Set Up - SORIN GROUP D901 DIDECO LILLIPUT Mode D'emploi

- 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.
- Inner surfaces of the system are Ph.I.S.I.O. coated; SORIN GROUP ITALIA is
currently not aware of any contraindication to the use of systems having
components treated with Ph.I.S.I.O.
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 (fig. 3)
- 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 (fig. 2 - ref. c) 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 9028.
- 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
All connections downstream of the pump must be secured by means of
ties.
Versions with SOFT VENOUS RESERVOIR (fig. 4)
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
4
prevents air entering the venous reservoir 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 3/16" 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 female
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.
If at the end of the bypass blood recovery is envisaged, disconnect the
male luer lock of the recirculation line and set up an "ON-OFF" manifold
(with female and male luer lock connections) between the recirculation
line and the "CARDIOTOMY RETURN" female luer connector on the soft
venous reservoir. Open the "ON-OFF" manifold (position "ON").
Version OXYGENATING MODULE only (fig. 5)
ARTERIAL LINE: remove the red cap on the oxygenator arterial
outlet (ref. I) in order to connect a 1/4" or 3/16" line.
PUMP LINE: the pump segment should be set up between the venous
reservoir outlet connector and the oxygenator venous
inlet connector (ref. F) taking account of the direction of rotation of the pump.
OXYGENATING MODULE PURGE LINE: remove the protective
cap and connect the male luer end (ref. B) to a female luer filte
red inlet on the cardiotomy.
OXYGENATING MODULE RECIRCULATION LINE: remove the
protective cap and connect the male luer end (ref. A) to a female 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 reservoir used. Open the "ON-OFF" manifold (position "ON").
ARTERIAL SAMPLING LINE: remove the protective cap from the luer
connection placed near the arterial outlet (ref. L). Attach to it the male luer of
an arterial sampling line.
Male luers not supplied with SORIN GROUP ITALIA products may
damage the one-way valve placed inside the oxygenator arterial
sampling luer. When connecting, make a visual check that the male luer
does not reach as far as the one-way valve.
7) SAMPLING MANIFOLD (fig.4)
Versions with SOFT VENOUS RESERVOIR
It is possible to remove the LILLIPUT manifold from its position and mount it
on the appropriate holder (D 712). The tube coil attached to the manifold
allows it to be repositioned to a range of approximately 1 metre. Check that
the selector switch (ref. 9) is in the "OFF" position.
8) CONNECTING THE TEMPERATURE PROBES (fig.4 and 5)
The connection for the arterial temperature probe (red - ref. 14 and H) is
positioned next to the arterial outlet, whilst the venous probe site (blue - ref. 13
and G) is at the side of the venous inlet. SORIN GROUP ITALIA temperature
probes have code 9026.
9) RECIRCULATION AND PURGE LINES
Check that the white clamp positioned on the recirculation line between the
LILLIPUT arterial outlet and the venous reservoir is open. Close the blue
clamp on the oxygenator purge line.
10) 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 Bird, code 9374 (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.
- SORIN GROUP ITALIA recommends the use of a bubble trap or filter
on the arterial line to reduce the risk of emboli transmission to the
patient. Such risk could be due to:
1) collapse of the soft venous reservoir, caused by a reduced venous
return; arterial pump cavitation generates emboli; LILLIPUT purge
GB - ENGLISH