User Manual

23. LIMITED WARRANTY
23. LIMITED WARRANTY
The INTENSIA implantable cardioverter defibrillator is the result of highly advanced research
and all components have been selected after exhaustive testing.
Sorin Group Italia S.r.l. (identified as “Sorin” hereafter) guarantees the product INTENSIA
against any damage caused by component failure or production defects during a period of
four years after the implantation date, and Sorin commits itself to replace all INTENSIA
devices according to the terms described in article 1 and described in article 2 of this
section.
Sorin makes no claim that the human body will not react unsuitably to the implantation of the
INTENSIA device, or that failure will never occur.
Sorin does not guarantee the suitability of INTENSIA in defined types of patients; selection
of the device is a medical decision.
Sorin shall not be held liable for any damage indirectly associated with the INTENSIA,
whether as part of normal or abnormal operation, nor damage from its explantation or
replacement.
Sorin does not authorise anyone to modify these limited warranty conditions.
23.1. ARTICLE 1 : TERMS OF LIMITED WARRANTY
1. The INTENSIA implantable cardioverter defibrillator is only guaranteed for the first
implantation.
2. The EURID/Eucomed implant form must be sent to Sorin within 30 days after
implantation.
3. The INTENSIA cardioverter defibrillator must be implanted prior to the use-before date
indicated on the packaging.
4. The limited guarantee only applies to suspect devices returned to the manufacturer,
carefully packed and accompanied by an explantation report duly completed by the
hospital or the doctor and considered defective after analysis by Sorin.
The device must be returned within the 30 days following explantation to Sorin.
Any device returned and replaced under the terms of this limited warranty will become
the exclusive property of Sorin.
Any rights under the terms of this limited warranty will be forfeited if the INTENSIA device
has been opened by anyone other than Sorin.
These rights will also be forfeited if the device has been damaged by carelessness or
accident.
This is the case especially if the device has been exposed to temperatures above 50°C,
to electrical abuse or to mechanical shock, particularly as a result of being dropped.
Consequently, any expert opinion offered by a third party after the device has been
removed also nullifies the guarantee.
5. The limited warranty will be forfeited if it is proven that the device has been misused or
inadequately implanted, against the physicians’manual recommendations of INTENSIA.
6. The limited warranty does not include leads and other accessories used for the
implantation.
7. The replacement terms or conditions described in article 2 include all devices that shall
be replaced within the limited warranty period because of battery depletion, without any
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SORIN – INTENSIA SonR CRT-D 184 – U150A