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INTENDED USE AND INDICATIONS FOR USE
TRILLY PAEDIATRIC AF is intended for use in
extracorporeal
perfusion
cardiopulmonary bypass in cardiac surgery to
oxygenate and remove carbon dioxide from the
blood and regulate the blood temperature.
TRILLY PAEDIATRIC AF, being integrated with
arterial filter, enables filtration of arterial blood
with removal of microemboli and microaggregates
larger than 38 µm.
TRILLY PAEDIATRIC AF is equipped of a hard-shell
cardiotomy/venous reservoir intended to collect,
store and filter venous and cardiotomy suctioned
blood during cardiopulmonary bypass procedure.
The hard-shell cardiotomy/venous reservoir is also
intended for use during vacuum-assisted venous
drainage (VAVD) procedures.
The blood to be treated should contain anticoagulant.
TRILLY PAEDIATRIC AF is a PAEDIATRIC oxygenator.
TRILLY PAEDIATRIC AF should not be used for
more than 6 hours. Contact with blood for longer
periods is not advised.
TRILLY PAEDIATRIC AF should be used in
combination with the medical devices listed in
section "MEDICAL DEVICES FOR USE WITH TRILLY
PAEDIATRIC AF".
CONTRAINDICATIONS
Do not use the device for any purpose other than
indicated.
Do not use if air leaks are observed during priming
or operation, this may result in air embolism to the
patient and/or fluid/blood loss.
RISKS AND SIDE EFFECTS
The possible risks and side effects of the TRILLY
PAEDIATRIC AF include:
• haemolysis,
• adverse blood / tissues reaction,
• coagulation/complement activation, platelet
dysfunction,
• thrombosis,
• gaseous embolism,
• thromboembolism,
• blood loss,
• haemodilution,
• infection.
SAFETY INFORMATION
Information to draw the user's attention to
potentially dangerous situations and to ensure
circuit
during
correct and safe use of the device is indicated in the
text as follows:
WARNING
Indicates serious adverse reactions and potential
safety hazards for the practitioner and/or the
patient, which may occur during proper use or
misuse of the device and also the limitations of use
and the measures to be adopted in such cases.
CAUTION
Indicates that the user must take every possibly
precaution for safe and effective use of the device.
The following is general safety information for the
operator preparing to use the device. Specific safety
information is also given in the instructions for
use where this information is relevant for correct
operation.
WARNINGS
•
Carefully read the instructions before use.
• Store in a dry place between 0°C (32°F) and
40°C (104°F).
• FRAGILE, handle with care.
• Single-use device. Do not reuse. Do not clean or
resterilize the device for subsequent reuse.
• Improper reuse may cause transfusion
reactions, cross-infection and alteration of
device performance.
• For use by professionally trained personnel
only.
• The device must be used in accordance with
these instructions. EUROSETS cannot be
held responsible for damage deriving from
inexperience or improper use.
• Carefully check the device seal during priming
and operation. Any leakage may give rise to loss
of sterility, blood leakage, gaseous embolism. If
you notice leakage during priming or operation,
replace the defective device following good
perfusion practices.
• During use, a spare TRILLY PAEDIATRIC AF
oxygenator must always be available.
• The connection lines must be correctly
connected in order to prevent any potential
tube constriction or occlusion which may lead
to reduced blood and/or water and/or gas flow.
• Before
the
cardiopulmonary
administer to the patient an adequate dosage
of anticoagulant, and adjust dosage through
bypass,
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