HealthGate Products

Elenium HealthGate Podium

(Model No.: EPTP10001010)

The HealthGate Podium offers flexibility as a free standing kiosk that can be easily moved and deployed.

  • Health symptom screening
  • Self-service registration
  • Ticketing
  • Self-service access control

Elenium HealthGate Desktop

(Model No.: EPTD10001010)

The HealthGate Desktop can be secured on a desk, table or wall mounted without modification making it suitable for many applications.

  • Self-service access control
  • Self-service registration
  • Ticketing
  • Health symptom screening
  1. Appointment booking / Or business communication

    • Contact to book visit
    • Facility creates an appointment ID and sends visitor link / QR code to online questionnaire
    or
    • Business sends staff text with link to online questionnaire

    01
  2. Online questionnaire

    • Visitor completes health questions & registers biometrics or enter contact details ahead of arrival
    • Visitor receives QR code

    02
  3. On-site screening 

    • Scan QR code on arrival
    • HealthGate confirms biometrics & fever detection
    • Feedback based on facility metrics

    03
  4. Outcome trigger

    • Printed onto sticker
    or
    • Scan QR code for access
    or
    • Referral to an outbound video or voice call

    04

HealthGate certification

Elenium HealthGate is registered on the ARTG No: 355032 meaning it is classified a Class IIa medical device and is certified to be sold as such in Australia and the EU. In these jurisdictions only medically certified fever screening devices are legally allowed. Elenium is ISO 13485 certified.

FAQs

Vital sign evaluation

Is HealthGate a medical device?

HealthGate is a medical device which is able to detect a febrile patient using a sophisticated array of sensors which meets IEC 80601-2-59 and ISO TR 13157:2017.

HealthGate is also independently certified as meeting a number of other medical device standards including IEC 60601-1, 60601-2, 60601-6, IEC 62366-1: 2015, ISO 14971:2019, ISO 15223-1. All software written for HealthGate complies with IEC 62304. Elenium HealthGate is a ‘one to one device’ meaning an individual user is screened for being febrile.
The device employs several automated techniques to ensure that a user is correctly positioned to take an accurate reading from the inner canthi (tear duct) the system can also inform the user to remove any obstructions like a face shield to take the reading (though face masks are permitted).

Elenium HealthGate can be deployed in indoor environments within the recommended operating environment. It can be used to authorize a person for entry into a facility if they are within the acceptable range for a non-febrile person and if they answer the health questionnaire appropriately using the touchless interface or via a mobile application.

The average transaction time for an accurate fever detection scan Is 3 seconds. The total time elapsed for the health declaration depends on the number or complexity of the questions set by the administrator.

Elenium HealthGate has several additional optional features including the ability to detect heart rate and respiratory rate of a user, validate their facial biometrics and ensure they meet compliance with rules relating to facemasks etc. These features can be enabled at any time through software configuration.

How does the vital sign detection work?

A multi spectrum imaging system in a self-service device, processes and analyses vital health data either during a transaction (like check-in in aviation), or as an access control device. It measures body temperature of the visitor.

If any vital sign the data exceeds the configured threshold, the system suspends registration (or other transaction) and sends a notification to a virtual or nearby Guest Services agent.

Its important to note that this technology is used to detect symptoms of illness. It is not used to diagnose COVID-19 .

How is body temperature measured?

The Elenium Sensor Array detects temperature and has configurable parameters defining normal or fever conditions. Temperature sensing is achieved using a near-infrared camera and a thermal sensor.

The near-infrared camera output determines the position of a person’s forehead in a frame. The location of the forehead, tear ducts and temples are then mapped and provided to the thermal sensor.  The risk of measuring the temperature from a different person is minimised and is not impacted by a foreign object such as a cup of coffee.

The temperature reading is compliant with ISO IEC 80601-2-59 (requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening) which considers a range of factors that affect accuracy, such as drift, stability, and background temperature.  We are compliant with FDA guidelines which require the offset error (often described as accuracy) to be -/+ 0.5°C.

Elenium HealthGate complies with ISO 15223-1, Medical Devices – Symbols to be used with medical device labels, labelling and information. From a user interface perspective, if a user is determined to be febrile the screen interface displays an alert icon and provides the user the relevant options depending on the configuration of the device. I.e. to conduct a video conference with a health professional, to navigate to a testing location, to wait for an attendant etc. As an option the detected temperature result can be displayed, however this is configurable due to the privacy nature of this option.  There is also an optional physical print out which can be generated.

Does Elenium HealthGate work with a face mask?

Yes, body temperature can be measured when an individual wears a face mask. It is also configurable to prompt the user to remove the face mask.

What are the applicable medical references?

