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

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Precautions
Cautions
• When this system is used for negative-pressure blood removal aid, be cautious as the correlation between the flow and
motor speed of the centrifugal pump will change according to the strength of negative pressure applied to the reservoir.
• When the Drive Motor is removed, place a cap on the plug. [Equipment may be damaged.]
• Ensure the Pressure Sensor Cable and the Temperature Sensor Cable are connected to the correct channel. [The
detected pressure or temperature may not be displayed in a proper position on the screen.]
• When a pressure sensor is used, keep in mind that pressure sensor measurement errors may affect the pressure value
indicated and the operation of the Pressure Alarm. [Pressure sensor measurement errors may occur due to occlusion of
tube or cannula placement.]
• Do not use this system with any equipment other than the dedicated medical equipment. [If equipment other than the
dedicated medical equipment is used, this may result in decreased performance.]
• When using this medical equipment in a clinical treatment, refer to the latest information such as academic guidelines.
• Before use, check the instructions for use of the medical supplies and medical equipment that are used in combination.
• This system is to be used under the constant supervision of doctors, or qualified persons who have received direction or
instructions from such doctors, who are familiar with operative procedures in which extracorporeal circulation of open-
heart surgery is applied or who are familiar with operative procedures involving percutaneous cardiopulmonary support.
[Health damages may occur on the patient if it is mistakenly used.]
• Before using this system or when reusing it after not having used for a long time, make sure to conduct a pre-usage
inspection to ensure that the system operates normally and safely. If any abnormality is found, do not use this system.
[This may result in decreased performance.] Contact Terumo’s service representative for inspection and repair.
• If this system is used in a cardiac catheterization laboratory, ICU, CCU or chest operating room, connect the system to the
centralized ground centre. [If it is not connected, electric shock may occur.]
• Use this system only after ensuring the power supply is sufficient. [If total power consumption exceeds the supply limit after
the system is connected, this may affect other equipment. Additionally, as the Controller operates on battery if the supply
power is insufficient, the Controller cannot be used in an emergency.]
• Use the following dedicated devices for this system. Drive Motor (Catalogue No.: ME * SP200M), Hand Crank (Catalogue
No.: XX * SP05), ABD/Flow Sensor (Catalogue No.: ME * SPFAS01, ME * SPFAS02), Temperature Sensor Cable (Catalogue
No.: XX * SPCBL011, XX * SPCBL012), Pressure Sensor Cable (Catalogue No.: XX * SPCBL021), Fast Clamp (Catalogue
No.: ME
*
SPCLP01), CDI Communication Cable (Catalogue No.: XX
*
SPCBL031), Cart (Catalogue No.: XX
*
SPCRT01),
Fast Clamp Attachment (for EBS) (Catalogue No.: XX * SPCLP01), Fast Clamp Arm (Catalogue No.: XX * SPCLP02). [If
other devices are used, this may result in decreased performance. In addition, influence may be given to the emission level
of electromagnetic wave and the tolerance of this system.]
• Do not attach the ABD/Flow Sensor and the Fast Clamp to any tube other than the dedicated tube (internal diameter:
9.5 mm (3/8 inches)). [If a tube other than the dedicated tube is used, this may result in decreased performance.]
• Do not use any cable other than the included AC power cable. [Otherwise an electric shock or short circuit may occur
resulting in failure of this system.]
• Connect to a grounded AC power source. [If used without grounding, the electrical safety of this system is not guaranteed.]
• Avoid sudden temperature changes even when operating within the system ʼ s indicated temperature specifications.
[Condensation inside the system results in damage, time degradation, and decreased performance.]
• The cables (the Drive Motor, the ABD/Flow Sensor, the Temperature sensor cable, the Pressure Sensor Cable, the Fast
Clamp, the LAN cable, the CDI Communication Cable, the AC power cable, etc.) used for this system should not be
pinched with forceps or equipment, e.g. caster, or punctured with a needle. Protect the cables laid across the floor from
being damaged by casters. [If a cable is damaged, electric shock or fire may occur, and decreased performance may
result.]
• When using this system, pay attention to how the cables (the Drive Motor, the ABD/Flow Sensor, the Temperature sensor
cable, the Pressure Sensor Cable, the Fast Clamp, the LAN cable, the CDI Communication Cable, the AC power cable,
etc.) lay on the floor. [An operator may trip over the cables and fall.]
• If this system is tainted with blood, wipe the system immediately with a damp (not wet) soft cloth. Be sure to wear gloves to
prevent infection. [Infection may occur.]
• Since this system is precision equipment, it should not be used if it has received any impact (drop to floor, falling, violent
shock). [Even though no fault is observed in the system appearance, internal components may damage. This may result in
decreased performance (flow rate accuracy and various alarm functions, etc.), and therefore inspection is required.]
• Do not take this system into or used in a control area for radiation devices/MRI or inside a hyperbaric oxygen therapy
room. If the system is brought into these environments, immediately discontinue use. [This system is not designed to be
used in these environments. Malfunction, damage or degradation of this system may occur or it may lead to explosion.]
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