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Emptying the cardiotomy and the soft venous reservoir might result in
air delivery to the oxygenator and, eventually, to the patient.
Version OXYGENATING MODULE only
- The venous reservoir attached to the oxygenator must always be
placed in a higher position than the oxygenator.
- The ACT (Activated Coagulation Time) must always be longer than or
equal to 480 seconds in order to ensure adequate anticoagulation of
extracorporeal circuit.
2) ARTERIAL SAMPLING (fig. 4)
Versions with SOFT VENOUS RESERVOIR
a) Turn the selector switch on the sampling stopcock (ref. 9) to the "A-
SAMPLE PURGE" position (the arterial line will then be automatically
purged).
b) Insert the syringe into the sampling female luer marked SAMPLE PORT
(ref. 8).
c)
Aspirate at least 2 ml of blood (the automatic purge avoids the need to
repeat the operation). A self-closing valve will avoid any blood leakage
from the luer.
3) VENOUS SAMPLING
Versions with SOFT VENOUS RESERVOIR
a) Turn the selector switch on the sampling stopcock to the "V-SAMPLE
PURGE" position.
b) Insert the syringe into the female luer marked "SAMPLE PORT".
c)
Aspirate and purge the blood sample a couple of times before proceeding
to the venous sampling analysis. This double operation (aspiration and
purge) can be done whilst maintaining the selector switch in the same
position.
4) DRUG DELIVERY (fig. 4)
Versions with SOFT VENOUS RESERVOIR
a) Turn the selector switch on the sampling stopcock to the DRUGS
INJECTION position.
b) Insert the syringe containing the drug into the female luer marked
DRUGS PORT (ref. 10) and inject the liquid.
c)
Turn the switch to the A-V SHUNT position. The system will be
automatically flushed and the drug will flow into the venous line.
5) LOW FLOW RECIRCULATION
(Hypothermia associated with circulatory arrest).
a) Reduce the gas flow to less than 200 ml/min.
b) Open the recirculation line and clamp the venous line.
c)
Reduce the flow from the arterial pump.
d) Clamp the arterial line.
e) Recirculate at a maximum flow of 200 ml/min. throughout the patient's
circulatory arrest.
f)
To restart bypass, after circulatory arrest, open the venous and arterial
lines and slowly increase the blood flow.
g) Clamp the recirculation line.
h) Adjust gas flow.
I. TERMINATING BYPASS
Must be carried out after consideration of each individual patient's state. Act as
follows:
1)
Turn the gas flow off.
2)
Turn the thermocirculator off.
3)
Slowly decrease the arterial flow to zero while closing the venous line.
4)
Open the recirculation line.
5)
Clamp the arterial line.
6)
Increase arterial flow to 200 ml/min.
- If extracorporeal circulation has to be restarted subsequently, a minimum
blood flow inside the LILLIPUT must be maintained (maximum 200 ml/min).
- If the use of the haemofilter is necessary, refer to its specific instructions for
use.
Versions with SOFT VENOUS RESERVOIR
In case of insufficient venous return flow the soft venous reservoir might
collapse. If this happens, consequent negative pressure might cause gas
extraction from the blood if the arterial pump is not stopped immediately. To
eliminate air from the soft venous reservoir, proceed as follows:
1) Turn the gas flow off.
2) Turn the arterial pump off.
3) Clamp the arterial line.
4) Restore the required volume of liquid in the soft venous reservoir (by
releasing the soft venous reservoir squeezer or by adding liquids).
5) Check for the absence of air bubbles in the soft venous reservoir.
6
6) Clamp the venous line.
7) Open the recirculation line and recirculate at a rate of 200 ml/min until
complete air removal from the system.
8) Restart bypass by opening the arterial and venous lines.
9) Clamp the recirculation line.
J. BLOOD RECOVERY AFTER BYPASS
1)
Recover as much blood as possible from the venous line and deliver it into the
aorta by means of the arterial pump, as required by the patient condition.
2)
Once the venous reservoir is empty and the venous cannulae have been
removed:
a) Turn the arterial pump off.
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 6 hours 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.), proceed as follows for oxygenator replacement:
1)
Turn the gas flow off.
2)
Reduce arterial pump blood flow to 100 ml/min.
3)
Empty the venous reservoir.
4)
Close, by means of a double clamp, the output line of the cardiotomy and add
appropriate liquids to the cardiotomy to prime the new oxygenator.
5)
Turn the thermocirculator off, clamp the water lines.
6)
Disconnect the gas line.
7)
Close the venous lines by means of a double clamp and stop the arterial blood
pump. Close:
-
the arterial line by means of a double clamp (placed next to the
oxygenator outlet).
-
the pump line by means of a double clamp (placed next to the venous
reserve outlet).
-
Place a double clamp next to the oxygenator venous inlet.
8)
Disconnect all monitoring lines.
9)
Cut all connector tubes in the section between the two clamps, leaving a
sufficient length of tubing to allow reconnection.
10) Remove the water from the LILLIPUT holder (according to the appropriate
instructions for use) and disconnect the oxygenator.
11) Place a new oxygenator on the holder. Connect all lines (i.e. venous to the
venous reservoir, and, where applicable, the cardiotomy to the soft venous
reservoir, arterial and gas to the oxygenator, pump line to venous reservoir and
oxygenator) and secure with ties.
12) Open the water lines on the holder, turn the thermocirculator on and check the
integrity of the new oxygenator.
13) Repeat all phases described in the priming and recirculation procedure.
L. MEDICAL DEVICES FOR USE WITH THE D901
DIDECO LILLIPUT
Versions with SOFT VENOUS RESERVOIR
The device must be used in combination with a paediatric cardiotomy.
Version OXYGENATING MODULE only
The oxygenating system must be used in combination with: -a venous reservoir
functioning as a paediatric cardiotomy ; or -a paediatric soft venous reservoir and
paediatric cardiotomy.
The arterial/venous sampling system must also be used, taking care to check at the
time of arterial connection, that the male luer connector does not reach as far as the
one-way valve placed inside the arterial sampling luer in the oxygenator.
All versions
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 (3/16" or 1/4").
Temperature controls must be carried out using SORIN GROUP ITALIA probes, code
9026 or compatible to YSI Series 400.
Use Sechrist air/oxygen mixer (SORIN GROUP ITALIA code 9046) 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 9028).
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.
GB - ENGLISH
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