• Caution must be taken because the relationship between blood flow rate and pump speed changes depending on the degree of
negative pressure applied.
PRECAUTIONS
• Do not connect the VAVD circuit to any other ports than the reservoir vent port. The vacuum circuit may
suck blood back in.
• 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 VAVD circuit and do not reuse it.
• A positive pressure-warning device should be equipped on the reservoir.
• The valve should be checked prior to cardiopulmonary bypass to ensure proper functionality.
• A controlled vacuum regulator is required.
• A positive pressure relief valve is required.
• The use of a negative pressure manometer gauge on the Hardshell Reservoir and a vacuum relief valve
[opening range at -150 mmHg (-20.0 kPa)] are recommended.
• Please be aware that use of vacuum may cause liquid level to appear higher than actual due to reservoir compliance. In case of
using RX25R/RX15R40, a liquid level of 230 mL on volume scale assures actual minimum volume of 200 mL at a negative pressure
of -150 mmHg (-20.0 kPa). In case of using RX15R30, a liquid level of 80 mL on volume scale assures actual minimum volume of
70 mL at a negative pressure of -20 kPa (-150 mmHg).
INSTRUCTIONS FOR USE
REQUIRED EQUIPMENT
A RX venous reservoir
B Sterile moisture trap
C Clamp
D Controlled vacuum regulator [adjustable between
0 to - 20 kPa (- 150 mmHg)]
SETUP CONFIGURATION
Non filtered
Vent port
Note: 1-8 refers to the Structure diagram (page 3) with numbered components and A~I refers to the Required Equipment for
use with vacuum assisted venous drainage with letter indications.
1. Prepare CPB circuit set-up as per standard procedure.
2. Verify that blue caps from suction inlet ports
3. Secure in place all yellow luer caps; all caps are non-vented
4. Install controlled vacuum regulator
5. Attach a 3-way stopcock to the non-filtered luer lock port 1, and connect the sterile manometer gauge line
6. Connect the negative manometer gauge
I
7. Attach the gas filter
to the tubing connected to the moisture trap
B
8. Attach sterile moisture trap
tube to the vent port
Initiating Bypass
1. Begin with gravity venous drainage; at this time, the vacuum release line
2. To initiate vacuum assist venous drainage: set the vacuum regulator D, then clamp the vacuum release line G.
3. Monitor the negative pressure inside the hardshell reservoir with the negative manometer gauge
4. Adjust the negative pressure to optimize venous return. Set vacuum regulator
Note:
• The "DO NOT OBSTRUCT" caution label near the vent port is not applicable for vacuum assisted venous drainage.
• Use an occlusive roller head for the suction and LV vent lines.
Coming off bypass
G
Unclamp vacuum release line
, venous return will quickly fall.
Come off bypass as per standard procedure.
14
E Sterile manometer gauge line
F Negative manometer gauge
G Sterile vacuum release line
H Sterile positive pressure relief valve [included
in reservoir with opening range from 0
to 8 mmHg (1.1 kPa)]
I
Sterile gas filter
6
2
and auxiliary port
of reservoir are pushed all the way to insure adequate seal.
4
8
,
.
D
on wall suction source.
F
to the sterile manometer line
B
and the "Y" connector.
5
on the hardshell reservoir.
Vacuum source
E
E
.
G
is unclamped.
F
.
D
.
.