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FDA: Source: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/non-contact-infrared-thermometers)

Preparing the Person being Evaluated for No-contact Infrared Thermometers (NCIT)

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:

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 and used at distance identified in manufacturer’s instructions.

Figure 2: Incorrect Use – Not perpendicular to forehead

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.

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