Terminating Perfusion; Blood Recovery After Perfusion; Device Change-Out; Return Of Used Products - sorin Synthesis C Gebrauchsanweisung

- If it is necessary to administrate anticoagulant to the patient, use the A/V
sampling stopcock.
- 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 through 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 Fi0
not exceeding 30%. This is to prevent reaching high non-physiological p02
values.
b. Open the recirculation/purge line (Ref.10 in Fig.1) and occlude the venous
reservoir inlet line (Ref 1 in Fig.1).
c. Reduce the arterial pump speed to a value of 1000 ml/min.
d. Occlude the arterial line of the oxygenator module (Ref 7 in Fig.1).
e. Recirculate at a flow of 1000 ml/min. for the entire duration of the circulatory
arrest.
f. To re-enter into bypass from the circulatory arrest, open the venous and
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 depending on the needs of the patient.
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- 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
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the oxygenator could be improved by a short but substantial increase in the
gas flow. For example, "washing" of 10 sec. with a gas to blood flow ratio of
2:1 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. Turn the gas flow off.
2. Turn the heater-cooler off.
3. Slowly decrease the arterial flow to zero while clamping the venous line.
4. Clamp the arterial line.
- If extracorporeal circulation has to be restored, maintain a minimum blood
flow inside the oxygenator (maximum 1000 ml/min).
- Check that the cardioplegia circuit connected to the coronary outlet port is
clamped.
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.
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and an increase of pCO the performance of
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3. When the venous reservoir is almost empty, stop the arterial pump and occlude
the arterial line.
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 collapsible venous reservoir from the oxygenator by unscrewing
the ring-nut.
7) Lift the reservoir.
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
to a value
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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.
15) With the arterial line clamped, recirculate through the recirculation/purge line to
remove the air from the connector and the filter.
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. MEDICAL DEVICES TO BE USED WITH SYNTHESIS C
- SYNTHESIS HOLDER (code 050128)
- SYNTHESIS HOLDER WITH BAG SQUEEZER (code 050350)
- Stopcock holder (code 050134).
- Active drainage kit (code 096834).
The circuit connections must be made with tubes of a diameter compatible with the
dimensions of the connectors located on the device (3/8", 1/4", 1/2").
Temperature control must be carried out with SORIN GROUP ITALIA probes, code 050122
or YSI Series 400 compatible.
Use a Sechrist air/oxygen blender (Sorin Group Italia code 09046) or a system with
compatible technical features to control the blood gas concentration.
Any heating/cooling system (thermocirculator) may be used, provided that the connectors to
the oxygenator are the Hansen type (Sorin Group Italia code 09028).
SORIN GROUP ITALIA is currently not aware of any contraindications to the use of the device
with occlusive or non-occlusive pumps. The use of other types of pumps must be agreed with
SORIN GROUP ITALIA.
M. RETURN OF USED PRODUCTS
Should the user be dissatisfied with anything related to the quality of the product, the
product distributor or the authorized local SORIN GROUP ITALIA representative
should be notified.
All the parameters considered critical by the user must be reported with particular
care and urgency. The following is the minimum information that should be provided:
 Detailed description of the event and, if pertinent, the conditions of the patient;
GB – ENGLISH
to not more than 40% and check the
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