Starting Perfusion; During Perfusion - sorin SYNTHESIS 4D Instrucciones De Uso

module must not exceed 750 mmHg (100 kPa / 1 bar / 14 psi).
- In order to maintain positive hydrostatic pressure during the
priming and recirculation phase, keep the reservoir above the
oxygenator.
- It is recommended to use a pre-bypass filter to capture any
particles that may be present in the circuit or in the priming
solution.
a. While not required, flushing the circuit with carbon dioxide gas will aid
in priming.
b. Open the venous line attached to the outlet of the reservoir and
slowly allow priming solution into the SYNTHESIS 4D.
c. Allow the priming solution to prime the pump, heat exchanger,
oxygenator and arterial filter.
d. Verify that the connection tube between the venous reservoir outlet
and the inlet connector of the centrifugal pump is completely primed
and debubbled.
e. Activate centrifugal pump to recirculate priming solution through
recirculation/purge line of the arterial filter.
- During this phase with the recirculation/purge line open and the
arterial line clamped, never exceed a pump rate of 1000 rpm.
f. Remove the clamp from the arterial line, increase the flow rate and
recirculate the priming fluid through the A/V loop in order to prime
and debubble the circuit.
g. Set the pump flow rate to 6 litres/min. Continue to recirculate for 3-5
minutes. While recirculating, check the system for air bubbles and
tap the entire circuit to facilitate the removal of air.
h. Ensure that the sampling manifold system is primed. The sample
system will prime itself during recirculation when the stopcocks are
positioned to allow flow through the sample lines and manifold. The
handles point to the off position. Flow through the sample system
should be stopped when there is not flow in the bypass circuit.
i. Ensure that all other parts of the circuit are primed and de-aired.
j. Once the circuit and device are primed, stop the centrifugal pump
and clamp the arterial and venous lines. Close the recirculation/purge
stopcock.
k. Prior to bypass, disconnect the A/V loop, clamp the arterial and
venous lines, then pass the clamped lines to the surgeon for
connection to the respective cannulae.
-
It is intended that systemic anticoagulation be utilized while the
pump is in use. Anticoagulation levels should be determined and
verified by the physician based on risks and benefits to the
patient and monitored throughout the case.
- If the cardioplegia circuit has been connected to the arterial blood
access port, check that the circuit has been primed.
- If tubing lines used for pressure measurement are connected,
check that the lines have 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) INITIATING FLOW
Start the centrifugal pump.
- Do not operate the pump for extended periods of time if the
arterial outlet to the patient is clamped and the purge/recirculation
stopcock is closed at the same time. The temperature inside the
pump may increase, increasing the risk of cellular damage.
- Do not operate the pump with the centrifugal pump inlet clamped.
A negative pressure would be generated in the pump and air
bubbles could form.
- Do not remove the arterial outlet clamp at the beginning of
extracorporeal circulation until an adequate outlet pressure has
been reached in order to prevent backflow. The pump must be
operated to provide a pressure higher than the patient systemic
pressure and the circuit head pressure. Monitor the pump flow
rate, its rpm and the systemic pressure as indices of potential
backflow.
- Carefully monitor for signs of occlusion throughout the circuit.
- Do not remove the arterial outlet clamp at the beginning of
extracorporeal circulation until an adequate outlet pressure has
been reached in order to prevent backflow. The pump must be
operated to provide a pressure higher than the patient systemic
pressure and the circuit head pressure. Monitor the pump flow
rate, its rpm and the systemic pressure as indices of potential
backflow.
8
2) INITIATING BYPASS
- Control the flow rate by adjusting the pump speed. Attempting to
adjust the blood flow rate by partial clamping of the device outlet
may augment the risk of cellular damage.
- When stopping circulation, clamp the device outlet and stop
pump rotation immediately, or reduce the pump speed to less
than 1000 rpm if the arterial filter recirculation line is open.
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.
3) ESTABLISH GAS FLOW
The suggested gas/blood flow ratio in normothermia is 1:1 with an
FiO of 80:100%.
2
- Always activate the gas flow after the blood flow. The gas/blood
flow ratio must never exceed 2:1.
4) FUNCTIONING OF HEAT EXCHANGER
Check the temperature of the venous and arterial blood.
5) MANAGING THE ARTERIAL FILTER
SYNTHESIS 4D has an integrated 40 μm self-debubbling filter.
The filter is equipped with a stopcock with two connections, one for the
re-circulation/purge line, and the other for the arterial sampling line.
With the stopcock of the re-circulation/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.
6) 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 re-circulation/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. However, to ensure an adequate response time in case
of venous inflow obstruction, it is recommended to maintain
an adequate volume in addition to the 300 ml minimum level.
Do not exceed 4300 ml in the venous reservoir.
- 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.
- The arterial sampling site is under pressure. Always insert a
syringe into the sampling site before opening the stopcock.
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
GB – ENGLISH
decrease FiO
2
Increase FiO
2
Increase gas flow
Decrease gas flow