Preparation And Setup - sorin SYNTHESIS M PH.I.S.I.O Gebrauchsanweisung

specific concerns about residual risks. Further information is available on
request at Sorin Group Italia.
-Position SYNTHESIS M Ph.I.S.I.O in such a way that the top part of the
oxygenating fibre is lower than the blood level of the venous reservoir. This
will prevent gas emboli from passing from the gas to the blood
compartment.
- 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 2250 mmHg (300
kPa/3 bar / 43.5 psi).
- The pressure in the blood compartment must always be maintained higher
than the pressure in the gas compartment to prevent the formation of gas
emboli in the blood compartment.
- Ensure that the flow of the main pump is always greater than that of the
cardioplegia or hemoconcentration pump. In any event, the flow of the
cardioplegia line must never exceed 1 l/min.
- Avoid occluding, even accidentally, the gas outlet: any overpressure in the
gas compartment may generate micro-emboli in the blood compartment.
- Check the patency of the gas circuit by circulating gas in the circuit. If the
gas circuit is occluded, replace the oxygenator.
- Arrange the surgical cannula in such a way that air is not aspirated into the
vein.
- SYNTHESIS M Ph.I.S.I.O may only be used with the appropriate SYNTHESIS
M HOLDER.
- Prevent that halogenated liquids such as halothane and fluothane come into
contact with the polycarbonate structure of SYNTHESIS M Ph.I.S.I.O. This
would cause damage which would compromise the integrity and
functionality of the device.
- Always mount and maintain SYNTHESIS M Ph.I.S.I.O at a level lower than the
patient.
- 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; 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. PREPARATION AND SET-UP
1) POSITIONING THE HOLDER
Position the SYNTHESIS HOLDER on the pump pole and fix it by means of the knob
clamp found at the upper end of the arm (Fig. 2).
2) FIXING THE OXYGENATOR ON THE HOLDER
- Do not use if the 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.
- In particular, turn the device upside down and verify the integrity of the four
fins connecting the arterial filter to the oxygenating module.
- 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 SYNTHESIS M Ph.I.S.I.O. onto the holder. Check that the word "OPEN" is
visible on the water connector locking system of the holder. Check that the notches
on the water connector locking system are aligned. Then fix the oxygenator onto the
holder, insert the Hansen connectors and push SYNTHESIS M Ph.I.S.I.O. down into
the holder and turn the locking lever to the "CLOSED" position.
Only when the locking lever shows "CLOSED" the oxygenator is correctly inserted in
the holder.
- Manually check that the arterial filter and the oxygenating module are stably
connected
3) PREPARING THE THERMOCIRCULATOR
Connect the water tubes coming from the thermocirculator to the oxygenator using
the Sorin Group Italia female Hansen connectors.
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- Using connectors different from those indicated may cause resistance inside
the circuit and reduce the efficiency of the heat exchanger.
- Do not obstruct the hole in the lower cover of the heat exchanger as it is the
outlet of the safety channel which helps prevent fluids from crossing from
one compartment to another.
4) CHECKING THE HEAT EXCHANGER
The device is checked by recirculating water in the exchanger for a few minutes. The
integrity of the structure is guaranteed if there are absolutely no water leaks from the
compartment or from the hole of the safety channel.
5) CONNECTING THE CIRCUIT
- All the connections downstream of the pump must be secured by means of
ties.
ARTERIAL LINE: Remove the red cap from the arterial outlet of the arterial filter on
the oxygenator marked "ARTERIAL OUTLET" (Ref. 1 in Fig. 1) and connect a 3/8"
line.
PUMP LINE: The pump segment must be mounted between the outlet connector of
the venous reservoir and the venous inlet connector of the oxygenator, marked
"VENOUS INLET" (Ref. 2 in Fig. 1), taking into account the direction of rotation of
the pump.
OXYGENATING MODULE PURGE/RECIRCULATION LINE: remove the protective
cap and connect the male Luer end (Ref. 9 in Fig.1) to the female Luer filtered inlet
of the cardiotomy.
- If oxygenated blood for blood cardioplegia needs to be used, remove the red
pos lock and connect the 1/4" blood line of the cardioplegia circuit to the
coronary outlet of SYNTHESIS M Ph.I.S.I.O. (Ref. 7 in Fig.1) by means of the
adaptor (provided with the product).
- Always make sure to select the suitable gas flow suggested in Sect. G point
3, adjusting the Fi0
clinician must always verify that the oxygenation level is appropriate for the
procedure requirements. The oxygen content in the blood flowing from the
coronary outlet line may be lower than that in the arterial line blood. If the
same level of oxygenation is required, cardioplegia blood should be drawn
from the Y-connector on the arterial line.
The coronary outlet is fitted with a safety valve which makes connection of the
adaptor possible without leakage or dripping during extracorporeal circulation.
- Connect the purge line fitted with a one-way valve to one of the connectors
of the reservoir.
If using the coronary outlet during bypass, the line to be connected must be
open and not under pressure so that the blood can flow into it.
6) SAMPLING STOPCOCK
The arterial/venous sampling system is supplied in a sterile bag (Ref. 6 in Fig. 1).
About 1 meter venous and arterial tubing lines are attached to a 3-stopcock
manifold. Remove the device from the packaging.
ARTERIAL SAMPLING LINE
Remove the protective cap from the Luer connector of the arterial sampling site,,
indicated as "SAMPLING SITE" on the recirculation/purge stopcock and located on
top of the arterial filter (Ref. 8 in Fig.1), beside the recirculation/purge line port.
Connect the red male Luer of the arterial sampling line to the arterial sampling site.
The Luer connector of the arterial sampling site does not include a one-way
valve. Check that there is a one-way valve in the sampling line to prevent
accidental air introduction into the arterial line.
VENOUS SAMPLING LINE
Remove the protective cap from the venous sampling site and connect the blue male
Luer end of the venous sampling line to the venous sampling Luer site on the
reservoir.
Check that all the Luer connections are secure. All the accessory lines
connected to the device must be connected tightly in order to prevent
accidental air introduction into the device or blood loss.
Attach the A/V sampling manifold on the dedicated holder or on the top of the
oxygenating module. Position the stopcock handles towards the access ports of the
manifold (A7V shunt position).
7) CONNECTING THE TEMPERATURE PROBE
The connection for the arterial temperature probe (Ref. 4 in Fig.1) is positioned near
the cardioplegia outlet.
Use Sorin Group Italia temperature probes (code 09026) or equivalent.
8) CONNECTING THE GAS LINE
Remove the green cap from the connector marked "GAS INLET" (Ref. 5 in Fig.1)
and connect the 1/4" gas line. The gas must be supplied through a suitable
air/oxygen mixer The connection for a capnograph is obtained on the central axis of
the "GAS ESCAPE" connector (Ref. 3 in Fig.1).
GB – ENGLISH
according to the desired level of oxygenation. The
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