Demarta Virginio SAS di Belletti Virginio e C, via Bozzalla 20, 13814 Pollone (BI), P.IVA 01530570025,
C.F. 00459790010, Tel. +39 015-9555440
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I Class Medical Device according
to directive UE 2017/745
INTRODUCTION
Thank you for choosing Demarta Virginio. The products have been designed and built to
meet all your needs for a practical, correct and safe use. This manual contains some small
suggestions for a correct use of the device of your choice and some precious advice for
your safety. We recommend that you carefully read the entirety of this manual before using
the item you purchased. If in doubt, please contact your dealer, who will be able to help
and advise you correctly.
The manufacturer reserves the right to make changes to the device and to this manual
without prior notice in order to improve its characteristics.
GENERAL WARNINGS
• Use the product in the manner indicated in this manual. If doubts persist, contact DEMARTA
VIRGINIO SAS.
• Always evaluate the compatibility of the pr
oduct with the characteristics of the subject
together with the doctor or therapist.
• Always check the integrity of the product before each use, even when new. Do not use if
damaged or worn.
• DEMARTA VIRGINIO SAS declines any responsibility for damage to
property or persons
resulting from improper use, not agreed with a professional figure, not corresponding to what
is indicated in the user manual.
• Any accidents, anomalies, breakages must be reported to DEMARTA VIRGINIO SAS in order
to monitor the quality and criticalities of the product.
DECLARATION OF CONFORMITY
DEMARTA VIRGINIO SAS declares under its sole responsibility that the product made and traded
by DEMARTA VIRGINIO SAS comply with the applicable provisions of the 2017/745 Regulation
on Medical Devices of 5 April 2017.
For this purpose, DEMARTA VIRGINIO SAS guarantees and declares under its sole responsibility
what follows:
• 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.
• The devices ARE NOT MEASURING INSTRUMENTS.
• The devices ARE NOT MADE FOR CLINICAL TESTS.
• The devices are packed in NON
-STERILE BOX.
• The devices belong to class I in
accordance with the provisions of Annex VIII of the above
mentioned regulation.