Idiomas disponibles
Idiomas disponibles
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
1. CODE
RP751
Aluminum rollator with 2 levers - 2 swivel wheels with lock - 2 fixed wheels with brakes
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. 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.
Note:
Complete product codes, the manufacturer registration code (SRN), the UDI-DI code
and any references to used regulations are included in the EU declaration of conformity that
Moretti S.p.A. releases and makes available through its channels.
I Class Medical Device
of 5 April 2017 concerning medical devices
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