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ENGLISH
INTENDED USE
This device is used to dilate biliary strictures.
This device is indicated for adult use only.
NOTES
Store in a dry location, away from temperature extremes.
CONTRAINDICATIONS
Those specific to ERCP.
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.
Do not use this device for any purpose other than stated intended use.
Use of this device restricted to a trained healthcare professional.
POTENTIAL COMPLICATIONS
Those associated with ERCP include, but are not limited to: pancreatitis, cholangitis, aspiration,
perforation, hemorrhage, infection, sepsis, allergic reaction to contrast or medication,
hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.
PRECAUTION
Refer to package label for minimum channel size required for this device.
If unexpected resistance is met during the procedure, do not continue advancement of catheter
without first determining the cause of the unexpected resistance and taking remedial action.
If bleeding occurs during the procedure, stop the procedure immediately and take
remedial action.
INSTRUCTIONS FOR USE
1.
Introduce device into accessory channel of endoscope over a pre-positioned wire guide.
Advance in small increments until it is endoscopically visualized exiting endoscope and
proceed with cannulation.
2.
Under fluoroscopic monitoring, advance device to appropriate position to dilate stricture or
papillary orifice and proceed with dilation.
Upon completion of procedure, dispose of device per institutional guidelines for
biohazardous medical waste.
ČESKY
URČENÉ POUŽITÍ
Tento prostředek je určen k dilataci striktur žlučových cest.
Tento prostředek je indikován k použití pouze u dospělých pacientů.
POZNÁMKY
Skladujte na suchém místě, chraňte před extrémními teplotami.
KONTRAINDIKACE
Specifické pro endoskopickou retrográdní cholangiopankreatografii (ERCP).
VAROVÁNÍ
Tento prostředek je určen pouze k jednorázovému použití. Pokusy o opakované zpracování
prostředku, jeho opětovnou sterilizaci nebo opakované použití mohou vést k selhání prostředku
nebo k přenosu onemocnění.
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