatureExternal Link Disclaimer, ASTM International, West Conshohocken, PA, 2016, www.astm.org DOI: 10.1520/E1965-98R16

ISO 80601-2-56:2017(E) Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurementExternal Link Disclaimer. 2017, International Organization for Standardization.

Tech Brief – Limits of elevated body temperature screening

First published on Vision Systems Design Jun2020

Everything you need to know about using thermal imaging cameras for identifying potentially sick people.

Elevated body temperature screening

As government and corporate America develop post-COVID-19 action plans for responsibly reopening the country, some businesses are scrambling to keep up with the demand for thermal cameras, which many believe can help identify novel coronavirus cases via elevated temperature detection

During the SARS outbreak in 2002, the same demand occurred, albeit on a much smaller scale and mainly in Asia. As with most infectious diseases, people want to keep it from spreading.  Fever represents a common COVID-19 symptom.  Sometimes a person with a fever may not feel particularly sick and may still attempt to travel or come to work. Afraid of being booted off a plane or sent home, the motivation for self-reporting a potential illness quickly outweighs the consequences. Technology offers an attractive route for companies looking to screen for sick people. Companies feel severe economic pressure to reopen their businesses to survive, while other essential businesses fear that a company outbreak could bring them to a screeching halt, as has happened in the food and restaurant industries.

Several methods to check somebody’s temperature exist (Figure 1), but the larger the company, the less practical it becomes to have a medical professional use a handheld thermometer to screen everyone entering the building. This method is somewhat invasive and not conducive to social distancing guidelines, which is why non-contact thermal imaging has emerged as a popular alternative.

Thermal camera solutions pop up like mushrooms as demands soar. MoviTHERM has counted 52 new solutions just in the past eight weeks in the US. Many of these are brand new startups, while others simply rebrand mass produced existing, commercially available thermal cameras. Offerings range from cell phone attachments with low resolution thermal cameras to dual view thermal and visible cameras with built in artificial intelligence for tracking people in a crowd. Marketing literature and demonstration videos from such companies may impress the panic buyer looking for a way to keep their workforce safe. What used to take engineers weeks and months of research is now being decided in 24 to 48 hrs. Even Amazon bought 1,500 thermal cameras for $10 million from a US Government-blacklisted Chinese supplier.

How hard can it be? A thermal camera is a thermal camera! Or is it?

If that was the case, why do the prices of these cameras vary from $400 to $40,000?  It isn’t just the thermal camera that matters, it is how it is being applied to the application. Measuring elevated body temperature happens to be a rather complex application once you peel back the layers. After all, this does not involve simply measuring the temperature of a piece of steel but measuring the temperature of living beings under various conditions. Throwing a startup company together and hiring a few software developers to get an image out of a thermal camera is missing the point entirely. Thermal imaging uses some rather complex physics and involves optics, thermodynamic laws, emissivity, atmospheric variables, thermal drift compensation, infrared radiation, reflection, transmission, and in the case of this application, a slew of physiological effects of the human body.

Thermal cameras cannot detect a fever or diagnose any disease. A thermal camera can only measure the infrared radiation emitted from the first surface it encounters. When pointed at a face, this first surface happens to be the surface of the skin. However, when examining the thermal landscape of a human face, one will quickly notice the complexities. Additionally, such measurements vary tremendously from individual to individual.

Figure 2: The tear duct region of the face (inner canthus) offers the most accurate part of the face when it comes to optical temperature measurementFigure 2: The tear duct region of the face (inner canthus) offers the most accurate part of the face when it comes to optical temperature measurement

Accurate measurements

Scientific research shows that most of the facial skin temperature is not even that closely correlated to the body’s core temperature. The human body thermoregulates its core temperature using a complex biological closed-loop system. It either exerts excess heat, conserves it, or maintains equilibrium, and it does so as a survival mechanism. This regulation causes the skin temperature to vary based on environmental condition (passive heating or cooling due to exposure to the elements), physical exercise, or other biological processes.

Studies show that the inner canthus (tear duct region) represents the most accurate part of the face when it comes to optical temperature measurement (Figure 2). The inner canthus is only about 5 to 7 mm in size. Using a thermal camera, the inner canthus needs to be covered with enough pixels for an accurate measurement. The projected pixel size for the inner canthus area needs to be around 1.5 mm/pixel or better for best results.

Table 1: Common detector resolutions and the corresponding recommended image size for inspection.Table 1: Common detector resolutions and the corresponding recommended image size for inspection.

Camera resolution vs. image size

Unlike typical machine vision or surveillance cameras, thermal cameras have low pixel resolutions. The most common resolution for thermal cameras is 320 x 240 or 640 x 480 pixels. Using the 1.5 mm/pixel figure from above makes it possible to calculate the field of view size of the thermographic measurement setup for measuring elevated body temperature.

For a 320 x 240-pixel detector, the horizontal field of view is therefore 320 pixels / 1.5 mm per pixel = 480 mm [18.9in.]. Other common detector resolutions and the recommended image size for inspection can be seen in Table 1.

Figure 3: An accuracy test of a thermal camera with 464 x 348-pixel resolution and 24° optics are shown here, with e= 0.98 representing camera’s emissivity setting and atmos referring to atmospheric reflection. These parameters must be set in the camera for accurate measurements, as an object absorbs, reflects, and may transmit infrared radiation.Figure 3: An accuracy test of a thermal camera with 464 x 348-pixel resolution and 24° optics are shown here, with e= 0.98 representing camera’s emissivity setting and atmos referring to atmospheric reflection. These parameters must be set in the camera for accurate measurements, as an object absorbs, reflects, and may transmit infrared radiation.

