Mopedia RP440, Instruction Manual

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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
RP440 Bidet and wc Duo raised toilet seat - h 10 cm
2. INTRODUCTION
Thank you for purchasing universal raised bidet and wc seat 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 bidet and wc seat 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 bidet and wc seat is a device to help people with movement
difficulties using the bidet and wc seat.
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
Moretti S.p.A.and belonging to the group of 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.