Return Of Used Products; Limited Warranty - SORIN GROUP D905 EOS Mode D'emploi

18) Fix it by moving the water connector locking system to the "CLOSE" position.
19) Connect the oxygenator inlet line and the arterial line to the oxygenating module
In this phase, keep the venous and arterial lines clamped.
20) Switch on the thermocirculator and check the heat exchanger.
21) Lift the reservoir and rotate the hook. Put the reservoir on the oxygenating
module. If possible couple the reservoir and the oxygenating module by means
of the white interface.
22) Connect the gas line, the arterial sampling line and all the monitoring lines.
23) Remove the clamp from the venous line.
24) Keeping the recirculation line open (purging/ricirculation stopcock in
"RECIRCULATION" position) prime the oxygenating module through the arterial
pump. Purge the air contained in the module at a maximum flow rate of 2000
ml/min
25) Close the recirculation line (purging/recirculation stopcock in "CLOSE" position.
26) Remove the clamp from the arterial line and restart the bypass.
27) Connect, if necessary, the cardioplegia line and purge it.
N. MEDICAL DEVICES FOR USE WITH THE D 905
EOS
For post-operative autotransfusion with the Venous Reservoir one of the two following
kits should be used:
- D 540 AUTOTRANSFUSION CONVERSION KIT code 05053.
- D 540 W AUTOTRANSFUSION CONVERSION KIT with water seal, code
05062.
All tubing used to make the circuit connections must be of a diameter 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 Bird air/oxygen mixer (SORIN GROUP ITALIA code 09374) or a system with
compatible technical features.
Any heating/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 information 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 under stand 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 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 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.
The shipping address for returned goods in the US is:
Sorin Group USA, Inc.
Returned CV Products
14401 West 65 Way
th
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 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 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 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, 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 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 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 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 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, 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 7