Moretti Mopedia RC400 Series, Инструкция по эксплуатации

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ENGLISH
Class I medical device
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017 on medical devices
1. CODES
RC400-XX Propelled fixed frame wheelchair
RC410-XX Self-propelled fixed frame wheelchair
*XX = seat sizes 40-43-45-48 cm
2. INTRODUCTION
Thank you for choosing a fixed frame wheelchair in the MOPEDIA range by Moretti. The
MOPEDIA fixed frame wheelchairs 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 fixed frame wheelchair 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.
3. INTENDED USE
The MOPEDIA fixed frame wheelchairs 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.
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
4. DECLARATION OF CONFORMITY
MORETTI SpA declares, under its own exclusive responsibility, that the products made and sold
by MORETTI SpA in the fixed frame wheelchairs - 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.
6. MORETTI SpA maintains and provides to the competent authorities, for at least ten years
from the date of manufacture of the last production lot, the technical documentation
proving conformity with Regulation (EU) 2017/745.