Initiating Bypass - SORIN GROUP VVR 4000i Instrucciones De Uso

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, discon-
tinue 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. Reinstitute 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 proce-
dures.
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 res-
ervoir 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) Sterile tubing cutter
Five (5) Tubing clamps
One (1) 3 inch (7.5 cm) section of 3/8" (9.5 mm) ID
sterile tubing
One (1) 3/8" x 3/8" (9.5 mm x 9.5 mm) sterile tubing
connector
One (1) VVR 4000i Venous Reservoir (catalog no.
050262400)
One (1) HVR 4000 mounting bracket (catalog no.
050305400)
1. Connect a second HVR 4000 mounting bracket (catalog no.
050305400) to the pump console. Orient the bracket as close
to the first bracket as is possible.
2. Remove the new venous reservoir from the shipping carton
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.
Sorin Group Italia
Place the new venous reservoir in the new bracket. The inlet
and outlet ports of the new venous reservoir should be ori-
ented in the same direction as the ports of the old venous
reservoir. Stop the flow through the sample system of the old
device. Check to be certain 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 appli-
cable).
4. Transfer the sample system from the old venous reservoir to
the new venous reservoir by disconnecting the venous sam-
ple line from the old reservoir venous inlet 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 res-
ervoir.
5. Using 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.
7. Transfer the cardiotomy suction lines, recirculation line, vent
lines, arterial filter purge, etc., from the old venous reservoir
to the new venous reservoir. Check the security of all the
connections.
8. Unclamp the recirculation line. Ensure that there is still a
clamp on the arterial line to the patient.
9. Start the arterial pump slowly, and transfer the blood from the
old venous reservoir to the new venous reservoir through the
recirculation line. Continue until all the blood is removed from
the old venous reservoir, but do not empty the line exiting the
venous reservoir. Turn off the pump.
10. Place two clamps on the old venous reservoir outlet line near
the reservoir outlet and approximately 1.5 inches (3.8 cm)
apart. Using aseptic technique, cut between the clamps, near
the clamp closest to the outlet.
11. Attach the reservoir outlet line to the 3/8" (9.5 mm) straight
connector on the outlet of the new venous reservoir.
12. Remove the venous line from the old reservoir, and attach it
to the new venous reservoir. Where applicable, remove and
reattach the left ventricular vent line, priming lines, and arte-
rial filter purge line.
13. Remove the clamp from the outlet line of the new venous res-
ervoir.
14. Check the security of all the connections. Ensure there is still
a clamp on the arterial line on the patient side of the recircula-
tion line.
15. Remove the clamps from the venous and arterial lines, and
reinitiate bypass according to normal procedures.
16. Transfer the temperature probe from the venous inlet of the
old venous reservoir to the venous inlet of the new venous
reservoir (if applicable).
17. Transfer the SAT/HCT probe from the SAT/HCT fitting of the
old venous reservoir to the SAT/HCT fitting of the new venous
reservoir (if applicable).
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