Our approach is not COVID-19 specific. We are ensuring that the solution can be used to help determine the fitness of a passenger across a range of potential infections. We detect the most common vital signs:

https://www.hopkinsmedicine.org/health/conditions-and-diseases/vital-signs-body-temperature-pulse-rate-respiration-rate-blood-pressure

https://medlineplus.gov/vitalsigns.html

https://www.mja.com.au/journal/2020/clinical-presentation-and-management-covid-19

Note: the following a paper from the WHO re SARS
https://www.who.int/csr/disease/coronavirus_infections/InterimGuidance_ClinicalManagement_NovelCoronavirus_11Feb13u.pdf

Note we are also researching into the ability to detect oxygen levels in the blood without coming into contact with the individual being screened .However this is still in the concept stage. We hypothesize that we can use the same sensor technology.

How long does it take to read temperature?

It takes 2 seconds to read the temperature.

What are the recommended thresholds for temperature?

The thresholds can be adjusted and should be tailored to each individual implementation, considering the profile of the people likely to be screened.  There are generally established thresholds that can be used to establish a baseline.  We are implementing machine learning algorithms which will dynamically adjust the thresholds based on analysis of large data sets.  As an example, the usual vital sign thresholds can be temperature – a person can be considered febrile if the body temperature exceeds 37.5°C.

What is the accuracy of the temperature measurement?

The temperature reading is compliant with ISO IEC 80601-2-59 (requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening) which considers a range of factors that affect accuracy, such as drift, stability, and background temperature.  We are compliant with FDA guidelines which require the offset error (often described as accuracy) to be -/+ 0.5°C.

From the experience you have so far, how many false alerts do you get?

To accurately determine the number of false negatives and false positives, we need to establish a large enough data-set with confirmed sick people.  To date we don’t have a sufficiently large data set.  Our testing and certification has shown the accuracy of the readings to be equivalent to the standard devices that medical professionals would use, so we would expect a similar outcome from Elenium HealthGate.

What else have you learned from live trials and practical use of your system?

People find the device easy and intuitive to use.  They like the peace of mind that comes with having their vital signs checked upon entry.  We have implemented systems with health screening questions available on people’s mobile phone or Elenium HealthGate.  We have found that majority prefer to use their mobile phone to answer the questions in advance.

Touchless technology

Why do we need touchless self-service?

The World Health Organization (WHO) highlights studies confirming contaminated hands can be vehicles for the spread of certain viruses and bacteria, noting that the organisms can survive on hands for up to 60 minutes and, in certain circumstances, up to three months.

How can the device be controlled?

Individuals can choose to interact as they feel comfortable or according to their physical ability with head movement detection or mobile phone to HealthGate interaction.

How does movement detection work?

The patent pending head movement technology uses a machine learning classifier to find a point of interest on a person face as an anchor point. When the user moves their head the cursor of the kiosk follows accordingly. The interaction is intuitive with no training required by the user.

Can interaction be managed via a mobile phone?

Yes, individuals engage and complete the health declaration questionnaires using their own devices. Vital sign screening is performed on arrival at the premises.

Triage questions and expert

What questions can be asked?

The solution offers the ability to include a question/answer process as part of the health check process. These questions can be determined on configuration of the device to be relevant to the circumstances. Questions are customizable by the client and typically focus on recent travel history and generic health questions.

The questions can be posed on the screen of the device, to be responded to by head movement detection. They can be sent via a link to the user’s cell phone and the QR would be then read by the device.

Accuracy & Technology

Where is Elenium HealthGate manufactured?

Australia

How has Elenium HealthGate been tested?

Elenium HealthGate has been extensively tested in our R&D Lab in Melbourne. Additionally, it has been tested in a variety of environmental scenarios, indoors and out. In the field it is used in Airports, Factories, Critical infrastructure and Health Care Facilities.

How are fluctuations of ambient temperature controlled?

Changes in ambient temperature during operations caused by environmental factors can dramatically affect the reading. Elenium HealthGate measures changes to ambient conditions and applies a compensating calculation to the result. The thermal sensor is housed within a protective thermal barrier that minimises the impact of changes to ambient conditions.

How is Elenium HealthGate calibrated?

Elenium HealthGate continually self-calibrates by using rolling averages of “healthy persons” as the reference point for on-going calibration. This approach conforms with FDA approved methods for calibration and drift adjustments ensuring ongoing accuracy once in the field.

What is the thermal camera resolution?

The resolution is 384×288 providing a high-resolution sensor able to achieve high specificity, meaning it detects more temperature points on a person’s face including tear ducts, forehead and temples.

Does HealthGate comply with any standards?

Yes, compliant with ISO IEC 80601-2-59 standard for thermographic febrile skin detection.

