Return Of Used Products; Limited Warranty - SORIN GROUP dideco D 905 AVANT Mode D'emploi

which is compatible with the dimensions of the connectors on the
device (3/8", 1/4", 1/2"). Temperature controls must be carried out
using SORIN GROUP ITALIA probes, code 09026 compatible to YSI
Series 400. Use Sechrist air/oxygen mixer (SORIN GROUP ITALIA
code 09046) or a system with compatible technical features. Any hea-
ting/cooling system (thermocirculator) may be used, provided that
the connectors to the water distributor holder are of the Hansen type
(SORIN GROUP ITALIA code 09028).
Currently SORIN GROUP ITALIA is not aware of any contraindications
to the use of the device with occlusive or non-occlusive peristaltic
pumps or with centrifugal pumps. The use of other types of pump
must be agreed with SORIN GROUP ITALIA.
O. RETURN OF USED PRODUCTS
Should the user be dissatisfied with anything related to the quality of
the product, the product distributor or the authorized local SORIN
GROUP ITALIA representative should be notified.
All parameters considered critical by the user must be reported with
particular care and urgency. The following is the minimum informa-
tion that should be provided:
• Detailed description of the event and, if pertinent, the conditions of
the patient;
• 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.
CAUTION
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 disea-
ses.
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 cardiovascular 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
6
damage during shipment, and it should be properly labelled with an
RGA number and an indication of the biohazardous nature of the con-
tent in the shipment.
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.
P. 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 conse-
quences 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 assu-
me 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 war-
ranties 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 expressly stated herein. SORIN GROUP ITA-
LIA disclaims any warranty of merchantability and any warranty of fit-
ness for purpose with regard to this product other than what is
expressly 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).