Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Thursday, July 16, 2020

Thermal Imaging Systems in COVID-19

Thermal Imaging Systems in COVID-19

Measuring a person’s temperature can be done in several ways. 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). A core issue is there are no independent tests of thermal camera performance /accuracy and no independent standards to measure against. This has allowed manufacturers to tout products meant for body/fire detection as a fever solution, or falsely claim pinpoint accuracy at long distances. We urge caution against buying low-cost thermal solutions from any manufacturer. 

Thermal imaging systems and non-contact infrared thermometers (NCITs) use different forms of infrared technology to measure temperature.

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 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:
Ø  The systems are used in the right environment or location.
Ø  The systems are set up and operated correctly.
Ø  The person being assessed is prepared according to instructions.
Ø  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).
Figure 2 demonstrates the proper thermal imaging room setup.
Preparing the Thermal Imaging System
Ø 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.
Ø  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:
Ø  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.
Ø  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).

Ø  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.
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.

Thermal camera selecting guide
Unlike regular cameras, not many customers are aware of certain key factors that they need to consider when selecting a thermal camera. This is mainly because thermal cameras are still a relatively new concept for many security customers.

1.  Accuracy
In border surveillance, some thermal camera can accurately detect the people or object more than 150 meters away. Thermal imaging cameras are often not just to detect higher or lower temperatures but also the calculate the differences. This means that the readings should be as accurate as possible. Most top-end cameras provide a +/- 2% accuracy. The distance at which the camera can maintain this accuracy is also critical. 
2.  Temperature range
Thermal cameras have a range within which they can detect temperature. You should purchase a camera that would meet your temperature needs. For example, the cameras used at airports now are for human temperature monitoring. Hence their range just needs to include the highest and lowest points that a human body can sustain. However, in the industrial segment, the temperature may be higher. 
3.  Resolution 
Thermal cameras tend to have lower resolution compared to their regular counterparts, and hence this should be an essential consideration before purchase. The size of the area you need to capture and the nature of the target will decide the resolution you need. If you need to capture small objects in detail, high-resolution cameras will be necessary. 
4.  Cybersecurity  
Developments in IP has enabled thermal cameras to connect with other network devices and be part of the IT infrastructure.  You will need to find companies that provide NDAA compliant products. 
Prefer Thermal Camera brand
Avigilon H4 Thermal Elevated Temperature Detection camera is embedded with edge-based analytics to detect faces and notify operators of elevated skin temperature.
3S Vision T9078- Dome Camera, T9079- Dome Camera, T6078- Bullet Camera, T6079- Bullet Camera, T6041- Bullet Camera, T6051- Bullet Camera, T6061- Bullet Camera.
FLIR FLIR Axxx-EST series, T5xx-EST series, Exx-EST series & TG 165(Hand Held type).
AMETEK VIRALERT 3 human body temperature screening system for buildings and facilities
MOBOTIX MOBOTIX TR (Thermal Radiometry) technology makes it possible to measure thermal radiation - even from people.
AXIS Axis Q19, Q29, Q86, Q87 & Modular Camera
Honeywell HRCF-FD384H- Temperature Detecter 7.8mm, HRCF-FD640H - Temperature Detecter 15mm, HRCF-KIT-FD384H - Temperature Detection kit 7.8mm -tripod, HRCF-KIT-FD640H - Temperature Detection kit 15mm – tripod, HRCF-KIT2-FD640H- Temperature Detection kit 15mm - tripod (no laptop), HRCF-KIT2-FD384H- Temperature Detection kit 7.8mm -tripod (no laptop).
Lilin P3T6522E2 & P3T6522E2-F – Dome Camera, 

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.
Temperature gun uses not recommendate. 

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.

Sunday, September 1, 2019

System integrator role in SSA Business

System integrator role in SSA Business

Yam, you know SSA is stands for Security Safety Automation (SSA Integrate). A security systems integrator by definition specializes in bringing together subsystems into a whole and ensuring that those subsystems function together. When the goal is physical security, those subsystems might be Video surveillance, Access control, Intrusion, FDA or Emergency notification, BAS, computer networks and more. Some security suppliers have established business simply on the procurement and installation of systems predefined by others. More fully developed are considered ‘design-build’ integrators. However the most capable security integrator is a full service provider capable of supporting your operations in every phase of the security system lifecycle:
1.   Security risk or needs assessments,
2.   System engineering and design for the major technologies,
3.   Broad access to the leading product lines,
4.   Custom engineering when required,
5.   Alternate investment options,
6.   Procurement, staging, installation, commissioning and training,
7.   Full lifecycle service and maintenance,
8.   System functional and technology upgrades.

