RX Locking Device

Prescriptive Information

Refer to the operator's manual for complete instructions for use.

Indications

The RX Locking Device is intended to lock the guidewire in place during ERCP. The RX Biopsy Cap is intended to facilitate the use of Rapid Exchange devices during ERCP.

Contraindications

None known.

Warnings

For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which in turn may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

Potential Adverse Effects

These devices are accessories used with Biliary RX devices. Read appropriate Instructions for Use for complications associated with the procedure and device being used. Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

Cautions

Cautions can be found in the product labeling supplied with each device. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

• The RX Locking Device should only be used by or under the supervision of physicians trained in Endoscopic Retrograde Cholangiopancreatography (ERCP) or Endoscopic Spincterotomy (ES). A thorough understanding of the technical principles, clinical applications and risks associated with ERCP/ES is necessary before using this device.
• The RX Locking Device is compatible with 0.035 in. (0,90 mm) and 0.025 in. (0,63 mm) guidewires.
• Any use of these devices, other than those indicated in these instructions, is not recommended.