Set Up - dideco D901 LiLLiPUT Mode D'emploi

symbol non sterile on the pack) contact SORIN GROUP ITALIA or
an authorised dealer to agree on a sterilisation method.
- The device must be used in accordance with the instructions for
use provided in this manual.
- The device is intended to be used by professionally trained
personnel.
- SORIN GROUP ITALIA is not responsible for problems arising
from inexperience or improper use.
- FRAGILE, handle with care.
- Do not expose to temperatures below 0°C (32°F) or above 60°C
(140°F).
- Keep dry.
- Always apply and maintain a correct dose and accurate monito-
ring 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 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.
- 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.
- 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.
- 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 (fig. 2)
Position the LILLIPUT holder on the pump structure (ref. a) by
means of the clamp at the upper end of the extension arm.
For more information on the holder set up, refer to the instruc-
2
tions for use for the holder.
2) PREPARE THE HOLDER (fig. 2)
Remove the black plastic cover from the water distributor. Turn
the lever (ref. b) to "DISENGAGED" position.
3) FIXING THE OXYGENATOR TO THE HOLDER (fig. 3)
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
housing of the device. This could cause damage which may
compromise the integrity and proper functioning of the
device.
Locate the LILLIPUT, taking care to insert the white water distri-
butor of the holder (fig. 2 - ref. c) into the heat exchanger. The
oxygenator must be locked into place using the marker guides
on the two red knobs.
Turn the lever (fig. 2 - ref. b) to "ENGAGED" position.
The LILLIPUT is now correctly set up.
4) THERMOCIRCULATOR SET UP
Connect the water tubes to the holder by means of the female
Hansen connectors SORIN GROUP ITALIA code 9028.
WARNING
- The use of different connectors from those indicated may
cause resistance inside the circuit and reduce the efficiency
of the heat exchanger.
- 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).
5) CHECKING THE HEAT EXCHANGER
Check the heat exchanger by recirculating water inside the heat
exchanger for a few minutes.
The integrity of the housing is guaranteed if there are absolutely
no leaks from the water compartment.
6) CIRCUIT CONNECTIONS
WARNING
All connections downstream of the pump must be secured by
means of ties.
Versions with SOFT VENOUS RESERVOIR (fig. 4)
VENOUS LINE: it is possible to connect a venous line of 1/4" or
3/16" to the connector indicated on the venous reservoir as
"VENOUS RETURN" (ref. 3).
CARDIOTOMY LINE: it is possible to connect the cardiotomy
1/4" or 3/16" line to the soft venous reservoir connector indica-
ted as "CARDIOTOMY RETURN" (ref. 5).
The line connecting the cardiotomy to the venous reservoir
must form a U-shaped trap located at least 5 cm below the
venous reservoir, such that the U prevents air entering the
venous reservoir from the cardiotomy.
The cardiotomy must be able to be easily raised or lowered to
allow for variations in haemodynamic state.
ARTERIAL LINE: remove the red cap on the oxygenator arterial
outlet (ref. 15) in order to connect a 1/4" or 3/16" line.
PUMP LINE: the pump segment should be set up between the
venous reservoir outlet connector (ref. 16) and the oxygenator
venous inlet connector (ref. 12) taking account of the direction
of rotation of the pump.
VENOUS PURGE LINE: remove the protective cap and connect
the male luer end of the venous reservoir purge line (ref. 1) to a
female luer located on the suction line (this connection must be
made on the "negative pressure" side of the line).
To find the best position, rotate the venous reservoir.
CAUTION
If at the end of the bypass blood recovery is envisaged,
disconnect the male luer lock of the recirculation line and set
up an "ON-OFF" manifold (with female and male luer lock
connections) between the recirculation line and the "CAR-
DIOTOMY RETURN" female luer connector on the soft venous
reservoir. Open the "ON-OFF" manifold (position "ON").
Version OXYGENATING MODULE only (fig. 5)
ARTERIAL LINE: remove the red cap on the oxygenator arterial