Codes; Introduction; Intended Use; Declaration Of Conformity - Mopedia ST340 Manual De Instrucciones

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL of 5 April 2017 concerning medical devices

1. CODES

ST340 Swivwl cushion
ST345 Wedge-shaped cushion Memory Foam
ST346 Lombar cushion Memory Foam
ST350L Memory foam half cylinder cushion for legs L
ST350S Memory foam half cylinder cushion for legs S
ST352 Cilinder cushion TWIST
ST383-1 Semi-cylindrical polyurethane coated leg positioner
ST383-2 Semi-cylindrical polyester coated leg positioner
ST385-1 Polyurethane coated triangular ergonomic positioner
ST385-2 Polyester coated triangular ergonomic positioner
ST386-1 Polyurethane coated ergonomic leg positioner
ST386-2 Polyester coated ergonomic leg positioner
ST387-1 Polyurethane coated multifunctional positioner cushion
ST387-2 Polyester coated multifunctional positioner cushion
ST388-1 Polyurethane coated orthopedic back support pillow
ST388-2 Polyester coated orthopedic back support pillow

2. INTRODUCTION

Thank you for purchasing an OPERA cushion of the line MOPEDIA by Moretti. The cushions are
designed and realized to meet all your needs for a practical, proper and safe use. 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.

3. INTENDED USE

The patient cushions of the line MOPEDIA by Moretti are devices to be used to give relief to the
patient during sitting, rest, in case of post-operative courses.
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 CUSHIONS FOR PATIENTS 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.
I Class Medical Device
3