Terminating Bypass; Blood Recovery After Bypass; Oxygenator Replacement; Return Of Used Products - dideco D 902 LiLLiPUt 2 Instrucciones Para El Uso

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) Open the recirculation line.
5) Clamp the arterial line.
6) Increase arterial blood flow to 200 ml/min.
CAUTION
- If extracorporeal circulation has to be restarted subsequently, a
minimum blood flow inside the LILLIPUT must be maintained
(maximum 200 ml/min).
- If the use of the haemofilter is necessary, refer to its specific
instructions for use.
WARNING
Versions with SOFT VENOUS RESERVOIR
In case of insufficient venous return flow the soft venous reservoir
might collapse. If this happens, consequent negative pressure
might cause gas extraction from the blood if the arterial pump is
not stopped immediately. To eliminate air from the soft venous
reservoir, proceed as follows:
1) Turn the gas flow off.
2) Turn the arterial pump off.
3) Clamp the arterial line.
4) Restore the required volume of liquid in the soft venous
reservoir (by releasing the soft venous reservoir squeezer or by
adding liquids).
5) Check for the absence of air bubbles in the soft venous reservoir.
6) Clamp the venous line.
7) Open the recirculation line and recirculate at a rate of
200 ml/min until complete air removal from the system.
8) Restart bypass by opening the arterial and venous lines.
9) Clamp the recirculation line.
Version with RIGID VENOUS RESERVOIR
Do not absolutely empty the rigid venous reservoir.
J. BLOOD RECOVERY AFTER BYPASS
1) Recover as much blood as possible from the venous line and
deliver it into the aorta by means of the arterial pump, as required
by the patient condition.
2) Once the venous reservoir is empty and the venous cannulae have
been removed:
a) Turn the arterial pump off.
b) Clamp the venous line, the arterial line and the recirculation line.
c) Close the "ON-OFF" manifold (position OFF).
Versions with SOFT and RIGID VENOUS RESERVOIR
d) Disconnect the male luer lock of the recirculation line from the
"ON-OFF" manifold.
e) Connect an additional recovery bag (500 ml) to the male luer
lock end of the recirculation line to empty the oxygenator and
the arterial line by gravity.
All versions
f) Open the recirculation line.
K. OXYGENATOR REPLACEMENT
A spare oxygenator must always be available during perfusion.
After 6 hours 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 fol-
lows for oxygenator replacement:
1) Turn the gas flow off.
2) Reduce arterial pump blood flow to 100 ml/min.
3) Empty the venous reservoir.
Versions with SOFT VENOUS RESERVOIR
4) Close, by means of a double clamp, the output line of the
cardiotomy and add appropriate liquids to the cardiotomy to prime
the new oxygenator.
All versions
5) Turn the thermocirculator off, clamp the water lines.
6) Disconnect the gas line.
7) Close the venous lines by means of a double clamp and stop the
arterial blood pump. Close:
- the arterial line by means of a double clamp (placed next to the
oxygenator outlet).
- the pump line by means of a double clamp (placed next to the
venous reserve outlet).
- the oxygenator venous inlet by means of a double clamp
(placed next to the oxygenator venous inlet).
8) Disconnect all monitoring lines.
9) Cut all connector tubes in the section between the two clamps,
leaving a sufficient length of tubing to allow re-connection.
10) Remove the water from the LILLIPUT holder (according to the
appropriate instructions for use) and disconnect the oxygenator.
11) Place a new oxygenator on the holder. Connect all lines (i.e.
venous to the venous reservoir, and, where applicable, the
cardiotomy to the soft venous reservoir, arterial and gas to the
oxygenator, pump line to venous reservoir and oxygenator) and
secure with ties.
12) Open the water lines on the holder, turn the thermocirculator on
and check the integrity of the new oxygenator.
13) Repeat all phases described in the priming and recirculation
procedure.
L. MEDICAL DEVICES FOR USE WITH THE D 902
LILLIPUT 2
Versions with SOFT VENOUS RESERVOIR
The device must be used in combination with a paediatric cardiotomy.
Version OXYGENATING MODULE only
The oxygenating system must be used in combination with:
- a venous reservoir functioning as a paediatric cardiotomy;
or
- a paediatric soft venous reservoir and paediatric cardiotomy.
The arterial/venous sampling system must also be used, taking care
to check at the time of arterial connection, that the male luer connec-
tor does not reach as far as the one-way valve placed inside the arte-
rial sampling luer in the oxygenator.
All versions
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. 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.
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 parameters considered critical by the user must be reported with
particular care and urgency. The following is the minimum informa-
tion 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.
5