sorin APEX HP Instrucciones De Uso página 10

15. Check that all the connections are secure. Ensure that there is still a clamp on
the arterial line to the patient.
16. Prime the new oxygenator and evacuate any air using the priming and
recirculation procedure.
17. Turn off the sample system. Turn off the arterial pump and close the purge/
recirculation valve.
18. Remove the clamps from the venous and arterial lines, and reinitiate bypass
according to normal procedures.
19. Remove the arterial temperature probe from the old oxygenator and connect it
to the arterial temperature probe fitting of the new oxygenator.
20. Remove the gas scavenging line from the old oxygenator and connect it to the
new oxygenator.
PROCEDURE FOR CHANGING THE ENTIRE SYSTEM DURING
CARDIOPULMONARY BYPASS
The following procedure enables the user to change out the entire
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 HP or Apex HP Ph.I.S.I.O. Smar
system
One (1) 3 inch (7.5 cm) section of 3/8" (9.5mm) ID sterile tubing
One (1) 3/8" x 3/8" (9.5mm x 9.5mm) sterile tubing connector
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 with preconnected venous reservoir 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/reservoir system 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.
4. Discontinue vacuum to the vent/vacuum port (if applicable).
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) tubing connector to this line.
6. Add priming fluid to the new venous reservoir to achieve and maintian the
minimum recommended volume of 200 ml.
7. Terminate bypass by following your normal procedures. This should involve
clamping of the venous line and the arterial line.
8. Turn off the ventilating gas. Remove the gas line from the old oxygenator and
place it on the new oxygenator.
9. 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.
10. Without removing the clamp, attach the 3/8" (9.5 mm) oxygenator inlet line
(coming from the pump head) to the inlet port of the new oxygenator.
11. 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.
12. Without removing the clamp, attach the 3/8" (9.5 mm) oxygenator outlet line to
the new oxygenator outlet port.
13. Disconnect the arterial blood access line from the old oxygenator and reconnect
it to the arterial blood access port on the new oxygenator.
14. Remove the clamp on the oxygenator inlet line of the new oxygenator.
15. Open the purge/recirculation valve on the new oxygenator to the recirculation
(large handle) position. Failure to do so will cause the new oxygenator to
become pressurized in the next step.
16. Start the arterial pump slowly, and transfer the blood from the old venous
reservoir to the new venous reservoir through the recirculation line. The
maximum flow should not exceed 1.5 LPM. 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.
17. The level in the new venous reservoir should now exceed 500 ml. Add priming
fluid to the reservoir if needed.
18. Check that all the connections are secure. Ensure that there is still a clamp on
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t oxygenator/reservoir
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RETURN OF USED PRODUCT
Should the user be dissatisfied with anything related to the quality of the product, the
product distributor or the authorized local SORIN GROUP ITALIA representative
should be notified.
All parameters considered critical by the user must be reported with particular care
and urgency. The following is the minimum information that should be provided:
 Detailed description of the event and, if pertinent, the conditions of the patient;
 Identification of the product involved;
 Lot number of the product involved;
 Availability of the product involved;
 All the indications the user considers useful in order to understand the origin of
the elements of dissatisfaction.
SORIN GROUP ITALIA reserves the right to authorize, if necessary, recall of the
product involved in the notification for assessment. If the product to be returned is
contaminated, it must be treated, packed and handled in conformity with the
provisions of the legislation in force in the country where the product was used.
It is the responsibility of the health care institution to adequately prepare and
identify the product for return shipment. Do not return products that have been
exposed to blood borne infectious diseases.
ONLY for US customers
If for any reason the product must be returned to the manufacturer, a returned goods
authorisation (RGA) number is required from Sorin Group USA, Inc. prior to shipping.
If the product has been in contact with blood or blood fluids, it must be thoroughly
cleaned and disinfected before packing. It should be shipped in either the original box
or an equivalent box to prevent damage during shipment, and it should be properly
labelled with an RGA number and an indication of the biohazardous nature of the
content in the shipment.
It is the responsibility of the health care institution to adequately prepare and
identify the product for return shipment. Do not return products that have been
exposed to blood borne infectious diseases.
The shipping address for returned goods in the US is:
Sorin Group USA, Inc.
Returned CV Products
14401 West 65th Way
Arvada, CO 80004-3599
FAX (800) 323 4031.
LIMITED WARRANTY
This Limited Warranty is in addition to any statutory rights of the Purchaser pursuant
to applicable law.
SORIN GROUP ITALIA warrants that all reasonable care has been taken in the
manufacture of this medical device, as required by the nature of the device and the
use for which the device is intended.
GB – ENGLISH
the arterial line to the patient.
Place two clamps on the old venous reservoir outlet line approximatly 3 inches
(7.5 cm) from the reservoir outlet and approximately 1.5 inches (3.8 cm) apart.
Using an aseptic technique, cut between the clamps near the clamp closest to
the outlet.
Without removing the clamp, attach the reservoir outlet line to the tubing
connector on the outlet of the new venous reservoir.
Remove the venous line from the old reservoir, and attach it to the new venous
reservoir.
Remove the gas scavenging line from the old oxygenator and connect it to the
new oxygenator.
Remove the clamp from the outlet line of the new venous reservoir, allowing the
oxygenator to fill if not filled in step 16.
If necessary, add more priming fluid to ensure there is at least 200 ml in the
venous reservoir.
Prime the new device and evacuate any air using the priming and recirculation
procedure.
Check thatthe sample system is primed.
Turn off the sample system. Turn off the arterial pump and close the purge/
recirculation valve. Remove the clamps from the venous and arterial lines, and reinitiate bypass
according to normal procedures.
Transfer the cardiotomy suction lines, vent lines, arterial filter purge, etc. from
the old venous reservoir to the new venous reservoir.
Remove the arterial temperature probe from the old oxygenator and connect it
to the arterial temperature probe fitting of the new oxygenator. Transfer the
SAT/HCT Probe to the SAT/HCT fitting of the new reservoir (if applicable).