dideco D 902 LiLLiPUt 2 Instrucciones Para El Uso página 4

personnel.
- SORIN GROUP ITALIA is not responsible for problems arising
from inexperience or improper use.
- FRAGILE, handle with care.
- Keep dry. Store at room temperature.
- 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.
- Always apply and maintain a correct dose and accurate monito-
ring of the anticoagulant before, during and after the bypass.
- 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.
- For further information and/or in case of complaint contact
SORIN GROUP ITALIA or the authorised local representative.
CAUTION
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. 4)
Position the LILLIPUT holder on the pump structure by means of
the clamp at the upper end of the extension arm.
For more information on the holder set up, refer to the instruc-
tions for use for the holder.
2) PREPARE THE HOLDER (fig. 4)
Remove the black plastic cover from the water distributor.
Turn the lever to "OPEN" position.
3) FIXING THE OXYGENATOR TO THE HOLDER (fig. 4)
WARNING
- 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
2
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.
WARNING
- 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 distri-
butor of the holder into the heat exchanger.
The oxygenator must be locked into place using the marker gui-
des on the two red knobs. Turn the lever to "CLOSE" 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 9028.
WARNING
- 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
WARNING
All connections downstream of the pump must be secured by
means of ties.
Versions with SOFT VENOUS RESERVOIR (fig. 1)
VENOUS LINE: it is possible to connect a venous line of 1/4" or
3/16" to the connector indicated on the venous reservoir as
"VENOUS RETURN" (ref. 3).
CARDIOTOMY LINE: it is possible to connect the cardiotomy 1/4"
or 3/16" line to the soft venous reservoir connector indicated as
"CARDIOTOMY RETURN" (ref. 5).
The line connecting the cardiotomy to the venous reservoir must
form a U-shaped trap located at least 5 cm below the venous
reservoir, such that the U prevents air entering the venous reser-
voir from the cardiotomy.
The cardiotomy must be able to be easily raised or lowered to
allow for variations in haemodynamic state.
ARTERIAL LINE: remove the red cap on the oxygenator arterial
outlet (ref. 15) in order to connect a 1/4" or 5/16" line.
PUMP LINE: the pump segment should be set up between the
venous reservoir outlet connector (ref. 16) and the oxygenator
venous inlet connector (ref.12) taking account of the direction of
rotation of the pump.
VENOUS PURGE LINE: remove the protective cap and connect the
male luer end of the venous reservoir purge line (ref. 1) to a fema-
le luer located on the suction line (this connection must be made
on the "negative pressure" side of the line).
To find the best position, rotate the venous reservoir.
Version with RIGID VENOUS RESERVOIR (fig. 2)
VENOUS LINE: it is possible to connect a venous line of 3/8" or
1/4" to the connector indicated on the venous reservoir as
"VENOUS INLET" (ref. 3) (by means of the suitable adapter provi-
ded with the device).
ARTERIAL LINE: remove red cap on the oxygenator arterial outlet
(ref. 15) to connect a 1/4"-5/16" line.
PUMPE LINE: The pump segment should be set up between the
rigid venous reservoir outlet connector (ref. 16) and the oxygena-
tor venous inlet connector (ref. 12) taking account of the direction
of rotation of the pump.
Version with SOFT and RIGID VENOUS RESERVOIR
CAUTION
If at the end of the bypass blood recovery is envisaged, set up
an "ON-OFF" manifold (with female and male luer lock con-
nections) between the male luer lock of the oxygenating modu-
le recirculation line and the venous reservoir used. Open the
"ON-OFF" manifold (position "ON").
CAUTION
If at the end of the bypass blood recovery is envisaged, discon-
nect the male luer lock of the recirculation line and set up an
"ON-OFF" manifold (with female and male luer lock connec-
tions) between the recirculation line and the "CARDIOTOMY
RETURN" female luer connector on the venous reservoir.