Method Of Operation - Terumo CAPIOX FX 25 Serie Instrucciones De Uso

PRECAUTIONS
Include information regarding any special care to be exercised by the practitioner
for the safe and effective use of the device.
PRECAUTIONS
• Read all the instructions of the drugs and the medical devices to be used in
combination with this device prior to use.
• This device should only be used by properly trained and qualified personnel.
• This device is sterile and non-pyrogenic in the unopened, undamaged package.
Inspect the device and package carefully. Do not use if the package and/or device is
damaged, or if caps are not in place.
• Dispose of safely after single use to avoid risk of infection.
• This product has been sterilized by ethylene oxide gas.
• For single use only. Do not reuse. Do not resterilize. Do not reprocess. Reprocessing
may compromise the sterility, biocompatibility and functional integrity of the device.
• In case of the need to replace the oxygenator, make sure that there is a spare
oxygenator available.
• Use aseptic technique in all procedures.
• Perform priming using crystalloid solution which contains no blood, plasma and/or
blood derived products.
• This device should be used with an appropriate holder supplied by TERUMO.
• Place CAPIOX FX25 Oxygenator module downstream from the blood pump.
• Thermistor probes can be used with a temperature monitor from Measurement
Specialties Inc. by use of the cables supplied.
• Temperature of water delivered to heat exchanger should not exceed 42°C (108°F),
otherwise blood damage may result.
• A minimum of 0.5 L/min oxygen gas flow is needed when blood is circulated. Less than
0.5 L/min oxygen gas flow may result in inadequate gas exchange.
• Stop the gas flow when circulation is suspended. During recirculation, check blood
gas pressure. Excessive gas flow may cause low PaCO
• Upon patient rewarming, adjust O concentration, gas flow rate and blood flow rate by
2
increasing them as needed based on an increase in patients metabolism. Failure to
adjust the gas supply and the blood flow rate appropriately may cause insufficient O
supply needed or the amount of the patient's gaseous metabolism.
• Use of a pre-bypass filter is recommended to trap any particulate matter in the circuitry
and priming solution.
• The Sampling Line is detachable. If the line is detached and not in use, please make
sure to cap the end.
• Use of a recirculation line is recommended in the arterial line after the FX oxygenator to
facilitate gaseous emboli removal during priming and emergency situations.
• It is recommended to use an air bubble detector between the reservoir outlet and FX
oxygenator inlet. In the event gaseous emboli are detected, determine the source
and take corrective action to eliminate further introduction of gaseous emboli into the
perfusion circuit.
• Ensure the oxygenator is never subjected to a negative pressure. Negative pressure
in the oxygenator can cause gaseous emboli to enter the blood phase from the gas
phase.

METHOD OF OPERATION

Read WARNINGS (page 6) and PRECAUTIONS (page 7) before use. The following is a
basic description of the use of the CAPIOX FX25 Oxygenator and Hardshell Reservoir.
a. SET-UP
1. Remove CAPIOX FX25 from package and examine it for defects.
CAUTION Do not use if the package or device is damaged (e.g. cracked) or any
of the port caps are off.
2. Place CAPIOX FX25 in its holder.
a. CAPIOX FX25 Oxygenator with Hardshell Reservoir:
Set the holder at the appropriate height to prevent the arterial line and the
blood cardioplegia line from kinking.
Making sure that the connecting ring is in place, set oxygenator in its holder
(Code No.: XX*CXH18R, 801804 or 801139) with lever up, then push the lever
down (See Fig. 1). If the oxygenator is not set into the holder correctly, the
amount of fluid in the reservoir cannot be correctly assessed.
When rotating the oxygenator module, be sure to hold the support arm. If the
oxygenator module is rotated while holding the oxygenator body, it could be
damaged (See Fig. 2).
Use CAPIOX FX25 Oxygenator with Hardshell Reservoir taking note of the additional
precautions below.
• Use the safety devices, including the level sensor and the air detector, in order to
control the volume of the blood in the reservoir and to detect gaseous emboli in the
arterial lines.
• When rotating the venous blood inlet port on the header of Hardshell Reservoir, make
sure that venous line and thermistor probe cable do not come into contact with any
solution or administration line connected to the Hardshell Reservoir to prevent it from
kinking.
• When separating Hardshell Reservoir from oxygenator module, hold the oxygenator
firmly and remove connecting ring.
• The caps of unused ports should be left in place. This avoids contamination and
prevents leakage of blood.
• Make sure the caps of unused luer ports are tightened firmly to prevent the leakage.
• The cardiotomy filter must be moistened in advance with the priming solution. If not
moistened then this could compromise the effectiveness of the filter and the ability to
use it up to the maximum blood flow rate.
• Where appropriate, introduce blood, plasma and/or blood derived products through
quick prime port or any of the luer ports leading to cardiotomy filter after de-airing
of oxygenator.
• Do not exceed the maximum operating volume of 4000 mL in the reservoir. This device
is designed to be used with the volume of blood in the reservoir below 4000 mL.
• Avoid introduction of hemostatic agents into the Cardiotomy Reservoir/Oxygenator.
Hemostatic agents are known to generate thrombi which may compromise
performance of the Reservoir/Oxygenator.
• If blood entering the Cardiotomy Reservoir filter inlet appears to spill over versus
entering the filter this may indicate that the filter is clogged. Discontinue using the
, alkalosis, or blood damage.
2
Cardiotomy Reservoir filter. Replace the reservoir.
• Regularly check all tubing connections and ports for looseness or leakage.
• Scientific literature contains reports of altered dose response to some medications,
2
such as nitroglycerin, fentanyl, etc., possibly due to varying degrees of absorption by
synthetic materials such as those found in extracorporeal circuits. Avoid injection of
medications into the Cardiotomy Reservoir filter.
• For a low dose of drug administration, do not inject from luer ports leading to the
cardiotomy filter. If drug is injected inside the cardiotomy filter, it could stagnate in
the filter.
• Avoid exposure to water, direct sunlight, extreme temperature, or high humidity during
storage.
Rx ONLY
Fig. 1
XX*CXH18R
801804 (Long Arm version)
801139 (Short Arm version)
CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the
order of a physician.
Holder
lever
Guide hole for
holder
Fig. 2
Connecting
ring
Support
arm
Oxygenator
7