Mopedia RS810, Instruction Manual

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3
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
RS810 Plastic bathtub seat with handle
RS815 Fodable bath bench
RS817 Bath stool
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 bath chair by Moretti is intended for disable patient assistance in bath tub
CAUTION!
• 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 SHOWER – BATHROOM 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.