Crowd scanning solutions

Based on the resolution criteria discussed above, crowd scanning solutions cannot produce the desired results. Artificial intelligence also does not help to bend physics and has no impact on human physiology. In addition to the pixel resolution problem, a second issue exists that impacts the accuracy of a crowd scanning camera – depth of field. In a crowd setting, individuals will be present at different distances to the camera. Not only does this change the projected pixel size, but it changes how well the pixels are in focus.

Figure 3 shows an accuracy test of a thermal camera with 464 x 348-pixel resolution with 24° optics. The test subject’s oral temperature was confirmed with a clinical grade thermometer prior to the test and determined to be 37°C [98.6°F]. Measurements were taken of both subjects starting from 0.5 m [1.64 ft] to 6 m [19.7 ft]. The maximum skin temperature (inner canthus) was recorded and graphed. This experiment shows a significant temperature drop with increase of distance. The camera used is a higher end thermal camera – the FLIR Model T540. Performing the same experiment with a lower grade and lower resolution camera will undoubtedly yield worse results.

Camera accuracy

Absolute accuracy represents an even bigger issue with these types of cameras. Such cameras are based on the same measurement principle and use a microbolometer type detector. These detectors do not capture photons, but directly measure infrared radiation. Each pixel comprises a small MEMS structure and represents a small temperature dependent resistor. The downside of these detectors is extreme temperature sensitivity. The slightest change in heat causes a bias in the measurement. The same thing happens with infrared optics made from Germanium or other exotic optics. These effects, along with noise equivalent temperature difference (NETD) create the error budget of these cameras. An achievable absolute accuracy specification is typically around +/- 2°C. Controlling the temperature drift to any tighter tolerances requires a sophisticated active heating and cooling system inside the camera, which would be cost prohibitive.

Some manufacturers claim their cameras can achieve an accuracy of +/- 0.5°C. The question people should consider is how the cameras measure accuracy. One way of achieving this would be to point the camera at a reference black body and rapidly take successive measurements before the camera drifts. Doing so would be cheating if the companies omit their method of determining accuracy, however.

Figure 4: A black body is an actively temperature-controlled device that provide a reference source for calibrating thermal cameras and other optical temperature sensors such as pyrometers.Figure 4: A black body is an actively temperature-controlled device that provide a reference source for calibrating thermal cameras and other optical temperature sensors such as pyrometers.

Black body method vs. relative difference

Two legitimate methods for measuring elevated body temperatures exist. One employs a calibrated reference source (or black body, Figure 4) and the other uses a baseline population to create an average for outlier detection. Using a black body allows the camera or software to calibrate out the long-term drift and correct the absolute temperature of the measurements to better than +/- 0.5°C. For this to occur properly, the black body must be visible in the field of view of the camera at the same working distance as the subject.

The other method does not require a black body and makes use of the repeatability of the thermal camera, although combining the two methods would be ideal. In the relative difference mode, 10 known healthy individuals present to the camera or screening system. Their maximum facial temperatures are taken to build an average baseline temperature. Now all subsequent subjects are measured and compared against that baseline reference. This creates an outlier detection. The baseline needs to be updated throughout the day to compensate for environment changes like temperature swings.

What is a black body?

A black body or calibrated reference source is an actively, temperature-controlled device. Black bodies typically provide a reference source for calibrating thermal cameras and other optical temperature sensors, such as pyrometers. These devices consist of an active surface with a special high emissivity coating, an internal temperature sensor and a closed loop (PID) temperature controller. Some black bodies have an adjustable temperature controller, simpler devices have a single, fixed temperature. For special high temperature applications, there are cavity style black bodies available. The name black body comes from physics – black body radiation. The name was given because the idealized version of a black body absorbs all radiation of all wavelengths. However, some practical limitations to this exist. A perfect black body would have an emissivity value of 1. However, most good black bodies only achieve an emissivity value of 0.98 or lower.

Planck’s law describes black-body radiation. The higher the radiated energy, the shorter the wavelength. This phenomenon can be seen when heating up a piece of metal. The heat cannot be seen until it reaches a certain energy level, then the piece of metal starts to faintly glow red. As the energy further increases, red becomes orange, orange becomes bright yellow. The wavelength shifts from the infrared region into the visible region and becomes perceptible by human vision (400 nm to 700 nm).

Rules and regulations

In the US, the Food and Drug Administration (FDA) deems this a medical application. As such, cameras need to have a 510k approval (bit.ly/VSD-510). Any customer or vendor using a camera without such an approval risks being subject to recalls and/or stringent corrective action measures, which is exactly what happened during the SARS outbreak. Although the FDA recently issued a non-binding and temporary guideline to ease their regulatory overview, the 510k ruling is still in place and may be enforced at any time. Besides the FDA, there is also a heightened risk of civil litigation for companies using a non-approved camera.

In conclusion, the most important questions to ask a potential supplier are:

  • How long has your solution/camera been on the market?
  • Has your solution been used successfully during the SARS outbreak?
  • What is the ideal distance to subject during screening?
  • Does your camera have a 510k approval and can you send it me?

More Information

Temperature Kiosk with Remote Services Frank Mayer & Associates, Inc.

Temperature Kiosk – KMA

Contactless kiosk – temperature screening kiosks – Pyramid

Temperature Check – 22MILES Thermal Sensing FAQ

NRF COVID Resources – Industry Partner Resource Headquarters

The Kiosk Manufacturer Association is pleased to announce our inclusion on the NRF COVID Industry Resource Partners Headquarters page.

From NRF : “The coronavirus pandemic is dramatically affecting businesses all over the world including the retail industry. To support retailers, NRF’s technology, research and consulting industry partners are providing free or discounted resources and guidance. This includes tools, strategic insights, products and services and more to help retailers navigate through the current environment.”

The below listing includes: webinars; research and consumer insights; free products and services; and discounted products and services.”

Temperature Check Kiosks – Olea

Temperature Kiosks Olea Kiosks –  Delivering

Temperature checks on employees and visitors is becoming commonplace for many businesses, hospitals, grocery stores, retailers and a host of others. Temperature sensing kiosks can help stem a crisis and optimize a return to business as employees and guests return to work and entertainment venues.

