
3
I Class Medical Device
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017 concerning medical devices
1. CODES
MP170 Cromed Universal Telescopic bedside rails
MP171 White Universal Telescopic bedside rails
2. INTRODUCTION
Thank you for choosing a Telescopic bedside rail by MOPEDIA, manufactured by MORETTI
S.p.A. Their design and quality are a guarantee of comfort, safety and reliability. Telescopic
bedside rails by MOPEDIA by MORETTI S.p.A. are designed and built to meet all your demands
for a practical, correct use. This user manual provides for some suggestions as to how correctly
use the aid you have chosen and offers a lot of valuable advices for your safety. Please read
carefully through the manual before using the Telescopic bedside rails. Should you have any
queries, please contact your retailer for advice and assistance.
NOTE: Check that the product has not been damaged during shipment. In case of
damage do not use it and contact your dealer for further instructions.
3. INTENDED USE
The bedside rail is a universal accessory designed to prevent an accidental fall of a person from
a bed for hospital or home care.
WARNING!
• 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 frame of 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
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.