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GB - ENGLISH - INSTRUCTION FOR USE
CATALOG NO. 050261000 and 050261700
DESCRIPTION
®
The Apex
is a hollow fiber membrane oxygenator with integral
heat
exchanger
(hereafter
conjunction with other ancillary equipment and disposable
products, this device will satisfy the patient's gas exchange and
body temperature regulation requirements.
The product has been sterilized by ethylene oxide gas and has
nonpyrogenic fluid pathways.
. The blood contact surfaces of the Apex
modified to improve blood comaptibility, resulting in reduced platlet
adhesion on the treated surface.
INDICATIONS FOR USE
The oxygenator is intended to be used in adult surgical procedures
requiring extracorporeal gas exchange support and blood
temperature control for periods of up to 6 hours.
CONTRAINDICATIONS
There are no known contraindications for this product.
Currently, Sorin Group Italia is not aware of any contraindications
to the use of this surface modified device (Apex
WARNINGS
1.
Do not allow the pressure on the blood side of the membrane
to fall below the pressure on the gas side of the membrane.
Due to the inertia of fluid flowing in a low resistance circuit
during priming and recirculation, rapidly reducing the blood
pump flow rate may cause the blood side pressure to fall
below the gas side pressure and draw air into the blood
pathway. Therefore, do not pulse, surge, or rapidly decrease
flow during priming and recirculation. These acts may cause
air to be pulled across the membrane and form bubbles in the
blood pathway. The result may be inadequate priming of the
oxygenator and potential infusion of bubbles into the patient,
which may cause an air embolus. Do not ventilate the
oxygenator at flows in excess of 6 lpm until blood products
are added to the circuit. Excess gas flows increase the
potential for air to pass across the membrane.
2.
Do not use additives or disinfectants, such as bleach, in the
heater/cooler water when the oxygenator is connected to the
heater/cooler. These substances may rapidly corrode the
heat exchanger material resulting in a water-to-blood leak and
potential infection and/or damage to the blood. If additives or
disinfectants are used in the heater/cooler system at other
times, ensure that this water system is thoroughly rinsed prior
to connection to an oxygenator.
3.
To prevent uncontrolled shunting of blood from the patient,
ensure that the purge/recirculation line is primed and clamped
prior to initiating bypass or reinstituting bypass, and remains
clamped at all times while on bypass. If left open,
compensate for the reduced flow to the patient as a result of
shunting.
4.
Do not occlude the holes on the heat exchanger bottom cover
as they are the outlet of the safety channel which prevents
contamination in the event of a seal failure.
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GB – ENGLISH
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5.
Do not use alcoholic priming solutions: such solutions could
compromise the proper functioning of the oxygenator module.
6.
Do not allow the pressure inside the oxygenator to exceed
750 mmHg (100 kPa).
7.
Always open the gas flow after the blood flow. The gas/blood
flow ratio must never exceed 2:1.
8.
Do not ventilate the oxygenator while the arterial and venous
lines to the oxygenator are clamped. This could cause
evaporation of prime solution across the microporous
membrane and result in air in the arterial line.
9.
Do not use solvents such as alcohol, ether, acetone, etc.: as
contact may cause damage to the device.
10. Use of a locking tie is recommended on all tubing
connections.
11. If a connection is made to the arterial blood access outlet port
during bypass, the line to be connected must be unclamped
and unpressurized such that blood will flow into it upon
connection.
Used
in
12. If the blood access connector and a circuit have been
connected to the arterial blood access port, check the priming
of the connected line.
13. Do not create a negative pressure at the arterial blood access
port. Negative pressure in the blood compartment could
cause microbubble formation.
14. 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 and may
compromise the integrity and proper function of the device.
15. Keep dry. Store at room temperature.
16: The device must be used in accordance with the instructions
for use provided in this manual.
17. The device is intended to be used by professionally trained
personnel.
18. Sorin Group Italia is not responsible for problems arising from
inexperience or improper use.
19. FRAGILE, handle with care.
20. The blood to be treated should contain anticoaugulant Always
apply and maintain a correct dose and accurate monitoring of
the anticoagulant before, during and after the bypass.
21. For single use and for single-patient use only. During use the
device is in contact with human blood, body fluids, liquids or
gases for the purpose of eventual infusion, administration or
introduction into the body, and due to its specific design it
cannot be fully cleaned and disinfected after use. Therefore,
reuse on other patients might cause cross-contamination,
infection and sepsis. In addition, the reuse increases the
probability of product failure (integrity, functionality and
clinical effectiveness).
22. The device must not undergo any further processing.
23. Do not resterilise.
24. After use, dispose of the device in accordance with applicable
regulations in force in the country of use.
25. 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.
26. Check the expiry date on the label attached. Do not use the
device after the date shown.
27. The device must be used immediately after opening the
sterile packaging.
28. The device must be handled aseptically.
29. 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.
30.
Handle all tubing carefully to avoid damaging it.
31. The device contains phthalates. Considering the nature of
contact with the body, the limited duration of contact and the
number of treatments per patient, the amount of phthalates
which might be released from the device does not raise
GB – ENGLISH
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