KYARA ST343, Instruction Manual

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3
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
ST343 Travel collar/cervical cushion
ST380 Soft collar/cervical cushion
2. INTRODUCTION
Thank you for purchasing a SINFONIA cushion of the line KYARA cushion by Moretti. The cushions
are designed and realized to meet all your needs for a practical, proper and safe use. 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 patient cushions of the line KYARA by Moretti are devices to be used to give relief to the patient
during sitting and rest.
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 Moretti
S.p.A.and belonging to the group of CUSHIONS FOR PATIENTS 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.