Esaote MyLabX6, Начало работы

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I N T R O D U C T I O N
MyLab
- G E T T I N G S T A R T E D 1 - 10
Vigilance System
This equipment is subject to Esaote vigilance system (post-market
surveillance) in case of potential or real hazards for the patient or for the
operator which might occur during the normal system functioning, in order
to be able to remove them with the best efficiency and timing.
The equipment is subject to a supervision system (post-sales supervision),
which ESAOTE S.p.A., all associates and authorized distributors apply to
products issued onto the market, in relation to real or potential hazards that
may arise for the patient or operator during normal use of the equipment, to
ensure optimal solutions in the most efficient and prompt manner possible.
Therefore if the user records any malfunction or deterioration in the
characteristics and/or performances of the device, as well as any inadequacy
in the labeling or the instructions for use which might lead to potential or real
hazards for a patient or for an operator, we kindly request to immediately
inform Esaote central plants, or one of our subsidiaries, or one of our official
distributors immediately through the following form, or through a
communication reporting the same data contained in this form. All data
relating to the system can be found on its identification label. In this way we
will be able to take all adequate measures with the best efficiency and timing.
Therefore, in the event of malfunctions, defective performance of the
equipment, or inadequate instructions, which may constitute a hazard to the
patient or operator, the user must notify ESAOTE S.p.A., associate company
or authorized distributor in writing, providing the information as specified in
the form below. Equipment data are found on the relative identification label.
On receipt of the notification ESAOTE S.p.A. will immediately activate the
process of examination and resolve the non-conformity that has been
reported.