Ancillary Equipment
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If combinations of ancillary equiment other than those described in this IFU are used, full
responsability is assumed by the medical treatment facility.
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A defective vacuum pump could lead to a loss of cooling and increased temperature at
the tip of the endoscope. Make sure to have another vacuum source available.
Operation of the Endoscope
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Never perform angulation control forcibly or abruptly. Never forcefully pull, twist, or
rotate the angulated bending section. Patient injury, bleeding, and/or perforation
may result. It may also become impossible to straighten the bending section during an
examination. Never operate the bending section, feed air or perform suction, insert
or withdraw the endoscope’s insertion section, or use endoscopic accessories without
viewing the live endoscopic image or when the image is frozen or magnified. Patient
injury, bleeding, and/or perforation may result.
•
Never insert, withdraw or operate the insertion section abruptly or with excessive force.
Patient injury, bleeding, and/or perforation may result.
•
Never insert or withdraw the endoscope’s insertion section while the bending section is
bent or locked in position. Patient injury, bleeding, and/or perforation may result.
•
Never insert or withdraw the endoscope while the elevator is raised, or when
endoscopic accessory extends from the distal end of the endoscope. Otherwise, patient
injury, bleeding, and/or perforation can result.
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Firmly connect the suction tube from the suction pump to the suction connector on the
endoscope. If the suction tube is not attached properly, debris may drip from the tube
and can pose an infection control risk, cause equipment damage, and/or reduce suction
capability.
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If the sterile water level in the water bottle is too low, replace the bottle with a new one.
An empty bottle can cause loss of rinsing and cooling function. Always keep a new bottle
of sterile water ready for this case.
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If blood unexpectedly adheres to the surface of the insertion section of the withdrawn
endoscope, carefully check the condition of the patient.
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Do not use the endoscope if any parts of the endoscope or endoscopic accessory fall off
inside the patient body due to equipment damage or failure. Stop using the endoscope
immediately and retrieve all parts in an appropriate way, otherwise serious patient injury
may occur.
Image
Always check whether the image on the screen is a live image or a recorded image and verify
that the orientation of the image is as expected. Do not use this device if the live image cannot
be observed, otherwise patient injury may occur.
•
Always set the intensity of electrosurgical instruments to the lowest required value
to avoid image disturbance. Do not increase the level of intensity above the standard
ERCP settings. Always limit the continuous activation time of electrical instruments to
a minimum.
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If an abnormal endoscopic image appears or an abnormal function occurs but
quickly corrects itself, the endoscope may have malfunctioned. In this case, consider
abandoning the procedure because the irregularity can occur again, and the endoscope
may not return to its normal condition. Stop the examination immediately and slowly
withdraw the endoscope while viewing the endoscopic image. Otherwise, patient injury,
bleeding, and/or perforation can result.
Over-insufflation & gas
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Confirm that the top hole of the insufflation/rinsing valve is not blocked. If the hole is
blocked, air is fed continuously and patient pain, bleeding, and/or perforation can result.
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Do not inflate air or a nonflammable gas excessively into the patient. This could cause gas
embolism and/ or over-insufflation.
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