Intended Use - Terumo Xcoating Capiox Rx Serie Bedienungsanleitung

3. Clamp the 1/2" (12.7 mm) circuit tubing attached to the 1/2" (12.7 mm) venous inlet port (10) of the reservoir, cut it and connect a
1/2" (12.7 mm) connector with 1/2" (12.7 mm) I.D. dead-end tube [c]. In case of using RX15R30: Clamp the 3/8" (9.5 mm) circuit
tubing attached to the 3/8" (9.5 mm) venous blood inlet port (10) of the reservoir, cut it and connect a 3/8" (9.5 mm) connector with
3/8" (9.5 mm) I.D. dead-end tubing [c]. In case of 1/4" (6.4 mm) adapter, take 1/4" (6.4 mm) adapter off first.
4. Connect the chest drainage tubes to the 3/8" (9.5 mm) X 3/8" (9.5 mm) Y connector with 96" (2438.4 mm) of 3/8" (9.5 mm) 40
Durometer tubing [d]; if only one chest tube is used, plug one of the 3/8" (9.5 mm) ports of the Y connector with a 3/8" (9.5 mm)
dead-end tube [e]. Attach the other end of the 3/8" (9.5 mm) X 3/8" (9.5 mm) Y connector with 96" (2438.4 mm) of tubing to the
vertical port to CR filter (7). In case 3 or more chest tubes are used, attach an additional 3/8" (9.5 mm) X 3/8" (9.5 mm) Y connector
with 96" (2438.4 mm) of 3/8" (9.5 mm) 40 Durometer tubing [d] to one of the suction inlet ports (6) that was capped off by a
dead-end tube.
5. Secure in place all yellow luer caps; all caps are non-vented (4, 8).
6. Disconnect sampling system (3) from the back of the venous blood inlet port (10) and attach a non-vented luer cap [k].
7. Attach a 1/4" (6.4 mm) dead-end tube [a] to the quick prime port (9) on the reservoir.
8. Hold the reservoir parallel to the floor with the venous blood outlet port at the top to prevent blood spillage. Clamp the circuit tubing
attached to the outlet port, cut it, then connect a 3/8" (9.5 mm) to 1/8" (3.175 mm) blood infusion adapter line [f]. Clamp the adapter
line and leave the end cap in place until autotransfusion is set up. In case of using 1/4" (6.4 mm) adapter, take 1/4" (6.4 mm) adapter
off first.
9. Remove luer cap from non-filtered luer port (1) and attach three-way stopcock. Secure to the stopcock the vacuum relief valve with
attached bacterial filter [g].
10. Install the Hardshell Reservoir into the autotransfusion holder (product code XX*XH032).
CAUTION Maintain the Hardshell Reservoir below the thorax to facilitate chest drainage.
11.a. Using a 1/4" (6.4 mm) I.D. tubing [h], connect the vent port (5) on top of the hardshell reservoir to a regulated vacuum source
with 1.5 to 2.0 kPa (15 to 20 cmH
NOTE : The "DO NOT OBSTRUCT" caution label near the vent port is not applicable for post-operative chest drainage and autotransfusion.
11.b. The use of a water seal/water manometer [i] is highly recommended for chest drainage. If using a water manometer, connect one
end of a 1/4" (6.4 mm) I.D. tubing [j] to the vent port (5) and the other end to the water manometer.
WARNING To minimize blood damage, vacuum should be regulated so as not to exceed 13.3-20 kPa
(100-150 mmHg) (136-204 cmH
12. Record the time that drainage into the reservoir begins.
WARNING It is recommended that autotransfusion continue no longer than 18 hours after surgery.
13. Continually monitor drainage and elapsed time. Determine hourly drainage rate.
WARNING Reinfusion of collected blood/fluid should be done on an hourly basis unless fewer than 50 mL are collected
hourly.
14. Upon collection of 50 mL of blood, remove the end cap of the blood infusion adapter line and attach the blood infusion adapter to
an I.V. Administration set/pump apparatus.
NOTE : It is recommended that the infusion pump be used with an air detection sensor for all reinfusion procedures.
15. Unclamp the blood infusion line and proceed with autotransfusion.
WARNINGS • To reduce risk of air embolism, evacuate all air completely from the infusion line prior to autotransfusion.
• To minimize blood damage, do not exceed 13.3-20 kPa (100-150 mmHg) (136-204 cmH
reinfusing blood.
• The physician is responsible for determining the optimal time, rate and volume to be autotransfused to
the patient.
• The clinician should be aware of potential complications such as air emboli, associated with the use of
the I.V. Administration set and the infusion pump in accordance with the instructions provided by the
manufacturers.
VACUUM ASSISTED VENOUS DRAINAGE

INTENDED USE

The RX Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures. The use of a controlled vacuum
on the Hardshell Reservoir 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.
• Always allow for a vented reservoir when vacuum is not being applied. Vent by unclamping the vacuum release line.
• Avoid obstruction or occlusion of vacuum line to prevent retrograde air to the patient. Potential occlusions of the VAVD circuit may
occur as a result of a kinked or clamped vacuum line, overfilled moisture trap, or condensation build up in the gas filter.
• The gas filter must be positioned at a level above the moisture trap.
• Do not exceed –150 mmHg (–20.0 kPa) 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.
• An arterial filter must be used during VAVD.
• Proceed slowly when returning to atmospheric pressure (elimination of vacuum). A sudden change in pressure may create
turbulence of the blood inside the reservoir.
• Do not open the auxiliary port on the venous reservoir during VAVD to prevent bubble formation inside the venous filter.
• Utilize maximum safe vacuum levels as indicated by institutional protocols.
• DO NOT OCCLUDE THE POSITIVE PRESSURE RELIEF VALVE. 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 indicated 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.
O) (11-15 mmHg).
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