User Manual

23. WARRANTY
Warranty duration: 5 Years
The ALIZEA implantable cardiac pacemaker is the result of highly advanced research and all
components have been selected after exhaustive testing.
MicroPort CRM S.r.l. (identified as “MicroPort” hereafter) guarantees the product ALIZEA
against any damage caused by component failure or production defects during a period of five
years after the implantation date, and warranty commits itself to replace all ALIZEA devices
according to the terms described in articles 1 and 2.
MicroPort makes no claim that the human body will not react unsuitably to the implantation of
a ALIZEA device, or that failure will never occur.
MicroPort does not guarantee the suitability of ALIZEA device in defined types of patients:
selection of the device is a medical decision.
MicroPort shall not be held liable for any damage indirectly associated with the ALIZEA
device, whether as part of normal or abnormal operation of the latter, nor damage from its
explantation or replacement.
MicroPort does not authorize anyone to modify these warranty conditions.
ARTICLE 1: TERMS OF WARRANTY
1. The ALIZEA implantable cardiac pacemaker is only guaranteed for the first implantation.
2. The EURID/IAPM implant form must be sent to MicroPort within 30 days after
implantation.
3. The ALIZEA cardiac pacemaker must be implanted by the end of the "use on or before"
date indicated on the packaging.
4. The 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 MicroPort.
― The device must be returned within the 30 days following explantation to MicroPort.
― Any device returned and replaced under the terms of this warranty will become the
exclusive property of MicroPort.
― Any rights under the terms of this warranty will be forfeited if the ALIZEA device has
been opened by anyone other than MicroPort.
― 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 warranty will be forfeited if it is proven that the device has been misused or
inadequately implanted, against the physicians’ manual recommendations of ALIZEA
device.
6. The warranty does not include leads and other accessories used for the implantation.
7. The replacement terms or conditions described in article 2 shall not apply to all devices
that shall be replaced within the warranty period because of battery depletion, and which
23.1.
23. WARRANTY
76 ALIZEA – UA10414A