Fusion® OMNI-Tome® Animation

Fusion® OMNI™ Sphincterotome with DomeTip®
INSTRUCTIONS FOR USE (IFU):
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MORE INFO:
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INTENDED USE
This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.
NOTES
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.
CONTRAINDICATIONS
Contraindications include those specific to ERCP and any procedures to be performed in conjunction with sphincterotomy. Contraindications to sphincterotomy include but are not limited to: coagulopathy and inability to properly position the sphincterotome cutting wire.
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.
POTENTIAL COMPLICATIONS
Potential complications 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.
PRECAUTIONS
Refer to package label for minimum channel size required for this device.
Maximum rated input voltage for this device is 1.5 kVp-p.
Any electrosurgical accessory constitutes a potential electrical hazard to patient and operator. Possible adverse effects include, but are not limited to: fulguration, burns, nerve and/or muscle stimulation and cardiac arrhythmia.
Before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode. Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout procedure.
Switch electrosurgical unit to“off”position when it is not in use.
When applying current, ensure cutting wire is completely out of endoscope. Contact of cutting wire with endoscope may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to endoscope.
If a non-protected wire guide is used in sphincterotome, it must be removed prior to applying electrosurgical current.
Do not over flex or bow tip beyond 90°, as this may damage or cause cutting wire to break.
Elevator should remain open/down when advancing or retracting sphincterotome.
If preloaded, use of wire guide with metal tip ERCP devices may result in damage to external coating and/or tip of wire guide.