Starting Perfusion; During Perfusion - sorin SYNERGY Ph.I.S.I.O Gebrauchsanweisung

above the SYNERGY.
It is recommended to use a pre-bypass filter to capture
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any particles that may be present in the circuit or in the
priming solution.
a. While not required, flushing the circuit with carbon dioxide
gas will aid in priming.
b. Prepare to prime with the appropriate amount of priming
solution.
c. Open the venous line attached to the inlet of the SYNERGY
bubble trap and slowly allow priming solution into the
SYNERGY.
d. Allow the priming solution to prime the pump, heat
exchanger, oxygenator and arterial filter.
e. Verify that the connection tube between the venous bubble
trap and the inlet connector of the pump is completely primed
and debubbled.
f. Prime bubble trap purge line and purge air from bubble trap
as needed.
g. Activate centrifugal pump to recirculate priming solution
through recirculation/purge line of the arterial filter.
During this phase with the recirculation/purge line open
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and the arterial line clamped, never exceed a pump rate of
1000 rpm.
h. Remove the clamp from the arterial line, increase the flow
rate and recirculate the priming fluid through the A/V loop in
order to prime and debubble the circuit.
i. Set the pump flow rate to 6 l/min. Continue to recirculate for
3-5 minutes. While recirculating, check the system for air
bubbles and tap the entire circuit to facilitate the removal of
air. Purge any air accumulating at the bubble trap top by
aspirating from the purge line.
j. Ensure that the sampling manifold system is primed. The
sample system will prime itself during recirculation when the
stopcocks are positioned to allow flow through the sample
lines and manifold. The handles point to the off position.
Flow through the sample system should be stopped when
there is not flow in the bypass circuit.
k. Ensure that all other parts of the circuit are primed, de-aired
and appropriately clamped as needed.
l. Once the circuit and device are primed, stop the centrifugal
pump and clamp the arterial and venous lines. Close the
recirculation/purge stopcock.
m. Prior to bypass, clamp the arterial and venous lines, then
pass the clamped lines to the surgeon for connection to the
respective cannulae.
Always apply and maintain a correct dose and accurate
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monitoring of the anticoagulant before, during and after
the bypass.
During recirculation, ensure a volume source is open to
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the circuit. Do not purge using the bubble trap purge line
unless a volume source is open to the device. Air will be
drawn across the membrane and into the device if the
SYNERGY is not open to a volume source.
If the cardioplegia circuit has been connected to the
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arterial blood access port, check that the circuit has been
primed.
If tubing lines used for pressure measurement are
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connected, check that the lines have been primed.
Occlude the arterial outlet line with a clamp some
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centimetres away from the outlet port.
Do not apply negative pressure to the arterial blood
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access port. Negative pressure in the blood compartment
may cause gas microemboli formation.
G.

STARTING PERFUSION

1) INITIATING FLOW
Start the centrifugal pump.
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Do not operate the pump for extended periods of time if
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the arterial outlet to the patient is clamped and the
purge/recirculation stopcock is closed at the same time.
The temperature inside the pump may increase,
increasing the risk of cellular damage.
Do not remove the arterial outlet clamp at the beginning of
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8
extracorporeal circulation until an adequate outlet
pressure has been reached in order to prevent backflow.
The pump must be operated to provide a pressure higher
than the patient systemic pressure and the circuit head
pressure. Monitor the pump flow rate, its rpm and the
systemic pressure as indices of potential backflow.
Carefully monitor for signs of occlusion throughout the
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circuit, paying particular attention to the venous line and
centrifugal pump inlet.
Do not remove the arterial outlet clamp at the beginning of
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extracorporeal circulation until an adequate outlet
pressure has been reached in order to prevent backflow.
The pump must be operated to provide a pressure higher
than the patient systemic pressure and the circuit head
pressure. Monitor the pump flow rate, its rpm and the
systemic pressure as indices of potential backflow.
2) STARTING PERFUSION
Control the flow rate by adjusting the pump speed.
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Attempting to adjust the blood flow rate by partial
clamping of the device outlet may augment the risk of
cellular damage.
When stopping circulation, clamp the device outlet and
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stop pump rotation immediately, or reduce the pump
speed to less than 1000 rpm if the arterial filter
recirculation line is open.
Remove clamp from venous line, remove clamp from arterial line,
and initiate bypass according to given standard clinical
procedure.
3) ESTABLISH GAS FLOW
Always open the gas flow after the blood flow. The
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gas/blood flow ratio must never exceed 2:1.
4) MANAGING THE VENOUS BUBBLE TRAP
As described in Paragraph A (Description), the SYNERGY
system is equipped with a venous bubble trap. The bubble trap is
fitted with a purge line that is manually controlled by the user
using a roller pump or other means suitable for removing the air
from the bubble trap. Carefully check for air in the bubble trap,
which must be evacuated by aspirating it via the purge line.
During circulation, the venous bubble trap is under
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negative pressure. Any air accumulating at the bubble
trap top can be removed only by aspirating it via the
purge line. A one-way safety valve is provided in the
purge line in order to prevent air from flowing back into
the system from the purge line.
5) FUNCTIONING OF HEAT EXCHANGER
Check the temperature of the arterial blood to verify the heat
exchanger is working.
6) MANAGING THE ARTERIAL FILTER
Evacuate air, if necessary, by positioning the recirculation/purge
stopcock in the purge position. Close the stopcock when purge is
finished.
7) BLOOD GAS ANALYSIS
After initiation of bypass, the blood gas parameters should be
checked via venous and arterial sampling. After sampling,
always move the stopcock back into the "closed" position.
Venous sampling site is under negative pressure. Always
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close stopcock before removing syringe.
Arterial sampling site is under pressure. Always insert a
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syringe into the sampling site before opening the
stopcock.
H.

DURING PERFUSION

1) CHECKING THE VENOUS DRAINAGE
The venous drainage is a function of the flow rate of the
centrifugal pump and is directly controlled via the centrifugal
pump.
If it is necessary to administer anticoagulant to the
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patient,
MEDICATION/ADDITIVES".
The difference between water and blood temperature in
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the heat exchanger should not exceed 15°C. Higher
values may result in the formation of microbubbles from
GB – ENGLISH
refer to § 3 "ADMINISTRATION OF