Use Of Cardiotomy For Post-Operative Autotransfusion; Oxygenator Replacement; Medical Devices For Use With The Compactflo Evolution; Return Of Used Products - dideco COMPACTFLO EVOLUTION Mode D'emploi

1. Open the packaging of 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, marked "VENT/VACUUM PORT" (fig. 2, ref. 7),
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 considered necessary to interrupt or suspend this method,
remove the yellow cap and open the clamp on the line.
WARNING
- It is advisable not to exceed -80 mmHg (10.4kPa / 0.10bar)
negative pressure applied to the reservoir.
- Periodically check functioning of the vacuum regulating device
and the degree of vacuum.
L. USE OF CARDIOTOMY RESERVOIR FOR POST-
OPERATIVE AUTOTRANSFUSION
If the use of the Cardiotomy Reservoir for post-operative
autotransfusion is envisaged, act as follows:
1. Disconnect the purging/recirculation line.
2. Separate the venous reservoir from the oxygenating module by
removing the white hook.
3. Locate the venous reservoir on the "Post Operative Chest
DrainageHolder code 05039" and use one of the following
optional kits referring to their respective instructions for use:
- D 540 AUTOTRANSFUSION CONVERSION KIT code 05053.
M. 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 follows for oxygenator replacement.
CAUTION
Use sterile methods during all replacement procedure.
1) Turn the gas flow off.
2) Close, by means of a double clamp, the venous line (5
centimetres apart).
3) Turn the arterial pump off and close, by means of a double
clamp, the arterial line (5 centimetres apart) placed next to the
oxygenator.
4) Turn the thermocirculator off, clamp and remove the water lines.
5) Disconnect the gas line, all monitoring and sampling lines.
6) Cut the venous return and the arterial lines in the section
between the two clamps, leaving a sufficient length of tubing to
allow re-connection.
7) Remove the COMPACTFLO EVOLUTION from the holder and
remove the pump segment from the arterial pump.
8) Place a new COMPACTFLO EVOLUTION on the holder.
Connect all lines (i.e. venous to the Venous Reservoir, arterial
and gas to the oxygenator, pump line to Venous Reservoir and
oxygenator).
WARNING
In this phase, keep the venous and arterial lines clamped.
9) Open the water lines on the holder, turn the thermocirculator on
and check the integrity of the new COMPACTFLO EVOLUTION.
10) Fill the cardiotomy reservoir of the new COMPACTFLO
EVOLUTION with priming solution through the 1/4" or 3/8"
quick prime connectors located on the head of the venous
reservoir.
11) Prime the new COMPACTFLO EVOLUTION and evacuate the
microbubbles, as described in the priming and recirculation
procedure.
12) Verify all connections and secure with ties.
13) Remove clamps from the venous and the arterial line, close the
purging/recirculation line and start the bypass again.
14) The blood remaining in the replaced Venous Reservoir may be
recovered by connecting its outlet port to one of the 3/8" inlet
connectors of the new reservoir.
15) The blood contained in the oxygenator and heat exchanger may
be poured into the new Venous Reservoir by connecting the
arterial line to one of the 3/8" inlet connectors of the new reser-
voir.
N. MEDICAL DEVICES FOR USE WITH THE COMPACTFLO
EVOLUTION
For post-operative autotransfusion with the Venous Reservoir one
of the two following kits should be used:
- D 540 AUTOTRANSFUSION CONVERSION KIT code 05053.
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", 1/2").
Temperature controls must be carried out using SORIN GROUP ITA-
LIA probes, code 09026 compatible to YSI Series 400.
Use Sechrist air/oxygen mixer (SORIN GROUP ITALIA code 09046)
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 09028).
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.
O. 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, pac-
ked and handled in conformity with the provisions of the legislation
in force in the country where the product was used.
CAUTION
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
be thoroughly cleaned and disinfected before packing. It should be
shipped in either the original carton or an equivalent carton to pre-
vent damage during shipment, and it should be properly labelled
with an RGA number and an indication of the biohazardous nature
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