Return Of Used Products; N Limited Warranty - SORIN GROUP D902 LILLIPUT 2 Mode D'emploi

10) Remove the water from the LILLIPUT holder (according to the appropriate
instructions for use) and disconnect the oxygenator.
11) Place a new oxygenator on the holder. Connect all lines (i.e. venous to the venous
reservoir, and, where applicable, the cardiotomy to the soft venous reservoir,
arterial and gas to the oxygenator, pump line to venous reservoir and oxygenator)
and secure with ties.
12) Open the water lines on the holder, turn the thermocirculator on and check the
integrity of the new oxygenator.
13) Repeat all phases described in the priming and recirculation procedure.
L. MEDICAL DEVICES FOR USE WITH THE D 902
LILLIPUT 2
Versions with SOFT VENOUS RESERVOIR
The device must be used in combination with a paediatric cardiotomy.
Version OXYGENATING MODULE only
The oxygenating system must be used in combination with:
- a venous reservoir functioning as a paediatric cardiotomy;
or
- a paediatric soft venous reservoir and paediatric cardiotomy.
The arterial/venous sampling system must also be used, taking care to check at the
time of arterial connection, that the male luer connector does not reach as far as the
one-way valve placed inside the arterial sampling luer in the oxygenator.
All versions
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 9026 or compatible to
YSI Series 400. Use Bird air/oxygen mixer (SORIN GROUP ITALIA code 9374) 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 9028).
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.
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).
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