dideco D902 LILLIPUT 2 ECMO, Instructions For Use Manual

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GB - ENGLISH

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 

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).