Set Up - SORIN GROUP dideco D 905 AVANT Mode D'emploi

of the anticoagulant before, during and after the bypass.
- For single use and for single-patient use only. During use the
device is in contact with human blood, body fluids, liquids or
gases for the purpose of eventual infusion, administration or
introduction into the body, and due to its specific design it cannot
be fully cleaned and disinfected after use. Therefore, reuse on
other patients might cause cross-contamination, infection and
sepsis. In addition, the reuse increases the probability of product
failure (integrity, functionality and clinical effectiveness).
- The device contains phthalates. Considering the nature of contact
with the body, the limited duration of contact and the number of
treatments per patient, the amount of phthalates which might be
released from the device does not raise specific concerns about
residual risks. Further information is available on request from
Sorin Group Italia.
- The device must not undergo any further processing.
- Do not resterilise.
- After use, dispose of the device in accordance with applicable
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 ste-
rilisation 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 903 AVANT holder D 630 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.
2
- 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 housing
of the device. This could cause damage which may
compromise the integrity and proper functioning of the device.
Fix the D 903 AVANT 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 903 AVANT down to the holder and turn the
locking lever on "CLOSED" position. The D 903 AVANT will be cor-
rectly 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.
WARNING
- 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
WARNING
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
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 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.
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 903 AVANT 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