3
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. CODE
CS910BL
“Aries Tilting” electric wheelchair
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 WHEELCHAIR 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.
Note:
The complete product codes, the manufacturer’s single registration number (SRN),
the basic UDI-DI code and any references to standards used are indicated in the EU Declaration
of Conformity that MORETTI SPA issues and provides through its own channels.
