Set Up - SORIN GROUP D 903 AVANT VAVD Mode D'emploi

- 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.
- The special positive and negative pressure relief valve (fig. 2, ref. 20)
installed on the vacuum line connector supplied with the product (fig. 2, ref.
19) operates to vent positive pressures above 0,7 KPa (0.007 bar/0.01 psi)
and negative pressures lower than -10 KPa (-0.1 bar/-1.5 psi). Do not plug
the external vent of this valve for any reason.
- 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.
E. SET UP
1) POSITION THE HOLDER
Position the D903 AVANT VAVD holder D630 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
- 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 yellow insert from the pressure relief valve.
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.
Fix the D903 AVANT VAVD 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 D903 AVANT VAVD down to the
holder and turn the locking lever on "CLOSED" position.
The D903 AVANT VAVD will be correctly positioned only when the locking
lever shows "CLOSED".
3) THERMOCIRCULATOR SET UP
Connect the water tubes to the oxy module by means of the female Hansen
connectors SORIN GROUP ITALIA code 09028.
- 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
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
All connections downstream of the pump must be secured by means of
ties.
4
VENOUS LINE: Connect a venous line of 1/2" to the connector indicated on
the venous reservoir as "VENOUS RETURN" (fig. 2, ref. 13). The Venous
Return connector can be rotated 180° to find the most convenient position of
the venous tubing. This rotation is possible only after removing the
polycarbonate insert that fixes the connector.
Remove the plastic insert only after connecting the venous tubing to
the venous return connector.
ASPIRATION LINES: after removing protective caps from the "filtered" inlet
connectors on the top of the Cardiotomy Reservoir (four 1/4" / 6,35 mm
connectors, two 3/8" / 9.53 mm connectors), connect the aspiration lines and
rotate the turrets (fig. 2, ref. 6) towards the suction pumps.
ARTERIAL LINE: remove the red cap on the oxygenator arterial outlet
indicated as "ARTERIAL OUTLET" (fig. 2, ref. 5) and connect a 3/8" line.
PUMP LINE: the pump segment should be set up between the Venous
Reservoir outlet connector (fig. 2, ref. 7) and the oxygenator venous inlet
connector (fig. 2, ref. 4) taking account of the direction of rotation of the
pump. Remove yellow cap from the gas scavenging connector (fig. 2, ref. 22)
of the Cardiotomy Reservoir.
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 D903 AVANT VAVD 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.
If a connection is made to the coronary outlet port during bypass, the
line to be connected must be unclamped and unpressurised such that
blood will flow into it upon connection.
6) SAMPLING RAMP
The arterial/venous sampling ramp is supplied in a single sterility bag
integrated with about 1 m venous/arterial tubing lines.
ARTERIAL SAMPLING LINE: remove the protective cap from the luer
connector placed beside the arterial outlet (fig. 2, ref. 8). Connect the male
luer of the arterial sampling line of the ramp.
Male luers not supplied with SORIN GROUP ITALIA products may
damage the one-way valve placed inside the oxygenator arterial
sampling luer. When connecting, make a visual check that the male luer
does not reach as far as the one-way valve.
VENOUS SAMPLING LINE: remove the protective cap from the luer
connector placed beside the venous inlet (fig. 2, ref. 14). Connect the male
luer of the venous sampling line of the ramp.
7) CONNECT THE TEMPERATURE PROBES
The connection for the arterial temperature probe (red - fig. 2, ref. 9) is
positioned next to the arterial outlet, while the venous probe site (blue - fig. 2,
ref. 10) is at the side of the venous inlet.
SORIN GROUP ITALIA temperature probes have the code 09026.
8) CLOSE THE PURGING/RECIRCULATION LINE
Close the purging-recirculation stopcock (refer to the diagram on the label).
9) CONNECT THE GAS LINE
Remove the green cap from the gas inlet connector indicated as "GAS
INLET" (fig. 2, ref. 11) and connect the 1/4" gas line.
Ensure that the gas supply is from a suitable air/oxygen mixer such as the
Bird, code 09374 (available from SORIN GROUP ITALIA) or a system with
compatible technical features.
A capnograph connector can be found in the centre of "GAS ESCAPE" (fig.
2, ref. 12) connector.
- The "GAS ESCAPE" system is designed to avoid any possible risk of
blocking the gas outlet; such blockage could cause the immediate
passage of air to the blood compartment.
- SORIN GROUP ITALIA recommends the use of a bubble trap or filter
on the arterial line to reduce the risk of emboli transmission to the
patient.
10) VACUUM LINE CONNECTION
To connect the vacuum regulator to the device act as follows:
1) Connect the adapter supplied with the product (Fig. 2, Ref. 19) to the
Pos-lock "Vacuum Line Port" on the cardiotomy reservoir (Fig. 2, Ref.
18)
2) Remove the yellow protective cap from the adapter
GB - ENGLISH