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Disclosures

The RELIEVA SPINPLUS^® Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.

For children aged 17 and under, the RELIEVA SPINPLUS^® Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.

CONTRAINDICATIONS

None.

WARNINGS

• Intended for single patient use only. DO NOT REUSE.
• Do not use a RELIEVA SPINPLUS^® Balloon Sinuplasty System if the integrity of the sterile packaging has been compromised or if the device appears damaged.
• Do not use a RELIEVA SPINPLUS^® Balloon Sinuplasty System if the device becomes damaged or touches a non-sterile object outside of the operating field.
• Never advance or retract the RELIEVA^® Spin Sinus Guide Catheter Tip, Sinus Balloon Catheter or Sinus Illumination System against unknown resistance, as this could cause tissue trauma or device damage.
• Do not try to move the Sinus Guide Catheter Tip or Sinus Balloon Catheter while the Sinus Balloon is inflated, as this could cause tissue trauma or device damage.
• Do not exceed the recommended maximum Sinus Balloon inflation pressure of 12 atmospheres.
• Use only sterile saline or sterile water for inflation. Do not inflate with air or radiopaque contrast.
• Prior to irrigation through the RELIEVA SPINPLUS^® Balloon Sinuplasty System, ensure that the balloon is fully deflated so that sinus contents and irrigation fluid can exit the sinus cavity.
• To prevent inadvertent fluid extravasation, such as into the orbit, do not irrigate in the presence of a bony dehiscence or defect in any sinus wall.
• Do not use the RELIEVA SPINPLUS^® Balloon Sinuplasty System without a Sinus Guide Catheter Tip attached.
• Do not insert or inflate the Sinus Balloon with the protective red-tipped Balloon Sheath in place.
• Ensure the Sinus Balloon has fully exited the guide tip before inflating.
• Use of a Sinus Balloon Catheter that is too large for the target sinus may cause damage to the Sinus Balloon and / or surrounding anatomy. Use of an undersized Sinus Balloon may result in failure to properly treat the target sinus.
• The Balloon Sinuplasty System has a suction function that is designed to remove non-viscous fluids from the surgical field such as blood. Ensure that the suction level is reduced to the lowest level required to remove non-viscous fluids from the field. Excessively high suction levels may cause mucosal trauma.

PRECAUTIONS

• The RELIEVA SPINPLUS^® Balloon Sinuplasty System has a suction function that is designed to remove non-viscous fluids from the surgical field such as blood. Attempting to remove viscous material from the surgical field, such as thick mucus, could lead to device clogging.
• Prior to connection with an ACCLARENT^® Balloon Inflation Device to the Sinus Balloon Catheter, any proximally connected tubing must be free of air or the efficiency of inflation/deflation may be compromised.
• Only move or withdraw the Sinus Balloon Catheter when the Sinus Balloon is completely deflated. Advancing or retracting the Sinus Balloon Catheter while the Sinus Balloon is inflated may cause damage to the RELIEVA SPINPLUS^® Balloon Sinuplasty System.
• Due to the variability of sinus development in pediatric patients and as is standard practice for endoscopic sinus surgery, appropriate radiographic imaging (e.g. CT scan) should be reviewed prior to surgery to assess the development of sinus anatomy and compatibility with the Sinus Balloon Catheter.
• As with any sinus surgery, the Balloon Sinuplasty System should only be used for treatment of pediatric patients who are not responsive to medical therapy. 
• The safety of Ethylene Oxide residuals has been established in patients weighing 10 kg and above.
• Before opening the sterile package, visually inspect the package to ensure that the seals remain intact, the sterile integrity has not been compromised, and no damage has occurred during shipping and handling.
• Do not use the Sinus Illumination System with light sources whose bulbs are less than 20 hours old. Device damage may occur.
• Do not pinch or kink the wire, as this may result in reduction or loss of transcutaneous illumination.
• Do not attempt to alter the distal tip of the wire, as this may result in device damage.
• If using the system to trans-illuminate the frontal sinus, pre-operative review of a CT, x-ray or other image is recommended to help facilitate identification of the frontal sinus.
• Use only RELIEVA LUMA^® Light Guide Cables.with the RELIEVA SPINPLUS^® Balloon Sinuplasty System, as standard light guide cables may damage the optical components.
• Light from the tip of the system may transcutaneously illuminate tissue structures. The location and intensity of the transcutaneous illumination will depend on the sinus entered, orientation of the wire, and patient characteristics.
• To ensure maximum light transmission for subsequent uses in the same patient, rinse the distal tip of the Sinus Illumination System in saline after use in each sinus. 

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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