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The Braun Thermoscan® IRT 4000 series and Braun Thermoscan@PRO 4000 series Clinical Infrared Ear Thermometers is indicated for the intermittent measurement and monitoring of thuman body temperature by consumers of all ages in a home use professional use environment respectively. The probecover is used as a santary barnier between the mometer and the car canal.

The Braun Thermoscan® Pro/IRT 4000 series thermometer is a hand held instrument that measures human body temperature through the opening of the auditory canal. It is a single mode ear thermometer that measures the natural thermal infrared radiation emitted from the tympanic membrane and adjacent surfaces with a built-in correction algorithm to compensate the influence of ambient temperature using a heated tip. The difference between the Pro 4000 series thermometer and the IRT 4000 series thermometer is that the Pro 4000 series sories themselver and any professional use in hospitals and healthcare or professional office settings, while the IRT 4000 series is meant for home use. There is no change to the thermometer or its manufacture as part of the modification described in this submission. The probe cover (also called as lens filter) is a disposable plastic cover made of a biocompatible clarified polypropylene material (Pacur) that is dimensionally manufactured to set tolerances so that it can be fitted on the probe tip of the thermometer. The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal to prevent any ear secretions or particulates from being transferred between different people.