Codes; Introduction; Intended Use; Declaration Of Confomity - Mopedia RS844 Manual De Instrucciones

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

1. CODES

RS844 - Tilting shower and WC chair with 4 castors
- Demountable shower and WC chair with 4 castors
RS846
RS847 - Self propelled shower and WC chair
RS848 - Foldable shower and WC chair with 4 castors

2. INTRODUCTION

Thank you for choosing a MOPEDIA shower and WC chair by Moretti S.p.A. MOPEDIA shower
and WC chair manufactured by Moretti S.p.A. are designed to satisfy all your requirements for
a practical, correct and safe use. This manual provides some useful suggestions to correctly
use the device you have selected and offers valuable advices for your safety. We recommend
carefully reading the entire manual before using the hospital bed you have purchased. Should
you have any queries, please contact your retailer for proper advice or assistance.
NOTE: Check all parts of the product have not been damaged during shipment. In case of
damage do not use the product and contact your dealer for further instructions.
CAUTION!
• Do not use the following device for purposes other than those described in this manual.
• Moretti S.p.A. disclaims any liability for damage resulting from improper use of the
device or use other than that described in this manual.
• We reserve the right to make changes to the device and this manual without notice in
order to improve the characteristics.

3. INTENDED USE

The MOPEDIA shower and WC chairs are created for people with movement difficulty and can be
used indoors as substitution of toilet or as aid under the shower.

4. DECLARATION OF CONFOMITY

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 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.
I Class Medical Device
of 5 April 2017 concerning medical devices
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