A client who selects an integrator fully capable in all the above can then take advantage of his unique perspective on what are the key ingredients for successful development of a physical security program that is supportive of a healthy enterprise.
Working with a full service security provider also reinforces quality. Consider why this is so. If, for instance, the integrator offers long term service and maintenance for the system he installs, then both the service provider and the customer are motivated that the design should be solid and the installation of high quality. And if the integrator can offer attractive long term financing, even operational leases, then he again has a further stake in the caliber of the security provided.
System integration is defined in engineering as the process of bringing together the component sub-systems into one system (an aggregation of subsystems cooperating so that the system is able to deliver the overarching functionality) and ensuring that the subsystems function together as a system, and in information technology as the process of linking together different computing systems and software applications physically or functionally, to act as a coordinated whole.
System Integrators in the automation industry typically provide the product and application experience in implementing complex automation solutions. Often, System Integrators are aligned with automation vendors, joining their various System Integrator programs for access to development products, resources and technical support. System integrators are tightly linked to their accounts and often are viewed as the engineering departments for small manufacturers, handling their automation system installation, commissioning and long term maintenance.

Are there tangible ways that we see interoperability trending in the industry?
There is certainly movement toward standard-compliant products but it is slow. I attribute this mainly due to engineers reusing portions of old or outdated specs along with their lack of knowledge of the current product offerings. IP cameras will help move the standards along since more and more clients are aware of megapixel technology and it forces the engineers to become more current.

Where do you see underserved or untapped opportunities for security systems integrators to provide integration and automation expertise?
Video and access technology have the potential to be integrated well beyond the traditional Big Brother stereotype applications. One example is warehouse distribution and processing applications where repetitive tasks performed incorrectly can slow production or cause injuries. Video analytics could be modified to monitor physical movement and monitor improper technique that could lead to injuries.
These videos could initiate notifications to HR and management staff to alert them to potential problems before they occur. Access to machines and forklifts could be controlled through HR records. Integrating the access system to training and safety certifications could help reduce unqualified employees from accessing and enabling critical operational systems. Security could monitor the traditional video footage, HR could assemble incident reports tagged with the video and management could build and expand training programs with real world examples.

Another area of potential growth is the smart building. A fully integrated structure including security, lighting, HVAC and building controls that provides a return on investment along with the ability to remotely manage a site.

How can a locally-based or small regional company have successes in enterprise-level organizations?
Local companies can have a distinct advantage over the national integrators. First, the small or regional company must be technically advanced and focused on cutting-edge technology so they can provide a value to an enterprise-level client. They must also network with similar dealers with related product lines so they can establish an installation network throughout North America or the regions they are required to service. They can also become an agent for the enterprise client and coordinate all installations and manage that system for that client. Compare that level of service to the big integrators. Yes, they have a handful of talented individuals that truly get the big picture and these men and women travel the country and the world implementing systems. But once the job is completed, they’re off to the next one and you may never see them again.

How can smaller integrators differentiate to better compete?
A commitment to service is the local integrators greatest strength. Through continuing education of its technical staff and building working relationships with clients, a local integrator can react quickly and see the big picture of their customers’ needs and requests. As the IT department begins to dominate the physical security industry the local integrator can help be a bridge between the security professionals and the sometimes frustrating “smartest man in the room” syndrome of the IT staff . Most integrators have a great respect for the current and former local and national law enforcement professionals we work with every day. Their knowledge of where and why a camera is placed and how to implement the concentric rings of security, lighting control and placement is invaluable. The human element of security beyond pure technology is something that some IT professionals do not always grasp. Integrators can successful bridging that gap when they strive to clearly communicate with both departments.
What is the Solution Development Process With a Full Service Systems Integrator?

Risk Assessment. Your integrator should be able to assist or guide you in this first step toward development of a security solution. The industry standard for this is the ASIS 7-step general security risk assessment guideline. The guideline defines a process which starts with identification of assets and risk events and ends with a solution cost benefit analysis. Properly done the end product is not only the security you want and need but a documented rationale for the investment.

Financial OptionsSimilar to many internal enterprise processes the best electronic security solution is sometimes planned to be phased-in over time to give the client the best possible security function progressively. Nonetheless a full service integrator enables you to tailor acquisition of enhanced security in a manner which meets your needs. As an example, reasonably priced capital leases can push the cash flow impact of security into outer years. Due to current accelerated tax depreciation in effect these leases can in some instances reduce the net cost below that of an outright purchase. If a full service integrator has the internal resources – service fleet, repair department, stocked inventory, etc. – to maintain their installed systems they may also offer and administer operational lease programs to the security solutions they provide. These leases differ from capital leases in that ownership of the physical security equipment is retained by the service provider yet the site installation and its sustained operability is available as a monthly service fee.

