Limited Warranty - dideco D905 EOS ECMO Instrucciones De Uso

• Identification of the product involved;
• Lot number of the product involved;
• Availability of the product involved;
• All the indications the user considers useful in order to
understand the origin of the elements of dissatisfaction.
SORIN GROUP ITALIA reserves the right to authorize, if necessary,
recall of the product involved in the notification for assessment. If the
product to be returned is contaminated, it must be treated, packed
and handled in conformity with the provisions of the legislation in
force in the country where the product was used.
- It is the responsibility of the health care institution to
adequately prepare and identify the product for return
shipment. Do not return products that have been exposed
to blood borne infectious diseases.
ONLY for US customers
If for any reason the product must be returned to the manufacturer, a
returned good authorisation (RGA) number is required from Sorin
Group USA, Inc. prior to shipping.
If the product has been in contact with blood or blood fluids, it must
be thoroughly cleaned and disinfected before packing. It should be
shipped in either the original carton or an equivalent carton to prevent
damage during shipment, and it should be properly labelled with an
RGA number and an indication of the biohazardous nature of the
content in the shipment.
- It is the responsibility of the health care institution to
adequately prepare and identify the product for return
shipment. Do not return products that have been exposed
to blood borne infectious diseases.
The shipping address for returned goods in the US is:
Sorin Group USA, Inc.
Returned CV Products
14401 West 65th Way
Arvada, CO 80004-3599
FAX (800) 323 4031
M. LIMITED WARRANTY
This Limited Warranty is in addition to any statutory rights of the
Purchaser pursuant to applicable law.
SORIN GROUP ITALIA warrants that all reasonable care has been
taken in the manufacture of this medical device, as required by the
nature of the device and the use for which the device is intended.
SORIN GROUP ITALIA warrants that the medical device is capable
of functioning as indicated in the current instructions for use when
used in accordance with them by a qualified user and before any
expiry date indicated on the packaging.
However, SORIN GROUP ITALIA cannot guarantee that the user will
use the device correctly, nor that the incorrect diagnosis or therapy
and/or that the particular physical and biological characteristics of an
individual patient, do not affect the performance and effectiveness of
the device with damaging consequences for the patient, even though
the specified instructions for use have been respected.
SORIN GROUP ITALIA, whilst emphasizing the need to adhere
strictly to the instructions for use and to adopt all the precautions
necessary for the correct use of the device, cannot assume any
responsibility for any loss, damage, expense, incidents or
consequences arising directly or indirectly from the improper use of
this device.
SORIN GROUP ITALIA undertakes to replace the medical device in
the event that it is defective at the time of placing on the market or
whilst being shipped by SORIN GROUP ITALIA up to the time of
delivery to the final user unless such defect has been caused by
mishandling by the purchaser.
The above replaces all other warranties explicit or implicit, written or
verbal, including warranties of merchantability and fitness for
purpose. No person, including any representative, agent, dealer,
distributor or intermediary of SORIN GROUP ITALIA or any other
industrial or commercial organization is authorized to make any
representation or warranty concerning this medical device except as
expressedly stated herein. SORIN GROUP ITALIA disclaims any
warranty of merchantability and any warranty of fitness for purpose
with regard to this product other than what is expressedly stated
herein. The purchaser undertakes to comply with the terms of this
Limited Warranty and in particular agrees, in the event of a dispute or
litigation with SORIN GROUP ITALIA, not to make claims based on
alleged or proven changes or alterations made to this Limited
Warranty by any representative, agent, dealer, distributor or other
intermediary.
The existing relations between the parties to the contract (also in the
case that it is not drawn up in writing) to whom this Warranty is given
as well as every dispute related to it or in any way connected to it as
well as anything related to it or any dispute concerning this Warranty,
its interpretation and execution, nothing excluded and/or reserved,
are regulated exclusively by the Italian law and jurisdiction. The court
chosen is the Court of Modena (Italy).
GB – ENGLISH – INSTRUCTIONS FOR USE 7