Potential Complications - COOK Medical Quantum QID-1 Manual

ENGLISH
INTENDED USE
This device is used to inflate, deflate and monitor pressure of the Cook line
of balloon dilators during GI balloon dilation.
This device is indicated for adult use only.
NOTES
Do not use this device for any purpose other than the stated intended use.
Store in a dry location, away from temperature extremes.
Use of this device is restricted to a trained healthcare professional.
This device is supplied non-sterile and may not be sterilized by
any method.
CONTRAINDICATIONS
Those specific to the primary endoscopic procedure to be performed in
gaining access to the desired dilation site.
Those specific to dilation include, but are not limited to: uncooperative
patient; asymptomatic rings, webs, or strictures; inability to advance
the balloon dilator through the strictured area; coagulopathy; known
or suspected perforation; severe inflammation or scarring near the
dilation site.

POTENTIAL COMPLICATIONS

Those associated with gastrointestinal endoscopy include, but are not
limited to: perforation, hemorrhage, aspiration, fever, infection, allergic
reaction to medication, hypotension, respiratory depression or arrest,
cardiac arrhythmia or arrest.
PRECAUTIONS
The inflation device is used in conjunction with a balloon dilator. Refer to
the balloon dilator instructions for use for specific inflation instructions.
WARNINGS
This device is designed for single use only. Attempts to reprocess,
resterilize, and/or reuse may lead to device failure and/or transmission
of disease.
If package is opened or damaged when received, do not use. Visually
inspect with particular attention to kinks, bends and breaks. If an
abnormality is detected that would prohibit proper working condition,
do not use. Please notify Cook for return authorization.
SYSTEM PREPARATION
1. Examine the features of the Q.I.D. (See fig 1). Ensure the pressurize/
depressurize (P/D) knob is rotated completely counterclockwise and
the plunger is pushed completely forward. To move the plunger,
depress and hold the inflate/deflate (I/D) button. Release the I/D button
to lock the plunger in position.
4