Codes; Introduction; Intended Use; Declaration Of Conformity - Mopedia RC325 Serie Manual De Instrucciones

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

1. CODES

RC325-xx* Commode chair with adjustable backrest, 125 mm wheels
RC330-xx* Commode chair with adjustable backrest, 200 mm wheels
RC340-xx* Commode chair with adjustable backrest, 600 mm rear wheels
RC345-XX* Commode chair with adjustable backrest, 600 mm front wheels
*xx corresponds with the width of the seat and the relative backrest with dimensions:
(40-43-46-48-50) cm

2. INTRODUCTION

Thank you for choosing a commode chair in the MOPEDIA range by Moretti. The MOPEDIA
commode chairs by Moretti have been designed and constructed to satisfy all your needs for
practical, correct and safe use. This manual contains useful suggestions for using your device
properly and safely.
Please read this manual in full before you use the commode chair you have purchased. Should
you have any queries, please contact your dealer for suitable advice and assistance.
NB Check to ensure that no parts of the product have been damaged during shipment. Do not
use the product if it is damaged and contact the retailer for further instructions.
WARNING!
• Do not use the product for any purpose other than that specified in this manual
• Moretti S.p.A. declines any and all liability for damages resulting from improper
use of the device or any use other than that specified in this manual
• The manufacturer reserves the right to modify the device and its relevant manual
without prior notice, in order to improve the product's features

3. INTENDED USE

The MOPEDIA commode chairs are intended for the transport and movement of people with
mobility impairments in indoor environments: at hospitals and/or healthcare structures and
entities or at home.

4. DECLARATION OF CONFORMITY

MORETTI SpA declares, under its own exclusive responsibility, that the products made and
sold by MORETTI SpA in the COMMODE CHAIRS - MOPEDIA product family conform with the
applicable provisions of Regulation (EU) 2017/745 of 5 April 2017 on MEDICAL DEVICES.
To this end, MORETTI SpA guarantees and declares as follows, under its own exclusive
responsibility:
1. The devices in question satisfy the general safety and performance requirements set out
in Annex I to Regulation (EU) 2017/745, as prescribed by Annex IV to said regulation.
2. The devices in question ARE NOT MEASUREMENT TOOLS.
3. The devices in question ARE NOT INTENDED FOR CLINICAL INVESTIGATION.
4. The devices in question are sold in NON STERILE packing.
5. The devices in question should be considered as belonging to class I, in accordance with the
rules set out in Annex VIII to said regulation.
Class I medical device
of 5 April 2017 on medical devices
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