Indication For Use - Terumo Xcoating Capiox Rx Serie Bedienungsanleitung

Read all warnings, cautions and instructions carefully prior to use.
DESCRIPTION OF PRODUCTS
The CAPIOX RX is a membrane oxygenator with microporous polypropylene hollow fibers, to be used as an extracorporeal gas exchange
device in which the blood flows on the outside of the fibers and the ventilating gas flows through the fibers.
The CAPIOX RX consists of a module for gas exchange with an integrated heat exchanger. The CAPIOX RX is available with or without a
Hardshell Reservoir with an integrated cardiotomy filter to provide a single-unit construction for ease of use. An optional level alarm system
(Code No.: ME*CE601), using ultrasonic waves, is available for use with the CAPIOX RX.
The RX15 oxygenator is available with a 3000 mL or 4000 mL Hardshell Reservoir. Reference codes that end with 40 use the 4000 mL Hardshell
Reservoir and product codes that end with 30 use the 3000 mL Hardshell Reservoir. The blood contacting surfaces are coated with Xcoating.
Xcoating is bio-compatible material that is applied on the blood-contacting surfaces of the device to reduce the adhesion of platelets to the device.

INDICATION FOR USE

The CAPIOX RX is intended to be used during open heart surgical procedures requiring cardiopulmonary bypass for periods up to 6 hours.
The CAPIOX RX25 is for use with patients when required blood flow rate will not exceed 7 L/min. The CAPIOX RX15 is for use with patients
when required blood flow rate will not exceed 5 L/min (4 L/min if using product codes 3CX*RX15RW30 or 3CX*RX15RE30). The CAPIOX RX
Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedure, in post-operative chest drainage and
autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement.
DIRECTION OF BLOOD OUTLET PORT
The oxygenator is available with TWO OUTLET PORT CONFIGURATIONS - LEFT side (W) or RIGHT side (E). Refer to the diagram
below to determine which configuration is needed for your circuit.
TYPE
Oxygenator with Hardshell Reservoir
Place waterports facing South as indicated in
the illustration. The blood outlet port orientation
is (W)est - LEFT side or (E)ast - RIGHT side.
Note: this illustration is a top view of the oxy-
genator.
WARNINGS
Describe serious adverse reactions and potential safety hazards, limitations in use imposed by them, and steps that should be
taken if they occur.
WARNINGS
• CAPIOX RX25 is designed to operate at blood flow rates within the range of 0.5 to 7.0 L/min. CAPIOX RX15R40 is designed to operate at
blood flow rates within the range of 0.5 to 5.0 L/min. In case of using RX15R30 the range is 0.5 to 4.0 L/min. Do not use any blood flow rate
outside this range.
• Do not use solvents such as alcohol, ether, acetone, etc. These solvents may cause damage if used in or on the device.
• DO NOT OBSTRUCT GAS OUTLET PORT. Avoid build up of excess pressure in the gas phase to prevent gaseous emboli entering
the blood phase.
• Pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase.
• The gas flow rate should not exceed 20 L/min for RX25 or 15 L/min for RX15. Excessive gas flow rate will bring about pressure increase
in the gas phase, allowing gaseous emboli to enter the blood phase.
• During recirculation, do not use pulsatile flow and do not stop the blood pump suddenly as these actions may cause gaseous emboli to
enter the blood phase from the gas phase due to inertia force.
• When the CAPIOX RX Oxygenator module is used separately from the Hardshell Reservoir, set the module so that the upper end of the
fibers is lower than the blood level in the venous reservoir. This prevents gaseous emboli from entering the blood phase from the gas
phase.
• To prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate of the
cardioplegia line. The blood flow rate of the cardioplegia line should not exceed 1 L/min.
• Pressure at the blood inlet of the oxygenator module should not exceed 1000 mmHg (133 kPa). Pressures greater than
1000 mmHg (133 kPa) may cause leaks or damage to the device.
• Water pressure at the heat exchanger inlet should not exceed 28 PSI (2 kgf/cm
28 PSI (2 kgf/cm , 196 kPa) may cause leaks or damage to the device.
2
• Adequate heparinization of the blood is required to prevent it from clotting in the system.
• When using the centrifugal pump on the arterial line, clamp the arterial line distal to the oxygenator (the patient's side) before stopping
the pump. Improper clamping may cause back-flow of blood or migration of gaseous emboli into the blood side.
Use CAPIOX RX Oxygenator with Hardshell Reservoir taking note of the additional warnings below.
4
Instructions for Use
P.4––P.14
LEFT
W
code: 3CX*RX15R / 3CX*RX25R
Blood inlet port
Gas outlet
Blood
port
outlet
port
(Left)
Water ports
, 196 kPa). Pressures greater than
2
W
code: 3CX*RX15R
Blood inlet port
RIGHT
E E
/ 3CX*RX25R
Gas outlet port
Blood outlet
port (Right)
Water ports