Elevated Body Temperature Measurement with IR Thermometers and TI Cameras Webinar Presented by Fluke

Presented by Fluke & Transcat November 2020
Elevated Body Temperature (EBT) Measurement
with IR Thermometers and TI Cameras
© 2020 Fluke Corporation. All rights reserved.

Elevated Body Temperature Measurement
Agenda
• Introductions
• What is Elevated Body Temperature (EBT) screening?
• What technologies can be used for EBT screening?
• Guidelines on EBT screening from FDA
• Discussion on TI Camera technology
• Discussion on IR Thermometer technology
• What to look out for when purchasing an IR thermometer
• What EBT products does Fluke offer?
• Q&A

Presenter Introductions
Michael Seaholm
Product Manager, Safety
Han Tran
Product Manager, Safety

Why evaluate Elevated Body Temperature (EBT)?
Fever is a common, and often the
first, symptom of COVID-19, and is
one way of identifying individuals
who potentially have contracted
COVID-19.
Evaluating fever with contact
thermometers is inefficient and
requires cleaning between uses.
The most popular technologies for
efficient fever evaluation make use
of non-contact methods of
measuring temperature.

Non-contact EBT Evaluation
Non-contact EBT evaluation can be accomplished
with 2 prevalent technologies: Infrared thermometers
and Thermal Imaging cameras.
IR thermometers
Measure temperature by means of infrared energy
emitting from the skin surface at a point on the body
- typically the forehead. Many utilize an offset to
approximate internal body temperature from skin
temperature.
Thermal imaging cameras
Scan infrared energy across the entire face for the
hottest temperature, often using the “inner canthus”
(tear duct) with an offset to account for differences
between inner-canthus and internal body
temperature.

Thermal Imaging vs IR Thermometer
Location of max temperature %
Inner canthi 74 %
Forehead (hairline) 11 %
Nose (bottom) 8 %
Temple 6 %
Other 1 %
“Our findings provide clinical confirmation of the utility of the
consensus approaches for fever screening, including use of
the inner canthi temperatures, while also indicating full-face
max temperatures may provide an effective alternative
approach.”
Conclusion2019 FDA Study
13 points/regions on face (N = 1109)
• (Correlation between spot-IR temp and oral
temp)
• Forehead single spot (R2 = 0.21 to 0.30)
• Canthus (tear duct) single point (R2 = 0.47 to
0.49)
Max over region is better
• Forehead max (R2 = 0.41)
• Canthus max (R2 = 0.62)
• Whole face max (R2 = 0.69) (sensitivity 0.98,
specificity 0.99)
Note: 2 cameras were used in the study:
IRT-1: FLIR A325sc & IRT-2: Infrared Cameras Inc. 8640 P-Series
https://www.spiedigitallibrary.org/journals/journal-of-biomedical-optics/volume-25/issue-09/097002/Clinical-evaluation-
of-fever-screening-thermography--impact-of-consensus/10.1117/1.JBO.25.9.097002.full?SSO=1

The FDA’s Enforcement Policy
https://www.fda.gov/media/136698/download
March 2020
April 2020
Oct 2020
Secretary of Health and Human
Services (HHS) declares National State
of Emergency
FDA issues Enforcement
Policies Permitting Certain
Products to be Marketed without
Obtaining Premarket
Authorization
State of Emergency declaration
extended through July 2020
State of Emergency extended through
January 2021
Excerpt from Clinical Thermometer Enforcement Policy Document
“However, to help ensure the availability of equipment that might offer
some benefit to health care providers and the general public during the
public health emergency, FDA does not intend to object to the
distribution and use of clinical electronic thermometers that are not
currently 510(k) cleared without compliance with the following regulatory
requirements where such devices do not create an undue risk in light of
the public health emergency…”
- Section IV. Policy A. Overview

