Blood Recovery After Bypass; Oxygenator Replacement; Medical Devices For Use With The D901 Dideco Lilliput; Return Of Used Products - dideco D901 LiLLiPUT Mode D'emploi

(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, pro-
ceed 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.
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).
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.
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 oxy-
genator performance, leaks, abnormal blood parameters etc.), pro-
ceed as follows for oxygenator replacement:
1) Turn the gas flow off.
2) Reduce arterial pump blood flow to 100 ml/min.
3) Empty the 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.
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).
- Place a double clamp 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 reconnection.
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 D901 DIDECO
LILLIPUT
Versions with SOFT VENOUS RESERVOIR
The device must be used in combination with a paediatric cardio-
tomy.
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 con-
nector does not reach as far as the one-way valve placed inside the
arterial sampling luer in the oxygenator.
All versions
All tubing used to make the circuit connections must be of a diame-
ter which is compatible with the dimensions of the connectors on
the device (3/16" or 1/4").
Temperature controls must be carried out using SORIN GROUP ITA-
LIA probes, code 9026 or compatible to YSI Series 400.
Use Sechrist air/oxygen mixer (SORIN GROUP ITALIA code 9046)
or a system with compatible technical features.
Any heating/cooling system (thermocirculator) may be used, provi-
ded 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 contraindica-
tions to the use of the device with occlusive or non-occlusive peri-
staltic 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 under-
stand 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 legi-
slation in force in the country where the product
CAUTION
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 good authorisation (RGA) number is required from Sorin
Group USA cardiovascular Inc. prior to shipping .
If the product has been in contact with blood or blood fluids, it must
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