Codes; Introduction; Intended Use; Declaration Of Conformity - Moretti Mopedia RS972-30 Manual De Instrucciones

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5

1. CODES

RS972-30 Ø 36 mm - bath handle 30 cm
RS972-45 Ø 36 mm - bath handle 45 cm
RS972-60 Ø 36 mm - bath handle 60 cm

2. INTRODUCTION

Thank you for purchasing a MOPEDIA bath handle by Moretti S.p.A. 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.
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.

3. INTENDED USE

The MOPEDIA safety bath handle by Moretti is a bathroom aid for people with motor difficulty.

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
April 2017 concerning medical devices
3