Mopedia RP145NC, Instruction Manual

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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
1.1 Folding walking cane codes
RP145NC Aluminum folding walking cane with T-handle – Black color
RP145NL Aluminum folding walking cane with T-handle – Black color
1.2 Aluminum walking canes height adjustable codes
RP146
Aluminum height adjustable walking cane T-handle - Black color
RP148 Aluminum height adjustable walking cane T-handle - Black color
RP153D Aluminum height adjustable walking cane anatomical right handle
RP153S
Aluminum height adjustable walking cane anatomical left handle
2. INTRODUCTION
Thank you for purchasing a MOPEDIA walking canes by Moretti S.p.A. 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.
3. INTENDED USE
The MOPEDIA by Moretti walking sticks are aids manipulated by one arm adapted to support and / or
help the mobility of people with mobility problems.
CAUTION!
• 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 Mo-
retti S.p.A.and belonging to the group of WALKING STICKS 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.