Preparation And Set-Up; Priming Procedure; Perfusion - SORIN GROUP CSC 14 Mode D'emploi

and disinfected at the end of use. Therefore, reuse on
other patients might
infection and sepsis. In addition, reuse increases the
probability of product failure (integrity, functionality
and clinical effectiveness).
- The device must not undergo any further processing.
- Do not resterilize.
- After use, dispose of the device in accordance with the
applicable regulations in force in the country of use.
- The maximum pressure in the blood compartment must
not exceed 107 KPa (1.07 bar/15.5 Psi).
- The water pressure in the heat exchanger must not
exceed 214 KPa (2.14 bar/31 Psi).
- The water temperature must not exceed 42°C (107.6°F).
- CSC14 and its accessories must be handled using
sterile techniques.
- CSC14 can only be used with an appropriate HSC
holder (fig.2).
- Make sure that the main pump flow always exceeds
that of the cardioplegia pump.
The device contains phthalates. Considering the nature
-
of body contact, the limited contact duration and the
number of treatments per patient, the amount of
phthalates which might be released from the device do
not raise specific concerns about residual risks. Further
information is available on request from Sorin Group
Italia.
- Only use the device if it is STERILE.
- For further information and/or in case of complaints
contact SORIN GROUP ITALIA or the authorised local
representative.
- Federal law (U.S.A.) restricts this device to sale by or
on the order of a physician.
E. PREPARATION AND SET-UP
Do not use if the sterile packaging is damaged,
-
unsealed, or has been exposed to moisture or other
conditions that would compromise the sterility of the
device.
- Check the expiry date on the label attached. Do not
use the device after the date shown.
- The device must be used immediately after opening
the sterile packaging.
- The device must be handled aseptically.
- CSC14 must be used immediately upon opening the
sterile package.
1. Remove the unit from its external packaging but only
remove it from the sterile wrapper just before use. CSC14
sterility is now only maintained by the protective
connector caps.
- Carry out a visual inspection and carefully check the
device before use.
conditions other than those prescribed may have
caused damage to the device.
- Do not use solvents such as alcohol, ether, acetone,
etc. as contact may cause damage to the device.
- Do not allow halogenated liquids such as Halothane
and Fluothane to come into contact with the
polycarbonate housing of the device. This could
cause damage which may compromise the integrity
and proper functioning of the device.
2. To set up the CSC14 unit, place it in the HSC holder
(fig.2). The HSC holder makes it possible to conveniently
position CSC14 for freedom of access and circuit
orientation. HSC allows CSC14 to be positioned either
on the left- or the right-hand side of the pump.
3. Connect the water tubes to CSC14 by means of the
8
cause cross-contamination,
Transport and/or storage
female Hansen connectors (Sorin Group Italia code
09028)
- Using connectors different from those indicated may
cause resistance inside the circuit and reduce the
efficiency of the heat exchanger.
- Check the heat exchanger by circulating water inside
the device for a few minutes. There should be no leaks
from the water compartment. In case of leaks discard
the unit.
- During recirculation, the water should never exceed a
pressure of 214 kPa (2.14 bar/31 Psi).
4. Connect the ¼" inlet and outlet connectors to the
extracorporeal circuit lines. Remove the caps relative to
this operation one by one as the connections are made.
All the tubes should be secured with nylon ties.
5. Attach the male Luer end of the purge line stopcock
(Fig.1, ref.7) to the CSC14 bubble trap Luer connector
(Fig. 1, ref. 5). The purge line is supplied with a one-way
valve to prevent retrograde flow into CSC14.
6. Connect the other end of the purge line to an unfiltered
Luer connection of the venous/cardiotomy reservoir.
- All the connections downstream of the pump must be
secured by means of ties
F. PRIMING PROCEDURE
1. Make sure that the priming dial is in "PRIME" position and
that the purge line is open.
2. Clamp the CSC14 outlet line and actuate the perfusion
pump at low flow (30-40 ml/min).
3. Let all the air escape from the CSC14 heat exchanger, then
turn the priming dial to the "PERFUSION" position
simultaneously closing the purging stopcock and removing
the clamp from the outlet line. Fill the table line and tap it if
necessary.
4. Stop the main pump and clamp the outlet line.
5. Insert the Sorin Group Italia temperature probe code 09026
(YSI 400 compatible) into the CSC14 temperature probe
site.
- The maximum pressure in the blood compartment must
not exceed 107 KPa (1.07 bar/15.5 Psi).
G. PERFUSION
- Before using CSC14 make sure that it is properly
debubbled. Should it not be debubbled, open the purge
line and clear the device of air by running 100-150
ml/min solution through it and tap it if necessary. Close
the purge line and let fluid flow through the table line.
Tap it until the latter is debubbled. Stop the pump flow
and clamp the CSC14 outlet line. Always leave the
prime dial in "PERFUSION" position. Operate the dial
only if CSC14 is emptied; in this case repeat the
PRIMING PROCEDURE described in paragraph F.
- Make sure that the main pump flow always exceeds that
of the cardioplegia pump
- Check that all the Luer connections are secure. All the
accessory lines connected to the device must be
connected tightly.
1. Let water circulate and make sure it is at the desired
temperature.
2. Remove the clamp from the CSC14 outlet line and
operate the cardioplegia pump to achieve the desired
flow.
3. Check the perfusate temperature and pressure.
4. Once the perfusion dose is complete clamp the CSC14
outlet line and stop the cardioplegia pump.
Repeat the above steps every time infusion is required and
CSC14 is actively used.
GB - ENGLISH