Terminating Perfusion; Blood Recovery After Perfusion; Device Change-Out; Use Of Active Venous Drainage With Vacuum - sorin Synthesis Gebrauchsanweisung

However, to ensure adequate response time in case of venous inflow
obstruction, it is recommended that an adequate volume in addition to
the 300 ml minimum level be maintained. Do not exceed 4300 ml in the
venous reservoir.
- Avoid that in the heat exchanger the difference between the water
temperature and the blood temperature exceeds 15 °C. Higher values
may cause the formation of bubbles from the gases dissolved in the
blood.
2) ARTERIAL SAMPLING
Insert a sample syringe into the arterial sample stopcock Luer. Position the stopcock
handles of the manifold to allow arterial blood to flow trough the manifold. The
pressure on the arterial side will allow flow. Draw the sample of blood from the
arterial sample stopcock. Turn off the arterial stopcock before removing the syringe.
3) VENOUS SAMPLING
Ensure that the arterial stopcock is closed. Insert a sample syringe into the venous
stopcock Luer. Open the central stopcock and draw at least 10-15 ml of blood prior
to taking the venous sample. Close the central and the venous stopcock. Return this
blood through one of the filtered Luer connections positioned on the top of the
reservoir. Open the venous stopcock and draw a sample of venous blood and close
the stopcock before removing the syringe.
4) DRUG INJECTION
Insert the medication syringe into the Luer connector of the central stopcock. Open
the central and venous stopcocks and inject the drug into the manifold and venous
sample line.
Close the central stopcock to the flow of the medication syringe and allow an
arterial-venous "wash" through the stopcock manifold. Turn the stopcocks to the
closed position when "washing" has been completed.
- Take the blood from the stopcocks only when the pump is running. If
not, the pressure in the blood compartment would decrease causing
the formation of air bubbles.
5) LOW-FLOW RECIRCULATION
(hypothermia associated with circulatory arrest).
a. Reduce the gas flow to a value below 500 ml/min. and reduce FiO
not exceeding 30%. This is to prevent reaching high non-physiological pO
values.
b. Open the recirculation/purge line and occlude the venous reservoir inlet line
(Ref. 2).
Reduce the arterial pump speed to a value of 1000 ml/min.
c.
Occlude the arterial line of the oxygenator module (Ref. 13).
d.
Recirculate at a flow of 1000 ml/min. for the entire duration of the circulatory
e.
arrest.
To re-enter into bypass from the circulatory arrest, open the venous and
f.
arterial lines and slowly increase the blood flow.
g. Set the recirculation/purge line to the automatic purging position.
h. Align the gas flow and FiO
- During the venous reservoir emptying phase at particularly low levels
and/or reduced flows greater care must be taken.
- If during a particularly long ECC, condensation forms in the gas outlet
with a corresponding drop of pO
performance of the oxygenator could be improved by a short but
substantial increase in the gas flow. For example, "washing" of 10 sec.
with a gas flow of 2 l/min could be sufficient. Should this not prove
effective, do not repeat washing, but replace the oxygenator.
I. TERMINATING PERFUSION
It should be terminated depending on the conditions of each individual patient. Act as
follows:
1. Close the gas flow;
2. Turn the thermocirculator off;
3. Slowly reduce the arterial pump speed to zero and at the same time gradually
occlude the venous line;
4. Open the recirculation/purge line to the recirculation position;
5. Occlude the arterial line;
6. Increase the pump speed up to a flow not exceeding 1000 ml/min.
- If extracorporeal circulation has to be restored, maintain a minimum blood
flow inside the oxygenator (maximum 2000 ml/min).
- Do not turn the thermocirculator off during the recirculation phase.
- Check that the cardioplegia circuit connected to the coronary outlet is
properly occluded.
J. BLOOD RECOVERY AFTER PERFUSION
1. Recover all the blood contained in the venous line into the venous reservoir as soon
as the surgeon has removed the cannulae from the vena cava of the patient.
2. Open the arterial line, perfuse the amount required according to the condition of the
patient through the aortic cannula, slowly reducing the level in the venous reservoir.
3. When the venous reservoir is almost empty, stop the arterial pump and occlude the
arterial line.
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depending on the needs of the patient.
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and an increase of pCO
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4. To recover the blood in the gas/heat exchanger/integrated filter module, connect the
recirculation line to a soft bag. Clamp the arterial line and activate the pump until
complete recovery of the residual blood. The recovered blood can be used
immediately, administering it intravenously, or can be used later provided that it is
suitably stored.
