Codes; Introduction; Intended Use; Declaration Of Conformity - Moretti Mopedia RP435-6 Manual De Instrucciones

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

1. CODES

RP435-6 PU universal raised toilet seat (6 cm)
RP435-10 PU universal raised toilet seat (10 cm)

2. INTRODUCTION

Thank you for purchasing universal raised toilet seats MOPEDIA by Moretti manufactured to
support people with movement difficulty. Their design and their quality guarantee maximum
comfort, liability and safety. MOPEDIA by Moretti universal raised toilet seats are designed
and realised to satisfy all your needs. This instruction manual contains some useful tips for a
correct use of the device you have bought as well as some important advises for your safety. In
case of doubts, please contact your retailer who will be able to help you correctly.

3. INTENDED USE

The MOPEDIA universal raised toilet seat is a device to help people with movement difficulties
using the wc.
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 RAISED TOILET SEATS - 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.
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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