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CAUTION:
Do NOT clinically use the endoscope if any irregularity or abnormality
is suspected. If there is any doubt as to the suitability of use for any
endoscope component, replace it with a new fully reprocessed one. An
instrument irregularity may cause endoscope damage and/or compromise
patient or user safety.
CAUTION:
Endoscopic accessory instruments (EAIs) may be used with PENTAX
exible endoscopes. It should be understood that special care and caution
must be exercised when using accessories, particularly non-PENTAX
products through the instrument/suction channel of an endoscope. This
is especially true when attempting to pass accessories through narrow
channels when curved in a tight bending radius.
Please note that damage to the endoscope and/or accessory instrument
is possible if excessive force is applied during insertion (or withdrawal) of
the EAI. Also, using excessive force during insertion causes the withdrawal
of the EAI to be more difcult. Subsequently it contributes to the cause of
injury to patient tissue/membrane. To prevent insrument damage, device
failure, or patient injury, please adhere to the following precautions:
• Never apply too much pressure or excessive force during insertion
through the instrument channel.
• Never attempt to force endoscopic accessories, such as biopsy forceps
through a fully angulated bending section.
• Prior to using accessories from another source (non-PENTAX products),
contact the manufacturers of the accessories to confirm if the device
has been checked for compatibility.
Failure to follow these recommendations can result in endoscope and/or
accessory damage/failure, including but not limited to:
• Channel puncture/leakage
• Fluid invasion
• Fiber breakage
• Other internal component failure
Should resistance be encountered when inserting an accessory, STOP! If
resistance is at the endoscope tip, slightly withdraw the accessory, reduce
the angulation (within the bending section), then slowly and carefully
advance the accessory under direct vision.
Several factors can affect the ease/difculty of accessory passage through
the endoscope channel:
• Outside diameter of accessory compared to inside channel diameter
• Non-exible (rigid) portions of an accessory
• The curve or bend (bending radius) within a channel through which the
accessory will pass
• Damaged accessory
Due to the variables above, prior to each procedure, it is important to
check the particular accessory intended to be used to satisfy the clinical
procedure to be performed. Such pre-use inspections will allow for
uninterrupted and more expeditious examinations.
To conrm the absence of severe channel damage affecting the watertight
integrity of the endoscope, perform appropriate leak testing of the
endoscope per PENTAX instructions.
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