Mopedia RP675, Instruction Manual

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ENGLISH
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
RP675
2-wheel steel rollator without seat POSEIDON
RP680 2-wheel steel rollator with seat ZEUS
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.
3.INTENDED USE
This rollator fit for people with movement problems. Can be used as assistance to facilitate
ambulation or even servo-assisted ambulatory. 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.
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 unauthorized alteration to the frame
of the product. The manufacturer can modify the device or the instruction
manual without prior notification.
4. DECLARATION OF CONFORMITY
Moretti S.p.A. declares under its sole responsibility that the product made and traded by Mo-
retti 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