sorin SYNTHESIS R Mode D'emploi page 7

- Do not exceed 4300 ml in the venous reservoir.
- The SYNTHESIS R blood level should possibly be kept under
control by means of a blood level detector.
- Check the anticoagulant level at regular intervals.
I. SUSPENDING BYPASS
1. Decrease the perfusion flow until the main pump stops.
2. Do not empty SYNTHESIS R and the lines connected to it. Keep a
minimum blood level (some dozens of ml) which will help resuming
bypass.
3. Clamp the venous and arterial lines. If the interruption lasts more
than 3 - 5 minutes, recirculate through the oxygenator and
SYNTHESIS R by opening the recirculation line.
J. REINITIATING BYPASS
1. Make sure that the circuit is debubbled.
2. Slowly reopen the venous and arterial lines and start the blood
pump only when the blood level corresponds to the minimum
operational level.
3. Perform perfusion using a suitable technique. Refer to the
paragraphs "INITIATING BYPASS", "DURING BYPASS" and
"SUSPENDING BYPASS" in this user's manual.
4. In case of problems or for further clarification, contact Sorin Group
Italia or one of its authorized representatives.
K. TERMINATING BYPASS
1. Gradually clamp the venous line and simultaneously decrease the
blood flow until the main pump stops completely.
2. Clamp the arterial line.
L. BLOOD RECOVERY AFTER BYPASS
1. Recover all the blood contained in the venous line, draining it into
the SYNTHESIS R venous reservoir once the surgeon has
removed the cannulae from the patient's vena cava.
2. Perfuse as much as possible from the venous reservoir through the
aortic cannula but do not drop below a level of 50 ml.
3. Arrange to recover the residual blood in a "transfer" bag. Collected
blood can be immediately reinfused or appropriately stored and
then reinfused.
M. USE OF ACTIVE VENOUS DRAINAGE WITH
VACUUM
This method may be applied at any time during extracorporeal
circulation, provided that the instructions below are followed. Using
the kit - code ID096834 or equivalent supplied separately - and a
vacuum regulation device, SYNTHESIS R can be used with active
venous drainage with vacuum. This technique constitutes an
alternative to venous drainage by gravity and allows the use of
shorter venous tubes with reduced diameter, as well as smaller-
gauged cannulas.
1. Open the kit for active venous drainage with vacuum, operating in
such a way that sterility of the system is not compromised.
2. Connect the end with the blue cap to the vent connector of the
venous reservoir (Rif. 10 in Fig.1) fitted with an overflow safety
valve and the end with the red cap to the vacuum regulating
device. The latter must be connected to the line vacuum.
3. Close the clamp and the green cap on the line connected to the
reservoir.
4. If necessary to interrupt or suspend this method, remove the yellow
cap and open the clamp on the line.
- It is advisable not to exceed –50 mmHg (-6.66kPa/-0.07bar/-0.97
Psi) negative pressure applied to the reservoir.
- Periodically check functioning of the vacuum regulating device
and the degree of vacuum.
N. USE FOR POSTOPERATIVE CHEST DRAINAGE
By means of the line sets/drainage kits, the SYNTHESIS R venous
reservoir can be transformed into a device for chest drainage for patients in
intensive care. The function performed by the resulting device is active and
calibrated suction of the blood spilt from surgical wounds into the chest and
its possible retransfusion.
These kits correspond to the specific needs of each single client and are
designed for aseptic conversion of the reservoirs, microfiltered recovery and
possible reinfusion of blood recovered in the first hours of use.
CONTRAINDICATIONS
Do not use the drainage and autotransfusion kit in the following cases:
- When protamine has been administered during surgery before the venous
reservoir has been removed from the extracorporeal circuit.
- When there is a mediastinal, pericardic, pulmonary or systemic infection.
- When there is the certainty or suspicion of large contaminations, tumours,
intestinal perforations, or lymphatic loss.
- If the patient undergoes another operation.
