Terminating Bypass; Oxygenator Replacement; Medical Devices For Use With The D905 Eos Ecmo; Return Of Used Products - dideco D905 EOS ECMO Instrucciones De Uso

- Always open the gas flow after the blood flow. The
gas/blood flow ratio must never exceed 2:1.
- The pressure in the blood compartment must always
exceed that of the gas compartment.
This is to prevent gas emboli appearing in the blood
compartment.
4) BLOOD GAS MONITORING
After a few minutes of bypass operation, measure gas content
of the blood. Depending on the values found, adjust the
relevant parameters as follows:
High pO 2 Decrease FiO 2
Low pO 2 Increase FiO 2
High pCO 2 Increase gas flow
Low pCO 2 Decrease gas flow
H. DURING BYPASS
– It is intended that systemic anticoagulation be utilized
while the pump is in use. Anticoagulation levels should
be determined and verified by the physician based on
risks and benefits to the patient and monitored
throughout the case.
2) LOW FLOW RECIRCULATION
(Hypothermia associated with circulatory arrest).
a) Reduce the gas flow to less than 500 ml/min.
b) Open the purging/recirculation line and clamp the venous
line.
c) Reduce the flow from the arterial pump to 1500 ml/min.
d) Clamp the oxygenator arterial line.
e) Recirculate at a maximum flow of 1500 ml/min. throughout
the patient's circulatory arrest.
f) To restart bypass after circulatory arrest, open the venous
and arterial lines and slowly increase the blood flow.
g) Close the recirculation line.
h) Adjust gas flow.
3) CONTINUOUS AIR PURGE
The purging/recirculation stopcock features the continuous
purge line diverting from the arterial line only a few mls/min
even at full arterial blood flow.
I. TERMINATING BYPASS
Must be carried out after consideration of each individual patient's
state. Act as follows:
1) Turn the gas flow off.
2) Turn the thermocirculator off.
3) Slowly decrease the arterial flow to zero while closing the venous
line.
4) Clamp the arterial line.
5) Open the purging/recircualtion line.
6) Increase pump flow until 1500 ml/min .
– If extracorporeal circulation has to be restarted subsequently,
a minimum blood flow inside the EOS ECMO must be
maintained (maximum 1500 ml/min).
– Verify that the circuit connected to the coronary outlet port is
properly clamped.
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J. OXYGENATOR REPLACEMENT
A spare oxygenator must always be available during perfusion. After
5 days of use with blood or if particular situations occur, which may
lead the person responsible for perfusion to determine that the safety
of the patient may be compromised (insufficient oxygenator
performance, leaks, abnormal blood parameters etc.), proceed as
follows for oxygenator replacement:
Use a sterile procedure during the entire replacement phase.
1) Turn the gas flow off.
2) Place two clamps on the oxygenator venous inlet line (at a 5 cm
distance).
3) Stop the arterial pump and place two clamps on the arterial line
(at a 5 cm distance) near the oxygenator.
4) Stop the water flow to the heat exchanger, clamp and remove the
water lines.
5) Remove the gas line and all the monitoring and sampling lines.
6) Cut the oxygenator venous inlet line and the arterial line in the
point between the two clamps.
7) Remove the D905 EOS ECMO to be substituted from the holder.
8) Place a new D905 EOS ECMO on the holder. Connect all lines
(i.e. venous line, arterial line, water lines ...).
During this phase the venous and arterial lines must be
clamped.
9) Remove the clamps from the water line and switch the
thermocirculator on. Check the sealing of the heat exchanger of
the new D905 EOS ECMO.
10) Prime the new D905 EOS ECMO and evacuate any air bubble,
following the priming and recirculation procedure.
11) Check the connections and seal them by means of ties.
12)Remove the clamps from the venous or arterial lines, close the
purging/recircualtion line and restart the by-pass procedure.
K. MEDICAL DEVICES FOR USE WITH THE
D905 EOS ECMO
An arterial/venous sampling system must also be used.
All tubing used to make the circuit connections must be of a diameter
which is compatible with the dimensions of the connectors on the
device (3/8",1/4").
Temperature controls must be carried out using SORIN GROUP
ITALIA probes, code 9026 or compatible to YSI Series 400.
Use Bird air/oxygen mixer (SORIN GROUP ITALIA code 9374) or a
system with compatible technical features.
Any heating/cooling system (thermocirculator) may be used, provided
that the connectors to the water distributor holder are of the Hansen
type (SORIN GROUP ITALIA code 9028).
Currently SORIN GROUP ITALIA is not aware of any
contraindications to the use of the device with occlusive or non-
occlusive peristaltic pumps or with centrifugal pumps. The use of
other types of pump must be agreed with SORIN GROUP ITALIA.
L. 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 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;
GB – ENGLISH – INSTRUCTIONS FOR USE