202B1263075
4.2 Insertion and Observation
WARNING
Do not release your finger suddenly from the suction valve during
suction. Doing so may cause body fluid to splatter and pose an
infection risk.
To avoid the potential for patient injury including perforation, do not
apply excessive force of the endoscope or endotherapy device against
mucosal surfaces. Only advance the endotherapy device under direct
visualization.
Do not inflate the balloon in the pharynx or esophagus. Doing so can
create a risk of suffocation.
Insert and withdraw the endoscope or Over-tube slowly. Do not press
the endoscope or Over-tube strongly onto the walls of the digestive
tract. Do not insert or withdraw the endoscope or Over-tube with the
balloon inflated. It may damage to the walls of the digestive tract,
causing perforation.
Use of devices such as endoscopic/enteroscopy overtubes may be
associated with potential complications including but not limited to
mucosal trauma, pancreatitis and/or hyperamylasemia. Users are
encouraged to closely monitor patients for such complications during
and after procedures and to appropriately treat patients as required.
[Note] If any resistance is felt during insertion, stop using this product immediately.
When using this product, monitor the status of the balloon, Over-tube and
endoscope with X-ray fluoroscopy.
[Note] If water enters the air feed inlet of the Over-tube, deflate the balloon using a
syringe, and then slowly withdraw the Over-tube along with the endoscope.
Chapter 4 Method of Use
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