Code; Introduction; Intended Use; Declaration Of Conformity - Mopedia RP513 Manual De Instrucciones

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

1. CODE

RP513 4-wheel aluminum rollator with seat ATLANTE MINI

2. INTRODUCTION

Thank you for purchasing the rollator, MOPEDIA by MORETTI S.p.A., realized to help people with
movement difficulty inward and outward, during voyages or in everyday life. The production has
been made according to the highest quality and safety standards in accordance with European
Directive on Medical devices (2017/745).
This instruction manual gives you suggestion for a correct use and for your safety. We recommend
you to read carefully this instruction manual before using. In case of doubts, please contact your
dealer.
Note: Check all parts to verify it won't be any shipping damage. In case of shipping damages, do
not use. Contact the dealer for further instructions.
WARNING!
• Do not use the product for a purpose not indicated in this manual.
• Moretti Spa declines all responsibilities for any consequences resulting from an incorrect
use of this product and from a different use compared to what indicated in this manual.
• The manufacturer can modify the device or the instruction manual without
prior notification.

3. INTENDED USE

This rollator fits for people with movement problems. Can be used as assistance to facilitate
ambulation or even servo-assisted ambulatory. The rollator provides stability, support and security
during thr deambulation. Anyway, it can't be used by people with evident malfunction of the hand
or the arm, even by people with balance problems. The rollator can be used inward and outward.
We recommend using on flat surface where the wheels can reach the land. It can't be used on
rock ground or on slanted area as the rollator can be unstable. The device is not intended to carry
people or things.

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 ROLLATORS 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.
I Class Medical Device
of 5 April 2017 concerning medical devices
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