Fluke Models: 67 MAX Clinical Infrared Thermometer User manual

Brand: Fluke

Model: Models: 67 MAX Clinical Infrared Thermometer

Type: User manual

67 MAX

Infrared Thermometer

Calibration Manual

March 2021 (English)

Specifications are subject to change without notice.

All product names are trademarks of their respective companies.

LIMITED WARRANTY AND LIMITATION OF LIABILITY

Each Fluke product is warranted to be free from defects in material and workmanship under normal use and

service. The warranty period is three years and begins on the date of shipment. Parts, product repairs, and

services are warranted for 90 days. This warranty extends only to the original buyer or end-user customer of a

Fluke authorized reseller, and does not apply to fuses, disposable batteries, or to any product which, in Fluke's

opinion, has been misused, altered, neglected, contaminated, or damaged by accident or abnormal conditions of

operation or handling. Fluke warrants that software will operate substantially in accordance with its functional

specifications for 90 days and that it has been properly recorded on non-defective media. Fluke does not

warrant that software will be error free or operate without interruption.

Fluke authorized resellers shall extend this warranty on new and unused products to end-user customers only

but have no authority to extend a greater or different warranty on behalf of Fluke. Warranty support is available

only if product is purchased through a Fluke authorized sales outlet or Buyer has paid the applicable

international price. Fluke reserves the right to invoice Buyer for importation costs of repair/replacement parts

when product purchased in one country is submitted for repair in another country.

Fluke's warranty obligation is limited, at Fluke's option, to refund of the purchase price, free of charge repair, or

replacement of a defective product which is returned to a Fluke authorized service center within the warranty

period.

To obtain warranty service, contact your nearest Fluke authorized service center to obtain return authorization

information, then send the product to that service center, with a description of the difficulty, postage and

insurance prepaid (FOB Destination). Fluke assumes no risk for damage in transit. Following warranty repair, the

product will be returned to Buyer, transportation prepaid (FOB Destination). If Fluke determines that failure was

caused by neglect, misuse, contamination, alteration, accident, or abnormal condition of operation or handling,

including overvoltage failures caused by use outside the product’s specified rating, or normal wear and tear of

mechanical components, Fluke will provide an estimate of repair costs and obtain authorization before

commencing the work. Following repair, the product will be returned to the Buyer transportation prepaid and the

Buyer will be billed for the repair and return transportation charges (FOB Shipping Point).

THIS WARRANTY IS BUYER'S SOLE AND EXCLUSIVE REMEDY AND IS IN LIEU OF ALL OTHER

WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF

MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. FLUKE SHALL NOT BE LIABLE FOR

ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOSSES, INCLUDING LOSS

OF DATA, ARISING FROM ANY CAUSE OR THEORY.

Since some countries or states do not allow limitation of the term of an implied warranty, or exclusion or limitation

of incidental or consequential damages, the limitations and exclusions of this warranty may not apply to every

buyer. If any provision of this Warranty is held invalid or unenforceable by a court or other decision-maker of

competent jurisdiction, such holding will not affect the validity or enforceability of any other provision.

11/99

Fluke Corporation

P.O. Box 9090

Everett, WA 98206-9090

U.S.A.

Table of Contents

Title Page

Introduction.......................................................................................................... 1

Contact Fluke ...................................................................................................... 1

Safety Information ............................................................................................... 1

Specifications ...................................................................................................... 3

Maintenance ........................................................................................................ 4

Change the Battery....................................................................................... 4

Clean the Product......................................................................................... 4

Calibration ........................................................................................................... 5

Preliminary Requirements ............................................................................ 5

Required Environmental Conditions for Calibration...................................... 6

Required Equipment..................................................................................... 6

Procedure ..................................................................................................... 7

Setup ............................................................................................................ 7

Black Body Source ................................................................................ 7

Prepare the Black Body Source ............................................................ 8

Prepare the Reference Thermometer System for Measurement .......... 9

Prepare the DUT for Measurement ....................................................... 9

Calibrate the DUT.................................................................................. 10

Analyzing Test Results ................................................................................. 11

User-Replaceable Parts ...................................................................................... 12

67 MAX

Calibration Manual

Introduction

The Fluke 67 MAX IR Thermometer (the Product) is a non-contact, clinical infrared (IR)

thermometer that measures the amount of infrared energy radiated by the subject's skin at a

reference point to determine a subject's temperature.

WWarning

Read all safety information before you use the Product.

For Product use instruction, refer to the 67 MAX Users Manual.

Contact Fluke

Fluke Corporation operates worldwide. For local contact information, go to our website:

www.fluke.com

To register your product, view, print, or download the latest manual or manual supplement, go to

our website.