Olea Temperature Sensing Kiosk from Craig Keefner on Vimeo.

Reference page on Olea Kiosks Website

olea-temperature-kiosks from Kiosk Manufacturer Association on Vimeo.

Benefits of Temperature Check Kiosks

The Temperature Sensing Kiosk provides a number of benefits to allow businesses to protect their most valued assets–their employees.

  • Reduce risk of access by infected persons*
  • Maintain a safe work/business environment
  • More hygienic than thermometers that require physical contact
  • Safer and more efficient than using a human resource to screen temperatures
  • Reduce stress and anxiety for employees and guests.

Prevention is the Key

There are many activities happening simultaneously to ensure a safe work environment.  The Temperature Sensing Kiosk reduces the risk of infection to your employees and costly and time-consuming contamination clean-up efforts.  Give employees and visitors the confidence to know you’re doing all you can do to protect them.

How It Works

The Temperature Sensing Kiosk is equipped with an infrared temperature sensor/detector and the system provides an alert if an individual is running a fever. The system uses an algorithm for fast detection temperature accuracy.

Protect Your Investment

Your people are your most valuable investment. To help stem the crisis and optimize a return to business, hospitals, grocery stores, and retailers and a host of other companies will look to temperature screening as employees report to work and venues open up again. This first layer of screening can curb the spread of virus as well as prevent costly and time-consuming contamination clean-up. This solution is equipped with an infrared temperature sensor/detector and the system provides an alert if an individual is running a fever.

  • Stop infection at the door
  • Maintain a safe work/business environment
  • More hygienic than thermometers that require physical contact
  • Safer and more efficient than using a human resource to screen temperatures
  • Avoid costly contamination clean-up
  • Reduce stress and anxiety for employees and guests

Specifications:

  • Uses an algorithm for object heat and fast detection temperature accuracy • +/- 0.5 degrees Celsius
  • Android Operating System and Software included
  • 1 second refresh rate
  • Scans people from 20 to 39 inches from kiosk

Olea Kiosks. Redefining Self-Service Technology.

For more information email Olea Kiosks or send contact form.

 

More Information

Frank Olea – I believe that as we venture back out into public places we’re all going to want to see what has been put in place to make us feel safe. Something visual and useful like hand sanitizer in the right places is a good start. Standing next to a bank of kiosks or mounted directly to the kiosk means I can use this machine without fear because I can immediately clean my finger afterward. Sometimes it’s the simple solutions.

Additional Temp Check Kiosk Links

Frost & Sullivan Recognizes Olea Kiosks – Outdoor Kiosk Design

Olea Showing New Healthcare Offerings at HIMSS

Vista Cinema and Veezi Approve Olea for Self-Service Ticketing Kiosks

Temperature Kiosk with Remote Services Frank Mayer & Associates, Inc.

Temperature Kiosk Frank Mayer

With more businesses looking to implement proper safety precautions while respecting employees’ privacy, we’re excited to offer a remote #kiosk option for #temperaturescreening. Learn more about the program at the link below.

In partnership with Agile Force Inc. and TES America, LLC, we’re proud to introduce a full-service solution to the growing demand for remote temperature screening #kiosks. Read more about the contactless option designed to offer minimal disruption and promote privacy and safety. https://bit.ly/3cXFzxX
#temperaturemonitoring #temperaturekiosks #covid19

When temperature screening is no longer a necessity, companies can continue to utilize the station and technology to monitor shift changes, assist employees with human resources needs, distribute PPE, interview job candidates, and more. “Three years ago, we developed a solution to help solve remote engagement challenges with employees,” says Michael Walsh, CEO of Agile Force, Inc. “Little did we know, we had built the perfect social distancing tool for all employers.”

The kiosks combine best-in-class technology components, including TES America touch technology, to provide a commercial-grade solution with a long lifecycle for the business marketplace. TES America General Manager Gene Halsey says, “We are pleased to be involved in such an important project when employers are looking for answers during this unusually challenging time.”

Frank Mayer and Associates, Inc. President Mike Mayer added, “By combining our core competencies, Agile Force, TES America, and Frank Mayer and Associates are going to market with more than just a temperature screening kiosk. We’re solving the problem of health screening while also improving operational efficiencies for companies and enabling a safer, more engaged workforce.”

For more information about the temperature check kiosks and employee engagement centers, visit https://www.frankmayer.com/temperature-screening-kiosk/.

Introducing the full-service solution to a growing demand for remote temperature screening.

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Using remote engagement software and thermal imaging cameras on a contactless temperature screening kiosk, employee temperature checks can be easily monitored offsite with minimal disruption and an emphasis on privacy and safety.

Employee Engagement Technology

More than a temperature screening kiosk, remote technology and software empowers Human Resources departments and staffing agencies

  • Onsite Activities — Allow staff to monitor shift changes, greet new hires, conduct temperature checks, and connect employees with departments like HR, payroll, or telemedicine – all while saving the cost of staffing management on-site.
  • Remote Control
  • Hiring Features — Interview job candidates, collect universal digital applications, and onboard new talent at different site locations – from anywhere.
Remote onsite management outsourcing is completed remotely, providing important benefits:
  • eliminates personal contact
  • minimizes health risk to employees
  • conducted by non-healthcare professionals
  • maintains employee privacy.

For more information here is our press release
Agile Force – FMA press release-converted

You can request demo and more information here if you wish

For more information from Frank Mayer and Associates, Inc.

Frank Mayer and Associates, Inc.

