User's Manual

BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual

potentially serious hazards during the normal use of the equipment, in order to be

able to remove the source of such hazards with the best efficiency and timing.

To the purpose of helping PREVENTICE take any timely and effective corrective

measure, it is extremely important that the user performs a careful inspection of

the equipment performances in order to identify or foresee any dangerous

situation for the patient’s and the user’s health.

For this reason, the user shall give immediate communication of any malfunction

or deterioration of the characteristics or the performances of the equipment or any

mistake found in these instructions that caused or could cause serious damages to

the patient’s and the user’s health.

In this case, the user may send a photocopy of the proper duly filled-in Post-

Marketing Vigilance Form (see enclosure 1.8), or communicate in writing the

data indicated in the form.

The instrument’s data can be collected from it’s 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.