dideco ECC.O5 Notice D'utilisation page 5

2) MOUNTING ECC.O ON THE HOLDER
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Sterility is guaranteed only if the sterile packaging is not wet,
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open, tampered with or damaged. Do not use the device if
sterility cannot be guaranteed.
Check the expiry date on the label. Do not use the device
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beyond this date.
The device must be used immediately after opening the
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sterile packaging.
a. Remove the device from the sterile packaging.
The user should carefully inspect ECC.O
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transport may cause structural and functional damage to the
device. SORIN GROUP ITALIA declines all responsibility and
will not guarantee integrity and function if ECC.O
damaged due to improper transportation.
Do not use the device if it has been cracked, dropped or
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otherwise physically damaged.
Do not use solvents such as alcohol, ether, acetone, etc., as
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contact with these substances may cause damage to the
device.
b. Set up the holder ensuring that the locking/unlocking lever is in
the "open" position.
c. Insert the ECC.O 5 water connectors located at the base of the
device into the corresponding female connectors of the holder.
d. Fix the ECC.O 5 in place by moving the locking/unlocking lever to
the "close" position.
e. Slide the pump driver in place and secure it to the pump head of
the ECC.O . Verify that the centrifugal pump is correctly engaged
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with the pump driver locking tab. Close the support collar around
the pump driver.
3) HEATER/COOLER SET UP
Connect the heater/cooler water lines to the holder using the
appropriate SORIN GROUP ITALIA female Hansen connectors.
Blood temperature control is necessary during ECC
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procedures and extended respiratory support applications
with ECC.O 5 .
Connectors different from those indicated may generate
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resistance inside the circuit and thereby reduce the heat
exchanger efficiency.
Do not occlude the holes on the heat exchanger bottom
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cover as they are the outlets of the safety channel, which
prevents contamination in event of a seal failure.
Heat exchanger inlet water temperature must not exceed
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42°C (108 °F).
Heat exchanger water inlet pressure must not exceed 750 mm
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Hg (100kPa).
4) CHECKING THE HEAT EXCHANGER
The integrity of the heat exchanger must be verified by recirculating
water in the exchanger for a few minutes. The integrity of the structure
is guaranteed if there are no water leaks from the compartment or
from the hole of the safety channel.
5) DEVICE SET-UP AND CONNECTIONS
a. Once the ECC.O5 has been positioned in the holder and the
centrifugal pump driver is put in place, complete the setup of the
remaining extracorporeal circuit components.
b. Verify that the 3/8" (9.5 mm) venous line is connected to the
venous inlet port located on the ECC.O5 bubble trap.
c. Verify that the 3/8" (9.5 mm) arterial line is connected to the
ECC.O outlet port. Connect the centrifugal pump flow probe to
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circuit where desired.
d. Connect the venous purge line provided with the product to the
purge luer connector at the top of the venous bubble trap. Verify
that a means to aspirate air from the bubble trap purge line (e.g.,
roller pump) is available during prime and device use.
e. Verify that the recirculation/purge line is connected to the
f.
g. Connect the Air Removal Control (APC) System per the APC
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prior to use;
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has been
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6) SAMPLING STOPCOCK MANIFOLD
a. Mount the sampling stopcock manifold on the dedicated holder.
b. Connect the arterial sampling line to a luer port on the arterial line.
c. Connect the venous sampling line to a venous luer port.
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7) TEMPERATURE AND PRESSURE MONITORING
a. Connect the arterial temperature probe to the arterial temperature
b. To measure the oxygenator inlet pressure, connect a pressure
c. To measure oxygenator outlet pressure, connect a pressure
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d. To measure venous inlet pressure in the venous inlet line, attach
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GB – ENGLISH – INSTRUCTIONS FOR USE
recirculation/purge luer of the ECC.O
appropriately connected to the storage reservoir.
Place the venous bubble sensor assigned to the Electric Remote
Clamp on the tubing line between the ECC.O
and Centrifugal Pump Inlet.
system instructions for use.
SORIN GROUP ITALIA recommends that an arterial filter be
used with the ECC.O 5 device.
Never infuse or introduce fluids through any luer port on the
arterial line.
If oxygenated blood for blood cardioplegia needs to be used,
remove the red pos lock and connect the 1/4" (6.4 mm) blood
line of the cardioplegia circuit to the arterial blood access
port of ECC.O by means of the adaptor (provided with the
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product).
The arterial blood access port is fitted with a safety valve that
makes connection of the adaptor possible without leakage or
dripping during extracorporeal circulation. However, the
connection with the cardioplegia blood line should be made
and the cardioplegia system primed prior to use to avoid
accidental introduction of air into the system during use.
Never use the purge/recirculation line with a vacuum source
to purge the oxygenator module. A negative pressure on the
arterial line could in some situations pull air across the
membrane.
If using the arterial blood access port during bypass, the
blood line connected to the port must be open and not under
pressure in order for fluid to flow into the tubing line.
Verify that the stopcock handles are in the "OFF" position.
Verify that there is a one way valve in the sampling line to prevent
accidental air introduction into the arterial line.
Check the security of all luer connections. The venous side
of the ECC.O 5 including the venous inlet line, bubble trap and
tubing line up to the inlet connector of the centrifugal pump,
is under negative pressure. All accessory lines connected to
the venous inlet line of the ECC.O
in order to prevent accidental introduction of air into the
negative pressure side of the device.
probe fitting, and connect the venous temperature probe to a
venous temperature probe fitting.
measurement line to the venous luer port near the heat exchanger
inlet.
measurement line to a luer port on the arterial line.
Luer port near ECC.O 5 arterial outel does not include one way
valve.
a pressure measurement line to a venous luer port.
Check the security of all luer connections. The venous side
of the ECC.O 5 including the venous inlet line, bubble trap and
tubing line up to the inlet connector of the centrifugal pump,
is under negative pressure. All accessory lines connected to
the venous inlet line of the ECC.O
and the opposite end is
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Bubble Trap Outlet
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5 must be connected tightly
5 must be connected tightly
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