Industry People – Reggie Medford joins Frank Mayer & Associates

Retail Marketing Psychology – Frank Mayer

Temperature Sensing Digital Signage Platform by Mimo Monitors

Stay Ahead of the Curve with Mimo Monitors’ Touch-Free Temperature-Taking Platform

The Temperature Sensing Digital Signage Platform by Mimo Monitors

Priced from $899. For configuration and pricing please contact us, call +1-855-937-6466, or email orders@mimomonitors.com

It’s more important than ever to stay ahead of the curve and ensure that your family, loved ones, and your business are safe. That’s why we’re pleased to introduce the groundbreaking Mimo Monitors touch-free temperature-taking platform with the revolutionary Revel Digital software, ensuring you have the most reliable and innovative technology at your disposal.

Including all the necessary components needed to protect businesses and communities, this enterprise-grade platform is reliable, customizable, and seamless to use. Designed specifically to be flexible, it contains an Award-Winning Mimo Monitors hardware display, Revel’s Digital’s CMS analytics and accurate temperature sensing software with a one-year license.

Available operating systems include Android and BrightSign, and bundle sizes from 7″ to 32″, the Mimo Monitors Temperature sensing platform was created with ultimate flexibility in mind. The software is built on top of digital signage software allowing for ultimate flexibility in messaging, instructions, and control, and, through its thorough analytics system, can be connected with existing databases to track personal temperatures daily and keep this on record. Remember – if identities and temperatures are tied to a person, you must secure their consent and follow all HIPAA regulations, etc.

The platform is also able to sync and work together for an all-encompassing picture. Ideal for entrances to grocery stores, assisted living facilities, office buildings, schools, or in taxis prior to riding, this kiosk uses advanced medical sensors to take a person’s temperature and ensure they are not putting others at risk. The kiosk must be located indoors and away from doors and HVAC systems for accurate results.

As a level-one device, the Mimo solution is ideal for pre-screening. For further evaluation, the solution should be used in combination with level-two, medical-grade devices and medical experts. It’s also important that, prior to escalating to a level-two device after an elevated reading, the person be allowed to acclimate to the area. FDA approval must also be secured in the event the device will be used for a medical purpose beyond simple pre-screening.
Seamless to set up and efficient to use, this groundbreaking, touch-free temperature platform can provide the peace of mind needed to ensure everyone’s safety.

Benefits:

  • Customizable, flexible, and comprehensive platform that can be utilized in a myriad of ways to fit the needs of every business. Examples include: providing a green or red light for someone to enter a building, with options to include syncing between locations, remote management and monitoring as well as a full analytics suite available.
  • Compact, durable, and reliable, for seamless install and intuitive use.
  • Integrates a state-of-the-art medical-grade temperature sensor. Runs on multiple hardware platforms including BrightSign and Android.
  • Available in wall mount, floor stand, standing kiosk, and in sizes 7-32” with varying complexity and customization of analytics to suit your needs.
  • Ideal for uses like grocery stores, assisted living facilities, office buildings, schools and more.
  • To simplify the temperature-taking process for those looking for a seamless and highly cost-effective solution, we also offer an entry level, non-CMS version that displays temperature and denotes a clear and easy-to-digest pass/fail temperature reading. This non-analytics solution ensures that everyone entering any public building is temperature-free and promoting safety
  • We also offer a touch-free, enterprise-grade kiosk bundle for manufacturers that includes a Mimo Monitors Android commercial display, BrightSign Built-in, or tablet, Revel’s Digital’s CMS analytics and accurate temperature sensing software with a one year license.

Analytics and Device Management

One key benefit with this system is the merging of signage with iOT devices, allowing for a safe working environment and keeping community members safe. temperature check analytics

Other benefits include:

  • Can notify you when the sensors are down
  • Collect and produce analytic reports
  • Scan ID badge and verify against employee database
  • Unlock doors to allow access
  • Send and email or text message
  • Provide real-time data
  • Provide a method of revenue generation / messaging
  • Networking multiple sites together
  • While sitting idle and not taking temperatures, the kiosk can display digital signage

Mimo Monitors’ new temperature-taking and touch-free platform, ideal for contactless entry, ensures everyone entering any building or public place is fever-free.

For more information on the platform hardware, please visit the detailed specifications for your size of interest

BrightSign Built-in

Android Tablets

Open Frame Displays

 

Request more information

Contactless kiosk – temperature screening kiosks – Pyramid

Temperature Screening Kiosks Pyramid

Full article CNBC May 2020 — Sarah Whitten @SARAHWHIT10

KEY POINTS
  • IntraEdge and Pyramid have created a contactless kiosk that can check the temperature of up to 1,500 people per hour.
  • The kiosk utilizes Pyramid’s thermal imaging technology and has an error margin of less than one-tenth of a degree Fahrenheit.
  • No data is stored on the kiosk itself. Using IntraEdge’s Truyo Privacy Rights Platform the data is immediately encrypted and transferred to Truyo’s cloud.
Janus, a temperature-reading kiosk from IntraEdge and Pyramid, can be installed freestanding, using a wall mount or on a countertop.

As states reopen to the public during the coronavirus pandemic, retailers, hotels, movie theaters and sports stadiums are all looking for ways to keep patrons and staff safe.

Many of these businesses have been closed since mid-March to help stop the spread of the virus, and they are eager to rehire staff and welcome back customers and the billions of dollars they bring. But these businesses want to do so safely to protect employees and encourage customers to return.

One common strategy is to implement temperature checks at the front door. While not perfect, temperature checks can weed out the most obvious of Covid-19 cases. Still, for venues that typically have large crowds, trying to do mass temperature checks can be an overwhelming undertaking. In these situations, the handheld temperature readers aren’t a perfect solution.

On Thursday, IntraEdge and Pyramid Computer said they are working with Intel on a possible solution that leverages existing screeing and privacy technology that the companies manfuacture.

