Gb - English - Instructions For Use; Indications For Use - sorin APEX HP M Instrucciones De Uso

GB – ENGLISH

GB - ENGLISH - INSTRUCTIONS FOR USE

CATALOG NO. 050550
DESCRIPTION
®
The Apex HP M is a hollow-fiber membrane oxygenator with integral
heat exchanger (hereafter called "oxygenator"). Used in 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 compatibility, resulting in reduced platelet
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.
This 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 in the bottom heat exchanger cover as
they are the outlet of the safety channel which prevents
contamination in the event of a seal failure.
5. Do not use alcoholic priming solutions: such solutions could
compromise 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.
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HP M Ph.I.S.I.O. have been
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GB – ENGLISH
8. Do not ventilate the oxygenator while the arterial and venous
lines to the oxygenator are clamped. This could cause
evaporation of priming
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.
12. If the blood access connector and a circuit have been connected
to the arterial blood access port, check 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 functioning of the device.
15. The heat exchanger has a preferential flow direction. Connect the
water OUTLET line of the thermocirculator to the water INLET
port of the heat exchanger (indicated by an arrow label and a
removable tab). Improper connection of the water lines will result
in reduced heat exchanger performance.
16. Keep dry. Store at room temperature.
17: The device must be used in accordance with the instructions for
use provided in this manual.
18. The device is intended to be used by professionally trained
personnel.
19. Sorin Group Italia is not responsible for problems arising from
inexperience or improper use.
20. FRAGILE, handle with care.
21. The blood to be treated should contain anticoaugulant. Always
apply and maintain a correct dose and accurately monitor the
anticoagulant before, during and after the bypass.
22. 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, reuse increases the probability of product
failure (integrity, functionality and clinical effectiveness).
23. The device must not undergo any further processing.
24. Do not resterilize.
25. After use, dispose of the device in accordance with the applicable
regulations in force in the country of use.
26. 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.
27. Check the expiry date on the label attached. Do not use the
device after the date shown.
28. The device must be used immediately after opening the sterile
packaging.
29. The device must be handled aseptically.
30. 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.
31. Handle all tubing carefully to avoid damaging it.
32. 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 specific concerns about
residual risks. Further information is available on request from
Sorin Group Italia
33. For further information and/or in case of complaint contact SORIN
GROUP ITALIA or the authorised local representative
solution across the microporous
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