Performance Data - Terumo Capiox Gebrauchsanweisung

CAUTION:
It is recommended that a three-way stopcock and a pressure barrier kit be attached to
the other end of the pressure monitoring line.
B. PRIMING
1. Prime the oxygenator and extracorporeal circuit before priming the CAPIOX CARDIOPLEGIA
and its circuit.
2. Release clamp from blood line and cardioplegic solution line. Prime the cardioplegia circuit to a
point beyond the cardioplegia pump before initiating bypass.
WARNING:
Failure to prime the cardioplegia circuit beyond the cardioplegia pump head can result
in air being introduced into the arterial line and/or the oxygenator.
CAUTION:
If the shunt is placed between blood line and cardioplegic solution line, it must be
primed whether or not its use is expected.
3. The remainder of the circuit and the device may be primed either before or immediately after
initiating bypass.
4. Tilt the device in the holder to prime the blood outlet port. Prime the device by running the
cardioplegia pump slowly (maximum flow rate: 50 ml/min.).
5. Once the priming solution reaches a point distal to the blood outlet port, clamp the blood outlet
line adjacent to the blood outlet port.
6. Place the device in its upright position and prime the pressure monitoring line. Clamp the
pressure monitoring line adjacent to the pressure monitoring port.
7. Prime the air-trapping chamber until all air is purged through the purge line. Stop the
cardioplegia pump.
CAUTION:
Do not tap the device with a clamp when removing air, otherwise the device may be
damaged and/or leak.
8. Close the three-way stopcock on the air vent port.
WARNING:
Ensure that all air is removed from the device and its circuit before delivery of the
cardioplegia to the patient.
9. Connect the outlet line to the table line from the surgical field. Prime table line slowly as usual
manner.
CAUTION:
If the shunt is placed between blood line and cardioplegic solution line, clamp the shunt
line to prevent the solution from going back to the bag after initiating bypass.
C. OPERATION DURING BYPASS
During and/or after operation, when air is trapped at the air trap chamber, open three-way
stopcock on the air purge port to remove air.
CAUTION:
Do not tap the device with a clamp when removing air, otherwise the device may be
damaged and/or leak.
1. Start water circulation to the CAPIOX CARDIOPLEGIA heat exchanger before delivery of
blood and/or cardioplegic solution.
2. Determine water temperature.
CAUTION:
Water temperature delivered to the device should not exceed 42°C (108°F), otherwise
blood damage may result.
3. After releasing clamp from pressure monitoring line, start the cardioplegia pump to deliver
blood and/or cardioplegic solution to the patient.
WARNINGS:
• Ensure that no clamp is present on the patient delivery line. If the patient delivery line
is clamped, the device can be damaged by abrupt, internal pressure build-up.
• 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.
• Pressure at the solution inlet should not exceed 500 mmHg (67 kPa), otherwise the
device may be damaged and/or leak.
4. Monitor the blood/cardioplegic solution temperature and the internal pressure.
5. Stop the cardioplegia pump when a desired amount of blood and/or cardioplegic solution has
been delivered.
6. Stop water circulation.
WARNING:
Failure to stop water circulation may result in cold agglutination when cold water is
used.
7. Repeat the above steps 1 to 6 to resume delivery of blood and/or cardioplegic solution to the
patient.
WARNING:
When replacing cardioplegic solution bags, care should be taken to avoid introducing
air into the device. Air introduced into the device may result in air embolism to the
patient.
PERFORMANCE DATA & SPECIFICATIONS
A. PERFORMANCE DATA
Heat Exchanger Performance Factor (in-vitro)
B. HEAT EXCHANGER SPECIFICATIONS
Holder
Housing Material
Heat Exchanger Type
Material
Effective Surface Area
Potting Material
Filter Screen Material
Pore Size
Support Material
Priming Volume
Blood Port Size Inlet Port
Outlet Port
Water Port Type
Size
Maximum Blood Flow Rate
Maximum Operating Blood Side
Pressure
Water Side
Method of Sterilization
XX*XH081
Polycarbonate (Clear)
Straight Pipe
Stainless Steel
640 cm²
Polyurethane
Polyester
96µm
Polypropylene
52 ml
1/4" (6.4 mm)
3/16" (4.8 mm)
Hansen Quick-Connect Fitting
1/2" (12.7 mm)
500 ml/min.
500 mmHg (67 kPa)
29 psi (2 ATM, 203 kPa)
Ethylene Oxide Gas