510(k) vs EUA vs Enforcement Policy
510(k) EUA Enforcement Policy
The process
1) Meet required standards
2) Submission of 510(k)
3) Clearance of request
4) Launch/market product
1) Public health emergency
3) Submission of EUA request
4) Approval of request
1) Public health emergency
Evidence provided to FDA that the
product meets the standards
Substantial Equivalence to
Predicate – FDA Review
Potential Benefit Outweighs
Risks – Abbreviated Review
Evidence not reviewed by FDA
(consequences for companies that
launch products that do not conform
to the standards)
Requires submission to FDA Y Y N
Requires formal authorization from
FDA
Y (clearance) Y (authorization) N
Timeline to market
(from submission)
6 months+
Days to weeks (depending on
criticality of the product)
No timeline
(launch when standards are met)
Always sellable Y N N
Only sellable during emergency N Y Y
Considered a medical device Y Y Y

What does this guidance really allow?
• Contact/non-contact thermometers can be
marketed without obtaining premarket
clearance
• Temperature screening products can be
marketed for use in fever screening
applications
• Products can claim alignment (but not
clearance/approval) to Enforcement Policy
What is allowed? What is not allowed?
• Using the FDA logo or stating anywhere that
the product is 510(k) compliant
• Marketing products that do not have the 510(k)
with the verbiage “FDA-cleared” or “FDA-
approved”
• Making competitive or marketing claims that
cannot be backed by facts and data
• Selling or marketing products that do not
comply with the Enforcement Policy

• End users may be purchasing products that claim
certain specifications that the product does not
actually meet
• Products which do not fully comply with standards
may possibly still be sold and marketed for the fever
screening application
- FDA has the right to issue warning letters to
companies who are producing and selling
products that do not comply with the stated
standards
• The market is flooded with 100’s, if not 1000’s, of
options at a broad range of prices that all claim the
same specifications
- Clutters the market and causes confusion
• There are a significant number of products in the
market with no brand name and no warranties/returns if
they do not perform to stated specifications
• It is difficult to determine which products actually meet
the standards and which do not comply
What it means for end-users
What does this guidance really allow?

Considerations
When Using TI
Camera Systems

General considerations with TI Camera systems
• IR reflections onto the camera and
ETRS can affect the measurement
• Area of focus on the face might not
be correct
• Resolution and uniformity of the
camera can affect the measurement
• Footprint of the whole system can
be large
• Often a set up process involved to
get the system running properly

Better uniformityPoor uniformity
Accuracy - Uniformity
• Testing accuracy only at the center point is not sufficient to conclude that you have accurate
results across the entire field of view.
• Uniformity describes how well each pixel behaves compared to every other pixel.

Accuracy - Resolution
• In addition to examples provided by the FDA, a key essential performance requirement
of IEC 80601-2-59:2017 is a minimum IR resolution of 320 X 240 pixels.
• Related requirements are 240 X 180 pixels on person’s face and 1 mm pixel size for each
pixel on face.
• 1mm pixel size can be achieved by having at least 240X180 pixels on face.
• 240 X 180 pixels on face while still leaving room for ETRS in field of view can be achieved by having at
least 320 X 240 total pixels.

1 mm pixel size for TI cameras
Why 1mm pixel size?
• Per IEC 80601-2-59, the inner eye (canthus) surface temperature has the best correlation to internal core temperature,
yet it is very small. The 2019 FDA study suggests that the hottest temperature o the face has the best correlation, which is
the inner canthus ~75% of the time
• The pixel on the left takes areas outside of the inner eye (canthus) into account due to pixel size.
• It is averaging the temperatures from the inner canthus, other parts of the eye, and the skin surrounding.
• The <1mm pixel on the right is generally more targeted to measure the hottest temperature on the face (most often the
inner canthus).
• Pixel size on the face is determined by the resolution of the IR sensor, the field of view of the lens, as well as the distance
the subject is from the lens of the camera.

TI Camera general notes on clothing & environment
• Infrared energy cannot penetrate through typical glass or
hat fabrics.
– With glasses on, you cannot measure the inner canthus
– With hats on, you may obstruct portions of the forehead
• Ambient temperature should be maintained between 20
oC and 24 oC and humidity between 10% and 50%.
• You should have an uncluttered, non-reflective
background.
• Wind, air temperature, sun, rain, etc. can all affect the
temperature of the skin.
Note: Environmental note excerpts from ISO/TR 13154

