Moretti MOPEDIA RP513, Instruction Manual

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. 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.