Required Equipment - Terumo CAPIOX FX 25 Serie Instrucciones De Uso

INSTRUCTIONS FOR USE
NOTE : 1~10 refers to the Structure diagram 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 6 and auxiliary port 2 of reservoir are
pushed all the way to insure adequate seal.
3. Secure in place all yellow luer caps; all caps are non-vented 4, 8.
4. Install controlled vacuum regulator D on wall suction source.
5. Remove positive pressure relief valve and attach a 3-way stopcock to the non-filtered
luer lock port, and connect the sterile manometer gauge line E.
6. Connect the negative manometer gauge F to the sterile manometer line E.
7. Also, to the above mentioned (in procedure 5) 3-way stopcock, connect the positive
pressure relief valve H to the other end of the 3-way stopcock.
8. Attach the gas filter I to the tubing connected to the moisture trap B and the "Y"
connector.
9. Attach sterile moisture trap B tube to the vent port 5 on the hardshell reservoir.
<Initiating Bypass>
1. Begin with regular venous gravity drainage; at this time, the vacuum release line G
is unclamped.
2. To initiate vacuum assist venous drainage: set the vacuum regulator D to –5.3kPa
(-40 mmHg), then clamp the vacuum release line G.
3. Monitor the negative pressure inside the hardshell reservoir with the negative
manometer gauge F.
4. Adjust the negative pressure to optimize venous return. Set vacuum regulator D
between -5.3 kPa and -8.0 kPa (-40 and -60 mmHg).
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>
Unclamp vacuum release line G, venous return will quickly fall. Come off bypass as per
standard procedure.
Post – Operative Chest Drainage
CONTRAINDICATIONS
Post-operative chest drainage with subsequent autotransfusion procedures are
contraindicated in the following events:
• Gross perforations to the chest wall or an air leak in the lungs.
• Infection or malignancy occurring systemically or in the pericardium, mediastinum, or
lungs.
• Suspected or evident gross contamination with foreign material, lymphatic failure, or
perforated intestine.
WARNINGS
• A qualified person should assess the quality and suitability of returning any blood that
has been collected before reinfusion begins. The safe reinfusion of collected fluids is
the sole responsibility of the attending physician.
• Complications such as the following have been associated with chest drainage
and subsequent reinfusion: blood trauma, blood coagulation, coagulopathies, and
particulate or air embolism.
• Reinfusion of collected blood/fluid should be done on an hourly basis unless fewer than
50 mL are collected hourly.
• A minimum reservoir level of 20 mL of fluid should always be maintained to prevent air
embolus passing to patient.
• Blood that has been in the reservoir for longer than 4 hours should not be transfused.
• It is not recommended that autotransfusion continue longer than 18 hours after
surgery.
2
• Attach a shunt line (the bridge) to connect the filtered and unfiltered sections in the
reservoir as indicated in instructions for use.
12

REQUIRED EQUIPMENT

A FX25R venous reservoir
B Sterile moisture trap
C Clamp
D Controlled vacuum regulator [adjustable
between 0 to -20 kPa (-150 mmHg)]
SET-UP CONFIGURATION
Non-filtered luer lock port
E
H
I
Vent port
B
STRUCTURE
1 Positive pressure
relief valve
2 Auxiliary port
3 Sampling system
4 Two luer locks
on venous inlet
Thermistor probe
5 Vent port
• Presence of the following in the aspiration site: topical hemostatic agents, bactericidal
wound irrigants or antibiotics not intended for parenteral administration.
• Open chest and vacuum applied.
• Administration of protamine prior to reservoir being removed from bypass circuit.
• Patient returned to surgery for any reason.
• Use of vented chest tubes that do not have vent flow regulation such as stopcocks.
• When using reservoir, monitor the attached shunt line for blood in the line. If blood is
detected in the line this is an indication that the reservoir filter has clotted. Replace
reservoir promptly.
• Filter occlusion during high volume chest drainage may cause blood/fluid to pass
through the external shunt line bypassing filtration. All fluids that pass through the
shunt line must be filtered prior to reinfusion.
• Accepted medical and nursing care routines must be followed during chest drainage.
• When vacuum is used during chest drainage, do not exceed -20 kPa (-150 mmHg)
(-195 cmH O).
2
Standards for Blood Banks and Transfusion Services, 16
1 1
Blood Banks
Page. R, et al, Hard-Shell Cardiotomy Reservoir for Reinfusion of Shed Mediastinal
2
Blood. Ann Thorac Surg 1989: 48:514-7.
E Sterile manometer gauge line
F Negative manometer gauge
G Sterile vacuum release line
H Sterile positive pressure relief valve
[opening range from 0 to 1.3 kPa
(10 mmHg)]
I Sterile gas filter
F
D
G
A
C
Vacuum source
6 Suction ports
9 Quick prime port
7 Vertical port to
cardiotomy filter
8 Three filtered luer
locks to cardiotomy
filter
Purge line
10 Venous blood inlet port
ed. American Association of
th