How close does an individual need to be to the device?

Temperature can be determined within a 2-3mm facial area of interest from 0.5meters.

Deployment

Where can Elenium HealthGate be used?

HealthGate can be used in numerous locations, indoors and out including airports, hospitals, care homes, public buildings and office in an indoor environment where the ambient temperature range is between 18’c and 24’c.

How soon can I order?

Orders are currently being delivered with a 4-6 week lead time, please email sales@elenim.com for further information.

Where can I see a demo of Elenium HealthGate?

Please look at our YouTube channel for demo’s and deep dives into the product particulars.

Privacy, reporting, license fees & others

Does the HealthGate device capture, record or store the face or biometrics of the user?

No, the HealthGate device doesn’t capture, record or store the face or biometrics of the user.

What user data is stored?

HealthGate Device:
The health declaration and the result of the transaction.

HealthGate Declare (i.e., mobile site):
User’s name, phone number and health declaration.

Who owns customer transaction records?

Customer has the ownership of the transaction records. We do not access or use customer transaction records for any purpose without customer’s consent. We never use customer transaction records or derive information from it for marketing or advertising.

Where is customer data stored?

HealthGate Device:
• The result of the transaction is stored locally on the device.

HealthGate Declare (i.e., mobile site):
• Elenium uses the AWS services in various AWS Regions around the globe. For customers in Australia, we use the AWS services exclusively in the Asia Pacific (Sydney) AWS Region.
• We may choose the AWS Region(s) nearest to the customer for data storage or we may use the AWS services in the location(s) of customer’s choice, in accordance with customer’s specific geographic requirements.

How is customer data transmitted and stored?

Customer data transmitted through a public network (e.g., Internet) are encrypted and/or transmitted through an encrypted tunnel via virtual private networks (VPN) or encrypted protocols. Customer data are stored in a secured environment and data is encrypted.

What steps does Elenium HealthGate take to protect user privacy?

Elenium is committed to protecting the privacy of individuals with whom we deal.

Personal information sharing and disclosure: We will not share, sell, license, trade or rent any Personal Information to or with any third party without user’s consent, unless we are required to do so when processing Personal Information under the instructions and on behalf of one of our business clients. We use the Personal Information only for providing and improving the product and enhancing the user experience and communicating with the user.

Information Collection And Use: While using our product, we may ask user to provide us with certain personally identifiable information that can be used to enhance the user’s experience and contact or identify the user. Personally identifiable information may include, but is not limited to your name (“Personal Information”) and email address.

What are the service support available and the process for handling troubleshooting of technical issues and turnaround time to resolve the issue?

Elenium provides 24×7 Support either via telephone, a portal or email. Users will be provided with several channels to find the contact information including the labels one the device.

Each of the support call or email will be assigned a Support ID. Our support team will document the support enquiries, walk user through a check list to identify and confirm the issue, and advise the next cause of actions. If the issue can be resolved by the user, we will get the user to perform a check list to confirm the issue has been resolved and provide the user with a root cause analysis report. If we require more in-depth trouble shooting, we will advise the user not to use the device and wait for our next advice.

What training is required to use the product?

Elenium HealthGate is designed to be a self-service device which does not require user training for general use. The administration of the device is also simple and fully described in the user manual. The user manual is written to a medical device standard and has undergone usability testing. However, we can provide onsite and virtual training upon request.

What does the license fee cover?

Elenium HealthGate Application and HealthGate Declare Mobile Site:

• Triage question system – Ask all visitors triage questions to better qualify their risk level. i.e. do they have a sore throat, have they been in contact with someone who has COVID-19.  Right now its important all visitors are asked, but as time goes on you might only ask visitor who show minor symptoms to categorize their risk level.

Vital Sign Detection:

• Licenses for the software to process the vital sign

Touchless Functionality:
• Licenses for software to achieve the above mentioned

Others:
• Privacy compliance – Ensuring the system is data compliant for the country/region where it is deployed, and all data is stored in a certified and secure environment.

General technical questions

Network security

Our approach to network security is for you to manage the compute device (PC) on the kiosk.  You can control network access and implement the level of security per your organisational needs and customer requirements

Network loss impact

Elenium HealthGate will work without an Internet connection.

What are the hardware and operating system requirements to use the HealthGate?

Elenium HealthGate is an out of the box device which includes all required hardware, including network interfaces. Elenium HealthGate is available in multiple configurations including a Windows 10 Operating system or Android. The compute unit used to undertake measurements of a fever is a dedicated compute unit running linux with an IoT platform for configuration and management. If Windows is chosen as the operating system, Elenium allows a BYOD license, or can provide enterprise licenses.

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