Codes; Introduction; Intended Use; Declaration Of Conformity - Mopedia MP310 Manual De Instrucciones

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

1. CODES

MP310 Premium bed rail protector cm 134 x 33 x 3h
MP315 Folding bed rail protector cm 127 x 66 x 2.5h

2. INTRODUCTION

Thank you for purchasing a Mopedia bed rail protector by Moretti S.p.A. These devices are designed
and realized to meet all your needs for a practical, proper and safe use. This user's manual provides
some suggestions as how to correctly use the product you have chosen and gives some valuable
advice for your safety. Please read through the manual carefully before using the product. Should
you have any queries, please contact your retailer for advice and assistance.

3. INTENDED USE

The MOPEDIA by Moretti bed rail protectors are designed to protect the patient from possible
critical accidental injury against the sides of the bed.
ATTENZIONE! ATTENZIONE!
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• Do not use the product for a purpose not indicated in this manual
• Moretti S.p.A declines all responsibilities for any consequences resulting
from an incorrect use of this product and from unauthorized alteration to the
the product
• The manufacturer reserves the right to change the information contained
in this document without previous notice.

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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