Terminating Perfusion; Blood Recovery After Perfusion; Device Change-Out; Use Of Active Venous Drainage With Vacuum - sorin SYNTHESIS 4D Instrucciones De Uso

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 OFF PUMP
(hypothermia associated with circulatory arrest).
a. Reduce the gas flow to a value below 500 ml/min. and reduce
FiO to a value not exceeding 30% in order to prevent reaching
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high non-physiological pO
b. Open the re-circulation/purge line and occlude the venous
reservoir inlet line.
c. Occlude the arterial line of the oxygenator module.
d. Re-circulate at 1000 ml/min for the entire duration of the circulatory
arrest.
e. To re-enter into bypass from the circulatory arrest, open the
venous and arterial lines and slowly increase the blood flow.
f. Set the re-circulation/purge line to the automatic purging
position.
g. Align the gas flow and FiO
patient.
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
pCO , the performance of the oxygenator could be improved by
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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:
a. Stop flow through the sample system prior to concluding bypass.
b. Conclude bypass according to normal operating procedures.
c. Turn the gas flow off.
d. Slowly reduce the centrifugal pump speed while gradually
occluding the arterial line.
e. Open the recirculation/purge line to the recirculation position.
f. Occlude the venous line between the patient and the reservoir.
g. Increase the pump speed to 1000 ml/min maximum.
h. Recirculate as required.
- If extracorporeal circulation has to be restored, maintain a
minimum blood flow inside the oxygenator (maximum 1000
rpm).
- Do not turn the thermocirculator off during the re-circulation
phase.
- Check that the cardioplegia circuit connected to the coronary
outlet is properly occluded.
J. BLOOD RECOVERY AFTER PERFUSION
The volume of blood inside the SYNTHESIS 4D can be recovered
according to normal operating procedures. Use aseptic techniques in
handling the device during volume recovery.
K. DEVICE CHANGE-OUT
A spare oxygenator/pump must always be available during perfusion.
After 6 hours of use with blood or if situations arise such that, on
judgment of the person responsible for perfusion, the safety
conditions for the patient are compromised (insufficient oxygenator
performance, leaks, anomalous blood parameters etc.), proceed as
follows to replace SYNTHESIS 4D.
Supplies needed for the change-out procedure:
- One (1) sterile tubing cutter
- Eight (8) tubing clamps
- One (1) sterile SYNTHESIS 4D
- One (1) SYNTHESIS 4D holder
- Use a sterile technique throughout the replacement procedure.
values.
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depending on the needs of the
2
and an increase of
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1) Connect a second oxygenator/pump assembly holder to the pump
console. Place the holder as close to the first holder as is possible,
such that the new oxygenator/pump will be oriented in the same
orientation as the old oxygenator.
2) Remove the new device from packaging and inspect sterile wrapper
for damage. Do not use if sterile barrier or device has been
compromised or damaged. Place the new device in the second
holder and mount the pump driver per § E2. The inlet and outlet ports
of the new device should be oriented in the same direction as the
ports of the device being replaced. Stop the flow though the sample
system of the old device, and verify that the recirculation/purge valve
is closed and that the arterial access line is clamped.
3) Connect the water lines to the new device. Circulate water through
the heat exchanger and check for leaks in the tubing connected to
the blood inlet port to from the hole on the bottom of the oxygenator.
4) Terminate bypass according to normal procedures. This should
involve clamping of the venous line and arterial line.
5) Turn off ventilating gas. Remove the gas line from the old oxygenator
module and place it on the new oxygenator module.
6) Connect the arterial sample line of the new sample system kit to the
arterial sampling port on the arterial filter. Remove the old venous
sample line from the venous sampling port of the venous reservoir,
and attach the venous sample line of the new sample system. Make
sure the stopcock handles on the sample manifold are positioned to
allow flow through the sample lines and manifold while ensuring
there is no leakage from the sample site ports.
7) Connect the recirculation/purge line of the new device to the
reservoir.
8) Place two tubing clamps on the 3/8" (9.5 mm) pump inlet line. This is
the line coming from the reservoir to the inlet port of the old device.
Place these clamps close to the pump inlet port and approximately
1.5 inches (3.8 cm) apart from each other. Using aseptic technique,
cut the line between the clamps. Cut near the clamp closest to the
pump.
9) Without removing the clamp, attach the 3/8" (9.5 mm) pump inlet line
(coming from the reservoir) to the new pump inlet port.
10) Place two tubing clamps on the 3/8" (9.5 mm) filter outlet line. Place
these clamps close to the outlet port and approximately 1.5 inches
(3.8 cm) apart from each other. Using aseptic technique, cut the line
between the clamps. Cut near the clamp closest to the filter outlet
port.
11) Without removing the clamp, attach the 3/8" (9.5 mm) outlet line to
the new filter outlet port.
12) Disconnect the arterial blood access line from the old device and
reconnect to the arterial access port on the new device.
13) Remove the clamp on the pump inlet line of the new device.
14) Open the recirculation/purge valve to the purge position.
15) Check the security of all the connections. Ensure that there is still a
clamp on the arterial line to the patient.
16) Prime the new device and evacuate any air using the priming and
recirculating procedure using the AV bypass loop in the circuit.
17) Turn off the sample system. Turn off the pump and close the
recirculation/purge line.
18) Remove the clamps on the venous and arterial lines, and reinstate
bypass according to normal procedures.
19) Remove the arterial temperature probe from the old device and
connect to the arterial temperature probe fitting of the new device.
20) Remove the gas scavenging line from the old device and connect to
the new device.
L. USE OF ACTIVE VENOUS DRAINAGE
WITH VACUUM
This method may be applied at any time during extra-corporeal
circulation, provided that the use of the device follows the constraints
described below. Using an active venous drainage tubing kit supplied
separately and a vacuum regulation device, SYNTHESIS 4D can be
used in active venous drainage applications with vacuum assist. Set up
the regulation device according to the manufacturer's instructions.
1) Aseptically open the packaging of the kit for active venous drainage
with vacuum.
2) Connect the end with the blue cap to the vent connector of the
venous reservoir, marked "VENT/VACUUM PORT", and the end
with the red cap to a vacuum regulating device. The latter must be
connected to a vacuum source.
3) Close the clamp and the green cap on the line connected to the
reservoir.
4) If considered necessary to interrupt venous assist, remove the yellow
cap and open the clamp on the line described in 3).
- Use aseptic technique and sterile tubing for the above
mentioned steps. Secure tubing ports by sliding tubing over
each port until fully engaged. Use of a locking tie is
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