Priming And Recirculation Procedure - SORIN GROUP PrimO2X Instrucciones De Uso

– The device must be used immediately after opening the sterile packaging.
– The device must be handled aseptically.
Remove the device from the sterile packaging.
– Carry out a visual inspection and carefully check the device before use.
Transport and/or storage conditions other than those prescribed may
have caused damage to the device.
– Do not use solvents such as alcohol, ether, acetone, etc.: as contact may
cause damage to the device.
– Do not allow halogenated liquids such as Halothane and Fluothane to
come into contact with the polycarbonate housing of the device. This
could cause damage which may compromise the integrity and proper
function of the device.
Attach the device to the holder.
The word "OPEN" on the water connectors locking system must be visible.
Check that the notches on the water connectors locking system are aligned.
Only then you can attach the oxygenator onto the holder.
Insert the Hansen connectors and push the device down to the holder and turn the
locking lever on "CLOSED" position.
The device will be correctly positioned only when the locking lever shows
"CLOSED".
3) HEATER-COOLER SET UP
Connect the water tubes to the holder by means of the female Hansen connectors
(SORIN GROUP ITALIA code 09028 or equivalent).
– The use of different connectors from those indicated may cause
resistance inside the circuit and reduce the efficiency of the heat
exchanger.
– Do not obstruct the hole on the heat exchanger lower cover as it is the
outlet of the safety channel (fig.2, ref.11) which helps preventing fluids
crossing from one comparment to another.
– The water temperature at the heat exchanger inlet must not exceed 42 °C
(108 °F).
– The water pressure in the heat exchanger must not exceed 2250 mmHg
(300 Kpa / 3 bar / 44 psi).
4) CHECK THE HEAT EXCHANGER
Check the heat exchanger by circulating water inside the heat exchanger for
a few minutes. There should be no leaks from the water compartment or
from the safety channel hole.
5) CIRCUIT CONNECTIONS
All connections downstream of the pump must be secured by means of ties.
ARTERIAL LINE: remove the red cap on the oxygenator arterial outlet (fig.2,
ref.1) indicated as "ARTERIAL OUTLET" and connect a 3/8" line.
PUMP LINE: the pump segment should be set up between the venous reservoir
outlet connector and the oxygenator venous inlet connector (fig.2, ref.2) taking
account of the direction of rotation of the pump.
OXYGENATING MODULE PURGING /RECIRCULATION LINE: connect the
purging/recircualtion line end (fig.2, ref.3 - 1/4" connector) to the recirculation line
inlet on the soft venous reservoir (closed system); otherwise to a filtered venous
inlet of the rigid venous reservoir (open system).
Check that the pos lock on the coronary outlet port is closed (fig.2, ref.5)
If oxygenated blood is necessary for blood cardioplegia, remove the red pos lock
and connect the 1/4" blood line of the cardioplegia circuit to the PRIMO
MODULE coronary outlet port using the D523C reducer (provided with the
product).
The coronary outlet port has a self-sealing valve which allows connection of the D
523C reducer during extracorporeal bypass without any leakage or spillage of
fluid.
6) SAMPLING SYSTEM
The arterial/venous sampling system is supplied in a sterility bag. About 1 meter
venous and arterial tubing lines are attached to a 3-stopcock manifold. Remove
the device from the packaging.
ARTERIAL SAMPLING LINE: Remove the protective cap from the arterial
sample site luer connector located on the side of the arterial outlet (fig. 2, ref. 6).
Connect the red male luer of the arterial sampling line to the arterial sampling site
luer.
The arterial sampling site connector luer does not include one way valve.
Verify that there is a one way valve in the sampling line to prevent accidental
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air introduction into the arterial line.
VENOUS SAMPLING LINE: Remove the protective cap from the venous sample
site luer connector located on the venous return connector. Connect the blue male
luer of the venous sampling line to the venous sampling site luer.
Check the security of all luer connections. All accessory lines connected to
the device must be connected tightly in order to prevent accidental
introduction of air into the device or blood loss.
Position the stopcock handles toward the access ports of the manifold (A/V shunt
position).
7) CONNECT THE TEMPERATURE PROBES
The connection for the arterial temperature probe (red -fig.2, ref.6) is positioned
next to the arterial outlet.
Use SORIN GROUP ITALIA temperature probes (code 09026) or equivalent
temperature probes (ref TMPMV).
8) CLOSE THE RECIRCULATION LINE
Close the purging-recirculation stopcock (refer to the diagram on the label) (fig.2,
ref.7).
9) CONNECT THE GAS LINE
Remove the green cap from the connector labelled "GAS INLET" (fig.2, ref.8) and
connect the 1/4" gas line.
Ensure that the gas supply is from a suitable air/oxygen mixer such as the
Sechrist, code 09046 (available from SORIN GROUP ITALIA) or a system with
compatible technical features.
A capnograph connector can be found in the center of the "GAS ESCAPE"
connector (fig.2, ref.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.
– SORIN GROUP ITALIA recommends the use of a bubble trap or arterial
filter on the arterial line to reduce the risk of emboli transmission to the
patient.
– The user should check for occlusions in tubing during set up.
10) VAPOROUS ANAESTHESTICS
The oxygenator is suitable for use with volatile anaesthetic isoflurane and
sevoflurane, by mean of a suitable narcosis gas evaporator.
If these vaporous anaesthetics are used, some method of scavenging the gas
from the oxygenator should be considered.
The protocol, the concentration and the monitoring of the anaesthetic gases
administrated to the patient, is under the sole responsibility of the physician in
charge of the treatment.
The only volatile anaesthetics suitable for this use are isofluorane and
sevolfuorane
The methods adopted for vaporous anaesthetic gas scavenging should not
increase or reduce in any way the pressure level at the oxygenator fibres.
F. PRIMING AND RECIRCULATION PROCEDURE
Do not use priming solutions containing alcohol: such solutions could
compromise the proper functioning of the oxygenating module.
1) KEEP THE GAS FLOW OFF
2) KEEP THE OXYGENATOR PURGING/RECIRCULATION LINE
CLOSED
X
Check that the purging-recirculation stopcock is closed (fig.2, ref.7).
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3) CLOSE THE VENOUS AND ARTERIAL LINES
Clamp the venous line coming from the patient. Clamp the arterial line some
centimetres from the arterial outlet.
When using a soft venous reservoir (closed system), clamp the line between the
auxiliary cardiotomy and the soft venous reservoir.
When using a rigid venous reservoir (open system), clamp the rigid venous
reservoir outlet.
4) CHECK THE HEAT EXCHANGER
Check for leakage from the heat exchanger, paying particular attention to possible
water leaks.
5) CARDIOTOMY/HARDSHELL VENOUS RESERVOIR PRIMING
Secure with ties all aspiration lines connected to the cardiotomy. Fill the
cardiotomy with sufficient liquid to ensure the intended haematocrit is obtained,
taking into account:
– the static priming volume of the oxygenator is 250 ml;
GB - ENGLISH