Terumo CAPIOX FX 25 Mode D'emploi page 6

STRUCTURE
Positive pressure
relief valve
Auxiliary port
Sampling
system
Two luer locks on
venous inlet
Thermistor
probe
Vent port
WARNINGS
Describe serious adverse reactions and potential safety hazards, limitations in use
imposed by them, and steps that should be taken if they occur.
WARNINGS
• CAPIOX FX25 is designed to operate at blood flow rates within the range of 0.5 to
7.0 L/min. Do not use any blood flow rate outside this range.
• Do not use solvents such as alcohol, ether, acetone, etc. These solvents may cause
damage if used in or on the device.
• In order to prevent gaseous emboli from entering the blood phase, follow the
instructions below.
• DO NOT OBSTRUCT GAS OUTLET PORT. Avoid build up of excess pressure in the
gas phase to prevent gaseous emboli entering the blood phase.
• Pressure in the blood phase should always be higher than that in the gas phase to
prevent gaseous emboli entering the blood phase.
• The gas flow rate should not exceed 20 L/min. Excessive gas flow rate will bring
about pressure increase in the gas phase, allowing gaseous emboli to enter the
blood phase.
• During recirculation, do not use pulsatile flow and do not stop the blood pump
suddenly as these actions may cause gaseous emboli to enter the blood phase
from the gas phase due to inertia force.
• When CAPIOX FX25 Oxygenator module is used separately from the Hardshell
Reservoir, set the module so that the upper end of the fibers is lower than the blood
level in the venous reservoir. This prevents gaseous emboli from entering the blood
phase from the gas phase.
• To prevent gaseous emboli from entering the blood phase, make sure that the
arterial pump flow rate always exceeds the flow rate of the cardioplegia line. The
blood flow rate of the cardioplegia line should not exceed 1 L/min.
• Do not exceed a 15°C (27°F) temperature difference between blood and water in
heat exchanger to prevent gas dissolved in blood from forming bubbles.
• Total flow rate of the arterial line and any separate arterial lines must not exceed the
flow rate at the oxygenator inlet port.
• Pressure at the blood inlet of the oxygenating module should not exceed 133 kPa
(1,000 mmHg). Pressures greater than 133 kPa (1,000 mmHg) may cause leaks or
damage to the device.
• Water pressure at the heat exchanger inlet should not exceed 28 PSI (2 kgf/cm
(196 kPa). Pressures greater than 28 PSI (2 kgf/cm
damage to the device.
• Adequate heparinization of the blood is required to prevent it from clotting in the
system.
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Hardshell Reservoir
Suction
ports
Vertical port to
cardiotomy filter
Quick prime
port
Purge line
Three filtered luer locks to
cardiotomy filter
) (196 kPa) may cause leaks or
2
Venous blood inlet port
Venous inlet
drop tube
Venous filter
Guide hole for
holder
Reservoir
outlet port
Blood inlet port
One way valve
Gas exchange module
Blood Cardioplegia port
Blood outlet port
• When using the centrifugal pump on the arterial line, clamp the arterial line distal to
the oxygenator (the patient's side) before stopping the pump. Improper clamping may
cause back-flow of blood or migration of gaseous emboli into the blood side.
• Use caution when removing air during priming and perfusion. Excessive shock to the
device – especially with hard objects – can cause damage to the device.
• Do not reduce heparin during circulation. Otherwise, blood clotting might occur.
Use CAPIOX FX25 Oxygenator with Hardshell Reservoir taking note of the additional
warnings below.
• The blood flow into the cardiotomy filter should not exceed the rate of 5 L/min.
Excessive blood flow rate may increase the pressure in the cardiotomy filter, resulting
in back-flow into any solution or blood administration line connected to the Hardshell
Reservoir.
• Yellow vent port cap need not be removed, since this port assures adequate venting
with the cap attached. Do not close the vent port, as this may cause positive pressure
in the Hardshell reservoir, resulting in back-flow into solution or blood administration
lines connected to the Hardshell Reservoir.
• Before stopping the pump, release the pressure inside of the reservoir to the
atmospheric pressure. Otherwise, venous blood might be drained from the patient.
• Negative pressure below -20 kPa (-150 mmHg) should not be applied to this reservoir
as this may damage it.
• When the level of blood in the reservoir is below the minimum operating level, blood
flow at a high flow rate into the cardiotomy filter may generate gaseous micro emboli
(GME) which could migrate to the patient.
• Minimum operating volume in the reservoir is 200 mL. Set appropriate blood storage
level, relative to venous flow rate, to prevent gaseous emboli passing to patient.
(Refer to Fig. 11, page 10 "SAFETY MARGIN")
• Do not use this product for a period in excess of six hours. Excessive use for over six
hours may lead to plasma leak and thrombi formation, which may compromise the gas
exchange performance.
• Do not change the position of the positive pressure relief valve on the hardshell
reservoir. Placing the positive pressure relief valve in any other location on the
reservoir could expose the positive pressure relief valve to fluid that could impair the
)
2
performance of the valve and could allow positive pressure build up to occur in the
reservoir. If this occurs during VAVD, it may result in reduced venous drainage and
retrograde flow of air into the venous line.
Cardiotomy filter
Connecting ring
Support arm
Purge line
Heat exchanger
Water inlet port
Arterial filter
Water outlet port
Gas inlet port
Thermistor probe
Oxygenator with integrated
arterial filter