Codes; Introduction; Intended Use; Declaration Of Conformity - Mopedia RP691 Manual De Instrucciones

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

1. CODES

RP691 4-wheel steel rollator with antibrachium rest ERA

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 - MOPEDIA 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
I Class Medical Device
of 5 April 2017 concerning medical devices
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