Setup Procedure - sorin APEX HP Instrucciones De Uso

recommends the use of safety devices, including level sensors, bubble
detectors, arterial filters, and prebypass filters, for all cardiopulmonary bypass
procedures.
2. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a
physician.
3. Do not exceed 44 psi (300 kPa) water inlet pressure to the heat exchanger.
4. The minimum operating volume in the venous reservoir is 100-200 ml (see
paragraph on unit specifications). However, to ensure an adequate response
time in case of venous inflow obstruction, it is recommended that an adequate
volume in addition to the 100-200 ml minimum level be maintained. Do not
exceed 4000 ml in the venous reservoir.
5. Do not flow more than 4 liters/min of combined blood and gas through the filter
bypass, recirculation, or rapid prime ports, except when it is necessary to
debubble the oxygenator.
6. The integral cardiotomy filter inlet pressure should be monitored. If the pressure
exceeds 50 mmHg, the cardiotomy filter should be bypassed.
7. Do not connect patient vent lines to the filtered ports of the venous reservoir
unless some means of preventing retrograde flow toward the patient is located
between the patient and the venous reservoir.
8. Do not use any filtered port as a return site when purging the arterial line filter.
9. Do not add drugs through the filtered Luer ports.
10. Unused ports should be kept tightly capped.
11. Do not infuse fluids or drugs through the arterial sample line.
12. Male Luers not supplied by Sorin Group Italia may damage the one-way valve
located in the arterial sampling port. When connecting, make sure that the male
Luer does not touch the one-way valve.
13. Ensure that the red pos-lock cap on the arterial blood access port is in place
unless the port is used. If oxygenated blood is necessary for blood cardioplegia,
connect the 1/4" blood line of the cardioplegia circuit to the oxygenator using the
blood access connector provided in the accessory package. Remove the red
cap from the arterial blood access port. The arterial blood access port contains
a self-sealing valve which allows leak-free connection during use. When the
provided connector is engaged in the port the valve will open, priming the
tubing.
14. To prevent air being pulled across the membrane Sorin Group Italia
recommends lowering the pump speed slowly to reduce or stop the arterial flow.
15. Do not use the pump on/off switch until the pump speed is zero.
16. The "GAS ESCAPE" system is designed to avoid any possible risk of blocking
the gas outlet; such blockage could cause the immediate passage of air to the
blood compartment.
17. If extracorporeal circulation has to be subsequently restarted, a minimum blood
flow inside the oxygenator must have been maintained. The maximum flow
rates through the oxygenator with the arterial and venous lines clamped and the
purge/ recirculation valve open are: 500 ml/min with the valve open to "PURGE"
and 1000 ml/min with the valve open to "RECIRCULATION."
18. During recirculation do not turn the heater/cooler off.
19. To ensure complete debubbling of the oxygenator, recirculate priming fluid at
the maximum achievable flow or 8 liters/min until no air is observed coming out
of the oxygenator.
20. Utilization of vacuum assisted venous return can lead to negative pressures in
the oxygenator and the potential for air to be pulled across the oxygenator
membrane into the blood pathway. The sample system, the arterial purge line, a
hemoconcentrator, a non-occlusive roller pump, or a centrifugal pump may also
provide a conduit for the vacuum to be applied to the arterial side of the
oxygenator.
21. The cap must be removed from the vent port to prevent inadvertent
pressurization of the reservoir.
22. Sorin Group Italia recommends use of the following in procedures utilizing
vacuum assisted venous return.
a. Reliable wall suction and calibrated vacuum regulator
b. Vapor trap in vacuum line
c. Venous line pressure monitor
d. Vacuum relief valve in vacuum line
e. One-way valves where necessary to prevent retrograde flow
23. Do not connect the arterial filter purge line to a filtered cardiotomy port or filtered
Luer port.
24. Use caution when infusing drugs during vacuum assisted venous return as they
may be rapidly infused into the reservoir.
PROCEDURE FOR CARDIOPULMONARY BYPASS
USE

