Initiating Bypass - SORIN GROUP WR4000I Instrucciones De Uso

blue protector. Secure the 1/2" (12.7 mm) ID venous tubing to the venous
inlet port.
7. Venous Reservoir Outlet
Remove the purple protector from the venous reservoir outlet port and
secure the 3/8" (9.5 mm) ID tubing going to the pump head.
8. Recirculation Port
Remove the protector and attach the 1/4" (6.4 mm) ID recirculation line to
the recirculation port.
9. Filter Bypass Port
The filter bypass port may be used as a return site for cardiotomy blood in
the event that the integral cardiotomy filter becomes clogged. For
cardiotomy blood, this port should be used in conjunction with a filtered
cardiotomy reservoir or a separate cardiotomy filter and a cardiotomy
reservoir.
10. Rapid Prime Port
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.
11. Arterial Filter Purge
If an arterial filter purge line is used, it should be connected to an unfiltered
Luer-lock port.
12. Fluid Administration
Large-volume bolus or continuous infusion of drugs or fluids may be
introduced through the unfiltered Luer-lock ports.
If an unfiltered Luer-lock port is needed for both arterial filter purge and
drug infusion, place a three-way stopcock on the port before attaching the
arterial filter purge line.
13. Sample System
A three-stopcock manifold is connected to the venous sampling port on the
venous reservoir via a Luer-lock connection. Connect the arterial sample
line to the preferred arterial sample site of the circuit. Check that these two
Luer-lock connections are secure.
The arterial sample line contains a one-way valve to help 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 Sorin Group manifold holder (catalog no. 041270000). To remove it, lift
upward on the manifold.
Make sure the stopcocks on the sample manifold are positioned to allow
flow-through and not leakage.
14. Excess Circuit Volume Removal
To provide for excess circuit volume removal during bypass, insert a Y-
connector in the venous line and connect it to an additional reservoir.
15. Setup of Remainder of Extracorporeal Circuit
For instructions on setup for the remainder of the circuit, refer to the
Instructions for Use for the oxygenator and other circuit components.
PRIMING THE CIRCUIT
1. Check that all the connections are secure; then introduce all the priming
fluid you estimate will be needed to prime the entire perfusion circuit.
The minimum operating volume in the venous reservoir for
cardiopulmonary use is 100-200 ml (see unit specifications paragraph).
However, to ensure an adequate response time in case of venous inflow
obstruction, it is recommended that an adequate volume in addition to the
200 ml minimum level be maintained.
For easier circuit debubbling, do not add non-crystalloid solutions or blood
products until the priming and debubbling steps are complete.
2. Start the arterial pump slowly at first to ensure that all the connections are
fluid tight.
Recirculate the priming fluid through the arterial-venous loop.
3. The sample system will prime itself during recirculation when the stopcocks
are positioned to allow flow-through. 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.
4. Non-crystalloid priming solutions, if used, may now be added and
recirculated slowly.
5. 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 circuit at a minimum flow rate of 500
ml/min to minimize the potential for thrombus formation.
6

INITIATING BYPASS

1. Ensure that the sample system is off.
2. Initiate bypass according to your 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 either the sample system or a Luer-lock port.
3. If the cardiotomy filter pressure exceeds 50 mmHg, discontinue suction
flow. Remove the protector from the filter bypass port and attach a 3/8" (9.5
mm) 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" (9.5 mm) 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.
4. For instructions on control of blood gases and other aspects of conducting
bypass, refer to the Instructions for Use for the oxygenator.
CONCLUDING BYPASS
1. Stop flow through the sample system prior to concluding bypass.
2. Conclude bypass according to your normal operating procedures.
3. Do not completely empty the venous reservoir until you are certain that it
will not be necessary to reinstate bypass.
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, ensuring that the
venous reservoir is not emptied.
PROCEDURE FOR CHANGING THE VVR 4000i VENOUS
RESERVOIR DURING CARDIOPULMONARY BYPASS
The following procedure enables the user to change out the VVR 4000i venous
reservoir during cardiopulmonary bypass.
Supplies needed for the change-out procedure:
One (1)
Five (5)
One (1)
One (1)
One (1)
One (1)
1. Connect a second HVR 4000 mounting bracket (catalog no. 050305400) to
the pump console. Orient the bracket as close as possible to the first
bracket.
2. Remove the new venous reservoir from the shipping box and inspect the
packaging for damage prior to opening. Remove the product from the
packaging and record the serial number of the new venous reservoir. Do
not use if sterility has been compromised.
Place the new venous reservoir in the new bracket. The inlet and outlet
ports of the new venous reservoir should be oriented in the same direction
as the ports of the old venous reservoir. Stop the flow through the sample
system of the old device. Make sure that the recirculation line is clamped.
3. Terminate bypass by following your normal procedures. This will involve
clamping of the venous and arterial lines, and the discontinuation of
vacuum to the Vent/Vacuum port (if applicable).
4. Transfer the sample system from the old venous reservoir to the new
venous reservoir by disconnecting the venous sample line from the venous
inlet of the old reservoir and attaching it to the venous inlet of the new
venous reservoir. If the sample manifold is mounted on the lid of the old
venous reservoir, transfer the sample manifold to the lid of the new venous
reservoir.
5. Using an aseptic technique, attach the 3 inch (7.5 cm) section of 3/8" (9.5
mm) sterile tubing to the reservoir outlet of the new venous reservoir and
clamp it. Attach the sterile 3/8" x 3/8" (9.5 mm x 9.5 mm) straight connector
to this line.
6. Add priming fluid to the new venous reservoir to achieve the minimum
recommended volume of 200 ml.
GB – ENGLISH
Sterile tubing cutter
Tubing clamps
3 inch (7.5 cm) section of 3/8" (9.5 mm) ID sterile tubing
3/8" x 3/8" (9.5 mm x 9.5 mm) sterile tubing connector
VVR 4000i Venous Reservoir
HVR 4000 mounting bracket (catalog no. 050305400)