COOK Medical G22658, Manual

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ENGLISH
INTENDED USE
This device is used to inflate, deflate and monitor pressure for biliary dilation balloons.
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.
CONTRAINDICATIONS
Those specific to ERCP and any procedures to be performed in conjunction with balloon dilation,
including, but not limited to: asymptomatic strictures; inability to advance the balloon dilator
through the strictured area; known or suspected perforation; severe inflammation or scarring
near the dilation site.
POTENTIAL ADVERSE EVENTS
Potential adverse events associated with ERCP.
Potential adverse events associated with biliary ductal dilation include, but are not limited to:
pancreatitis, cholangitis, perforation, and hemorrhage.
PRECAUTIONS
The inflation device is used in conjunction with a balloon dilator. DO NOT use air or gaseous
substances to inflate the balloon, as this will result in reduced balloon effectiveness.
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 the 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. Notify Cook for return authorization.
SYSTEM PREPARATION
1. Ensure the plunger handle of the inflation device is rotated completely clockwise and is
pushed all the way in. To move the plunger, squeeze and hold the plunger lever located to
the side of the syringe cylinder. Release the lever to lock the plunger in position.
2. Rotate the stopcock and the connecting tube fittings until tight. The stopcock is provided to
facilitate purging of air.
3. Verify the sideport of the stopcock is closed by turning the “off” arm of the stopcock to
the sideport.
INSTRUCTIONS FOR USE
1. While holding the inflation device, submerge the connecting tube in a minimum of 30 ml
of fluid. Fill the device by compressing the plunger lever and pulling the plunger handle.
Release the plunger lever to lock the plunger in place. (See fig. 1)
2. To completely purge the inflation device of air, hold the inflation device upright and
compress the plunger lever while simultaneously grasping and pushing the plunger handle
until all air is expelled, and a maximum of 15 ml of fluid is in the device. (See fig. 2) While
maintaining the position of the plunger handle, release the plunger lever to lock the plunger
in place. Release the plunger handle. To add fluid to the syringe, repeat steps 1 & 2.
3. Attach the male Luer lock fitting of the stopcock to the hub of the balloon, and secure by
rotating the fittings. (See fig. 3)
4. While compressing the plunger lever, pull the plunger handle until vacuum is indicated
on pressure gauge. (See fig. 4). Maintain a vacuum with the handle, and then release the
plunger lever.
5. For rapid inflation, compress the plunger lever, then push the plunger handle forward until
significant resistance is met. (See fig. 5) Release the plunger lever while maintaining plunger
handle position. (See fig. 6)