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elepho eClear - Foreward; Declaration of Conformity; Product Type

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3
Thank you for choosing the eClear from Elepho Inc. This product is used to clean a baby’s nose from
mucus which is difficult to extract natually.
This product is for consumer use; it is made up of precise components; please keep it away from
high temperature, humid environments, sunlight and dust. For correctly use, please read this user
manual. Please keep it for future reference as required.
This product is designed according to the Standard IEC 60601-1: 2012, Medical electrical
equipment Part 1: General requirements for basic safety and essential performance and ANSI/
AAMI ES60601-1:2005/(R) 2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012.
This device has been tested in accordance with IEC 60601-1-2:2014 for EMC. This does not
guarantee in any way that the device will not be affected by electromagnetic interference. Avoid
using the device in high electromagnetic environment.
The product is classified as Class II ME equipment when it works with an adapter.
The product is internally powered when it is battery operated.
3.1 - Intended Use
The device which is a portable, hand-held, reusable, battery-powered suction device is intended to
enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant
or child to facilitate easier breathing in a home care environment.
3.2 - Contraindications
Babies or children with the following symptoms should not use this product:
1) Nasal bleeding
2) Coagulopathy (condition of excessive bleeding or clotting or any other bleeding disorder)
3) Cartilage damage or nose injury
4) Acute head, facial or neck injury.
3.3 - Lifespan
The lifespan of the product is 5 years.
1. Foreward
2. Declaration of conformity
3. Product type