Initiating Bypass - sorin APEX HP Instrucciones De Uso

The rapid prime port may be used for rapid priming when filtration is not desired.
It may also be used as a return site for patient vent blood.
16. Arterial Filter Purge
If an arterial filter purge line is used, it should be connected to an unfiltered Luer-
lock port on the reservoir lid.
17. Fluid Administration
Large-volume bolus or continuous drug or fluid infusion may be introduced
through the unfiltered Luer-lock ports.
18. Sample System
A sterile three-stopcock manifold is connected to the venous and arterial sample
lines which are preconnected to the arterial and venous sample ports via a Luer-
lock connection. Check that these two Luer-lock connections are secure.
The arterial sample line contains a one-way valve to prevent flow into the arterial
line from the manifold. The manifold may be used in its current location on the
venous reservoir cover, or it may be removed and mounted in a manifold holder.
To remove it, lift upward on the manifold.
PRIMING THE CIRCUIT
1. While not required, the oxygenator and the circuit components may be flushed
with carbon dioxide gas prior to priming.
2. Keep the gas flow off.
3. Open the oxygenator purge/recirculation valve to the purge position.
4. 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 port or drip from the hole on the bottom
of the oxygenator indicating that the oxygenator should not be used. The
maximum pressure rating of the heat exchanger is 44 psi (300 kPa).
5. Check that all the connections are secure. Introduce all the priming fluid
anticipated to be needed to prime the entire perfusion circuit. Do not pulse,
surge, or rapidly decrease flow during priming and recirculation.
6. For easier circuit debubbling, it is suggested not to add non-crystalloid solutions
or blood products until the priming and debubbling steps are complete.
7. Clamp the arterial line near the oxygenator outlet port.
8. Start the arterial pump slowly and check that all the connections are fluid tight.
9. Prime the oxygenator at 0.3 liters/min. until the purge line is filled.
10. Remove the clamp from the arterial line. Recirculate the priming fluid through
the arterial-venous loop at a maximum flow of 6 liters/min.
11. 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. Close the
purge/recirculation valve.
12. Ensure that the sample system is primed. The sample system will prime itself
during recirculation when the stopcocks are positioned to allow flow through the
sample lines and the manifold. The handles point to the OFF position. Flow
through the sample system should be stopped when there is no flow in the
bypass circuit.
13. Blood products, if used, may now be added to the circuit through a filtered port.
When the priming technique employs the use of blood products, continue
recirculation through the oxygenator at a minimum flow rate of 500 ml/min to
minimize potential thrombus formation.

