Codes; Introduction; Intended Use; Declaration Of Conformity - ARDEA ONE CP100B-38 Manual De Instrucciones

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF
THE COUNCIL of 5 April 2017 concerning medical devices

1. CODES

CP100-xx Series START 60 cm wheels - Self-Propelled
CP100R-xx Series START 60 cm wheels - Self-Propelled
CP103R-xx Series START2 60 cm wheels - Self-Propelled
CP500-xx Series GO! 30 cm wheels - Transit
CP500R-xx Series GO! 30 cm wheels - Transit
(R = Red; B = Blu; XX =Refers to size available for each wheelchair model ex. 40-43-45-48-50 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 the whole manual carefully before using the
product. In case of 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 that any part of the wheelchair has not been damaged during the shipment.
In case of damage/s don't use the product. Contact your dealer for further instruction.

3. INTENDED USE

This wheelchair is designed for the mobility of people with mobility problems and can be used for
self-propelling (if equipped with big rear wheels) or with the aid of an operator.
In all cases, however, the intervention of an operator is required for the various adjustments you
need.
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 ARDEA ONE WHEELCHAIRS 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.
I Class Medical Device
3