Code; Introduction; Intended Use; Eu Declaration Of Conformity - Moretti ARDEA MOBILITY VIRGO Manual De Instrucciones

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

1. CODE

HS-2850 "Virgo" 6-wheel electric wheelchair (Rif. Moretti CS930)

2. INTRODUCTION

Thank you for choosing an ARDEA MOBILITY electric wheelchair by Moretti. Moretti electric
wheelchairs have been designed and manufactured to satisfy all your needs for practical,
correct and safe use. This manual contains useful suggestions for using your device properly
and safely. Please read this manual in full before you use the electric wheelchair. Should you
have any queries, please contact your retailer for suitable advice and assistance.
Note: 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

The electric wheelchair is intended for people with mobility impairments.
• Do not use the product for any purpose other than that specified in this manual
• The electric wheelchair 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. EU DECLARATION OF CONFORMITY

CHIEN TI ENTERPRICE CO., LTD. declares, under its own exclusive responsibility, that the
products manufactured and sold by CHIEN TI ENTERPRICE CO., LTD. in the ELECTRIC
WHEELCHAIR product family conform with the applicable provisions of Regulation (EU)
2017/745 of 5 April 2017 on MEDICAL DEVICES.
To this end, CHIEN TI ENTERPRICE CO., LTD. guarantees and declares as follows, under its own
exclusive responsibility:
1. The devices in question satisfy the general safety and performance requirements set out in
Annex I to Regulation (EU) 2017/745, as prescribed by Annex IV to said regulation.
2. The devices in question ARE NOT MEASUREMENT TOOLS.
3. The devices in question ARE NOT INTENDED FOR CLINICAL INVESTIGATIONS.
4. The devices in question are sold in NON STERILE packing.
5. The devices in question should be considered as belonging to class I, in accordance with the
rules set out in Annex VIII to said regulation.
6. CHIEN TI ENTERPRICE CO., LTD. maintains and provides to the competent authorities, for
at least ten years from the date of manufacture of the last production lot, the technical
documentation proving conformity with Regulation (EU) 2017/745.
Note: The complete product codes, the manufacturer's single registration number (SRN),
the basic UDI-DI code and any references to standards used are indicated in the EU Declaration
of Conformity that CHIEN TI ENTERPRICE CO., LTD. issues and provides through its own
channels.
Class I medical device
of 5 April 2017 on medical devices
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