Considerations
When Using IR
Thermometers
17

Ambient temperature, perspiration and clothing can influence skin temperature
General considerations with IR thermometers
• Skin temperature is generally lower
than internal core body temperature
• Temperatures can be inconsistent
across the forehead
• Skin temperature is susceptible to
outside influences:
- Perspiration
- Ambient Temperature
- Clothing
• It is not a means of diagnosing if an
individual has COVID-19
• People can be infected with no
elevated body temperature
(asymptomatic)

IR thermometer general principles for use
• Fever screening should be
performed by an individual
wearing the proper PPE when
there is concern of infection
(mask, face shield, gloves, etc.)
• The individual being screened
should be remove any obstructive
clothing
(hats, beanies, glasses, etc.)
• The individual should minimize
the number of outside influences
on skin temperature before the
screening (exercise, standing in
the cold or heat for too long, etc.)
Photo Credit: [1]

Body mode
An offset built into an IR thermometer
that accounts for the difference
between skin and body temperature
Accuracy
How close the value displayed by an IR
thermometer is to the true temperature
of the person’s skin under test
Emissivity
How efficiently an object or body gives
off IR radiation. Note: ‘perfect efficiency’
is represented by a value of 1.00
Ensure the product’s accuracy is tested to
ASTM E1965-98:2016. Be conscious of
products that make blanket accuracy claims
Products that have a body mode option.
Skin temperature is generally lower than
internal body temperature.
Products that use an emissivity value of
0.98, which is the widely accepted emissivity
of human skin
Attribute definitions What to look out for
What to look out for in Clinical IR Thermometers

EMC
The product has been designed to
function within specification in the
presence of EM waves
Drop test
The product can withstand a drop
from a specified height without
affecting the stated specifications
Attribute definitions What to look out for
Scan functionality
The ability to scan the forehead for the
highest measurement as opposed to
taking point measurements
Ensure the product’s EMC performance is
tested to IEC 60601-1-2. Look out for “ * ” in
specifications related to EMC performance
While not necessary, products with scan
functionality can improve measurement
repeatability as it minimizes the
variability between measurements
Products must be drop tested per ASTM
E1965-98:2016 to at least 1m. Be sure the
product has a drop test rating to at least 1m
What to look out for in Clinical IR Thermometers

Introducing…
Fluke 67 MAX
Infrared Forehead Thermometer Note: The 67 MAX complies with ASTM and IEC standards
but is not FDA 510(k) cleared or approved.

Price (MSRP) $199.99
Accuracy 0.5 oF (0.3 oC)
Resolution 0.1 oF (0.1 oC)
Measurement Range 71.6 oF to 109 oF (22 oC to 43 oC )
Measurement Distance 50 mm to 150 mm (2 in to 6 in)
Spectral Response 8 to 14 microns
Emissivity Fixed (0.98)
Battery Life 100 hours
Drop Test 2 m
Warranty 3 years
Regulatory Standards ASTM E1965-98:2016
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
ISO 80601-2-56:2017
Intended Use
The FLUKE 67 is a non-sterile, reusable, handheld and non-
contact infrared thermometer. It is intended for temperature
measurement in a home-use and clinical setting for adult
patients.“
23
Features and specifications
Fluke 67 MAX Infrared Forehead Thermometer
Note: The 67 MAX complies with ASTM and IEC standards

“Body Mode” adds a temperature offset to
account for the difference in skin vs internal core
body temperature
SCAN functionality allows the user to scan the
forehead for the highest temperature to improve
measurement repeatability
EMC performance complies with IEC-60601-1-2 to
remain accurate near other devices like portable
RF equipment such as two-way radios
Emissivity setting of 0.98 is widely accepted as
the most accurate setting for measuring human
temperature
Fluke 67 MAX Infrared Forehead Thermometer
© 2020 Fluke Corporation. All rights reserved. Note: The 67 MAX complies with ASTM and IEC standards

How 67 MAX addresses market needs
Fluke 67 MAX IR Thermometer
Body mode
An offset built into an IR thermometer
that accounts for the difference
between skin and body temperature
Accuracy
Emissivity
How efficiently an object or body gives
off IR radiation. Note: ‘perfect efficiency’
is represented by a value of 1.00
Attribute definitions
The 67 MAX’s product’s accuracy is tested
to and meets the ASTM E1965-98:2016
standard
The 67 MAX has a “body mode” that
automatically provides a fixed offset for
the difference between skin and body
temperature
The 67 MAX uses an emissivity value of
0.98, which is the widely accepted emissivity
of human skin
Note: The 67 MAX complies with ASTM and IEC standards but is not FDA 510(k) cleared or approved.

