ARDEA ONE TRAVEL CP850-37, Instruction Manual

Page: 15 / 36

3
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
CP850-37
Wheelchair TRAVEL seat 37 cm
2. INTRODUCTION
Thank you for purchasing a ARDEA ONE 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 damage and test before using. In case of damage, do not use the
device. Contact your dealer for further instruction.
3. INTENDED USE
The wheelchairs are intended for people with movement difficulties. The wheelchairs can be for sel-
f-propulsion (with 60cm casters) or can be wheeled. In all cases however it requires the intervention
of an operator for the various adjustments you require.
WARNING!
• 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 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 ARDEA ONE complies with the pro-
visions 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 Moretti
S.p.A. releases and makes available through its channels.