SnapLoc™ Wire Guide Locking Device Animation

SnapLoc™ Wire Guide Locking Device
INSTRUCTIONS FOR USE (IFU):
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MORE INFO:
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CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or a properly licensed practitioner). Please read all instructions before using this device.
DEVICE DESCRIPTION
The SnapLoc wire guide locking device is an accessory device that attaches to the endoscope accessory channel to lock the wire guide in place during ERCP procedures. The device is designed to be compatible with Olympus®, Pentax®, and/or FujiFilm® endoscopes.
Performance Characteristics
For optimal performance, utilize device with non-fully hydrophilic coated .025” and .035” Cook wire guides. This device can accept up to 11.5 Fr Cook catheters.
Patient Population
The device is indicated for adult use only.
Contact with Body Tissue
The device has indirect patient contact.
Operating Principle
The device attaches onto the endoscope accessory channel. The device resists motion of the wire guide so other endoscopic accessory devices can be passed to the area of interest.
Intended User
Use of this device is restricted to a trained healthcare professional.
INTENDED USE
This device is an accessory to be used with endoscopic biliary and pancreatic devices to lock the wire guide(s) in place and to prevent reflux of bodily fluids during ERCP.
INDICATIONS FOR USE
This device is used for duodenoscope during the ERCP procedure.
CLINICAL BENEFITS
This device supports device placement or insertion during various ERCP procedures.
CONTRAINDICATIONS
Contraindications include those specific to ERCP and any procedures to be performed in conjunction with sphincterotomy.
WARNINGS
This device is designed for single use only. Attempts to reprocess, sterilize, and/or reuse may lead to contamination with biological or chemical agents and/or mechanical integrity failure of device.
If the package is opened or damaged when received, do not use. Visually inspect device. If an abnormality is detected that would prohibit proper working condition, do not use. Notify Cook for return authorization.
PRECAUTIONS
Do not use this device for any purpose other than the stated intended use.
POTENTIAL COMPLICATIONS
This device is used with Cook biliary and pancreatic devices. Read appropriate Instructions for Use for complications associated with the procedure and device being used.
HOW SUPPLIED
This device is supplied ethylene oxide (EtO) sterile, in a peel-open pouch. The peel-open pouches are packaged in multiples, inside of a protective packaging layer. The devices may not be re-sterilized by any method. Store in a dark, dry, cool place. Avoid extended exposure to light and extremes of temperature and humidity, direct sunlight, radiation, and sharps.