Preparation And Setup - sorin Synthesis C Gebrauchsanweisung

- 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.
- 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
- The water temperature at the heat exchanger inlet must not exceed 42 °C
(108 °F).
- The maximum operating pressure of the collapsible venous reservoir must
never exceed 84.75 mmHg (11.3 kPa /0.11 bar/1.6 psi)
- 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.
- Do not separate the SYNTHESIS C Ph.I.S.I.O modules in order to place the
gas module at a level or position different from its original configuration at
the time of opening the sterile package.
- Arrange the surgical cannula in such a way that air is not aspirated into the
vein.
- SYNTHESIS C Ph.I.S.I.O may only be used with the appropriate SYNTHESIS
HOLDER.
- Prevent that halogenated liquids such as halothane and fluothane come
into contact with the polycarbonate structure of the device. This would
cause damage which would compromise the integrity and functionality of
the device.
- Always mount and maintain SYNTHESIS C 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 SETUP
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.
HOLDER WITHOUT BAG SQUEEZER (FIG.2)
6
Fix the SYNTHESIS C Ph.I.S.I.O. oxygenator onto the holder. Check that the water
connector locking lever is in the "OPEN" position. Make sure that the water
connectors of the oxygenator are aligned with the Hansen connectors of the holder.
Insert the oxygenator Hansen connectors and push SYNTHESIS C Ph.I.S.I.O. down
into the holder.
Turn the locking lever to the "CLOSED" position.
Only when the locking lever shows "CLOSED" the oxygenator is correctly inserted in
the holder.
HOLDER WITH BAG SQUEEZER (FIG.3)
Lift the bag squeezer handle positioned in the upper part of the holder in order to
release the bag squeezer plate.
Turn up the bag squeezer plate or remove it completely.
Fix the SYNTHESIS C Ph.I.S.I.O. oxygenator onto the holder. Check that the water
connector locking lever is in the "OPEN" position. Make sure that the water
connectors of the oxygenator are aligned with the Hansen connectors of the holder.
Insert the oxygenator Hansen connectors and push SYNTHESIS C Ph.I.S.I.O. down
into the holder.
Check that the SYNTHESIS C Ph.I.S.I.O. closed reservoir is correctly aligned with
the bag squeezer.
Turn the locking lever to the "CLOSED" position.
Turn the bag squeezer plate back to its original closed position and carefully push
down the handle in order to insert it in the bag squeezer slots.
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.
- 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.
VENOUS LINE: A 1/2" venous line can be attached to the connector marked on the
collapsible venous reservoir as "VENOUS RETURN" (Ref. 1 Fig.1).
A cardiotomy reservoir must be connected to the special 3/8" connector located on
the rear of the SYNTHESIS C Ph.I.S.I.O collapsible venous reservoir.
ARTERIAL LINE: Remove the red cap from the arterial outlet of the arterial filter on
the oxygenator marked "ARTERIAL OUTLET" (Ref. 7 Fig.1) and connect a 3/8" line.
PUMP LINE: The pump segment must be mounted between the outlet connector of
the venous reservoir (Ref.3 in Fig.1) and the venous inlet connector of the
oxygenator (Ref.6 in Fig.1) taking into account the direction of rotation of the pump.
- 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 C Ph.I.S.I.O 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 Fi02 according to the desired level of oxygenation. The
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 cardiotomy 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
GB – ENGLISH