Priming And Recirculation Procedure - SORIN GROUP D 905 E0S Instrucciones De Uso

- Do not use if sterile packaging is damaged, unsealed, or has been
exposed to moisture or other conditions that would compromise the
sterility of the device.
- Check the expiry date on the label attached. Do not use the device after
the date shown.
- 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
functioning 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 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. In case of leaks discard the unit.
5) CIRCUIT CONNECTIONS
All connections downstream of the pump must be secured by means of
ties.
VENOUS LINE: Connect a venous line of 1/2" to the connector indicated on the
venous reservoir as "VENOUS RETURN" (fig. 2, ref.2).
The Venous Return connector can be rotated 360 to find the most convenient
position of the venous tubing.
CARDIOTOMY SUCTION LINES: After removing the protective caps from the
"filtered" inlets on the top of the venous reservoir (four 1/4" / 6.35 mm inlets, two
3/8" / 9.53 mm inlets), connect the ends of the suction tubes and rotate the turret
(fig. 2, ref. 8) orienting the filtered inlets towards the suction pumps.
ARTERIAL LINE: remove the red cap on the oxygenator arterial outlet indicated
as "ARTERIAL OUTLET" (fig. 2, ref. 12) and connect a 3/8" line.
Never infuse or introduce fluids through any luer port on the arterial line.
PUMP LINE: the pump segment should be set up between the Venous
Reservoir outlet connector (fig. 2, ref. 5) and the oxygenator venous inlet
connector (fig. 2, ref. 11) taking account of the direction of rotation of the pump.
RESERVOIR VENT Remove yellow cap from the reservoir vent connector
(fig. 2, ref. 7).
Check that the pos lock on the coronary outlet port is closed
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 D
6
905 EOS 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.
If a connection is made to the coronary outlet port during bypass, the line
to be connected must be unclamped and unpressurized such that blood
will flow into it upon connection.
Connect the recirculation line to one of the rear connectors of the reservoir.
6) SAMPLING SYSTEM
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.
Attach the A/V sampling manifold on the dedicated holder or on the specific
housing located to the top of the venous reservoir. 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 (fig. 2, ref. 19) is located next
to the arterial outlet, while the venous probe site (fig. 2, ref. 3) is located on the
venous inlet connector of the reservoir.
Use SORIN GROUP ITALIA temperature probes (code 09026).
8) CLOSE THE PURGING/RECIRCULATION LINE
Close the purging/recirculation stopcock (refer to the diagram on the label) prior
to priming.
9) CONNECT THE GAS LINE
Remove the green cap from the gas inlet connector indicated as "GAS INLET"
(fig. 2, ref. 13) 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 "GAS ESCAPE" (fig. 2,
ref. 14) connector.
- 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 pathway.
- Do not for any reason occlude the external access holes of gas
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 function of the oxygenating module.
1) KEEP THE GAS FLOW OFF
2) KEEP THE OXYGENATOR PURGING/ RECIRCULATION LINE
CLOSED
Check that the purging/recirculation stopcock is closed.
3) CLOSE VENOUS AND ARTERIAL LINES
Clamp the venous line. Clamp the arterial line some centimetres away from
arterial outlet connector of the oxygenator.
4) CHECK THE HEAT EXCHANGER
GB – ENGLISH