Procedures For Use - SORIN GROUP APEX Instrucciones Para El Uso

specific concerns about residual risks. Further information is
available on request from Sorin Group Italia
32. For further information and/or in case of complaint contact
SORIN GROUP ITALIA or the authorised local representative
PRECAUTIONS
1. To aid in the prevention of gas or particulate embolization,
Sorin Group Italia recommends the use of safety devices,
including level sensors, bubble detectors, arterial filters, and
prebypass filters, for all cardiopulmonary bypass procedures.
2. Federal law (USA) restricts the sale and use of this device by
or on the order of a physician.
3. Do not exceed 44 psi (300 kPa) water inlet pressure to the
heat exchanger.
4. Do not infuse fluids or drugs through the arterial sample line.
5. 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 contact the
one-way valve.
6. Ensure that the pos-lock cap on the arterial blood access port
is closed. If oxygenated blood is necessary for blood
cardioplegia, remove the red pos-lock cap and connect the
1/4" blood line of the cardioplegia circuit to the oxygenator
using the blood access connector provided. The arterial blood
access port contains a self-sealing valve which allows leak
free connection during use.
7. Sorin Group Italia recommends the use of the pump speed
control to reduce or stop the arterial flow slowly.
8. Do not use the pump on/off switch until the pump speed is
zero.
9. 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.
10. If extracorporeal circulation has to be subsequently restarted,
a minimun blood flow inside the oxygenator must be
maintained. The maximum flow rates through the oxygenator
with the arterial and venous lines clamped and the
purge/recirculation valve open are: 800 ml/min with the valve
open to "PURGE" and 1500 ml/min with the valve open to
"RECIRCULATION."
11. During recirculation do not turn the thermocirculator off.
12. To ensure complete debubbling of the oxygenator, be sure to
recirculate priming fluid at maximum achievable flow or 8
liters/min until all air coming out of the oxygenator is
eliminated.
REQUIRED ANCILLARY EQUIPMENT
1. Heat exchanger water supply
2. Blood temperature monitor and probe
3. Sorin Group Italia oxygenator bracket
4. Perfusion blood pump
5. Compatible tubing pack (sterile)
6. Compatible venous reservoir (sterile)
7. Gas supply with blender

PROCEDURES FOR USE

SETUP PROCEDURES
1. Placing the oxygenator in the bracket
Ensure that the mounting bracket (catalog no. 050235000) is
securely fastened to the pump console and oriented to
provide maximum visibility during use. The bracket can be
placed on either side of the pump.
Remove the 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.
Release the mounting bracket jaws by pulling the knob
located on the back of the bracket. Install the oxygenator in
the mounting bracket and push the release knob to lock the
jaws. Ensure that the locking mechanism is in the locked
position.
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" x 3/32" (9.5
mm x 2.4 mm) ID 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. Reusable quick connect
couplings (catalog numbers 050111000 or 050111090) are
recommended for firm attachment.
5. Blood Temperature Monitoring
If desired, insert a
temperature probe (catalog no. 042229000) into the arterial
temperature probe fitting. Lock the temperature probe into
place by twisting the connector sleeve clockwise into the
locked position. Attach the probe jack to any temperature
monitor accepting Yellow Springs Instrument series 400
probes.
6. Oxygenator Inlet
Use aseptic technique for the following steps. Secure tubing
to ports by sliding tubing over each port until the stop is
contacted. Use of a locking tie is recommended on all tubing
connections.
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 the venous reservoir
and into the oxygenator.
7. Oxygenator Outlet
Remove the protector from the oxygenator outlet port. Secure
3/8" (9.5 mm) ID arterial tubing to the outlet port.
8. Purge/Recirculation Line
Remove the protector from the purge/recirculation line and
connect it to the recirculation inlet port on the venous
reservoir.
9. Arterial Blood Access
If access is desired, remove the red pos-lock cup and attach
a 1/4" (6.4 mm) line to the arterial blood access port using the
blood access connector provided.
The arterial blood access port contains a self-sealing valve
which will seal the port if it is not used.
10. Arterial Sampling Port
The oxygenator has a female luer lock arterial sampling port.
A blood gas sample system accessory kit (catalog no.
050251003) is available for blood gas sampling. The sample
system kit consists of a 3-stopcock manifold, with venous and
arterial blood sample lines. There is a one-way valve in the
arterial sample line.
If the sample system kit is used, remove the cap from the
arterial sampling port on the oxygenator and attach the
arterial sample line of the sample system kit. Attach the
venous sample line to the venous sampling site of the circuit.
Make sure the stopcocks on the sample manifold are
positioned to allow flow through the sample lines and
manifold ensuring no leakage from the sample site ports.
If the sample system kit is not used, make sure the cap on the
arterial sampling port is tightly sealed.
PRIMING THE CIRCUIT
1. While not
components may be flushed with carbon dioxide gas prior to
priming.
2. Keep the gas flow off.
3. Open the oxygenator purge/recirculation valve to the purge
position.
4. Circulate water through the heat exchanger prior to priming
GB – ENGLISH
Sorin Group Italiareusable (nonsterile)
required, the oxygenator and the circuit
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