Terumo CAPIOX EBS Circuit with X coating, Instructions For Use Manual

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To ensure safe and correct use of this product, please observe all precautions.
Non-compliance with precautions and incorrect use may result in damage or injury.
The following are symbols used in this manual and their meanings:
This label preceding a precaution indicates that there will be a possible risk of death or
personal injury if the precaution given is not complied with.
This label preceding a precaution indicates that there will be a possible risk of
personal injury or property damage if the precaution given is not complied with.
Use
Warnings
(All equipment)
• Always prepare a backup system (the Backup Controller, the Hand Crank, etc.) to maintain circulation during an
emergency. [Circulation cannot be maintained during an emergency.]
• Monitor the circulation status (the operation status of the system, blood storage state of a reservoir, etc.) during
extracorporeal circulation without fail. [1. As this system does not have a function to monitor the status of the patient, the
system cannot detect when the status of the patient changes even if the system operates properly. 2. The system cannot
detect the leakage of liquid (including blood) caused by damage to the extracorporeal circulation circuit. 3. It is possible
that the system will not detect a flow abnormality, even if the ABD/Flow Sensor is used. 4. This system may not operate in
accordance with the specifications if the system is used together with another system.]
• The Drive Motor and the Hand Crank contain magnets, and therefore do not bring metal objects or magnets near these
devices. [Malfunction may occur.]
• Adjust the motor speed of the centrifugal pump so that the pressure at the blood flow path of the oxygenator is always
higher than the pressure at the gas passage. [If the pressure at the gas passage is higher than the pressure at the blood
flow path, air may enter into the blood.]
• When using devices (mobile phones, radio devices, electrosurgical knives, defibrillators, etc.) that emit an electromagnetic
wave near this system, they should be used as far away as possible. This system should use a power supply isolated from
these devices and should obtain secure grounding. [Malfunction in this system caused by electronic interference may
result in critical harm to the patient.]
• Do not use this system with other equipment placed next to it or stacked together. [Malfunctions may occur due to
electromagnetic interference.]
• This system requires special attention to electromagnetic compatibility (“EMC”) and must be used in accordance with the
EMC information described in “For Medical Staff” in this instructions for use.
• Do not clamp the blood inlet line of the centrifugal pump during circulation. [Air bubbles may occur in the blood as the
inside of the centrifugal pump is negatively pressured.]
• When using this system, do not touch the following 2 places at the same time. [Otherwise an electric shock or short circuit
may occur.]
• Patient and connector at the back of the Controller
• Patient and connector at the front of the Backup Controller
• Do not use this system for the following purposes.
• Usage other than percutaneous cardiopulmonary support/ECMO/ECLS, open heart surgery and aortic surgery
• Long-term use in bridge to transplant or pending recover of the natural heart
(Controller/Backup Controller)
• Connect the AC power cable to the AC power inlet of the Controller or the Backup Controller until you hear a click.
Subsequently, check that the AC power lamp in the control panel of the Controller is lit. [If the connection is insufficient,
the Controller will be powered by the battery. And therefore the battery will be depleted, the devices will shut down and
circulation will not be maintained. (The battery is installed only in the Controller and not in the Backup Controller.)]
• When the Controller signals the Serious System Error (device alarm (high priority)) attach the centrifugal pump with the
Drive Motor connected to the Backup Controller or the Hand Crank to maintain circulation. When the Backup Controller
signals the Serious System Error (Overspeed Rotation Alarm), attach the centrifugal pump with the Hand Crank to
maintain circulation. [Otherwise, the pump may stop and may cause injury to the patient.]
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Precautions
Warning
Caution