Terminating Perfusion; Blood Recovery After Perfusion; Device Change-Out; Medical Devices For Use With Synthesis Mph.i.s.i.o - sorin SYNTHESIS M PH.I.S.I.O Gebrauchsanweisung

5) LOW-FLOW RECIRCULATION
(hypothermia associated with circulatory arrest).
a) Reduce the gas flow to a value below 500 ml/min. and reduce FiO
not exceeding 30%. This is to prevent reaching high non-physiological pO
values.
b) Open the recirculation/purge line and occlude the venous reservoir inlet line.
c) Reduce the arterial pump speed to a value of 1000 ml/min.
d) Occlude the arterial line of the oxygenator module (Ref. 1 in Fig.!).
e) Recirculate at a flow of 1000 ml/min. for the entire duration of the circulatory
arrest.
f) To re-enter into bypass from the circulatory arrest, open the venous and arterial
lines and slowly increase the blood flow.
g) Set the recirculation/purge line to the automatic purging position.
h) Align the gas flow and FiO depending on the needs of the patient.
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- During the venous reservoir emptying phase at particularly low levels and/or
reduced flows greater care must be taken.
- If during a particularly long ECC, condensation forms in the gas outlet with a
corresponding drop of pO and an increase of pCO
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oxygenator could be improved by a short but substantial increase in the gas
flow. For example, "washing" of 10 sec. with a gas flow of 2 l/min could be
sufficient. Should this not prove effective, do not repeat washing, but
replace the oxygenator.
I.

TERMINATING PERFUSION

It should be terminated depending on the conditions of each individual patient. Act
as follows:
1. Close the gas flow;
2. Turn the thermocirculator off;
3. Slowly reduce the arterial pump speed to zero and at the same time gradually
occlude the venous line;
4. Open the recirculation/purge line to the recirculation position;
5. Occlude the arterial line;
6. Increase the pump speed up to a flow not exceeding 1000 ml/min.
- If extracorporeal circulation has to be restored, maintain a minimum blood
flow inside the oxygenator (maximum 2000 ml/min).
- Do not turn the thermocirculator off during the recirculation phase.
- Check that the cardioplegia circuit connected to the coronary outlet is
properly occluded.
- Check that the port is clamped.
J.

BLOOD RECOVERY AFTER PERFUSION

1. Recover all the blood contained in the venous line into the venous reservoir as
soon as the surgeon has removed the cannulae from the vena cava of the patient.
2. Open the arterial line, perfuse the amount required according to the condition of
the patient through the aortic cannula, slowly reducing the level in the venous
reservoir.
3. When the venous reservoir is almost empty, stop the arterial pump and occlude
the arterial line.
4. To recover the blood in the gas/heat exchanger/integrated filter module, connect
the recirculation line to a soft bag. Clamp the arterial line and activate the pump
until complete recovery of the residual blood. The recovered blood can be used
immediately, administering it intravenously, or can be used later provided that it is
suitably stored.
K.

DEVICE CHANGE-OUT

A spare oxygenator must always be available during perfusion. After 6 hours of use
with blood or if situations arise such that, on judgement of the person responsible for
perfusion, the safety of the patient is compromised (insufficient oxygenator
performance, leaks, anomalous blood parameters etc.), proceed as follows to
replace the oxygenator.
- Use a sterile technique throughout the replacement procedure.
1. Close the gas flow and place a clamp on the venous return.
2. Stop the arterial pump and place two clamps on the arterial line (5 cm apart)
near the integrated filter.
3. Place two clamps on the venous line (5 cm apart) in proximity of the heat
exchanger.
4. Turn off the thermocirculator, occlude and remove the water lines.
5. Remove the gas line and all the arterial sampling and recirculation/purge lines,
disconnecting them from the reservoir.
6. Cut the arterial and venous lines between the two clamps.
- In this phase, keep the venous and arterial lines occluded.
7. Remove the oxygenator from the holder.
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to a value
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the performance of the
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GB – ENGLISH
8. Mount the new oxygenator, connect the water lines and check the integrity of
the heat exchanger. Connect the venous and arterial lines, then remove the
venous clamp.
9. Connect the recirculation/purge and sampling lines.
10. Ensure that the stopcock is in the recirculation position.
11. Connect the gas line and adjust the FiO
integrity of the device.
12. Incline the arterial connector of the new oxygenator slightly downward before
mounting it on the holder.
13. With the arterial line clamped, recirculate through the recirculation/purge line to
remove the air from the connector and the filter.
- To facilitate the replacement procedure, it is recommended to use a circuit
with an arterial/venous shunt which, occluded during normal use, during
replacement of the oxygenator allows purging the air from the arterial line
towards the reservoir.
14. Circulate at a flow of 500-600 cc/min. priming the oxygenator.
15. When priming has been completed, remove the arterial and venous return
clamps and start ECC.
16. Position the recirculation/purge stopcock in the automatic purging position for 4-
5 minutes, and then close it if necessary.
17. The blood contained in the replaced oxygenator can be recovered by
connecting the arterial outlet to a connector of the reservoir and opening the
recirculation/purge stopcock.
L. MEDICAL DEVICES FOR USE WITH SYNTHESIS M
PH.I.S.I.O
- The user should observe the warnings and cautions and follow the
instruction for use accompanying the separate device.
The device must be used in combination with an adult collapsible venous reservoir
and an auxiliary cardiotomy reservoir of not less than 2 l: in this case the
oxygenator-venous reservoir system is said to be closed.
The device must be used in combination with a venous reservoir with a capacity of
not less than 2 l: in this case the oxygenator-venous reservoir is said to be open.
SYNTHESIS HOLDER (code 050350)
Stopcock holder (code 050134).
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).
SORIN GROUP ITALIA is currently not aware of any contraindications to the 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 PRODUCTS
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 the 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.
ONLY for US customers
If for any reason the product must be returned to the manufacturer, a returned goods
authorisation (RGA) number is required from Sorin Group USA Inc. prior to shipping.
If the product has been in contact with blood or blood fluids, it must be thoroughly
cleaned and disinfected before packing. It should be shipped in either the original
carton or an equivalent carton to prevent damage during shipment, and it should be
properly labelled with an RGA number and an indication of the biohazardous nature
of the content in the shipment.
to not more than 40% and check the
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