Mopedia GAYA 2.0, Instruction Manual

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3
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
RP540
4-wheel aluminum rollator with seat and footrest GAYA 2.0
RP545 4-wheel aluminum rollator demountable with seat OCEANO 2.0
RP550 4-wheel aluminum rollator with seat URANO 2.0
RP551 4-wheel aluminum rollator with seat and antibrachial support SATURNO
2. INTRODUCTION
Thank you for choosing a MOPEDIA range rollators by Moretti S.p.A. MOPEDIA range rollators
manufactured by Moretti S.p.A. are designed to satisfy all your requirements for practical, correct
and safe use. This manual provides some useful suggestions for correctly using the device you
have selected and offers valuable advice for your safety. We recommend reading the entire manual
carefully before using the rollator you have purchased. Should you have any queries, please contact
your retailer for proper advice or assistance.
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 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 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
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.