Codes; Introduction; Intended Use; Declaration Of Conformity - Mopedia AU120 Manual De Instrucciones

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

1. CODES

AU120 - Handy grip with swivel head and magnet - 67 cm
AU121 - Handy grip with swivel head and antibrachial rest - 55cm
AU122 - Handy grip with swivel head - 71cm
AU123 - Handy grip - 74cm

2. INTRODUCTION

Thank you for choosing an accessory MOPEDIA by Moretti S.P.A. The handy grip have been
designed and built to meet all your needs for a practical, correct and safe use. This manual
contains some suggestions for proper use of the accessory of your choice and valuable tips
for your safety. You should read carefully all of this manual before using the Handy grip. If in
doubt please contact your dealer, who will help and advise you properly.

3. INTENDED USE

The handy grip by Moretti S.P.A. are designed to help people with hands and fingers limited
mobility to keep objects.
CAUTION!
• Do not use the following device for purposes other than those described
in this manual.
• Moretti S.p.A. disclaims any liability for damage resulting from improper use of the
device or use other than that described in this manual.
• We reserve the right to make changes to the device and this manual without notice
in order to improve the characteristics.

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 HANDY GRIP 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.
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.
I Class Medical Device
of 5 April 2017 concerning medical devices
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