Safety Information

The Product meets requirements established in ASTM Standard E1965-98 (2016) Standard

Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

and ISO 80601-2-56 Medical electrical equipment part 2-56: Particular requirements for basic

safety and essential performance of clinical thermometers for body temperature measurement.

Public health officials, through their experience, should determine the significance of any fever or

elevated temperature. Should a subject with an elevated temperature or fever be identified, Fluke

recommends that a physician or qualified healthcare provider be consulted.

Fluke Corporation

6920 Seaway Blvd

Everett, WA 98203

+1-425-446-5500

[email protected]

67 MAX

Calibration Manual

Note

• The Product is not FDA Approved or cleared.

• The Product is intended for consumer use and is NOT INTENDED for use to collect

information for medical diagnosing purposes.

• The Product complies with the FDA Enforcement Policy for Clinical Electronic

Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health

Emergency.

Warnings and Cautions

A Warning identifies conditions and procedures that are dangerous to the user. A Caution

identifies conditions and procedures that can cause damage to the Product or effect essential

performance.

WWarning

To prevent personal injury, do not use the Product around explosive gas, vapor, or

in damp or wet environments.

WCaution

To prevent product damage or possible mis-diagnosis of body temperature:

• Read all safety information before you use the Product.

• Have an approved technician repair the Product.

• Do not alter the Product and use only as specified, or the protection supplied by

the Product and its measurement accuracy can be compromised.

• Before you use the Product, inspect the case and optical lens. Look for cracks in

case plastics, scratches, or other damage to the optical lens. Do not use the

Product if it appears damaged.

• Do not use in ambient environments outside of the specified operating

temperature and humidity range or subject the Product to excessive mechanical

shock. Permanent damage to the Product including inaccurate temperature

measurement may result.

• Do not use or store the Product in direct sunlight or near other sources of radiant

heat. This can cause the Product temperature to differ from ambient conditions

and affect measurement accuracy. Allow the Product time to equalize to ambient

conditions before use.

• Do not use the Product if it operates incorrectly.

• Optical lens components must be free of moisture, dust, and debris to ensure

measurement accuracy. Clean and disinfect only as specified.

Infrared Thermometer

Specifications

• Replace the batteries when the low battery indicator shows to prevent incorrect

measurements.

• Do not store the Product for long periods with the battery installed to prevent

battery leakage.

• Repair the Product before use if the battery leaks. Battery leakage may damage

the Product.

• Do not attempt to service the Product.

• Hot or cold ambient temperature conditions can affect skin temperatures and will

impact the temperatures produced.

• Temperature taken from a forehead of the person that is covered by hair, head-

wear (for example, hat or helmet), or sweat may be inaccurate.

• When you take a measurement, maintain a distance of 50 mm to 150 mm (2 in to

6 in) between the Product and the forehead of the person.

• Product must be in body mode for accurate human temperature measurements.

Inaccurate measurements will occur if human temperature measurements are

taken while not in body mode.

See Table 1 for symbols used on the Product and in this manual.

Specifications

For Product specifications, refer to the 67 MAX Users Manual.

Table 1. Symbols

Symbol Meaning Symbol Meaning

WARNING - RISK OF

DANGER.

Consult user documentation.

Operating ambient

temperature

(59 °F to 104 °F)

(15 °C to 40 °C)

Measured temperature range

(72 °F to 109 °F)

(22 °C to 43 °C)

Storage temperature

(-4 °F to 122 °F)

(-20 °C to 50 °C)

Battery/Power

Ô

Manufacturer

Date of Manufacture

Serial Number

Medical Device

Catalog Number

Protected against the ingress of >1

mm diameter solid foreign objects

and dripping water

67 MAX

Calibration Manual

Maintenance

Change the Battery

To install or change the AA IEC LR6 battery, open the battery compartment and replace the

battery as shown in Figure 1. Battery should be replaced when the low-battery indicator appears.

• Dispose of battery when low battery is indicated or when the unit dies.

• Do not dispose of this Product or product battery as unsorted municipal waste.

Clean the Product

Use 70 % isopropyl alcohol on a sponge or soft cloth to clean the Product case. A swab may be

used to clean the IR lens. See Figure 1.

WCaution

Do not submerge the Product.

Figure 1. Change the Battery and Clean the Product

Infrared Thermometer

Calibration

This section of the manual provides instructions for the in-house verification of the Product. In

this section, the Product is referred to as the DUT (device under test).

Calibration consists of these procedures:

• Comparison of a known value with an unknown value.

• Verification of the DUT that tests each function and range for compliance to specifications.

After you do this procedure, if the DUT does not meet its specifications, it should be sent to a

qualified Fluke Service Center for adjustment. See Contact Fluke.

Preliminary Requirements

WCaution

To prevent damage to the Product and prevent incorrect readings:

• Do not drop the DUT.

• Handle the DUT with care.

