Terumo CAPIOX Gebrauchsanweisung Seite 2

INSTRUCTIONS FOR USE
Read all warnings, cautions, and instructions carefully prior to use.
DESCRIPTION OF PRODUCT
The CAPIOX CARDIOPLEGIA is a heat exchanger device comprised of stainless steel pipes
within a clear plastic housing and designed to cool or warm oxygenated blood, cardioplegic
solution, or their mixture. Blood and/or cardioplegic solution flow(s) inside the stainless steel pipes
while water flows outside the pipes. The housing incorporates a thermistor probe for monitoring
fluid temperature and an air-trapping chamber with a filter screen, an air vent port, and a pressure
monitoring port.
INDICATION FOR USE
The CAPIOX CARDIOPLEGIA is intended to cool or warm oxygenated blood, cardioplegic
solution, or their mixture for a period up to 6 hours.
WARNINGS
Describes serious adverse reactions and potential safety hazards, limitations in use imposed by
them, and steps that should be taken if they occur.
WARNINGS
• Water pressure at the water inlet should not exceed 2 ATM (29 PSI or 203 kPa); otherwise, the
device may be damaged and/or leak.
• When used in conjunction with a membrane oxygenator, to avoid introducing air into the arterial
circuit:
− Do not start the cardioplegia pump until the extracorporeal pump is on.
− Do not stop the extracorporeal pump until the cardioplegia pump is off.
− Extracorporeal pump flow rate must always exceed cardioplegia pump flow rate.
• Cardioplegic solution bags should not be allowed to become empty to avoid introducing air into
the device. Air introduced into the device may result in air embolism to the patient.
• Always observe the device for leaks at connections of components during priming and operation.
Do not use the device if any leaks are detected. Leakage may cause air embolism and/or
solution loss.
• The device must be checked for air bubbles whenever delivery temperature is changed from cold
to warm as degassing of the fluid may occur.
• Do not use solvents such as alcohol, ether, cyclohexanone, etc. as they may cause damage if
used in or on the device.
• Adequate heparinization of the blood is required in order to prevent it from clotting in the device.
• Pressure at the solution inlet should not exceed 500 mmHg (67 kPa), otherwise the device may
be damaged and/or leak.
PRECAUTIONS
Includes information regarding any special care to be exercised by the practitioner for the safe and
effective use of the device.
PRECAUTIONS
• This device should only be used by properly trained and qualified personnel.
• This device is intended for single use only. DO NOT RESTERILIZE OR REUSE.
• 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 are/is damaged, or if
caps are not in place.
• Use immediately after opening the unit packaging.
• Dispose of safely after single use to avoid the risk of infection.
• Use aseptic technique in all procedures.
• Water temperature delivered to the device should not exceed 42°C (108°F), otherwise blood
damage may result.
• It is recommended that a cold agglutinin test be performed with the patient's blood before using
the device. If cold agglutinin is detected, the temperature of oxygenated blood and/or
cardioplegic solution should not be lowered below the cold agglutinin temperature.
• The concentration of cardioplegic solution additives should be adjusted to achieve its final,
desired concentration in the blood and cardioplegic solution.
ENGLISH
• Always have an extra set of the device ready for emergency replacement.
• The
device
(Code: XX*XH081).
• Connect the water lines to the water in/outlet ports properly as indicated on the housing.
• Do not remove the thermistor on the blood outlet port. Twist the thermistor and all luer caps that
are not being used firmly to prevent leakage.
CAUTION:
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
PRECAUTION FOR STORAGE
Do not store at extreme temperature and humidity. Avoid direct sunlight.
METHOD OF OPERATION
A. SET-UP
CAUTIONS:
•
Use aseptic technique to connect tubing to the device.
•
Band all tubing connections.
1. Install the appropriate holder provided by TERUMO onto a pole.
2. Remove the CAPIOX CARDIOPLEGIA from its package and inspect it for defects.
CAUTION:
Do not use if the package and/or device are/is damaged, or if the caps are off.
3. Attach the device vertically to the holder with the air-trapping chamber upward.
4. Connect the water lines tightly to the appropriate water in/outlet ports of the device and
circulate water for at least five (5) minutes. Inspect the device for water leaks.
WARNING:
If any leaks are detected, replace the device with another one.
5. Connect 1/4" (6.4 mm) tubing to the blood inlet port and 3/16" (4.8 mm) tubing to the blood
outlet port. Attach a three-way stopcock to the air vent port and connect it to any available luer
port on a vented cardiotomy reservoir with appropriate purge line tubing. Open the three-way
stopcock to atmospheric pressure.
CAUTIONS:
• It is recommended
300 – 500 mmHg) be inserted in the purge line connecting the air vent port and the
vented cardiotomy reservoir.
• Alternatively, it is recommended to monitor the internal pressure. If increased
pressure is observed, open the three-way stopcock above the air vent port to release
the internal pressure to the air vent line.
• In either case, stopping the pump will avoid damage to the device or circuit until the
cause is identified and corrected.
• Do not remove thermistor on the blood outlet port. Twist the thermistor and all luer
caps that are not being used firmly to prevent leakage.
6. Install the blood and cardioplegic solution lines in the roller pump head. Ensure that both lines
are fully occluded.
WARNING:
Both lines must be fully occluded to ensure that blood and cardioplegic solution do not
flow back to the oxygenator and the specified ratio of blood/cardioplegic solution is
maintained.
7. Connect cardioplegic solution line tubing to cardioplegic solution bags.
8. Connect blood line tubing to the blood cardioplegia port of the oxygenator or the arterial line,
and clamp the blood line before priming the extracorporeal circuit.
9. Connect the thermistor probe to a temperature monitor.
monitor can be used in conjunction with the following part: Code No.: CX*BP021 (blue cable)
or CX*BP022 (red cable). (* Y.S.I.: trade name, Yellow Springs Instrument Co., Inc.)
10. Connect pressure monitoring line tubing to the pressure monitoring port.
should be used with the appropriate
that a pressure relief
holder supplied by TERUMO
valve (activating pressure:
Y.S.I.* 400 Series temperature