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Idiomas disponibles
Idiomas disponibles
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
1. CODES
MP167 - Folding half-length bedrail
MP168 - Large folding bedrail
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 use, correctly and safely. This manual
contains some suggestions for proper use of the accessory of your choice and valuable tips
for your safety. You should read carefully all of this manual before using the bedside rails.
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.
• Always pay close attention to the presence of moving parts that could cause
limb entrapment and injury.
• Always pay attention to the presence of children.
3. INTENDED USE
Folding half-length bedrail is an accessory designed to prevent an accidental fall of a person
from a any bed. It may provide a useful support to facilitate the raising and the seat from the
bed and can be placed, optionally on both sides of the bed.
4. DECLARATION OF CONFOMITY
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 BEDS - TULIPANO complies with the provisions 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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