What it means for end-users
EMC
The product has been designed to
function within specification in the
presence of EM waves
Drop test
The product can withstand a drop
from a specified height without
affecting the stated specifications
Scan functionality
The ability to scan the forehead for the
highest measurement as opposed to
taking point measurements
The 67 MAX has been tested to IEC 60601-
1-2 to remain accurate when near other
devices like portable RF communication
equipment such as two-way radios
The 67 MAX comes standard with SCAN
functionality that allows you to take the
largest temperature measurement across
the entire forehead
The 67 MAX is drop tested to a height of 2m
which goes beyond the requirements of the
ASTM E1965-98:2016 standard.
How 67 MAX addresses market needs
Note: The 67 MAX complies with ASTM and IEC standards but is not FDA 510(k) cleared or approved.

Introducing…
Fluke FS100
Thermal Body Screener
The Fluke FS100 accuracy complies and is tested in accordance with the
FDA’s Enforcement Policy, but is not FDA 510(k) cleared or approved

Fluke FS100 Thermal Body Screener
Price (MSRP) $21,499.99
Regulatory Status FDA Enforcement Policy
Accuracy* ± 0.25 °C (0.45 oF)
Resolution 640 x 480 pixels
Measurement Range 34 oC - 39 oC (93.2 oF - 102.2 oF)
Measurement Distance 1 meter
Spectral Response 8 -14 microns
Warranty 1 yr
Facial Detection 
Temperature Correction 
Data Privacy Controls 
Intended Use The FS100 is intended for initial body temperature assessment for
triage. Elevated body temperature in the context of use should be
confirmed with secondary evaluation methods (e.g., an NCIT or
clinical grade contact thermometer). The measurement should not
be solely or primarily relied upon to diagnose or exclude a
diagnosis of COVID-19, or any other disease.
*Accuracy is defined here as the difference between actual and expected readings using a second blackbody
calibration source. When combined with other system uncertainties including stability, long-term drift,
uniformity, and uncertainty in the accuracy of the calibration source and ETRS, the combined accuracy
including all system uncertainties is +/- 0.5C.
The Fluke FS100 accuracy complies and is tested in accordance with the
FDA’s Enforcement Policy, but is not FDA 510(k) cleared or approved

How FS100 addresses market needs
FS100 Thermal Body Screener
Resolution
The amount of detail that the camera
can capture, measured in pixels
Accuracy
Throughput
The amount of time it takes to screen
an individual
The accuracy of the FS100 is tested to, and
complies with, the ASTM E1965-98:2016
standard
The resolution of the FS100 is tested to,
and complies with, the FDA’s
Enforcement Policy
The time required to get individuals through
the screening system is approximately 1
second once in the proper position
Note: The Fluke FS100 operation and accuracy complies and is tested in accordance with the FDA’s Enforcement Policy, but is not FDA 510(k) cleared or approved

How FS100 addresses market needs
FS100 Thermal Body Screener
Social Distance
The ability to measure individuals from
a distance of 6 feet or greater to
maintain recommended distancing
Face Detection
Having the ability to detect the face of
an individual when being screened, as
opposed to detecting other objects
The FS100 not only offers facial detection,
but also ensures there are enough pixels
(240x180) on the face
The FS100 allows for the screening
operator to be at least the recommended
6 ft from the individual being screened
Made in the USA
The camera and ETRS are fully
designed, assembled, and
manufactured in the USA
The FS100 camera and ETRS are fully
designed, assembled, and manufactured
in the USA
Note: The Fluke FS100 operation and accuracy complies and is tested in accordance with the FDA’s Enforcement Policy, but is not FDA 510(k) cleared or approved

Questions or Comments?
Email Christina Spearman christina.spearman@transcat.com
800-828-1470 www.transcat.com
For related product information, go to:
www.transcat.com/brand/fluke-store

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