User's Manual

BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
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1.6 ATTENTION SYMBOL
The ATTENTION symbol shown below, placed on the equipment casing, refers
the user to the Operator Manual for information, warnings and suggestions which
are particularly important for a correct and safe use of the equipment.
In particular, when it is placed on connecting points or commands or led
indicators, this symbol refers the user to carefully read the Operator Manual for
instructions concerning the nature and safety of such connection and/or detailed
description of the commands and meaning of indicated events/situations for the
operator.
For location of the ATTENTION symbols placed on the equipment, please refer
to chapter 2 “Description of the Device” of this Operator Manual. This chapter
shows the pictures of the equipment panels with the corresponding commands,
connections, symbols, and labels. Each attention symbol comes with a detailed
explanation of its meaning.
1.7 PRODUCT TRACEABILITY
In order to guarantee the traceability of the product, according to what stated in
the ISO 13485 quality standard, QSR 21 CFR Parte 820 FDA, and the 93/42/EEC
European Directive on Medical Devices (and its revised version 2007/47/EC
directive), PREVENTICE kindly requests the original owner of the equipment to
give communication to our main offices of any conveyance of the product to third
parts, by sending a photocopy of the proper duly filled-in Product traceability
form (see enclosure 1.7), or by communicating in writing the data indicated in the
form. The data concerning the device can be found on its identification label.
The form shall be sent either directly or through any subsidiary or the nearest
authorized distributor to the any PREVENTICE operating office. The list of the
main PREVENTICE head and branch offices is contained in chapter “Request for
assistance” of this manual.
1.8 VIGILANCE SYSTEM
The device is subject to a vigilance system (post-marketing vigilance) that
PREVENTICE and their distributors and retailers apply to the products they put
on the market to safeguard the patient and the physician from serious or