INITIATING BYPASS

1. Ensure that ventilating gas is flowing into the oxygenator.
2. Ensure that the sample system is off.
3. Ensure that the purge/recirculation valve is closed.
4. Ensure that the line connected to the arterial blood access port is properly
clamped.
5. Initiate bypass according to normal procedure.
CONDUCTING BYPASS
1. 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 blood sample, shut off the arterial side of the
sample system and withdraw at least 10 ml from the middle stopcock.
2. While on bypass, add all small-volume drugs to the venous blood through the
sample system to ensure thorough mixing. Large-volume drugs can be added
through an unfiltered Luer port.
3. The blood gases may be controlled as follows:
Oxygen transfer is controlled by varying the concentration of oxygen in the
ventilating gas.
An oxygen/air blender will provide a controlled oxygen concentration. To decrease
arterial pO2, decrease the oxygen concentration. To increase arterial pO2, increase
the oxygen concentration.
Carbon dioxide transfer may be controlled by varying the total ventilating gas
flow rate.
To reduce arterial pCO2, increase the gas flow rate. To increase arterial pCO2,
reduce the gas flow rate.
4. The purge/recirculation valve in "PURGE" position allows continuous air purge
from the oxygenator module during bypass.
5. If the cardiotomy filter inlet pressure exceeds 50 mmHg, discontinue suction
flow. Remove the protector from the filter bypass port and attach a 3/8" (9.5mm)
ID line. Connect the other end of this line to a filtered cardiotomy reservoir or a
separate cardiotomy filter. If a separate cardiotomy filter is used, connect a 3/8"
(9.5mm) line from the filter to a cardiotomy reservoir. Disconnect the cardiotomy
suction lines from the cardiotomy ports of the venous reservoir and connect
them to the cardiotomy reservoir. Reinstate suction flow.
CONCLUDING BYPASS
1. Stop flow through the sample system prior to concluding bypass.
2. Conclude bypass according to normal operating procedures.
3. Check that the line connected to the arterial blood access port is properly
clamped.
4. Do not completely empty the venous reservoir until you are certain it will not be
necessary to reinstate bypass.
5. If desired, maximum blood return to the patient may be accomplished by adding
clear priming fluid to the venous reservoir when the blood reaches minimum
volume. Pump slowly through the oxygenator to ensure that the reservoir is not
emptied.
PROCEDURE FOR CHANGING THE OXYGENATOR DURING
CARDIOPULMONARY BYPASS
The following procedure enables the user to change out only the oxygenator module
of the oxygenator/reservoir system during cardiopulmonary bypass.
Supplies needed for the change-out procedure:
One (1) sterile tubing cutter
Eight (8) tubing clamps
One (1) Sterile Apex
One (1) sterile blood gas sample system accessory kit
One (1) Oxygenator mounting bracket
1. Connect a second oxygenator mounting bracket to the pump console. Place the
bracket as close as possible to the first bracket and in such a way that the new
oxygenator will be oriented in the same orientation as the old oxygenator.
2. Remove the new oxygenator from the shipping box and inspect the sterile
wrapper for damage. Do not use if the wrapper or the device has been
compromised or damaged. Record the serial number located on the oxygenator.
Place the new oxygenator in the second mounting bracket. The inlet and outlet
ports of the new oxygenator should be oriented in the same direction as the ports
of the old oxygenator. Stop the flow through the sample system of the old device
and check that the purge/ recirculation valve is closed and the arterial blood
access line clamped.
3. Connect the water lines to the new oxygenator. Circulate water through the heat
exchanger and check for leaks in the tubing connected to the blood inlet port or
from the hole on the bottom of the oxygenator.
4. Terminate bypass according to your normal procedures. This should involve
clamping of the venous line and the arterial line.
5. Turn off the ventilating gas. Remove the gas line from the old oxygenator and
place it on the new oxygenator.
6. Connect the arterial sample line of the new sample system kit to the arterial
sampling port of the new oxygenator. Remove the old venous sample line from
the venous sampling port on the venous reservoir; attach the venous sample
line of the new sample system. Make sure the stopcocks on the sample
manifold are positioned to allow flow through the sample lines and the manifold,
and check that there is no leakage from the sample site ports.
7. Connect the purge/recirculation line of the new oxygenator to the venous
reservoir.
8. Place two tubing clamps on the 3/8" (9.5 mm) oxygenator inlet line. This is the
line coming from the pump head to the inlet port of the old oxygenator. Place
these clamps close to the oxygenator inlet port and approximately 1.5 inches
(3.8 cm) apart. Using an aseptic technique, cut the line between the clamps. Cut
near the clamp closest to the oxygenator.
9. Without removing the clamp, attach the 3/8" (9.5 mm) oxygenator inlet line
(coming from the pump head) to the new oxygenator inlet port.
10. Place two tubing clamps on the 3/8" (9.5 mm) oxygenator outlet line. Place
these clamps close to the oxygenator outlet port and approximately 1.5 inches
(3.8 cm) apart. Using an aseptic technique, cut the line between the clamps. Cut
near the clamp closest to the oxygenator.
11. Without removing the clamp, attach the 3/8" (9.5 mm) oxygenator outlet line to
the new oxygenator outlet port.
12. Disconnect the arterial blood access line from the old oxygenator and reconnect
it to the arterial blood access port on the new oxygenator.
13. Remove the clamp on the oxygenator inlet line of the new oxygenator.
14. Open the purge/recirculation valve to the purge position.
GB – ENGLISH
HP M Ph.I.S.I.O. oxygenator
®
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