Codes; Introduction; Intended Use; Eu Declaration Of Conformity - Moretti Mobility CM900-41 Manual Del Usuario

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

1. CODES

CM900-41 "Escape DX" electric wheelchair with 41 cm seat
CM900-46 "Escape DX" electric wheelchair with 46 cm seat
CM900L-41 "Escape DX" electric wheelchair with lights and 41 cm seat
CM900L-46 "Escape DX" electric wheelchair with lights and 46 cm seat
CM910-46 "Escape LX" electric wheelchair with reclining backrest and 46 cm seat
CM910L-46 "Escape LX" electric wheelchair with reclining backrest, lights and 46 cm seat

2. INTRODUCTION

Thank you for choosing an ARDEA MOBILITY electric wheelchair by Moretti. Moretti electric
wheelchairs have been designed and manufactured 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 electric wheelchair. Should you
have any queries, please contact your retailer for suitable advice and assistance.
Note: Check to ensure that no parts of the wheelchair 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 electric wheelchair is intended for people with mobility impairments.
• Do not use the product for any purpose other than that specified in this manual
• The electric wheelchair must always be used by people of sound body and mind
and not under the influence of drugs or alcohol.
• 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. EU DECLARATION OF CONFORMITY

MORETTI SpA declares, under its own exclusive responsibility, that the products manufactured
and sold by MORETTI SpA in the ELECTRIC WHEELCHAIRS 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.
Class I medical device
of 5 April 2017 on medical devices
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