Mopedia RP420, 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
RP418 Raised toilet seat 12cm
RP420 Raised toilet seat 13 cm with armrests
2. INTRODUCTION
Thank you for purchasing raised toilet seats MOPEDIA by Moretti S.p.A. manufactured to
support people with movement difficulty. Their design and their quality guarantee maximum
comfort, liability and safety. MOPEDIA by Moretti S.p.A. 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.
Note Check if any part has shipping damages and test before using. In case of damage, do
not use the device. Contact your dealer for further instructions.
3. INTENDED USE
The wall shower bench by Moretti is intended for disable patient assistance in bath operations.
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 SEAT - 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.