SETUP PROCEDURE

1. Placing the device in the bracket:
Ensure that the mounting bracket is securely fastened to the pump console and
8
oriented to provide maximum visibility during use. The bracket can be placed on
either side of the pump.
Remove the oxygenator/reservoir system 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.
Release the oxygenator mounting bracket jaws by pulling the knob located on the
back of the bracket. Install the oxygenator/reservoir system in the mounting
bracket and push the release knob to lock the jaws. Ensure that the locking
mechanism is in the locked position.
For better orientation of the ports on the top of the venous reservoir, the cover
can be rotated to the desired orientation.
2. Ventilating Gas Supply
Connect the 1/4" (6.4 mm) gas supply line to the gas inlet of the oxygenator.
3. Vaporous Anesthetics
If vaporous anesthetics are used, some method of scavenging this gas from the
oxygenator should be considered. An integral 3/8" (9.5 mm) gas scavenge fitting
is available for this purpose. It is located in the center of the "Gas Escape"
system. Connect a piece of 3/8" × 3/32" (9.5 mm × 2.4 mm) tubing to this fitting
and to a negative pressure source with a flow rate in excess of the ventilating gas
flow rate.
4. Heat Exchanger Water Supply
Attach the water lines to the water inlet and outlet fittings on the bottom of the
oxygenator. The heat exchanger water inlet is indicated by an arrow on the gas
escape cap and a removable tab. Reusable quick-couplings are recommended
for secure attachment.
Remove WATER IN tab prior water lines connection
5. Blood Temperature Monitoring
If desired, insert a Sorin Group reusable (non-sterile) temperature probe (catalog
no. 042229000) into the arterial and/or venous temperature probe fitting. Lock the
temperature probe into place by twisting the connector sleeve clockwise into the
locked position. Attach the probe jack to a temperature monitor accepting Yellow
Springs Instrument series 400 probes.
6. Connection of Sorin Group Italia SAT/HCT Monitor
If desired, connect the Sorin Group Italia SAT/HCT Monitor to the SAT/HCT fitting
on the venous inlet of the venous reservoir. For connection instructions, refer to
the Operator's Manual for the Sorin Group Italia SAT/HCT Monitor.
7. Vent/Vacuum Port
Remove the cap from the vent/vacuum port. If vacuum is to be used, attach the
vacuum source.
Use an aseptic technique and sterile tubing for the following steps. Secure the
tubing to the ports by sliding the tubing over each port until fully engaged. Use
of a locking tie is recommended on all tubing connections.
8. Cardiotomy Return
Remove the protectors from the filtered cardiotomy ports and secure the 1/4" (6.4
mm) ID suction tubing to the ports. If a filtered cardiotomy port is not to be used,
press in the self-sealing protector to form a liquid seal. The protectors on the
vertical filtered cardiotomy ports are sealed if not removed.
Attach a monitoring line to one of the filtered Luer ports for pressure monitoring.
9. Venous Blood Inlet
Rotate the venous inlet port to the optimal position and remove the protector.
Secure the 1/2" (12.7 mm) ID venous tubing to the venous inlet port.
10. Venous Reservoir Outlet
Remove the protector from the venous reservoir outlet port and secure the 3/8"
(9.5 mm) ID tubing going to the pump head.
11. Oxygenator Inlet
Remove the protector from the oxygenator inlet port and secure the 3/8" (9.5
mm) ID tubing coming from the pump head. The direction of blood flow is out of
the venous reservoir and into the oxygenator.
12. Oxygenator Outlet
Remove the protector from the oxygenator outlet port. Secure the 3/8" (9.5 mm)
ID arterial tubing to the outlet port.
13. Arterial Blood Access
If access is desired, remove the red pos-lock cap and attach a 1/4" (6.4 mm) line
to the blood access connector provided, then connect to the blood access port.
The arterial blood access port contains a self-sealing valve which will seal the
port if it is not used. When the blood access connector is engaged to the port the
valve will open, allowing priming fluid or blood to flow from the oxygenator.
14. 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.
15. Rapid Prime Port
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