Set Up; Sampling System - SORIN GROUP dideco KIDS D100 Instrucciones Para El Uso

- 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. 4, 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. 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.
Attach the device to the holder:
Position the locking mechanism of the holder (fig. 4, ref. 3) on ''OPEN'
-
position.
Insert the device into the locking arm of the holder (fig 4, ref. 2)
-
Carry out a visual inspection and carefully check to have the device properly fixed into
the locking arm of the holder (fig. 5).
Position the locking mechanism of the holder in ''CLOSED' position (fig. 4, ref.
-
3).
3) HEATER-COOLER SET UP
Connect the water tubes to the holder by means of the female Hansen connectors
(SORIN GROUP ITALIA code 09028 or equivalent).
- 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 (fig 1-2-3, ref. 8) as it
is the outlet of the safety channel which helps preventing fluids crossing from one
compartment to another.
- 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 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 1-2-3, ref. 8). In case of leaks discard the unit.
5) CIRCUIT CONNECTIONS
All connections downstream of the pump must be secured by means of 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. 1-2-3, ref. 9). The third stopcock way will supply oxygenated
blood.
- Never infuse or introduce fluids through any luer port 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
8
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: 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. 12)
The Venous Return connector can be rotated 360° to find the most convenient
position of the venous tubing.
CARDIOTOMY SUCTION LINES: after removing protective caps from the "filtered"
inlet connectors on the top of the Cardiotomy Reservoir (7 x Luer-Locks inlets)
connect the extremities of the aspiration tubes.
Always use male Luer-Lock provided by SORIN GROUP ITALIA. Male luers not
supplied with SORIN GROUP ITALIA products may damage the female luer-locks at
the top of the reservoir and may not be correctly secured.
ARTERIAL LINE: remove the red cap on the oxygenator arterial outlet indicated as
"ARTERIAL OUTLET" (ref. 2) and connect a 3/16" line.
PUMP LINE: the pump segment should be set up between the venous reservoir outlet
connector (ref. 13) and the oxygenator venous inlet connector (ref. 1) taking account
of the direction of rotation of the pump.
RESERVOIR VENT: Remove yellow cap from the reservoir vent connector (ref. 16).
Version [B], CLOSED SYSTEM (fig 2)
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. 12).
CARDIOTOMY LINE: it is possible to connect the cardiotomy 1/4" or 3/16" line to the
soft venous reservoir connector indicated as "CARDIOTOMY RETURN" (ref. 14).
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. 2) in order
to connect a 3/16" line.
PUMP LINE: the pump segment should be set up between the venous reservoir outlet
connector (ref. 13) and the oxygenator venous inlet connector (ref. 1) 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 soft venous reservoir purge line (ref. 15) to a female luer located on a suction line
(this connection must be made on the "negative pressure" side of the line).
Version [C], OXYGENATING MODULE (fig. 3)
ARTERIAL LINE: remove the red cap on the oxygenator arterial outlet (ref. 2) in order
to connect a 3/16" line.
PUMP LINE: the pump segment should be set up between the venous reservoir outlet
connector and the oxygenator venous inlet connector (ref.1) taking account of the
direction of rotation of the 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.
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

D100 KIDS is supplied with a pre-connected sampling system. The sampling system
must be fixed on the appropriate holder (D 712). The tube coil attached to the
manifold allows it to be positioned to a range of approximately 1 metre.
The arterial sampling site connector luer does not include one way valve. Verify that
there is a one way valve in the sampling line to prevent accidental air introduction into
the arterial line.
7) CONNECT THE TEMPERATURE PROBES
Use SORIN GROUP ITALIA temperature probes (code 09026) or equivalent.
The connection for the arterial temperature probe (fig. 1-2-3, ref. 5) is located next to
the arterial outlet.
Version [A], OPEN SYSTEM:
the venous probe site (fig. 1, ref. 14) is located on the venous inlet connector of the
reservoir.
8) CLOSE THE PURGING/RECIRCULATION LINE
Close the clamp positioned on the purging/recirculation line(fig. 1-2-3, ref. 7)
between oxygenating module and venous reservoir prior to priming.
9) CONNECTING THE GAS LINE
Remove the green cap from the gas inlet connector indicated as "GAS INLET" (fig. 1-
2-3, ref. 3) and connect the 1/4" gas line. Ensure that the gas supply is from a
GB - ENGLISH