Alliance™ II Inflation System

Prescriptive Information

Indications

The Alliance™ Inflation System is indicated for inflation and deflation of balloon dilation catheters while simultaneously monitoring balloon catheter pressures and for the crushing of biliary calculi when used with the Trapezoid™ RX Wireguided Retrieval Basket.

Contraindications

None known.

Warnings

For Alliance II Syringe / Gauge Assembly:

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.

Syringe for single patient 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.

After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Potential Adverse Events

None known.

Please be aware that potential adverse events 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.