K. DEVICE CHANGE-OUT
A spare oxygenator must always be available during perfusion. After 6 hours of use with
blood or if situations arise such that, on judgement of the person responsible for
perfusion, the safety of the patient is compromised (insufficient oxygenator performance,
leaks, anomalous blood parameters etc.), proceed as follows to replace the oxygenator.
- Use a sterile technique throughout the replacement procedure.
1. Close the gas flow and place a clamp on the venous return.
2. Stop the arterial pump and place two clamps on the arterial line (5 cm apart) near
the integrated filter.
3. Place two clamps on the venous line (5 cm apart) in proximity of the heat
exchanger.
4. Turn off the thermocirculator, occlude and remove the water lines.
5. Remove the gas line and all the arterial sampling and recirculation/purge lines,
disconnecting them from the reservoir.
6. Disconnect the reservoir from the oxygenator by unscrewing the ring-nut.
7. Lift the reservoir by means of the telescopic arm of the holder.
8. Cut the arterial and venous lines between the two clamps.
- In this phase, keep the venous and arterial lines occluded.
9. Remove the oxygenator from the holder.
10. Mount the new oxygenator, connect the water lines and check the integrity of the
heat exchanger. Connect the venous and arterial lines, then remove the venous
clamp.
11. Connect the recirculation/purge and sampling lines.
12. Ensure that the stopcock is in the recirculation position.
13. Connect the gas line and adjust the FiO
integrity of the device.
14. Incline the arterial connector of the new oxygenator slightly downward before
mounting it on the holder.
to a value
15. With the arterial line clamped, recirculate through the recirculation/purge line to
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remove the air from the connector and the filter.
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- To facilitate the replacement procedure, it is recommended to use a circuit
with an arterial/venous shunt which, occluded during normal use, during
replacement of the oxygenator allows purging the air from the arterial line
towards the reservoir.
16. Circulate at a flow of 500-600 cc/min. priming the oxygenator.
17. When priming has been completed, remove the arterial and venous return clamps
and start ECC.
18. Position the recirculation/purge stopcock in the automatic purging position for 4-5
minutes, then close it if necessary.
19. The blood contained in the replaced oxygenator can be recovered by connecting the
arterial outlet to a connector of the reservoir and opening the recirculation/purge
stopcock.
L. USE OF ACTIVE VENOUS DRAINAGE WITH VACUUM
This method may be applied at any time during extracorporeal circulation, provided that
, the
the instructions below are followed. Using the kit code 096834, or equivalent supplied
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separately, and a vacuum regulation device, SYNTHESIS can be used with active
venous drainage with vacuum. This technique constitutes an alternative to venous
drainage by gravity and allows the use of shorter venous tubes with reduced diameter, as
well as smaller-gauged cannulas.
1. Open the packaging of the kit for active venous drainage with vacuum, operating in
such a way that sterility of the system is not compromised.
2. Connect the end with the blue cap to the vent connector of the venous reservoir,
marked "VENT/VACUUM PORT" (Ref. 7), and the end with the red cap to the
vacuum regulating device. The latter must be connected to the line vacuum.
3. Close the clamp and the green cap on the line connected to the reservoir.
4. If necessary to interrupt or suspend this method, remove the yellow cap and open
the clamp on the line.
- It is advisable not to exceed -50 mmHg (-6.66kPa / -0.07 bar / -0.97 psi)
negative pressure applied to the reservoir.
- Periodically check functioning of the vacuum regulating device and the
degree of vacuum.
M. USE FOR POSTOPERATIVE CHEST DRAINAGE
By means of the line sets/drainage kits, the SYNTHESIS venous reservoir can be
transformed into a device for chest drainage for patients in intensive care. The function
performed by the resulting device is active and calibrated suction of the blood spilt from
surgical wounds into the chest and its possible retransfusion.
These kits correspond to the specific needs of each single client and are designed for
aseptic conversion of the reservoirs, microfiltered recovery and possible reinfusion of
blood recovered in the first hours of use.
CONTRAINDICATIONS
Do not use the drainage and autotransfusion kit in the following cases:
- When protamine has been administered during surgery before the venous reservoir
has been removed from the extracorporeal circuit.
- When there is a mediastinal, pericardic, pulmonary or systemic infection.
GB – ENGLISH
to not more than 40% and check the
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