ACCLARENT^® SE Inflation Device

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Disclosures

Important Safety Information:

The ACCLARENT^® SE Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus and Eustachian tube procedures.

WARNINGS AND PRECAUTIONS

• Intended for single patient use only. DO NOT REUSE.
• After use, the Inflation Device may be a potential biohazard. Handle and dispose of in accordance with accepted hospital procedures.
• Do not use a device where the integrity of the sterile packaging has been compromised or if the device appears damaged.
• Do not exceed the recommended maximum inflation pressure of the balloon catheter being used.
• Do not use air or a gas medium to inflate the balloon.
• Not compatible with INSPIRA AIR^® Balloon Dilation System.

Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings, and precautions.

Caution: Federal (US) law restricts the sale, distribution or use of these devices to, by or on the order of a physician. Third party trademarks used herein are trademarks of their respective owners. This content is intended for audience within the US only.

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