Method Of Operation; Priming Procedure - Terumo Xcoating Capiox Rx Serie Bedienungsanleitung

METHOD OF OPERATION

Read WARNINGS (page 4) and PRECAUTIONS (page 5) before use. The following is a basic description of the use of the
CAPIOX RX Oxygenator and Hardshell Reservoir when no other particular indications apply.
NOTE: The reservoir volumes illustrated by the scale labels are not absolute volumes. Please keep this in mind when considering safe operating
volumnes during the use of the product.
SET-UP
1. Remove CAPIOX RX from package and examine it for defects.
CAUTION Do not use if the package or device is damaged (e.g. cracked) or any of the port caps are off.
2. Place CAPIOX RX in its holder.
CAPIOX RX Oxygenator with Hardshell Reservoir:
Set the holder at the appropriate height to prevent the arterial line and the blood cardioplegia line from kinking. Making sure
that the connecting ring is in place, set oxygenator in its holder (Code No.:XX*CXH18R) with lever up, then push the lever down
(See Fig. 1). When rotating the oxygenator module, be sure to hold the support arm. If the oxygenator module is rotated while
holding the oxygenator body, it could be damaged. (See Fig. 2)
NOTE: When using CAPIOX RX Oxygenator module and Hardshell Reservoir separately,
a) Hold the module firmly and separate it from Hardshell Reservoir by removing connecting ring.
b) Set reservoir in the holder (Code No.:XX*CXH18R) for CAPIOX RX Oxygenator with Hardshell Reservoir
c) Set the oxygenator module in its holder (Code No.:XX*CXH18) and close the "lock" cover. (see Fig. 3)
CAUTION In case a shock by dropping etc. has been given to this product during set-up, do not use it.
3. Connect water lines (1/2" (12.7 mm) tubing or couplers) to the water ports of CAPIOX RX. (See Fig.4 - (1))
CAUTION Use the upper port for water supply and the lower port for water drainage. Otherwise heat exchange will
not be performed sufficiently.
4. Start water circulation through heat exchanger and circulate for at least 5 minutes. Check for leaks.
WARNING Do not use an oxygenator that leaks.
Note: If using the 3/8" to 1/4" adapter, place adapter onto the port and twist to seal tightly. The winged adapter may be used with the 3L reser-
voir venous blood inlet port, 3L reservoir blood outlet port, RX15 oxygenator blood inlet port, and RX15 oxygenator blood outlet port.
5. Attach venous line to the venous blood inlet port of venous reservoir. (See Fig.4 - (2))
6. Attach 3/8" (9.5 mm) arterial line to the blood outlet port of CAPIOX RX Oxygenator. (See Fig.4 - (3))
7. Remove the cap from the blood cardioplegia port and attach 1/4" (6.4 mm) blood cardioplegia line tubing. (See Fig.4 - (4))
WARNING If the port is not to be used, push cap in and twist it to seal tightly or attach a short 1/4" (6.4 mm) tubing
and clamp for security.
8. Connect 3/8" (9.5 mm) pump line to the blood outlet port of Hardshell Reservoir. Connect other end to 3/8" (9.5 mm) blood inlet port
of oxygenator. (See Fig.4 - (5))
9. Push all tubing past the second barb and band all connections in the circuit securely between the first and second barb.
10. Connect 1/4" (6.4 mm) gas line to gas inlet port. (See Fig.4 - (6))
WARNING DO NOT OBSTRUCT GAS OUTLET PORT. (Fig.4 - (7))
11. The following thermistor probes can be used with Y.S.I. 400 series* temperature monitor:
Blue Cable (venous line) : Code No.: CX*BP021
Red Cable (arterial line) : Code No.: CX*BP022
*Y.S.I. 400 (trade name : Measurement Specialties Inc.)
CAUTION Check for functionality of arterial and venous thermistors during setup and/or prime.
12. Suction ports of CAPIOX RX Hardshell Reservoir have blue caps. Remove the blue caps, connect the suction lines and vent line tosuction
ports on Hardshell Reservoir. (See Fig. 5)
13. When using the CAPIOX RX Oxygenator module without Hardshell Reservoir, connect venous side male luer lock of sampling
system to venous line. (See Fig. 6)
14. Check figures and labels to make sure tubing is connected to the correct port. Special care should be taken to connect the correct
tubing to the 1/4" (6.4 mm) gas inlet port (Fig.4-(6)), the 1/4" (6.4 mm) gas outlet port (Fig.4-(7)) and 1/4" (6.4 mm) blood cardioplegia
port (Fig.4-(4)).
CAUTION Ensure that all connected parts including the luer caps, the lock adapters and the port caps are securely
affixed. Loose connections may cause contamination or a blood leak.
CO FLUSH PROCEDURE
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1. Clamp 1/4" (6.4 mm) gas tubing connected to gas inlet port. Clamp 1/4" (6.4 mm) cardioplegia line tubing.
2. Attach CO supply tubing to vent port of Arterial Filter or Bubble Trap.
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3. Circuit should be vented from gas outlet port of Oxygenator and/or vent port of Venous Reservoir. Close other vent sites.
4. Remove pump line from pump and check circuit tubing for kinks.
5. Begin CO flush.
2
• Minimum flow rate :
• Flow time at minimum flow rate :
CAUTION Vent port of CAPIOX RX Hardshell Reservoir is open to atmosphere even with port cap attached. A CO
rate less than 5 L/min cannot achieve a proper CO
6. Stop the flow of CO gas, close CO
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7. Begin priming as usual.

PRIMING PROCEDURE

CAUTION CAPIOX RX Oxygenator module should be primed with crystalloid solution containing no blood, plasma, or
blood-derived products.
Note: CAPIOX RX can be primed without CO
debubbling in a shorter time.
6
and pull the lever down (See Fig. 1).
5 L/min
5 minutes
vent on Arterial Filter or Bubble Trap, and remove CO
2
flush when crystalloid priming solution is used. Use of CO
2
flush to oxygenator module.
2
supply tubing.
2
flow
2
flush permits
2