COOK Medical NASAL BILIARY DRAINAGE SET, Instructions For Use Manual

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respiratory depression or arrest, sepsis, trauma / edema to upper GI tract
Potential adverse events associated with nasal biliary drainage include, but are
not limited to: blockage of the drainage catheter, cholangitis, fever, hemorrhage,
infection, nasal irritation and/or sore throat, obstruction of the pancreatic duct,
pain / discomfort, perforation, stasis, trauma / edema of duct, trauma / edema of
papilla / papillary fronds, trauma to duodenum, trauma to nasal cavity.
PRECAUTIONS
The product is intended for use by physicians trained and experienced in upper GI
endoscopy and ERCP techniques.
Standard techniques for the endoscopic placement of a drainage catheter in the
biliary duct should be employed.
Refer to package label for minimum channel size required for this device.
A complete diagnostic evaluation of the patient prior to use to determine proper
catheter size should be carried out.
Do not use this device for any purpose other than stated intended use.
Store in a dry location, away from temperature extremes.
Use of this device restricted to a trained healthcare professional.
Pigtail straightener, if any, is not intended for use in accessory channel of
endoscope.
This device is not intended for use beyond 29 days.
Sphincterotomy is not required for device placement.
It is recommended that drainage collection bag be available for use during
procedure.
3-way stopcock in Drainage connecting tube is not intended for introduction of
any medication, contrast media or saline to the patient.
It is recommended that drainage catheter be periodically evaluated for patency.
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.
Visually inspect the packaging and device. If the packaging is opened or damaged
when received, do not use. If a device abnormality is detected that would prohibit
proper working condition, do not use. Please notify Cook for return authorization.
MR Safety Information
This symbol means the device is MR Conditional.
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