Mopedia RS921, 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
RS921 Wood bath chair
RS922 Wood bath chair
RS923 Moplen bath chairs
RS925 Moplen bath chairs
2. INTRODUCTION
Thank you for purchasing a MOPEDIA bath products by Moretti S.p.A. product range. This
user’s manual provides some suggestions as how to correctly use the product you have
chosen and gives some valuable advice for your safety. Please read through the manual
carefully before using the product. Should you have any queries, please contact your retailer
for advice and assistance. In case of doubts, we recommend to contact the dealer who can
help and advice you properly.
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 wood bath chair 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
Moretti S.p.A.and belonging to the group of BATH CHAIRS 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.