Set-Up - SORIN GROUP Dideco KIDS D101 Instrucciones Para El Uso

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
- Always apply and maintain a correct dose and accurate monitoring of the
anticoagulant before, during and after the bypass.
- The device must not undergo any further processing.
- Do not resterilize.
- 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.
- For further information and/or in case of complaint contact SORIN GROUP
ITALIA or the authorised local representative.
- 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, currently SORIN GROUP
ITALIA is 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
Position the D633 holder on the pump structure by means of the clamp at the
upper end of the arm (fig. 3, ref. 1).
2) FIX THE OXYGENATOR TO THE HOLDER
- Do not use if sterile packaging is damaged, unsealed, or has been
exposed to moisture or other conditions that would compromise the
sterility of the device.
- 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.
- Carry out a visual inspection and carefully check the device before
use. Transportation and/or storage conditions other than those
prescribed may have caused damage to the device.
- Check and tighten all luer lock connections.
- 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.
Attach the device to the holder:
- Position the locking mechanism of the holder (fig. 3, ref. 3) on ''OPEN'
position.
- Insert the device into the locking clamp of the holder (fig 3, ref. 2).
Carry out a visual inspection and carefully check to have the device
properly placed into the locking clamp of the holder (fig. 4).
- Position the locking mechanism of the holder in ''CLOSED' position (fig. 3,
ref. 3).
3) HEATER-COOLER SET-UP
Connect the water lines to the Kids D101 water connectors by means of the
female Hansen connectors (SORIN GROUP code 09028 or equivalent).
- The use of different connectors from those indicated may cause
resistance inside the water circuit and reduce the efficiency of the
heat exchanger.
- Do not obstruct the hole on the heat exchanger lower cover (fig 1-2,
ref. 8) as it is the outlet of the heat exchanger safety channel.
- 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 1500
6
mmHg (200 Kpa / 2 bar / 29 psi).
4) CHECK THE HEAT EXCHANGER
Check the heat exchanger by circulating water inside the heat exchanger
for a few minutes. There should be no leaks from the water compartment
or from the safety channel hole (fig 1-2, ref. 8). In case of leaks discard the
unit.
5) CIRCUIT CONNECTIONS
All connections downstream of the pump must be secured by means of
safety ties.
- If oxygenated blood is necessary for blood cardioplegia, connect a 3
way stopcock (not supplied with the device) to luer connection
positioned on the arterial sampling line (fig. 1-2, ref. 9). The third
stopcock way will supply oxygenated blood.
- As alternative to the stopcock, the arterial temperature probe site (fig.
1-2, ref. 5) can be unscrewed and the blood cardioplegia line
connected onto this access port.
- Never infuse or introduce fluids through any connector on the arterial
line.
Version [A], OPEN SYSTEM (fig. 1)
- The special positive and negative pressure relief valve is mounted on
the lid of the venous reservoir. It starts to release positive pressures
at +5 mmHg (0.7 kPa/ 0.007 bar/ 0.1 psi) and negative pressures at
-80 mmHg (-10.4 kPa / -0.10 bar / -1.53 psi). The action of the valve by
itself does not prevent from the over / under pressurization of the
reservoir in all operating conditions.
- Do not for any reason occlude the external access hole of pressure
relief valve. Remove tab inserted in pressure relief valve (ref. 17) from
the valve prior to use.
VENOUS LINE: Remove the protective cap and connect a 3/8" venous line. A
special locking 3/8"-1/4" adapter (ref. 24) provided with the device allows the
connection of 1/4" venous line. The venous connector is indicated as "VENOUS
RETURN" (ref. 12).
The Venous Return connector can be rotated 360° allowing to find the most
convenient position of the venous line.
CARDIOTOMY SUCTION LINES: after removing protective caps from the
suction inlet connectors located on the top of the venous reservoir (ref. 20)
connect the extremities of the suction lines.
ARTERIAL LINE: remove the red cap on the oxygenator arterial outlet indicated
as "ARTERIAL OUTLET" (ref. 2) and connect a 1/4" line.
PUMP LINE: the pump loop should be connected between the venous reservoir
outlet connector (ref. 13) and the oxygenator venous inlet connector (ref. 1)
always paying attention to the direction of rotation of the main pump.
RESERVOIR VENT: Remove yellow cap from the reservoir vent connector (ref.
16).
Version [B], OXYGENATING MODULE (fig. 2)
ARTERIAL LINE: remove the red cap on the oxygenator arterial outlet (ref. 2) in
order to connect a 1/4" line.
PUMP LINE: the pump loop should be connected between the venous reservoir
outlet connector and the oxygenator venous inlet connector (ref.1) always
paying attention to the direction of rotation of the main pump.
OXYGENATING MODULE PURGE/RECIRCULATION LINE: remove the
protective cap and connect the male luer end (ref. 7) to a female luer filtered
inlet on the cardiotomy section of the venous reservoir.
VENOUS SAMPLING LINE: remove the protective cap and connect the male
luer end of the venous sampling line to the venous sampling luer site on the
reservoir used in combination.
6) SAMPLING SYSTEM
D101 KIDS is supplied with a pre-connected sampling system. The sampling
system must be fixed to the appropriate holder (D 712). The sampling lines allow
the sampling manifold to be positioned in the range of approximately 1 metre.
The arterial sampling luer connector does not include a one way valve.
Verify that there is a one way valve in the sampling line to prevent
accidental air introduction into the arterial line.
GB - ENGLISH