Terumo CAPIOX FX 25 Mode D'emploi page 11

PERFORMANCE DATA
Fig. 12
O Transfer Rate (in vitro)
2
600
Condition
500 Bovine Blood
Hb = 12±1g/dL
400
Temp = 37±1°C
pH = 7.4
300
SvO = 65±5%
2
PvCO = 45±5mmHg
200
2
B.E. = 0±5mEq/L
100
V/Q = 1.0
0
0 2 4 6
Blood Flow Rate (L/min)
Dedicated holders (sold separately)
Integrated holder
(Code No. XX*CXH18R)
Vacuum Assisted Venous Drainage (VAVD)
INTENDED USE
The FX25 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures. The use of a controlled vacuum on the hardshell improves venous drainage
during minimally invasive surgical techniques or regular bypass surgery.
WARNINGS
• For drug administration in the hardshell reservoir, be aware that negative pressure in
this line could draw more drug than intended. To prevent non intended drug amounts
to be drawn, it is recommended to include only the intended amounts in the syringe.
• Always allow for a vented reservoir when vacuum is not being applied. Vent by
declamping the vacuum release line.
• Avoid obstruction or occlusion of vacuum line to prevent retrograde air to the patient.
• Do not exceed -20 kPa (-150 mmHg) when using vacuum source for assisted venous
drainage technique to prevent hemolysis.
• Open any port at the top of the reservoir for releasing negative pressure before
stopping the pump. Otherwise the blood may flow sharply from the patient.
• When stopping the pump or when the blood flow rate is low during VAVD, all A-V shunt
lines (ex. sampling line, purge line, etc) must be closed to prevent drawing air into the
blood side of the oxygenator from the fiber and reversing the blood flow to the reservoir
from the arterial side of the patient.
• The roller pump must be occluded properly because it is more likely to draw air into the
blood side of the oxygenator from the fiber when VAVD is performed.
• Proceed slowly when returning to atmospheric pressure (elimination of vacuum). A
sudden change in pressure may create turbulence of the blood inside the reservoir.
PRECAUTIONS
• Do not connect the negative pressurized circuit to any other ports than the reservoir
vent port. The negative pressurized circuit may suck blood back in it.
• Do not leave the ports that are not in use open.
• A moisture trap is required due to the volume of condensation generated.
• Use a sterile negative pressurized circuit and do not reuse it.
• A positive pressure-warning device should be equipped on the reservoir.
• A controlled vacuum regulator is required.
Fig. 13
CO Transfer Rate (in vitro)
2
600
Condition
Bovine Blood
500
Hb = 12±1g/dL
400
Temp = 37±1°C
pH = 7.4
300
200
SvO = 65±5%
2
100 PvCO = 45±5mmHg
2
B.E. = 0±5mEq/L
0
8 0 2 4 6
Blood Flow Rate (L/min)
Holder for Oxygenator detached from Hardshell
Reservoir
(Code No. XX*CXH25F)
Fig. 14
Heat Exchanger Performance Factor
V/Q = 2.0
1.0
0.9
V/Q = 1.0
0.8
Condition
0.7
Bovine Blood
0.6
V/Q = 0.5
0.5
Hb = 12±1g/dL
0.4
Tbi = 30±1°C
0.3
Twi = 40±1°C
0.2
Water flow rate = 15L/min
0.1
0.0
0 2 4
8
Blood Flow Rate (L/min)
Holder for Reservoir
(Code No. XX*XH032)
• Do not open the auxiliary port on the venous reservoir during VAVD to prevent bubble
formation inside the venous filter.
• Do not occlude the positive pressure relief valve when vacuum assisted venous
drainage is used. Over pressurization of the venous reservoir could obstruct venous
drainage, decreasing the blood level in the venous reservoir and allowing air to enter
both the venous and arterial side of the circuit. This could result in gaseous emboli
entering the blood phase.
When VAVD is performed in conjunction with a centrifugal pump take caution as
below.
• The line between the oxygenator and the centrifugal pump must be clamped before
stopping the pump. Not clamping off the arterial line may draw air into the blood side of
the oxygenator from the fiber. An arterial line one-way valve is recommended between
the oxygenator and the centrifugal pump.
• Caution must be taken because the relationship between blood flow rate and pump
speed changes depending on the degree of negative pressure applied.
• A positive pressure relief valve is required.
• The use of a negative pressure manometer gauge on the hardshell reservoir
and a negative pressure relief valve [opening range at -20 kPa (-150 mmHg)] are
recommended.
• Use of vacuum may cause liquid level to appear higher than actual due to reservoir
compliance. A liquid level of 230 mL on volume scale assures actual minimum volume
of 200 mL at a negative pressure of -20 kPa (-150 mmHg).
Fig. 15
Blood Side Pressure Drop (in vitro)
(in vitro)
150
Condition
Bovine Blood
100 Hb = 12±1g/dL
B.E. = 0±5mEq/L
Temp = 37±1°C
50
0
0 2 4
6 8
Blood Flow Rate (L/min)
Holder for Oxygenator
(Code No. XX*CXH15)
15
10
5
0
6 8
11