12
General warnings and cautions
Warning
• The medical facility should determine whether or not to conduct an endoscopic examination
in patients determined to have lowered immunity.
• Do NOT use this endoscope with equipment other than those that have been specified for
combined use. Doing so may result in damage to the endoscope and patient injury.
• Do NOT drop the endoscope onto a hard surface or subject it to severe impact. This applies
particularly to the distal tip lens. Doing so may negatively impact image quality.
• Ensure to attach /connect an appropriate device to the connectors of the scope connector
such suction nipple, air/ water port, water jet port, or venting connector according to the IFU.
Incorrect connection or inappropriate use may result in unforeseen events.
• Always check the endoscopic image during endoscope angulation, air/ water feeding, and
suctioning, use of endoscopic devices, and endoscope insertion and withdrawal. Ensure that
these operations are performed in the normal (non- frozen, non - magnified) mode. Endoscope
peration in the freeze or magnification mode may result in damage to the endoscope and /or
patient injury.
• Do NOT forcefully insert and withdraw the endoscope. Doing so may result in patient injuries,
including bleeding and perforation.
• Do NOT perform retroflexed observations inside a narrow lumen. Doing so may cause patient
injury or make it impossible to withdraw the endoscope.
• After using operational /cleaning accessories (e.g., forceps, needles, snares, brushes, etc.)
with the endoscope, carefully check that all accessories are intact and that no parts have fallen
off and become lodged within the endoscope’s instrument /suction channel. Furthermore,
ensure that any endoscopic devices (e.g., clips, stents, etc.) passed through the channel
are accounted for after use. If the instrument /suction channel becomes blocked or clogged
due to the accumulation of debris, an accessory that can NOT be removed, or other cause,
do NOT attempt to correct the blockage or continue to use the endoscope. In such a case,
contact your local PENTAX Medical service facility to have the endoscope repaired. The use
of an endoscope with a blocked internal channel may result in ineffective reprocessing and /
or the introduction of debris and /or device components into a patient during a subsequent
procedure, posing a risk of cross contamination.
• This product is intended to be used in the electromagnetic environment specified by
"Electromagnetic disturbances". Using the product in an unintended environment may result
in incorrect exposure control of the light emitted from distal end of the endoscope due to
electromagnetic interference.
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