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PM-1157-01-07/2013
Intended Use
Medical product’s intended use as determined by the manufacturer.
The device is a digital ear thermometer to measure the infrared heat given off by the
eardrum and surrounding tissues, and converts this heat into an equivalent ear
temperature.
Application field:
This device is designed for use in a physician’s office, hospitals, clinics and other
medical facilities as well as home use.
User:
This device may be used by a medical professional or adult on themselves or
children. The device is intended for use on adults and children as well as babies.
Intended Use of the Probe Covers
Medical product’s intended use as determined by the manufacturer.
The probe cover is designed to be used on the Omron Gentle Temp 520 digital ear
thermometer. It protects the sensor from dirt and ear wax to ensure accurate
measurements.
Application field:
This device is designed for use in a physician’s office, hospitals, clinics and other
medical facilities as well as home use.
User:
This device may be used by a medical professional or adult on themselves or
children. The device is intended for use on adults and children as well as babies.
