Set Up - dideco COMPACTFLO EVOLUTION Mode D'emploi

- Keep dry. Store at room temperature.
- 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 can-
not 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 effective-
ness).
- The device contains phthalates. Considering the nature of con-
tact with the body, the limited duration of contact and the num-
ber of treatments per patient, the amount of phthalates which
might be released from the device does not raise specific con-
cerns about residual risks. Further information is available on
request from Sorin Group Italia
- Always give and maintain a correct dose and accurate monito-
ring of the anticoagulant before, during and after the bypass.
- 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.
- 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 COMPACTFLO EVOLUTION 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.
2
- 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
housing of the device. This could cause damage which may
compromise the integrity and proper functioning of the
device.
Fix the COMPACTFLO EVOLUTION 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 COMPACTFLO
EVOLUTION down to the holder and turn the locking lever on
"CLOSED" position.
The COMPACTFLO EVOLUTION 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.
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. 2).
The Venous Return connector can be rotated 360° to find the
most convenient position of the venous tubing.
ASPIRATION 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.
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.
Remove yellow cap from the gas scavenging connector (fig. 2,
ref. 7) 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 COMPACTFLO EVOLUTION 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.