Codes; Introduction; Intended Use; Declaration Of Conformity - Mopedia CROSSY FIX Manual De Instrucciones

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

1. CODES

RP922 CROSSY FIX - Pedal exerciser in painted steel
RP924 CROSSY FOLDY - Folding pedal exerciser in painted steel
RP926 CROSSY TOP - Folding pedal exerciser in painted steel, with display

2. INTRODUCTION

Thank you for choosing a MOPEDIA pedal exerciser by Moretti S.p.A. The Moretti pedal
exercisers are designed and built to meet all your demands for a practical, correct and safe
use. This user manual provides some suggestions as to how correctly use the device you have
chosen and offers a lots of valuable advice for your safety. Please read carefully through the
manual before using the pedal exerciser. Should you have any queries, please contact your
retailer for advice and assistance.
Note: Check that all parts of the product have not been damaged during the shipment. In case
of damage do not use the product and contact the retailer for further instructions.
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.

3. INTENDED USE

The pedal exerciser is a medical device indicated for people with mobility difficulties and it is
indicated to reestablish coordination and the muscle mass of arms and legs.

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 PEDAL EXERCISERS 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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