Set Up - SORIN GROUP D905 EOS Instrucciones Para El Uso

to agree on a sterilisation method.
- The EOS venous reservoir, applying the method of active venous drainage
with vacuum, must be used carefully following the instructions "USE OF
ACTIVE VENOUS DRAINAGE WITH VACUUM" in this user manual in
paragraph K.
- The special positive and negative pressure relief valve installed on the EOS
cardiotomy/venous reservoir ensures optimum post-operative performance:
it operates to vent positive pressures above 0,7 KPa (0.007 bar/0.1 psi) and
negative pressures lower than -10 KPa (-0.1 bar/-1.5 psi). Do not plug the
external vent of this valve for any reason.
- For further information and/or in case of complaint contact SORIN GROUP
ITALIA or the authorised local representative.
- Federal law (U.S.A.) restricts this device to sale by or on the order of a
physician.
- Inner surfaces of the system are Ph.I.S.I.O. coated; SORIN GROUP ITALIA is
currently not aware of any contraindication to the use of systems having
components treated with Ph.I.S.I.O.
E. SET UP
1) POSITION THE HOLDER
Position the D 905 EOS holder D632 on the pump structure by means of the
clamp at the upper end of the arm.
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 oxy module 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
4
- All connections downstream of the pump must be secured by means
of ties.
- Remove the yellow cap from the vent connector (fig. 2, rif. 18) of the
Cardiotomy Reservoir.
- Remove the yellow insert from the pressure relief valve (fig. 2, rif. 17)
VENOUS LINE: Connect a venous line of 1/2" to the connector indicated on
the venous reservoir as "VENOUS RETURN" (fig.2, ref.13).
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:
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.6)
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", (fig.2, ref.
15)). 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. 6). During the entire procedure, keep the connection key (fig.2, ref. 3)
closed (positioned at the bottom).
ARTERIAL LINE: remove the red cap on the oxygenator arterial outlet
indicated as "ARTERIAL OUTLET" (fig.2, ref.5) and connect a 3/8" line.
PUMP LINE: the pump segment should be set up between the Venous
Reservoir outlet connector (fig.2, ref.7) and the oxygenator venous inlet
connector (fig.2, ref.4) taking account of the direction of rotation of the pump.
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 RAMP
The arterial/venous sampling ramp is supplied in a single sterility bag
integrated with about 1 m venous/arterial tubing lines.
ARTERIAL SAMPLING LINE: remove the protective cap from the luer
connector placed beside the arterial outlet (fig.2, ref. 8). Connect the male luer
of the arterial sampling line of the ramp.
Male luers not supplied with SORIN GROUP ITALIA products may
damage the one-way valve placed inside the oxygenator arterial
sampling luer. When connecting, make a visual check that the male luer
does not reach as far as the one-way valve.
VENOUS SAMPLING LINE: remove the protective cap from the luer
connector placed beside the venous inlet (fig.2, ref. 14). Connect the male luer
of the venous sampling line of the ramp.
7) CONNECT THE TEMPERATURE PROBES
The connection for the arterial temperature probe (red - fig.2, ref.9) is
positioned next to the arterial outlet, while the venous probe site (blue - fig.2,
ref.10) 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.11) and connect the 1/4" gas line.
Ensure that the gas supply is from a suitable air/oxygen mixer such as the
Bird, code 09374 (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.12) connector.
GB - ENGLISH