Codes; Introduction; Intended Use; Declaration Of Conformity - Mopedia ARKIMED RI700C Manual De Instrucciones

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

1. CODES

RI700C - Hydraulic actuator max load 135 Kg, with pedal
RI701 - Hydraulic actuator max load 180 Kg
RI701C - Hydraulic actuator max load 180 Kg
RI703C - TiMOTION actuator max load 135 Kg, with pedal
RI705 - TiMOTION actuator max load 150 Kg
- TiMOTION actuator max load 180 Kg
RI710
RI710C - TiMOTION actuator max load 180 Kg

2. INTRODUCTION

Thank you for choosing a patient lift ARKIMED by MOPEDIA range, manufacturer by MORETTI S.p.A.
Their design and quality are a guarantee of comfort, safety and reliability. ARKIMED by MOPEDIA lifts
by MORETTI S.p.A. are designed and built to meet all your demands for a practical, correct use. This user
manual provides for some suggestions as to how correctly use the lift you have chosen and offers a lots of
valuable advice for your safety. Please read carefully through the manual before using the patient lift/stand
up lift. Should you have any queries, please contact your retailer for advice and assistance.

3. INTENDED USE

ARKIMED by MOPEDIA patient lifts are intended to lift and move people with motor
difficulties. An assistant operates the machine. The lifts cannot be used by only one person.
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 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 PATIENT LIFTS - MOPEDIA 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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