Design. The functional design should clearly define for the end user the extent of the solution’s protection. It may involve multiple technologies for the most effective solution. Minimizing the burden placed on general staff to maintain security and respond to emergencies should typically be a demonstrable objective.
Value driven component selection may require a number of different supplier sources. Exterior components will be weatherproof, interior components will be vandal and wear resistant as needed. System operation will be well protected from the dangers of tampering, surges, electrical strikes, etc. as well as single points of failure if possible. A good design will not dead-end the customer but position the delivered security solution for adaptation to meet anticipated future needs. Good designs may even enhance as well as protect enterprise and site operations.
Installation & Commissioning. The installation should conform to and even exceed state and federal regulations and guidelines and be performed by licensed personnel as required. The installation should be safe for all onsite, reflect excellent workmanship and conduct should be courteous and respectful to all involved. System configuration should be performed by individuals with good system knowledge. The end user training should be complete enough to address at least typical daily tasks and provide them the resources they need to reinforce the training and administer further if required. This is most likely provided by a resource positioned to be a partner in meeting your security needs.
System Maintenance and Service. The overarching goal is to maintain the operability of your security solution with the same effectiveness experienced as it was commissioned. But electronics degrade and fail and sites often continuously require system tweaks as they grow. A good service program will make available to you certified service personnel as well as standard and emergency response times you can depend on. The best providers will often maintain stock for repair and loan and even have in house bench repair capability for rapid, cost effective turn around. And if you have outgrown your security systems or they are generally showing their age a good provider can offer mid-life upgrades and/or ‘system refreshes’ which progressively secure your operations and people.

Enterprise Security is Not A Commodity.
Why is enterprise physical electronic security more than just a commodity to be procured? Because the security risks are multiple, varied and changing. Some which occur infrequently are the most potentially damaging. An outside perspective developed from meeting a variety of client needs can help prioritize. The current solution state of the art is technical, multidisciplinary and rapidly evolving. There is not a consumer protected design-bid-build process which guarantees success. Only a subset of security industry service providers are equipped and positioned to reliably assist you from needs development through to system maintenance.

Trust on your selective System Integrator or Solution Service Provider.
System Integrator who really work in different system with different brand system, they are know who or which OEM  has good service support. No one integrator is wise for all product. System Integrator surve customer. OEM will not provide service.


Tips to choose Best System Integrator in India
·         Choose a systems integrator who has a list of successful projects with appreciation letter from customer. Check references, talk to their clients and take reviews. Find out for how long they have been in the field.
·         System Integrator should have long-term relationship and close ties with the leading OEMs. These relationships allow an integrator to keep up to date on new technologies, get the best prices, and provide you with the most complete support network available. The best integrators focus on customer needs and build solutions using best of breed technologies. They should have a broad range of products they have worked with and enough staff to handle different areas of the project.
·         The integrator should prove that they understood your requirements. Take Quote from multiple System Integrators. Be especially careful if you get lower price than expected or that others have quoted. Make sure the system integrator doesn’t over commit during negotiations.
·         System Integrator should have specialized expertise and that can be applied to create an architecture that ensures security, flexibility, and scalability to meet your IT service availability demands. Focus on their knowledge, techniques and skills. Make sure they have full knowledge of system engineering, as well as sufficient experience to handle your project.
·         If you don’t have in-house expertise for making the integrator selection, consider hiring a third-party technical consultant to establish selection criteria and/or participate in the review process. Get involved at the zero level in the planning, simulation, detailed layout, software handling techniques and maintenance requirements as much as you possibly can in order to get the biggest possible benefits. In this point our Writer can help, you may connect with this article writer.
·         Keep up-to-date milestone records during the course of the project. If you have to replace an integrator, refer to the specification and decide on a fair settlement covering payment for all completed deliverables. System Integrator should have a knowledge transfer process in place. This ensures you have the time and resources necessary to ensure your team understands the work product and can continue on – independently and successfully.
·         Look for an integrator that listens to your needs, communicates well, and provides customized solutions for your business.
·         Select an integrator that has a large, experienced engineering core with a holistic understanding of your entire ELV ecosystem. This will facilitate better design, deployment and support.

·         System Integrator 2/3 team member should have Membership their own technology field like: ASIS International, SIA (SECURITY INDUSTRY ASSOCIATION), FSAI, National Safety Council.


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