Mopedia GAYA 2.0, 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. 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.