REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
1 CODES
CP900-40
RELIEF wheelchair- 30 cm wheels - 40 cm seat
CP900-45
RELIEF wheelchair- 30 cm wheels - 45 cm seat
CP910-40
RELIEF wheelchair- 60 cm wheels - 40 cm seat
CP910-45
RELIEF wheelchair- 60 cm - 45 cm seat
2. INTRODUCTION
Thank you for purchasing an ARDEA ONE RELIEF wheelchair by Moretti S.p.A. product range. This
user's manual provides some suggestions as how to correctly use the product you have chosen and
gives some valuable advice for your safety. Please read through the manual carefully before using
the product. Should you have any queries, please contact your retailer for advice and assistance. In
case of doubts, we recommend to contact the dealer who can help and advice you properly.
NOTE:
check all parts for shipping damages and test before using. In case of damage, do not use the
device. Contact your dealer for further instructions.
3. INTENDED USE
This wheelchair is intended for people with mobility problems and can be used for self-propelling or
with the aid of an operator. In all cases however it requires the intervention of an operator for the
various adjustments you require.
CAUTION!
• Do not use the product for a purpose not indicated in this manual
• Moretti S.p.A declines all responsibilities for any consequences resulting from an
incorrect use of this product and from unauthorized alteration to the frame of the
product
• The manufacturer reserves the right to change the information contained in this
document without previous notice
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 MANUAL WHEELCHAIRS COMFY/RELIEF 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
3