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

GB - ENGLISH - INSTRUCTIONS FOR USE

CATALOG NO. 050551 and 050552
DESCRIPTION
The Apex HP hollow-fiber membrane blood oxygenator with hardshell venous
®
reservoir is a modular blood oxygenation system. The system is comprised of two
components preconnected for ease of setup and use: the Apex
Membrane Oxygenator with Integral Heat Exchanger (hereafter called "oxygenator")
and the VVR4000i hardshell venous reservoir (hereafter called "venous reservoir").
The oxygenator and reservoir can be separated and mounted individually if desired.
The system has been sterilized by ethylene oxide gas and has nonpyrogenic fluid
pathways.
Blood contact surfaces of the APEX
SMARxT have been modified to improve blood compatibility, resulting in reduced
platelet adhesion on the coated surfaces.
The Venous Reservoir contains a sealed lid and integral vacuum/vent port and
pressure relief valve, permitting its use in cardiopulmonary bypass procedures
utilizing vacuum assisted venous drainage (VAVD).

INDICATIONS FOR USE

The Apex HP hollow-fiber membrane blood oxygenator with hardshell venous
®
reservoir (VVR 4000i) is intended to be used in surgical procedures requiring
extracorporeal gas exchange support and blood temperature control for periods of up
to 6 hours.
CONTRAINDICATIONS
Currently, Sorin Group Italia is not aware of any contraindications to the use of this
surface modified device.
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 that the purge/ recirculation valve is
closed prior to initiating bypass or reinstituting bypass, and remains closed at all
times while on bypass. If left open, compensate for the reduced flow to the
patient as a result of shunting.
4. The blood flow rate through the blood access port must be lower than the blood
flow rate from the arterial pump to prevent gas from being pulled across the
membrane and creating the potential for gas embolism.
5. Do not occlude the hole in the bottom heat exchanger cover as it is the outlet of
the heat exchanger safety channel which prevents contamination in the event of
a seal failure.
6. Do not use alcoholic priming solutions: such solutions could compromise
proper functioning of the oxygenator module.
7. Do not allow the pressure inside the oxygenator to exceed 750 mmHg (100
kPa).
8. Always open the gas flow after the blood flow. The gas/blood flow ratio must
never exceed 2:1.
GB – ENGLISH
HP Hollow Fiber
®
HP Ph.I.S.I.O./M, APEX HP Ph.I.S.I.O.
® ®
9. Do not ventilate the oxygenator while the arterial and venous lines to the
oxygenator are clamped. This could cause evaporation of priming solution
across the microporous membrane and result in air in the arterial line.
10. Do not use halogenated liquids such as Halothane and Fluothane, or solvents
such as alcohol, ether, acetone, etc., as contact may cause damage to the
device.
11. 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
performance.
12. Use of a locking tie is recommended on all tubing connections.
13. If a connection is made to the arterial blood access port during bypass, the line
to be connected must be unclamped and unpressurized such that blood will flow
into it upon connection.
14. If the blood access connector and a circuit have been connected to the arterial
blood access port, check priming of the connected line.
15. Do not apply a negative pressure at the arterial blood access outlet port. If the
pressure on the blood side of the membrane falls below the pressure on the gas
side of the membrane, air may be pulled across the membrane.
16. Keep dry. Store at room temperature.
17. Obstruction of the vent port may result in pressurization of the reservoir and
potentially gaseous bubbles passing air emboli to the patient and/or damage to
the device.
18. Do not allow the venous reservoir to become pressurized as this could obstruct
venous drainage, force air retrograde into the patient, or cause air to enter the
blood path of the oxygenator.
19. Do not allow any VAVD vapor trap to become completely filled during use. This
may allow fluid to enter the vacuum controller or may prevent the reservoir from
being vented to the atmosphere when no vacuum is applied.
20. The vent must be open at all times during operation of the reservoir or be
attached to a regulated vacuum source not exceeding –90 mmHg in procedures
utilizing vacuum assisted venous return.
21. Ensure that the cap on any unused port is airtight prior to initiating vacuum
assisted venous return.
22. The device must be used in accordance with the instructions for use provided in
this manual.
23. The device is intended to be used by professionally trained personnel.
24. Sorin Group Italia is not responsible for problems arising from inexperience or
improper use.
25. FRAGILE, handle with care.
26. The blood to be treated should contain anticoagulant. Always apply and
maintain a correct dose and accurately monitor the anticoagulant before, during
and after the bypass.
27. 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).
28. The device must not undergo any further processing.
29. Do not resterilize.
30. After use, dispose of the device in accordance with the applicable regulations in
force in the country of use.
31. 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.
32. Check the expiry date on the label attached. Do not use the device after the
date shown.
33. The device must be used immediately after opening the sterile packaging.
34. The device must be handled aseptically.
35. 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.
36. Handle all tubing carefully to avoid damaging it.
37. 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
38. For further information and/or in case of complaint contact SORIN GROUP
ITALIA or the authorised local representative.
PRECAUTIONS
1. To aid the prevention of gas or particulate embolization, Sorin Group Italia
GB – ENGLISH
reduced heat exchanger
7