• Do not touch the DUT lens and keep it free of contamination.

• Handle the test equipment with care and follow recommended best practices for

its use.

WWarning

To prevent possible electrical shock, fire, or personal injury:

• Even though these documented procedure do not require higher temperatures, be

aware that the black body source target temperature can be a burn hazard if it is

set accordingly.

• The reference equipment has line voltage that is lethal. Ensure that power is

disconnected if the equipment is being serviced.

• Do not use the equipment if covers are missing and if power cords are not in a

safe condition.

67 MAX

Calibration Manual

Required Environmental Conditions for Calibration

Ambient temperature and humidity must be stable during calibration:

• Temperature range: 73 °F ±3 °F (23 °C ±3 °C)

• Ambient relative humidity: <70 %RH

During this process:

• Keep the DUT lens housing at a constant temperature. Do not hold the DUT by hand on the

lens housing. Do not place the DUT in a location where the lens housing would be exposed to

a temperature that is different than ambient temperature.

• Do not do the calibration process in a high-traffic area unless high emissivity, IR-blocking

guards are installed on the calibration station.

• Make sure the black body source is not placed near a building vent or a device with a fan that

blows air across the target to cause a convection temperature error and a temperature

instability problem.

• Make sure there are no heat sources facing the black body source that will cause reflected

radiation error. This includes any device or radiating body that has a body temperature of

≥30 °C. Common sources of radiation of this type include:

• exterior windows

•coffee makers

• calibration instruments (furnaces, baths, other black body sources)

• heaters

• HVAC vents

• lamps

• human bodies

Required Equipment

Tab le 2 shows the required equipment necessary for these tests. Make sure to read the safety

information and other product documentation for this equipment.

Infrared Thermometer

Calibration

Table 2. Recommended Reference Equipment and Specifications

Procedure

Visual Inspection

Inspect the DUT for visual signs of damage. If you find a problem, correct it before you continue

with this procedure. Examine the lens for debris or damage. If negligible dirt or damage is found,

proceed with the test.

Inspect the black body source and make sure that the display works correctly and that the target

is clean and free of any debris, contamination (fingerprints or chemical stain), and that the paint is

in good condition with no visible scrapes or cracks. Make sure that the vent fan, fan grill, and vent

ports are clean and free of dust and debris.

Inspect the reference thermometer for damage such as bends or dents in the sheath and cracked

or frayed cabling. Ensure the thermometer fits easily into the 4180 measurement well.

Setup

Fluke highly recommends that a calibration fixture be used.

Black Body Source

The calibration station consists of black body sources that are measured by a precision

thermistor thermometer and a thermometer readout. This combination of equipment is referred to

as the Precision Black Body Source (PBBS).

Classification Minimum Use Specifications Suggested Equipment

Black Body Source

Range:

Stability:

Resolution:

True Emissivity:

°C to 50 °C

0.1

°C

0.01

°C

>0.9

Fluke Calibration 4180

Reference

Thermometer

Readout

Range:

Uncertainty:

5 kΩ to 10 kΩ

100 µΩ/Ω (0.003 °C)

Fluke Calibration 1504

or better

Reference

Thermometer

Sheath Diameter:

Sheath Length:

Range:

Uncertainty:

1/8 in

6 in or 9 in

°C to 50 °C

0.01 °C calibration

0.01 °C long-term drift

Fluke Calibration 5610

67 MAX

Calibration Manual

Figure 2. Precision Black Body Source System (PBBS)

Prepare the Black Body Source

Make sure that the black body is powered on and is allowed to warm up for at least 1 hour.

To configure the black body:

1. Remove the target cover.

2. Set the apparent emissivity setting to 0.98.

84.9814 C

Infrared Thermometer

Calibration

3. On the black body menu:

a. Push F1 > TEMP SETUP

b. Select IRT

c. Push ENTER to allow you to edit this field and type in 0.98.

d. Push ENTER to save the value.

Prepare the Reference Thermometer System for Measurement

To prepare the Reference Thermometer System for Measurement:

1. Make sure that the reference thermometer readout is powered on and allowed to warm up for

at least 1 hour.

2. Make sure that the reference thermistor calibration coefficients are entered into the reference

thermometer readout. See the Users Manual for more information on how to enter

coefficients.

3. Insert the reference thermometer into the contact measurement well of the 4180. Ensure the

tip of the thermistor is touching the bottom of the well at a depth of 13.3 cm (5.25 inches) as

measured from the outside chassis of the black body source.

Prepare the DUT for Measurement

To prepare the DUT for Measurement:

1. Make sure that the DUT has been in the calibration ambient conditions for at least 1 hour if it

has been in ambient conditions that are within the product specified operating range for at

least 4 hours. Otherwise, then allow it to stabilize in the calibration ambient conditions for at

least 4 hours before beginning calibration.

