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Idiomas disponibles
Idiomas disponibles
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
1. CODES
CL200x-38
Atmos ultra lightweight folding wheelchair - 38 cm seat
CL200x-40
Atmos ultra lightweight folding wheelchair - 40 cm seat
CL200x-42
Atmos ultra lightweight folding wheelchair - 42 cm seat
CL200x-44
Atmos ultra lightweight folding wheelchair - 44 cm seat
CL200x-46
Atmos ultra lightweight folding wheelchair - 46 cm seat
2. INTRODUCTION
Thank you for choosing an ARDEA ONE wheelchair by Moretti S.p.A. This wheelchair is designed
for people who have difficulty moving both inside and outside the home, while travelling or
performing simple, everyday activities. This user manual contains some suggestions on how
to use the wheelchair properly and safely. Please read this manual in full before you use the
wheelchair. Should you have any queries, please contact your dealer for suitable advice and
assistance.
N.B.
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
This wheelchair is designed for people with mobility problems and can be self-propelled.
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 S.p.A. declares under its sole responsibility that the product made and traded by Mo-
retti S.p.A.and belonging to the group of MANUAL WHEELCHAIRS – ATMOS 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.
I Class Medical Device
of 5 April 2017 concerning medical devices
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