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Idiomas disponibles
Idiomas disponibles
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
1. CODES
MP180
Anodized aluminum folding bedside rails - pair
MP181
Painted steel folding bedside rails - pair
2. INTRODUCTION
Thank you for choosing an accessory MOPEDIA by Moretti. The bedside rails have been
designed and built to meet all your needs for a practical correct use, correctly and safely. This
manual contains some suggestions for proper use of the accessory and valuable tips for your
safety. You should read this manual carefully before using the bedside rails. Should you have
any queries, please contact your retailer for advice and assistance.
3. INTENDED USE
The bedside rail is an accessory designed to prevent an accidental fall of a person from a any
bed for hospital or home care.
CAUTION!
• Do not use the following device for purposes other than those described in this
manual.
• Moretti S.p.A. disclaims any liability for damage resulting from improper use of the
device or use other than that described in this manual.
• We reserve the right to make changes to the device and this manual without notice in
order to improve the characteristics.
4. DECLARATION OF CONFORMITY
Moretti S.p.A. declares under its sole responsibility that the product made and traded by
Moretti S.p.A.and belonging to the group of ACCESSORIES FOR BEDS complies with the provi-
sions of the regulation 2017/745 on MEDICAL DEVICES of 5 April 2017.
For this purpose, Moretti S.p.A. guarantees and declares under its sole responsibility what
follows:
1. The devices satisfy the requirements of general safety and performance requested by
the Annex I of regulation 2017/745 as laid down by the Annex IV of the above mentioned
regulation.
2. The devices ARE NOT MEASURING INSTRUMENTS.
3. The devices ARE NOT MADE FOR CLINICAL TESTS.
4. The devices are packed in NON-STERILE BOX.
5. The devices belong to class I in accordance with the provisions of Annex VIII of the above
mentioned regulation
6. Moretti S.p.A. provides to the Competent Authorities the technical documentation to
prove the conformity to the 2017/745 regulation, for at least 10 years from the last lot
production.
Note:
Complete product codes, the manufacturer registration code (SRN), the UDI-DI code
and any references to used regulations are included in the EU declaration of conformity that
Moretti S.p.A. releases and makes available through its channels.
I Class Medical Device
of 5 April 2017 concerning medical devices
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