Set Up - dideco D 901 LILLIPUT 1 Instrucciones De Uso

The following is general safety information with the aim of advising
the operator in preparing to use the device.
Also, specific safety information is given in the instructions for use
at locations in the text where that information is relevant for correct
operation.
WARNING
- 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.
- 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 apply 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 indi-
cated by the wording "NOT STERILE" on the pack) contact DIDE-
CO or an authorised dealer to agree on a sterilisation method.
- For further information and/or in case of complaint contact
SORIN GROUP ITALIA or the authorised local representative.
CAUTION
2
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 625 LILLIPUT holder on the pump structure by
means of the clamp at the upper end of the arm (fig. B).
For more information on the holder set up, refer to the instruc-
tion for use for the holder.
2) PREPARE THE HOLDER
Remove the black plastic bag cover from the water distributor.
Turn the lever (ref. 19) to "OPEN" position.
3) FIXING THE OXYGENATOR TO THE HOLDER (fig. B)
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
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 hou-
sing of the device. This could cause damage which may
compromise the integrity and proper functioning of the device.
Locate the LILLIPUT 1 OPEN SYSTEM, taking care to insert the
white water distributor of the holder (fig. C) into the heat exchan-
ger. The oxygenator must be locked into place using the marker
guides on the two red knobs. Turn the lever (fig. B - ref. 19) to
"CLOSE" position.
The LILLIPUT 1 OPEN SYSTEM is 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 gua-
ranteed if there are absolutely no leaks from the water compart-
ment.
6) CIRCUIT CONNECTIONS
WARNING
All connections downstream of the pump must be secured by
means of ties.
VENOUS LINE: it is possible to connect a venous line of 3/16" or
1/4" to the connector indicated on the venous reservoir as
"VENOUS RETURN" (ref. 4)
ASPIRATION LINES: after removing protective caps from the "fil-
tered" inlet connectors on the top of the Cardiotomy Reservoir (4
x 3/16" - 1/4" (4,76 - 6,35 mm) inlets) connect the extremities of
the aspiration tubes and rotate the turrets (ref. 5) towards the
suction pumps.
ARTERIAL LINE: remove the red cap on the oxygenator arterial
outlet indicated as "ARTERIAL OUTLET" (ref. 6) and connect a
3/16" - 1/4" line.
PUMP LINE: the pump segment should be set up between the
venous reservoir outlet connector (ref. 7) and the oxygenator
venous inlet connector (ref. 8) taking account of the direction of
rotation of the pump.
Remove yellow cap from the gas scaveging connector (ref. 9) of
the Cardiotomy Reservoir.
CAUTION
If oxygenated blood is necessary for blood cardioplegia, con-
nect a 3 way stopcock to luer connection positioned on the
ricirculation line. The third stopcock way will supply oxygena-
ted blood.
CAUTION
opening the
If at the end of the bypass blood recovery is envisaged, set up
an "ON-OFF" manifold (with female and male luer lock con-
nections) between the male luer lock of the oxygenating modu-
le recirculation line and the used venous reservoir. Open the