Initiating Bypass - SORIN GROUP APEX Instrucciones Para El Uso

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 the oxygenator should not
be used. The maximum pressure rating of the heat exchanger
is 44 psi (300 kPa).
5. Check the security of all connections. Introduce all the prime
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 priming and
debubbling steps are complete.
7. Clamp the arterial line near the oxygenator outlet port.
8. Start the arterial pump slowly at first to assure all 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 maximum
achievable flow or 8 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. If the sample system is used, it 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 no flow in the bypass circuit. This is to
prevent arterial to venous shunting.
13. Blood products, if used, may now be added to the circuit.
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 the potential for
thrombus formation.

INITIATING BYPASS

1. Ensure that ventilating gas is flowing into the oxygenator.
2. Ensure that the sample system is off, if used.
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. If the sample system kit is used, open the 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. Control of blood gases may be achieved as follows:
– Oxygen transfer
concentration of oxygen in the ventilating gas.
An oxygen/air blender will provide a controlled oxygen
concentration. To decrease arterial pO
concentration. To increase arterial pO
concentration.
– Carbon dioxide transfer may be controlled by varying the
total ventilating gas flow rate.
To reduce arterial pCO
increase arterial pCO , reduce the gas flow rate.
2
3. The purge/recirculation valve in "PURGE" position allows
continuous air purge from the oxygenator module during
bypass. In this position and at full arterial blood flow, the
continuous purge diverts only a few ml blood/min from the
arterial line.
6
is controlled by varying
, decrease the oxygen
2
, increase the oxygen
2
, increase the gas flow rate. To
2
CONCLUDING BYPASS
1. Stop flow through the sample system prior to concluding
bypass.
2. Conclude bypass according to normal operating procedures.
3. Verify that the line connected to the arterial blood access port
is properly clamped.
4. 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, assuring that the reservoir is
not emptied.
PROCEDURE FOR CHANGING THE OXYGENATOR DURING
CARDIOPULMONARY BYPASS
The following procedure enables the user to change out the
oxygenator during cardiopulmonary bypass.
Supplies needed for the change-out procedure:
One (1) Sterile tubing cutter
Eight (8) Tubing clamps
One (1) Sterile Apex
(catalog no. 050261000 or 050261700)
One (1) Blood gas sample system accessory kit (catalog no.
050251003)
One (1) CMS oxygenator mounting bracket (catalog no.
050235000)
1. Connect a second CMS oxygenator mounting bracket
(catalog no. 050235000) to the pump console. Place the
bracket as close to the first bracket as is possible and such
that the new oxygenator will be oriented in the same
orientation as the old oxygenator.
2. Remove the new oxygenator from the shipping carton and
inspect the sterile wrapper for damage. Do not use if wrapper
has been compromised or damaged. Do not use if the
oxygenator 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. Check to be certain that the purge/ recirculation
valve is closed and the arterial blood access line is clamped.
3. Connect the water lines to the new oxygenator. Circulate
water through the heat exchanger and check for leaks.
4. Terminate bypass by following your normal procedures. This
will involve clamping of the venous line and the arterial line.
5. Turn off 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 existing 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
the
sample manifold are positioned to allow flow through the
sample lines and manifold ensuring 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 from each other. Using aseptic technique, cut the
line between the clamps. Cut near the clamp closest to the
oxygenator.
9. 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
GB – ENGLISH
® ®
M or Apex M Ph.I.S.I.O. oxygenator