Priming And Recirculation Procedure - dideco ECC.O5 Notice D'utilisation

in order to prevent accidental introduction of air into the
negative pressure side of the device.
8) VENTILATING GAS SUPPLY
Connect the 1/4" (6.4 mm) gas supply line to the gas inlet of the
oxygenator.
The "gas escape" system is designed to prevent any
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potential risk of occlusion of the gas outlet; such blockage
could cause the immediate passage of air to the blood
compartment.
F. PRIMING AND RECIRCULATION PROCEDURE
- Do not use alcohol based priming solutions as they can
compromise the structural integrity and functionality of the
device.
1) CHECK THE HEAT EXCHANGER
Circulate water through the heat exchanger prior to priming the oxygenator.
Check the water system for leaks, proper water temperature range, and
adequate water flow. If a water to blood leak exists, water will collect in the
tubing connected to the oxygenator inlet/centrifugal pump outlet port or
drip from the hole in the bottom of the oxygenator module indicating the
device must not be used.
2) KEEP THE GAS FLOW OFF
3) VERIFY THAT THE
STOPCOCK IS OPEN
4) CLAMP THE VENOUS INLET LINE AND ARTERIAL LINE OF
THE ECC.O
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5) PRIME THE CIRCUIT
The blood compartment maximum pressure in the
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oxygenator module must not exceed 500 mmHg (67kPa).
In order to maintain positive hydrostatic pressure during the
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priming and recirculation phase, keep the priming bag above
the ECC.O .
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It is recommended to use a pre-bypass filter to capture any
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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
greatly aid in priming. Therefore CO
recommended.
b. Verify the recirculation/purge line is open to the purge position.
c. Prepare to prime with the appropriate amount of priming solution.
d. After priming the A/V loop, open the venous line attached to the
inlet of the ECC.O5 bubble trap and slowly allow priming solution
into the ECC.O5.
e. Allow the priming solution to prime the pump, heat exchanger,
and oxygenator.
f. Verify that the connection tube between the venous bubble trap
and the inlet connector of the pump is completely primed and
debubbled.
g. Prime bubble trap purge line and purge air from bubble trap as
needed.
h. Activate centrifugal pump to recirculate priming solution through
recirculation/purge line of the oxygenator module.
- During this phase with the recirculation/purge line open and the
arterial line clamped, never exceed a pump rate of 1000 rpm.
i. 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.
j. Set the pump flow rate to 5 LITERS/MIN . Continue to recirculate
for 3-5 minutes. While recirculating, check the system for air
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RECIRCULATION/PURGE
flush of the circuit is highly
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GB – ENGLISH – INSTRUCTIONS FOR USE
bubbles and tap the entire circuit to facilitate the removal of air.
Purge any air accumulating at the bubble trap top by aspirating
from the purge line.
k. 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.
l. Ensure that all other components of the circuit are primed, de-
aired and appropriately clamped as needed.
m. Once the circuit and device are primed, stop the centrifugal pump
and clamp the arterial and venous lines. Close the
recirculation/purge stopcock.
n. Prior to bypass, 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
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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.
The venous and arterial lines are identical in diameter as they
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are both 3/8" lines. Care must be taken to be certain that the
venous line is connected to the venous cannula and that the
arterial line is connected to the arterial cannula.
LINE
During recirculation, ensure a volume source is open to the
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circuit. Do not purge using the bubble trap purge line unless
a volume source is open to the device. Air will be drawn
across the membrane and into the device if the ECC.O
open to a volume source.
If the cardioplegia circuit has been connected to the arterial
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blood access port, check that the circuit has been primed.
If tubing lines used for pressure measurement are connected,
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check that the lines have been primed.
Occlude the arterial outlet line with a clamp some
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centimeters away from the outlet port.
Do not apply negative pressure to the arterial blood access
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port. Negative pressure in the blood compartment may cause
gas microemboli formation.
G. STARTING PERFUSION
1) INITIATING FLOW
Start the centrifugal pump.
- 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.
2) INITIATION OF BYPASS
Remove clamp from venous line, remove clamp from arterial line, and
initiate bypass according to given standard clinical procedure.
3) ESTABLISH GAS FLOW
- Always open the gas flow after the blood flow. The gas/blood
flow ratio must never exceed 2:1.
4) MANAGING THE VENOUS BUBBLE TRAP
As described in Paragraph A (Description), the ECC.O
equipped with a venous bubble trap. The bubble trap is fitted with
a purge line that is controlled by the user using a roller pump or
other means suitable for removing the air from the bubble trap in
ECC, such as the Stöckert Air Purge Control (APC) System.
is not
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system is
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