- Before use ensure that the SYNTHESIS R venous reservoir has not
been polluted as a result of handling which has compromised
sterility.
- The SYNTHESIS R venous reservoir can function as chest drainage
activated by the line vacuum.
- The sterility of the system depends on the degree of asepsis
resulting from use of the venous reservoir and the care taken in
connecting the kit during the conversion to chest drainage.
- Prepare the vacuum regulating device with integrated valve for use,
following the instructions of the manufacturer provided with the
device.
- Should negative pressure be applied to the system such that the
overpressure valve intervenes, the recovered blood will no longer
be suitable for transfusion since contaminated.
- Periodically check functioning of the vacuum regulating device.
- If the recovered blood exceeds the amount established by
postoperative routine, immediately notify the physician in charge.
- If the recovered blood is to be re-infused, an increase in vacuum will
be noted in the reservoir. A filtered venting system must therefore
be arranged in order to restore the original negative operating
pressure.
- Using suitable tests, check the degree of "pollution" of the blood
collected related to the time of use of the drainage system. The
results of these tests must be taken into account for blood
transfusion.
- The recovered blood must be re-transfused with a suitable
volumetric infusion pump or with the syringe and three-way
stopcock technique used manually as an alternative to the pump.
- To prevent air from entering the vein of the patient, ensure that the
infusion pump has an efficient stopping system in the event of air in
the line; likewise, be careful not to aspirate air during re-transfusion
with syringe.
- If the reservoir used does not have an integrated microfilter, fit the
re-infusion line with a 25-40 micron blood filter.
USE WITH A VACUUM SOURCE
Immediately after intraoperative use of the SYNTHESIS R reservoir,
convert it to chest drainage using the line sets/chest drainage kits, and
operate in such a way as not to compromise sterility of the system
to obtain the best out of the system, set up the operational routine in such a
way that the priming fluid of the extracorporeal circuit generously wets the
filter of the SYNTHESIS R reservoir to the maximum possible level; do not
for any reason transfer to the reservoir blood that has not been suitably
uncoagulated.
1. Clamp all the openings.
2. Set up the device for connection to the patient and to a possible vacuum
source fitted with a safety valve and suitable pressure regulator.
3. Position the SYNTHESIS R venous reservoir suitably close to the patient
and in any case at a level lower than the patient: for this purpose use the
RESERVOIR HOLDER securing it to the bed frame
4. After making the appropriate connections to the patient, connect to the
vacuum line, taking care to place a vacuum regulator and a safety valve
between the vacuum line and the SYNTHESIS R reservoir. These two
devices must be extremely reliable and accurate
5. Adjust the desired degree of negative pressure.
6. Ensure that the safety valve functions properly.
7. Start the drainage procedure and periodically check that the system
functions regularly.
- Use of the SYNTHESIS R venous reservoir as chest drainage is the
responsibility of the intensive care staff.
- Its preparation is the joint responsibility of the person performing
perfusion and the intensive care staff.
- Its connection to the patient is the responsibility of the attending
surgeon.
- Use by untrained and unqualified personnel is not permitted.
- All the connections to the Sorin reservoir should be carried out with
the utmost care and rapidity in order to prevent contamination.
- The connections and the caps should be checked to assure that the
system is tight.
- Always keep the device in a vertical position: do not incline it, not
even when the patient is being moved.
- The SYNTHESIS R reservoir must always be placed at a subthoracic
level so that its drainage functions can properly be performed.
- Activate the line vacuum following the instructions provided by the
manufacturer of the vacuum regulator.
- It is advisable not to exceed –50 mmHg (-6.66kPa/-0.07bar/-
0.97Psi) negative pressure applied to the reservoir.
- Periodically check functioning of the vacuum regulating device
and the degree of vacuum.
- Any re-infusion of recovered blood is on the responsibility and at
the discretion of the attending physician.
- The recovered blood may become contaminated and hence not
be suitable for retransfusion: performing the appropriate tests
GB – ENGLISH
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In order
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