Keeler Loupe Frame, Инструкция по эксплуатации

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EN
KEELER LOUPE FRAME
Consult instructions for use General warning sign
Date of manufacture Conformité Européene
Manufacturer’s name and
address
Temperature limit
Country of manufacture
Authorised representative in
the European Community
Waste Electrical and Electronic
Equipment (WEEE) recycling
Catalogue number
This way up Batch code
Keep dry
Atmospheric pressure
limitation
Fragile Humidity limitation
Do not use if package is
damaged
Translation
The Keeler Loupe Frame is designed and built in conformity with Directive 93/42/EEC, Regulation (EU) 2017/745
and ISO 13485 Medical Devices Quality Management Systems.
Classifi cation: CE: Class I
FDA: Class II
The information contained within this manual must not be reproduced in whole or part without the manufacturer’s
prior written approval. As part of our policy for continued product development we the manufacturer reserve the right
to make changes to specifi cations and other information contained in this document without prior notice.
This IFU is also available on the Keeler UK and Keeler USA websites.
Copyright © Keeler Limited 2021. Published in the UK 2021.
1. INDICATIONS FOR USE
Intended use / purpose of instrument
The Keeler Loupes and Frames are intended for use in various clinical settings including but
not limited to users in dental practices, ophthalmology clinics, operating theatres, hospitals,
veterinary practices, private consulting rooms and surgical environments and used by trained
students and experienced professionals.
1.1 WARNINGS AND CAUTIONS
Please note that the proper and safe functioning of our instruments is only guaranteed if both
the instruments and their accessories are exclusively from Keeler Ltd.