622513 40cc / 15ATM Switch Back ™ QL ® Voluminous™ Inflation Device Box of 10

Instructions for Use: Contents of unopened, undamaged package are: STERILE • NONPYROGENIC Disposable - This device is intended for one use only. Do not reuse or resterilize. Sterilized with Ethylene Oxide.

This device has been designed for single patient use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices (particularly those with long and small lumina, joints, and/or crevices between components) are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the combination of the device with pyrogens or microorganisms, which may lead to infectious complications. Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination, which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on the components that are influenced by thermal and/or mechanical changes.

Indications: The inflation device is recommended for use while performing balloon dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.