Mopedia RC300-43, Instruction Manual

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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
RC300-43 4-tip height-adjustable commode chair - 43 cm
RC300-45 4-tip height-adjustable commode chair - 45 cm
RC300-48 4-tip height-adjustable commode chair - 48 cm
RC310-43 4-wheel commode chair - 43 cm
RC310-45 4-wheel commode chair - 45 cm
RC310-48 4-wheel commode chair - 48 cm
RC320-43 4-wheel folding commode chair - 43 cm
2. INTRODUCTION
Thank you for choosing a MOPEDIA commode chair by MORETTI S.p.A., designed to assist
people who have difficulties in walking, evacuation and mobility. The product satisfies the
requirements of current European regulations on medical devices (2017/745). This user manual
contains some suggestions on how to use the device properly and safely. Please read this entire
manual carefully before you use the device. Should you have any queries, please contact your
retailer for suitable advice and assistance.
NB Check to ensure that no parts of the device have been damaged during shipment. Do not
use the product if it is damaged and contact the retailer for further instructions.
3. INTENDED USE
Commode seats are devices to assist in evacuation and mobility for people with walking
difficulties.
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 this manual
without prior notice, in order to improve its features
4. EU 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 INVESTIGATIONS.
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.