Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. Caution: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please check availability with your local sales representative or customer service.
Warning
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. 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. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy
Intended Use/Indications for Use
The Occlusion Balloon Catheters are indicated for use for temporary ureteral occlusion and applications including, renal opacification, dislodgment of calculi and preventative calculi migration. Any use for procedures other than those indicated in instructions is not recommended.
Warnings
See the product label for recommended shelf life. As with all latex rubber, the latex used in the balloon suffers deterioration over time. Storage beyond the expiration date listed on the package may cause the balloon to deteriorate.
Precautions
Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. • As with other balloon catheters, the likelihood of infection increases with prolonged insertion. It is recommended that the maximum insertion time be kept under 24 hours. • Care should be exercised in both introducing and removing balloons to avoid adding undue stress, which might rupture a balloon catheter. • Carefully read all instructions prior to using this device. Caution: A thorough understanding of the technical principles, clinical applications and risks associated with occlusion procedures is necessary before using this product.
