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GB - ENGLISH
monitoring of blood compartment pressure drop, whole blood
coagulation time, inspection for thrombus formation and
system component wear.
For single use and for single-patient use only. During use the
device is in contact with human blood, body fluids, liquids or
gases for the purpose of eventual infusion, administration or
introduction into the body, and due to its specific design it
cannot be fully cleaned and disinfected after use. Therefore,
reuse on other patients might cause cross-contamination,
infection and sepsis. In addition, the reuse increases the
probability of product failure (integrity, functionality and
clinical effectiveness).
The device contains phthalates. Considering the nature of
contact with the body, the limited duration of contact and the
number of treatments per patient, the amount of phthalates
which might be released from the device does not raise
specific concerns about residual risks. Further information is
available on request from Sorin Group Italia
The device must not undergo any further processing.
Do not resterilise.
After use, dispose of the device in accordance with
applicable regulations in force in the country of use.
This device does not allow the administation of anaesthetic
gases (i.e. isofluorane) to the patient.
This device is Phosphorylcholine (Ph.I.S.I.O.) coated;
currently SORIN GROUP ITALIA is not aware of any
contraindication to the use of systems having components
treated with Phosphorylcholine.
For further information and/or in case of complaint contact
SORIN GROUP ITALIA or the authorised local representative.
Federal law (U.S.A.) restricts this device to sale by or on the order of
a physician.
E. SET UP
1) POSITION THE HOLDER (fig. 2)
Position the LILLIPUT holder on the pump structure (ref. A) by
means of the clamp at the upper end of the extension arm.
For more information on the holder set up, refer to the instructions
for use for the holder.
2) PREPARE THE HOLDER (fig. 2)
Remove the black plastic cover from the water distributor. Turn the
lever (ref. B) to "DISENGAGED" position.
3) FIXING THE OXYGENATOR TO THE HOLDER
Sterility is guaranteed only if the sterile packaging is not
wet, opened, damaged or broken. Do not use the device if
sterility cannot be guaranteed.
Check the expiry date on the label attached. Do not use the
device after the date shown.
The device must be used immediately after opening the
sterile packaging.
The device must be handled aseptically.
Remove the device from the sterile packaging.
Carry out a visual inspection and carefully check the device
before use. Transport and/or storage conditions other than
those prescribed may have caused damage to the device.
Do not use solvents such as alcohol, ether, acetone, etc.:
as contact may cause damage to the device.
Do not allow halogenated liquids such as Halothane and
Fluothane to come into contact with the polycarbonate
housing of the device. This could cause damage which may
compromise the integrity and proper functioning of the
device.
Locate the LILLIPUT, taking care to insert the white water distributor
of the holder into the heat exchanger. The oxygenator must be
locked into place using the marker guides on the two red knobs.
Turn the lever (fig. 2 - ref. B) to "ENGAGED" position.
The LILLIPUT is now correctly set up.
4) THERMOCIRCULATOR SET UP
Connect the water tubes to the holder by means of the female
Hansen connectors SORIN GROUP ITALIA code 09028.
The use of different connectors from those indicated may
cause resistance inside the circuit and reduce the
efficiency of the heat exchanger.
The water temperature at the heat exchanger inlet must not
exceed 42 °C (108 °F).
The water pressure in the heat exchanger must not exceed
300 KPa (3 bar / 44 psi).
5) CHECKING THE HEAT EXCHANGER
Check the heat exchanger by recirculating water inside the heat
exchanger for a few minutes. The integrity of the housing is
guaranteed if there are absolutely no leaks from the water
compartment.
6) CIRCUIT CONNECTIONS (fig. 1)
All connections downstream of the pump must be secured by
means of ties.
ARTERIAL LINE: remove the red cap on the oxygenator arterial
outlet (ref. I) in order to connect a 1/4"-5/16” line.
PUMP LINE: the pump segment should be set up between the
venous line and the oxygenator venous inlet connector (ref. F) taking
account of the direction of rotation of the pump.
OXYGENATING MODULE RECIRCULATION LINE: remove the protective
cap and connect the female luer end (ref. A) to a male luer placed on the
venous return line.
If at the end of the bypass blood recovery is envisaged, set up
an "ON-OFF" manifold (with female and male luer lock
connections) between the male luer lock of the oxygenating
module recirculation line and the venous return line. Open the
"ON-OFF" manifold (position "ON").
7) CONNECTING THE TEMPERATURE PROBES (fig. 1)
The connection for the arterial temperature probe (red ref. H) is
positioned next to the arterial outlet, whilst the venous probe site
(blue - ref. G) is at the side of the venous inlet.
SORIN GROUP ITALIA temperature probes have code 09026.
8) RECIRCULATION LINE
Check that the recirculation line between the LILLIPUT arterial outlet and the
venous return line is closed.
9) CONNECTING THE GAS LINE
Connect the 1/4" gas line to the connector on the upper cover
labelled "GAS INLET". Ensure that the gas supply is from a suitable
air/oxygen mixer such as the Sechrist, code 09046 (available from
SORIN GROUP ITALIA) or a system with compatible technical
features. A capnograph connector can be found in the centre of the
connector marked "GAS ESCAPE".
The "gas escape" system is designed to avoid any possible
risk of blocking the gas outlet; such blockage could cause
the immediate passage of air to the blood compartment.
