Set Up - dideco D 905 EOS Instrucciones De Uso

regulations in force in the country of use.
- The device must only be used if sterile. In the event of the
device being supplied NOT STERILE (in which case, this is
indicated by the wording "NOT STERILE" on the pack) contact
SORIN GROUP ITALIA or an authorised dealer to agree on a
sterilisation method.
- In the version with safety valve it is inadvisable to apply the
vacuum to the cardiotomy/venous reservoir.
- For further information and/or in case of complaint contact
SORIN GROUP ITALIA or the authorised local representative.
CAUTION
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
WARNING
- 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.
WARNING
- 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 hous-
ing of the device. This could cause damage which may com-
promise 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.
2
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 lock-
ing 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.
WARNING
- The use of different connectors from those indicated may
cause resistance inside the circuit and reduce the efficien-
cy of the heat exchanger.
- Do not obstruct the hole on the heat exchanger lower cover
situated near the venous temperature probe. This hole con-
nects 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
WARNING
Check the heat exchanger by recirculating water inside the heat
exchanger for a few minutes. The integrity of the unit is guaran-
teed if there are absolutely no leaks from the water compartment
or from the safety channel hole.
5) CIRCUIT CONNECTIONS
WARNING
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.
CAUTION
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 connec-
tors on the top of the Cardiotomy Reservoir (four 1/4" / 6,35 mm
connectors, two 3/8" / 9.53 mm connectors), connect the aspi-
ration lines and rotate the turrets (fig. 2, ref. 8) towards the suc-
tion 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: ven-
tricular 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 proce-
dure, 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 con-
nect 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 oxy-
genator 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.
CAUTION
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.
WARNING
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