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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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
1.
Use the product in the manner indicated in this manual. If doubts persist, contact DEMARTA
VIRGINIO SAS.
2.
Always evaluate the compatibility of the product with the characteristics of the subject together
with the doctor or therapist.
3.
Always check the integrity of the product before each use, even when new. Do not use if
damaged or worn.
4.
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.
5.
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.
INTENDED USE
The ADIGGY Line includes all the aids used to immobilize the patient in a wheelchair, bed, etc. They
are used to ensure maximum safety of those who use them to prevent falls or traumas of various kinds.
WARNINGS
• Restraint systems must be used by qualified healthcare personnel.
If used at home, you should ask your doctor or therapist for advices.
• Patients with
restraint products require frequent monitoring.
