Priming And Recirculation Procedure; Starting Perfusion; During Perfusion - sorin Synthesis Gebrauchsanweisung

of about 1 meter. Position the stopcock handles toward the access ports of the
manifold (A/V shunt position).
ARTERIAL SAMPLING LINE:
connector of the arterial sampling site, indicated as "SAMPLING SITE" on the
recirculation/purge stopcock and located on top of the arterial filter (fig.1, ref. 23),
beside the recirculation/purge line port. Connect the red male Luer of the arterial
sampling line to the arterial sampling site.
- The Luer connector of the arterial sampling site does not include a
one-way valve. Check that there is a one-way valve in the sampling line
to prevent accidental air introduction into the arterial line.
VENOUS SAMPLING LINE:
of the venous sample site located on the venous return connector (fig.1, ref. 2).
Connect the blue male Luer of the venous sampling line to the venous sampling site
Luer.
- Check that all the Luer connections are secure. All the accessory lines
connected to the device must be connected tightly in order to prevent
accidental introduction of air into the device or blood loss.
7) CONNECTING THE TEMPERATURE PROBES
Use SORIN GROUP ITALIA temperature probes (code 09026) or equivalent.
The connection for the arterial temperature probe (Fig. 1, Ref. 17) is positioned near
the cardioplegia outlet, while the venous probe holder (Fig. 1, Ref. 3) is located on
the venous return connector of the reservoir.
8) CONNECTING THE GAS LINE
Remove the green cap from the connector marked "GAS INLET" (Fig. 1, Ref. 14)
and connect the 1/4" gas line. The gas must be supplied through a suitable
air/oxygen mixer. The connection for a capnograph is obtained on the central axis of
the "GAS ESCAPE" connector (Fig. 1, Ref. 15).
- The "gas escape" system was designed to prevent any potential risk of
occlusion of the gas outlet; such occlusion would cause immediate
passage of air to the blood compartment.
- It is recommended to use a pre-bypass filter to capture any particle
that may be present in the circuit or in the priming solution.
9) VAPOROUS ANAESTHETICS
The oxygenator is suitable for single use with volatile anaestheti
sevofluorane by means 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
monitoring of the anaesthetic gases administered to the patient is under the sole
responsibility of the physician performing the treatment.
- The only volatile anaesthetics suitable for this use are isofluorane and
sevofluorane.
- The methods adopted for vaporous anaesthetic gas scavenging should
not in any way increase or reduce the pressure level at the oxygenator
fibres.
F. PRIMING AND RECIRCULATION PROCEDURE
- Do not use alcohol-based priming solutions: these would compromise
functionality of the oxygenator module.
1) KEEP THE GAS FLOW CLOSED
2) CHECK THAT THE RECIRCULATION/PURGE LINE IS OPEN
3) OCCLUDE THE VENOUS AND ARTERIAL LINES
4) CHECK THE HEAT EXCHANGER
Once more check the integrity of the heat exchanger and that there are no water
leaks.
5) PRIME THE VENOUS RESERVOIR
Secure all the aspiration lines connected to the venous reservoir with ties. Fill the
venous reservoir with sufficient liquid to ensure that the intended hematocrit is
obtained, taking into account::
- the recovered priming volume of the oxygenator already including the arterial filter
is 430 ml;
- the 3/8" tube contains 72 ml/m;
- the 1/2" tube contains 127 ml/m.
6) PRIME THE CIRCUIT
- The pressure in the blood compartment of the oxygenator module
must not exceed 750 mmHg (100 kPa / 1 bar / 14 psi).
Remove the clamp from the venous line and start with the pump at a reasonably
high flow so that the pump segment is primed. Reduce the flow rate to 100-300
cc/min. as soon as the priming liquid reaches the arterial filter. Slowly fill the filter in
such a way that the air is pushed to the top, both on the outside and inside of the
screen. In order to encourage the fluid to permeate the screen, stop the pump,
Remove the protective cap from the Luer
Remove the protective cap from the Luer connector
c
isofluorane and
lightly tap the filter until the levels inside and outside the screen are equivalent, then
restart the pump and continue priming. After priming the filter, open the arterial
clamp and increase the flow rate to 5-6 litres/min. priming the rest of the circuit.
7) EVACUATE THE AIR FROM THE CIRCUIT
Work with a clamp on the arterial line, opening and closing it rapidly in order to
encourage evacuation of the air which collects in the top part of the filter.
8) PRIME THE SAMPLING STOPCOCK
Priming of the A/V sampling stopcock is automatic and is carried out by suitably
positioning the arterial, venous and central selectors in such a way as to allow the
priming liquid to flow from the arterial outlet to the venous reservoir.
9) CLOSE THE RECIRCULATION/PURGE LINE
After 3-5 minutes of recirculation at high flow when all the residual air will have been
evacuated, set the stopcock selector to the automatic purging position. Stop the
pump.
- During the continuous purging phase with the purge line open and the
arterial line closed, never exceed a flow of 400 ml/min.
10) OCCLUDE THE VENOUS AND ARTERIAL LINES
- Do not use pulsed flow during the priming phase.
- Check the correct dosage of anticoagulant in the system before
starting the bypass.
- Sorin Group Italia suggests using the pump speed regulator to slowly
reduce or interrupt the arterial flow.
- Do not use the on/off switch until the pump speed is zero.
- Do not turn the thermocirculator off.
- If the reduction line and a circuit have been connected to the coronary
outlet, check that the circuit has been primed.
- Occlude the line with a clamp some centimetres away from the outlet.
- Do not apply negative pressures to the coronary outlet. Negative
pressures in the blood compartment may cause the formation of gas
micro-emboli.
G. STARTING PERFUSION
1) OPENING THE ARTERIAL AND VENOUS LINES
First remove the clamp from the arterial line and then from the venous line. Enter
into bypass with a blood flow suited to the size of the patient. Constantly check the
blood level in the venous reservoir.
2) CHECKING FUNCTIONING OF THE HEAT EXCHANGER
Check the temperature of the venous and arterial blood.
3) SELECTING THE SUITABLE GAS FLOW
The suggested gas/blood flow ratio in normothermia is 1:1 with an FiO
- Always activate the gas flow after the blood flow. The gas/blood flow
ratio must never exceed 2:1.
4) MANAGING THE ARTERIAL FILTER
As described in Paragraph A, SYNTHESIS has an integrated 40 m self-debubbling
filter.
The filter is equipped with a stopcock with two connections, one for the
recirculation/purge line, and the other for the arterial sampling line (fig. 2, ref. 23).
With the stopcock of the recirculation/purge line in the automatic purging position,
the air can continuously be evacuated from the oxygenator module during bypass.
It is recommended to continuously evacuate the air for the first 10-15 min. of
extracorporeal circulation.
5) BLOOD GAS ANALYSIS
After a few minutes of bypass, the amount of gas in the blood must be checked. In
consideration of the values read, act as follows:
High pO
2
Low p O
2
High pC O
2
Low pC O
2
Close the recirculation/purge stopcock.
H. DURING PERFUSION
1) CHECKING THE VENOUS RETURN
If a higher venous return is required, lower the oxygenator/venous reservoir level
with respect to the patient.
- The ACT (Activated Coagulation Time) must always be greater than or
equal to 480 seconds in order to assure proper anticoagulation of the
extracorporeal circuit.
- If it is necessary to administrate anticoagulant to the patient, use the
A/V sampling stopcock.
- The minimum operating volume of the cardiotomy reservoir is 300 ml.
GB – ENGLISH
decrease Fi O
2
Increase Fi O
2
Increase gas flow
Decrease gas flow
of 80:100%.
2
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