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ROADRUNNER® BILIARY WIRE GUIDE
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or a properly licensed practitioner).
DEVICE DESCRIPTION
The Roadrunner® Biliary Wire Guide is coated with AQ (a biocompatible
hydrophilic coating), which when activated becomes lubricious. The wire
guide is made of a nitinol core with a distal platinum inner spring coil tip,
which is completely covered by a bismuth-impregnated polymer jacket.
INTENDED USE
The Roadrunner Biliary Wire Guide assists in cannulation for laparoscopic
and general surgical procedures for the dilation of the cystic duct to facilitate
common bile duct exploration.
CONTRAINDICATIONS
• Peritonitis
• Severe cholangitis
• Severe acute pancreatitis
• Known or suspected perforation of the cystic and/or bile ducts
WARNINGS
• Altering the tip's configuration or curve manually may damage the wire
guide.
• Excessive tightening of a torque device may abrade the coating on the
wire guide.
• 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.
• Carefully read all instructions prior to use. Failure to observe all warnings
and precautions may result in complications.
PRECAUTIONS
• This product is intended for use by physicians trained and experienced in
diagnostic and interventional techniques. Standard techniques for biliary
access and procedures should be employed.
• Always keep the surface of the wire guide wetted for optimal results.
• Roadrunner wire guides are very slippery when wet. Always maintain
control of the wire guide when manipulating it through the catheter.
INSTRUCTIONS FOR USE
Activating the AQ® Hydrophilic Coating
1. Attach the syringe with normal saline solution or sterile water to the Luer
lock fitting of the wire guide holder. (Fig. 1)
2. Inject enough solution or sterile water to wet the wire guide surface
entirely. This will activate the AQ coating, making the wire guide surface
very lubricous.
3. Attach the torque device to the wire guide.
4. Standard wire guide use may now be initiated. An initial flush of normal
saline or sterile water through the catheter lumen will enhance initial
movement of the wire guide through the catheter.
NOTE: If the surface of the wire guide becomes dry after removal from
the holder or catheter, wetting with additional normal saline or sterile
water will renew the hydrophilic effect.
2
Fig. 1
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