Set Up - sorin ECMO Gebrauchsanweisung

specific concerns about residual risks. Further information is
available on request from Sorin Group Italia
Always administer and maintain a correct dose and accurate
monitoring of the anticoagulant before, during and after the
bypass.
The device must not undergo any further processing.
Do not resterilise.
After use, dispose of the device in accordance with
applicable regulations in force in the country of use.
Sterility is guaranteed only if the sterile packaging is not wet,
opened, damaged or broken. Do not use the device if sterility
cannot be guaranteed.
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.
Carry out a visual inspection and carefully check the device
before use. Transport and/or storage 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.
The instructions for use of individual components should be
read and understood also.
Carefully read and follow the instructions for use of the
manufacturer of the Heart Lung Machine (HLM) in use
regarding tubing specifications and installation.
Handle all tubing carefully to avoid damaging it.
The user is responsible for any changes made either to the
set or to the procedure that may affect the function of the set.
Carefully check for leaks before and during use. Leaks may
cause loss of sterility, loss of perfusate, or air emboli. Should
leakage be observed before or during use, re-tighten or
replace the leaking component following good perfusion
practice. The use of an arterial filter or bubble trap is
recommended to reduce the possibility of transmitting
gaseous emboli to the patient when used in accordance with
manufacturers instructions.
If the set contains a pre-bypass filter, it must not be exposed
to blood or other cellular fluids and must be removed before
initiating bypass.
The effectiveness of myocardial cooling may only be
ascertained by the measurement of myocardial temperature.
It is affected by variables such as, but not limited to: use and
degree of whole body hypothermia, cannulation and topical
cooling, surgical technique and cardiac anatomy and
pathology.
For further information and/or in case of complaint 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.
D. SET UP
When setting-up the tubing pack take care to avoid kinking,
cutting, piercing, puncturing of the tubing and other damage to
any individual component part of the device.
4
Tubing used as pump segment in roller pump applications
may get damaged or may lead to patient injury, if use is
prolonged or installation is improper.
The following factors have been found to influence tubing life in roller
pump applications:
Type of fluid being pumped/ transported.
-
Occlusion degree of tubing walls.
-
Pump speed (roller impacts/minute).
-
Downstream backpressure.
-
Temperature of transported fluid and operating theatre.
-
Wear due to friction of rollers and guides (also caused by
-
equipment improper maintenance or wearing).
Excessive length of tubing installed into pump raceway.
-
Wall thickness and wall thickness size tolerance.
-
If this set is to be used with a roller pump, then carefully set
up and monitor each of the foregoing variables during use of
the tubing and observe the following:
Inspect tubing for any damage, if none install in pump. Also
a)
monitor during use for any signs of excessive wear, cracks,
leaks or air entrainment and take appropriate action.
It is recommended that pump occlusion is adjusted as per the
b)
HLM manufacturer's instructions prior to each procedure.
Improper occlusion settings may cause pump segment tube
failure, excessive spallation, haemolysis and/or inaccurate
blood flow.
When placing tubing in a rollerpump, maintain the natural
c)
curvature of the tube and avoid twisting of the tube.
The roller pump should be maintained in accordance with the
d)
HLM manufacturer's recommendations in order to avoid
increased tubing wear and possible premature failure.
The correct size or adjustment of the tube clamps should be
e)
used to avoid damage to the tube and to hold it securely.
If the set contains a cooling coil use only salt-free water and
ice. Do not add alcohol. Reducing the ice bath temperature
below 0 C may cause cold-induced injury to the patient.
1. Remove the set from the package using aseptic technique.
2. When making any connections use aseptic technique.
3. Connect luer locks or fittings finger tight. Do not over
tighten, but make sure connection is secure.
4. Position stopcock handles as appropriate.
5. Connect the set as appropriate to oxygenator, heat
exchangers, filters and other components in accordance
with their instructions for use.
6. When making any connections, ensure component parts are
properly joined.
7. Ensure any one-way valves in the set are pointing in the
correct direction.
8. Prime the circuit in accordance with the instructions relating
to the oxygenator and any other components of the circuit.
9. Inspect to make sure that all parts to be primed are free of
air bubbles.
10. Inspect to make sure that there are no leaks.
11. Initiate cardiopulmonary bypass in accordance with
oxygenator instructions and good perfusion practice.
Select appropriate occlusion and RPM settings that will
achieve desired flow rate with the minimum stress to the
tubing.
Carefully re-set occlusion whenever the tubing is either
moved or changed in the pump raceway.
E DEVICE REPLACEMENT
A spare device must always be available during perfusion. After 6
GB - ENGLISH