Moretti ARDEA MOBILITY 220, Instruction Manual

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ENGLISH
I Class Medical Device
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017 concerning medical devices
1. CODES
CN220
Mobility Scooter 220
2. INTRODUCTION
Thank you for choosing an ARDEA MOBILITY scooter by Moretti. Moretti electric scooters have
been designed and constructed to satisfy all your needs for practical, correct and safe use. This
manual contains useful suggestions for using your scooter properly and safely. Please read this
manual in full before you use the scooter. 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 electric scooter is intended for people with mobility impairments.
WARNING!
• Do not use the product for any purpose other than that specified in this manual.
• The electric scooter 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. DECLARATION OF CONFORMITY
Moretti S.p.A. declares under its sole responsibility that the product made and traded by
Moretti S.p.A.and belonging to the group of ELECTRIC SCOOTER – ARDEA MOBILITY complies
with the provisions of the regulation 2017/745 on MEDICAL DEVICES of 5 April 2017.
For this purpose, Moretti S.p.A. guarantees and declares under its sole responsibility what
follows:
1. The devices satisfy the requirements of general safety and performance requested by
the Annex I of regulation 2017/745 as laid down by the Annex IV of the above mentioned
regulation.
2. The devices ARE NOT MEASURING INSTRUMENTS.
3. The devices ARE NOT MADE FOR CLINICAL TESTS.
4. The devices are packed in NON-STERILE BOX.
5. The devices belong to class I in accordance with the provisions of Annex VIII of the above
mentioned regulation
6. Moretti S.p.A. provides to the Competent Authorities the technical documentation to
prove the conformity to the 2017/745 regulation, for at least 10 years from the last lot
production.
Note: Complete product codes, the manufacturer registration code (SRN), the UDI-DI code and
any references to used regulations are included in the EU declaration of conformity that Moret-
ti S.p.A. releases and makes available through its channels.