Indication For Use - Terumo CAPIOX FX 25 Serie Instrucciones De Uso

Read all warnings, cautions and instructions carefully prior to use.
DESCRIPTION OF PRODUCTS
The CAPIOX FX25 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 with the ventilating gas flowing through the fibers.
The CAPIOX FX25 consists of a module for gas exchange with an integrated heat exchanger and Arterial Filter. The CAPIOX FX25 is available with (Code No.: CX*FX25RW,
CX*FX25RE) or without (Code No.: CX*FX25W, CX*FX25E) a Hardshell Reservoir with an integrated cardiotomy filter to provide a single-unit construction for ease of use.
(CX*FX25RW, CX*FX25W and CX*FX25RE, CX*FX25E differ in the positioning of the arterial blood port of the oxygenator.)
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 FX25 is intended to be used during open heart surgical procedures requiring cardiopulmonary bypass for periods up to 6 hours. The CAPIOX FX25 is for use with patients
when required blood flow rate will not exceed 7L/min.
The CAPIOX FX25 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.
The Integral Arterial Filter is intended to filtrate non-biologic particles and emboli and to facilitate gaseous emboli removal from the blood flowing through a cardiopulmonary bypass
circuit.
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
Oxygenator without 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 oxygenator.
STRUCTURE
: CX*FX25RW
CX*FX25RW, CX*FX25W and CX*FX25RE, CX*FX25E differ in the positioning of the arterial blood outlet port of the oxygenator. All figures hereafter only refer to FX25RW.
ENGLISH
LEFT
code : CX*FX25R
code : CX*FX25
Blood inlet port
Blood outlet
port (Left)
Water ports
: CX*FX25RE
W
W
Blood inlet port
Gas outlet
port
Water ports
: CX*FX25W
RIGHT
E
code : CX*FX25R
E
code : CX*FX25
Gas outlet port
Blood outlet port
(Right)
: CX*FX25E
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