Codes; Introduction; Intended Use; Declaration Of Conformity - Mopedia RS950 Manual De Instrucciones

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

1. CODES

RS950 Safety bath handle 30cm
RS951 Safety bath handle 40cm
RS952 Safety bath handle 45cm
RS953 Safety bath handle 60cm
RS954 Safety bath handle 80cm

2. INTRODUCTION

Thank you for choosing a Safety bath handle from the MOPEDIA by MORETTI S.p.A. Their design and
quality are a guarantee of comfort, safety and reliability. The Safety bath handles from the MOPEDIA
by MORETTI S.p.A. are designed and built to meet all your demands for a practical and correct use.
This user manual provides some suggestions as how to use the item you have chosen correctly and
offers a lots of valuable advices for your safety. Please read carefully this manual before using the
metal ward screen. Should you have any queries, please contact your retailer for advice and assistance.

3. INTENDED USE

The Safety bath handle from the MOPEDIA is a device made to support people with movement
difficulty and allow the patient to get up and sit down on the WC toilet easier.
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 SAFETY BATH HANDLES complies with the provi-
sions 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.
I Class Medical Device
of 5 April 2017 concerning medical devices
3