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Manually verify that the arterial filter and oxygenating
-
module are stably connected.
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 in the lower cover on the heat
-
exchanger as it is the outlet of the safety channel which
helps prevent fluids from 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 2250 mmHg (300 kPa / 3 bar / 44 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. In case of leaks discard the unit.
5) DEVICE SET-UP AND CONNECTIONS
a. Once the SYNERGY has been positioned in the holder and
the centrifugal pump driver is put in place, complete the
setup of the remaining extracorporeal circuit components.
b. Verify that the 3/8" (9.5 mm) venous line is connected to the
venous inlet port located on the SYNERGY bubble trap
(ref.1, fig.1).
c. Verify that the 3/8" (9.5 mm) arterial line is connected to the
arterial filter outlet port (ref.7, fig.1). Connect the centrifugal
pump flow probe to circuit where desired.
d. Connect the venous purge line provided with the product to
the purge Luer connector at the top of the venous bubble
trap (ref.2, fig.2). Verify that a means to aspirate air from the
bubble trap purge line (e.g., roller pump) is available during
prime and device use.
e. Verify that the arterial recirculation/purge line is connected to
the recirculation/purge Luer of the arterial filter.
f.
Place the venous bubble sensor assigned to the Electric
Remote Clamp on the tubing line between the SYNERGY
Bubble Trap Outlet and Centrifugal Pump Inlet.
If oxygenated blood for blood cardioplegia needs to be
-
used, remove the red pos lock and connect the 1/4" (6.4
mm) blood line of the cardioplegia circuit to the arterial
blood access port of SYNERGY by means of the adaptor
(provided with the product).
The blood cardioplegia outlet is fitted with a safety valve that
makes connection of the adaptor possible without leakage or
dripping during extracorporeal circulation.
If using the blood cardioplegia outlet during bypass, the
-
blood line connected to the port must be open and not
under pressure in order for fluid to flow into the tubing
line.
6) SAMPLING SYSTEM
a. Mount the sampling stopcock manifold on the dedicated
holder. Verify that the stopcock handles are in the "Off"
position.
b. Connect the arterial sampling line to the Luer next to the
recirculation/purge Luer at the top of the arterial filter.
The arterial sampling site connector Luer does not
-
include a one-way valve. Verify that there is a one-way
valve in the sampling line to prevent accidental air
introduction into the arterial line.
c. Connect the venous sampling line to a venous Luer port.
Check the security of all Luer connections. The venous
-
side of the SYNERGY including the venous inlet line,
bubble trap and tubing line up to the inlet connector of the
centrifugal pump, is under negative pressure. All
accessory lines connected to the venous inlet line of the
SYNERGY must be connected tightly in order to prevent
accidental introduction of air into the negative pressure
side of the device.
7) TEMPERATURE
MONITORING
a. Connect the arterial temperature probe to the arterial
temperature probe fitting (ref.14, fig.1), and connect the
venous temperature probe to a venous temperature probe
fitting.
b. To measure the oxygenator inlet pressure, connect a
pressure measurement line to the venous Luer close to the
heat exchanger inlet.
c. To measure oxygenator outlet pressure, connect a pressure
measurement line to the Luer port close to the arterial blood
access port.
d. To measure venous inlet pressure in the venous inlet line,
attach a pressure measurement line to a venous Luer port.
8) VENTILATING GAS SUPPLY
Connect the 1/4" (6.4 mm) gas supply line to the gas inlet
of the oxygenator.
The "gas escape" system was designed to prevent any
-
potential risk of occlusion of the gas outlet; such
occlusion would cause immediate passage of air to the
blood compartment.
Do not for any reason occlude the external access holes
-
of the gas compartment (ref. 4).
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
9) VAPOROUS ANAESTHETICS
If vaporous anaesthetics are used, some method of scavenging
this gas should be considered. An integral 3/8" (9.5 mm) gas
scavenging fitting is available for this purpose. It is located in the
centre of the gas escape system. Connect a piece of 3/8 x 3/32"
(9.5 x 2.4 mm) tubing to this fitting and to a negative pressure
source with a flow rate in excess of the ventilating gas flow rate.
The only volatile anaesthetics suitable for this use are
-
isofluorane and sevolfuorane.
The methods adopted for vaporous anaesthetic gas
-
scavenging should not in any way increase or reduce the
pressure level at the oxygenator fibres.
F.
PRIMING AND RECIRCULATION
PROCEDURE
- Do not use alcohol-based priming solutions as they can
compromise the structural integrity and functionality of the
device.
1) CHECK THE HEAT EXCHANGER
Circulate water through the heat exchanger prior to priming the
oxygenator. Check the water system for leaks, proper water
temperature range, and adequate water flow. If a water to blood
leak exists, water will collect in the tubing connected to the
oxygenator inlet/centrifugal pump outlet port or drip from the hole
in the bottom of the oxygenator module indicating the device
must not be used. The maximum pressure rating of the heat
exchanger is 2275 mmHg (300 kPa/ 44psi).
2) KEEP THE GAS FLOW CLOSED
3) VERIFY
RECIRCULATION/PURGE LINE STOPCOCK
IS OPEN
4) OCCLUDING THE VENOUS AND ARTERIAL
LINES
5) CIRCUIT PRIMING
The pressure level inside the blood compartment of the
-
oxygenating module may not exceed 750 mmHg (100kPa /
1 bar / 14 psi).
In order to maintain positive hydrostatic pressure during
-
the priming and recirculation phase, keep the priming bag
GB – ENGLISH
AND
PRESSURE
THAT
THE
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