sorin 75220, Operator'S Manual, Page: 274 / 304

Warranty
17-2
20077/021 US
X
TRA
Operator’s Manual
Cases in which the Warranty shall not be effective
The warranty shall not be effective in the case of products and/or materials with defects deriving from:
poor handling and maintenance of the machine, incorrect use of device, tampering, modifications
made by unauthorized personnel, use of materials and devices wrong or different from those indicated
by the supplier and, however, in all those cases where the reasons for the defect or problem can be
ascribed to the Buyer’s environment or personnel.
Warranty for replaced parts
The warranty provided by LivaNova with respect to repairs or updating of a device no longer under
guarantee, as provided for by this certificate, shall be restricted to the replaced parts only, in the case
of these not being included among those indicated above, according to paragraph d of “Contents and
necessary requirements of the Warranty” on page 17-1, and shall not be effective for more than three
months from the date of replacement.
Availability of spare parts
LivaNova guarantees availability of spare parts and trained personnel to repair and/or service its
devices for a period of 60 months (5 years) from the date of going out of production of each model
and, in any case, for a period of not more than 12 months (1 year) from the date of notification to the
user of suspension of production in the event of such notification being given after 4 years from the
date of going out of production of the equipment.
Technical documentation
a. LivaNova products are always supplied complete with adequate documentation, including,
inter
alia , instructions for correct use, identification of replaceable parts and relevant replacement
procedures, as well as the list of routine and preventive maintenance activities. Other details may
concern any disposables needed for correct use of the device.
b. All the documentation and information, drawings and descriptions contained in the manual or, for
whatever reason, provided to the user, shall be considered as confidential and as belonging
exclusively to LivaNova. These shall not therefore be revealed, distributed, copied or reproduced
by any means and for whatever purpose, nor to be given out for consultation, total or partial, to
anyone, without specific prior authorization being formally given by LivaNova.
c. LivaNova reserves the right to make, without prior notice, amendments or updates to the
contents of previously distributed documentation.
Maintenance contracts
LivaNova offers its customers “customized” maintenance contracts to meet specific requirements. In
the event of customers being interested, they are kindly asked to contact LivaNova or the local
representative/distributor for further details and applicable contractual conditions.
LivaNova guarantees that all maintenance work done on its own responsibility, including work done in
performance of maintenance contracts executed with LivaNova, will be made by specialized personnel,
using original spare parts. In this way, products are kept in very best condition and maintain their
original characteristics and capacity to achieve and assure the performances for which they were
designed, manufactured and marketed.
Limits to the warranty with regard to product use by the buyer and/or
user
Without prejudice to the provisions of the previous clauses, LivaNova guarantees that in
manufacturing the medical device in question, all reasonable precautions have been taken as imposed
by the nature and use for which the product is intended.
LivaNova guarantees that the medical device is able to operate in conformity with the information
contained in the USER MANUAL, provided that it is used in compliance with the instructions given in
such Manual and within the expiry date (whenever indicated on the device and/or its packaging).
Nevertheless, LivaNova cannot guarantee that the device will be correctly used by the user, nor that
the diagnosis, pathology and/or specific physical and biological characteristics of the individual
patients will, even when the aforementioned instructions are followed, not impair the performance and
effectiveness of the device, with negative consequences for the patient.