2. Ensure the DUT batteries have enough life to complete the verification steps without having

to be replaced.

3. Turn Body mode OFF.

4. The measurement distance from the front of the DUT lens housing to the black body target

surface is 10 cm.

If a calibration fixture is used:

1. Insert the DUT into the fixture.

2. Align the DUT optics (measurement spot) with the center of the black body target.

3. Ensure that the optics meet the measurement distance of 10 cm away from the target (see

Figure 3).

67 MAX

Calibration Manual

Figure 3. Measurement Distance

Calibrate the DUT

To Calibrate the DUT:

1. Set the black body source to the required temperature point and allow it time to ramp,

stabilize, and equilibrate (approximately 30 minutes in addition to the 1-hour warmup period).

2. Position the DUT in front of the black body source. Ensure the DUT optics are aligned to

measure the center of the target.

3. If the DUT is being held in hand, the technician must hold the DUT at the correct

measurement distance while ensuring that the DUT is geometrically centered on the target.

Fluke highly recommends that a calibration fixture be used.

4. Simultaneously record the DUT IR temperature readings, ambient temperature, and

reference thermometer readings with these instructions.

a. Set the DUT to measure for at least 10 seconds.

b. Record the ambient temperature.

c. Record the reference thermometer indication.

d. Repeat until at least 5 samples are obtained.

Measurement Distance (d)

Infrared Thermometer

Calibration

5. Calculate and record the average of the ambient temperature measurements. Compare the

average with the Ambient Temperature Limit listed in Table 3. If the average temperature

exceeds this limit, make sure the distance is correct and repeat the test.

6. Calculate and record average and standard deviation of the DUT IR temperature

measurements and the reference thermometer measurements.

7. Compare the standard deviations, calculated in step 6, to the maximum limits detailed in

Tab le 3. If any of the limits are exceeded, retry the test point.

8. Repeat these steps for the remainder of the required test points.

See Table 3 for a list of the required calibration points, calibration process limits, and parameters.

Analyzing Test Results

Display Error

Calculate the DUT temperature display error for each reported calibration point. The display error

for each test point is calculated as:

Display_Error = Average_DUT_Indication - Average_Compensated_Reference.

Average_Compensated_Reference calculation is required because the DUT emissivity setting of

0.98 does not match the true surface emissivity of the black body source.

To calculate the Average_Compensated_Reference:

Equation 1:

Equation 2:

Where k

= 9223.527 and k

= 166.1701 and T is measured in degrees Celsius. Equations 1 and

2 allow for the conversion to and from radiometric power, P.

Table 3. DUT Calibration Points and Process Parameters

Test Points

(

°C) Minimum

No. of

Samples

(Reference

Thermometer)

Minimum No.

of Samples

(DUT)

Maximum

Reference

Thermometer

Std. Deviation

Limit (1

σ, °C)

Maximum DUT

Std. Deviation

Limit (1

σ, °C)

Ambient

Temperature

Limit (

°C)

[Max - Min]

22 5 5 0.01 0.05 1

30 5 5 0.01 0.05 1

38 5 5 0.01 0.05 1

43 5 5 0.01 0.05 1

67 MAX

Calibration Manual

First, convert the averaged reference thermometer temperature to radiometric power, P(T

src

Then, convert the averaged ambient temperature to radiometric power, P(T

amb

). Use Equation 3

to calculate the emissivity-corrected radiometric power.

Equation 3:

Where

4180

is the true emissivity of the 4180 plate. This value typically comes from a special

calibration report.

Finally, use Equation 2 to convert radiometric power back to degrees Celsius, T

src

0.98

. This value

is the Average_Compensated_Reference that is used in the display error calculation. Compare

Display_Error with DUT specification to verify compliance with specification.

User-Replaceable Parts

To order replacement parts, call one of the numbers listed under Contact Fluke. User-replaceable

parts are listed in Table 4.

Table 4. User-Replaceable Parts

Qty

Fluke Part

Number

Description

1 376756

BATTERY,PRIMARY,ZN-

MNO2,1.5V,2.24AH,15A,LR6,ALKALINE,AA,14X50MM,BULK

1 4103199 FLUKE-62MAX-2014,BATTERY DOOR ASSEMBLY

1 5224967 FLUKE-67 MAX-8002,LEFT DECAL,3M DROP

1 5224971 FLUKE-67 MAX-8003,RIGHT DECAL,SAFETY MARKINGS

1 5224845 FLUKE-67 MAX-8001,REAR DECAL

Fluke Models: 67 MAX Clinical Infrared Thermometer User manual

Fluke Models: 67 MAX Clinical Infrared Thermometer User manual

Fluke Models: 67 MAX Clinical Infrared Thermometer User manual

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