5
GB - ENGLISH
A spare oxygenator must always be available during perfusion. After 5
days of use with blood or if particular situations occur, which may lead the
person responsible for perfusion to determine that the safety of the patient
may be compromised (insufficient oxygenator performance, leaks,
abnormal blood parameters etc.), the oxygenator has to be replaced.
L. MEDICAL DEVICES FOR USE WITH THE D
902 LILLIPUT 2 ECMO
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.
Temperature controls must be carried out using SORIN GROUP ITALIA
probes, code 09026 or compatible to YSI Series 400.
Use Sechrist air/oxygen mixer (SORIN GROUP ITALIA code 09046) 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.
Incorrect occlusion setting or incorrect use of the pump are not covered by the tube
quality guarantee, since these are variables which cannot be controlled by SORIN
GROUP ITALIA.
M. 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 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 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 65th Way
Arvada, CO 80004-3599
FAX (800) 323 4031
N. 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).