Read Full article CNBC May 2020

You Can Request More Information

Tech Brief – Temperature Elevated & Body Temperature EBT

Tech Brief Thermal Imaging

The rush for temperature check and elevated body temperature is still going strong. Like any other technology though there are different solutions with different accuracy and different application extensions.  Instead of touch technology terms such as PCap or SAW we now talk in terms of thermopiles and thermal imaging cameras.  Pixels are still the determining factor ironically enough even between those two technologies. With touch technologies we have even entered new territory with “Touchless Touchscreens”. Reminds me of interactive digital signage.

Another great source of information on thermal sensing is FAQ by 22Miles. 22MILES Thermo Sensing FAQ-converted-compressed

Thermal Camera Imaging – Plain English

facial temperature check
Click for full size image

The advantage of thermal cameras — look at this purely from a physics and physiological point of view. Take the thermal image from a face below. The colors represent the temperature distribution across my face. Would you agree that the thermal landscape is rather complex? The spread of temperatures is quite dramatic.

If you now take a pyrometer with a single pixel and measure a 1 inch or 2 inch region of my face, you will measure the AVERAGE temperature of that region. Even if the accuracy of that device is +/- 1C it doesn’t matter. This has to do with optics. If we focus thermal radiation with different energy levels onto the same detector element, we end up with an AVERAGE. 

Mathematically, the average will be lower than the max. temperature. Hence, this is the largest source of error, using these sort of detectors. That is why a thermal camera with 320 x 240 detector elements (pixels) is far superior to any single element or 32×32 pixel sort of detector. It doesn’t matter who makes it. Simple physics!

The way these manufacturers test the accuracy of their sensors is to point them at a black body. That surface temperature of that black body (calibration source) is UNIFORM and at least as large as the measurement region of that detector. A human face is anything but uniform as you can see below. So looking at their accuracy specification for this application is pointless, as it ignores the spatial resolution requirement for accurately resolving the temperature variations of the human face. This is the same problem with using forehead thermometers. As these tend to also just have a single detector in them.

facial temperature
Click for full size image

Take the example. we took a small region from the face and zoom in. This would be one pixel of one of the detectors you sent to us. You can see the pixels of the thermal camera clearly measuring all temperatures present. The thermal camera would report 97.3F in that region.

If that is the pixel size of one of the low cost detectors – these temperatures would be averaged. (92.6+91.2+95.8+97.3)/4= 94.2F  A 3 degree error! In other words, the low resolution sensor would have missed that person.

Again – this has nothing to do with brand bias – it is Physics/Optics/Math related.

Thermal Camera Imaging Technical

Elevated Body Temperature Screening – Read this, before buying a Thermal Camera

Elevated body temperature screening. This article discusses six topics you need to know before buying a thermal camera. There are so many options out there, it can quickly can overwhelming. Especially when you have no background in using thermal cameras for elevated body temperature screening or “EBT”.

This “6 Things you need to know before buying a thermal camera for elevated body temperature screening” article and accompanying video is intended for readers that are in the research and decision making process. Which thermal camera screening solution is right for me?

I have witnessed about 30 new “solutions” and entire new companies enter the market, just in the past two month alone. There is so much misinformation out there and so many false claims, that I felt compelled to write this article and make this video. The COVID-19 crisis has brought out the best in people and unfortunately also the worst.

A lot of companies are currently investing significant sums of money into technology they do not understand the first thing about. A lot of vendors out there didn’t even know how a thermal camera worked two months ago and are now calling themselves experts.

Elevated body temperature screening (EBT) not only requires an in depth understanding about thermography, but also a solid understanding of physiological effects of the human body. In particular, how the body thermally regulates.

Visit our Youtube channel for more educational video content: https://www.youtube.com/user/movitherm

Some companies promote their solutions as “fever screening” cameras. This is a misleading statement, since no thermal camera has ever been cleared by the FDA for fever screening.

These cameras can merely detect a variation in skin surface temperature. My name is Markus Tarin, and I am the President & CEO of MoviTHERM – Advanced Thermography Solutions.

I have spent the past 20 years developing thermal imaging systems for industry and research. Never before have I seen such a frenzy and unethical business practices when it comes to thermal cameras being offered for elevated body temperature screening.

When I started to learn about thermal imaging technology, back in the 90s, it took a go six months to get a fundamental understanding about the infrared spectrum, heat radiation, conduction, convection, emissivity, reflectivity, transmissivity and all the other fancy physical effects that influence the accuracy of a thermographic measurement.

So I empathize with so many of you out there trying to make an “informed” purchase decision within a very short period of time. Many of you may not even have an engineering background, let alone the ability to interpret technical specifications of thermal cameras. Now add to this the complexity of human physiology and how the body’s thermoregulation may skew the results of an optical instrument used for temperature measurement.

The reality is that you won’t have enough time to properly understand enough about these subject matters to truly make an educated and sound decision. What you are left with, is often the marketing literature of the solution provider. And their whole purpose is to play into the panic and fear around this subject matter to sell you their solution.

I felt compelled to share my knowledge and help educate people on this topic. For that purpose, I have put together six topics and boiled them down to the essentials. Hopefully people will find some value in this. This article is not meant to be an exhaustive “training course” or white paper by any stretch of the imagination. Rather, it is meant to convey some basic concepts to separate the marketing hype from technical facts.

Topic# 1 – How does a Thermal Camera work?

A thermal camera captures the radiated infrared energy from the surface of a solid object. The captured energy is then mathematically converted to a temperature reading. The temperature reading of each pixel of the camera is then being associated with a color, representing a temperature.

The absolute accuracy of a thermal camera depends on many factors. Considering all factors (Emissivity, spatial resolution, detector and system noise, temperature drift etc.), the expected accuracy of these cameras is no better than ±2° Celsius or ±3.6 °Fahrenheit. It technically can’t be better, unless you are placing the thermal camera into a very tightly controlled thermal chamber under laboratory conditions.

