Priming And Recirculation Procedure - SORIN GROUP D901 LILLIPUT 1 Mode D'emploi

available on request from Sorin Group Italia
- Always apply and maintain a correct dose and accurate monitoring 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.
- The device must only be used if sterile. In the event of the device being
supplied NOT STERILE (in which case, this is indicated by the wording
"NOT STERILE" on the pack) contact SORIN GROUP ITALIA or an
authorised dealer to agree on a sterilisation method.
- 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
Position the D 625 LILLIPUT holder on the pump structure by means of the
clamp at the upper end of the arm (fig. B). For more information on the holder
set up, refer to the instruction for use for the holder.
2) PREPARE THE HOLDER
Remove the black plastic bag cover from the water distributor. Turn the lever
(ref. 19) to "OPEN" position.
3) FIXING THE OXYGENATOR TO THE HOLDER (fig. B)
- 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 1 OPEN SYSTEM, taking care to insert the white water
distributor of the holder (fig. 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. B - ref. 19) to "CLOSE" position.
The LILLIPUT 1 OPEN SYSTEM is 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.
VENOUS LINE: it is possible to connect a venous line of 3/16" or 1/4" to the
connector indicated on the venous reservoir as "VENOUS RETURN" (ref. 4)
4
ASPIRATION LINES: after removing protective caps from the "filtered" inlet
connectors on the top of the Cardiotomy Reservoir (4 x 3/16" - 1/4" (4,76 -
6,35 mm) inlets) connect the extremities of the aspiration tubes and rotate
the turrets (ref. 5) towards the suction pumps.
ARTERIAL LINE: remove the red cap on the oxygenator arterial outlet
indicated as "ARTERIAL OUTLET" (ref. 6) and connect a 3/16" - 1/4" line.
PUMP LINE: the pump segment should be set up between the venous
reservoir outlet connector (ref. 7) and the oxygenator venous inlet connector
(ref. 8) taking account of the direction of rotation of the pump. Remove yellow
cap from the gas scavenging connector (ref. 9) of the Cardiotomy Reservoir.
If oxygenated blood is necessary for blood cardioplegia, connect a 3
way stopcock to luer connection positioned on the recirculation line.
The third stopcock way will supply oxygenated blood.
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
used venous reservoir. Open the "ON-OFF" manifold (position "ON").
7) SAMPLING MANIFOLD (fig. A)
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. 10) is in the "OFF" position.
8) CONNECTING THE TEMPERATURE PROBES
The connection for the arterial temperature probe (red - ref. 11) is positioned
next to the arterial outlet, whilst the venous probe site (blue - ref. 12) is
opposite the venous inlet. SORIN GROUP ITALIA temperature probes have
code 9026.
9) RECIRCULATION AND PURGE LINES
Check that the white clamp (ref. 13) positioned on the recirculation line
between arterial outlet of the oxygenating module and venous reservoir is
open. Close the blue clamp on the oxygenator purge line.
10) CONNECTING THE GAS LINE
Remove the green cap from the gas inlet connector indicated as "GAS
INLET" (ref. 14) and connect the 1/4" gas line. Ensure that the gas supply is
from a suitable air/oxygen mixer such as the Sechrist, code 9046 (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" (ref. 15).
- 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.
- If there is to be continuous administration of anticoagulant to the
patient, use a unfiltered female luer lock connector on the head of the
reservoir.
11) VAPOROUS ANAESTHESTICS
The oxygenator is suitable for use with volatile anaesthetic isoflurane and
sevoflurane, by mean of a suitable narcosis gas evaporator. If these
vaporous anaesthetics are used, some method of scavenging the gas from
the oxygenator should be considered. The protocol, the concentration and
the monitoring of the anaesthetic gases administrated to the patient, is under
the sole responsibility of the physician in charge of the treatment.
The only volatile anaesthetics suitable for this use are isofluorane and
sevolfuorane
The methods adopted for vaporous anaesthetic gas scavenging should
not increase or reduce in any way the pressure level at the oxygenator
fibres.
F. PRIMING AND RECIRCULATION PROCEDURE
Do not use alcoholic priming solutions: such solutions could compromise the
proper functioning of the oxygenating module.
1) KEEP THE GAS FLOW OFF
2) KEEP THE OXYGENATOR PURGE LINE CLOSED
Check that the blue clamp, placed on the oxygenator purge line, is in the
closed position. Keep the white clamp, placed on the recirculation line, open.
GB - ENGLISH