Priming And Recirculation Procedure; Starting Perfusion; During Perfusion - sorin SYNTHESIS M PH.I.S.I.O Gebrauchsanweisung

- 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 anaesthetic isofluorane and
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 500-1000
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. 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 has 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 M Ph.I.S.I.O has an integrated 40 m
debubbling arterial filter.
The filter is equipped with a stopcock with two connections, one for the
recirculation/purge line, the other for the arterial sampling line.
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 pO
2
High pCO
2
Low pCO
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.
- 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.
GB – ENGLISH
decrease FiO
2
Increase FiO
2
Increase gas flow
Decrease gas flow
of 80:100%.
2
7