This is due to the fact that the image detector in the camera, the lens and the electronics warm up and create a temperature drift. Without active temperature compensation, this drift is a large contributing factor to the achievable accuracy on these cameras. All the cameras that are being offered for elevated body temperature screening are based on microbolometer type detectors.

Micro-Bolometer Pixel

Micro-Bolometer Pixel

I have to get technical – sorry…
I have seen marketing literature lately, that claim a camera accuracy of +/- 0.5C without the use of an external black body i.e. calibrated temperature reference source. They back up the claim with the fact that the entire calibrated temperature range was optimized for human body temperature, rather than the typical 170C to 350C range of typical thermal cameras. It is true that using a smaller dynamic range potentially helps with accuracy. However, this also requires a higher degree of amplification. With amplification comes additional noise. If the detector has an NETD of 0.05k (50mK) at 30C. The best theoretical accuracy achievable is about 10 times NETD. So 0.05K x 10 = 0.5K or 0.5C, ignoring all other error sources. Typical dynamic ranges of microbolometer detectors require a 14bit analog to digital converter. So, in order to make use of the largely reduced dynamic range, one would have to amplify the signal from the detector. This will also amplify the detector noise and hence will affect the achievable accuracy negatively. None of this helps and none of this deals with the temperature drift problem.

Takeaway: Achieving an accuracy of 0.5C with a microbolometer detector based camera requires one of two things:

– Active cooling and temperature control of the lens, the detector and signal electronics, which none of these have OR
– Using a external temperature reference source (aka black body, that is stabilized to better than +/- 0.5C)

Topic# 2 – What can a Thermal Camera detect?

A thermal camera can only detect, measure and document the variations of skin surface temperatures.

It cannot detect or diagnose any of the following:

  • If somebody has a fever or not
  • If somebody is sick or healthy
  • If somebody has an infection of any kind
  • If somebody is contagious or not

A diagnostic decision can only be rendered by a healthcare professional, using other FDA approved methods (fever thermometer, blood test, viral tests etc.)

A thermal camera used for this application requires an FDA 510k clearance. With such a clearance, it can be used as an “adjunct” screening tool for skin surface temperature measurements. It shall never be used on its own to render any diagnostic decision.

Topic# 3 – How to properly measure elevated body temperature?

Thermal image of tear duct for elevated body temperature screening

  • Body temperature is correlated closest at the inner canthus/tear duct.
  • Measuring skin surface temperatures anywhere else in the face, will not work properly.
  • Eye-wear will obstruct the tear ducts and must be removed
  • Person should be standing still at a fixed distance to the camera
  • The inner canthus should be covered by a sufficient number of camera pixels to allow for an accurate measurement. (At a minimum 3 x 3 pixels, ideally more)

Topic# 4 – What camera pixel resolution do I need?

  • The tear duct area is about 5mm. We need at a minimum 3 pixels to cover that region for an accurate measurement.
  • 5mm / 3 pixels = 1.6mm/pixel
  • Using a thermal camera with 320 pixels, we can capture an image size of 320 pixels x 1.6mm/pixel = 512 mm [~ 20 inches]
  • Using a camera with 160-pixel resolution, we are left with an image size of ~10 inches.
  • Therefore, pointing a camera into a crowd to detect elevated body temperature will not work.
  • Assuming an image size of 5 feet, it would require a thermal camera with >12 Megapixels and these do not exist.

Topic# 5 – Reference black body vs. reference population

  • There are two legitimate measurement setups available for elevated body temperature measurement.
  • One uses an external black body reference to increase the accuracy of the measurement to about ±0.5° Celsius or better.

Reference black body for elevated body temperature screening

  • The other one uses a relative comparison of skin surface temperatures (baseline group)
  • Both setups are valid and require a manual correction from time to time to account for external factors that are impacting the thermoregulation of the human body.
  • Thermoregulation is the ability of the human body to keep its inner core temperature stable.
  • Core body temperature is: 36.4–37.1 °C (97.5–98.8 °F)
  • The body will either try to conserve energy or try to get rid of excess energy to maintain its ideal core temperature.
  • This results in increased or decreased skin surface temperatures, as the skin is the
    interface to the environment.

Topic# 6 – Which solution can I trust?

  • Be aware of “ambulance chasers”. More than 30 new solutions and companies have been created in the past two months.
  • Work only with reputable companies with a proven track record.
  • How long has the solution they are selling been on the market? Was it successfully used during previous pandemics, such as SARS & Swine Flu?
  • Be aware of false camera accuracy claims.
  • Be aware of fully automated systems.
  • Be aware of low-cost solutions.
  • Do not buy a solution that claims to be able to scan more than one person at a time. (Crowd scanning).
  • Be aware of false claims in marketing literature and websites.
    (i.e. Fever detection, avoids spreading infection, any diagnostic claims, keeping you safe etc.)
  • Not all thermal cameras and solutions are created equal!

So, what is an example of a trustworthy solution?

FLIR A320 Tempscreen for elevated body temperature screening

  • FLIR A320 Tempscreen
  • Originally developed for previous pandemics, such as SARS, Swine Flu etc.
  • Installed thousands of times around the world at airports, public buildings etc.
  • Proven solutiontried and tested.
  • FDA 510k Clearance for skin surface temperature measurements
  • Manufactured by the world’s largest manufacturer of thermal camera – FLIR Systems, Inc

For more information send us a request

More Information on Kiosk Industry

Contactless Touchscreen – No Touch Touchless Touchscreen

Temperature Kiosks

Thermal Sensing Solution Kiosks

22Miles Thermal Sensing Kiosk Solution

For more information and to request a demo click here

 

    Temperature Sensor Solution

Newer image of strip temp

To meet the new challenges COVID-19 and other viruses present in public spaces, TempDefend TM is 22MILES latest innovation. As a component of our suite of Protection as a Service TM solutions 22MILES TempDefend TM thermo-sensing technology leverages a combination of camera technology, facial and body temperature detection software, integrated sensors, and dynamic machine learning algorithms to aid in the prevention of viral spread. TempDefend is the ideal plug-and-play solution that allows businesses and employers to rebuild consumer/ employee confidence and safety as stay-at-home orders and restrictions ease around the world

22M Temp Sensing without Face 22M Temp Sensing with Face-1

Why TempDefend?

