Terminating Perfusion; Blood Recovery After Perfusion; Device Change-Out; Medical Devices For Use With Synergy - sorin SYNERGY Ph.I.S.I.O Gebrauchsanweisung

the dissolved blood gases.
Using a blood collecting bag in some particular and
-
uncommon conditions (high blood volume, bag almost
full, continuous shrinking and swelling of the bag) a
collapse of the filtering net with partial occlusion of the
outlet can occur. This may cause a momentary block of
flow from the outlet connector of the bag. In this case a
manual pulling of the bag and a manoeuvre to keep the
connector in a straight position is recommended.
2) VENOUS AND ARTERIAL SAMPLING
Use the stopcock manifold for venous and arterial sampling as
needed. Open the sample system to permit continuous flushing
with arterial blood. This eliminates the necessity of using a flush
syringe when drawing an arterial sample. Before taking a venous
sample, shut off the arterial side of the sampling system and
withdraw at least 10 ml from the centre stopcock.
Samples must be taken only when the pump is running
-
and there is blood flow through the SYNERGY. If not, the
pressure in the blood compartment may decrease,
resulting in the possible formation of air bubbles.
Venous sampling site is under negative pressure. Always
-
close stopcock before removing syringe.
Arterial sampling site is under pressure. Always insert a
-
syringe into the sampling site before opening the
stopcock.
3) ADMINISTRATION OF
MEDICATION/ADDITIVES
While on bypass add all small volume drugs to the venous blood
through the sample system to ensure thorough mixing.
Medication/additives must be injected into the device at
-
the inlet of the venous bubble trap in order to trap and
remove any air introduced into the SYNERGY during
medication/additive injection.
4) PURGING THE BUBBLE TRAP
The bubble trap must be visually checked periodically for the
presence of entrained air. If air is observed or detected by a
venous air sensor, manually purge the air from the bubble trap.
If air is detected, reduce the flow rate, isolate and resolve
-
the cause or source of the air (obstruction of venous inlet
line, venous cannula occlusion etc.), and purge the air
from the bubble trap as soon as possible.
I.

TERMINATING PERFUSION

It should be terminated depending on the conditions of each
individual patient. Act as follows:
1) Turn the gas flow off.
2) Slowly reduce the centrifugal pump speed while gradually
occluding the arterial line.
3) Open the recirculation/purge line to the recirculation position.
4) Occlude the venous line.
5) Verify a volume source is open to the device.
6) Recirculate as required at 1000 rpm maximum.
- Do not turn the thermocirculator off during the recirculation
phase.
- Verify that the cardioplegia circuit connected to the arterial
blood access port is properly occluded.
J. BLOOD RECOVERY AFTER
PERFUSION
If desired, maximum blood volume return to the patient may be
accomplished by using priming fluid in the priming bag when the blood
reaches minimum volume. Pump slowly through the device, delivering
blood from the device to the patient while simultaneously verifying that
the priming bag is not completely emptied.
K.

DEVICE CHANGE-OUT

A spare oxygenator/pump must always be available during perfusion.
After 6 hours of use with blood or if situations arise such that, on
judgment of the person responsible for perfusion, the safety
conditions for the patient are compromised (insufficient oxygenator
performance, leaks, anomalous blood parameters etc.), proceed as
follows to replace SYNERGY.
1) Stop the gas flow, turn off the heater/cooler, and occlude the water
lines.
2) Place two clamps on the arterial line (5 cm apart) near the
integrated filter, and immediately stop the centrifugal pump.
3) Place two clamps on the venous line (5 cm apart) near the inlet of
the venous bubble trap.
4) Disconnect the water lines, the gas line, the arterial and venous
sampling lines, the recirculation/purge line of the integrated arterial
filter and the purge line of the venous bubble trap.
5) Cut the arterial and venous lines between the clamps.
6) Remove the SYNERGY from the holder and disconnect the
centrifugal pump from the driver.
7) Prepare the SYNERGY unit to be used as replacement,
disconnecting the arterial and venous lines using aseptic
techniques in order to maintain device sterility.
8) Place the new SYNERGY on the holder and follow the above
described procedure to mount the device (Ref. § E 2). Connect the
pump driver after positioning the replacement SYNERGY properly.
Connect the water lines and check integrity of the heat exchanger
(Ref. § E 3 and E4).
9) Connect the arterial and the venous lines.
10) Reconnect the gas line, purge/recirculation lines of the integrated
arterial filter, the purge line of the venous bubble trap and the
arterial/venous sampling lines.
11) Make sure that the purge/recirculation stopcock handle is in the
recirculation position.
12) Prime the device per § F5 using the AV bypass loop.
13) Ensure that all the air is evacuated from the SYNERGY arterial
outlet. Close the purge/recirculation line.
14) When debubbling has been completed, remove the clamps and
resume use of the system.
L. MEDICAL DEVICES FOR USE WITH
SYNERGY
The centrifugal pump is intended for use only with Sorin Group
Deutschland Stöckert Centrifugal Pump Consoles. Refer to the console
operator's manual for console operating procedures.
The Sorin Group Deutschland Stöckert Electric Remote Clamp (ERC)
is intended for use only with Sorin Group Deutschland Stöckert
Centrifugal Pump Consoles. Refer to the ERC operator's manual for
ERC operating procedures.
SYNERGY Holder code 050531.
Stopcock holder
The circuit connections must be made with tubes of a diameter compatible
with the dimensions of the connectors located on the device (3/8", 1/4",
1/2").
Temperature control must be carried out with SORIN GROUP ITALIA
probes, code 050122 or YSI Series 400 compatible.
Use a Sechrist air/oxygen blender (Sorin Group Italia code 09046) or a
system with compatible technical features to control the blood gas
concentration.
Any heating/cooling system (thermocirculator) may be used, provided that
the connectors to the oxygenator are the Hansen type (Sorin Group Italia
code 09028).
Currently SORIN GROUP ITALIA is not aware of any contraindications to
use of the device with occlusive or non-occlusive pumps . The use of other
types of pumps must be agreed with SORIN GROUP ITALIA.
M.

RETURN OF USED PRODUCT

Should the user be dissatisfied with anything related to the quality of
the product, the product distributor or the authorized local SORIN
GROUP ITALIA representative should be notified.
All parameters considered critical by the user must be reported with
particular care and urgency. The following is the minimum
information that should be provided:
Detailed description of the event and, if pertinent, the
conditions of the patient;
Identification of the product involved;
Lot number of the product involved;
Availability of the product involved;
All the indications the user considers useful in order to
understand the origin of the elements of dissatisfaction.
Sorin Group Italia reserves the right to authorize, if necessary, recall
of the product involved in the notification for assessment. If the
product to be returned is contaminated, it must be treated, packed
and handled in conformity with the provisions of the legislation in
force in the country where the product was used.
It is the responsibility of the health care institution to adequately
prepare and identify the product for return shipment. Do not
return products that have been exposed to blood-borne
infectious diseases.
GB – ENGLISH 9