Initiating Bypass; During Bypass; Terminating Bypass - SORIN GROUP PrimO2X Instrucciones De Uso

– the 3/8" tube capacity is 72 ml/m;
– the 1/2" tube capacity is 127 ml/m.
When using a soft venous reservoir (closed system), open the auxiliary
cardiotomy outlet to fill the soft venous reservoir.
Operate the aspiration line to purge air from the soft venous reservoir.
6) CIRCUIT PRIMING
– The pressure level inside the blood compartment of the oxygenating
module shall not exceed 725 mm Hg (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 loop tubing isprimed. Reduce the flow rate to 500-1000
cc/min and prime the oxygenator.
7) OPEN VENOUS AND ARTERIAL LINES
Remove the clamp from the venous and arterial lines and increase flow up to 2000
ml/min.
8) OPEN THE PURGING/RECIRCULATION LINE
Once the steps up to and including point 7 have been carried out, increase the
arterial pump speed until the flow reaches the maximum value of 8 l/min. Open the
purging recirculation stopcock for some seconds in order to prime the oxygenator
recirculation line.
9) PURGE THE AIR CONTAINED IN THE CIRCUIT
During this phase it is necessary to tap the entire circuit in order to facilitate the
removal of microbubbles from the tube walls.
After some minutes in which the flow is maintained at a high rate, all air will be
evacuated.
10) PRIME OF THE SAMPLING SYSTEM
Priming of the A/V sampling system occurs automatically when the arterial,
venous and central stopcock handles are positioned in such a way as to allow the
prime to flow from the arterial outlet to the venous reservoir.
11) CLOSE THE PURGING/RECIRCULATION LINE
After 3-5 minutes of high flow recirculation/purge all the residual air will be
evacuated and the purging/recircualtion line can be clamped.
Stop the arterial pump.
12) CLAMP THE VENOUS AND ARTERIAL LINES
Clamp the venous and arterial line
– During the priming and purge phases, the arterial/venous circuit must be
maintained at least 30 cm higher than the arterial outlet of the oxygenator.
- Do not use pulsatile flow during priming. Sudden changes in flow rate
during priming can pull air across the membrane in to the blood pathway.
- SORIN GROUP ITALIA recommends the use of the pump speed control to
reduce or stop the arterial flow slowly.
- Do not use the pump on/off switch until the pump speed is zero.
- Do not turn off the Heater-cooler.
- Check the correct dosage of anticoagulant in the system before starting
the bypass.
- The user should carry out a gross inspection for air removal.
– If the reduction connector (D523C) and a cardioplegia circuit have been
connected to the coronary outlet port, check the priming of the connected
line.
– Do not create a negative pressure at the coronary outlet. Negative
pressure in the blood compartment could cause microbubbles formation.
G. INITIATING BYPASS
1) OPEN THE ARTERIAL AND VENOUS LINES
Remove first the clamp from the arterial line, then remove the clamp on the
venous line. Start the bypass with a blood flow appropriate to patient size.
Check constantly the blood level in the venous reservoir.
2) CHECK THE CORRECT OPERATION OF THE HEAT
EXCHANGER
Check the temperature of the venous and arterial blood.
3) SELECTION OF THE APPROPRIATE GAS FLOW
The suggested gas/blood flow ratio in normothermia is 1:1 with a FiO
80:100%.
- Always open the gas flow after the blood flow. The gas/blood flow ratio
must never exceed 2:1.
- The pressure in the blood compartment must always exceed that of the
gas compartment to prevent gas emboli appearing in the blood
compartment.
4) BLOOD GAS MONITORING
After a few minutes of bypass operation, measure gas content of the blood.
Depending on the values found, adjust the relevant parameters as follows:
High pO
2
Low pO
2
High pCO
2
Low pCO
2
H. DURING BYPASS
1) CHECK THE VENOUS RETURN
If a higher venous return flow is necessary lower both the oxygenator and the
venous reservoir with respect to the patient position.
– The venous reservoir attached to the oxygenator must always be placed
in a higher position than the oxygenator.
– The auxiliary cardiotomy must always be placed in a higher position with
respect to the soft venous reservoir (closed system).
– The ACT (Activated Coagulation Time) must always be longer than or
equal to 480 seconds in order to ensure adequate anticoagulation of
extracorporeal circuit.
– If administration of anticoagulant to the patient is necessary, use the luer
connector of the central stopcock on the sampling manifold
2) ARTERIAL SAMPLING
Insert a sample syringe into the arterial sample stopcock luer. Position all
stopcocks on the sample 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 and a flush syringe into the center stopcock. Open the center
stopcock and draw at least 10-15 ml of blood prior to taking the venous sample.
Close the center stopcock. Return this blood through one of the filtered luer
connectors 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) DRUGS INJECTION
Insert the medication syringe into the luer connector of the central stopcock. Open
the central and venous stopcocks and inject into the drug into the manifold and
venous sample line.
Close the central stopcock to the medication syringe and allow an arterial-venous
"wash" through the stopcock manifold. Turn the stopcocks to the closed position
when the drug has been delivered to the venous line.
5) LOW FLOW RECIRCULATION
(Hypothermia associated with circulatory arrest).
a) Reduce the gas flow to less than 500 ml/min.
b) Open the purging/recirculation line and clamp the venous line.
c) Reduce the flow from the arterial pump to 2000 ml/min.
d) Clamp the oxygenator arterial line.
e) Recirculate at a maximum flow of 2000 ml/min. throughout the patient's
circulatory arrest.
f) To restart bypass after circulatory arrest, open the venous and arterial lines and
slowly increase the blood flow.
g) Close the recirculation line.
h) Adjust gas flow.
6) CONTINUOUS AIR PURGE
The purging/recirculation stopcock in "PURGE" position features the continuous
purge of blood and any incidental air from the gas exchange module during
bypass.
In this condition and at full arterial blood flow, the continuous purge diverts only
few mls/min of blood from the patient.
Always carefully check the level inside the venous reservoir. Greater care
should be taken during emptying over particularly low levels and/or reduced
flows.
I. TERMINATING BYPASS
Bypass should only be terminated after consideration of each individual patient's
of
2
condition 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 subsequently reinitiated, a minimum blood
flow inside the oxygenator must be maintained (maximum 2000 ml/min).
GB - ENGLISH
Decrease FiO
2
Increase FiO
2
Increase gas flow
Decrease gas flow
7