Protecting yourself, your staff, and other visitors and patrons from the spread of contagious diseases begin with identifying, quarantining, and treating infected individuals. TempDefend’s thermal sensor technology provides an accurate and affordable solution to alert individuals of heightened temperature (possible infection) status while protecting others in and around your facilities. 22MILES TempDefend can capture analytics that ensures your operational, compliance, and HR requirements (optional client consent). AI enabling of response customization, analytics, networking, and synchronizing of TempDefend anomaly alerts, as well as compliance logs for legal audit trails, are available.

TempDefend TM is compatible with your own sensor hardware or 22M suggested/provided sensors.

TempDefend Protection as a Service TM  Packages

COVID

TempDefend can be customized to the needs of your organization. Packages available include:

TempDefendTM Protection Basic

TempDefendTM Premium – Protection as a ServiceTM (PaaS)tempdefend1

TempDefendTM Reception – Protection as a ServiceTMtempdefend2

TempDefendTM Multi Tracking – Protection as a ServiceTMtempdefend4

A La Carte Features available include:

  • Facial Recognition integration with employee database for check-in,
  • Facial Recognition integration with Access Control systems

FILL OUT THE CONTACT FORM FOR PLAN DETAILS OR TO REQUEST A CUSTOM QUOTE

image-7is committed to working with all U.S manufactured solutions.

Some of our partners include: 

                elo logo                    aopen logo               

Our current supported OS include:

            intel logo           android loho     

For more information and to request a demo click here

Request more information here

Pyramid health screening kiosk Covid-19

New Health Kiosk for Temperature Verification by Pyramid

Provides fast temperature sensing before allowing access to buildings and venues.  Easy, safe deployment including office, healthcare, transportation, leisure and retail environments 

 Freiburg, Germany, May 18 2020 – Pyramid Computer GmbH today announced the worldwide availability of its new polytouch® 32 curve – access control kiosk which automatically measures human body temperature as part of authorized personnel and visitor access to buildings and public areas.

By streamlining the flow of people through the kiosk, quick but very accurate contactless checks can determine if an individual is running a fever and therefore potentially has the coronavirus (SARS-CoV-2) or possibly another virus or bacterial disease such as influenza. With the gradual easing of public lockdown measures and a return to work, the Pyramid polytouch® 32 curve kiosk helps businesses, institutions, public transportation and venue operators rapidly detect and reduce the potential spread of infection among employees, guests and visitors.

Temperature check kiosks

They are becoming the new norm and part of the access process to many places such as workspace, airports, stations, shops, restaurants, healthcare facilities, schools, universities, conference, concert and sporting venues. Combining contactless thermal temperature screening sensors with software from ZipKey – well-proven in border control passport verification and biometric facial recognition – the Pyramid polytouch® 32 curve kiosk offers a level of public access safety and accuracy that cannot be matched by existing human-error prone processes.

Using intelligent sensor technology – with over 1.000 measuring points – and tracking the distance of the subject to the sensor results in a reliable statement of body temperature. This is performed in less than a second enabling fast processing of up to 700 people per hour, therefore maximizing user convenience and safety without compromising the customer organization’s need for efficiency and security. Single or multiple kiosks are easily and safely deployed in and around buildings and can be connected to automatic doors, turnstiles, locks or barriers for access control after successful testing.

“As we strive to take back control of our daily lives, the combination of personal identity verification with real-time body temperature measurement is the ultimate key for ensuring safe, secure public access,” said Patrick Hagemeister, International Account Director at Pyramid Computer. “Our new polytouch® 32 curve – access control kiosk establishes a test barrier at the entrance to your building – it could be your contribution to helping prevent virus spread by offering more protection to employees, visitors, suppliers and the general public.”

Using ZipKey’s software, the Pyramid’s polytouch® 32 curve – access control kiosk scans, verifies and extracts data from an individual’s identity credentials (e.g. card or driver’s license) and performs facial recognition to verify their identity. At the same time their body temperature is monitored. Protection from user manipulation is assured through intelligent thermal image analysis technology. The system is fully GDPR compliant with anonymized data collection and pre-defined automatic data deletion mechanisms. Data required for auditing requirements can be centrally accessed.

Patrick Hagemeister added: “Our easy to use health screening kiosk will help hasten the return of social contact and provide greater confidence in public health safety. Government and health organizations could also leverage our solution when tracking localized infection hotspots, by utilizing the real-time anonymized data capture functionality.”

Pyramid’s modular, ergonomic polytouch® 32 curve – access control kiosk can be easily customized with add-on peripherals where necessary for accommodating customer-specific access control management tasks. These include RFID card/token dispensers and label/badge printers. A retrofit kit is available for modifying existing kiosk systems.

Note to editors:

With the current COVID-19 pandemic and other viral infections and bacterial diseases, fever/raised temperature is the most frequent initial diagnosis: according to the WHO Report 2/2020: 87.9% for COVID-19.

 About Pyramid Computer

Pyramid Computer has focused on the development of high performance and tailor-made IT solutions since 1985. The company has produced more than 30,000 customized kiosk terminals for retail and QSR customers throughout the world. In addition, it has developed a uniquely precise system for localization and automation in hospitality and retail – Pyramid Location System. All IT hardware, indoor localization, and network & security and industrial PC & imaging products are engineered and designed in Germany by Pyramid for shipment and installation via worldwide OEM and distribution partners.

https://pyramid-computer.com/health-screening-access-control-kiosk

About ZipKey

ZipKey is a spin-off of the leading provider of data-center facilities and services in Europe. More than 15 years of experience and excellence in access control management has been productized in ZipKey which and is now available to customers for any location and security requirement.

