Oxygenator Replacement; Medical Devices For Use With Thed 902 Lilliput 2 Ecmo; Limited Warranty - dideco D 902 LILLIPUT 2 ECMO Gebrauchsanweisung

b) Clamp the venous line, the arterial line and the recirculation line.
c) Close the "ON-OFF" manifold (position OFF).
d) Disconnect the male luer lock of the recirculation line from the
"ON-OFF" manifold.
e) Connect an additional recovery bag (500 ml) to the male luer lock
end of the recirculation line to empty the oxygenator and the
arterial line by gravity.
f) Open the recirculation line.
K. OXYGENATOR REPLACEMENT
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.
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
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this product other than what is expressedly stated herein.
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
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