Procedures For Use; Setup Procedures - sorin APEX HP M Instrucciones De Uso

PRECAUTIONS
1. To aid 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 touch the
one-way valve.
6. Ensure that the 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, 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 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.
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
minimum 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: 500 ml/min with the valve open to "PURGE" and 1000 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 the 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 probes
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 box and inspect the
sterile wrapper for damage. Do not use if the 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
6
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. The heat exchanger water inlet is
indicated by an arrow on the gas escape cap and a removable
tab. Reusable quick-couplings (catalog numbers 050111000 or
050111090) are recommended for secure attachment.
Remove WATER IN tab prior water lines connection
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 an aseptic technique for the following steps. Secure the
tubing to the ports by sliding the tubing over each port until
contacting the stop. 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 of the venous reservoir and into the
oxygenator.
7. Oxygenator Outlet
Remove the protector from the oxygenator outlet port. Secure the
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 the manifold and check that there is 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 required, the oxygenator and the circuit 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 the
oxygenator. Check the water system for leaks, proper water
temperature range, and adequate water flow. If a water-to-blood
leak exists, water will collect in the tubing connected to the
oxygenator inlet port or drip from the hole on the bottom of the
oxygenator indicating that the oxygenator should not be used.
The maximum pressure rating of the heat exchanger is 44 psi
(300 kPa).
5. Check that all the connections are secure. Introduce all the
priming fluid anticipated to be needed to prime the entire
GB – ENGLISH
Sorin Group reusable (non-sterile)