Set Up - SORIN GROUP D905 EOS Instrucciones Para El Uso

ITALIA or the authorised local representative.
Federal law (U.S.A.) restricts this device to sale by or on the order of a
physician.
E. SET UP
1) POSITION THE HOLDER
Position the D 905 EOS holder on the pump structure by means of the clamp
at the upper end of the arm (fig.1, ref. 1).
2) FIX THE OXYGENATOR TO THE HOLDER
- Sterility is guaranteed only if the sterile packaging is not wet, opened,
damaged or broken. Do not use the device if sterility cannot be
guaranteed.
- 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.
Fix the D 905 EOS onto 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 fix the oxygenator onto the holder.
Insert the Hansen connectors and push D 905 EOS down to the holder and
turn the locking lever on "CLOSED" position.
The D 905 EOS will be correctly positioned only when the locking lever shows
"CLOSED".
3) THERMOCIRCULATOR SET UP
Connect the water tubes to the holder by means of the female Hansen
connectors SORIN GROUP ITALIA code 09028.
- 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 situated
near the venous temperature probe. This hole connects the safety
channel which helps prevent fluids crossing from one compartment to
the other.
- 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 300 KPa (3
bar / 44 psi).
4) CHECK THE HEAT EXCHANGER
Check the heat exchanger by recirculating water inside the heat
exchanger for a few minutes. The integrity of the unit is guaranteed if
there are absolutely 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.
VENOUS LINE: Connect a venous line of 1/2" to the connector indicated on
the venous reservoir as "VENOUS RETURN" (fig. 2, ref.15).
The Venous Return connector can be rotated 180∞ to find the most
convenient position of the venous tubing. This rotation is possible only after
removing the polycarbonate insert that fixes the connector.
Remove the plastic insert only after connecting the venous tubing to the
venous return connector.
ASPIRATION LINES:
4
Without separation of blood recovered by the aspirators:
after removing protective caps from the "filtered" inlet
connectors on the top of the Cardiotomy Reservoir (four 1/4" /
6,35 mm connectors, two 3/8" / 9.53 mm connectors), connect
the aspiration lines and rotate the turrets (fig. 2, ref. 8) towards
the suction pumps.
With separation of blood recovered by the aspirators:
connect the two "Y" adapters found in the convenience kit to the
two connectors on the top of the Cardiotomy ("Cardiotomy
Bypass Port",s (fig. 2, ref. 16)). Connect to the inlets of the two
adapters (four 1/4" / 6,35 mm inlets, two Luer lock inlets) any
lines that should connect directly to the Venous Reservoir:
ventricular aspirators, aortic root aspirator, arterial filter
drainage, blood concentrator, Venous Reservoir quick-priming.
Finally, connect the remaining suction lines to the filtered inlets
on the Cardiotomy Reservoir (fig. 2, ref. 8). During the entire
procedure, keep the connection (fig. 2, ref. 5) key closed
(positioned at the bottom).
ARTERIAL LINE: remove the red cap on the oxygenator arterial outlet
indicated as "ARTERIAL OUTLET" (fig. 2, ref. 7) and connect a 3/8" line.
PUMP LINE: the pump segment should be set up between the Venous
Reservoir outlet connector (fig. 2, ref. 9) and the oxygenator venous inlet
connector (fig. 2, ref. 6) taking account of the direction of rotation of the pump.
Remove yellow cap from the gas scavenging connector (fig. 2, rif. 18) of the
Cardiotomy Reservoir.
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 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 also 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 unpressurised such that
blood will flow into it upon connection.
6) SAMPLING MANIFOLD
When sampling is needed from a more remote position remove the A/V
manifold (fig. 2, ref. 10) from its housing and insert the plate in the "D 712
Holder for Sampling Manifold". The tube coil attached to the manifold allows it
to be repositioned to a range of approximately 1 metre. Verify the connection
of the manifold purge line with the "filtered" luer lock of the Venous Reservoir.
Check that the selector switch is in the "OFF" position.
7) CONNECT THE TEMPERATURE PROBES
The connection for the arterial temperature probe (red – fig. 2, ref. 11) is
positioned next to the arterial outlet, while the venous probe site (blue – fig. 2,
ref. 12) is at the side of the venous inlet. SORIN GROUP ITALIA temperature
probes have the code 09026.
8) CLOSE THE PURGING/RECIRCULATION LINE
Close the purging/recirculation stopcock (refer to the diagram on the label).
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 centre 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 compartment.
- SORIN GROUP ITALIA recommends the use of a bubble trap or filter
on the arterial line to reduce the risk of emboli transmission to the
patient.
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.
GB - ENGLISH