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Warranty
X
TRA
Operator’s Manual
20077/021 US
17-3
LivaNova consequently renews its invitation to scrupulously follow the user instructions and to take all
the precautions necessary to ensure correct use of the device and declines all responsibility for any
loss, damage, cost, accident or consequences deriving directly or indirectly from the improper use of
the device.
This “Limited Warranty” substitutes any legal warranty, explicit or implicit, written or verbal, including
marketability and/or operation warranties.
Technical safety standards applicable for the purpose of the Warranty
a. The safety standards applicable for the purpose of this warranty shall be those enforced in the
Country where the device is addressed by the Manufacturer at the time of marketing of such
device.
b. In Europe, safety as regards electrical and mechanical hazards, explosions and fires, with respect
to medical electrical equipment, is defined by the following harmonized standard:
EN 60601-1: Medical electrical equipment - Part 1: general requirements for safety which
implements the requirements of the International Standard IEC 60601-1
Such standards apply to medical electrical equipment intended for use by or under the control of
qualified personnel in the immediate proximity of the patient and in relation to the patient him/
herself (by proximity is meant the area within 1.5 m from the patient).
c. Each equipment manufactured by LivaNova undergoes safety tests as prescribed by the relevant
standard IEC 60601-1, the results of which are available from LivaNova.
d. Any requests for specific measurements of safety parameters different from those above quoted
shall be analyses and assessed by LivaNova as appropriate and, in the event of these being
accepted by LivaNova, shall be expounded in a specific statement.
Absolute prohibition to amend the conditions of this Warranty
No representative, agent, dealer, retailer or intermediary of LivaNova shall be authorized to amend the
contents of this document or assume any other liability in relation to the medical device in question.
LivaNova only is entitled to amend, albeit formally and in writing, the contents of this “Limited
Warranty” whenever, according to its own decision, LivaNova considers it appropriate or necessary.
The purchasing party takes note of such prohibition and shall not consequently request LivaNova to
accept amendments or any other changes made by the aforementioned persons in contrast and/or in
addition to the provisions indicated herein.
Applicable law and jurisdiction - Competent court
Relations between the parties with respect to the agreement for which this warranty is issued, as well
as any disputes relating or in any way connected thereto, and all relations or any disputes concerning
this warranty, its construal and execution, nothing excluded and/or reserved, by express agreement
between the parties themselves, shall be exclusively governed by Italian law and Italian jurisdiction.
The competent court for the settlement of any disputes shall be exclusively the Court of Modena -
Italy.