Further information

Pyramid Computer GmbH

Marketing Department

Boetzinger Strasse 60

79111 Freiburg, Germany

Email: marketing@pyramid.de

https://pyramid-computer.com/health-screening-access-control-kiosk

Press contact:

Nigel Parker
Strategic Public Relations Limited

M +44 (0) 7778 872 457
nigelp@strategicpr.net
www.strategicpr.net

For More Information Send Us Your Request

More Pyramid Kiosk Information

Pyramid Computer Kiosk

Pyramid self-service kiosks – the perfect fit for retailers – Booth # 5860 NRF2020

First 4-in-1 self service kiosk

Honeywell AI-Driven Thermal Imager Detects Elevated Body Temperature

The Honeywell ThermoRebellion temperature monitoring solution can be rapidly deployed at the entryway of a factory, airport, distribution center, stadium or other commercial buildings to quickly and efficiently identify whether personnel exhibit an elevated facial temperature. As individuals pass in front of a high-resolution, thermal imaging camera, their skin temperature is automatically detected within two seconds and displayed on an accompanying monitor.

This can alert a person with an elevated temperature to seek additional screening. In addition, operators gain reliable, real-time information about personnel entering their facilities enabling them to take measures to keep their premises safe and secure.

The Honeywell ThermoRebellion system can also identify if individuals are wearing the required personal protective equipment needed for entering the building.

“Protecting worker safety is the top priority for any building operator and today, more than ever, managers are looking for innovative solutions to enhance their health screening processes,” said Renaud Mazarguil, president of Honeywell’s Gas Analysis and Safety business. “We’ve developed this breakthrough technology to automate and streamline the monitoring of an individual’s temperature and reduce the need for invasive monitoring. Honeywell is committed to developing new solutions to help workers, families and communities stay safe.”

Honeywell is piloting its new temperature monitoring solution at two of its U.S. production facilities, including the company’s new N95 face mask manufacturing center in Phoenix.

The Honeywell ThermoRebellion solution incorporates software powered by AI allowing for each individual pixel captured by the camera to be rapidly assessed for elevated temperature. The solution is easy to install and commission, and it is simple to operate with minimal training using an intuitive graphical user interface. The system also automatically logs data to simplify and standardize record-keeping for compliance, reducing the need for potentially error-prone manual tracking processes.

The system integrates seamlessly with the Honeywell Forge platform and Honeywell’s Healthy Building Solutions that provide a holistic view of a building’s health based on key factors such as air quality, social distancing, occupant flow, sanitation, wellness density and governance adherence.

The new temperature screening solution incorporates intelligent, visual monitoring technology from Rebellion Photonics, which Honeywell acquired in December 2019. Rebellion offers the oil and gas and petrochemical industries’ real-time monitoring platform that visually identifies and quantifies gas releases to quickly detect and analyze leaks keeping workers safe. The business features a sophisticated AI software platform to provide operators with automated notifications for gas leaks, security issues, and fires.

Honeywell’s Gas Analysis and Safety (HGAS) business delivers fixed and portable gas detection solutions for industrial, commercial and governmental applications where workers can be exposed to toxic or flammable gases. The business also provides protective gear for first responders and advanced electrical safety solutions for workers in high-risk environments. For more information about HGAS solutions, please visit safety.honeywell.com.

Honeywell (http://www.honeywell.com) is a Fortune 100 technology company that delivers industry-specific solutions that include aerospace products and services; control technologies for buildings and industry; and performance materials globally. Our technologies help aircraft, buildings, manufacturing plants, supply chains, and workers become more connected to make our world smarter, safer, and more sustainable. For more news and information on Honeywell, please visit www.honeywell.com/newsroom.

Free COVID-19 Services Kiosk Manufacturers Association

Free COVID-19 Kiosk Services from KMA

The Kiosk Manufacturer Association sponsors, members and working groups understand the pain and trouble that current companies are undergoing with business disruption. Many of these COVID specials are free, or discounted, or deferred payment. We share your pain. All hands on deck is a good motto.

To help here are some COVID-19 specific solutions being offered, many of them free.  THey range from Ecommerce, Digital Signs, Portable Digital Signs, Temperature Check Kiosks, Secure Endpoints for home corporate and footfall or customers-in-store count.

Free eCommerce functionality from Datacap — make takeout & delivery-only easier.

Antibacterial Touchscreen Treatment recommendations by industry manufacturers. Link

Voice Activation & Control – basic version and advanced version for full engagement. More info

Free Mobile Wayfinding App from 22MilesDownload free app

E-Ink Battery Mobile Signs & Powered Digital Room / Wayfinding Signs – Free 6 months. More info

Temperature Check Kiosks – countertop and pedestal from Olea

Free Notifications Suite — keeps Shelter-in-Place employees informed. link for more information.

Relief Program — Hospitality, education, & healthcare industries. 3 free months hosting  Link.

Digital Signage Quick Bundle — 22Miles with hardware display partner Peerless-AV®. More info

Large Capacity Sanitizer and Water Refilling Stations – For More Information

Multifunction Kiosk with integrated Hand Sanitizer dispenseFor more information

Free 3D-Printed Sani-Holders for iPad kiosk or Wall. Developed for Panera by Lilitab. Contact KMA

Portable Digital Signage – 5 rolling 43 inch LCDs w/software. Free setup, training. $9900. Contact KMA

Secure Corporate Endpoint VXL low-cost, 6-month license to convert current desktops and laptops 

Customer Count Analysis – regulate number of customers entering premises with floor sensors. Link

We will be adding to this list in the coming days. Be sure and check back with the Kiosk Manufacturer Association for more assistance in the coming days.

For more information you can contact us