Preparation And Setup - sorin Synthesis Gebrauchsanweisung

failure (integrity, functionality and clinical effectiveness).
- The device must not undergo any further processing.
- Do not resterilize.
- After use, dispose 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 body contact,
the limited contact duration and the number of treatments per patient, the
amount of phthalates which might be released from the device do 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 water pressure in the heat exchanger must not exceed 2250 mmHg (300
kPa / 3 bar / 44 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.
- When using the SYNTHESIS venous reservoir as postoperative chest
drainage, carefully follow the instructions in paragraph M "USE FOR
CHEST DRAINAGE" in this user manual.
- Do not for any reason separate the gas module/heat exchanger/arterial filter
from the venous reservoir. Only perform this operation if the venous
reservoir is to be used as postoperative chest drainage and only when
extracorporeal circulation has been terminated.
- Do not separate the SYNTHESIS 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.
- When using the SYNTHESIS venous reservoir applying the method of
active venous drainage with vacuum, carefully follow the instructions in
paragraph L "USE OF ACTIVE VENOUS DRAINAGE WITH VACUUM" in this
user manual.
- The special positive and negative overpressure valve mounted on the
SYNTHESIS venous reservoir assures perfect postoperative functioning of
the system: it starts operating and releases positive pressures above 5
mmHg (0.7 kPa / 0.007 bar/0.1 psi) and negative pressures below –80 mmHg
(–10,4 kPa / -0.10 bar/-1,53 psi). Do not for any reason occlude the external
access hole of this valve.
- Arrange the surgical cannula in such a way that air is not aspirated into the
vein.
- SYNTHESIS may only be used with the appropriate HOLDER.
- Prevent that halogenated liquids such as halothane and fluothane come
into contact with the polycarbonate structure of device. This would cause
damage which would compromise the integrity and functionality of the
device.
- Always mount and maintain SYNTHESIS 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 HOLDER on the pump pole and fix it by means of the clamp found
behind the load-bearing "arch" (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
8
- 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.
Attach the slot in the venous reservoir to the top part of the holder.
Gently place the oxygenator module on the bottom arch of the holder and extend
the end until engaging it.
- 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:
the venous reservoir as "VENOUS RETURN" (Ref. 2 Fig.1).
The venous return connector can be rotated 360° in order to find the best position
for the venous line.
SUCTION LINES:
the top of the venous reservoir (four 1/4" / 6.35 mm inlets, two 3/8" / 9.53 mm inlets),
connect the ends of the suction tubes and rotate the turret (Ref. 8, Fig1) orienting
the filtered inlets towards the suction pumps.
ARTERIAL LINE:
on the oxygenator marked "ARTERIAL OUTLET" (Ref. 13, Fig.1) and connect a 3/8"
line.
PUMP LINE:
the venous reservoir (Ref. 5,Fig.1) and the venous inlet connector of the oxygenator
(Ref. 12, Fig.1) taking into account the direction of rotation of the pump.
Remove the yellow cap from the vent connector marked "VENT/VACUUM PORT"
(Ref. 7, Fig.1) of the venous reservoir.
- 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 (Ref. 16 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 FiO
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 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
If it is preferred to take samples from a more distant position, remove the A/V
sampling manifold (fig. 1, ref. 6) from its housing and attach it on the dedicated
holder. The tubing lines of the sampling system allow manifold positioning in a range
GB – ENGLISH
A 1/2" venous line can be attached to the connector marked on
After removing the protective caps from the "filtered" inlets on
Remove the red cap from the arterial outlet of the arterial filter
The pump segment must be mounted between the outlet connector of
according to the desired level of
2