dideco ECC.O5 Notice D'utilisation page 7

Carefully check for air in the bubble trap, which must be
evacuated by aspirating it via the purge line.
During circulation, the venous bubble trap is under negative
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pressure. Any air accumulating at the bubble trap top can be
removed only by aspirating it via the purge line. A one-way
safety valve is provided in the purge line in order to prevent air
from flowing back into the system from the purge line.
5) FUNCTIONING OF HEAT EXCHANGER
Check the temperature of the arterial blood to verify the heat
exchanger is working.
6) MANAGING ASPIRATION AND VENT LINE(S)
Vent blood should be reintroduced into the circuit via storage reservoir
or other means. Suction blood from the chest cavity is to be
managed using a separate cardiotomy reservoir in combination
with an Autotransfusion (ATS) or cell saving system, refer to
system instructions for use regarding clinical utilization of the
ATS/cell saver system.
7) MANAGING THE PURGE LINE ON OXY MODULE
Evacuate air, if necessary, by positioning the recirculation/purge
stopcock in the purge position. Close the stopcock when purge is
finished.
8) BLOOD GAS ANALYSIS
After initiation of bypass, the blood gas parameters should be
checked via venous and arterial sampling. After sampling, always
move the stopcock back into the "closed" position.
Venous sampling site is under negative pressure. Always
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close stopcock before removing syringe.
Arterial sampling site is under pressure. Always insert a
-
syringe into the sampling site before opening the
stopcock.
H. DURING PERFUSION
1) CHECKING THE VENOUS DRAINAGE
The venous drainage is a function of the flow rate of the
centrifugal pump and is directly controlled via the centrifugal
pump.
If it is necessary to administer anticoagulant to the
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patient, refer to § H 3) "ADMINISTRATION OF
MEDICATION/ADDITIVES".
The difference between water and blood temperature in
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the heat exchanger should not exceed 10°C. Higher
values may result in the formation of microbubbles from
the dissolved blood gases.
2) VENOUS AND ARTERIAL SAMPLING
Use the stopcock manifold for venous and arterial sampling as
needed. Open the sample system to permit continuous flushing
with arterial blood. This eliminates the necessity of using a flush
syringe when drawing an arterial sample. Before taking a venous
sample, shut off the arterial side of the sampling system and
withdraw at least 10 ml from the center stopcock.
Samples must be taken only when the pump is running
-
and there is blood flow through the ECC.O
pressure in the blood compartment may decrease,
resulting in the possible formation of air bubbles.
Venous sampling site is under negative pressure. Always
-
close stopcock before removing syringe.
Arterial sampling site is under pressure. Always insert a
-
syringe into the sampling site before opening the
stopcock.
3) ADMINISTRATION OF MEDICATION/ADDITIVES
4) PURGING THE BUBBLE TRAP
I. TERMINATING PERFUSION
Perfusion should be terminated and blood volume managed
depending on the hemodynamic conditions of each individual patient.
Act as follows:
1) Turn the gas flow off.
2) Slowly reduce the centrifugal pump speed while gradually
3) Open the recirculation/purge line to the recirculation position.
4) Occlude the venous line.
5) Verify a volume source is open to the device.
6) Recirculate as required at 1000 rpm maximum.
-
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J. BLOOD RECOVERY AFTER PERFUSION
If desired, maximum blood volume return to the patient may be
accomplished by using priming fluid in the priming bag when the blood
reaches minimum volume. Pump slowly through the device, delivering
blood from the device to the patient while simultaneously verifying that
the priming bag is not completely emptied.
- After ECC, ECC.O
cardiorespiratory support of the patient.
- Do not reuse the same ECC.O
device in respitatory or cardiorespiratory support.
K. REPLACEMENT
A spare system must always be available during perfusion. After 5
days of use with blood or if situations arise such that, on judgment of
the person responsible for perfusion, the safety condition of the patient
is compromised (insufficient oxygenator performance, leaks,
anomalous blood parameters etc.), proceed as follows to replace the
device. Use a sterile technique throughout the replacement procedure.
1) Stop the gas flow, turn off the heater/cooler, and occlude the
2) Place two clamps on the arterial line (5 cm apart) near the arterial
3) Place two clamps on the venous line (5 cm apart) near the inlet of
5 . If not, the
4) Disconnect the water lines, the gas line, the arterial and venous
5) Cut the arterial and venous lines between the clamps.
6) Remove the ECC.O
7) Prepare the ECC.O
GB – ENGLISH – INSTRUCTIONS FOR USE
While on bypass add all small volume drugs to the venous blood
through the sample system to ensure thorough mixing.
Medication/additives must be injected into the device at
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the inlet of the venous bubble trap in order to trap and
remove any air introduced into the ECC.O
medication/additive injection.
The bubble trap must be visually checked periodically for the
presence of entrained air. If air is observed or detected by a
venous air sensor, manually purge the air from the bubble trap.
If air is detected, reduce the flow rate, isolate and resolve
-
the cause or source of the air (obstruction of venous
inlet line, venous cannula occlusion etc.), and purge the
air from the bubble trap as soon as possible.
occluding the arterial line.
Do not turn off the heat exchanger during the recirculation
phase.
Verify that the cardioplegia circuit connected to the arterial
blood access port is properly occluded.
can be used for respiratory and/or
5
in ECC after initiating use of the
5
water lines.
outlet, and immediately stop the centrifugal pump.
the venous bubble trap.
sampling lines, the recirculation/purge line of the oxygenator
module and the purge line of the venous bubble trap.
from the holder and disconnect the
5
centrifugal pump from the driver.
5 unit to be used as replacement,
disconnecting the arterial and venous lines using aseptic
techniques in order to maintain device sterility.
during
5
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