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weighed against the benefits of extracorporeal support when
this device is considered.
Technical complications during long-term use are generally
-
due to ineffective anticoagulation, which reduces oxygenator
efficiency. Product use lasting >6 hours should include
monitoring of blood compartment pressure drop, whole blood
coagulation time, inspection for thrombus formation and
system component wear.
In estracorporeal circulation (ECC), ECC.O
-
active venous drainage system and does not include a venous
reservoir. Care must be taken to strictly monitor the pump rpm,
delivery flow rate and circuit/patient pressures such that, in
case of massive blood loss or slow blood loss, the pump can
be adjusted accordingly.
This device is intended for one-time, single patient use only. Do
-
not resterilize.
Do not strike the device, as excessive shock may cause
-
damage to the device and cause device malfunction.
It is intended that systemic anticoagulation be utilized while the
-
device is in use. Anticoagulation levels should be determined
by the physician based on risks and benefits to the patient, and
should be monitored throughout the case.
In ECC, ACT (Activated Coagulation Time) must always be
-
longer than or equal to 480 seconds in order to assure
adequate anticoagulation of the blood in the extracorporeal
circuit.
This device does not allow the administation of anaesthetic
-
gases (i.e. isofluorane) to the patient.
After use, dispose of the device in compliance with the
-
regulations in force in the country of use.
In the event of problems or if you have any questions, contact
-
SORIN GROUP ITALIA or one if its authorized representatives.
ECC.O
5
and the devices connected to it must be handled using
-
aseptic techniques.
Ensure that ECC.O
5
-
proceeding with bypass.
Do not operate the pump for extended periods of time if the
-
arterial
outlet
to
purge/recirculation stopcock is closed at the same time. The
temperature inside the pump may increase, increasing the risk
of cellular damage.
The ECC.O
5
is a closed loop, kinetically-assisted drainage
-
system. It is therefore mandatory that the utmost care be taken
to avoid the accidental introduction of air into the system.
High vacuum pressures can be generated in the venous line
-
due to cannulae manipulation/movement, flow obstructions
including kinking of the venous line, etc. It is highly
recommended that the negative pressure at the inlet of the
ECC.O
5
be monitored in order to avoid situations of excessive
negative pressure at the venous inlet of the device. It is
imperative that the maximum allowable negative pressure limit
of –100 mm Hg in the venous line is never exceeded. If the
venous inlet pressure exceeds this limit, reduce the pump flow
rate, then identify and resolve the problem creating the high
negative pressure.
High vacuum pressures can be generated based on venous
-
cannulae diameter selection. A minimum venous cannula
diameter of 28 French is recommended in order to reduce the
risk of generating high vacuum pressures in the venous line.
Do not operate the pump with the centrifugal pump inlet
-
clamped. A negative pressure would be generated in the pump
and air bubbles could form.
Do not remove the arterial outlet clamp at the beginning of
-
extracorporeal circulation until an adequate outlet pressure has
been reached in order to prevent backflow. The pump must be
operated to provide a pressure higher than the patient systemic
pressure and the circuit head pressure. Monitor the pump flow
rate, its rpm and the systemic pressure as indices of potential
backflow.
Monitor carefully for signs of occlusion throughout the circuit,
-
paying particular attention to the venous line and centrifugal
pump inlet.
4
is a closed loop,
5
is completely primed and de-aired before
the
patient
is
clamped
GB – ENGLISH – INSTRUCTIONS FOR USE
Control the flow rate by adjusting the pump speed. Attempting
-
to adjust blood flow rate by partial clamping of the device
outlet may augment the risk of cellular damage.
When stopping circulation, clamp the device outlet and stop
-
pump rotation immediately, or reduce pump speed to less than
1000 rpm if the recirculation line is open.
When using ECC.O
-
Remote Clamp (ERC) and a bubble sensor with ECC.O
highly recommended.
When using ECC.O
-
Control (APC) system in conjunction with the Stöckert SIII
system is highly recommended.
Do not allow the blood side pressure to exceed 500 mmHg
-
(67kPa).
Do not allow the water side inlet pressure in the heat exchanger
-
to exceed 750 mmHg (100kPa).
Do not use additives or disinfectants, such as bleach, in the
-
heater/cooler while the ECC.O
cooler.
Do not allow the pressure on the blood side of the membrane
-
to fall below the pressure on the gas side of the membrane.
Blood compartment pressure must always be maintained
higher than gas compartment pressure to prevent formation of
gas emboli in the blood compartment.
Do not place the ECC.O
-
Ensure that pump flow rate is always greater than cardioplegia
-
and/or
cardioplegia delivery flow rate must not exceed the
cardioplegia device maximum rated flow rate.
Avoid occluding, even accidentally, the gas outlet line: any
-
over-pressurization of the gas compartment may generate
microemboli in the blood compartment.
Check the patency of the gas circuit by circulating gas in the
-
circuit. If the gas circuit is occluded, replace the oxygenator.
Insert and secure the venous cannula in such a way that air is
-
not aspirated into the venous line.
ECC.O
-
and
the
Do not ventilate the ECC.O
-
are clamped.
Do not allow anaesthetic agents such as isoflurane to come
-
into direct contact with the device. Halogenated liquids such as
halothane and fluothane must also not come into direct contact
with the ECC.O
the integrity and/or functionality of the device.
The device is Phosphorylcholine (Ph.I.S.I.O.) coated; currently
-
SORIN GROUP ITALIA is not aware of any contraindication to
the use of systems having components treated with
Phosphorylcholine.
The device must only be used if STERILE.
-
Do not use ECC.O
-
pressures on the venous side of the device may result.
- Federal law (U.S.A.) restricts this device to sale by or on the order
of a physician.
- Do not operate the pump unprimed. Doing so may damage the
pump.
- To aid in the prevention of gas or particulate embolization, the use
of safety devices including bubble sensors, arterial filters, and
pre-bypass filters, is recommended for all ECC procedures
using the ECC.O
- Entry of massive air into the pump will cause the device to
deprime and the blood flow to stop.
- The pump must not be run unattended.
E. PREPARATION AND SET-UP
1) HOLDER SET-UP
Position the holder on a pole and fix it by means of the clamp behind
the load-bearing "arch." Be sure to orient the holder such that the
device will be upright, and check that there is sufficient space for the
pump driver.
5
in ECC, the use of the Stöckert Electric
5
in ECC, the use of the Stöckert Air Purge
is connected to the heater
5
above the level of the patient.
5
hemoconcentration
flow
5
can only be used with the appropriate holder.
while the arterial and venous lines
5
5
. This may cause damage and can compromise
in pulsatile flow. Excessive negative
5
.
5
5
is
rates.
In
any
event,
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