Presentation of the manual
NOTE
UPON RECEIPT OF THE MEDICAL DEVICE, BEFORE PERFORMING ANY OPERATION, PLEASE READ THE INSTRUCTION MANUAL CAREFULLY.
The manual is composed of various sections, each covering a series of topics divided into chapters and paragraphs. The general index lists all the topics covered in the entire manual.
Page numbering is sequential and the page number appears on every page. This manual is intended for personnel and patients responsible for the use and maintenance of the medical device and relates to its technical life after production and sale.
If the device is subsequently transferred to third parties for any reason (sale, loan for use, or any other motivation), the medical device must be delivered complete with all documentation. Before starting any operation, it is necessary to have read the entire manual.
This manual contains proprietary information and cannot be provided, even partially, to third parties for any use or in any form, without prior written consent from the manufacturer.
The manufacturer declares that the information contained in this manual complies with the specifications of the medical device to which the manual refers.
A certified copy of this manual is filed in the device’s technical dossier, kept by the manufacturer.
The manufacturer does not recognize any documentation that has not been produced, issued, or distributed by itself or by an authorized representative.
This manual, along with the entire technical dossier, will be kept by the manufacturer for the period required by law.
During this period, a copy of the documentation accompanying the product at the time of sale may be requested.
The entire technical dossier remains available during this period exclusively to regulatory authorities, who may request a copy.
After this period, it is the responsibility of whoever manages the product to ensure that both the product and the documentation comply with the laws in force in order to use it in accordance with current legislation.