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RELIEVA SPINPLUS® NAV Balloon Sinuplasty System
The RELIEVA SPINPLUS® NAV Balloon Sinuplasty System provides precise, single-handed control for navigated sinus access, dilation, and irrigation.
|Catalog Number||Balloon Diameter (mm) x Length (mm)|
|RSP0516MFSN||5 x 16|
|RSP0616MFSN||6 x 16|
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- Intended for single patient use only. DO NOT REUSE.
- Do not use a RELIEVA SPINPLUS® NAV 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® NAV 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, or Sinus Balloon Catheter 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 airor radiopaque contrast.
- Prior to irrigation through the RELIEVA SPINPLUS® NAV 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® NAV 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.
- The RELIEVA SPINPLUS® NAV 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® NAV 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.
- The Sinus Navigation Guidewire is a precision instrument and must be handled with care. Do not pinch or kink the body of the Sinus Navigation Guidewire.
- Do not attempt to alter the distal tip shape of the Sinus Navigation Guidewire, as this may result in device damage.
- Use care when connecting the Sinus Navigation Guidewire to the ACCLARENT® ENT Navigation System Instrument Hub to prevent damage to the proximal connector pins.
- RELIEVA SPINPLUS® NAV System materials are not compatible with magnetic resonance imaging (MRI).
- The RELIEVA SPINPLUS® NAV Balloon Sinuplasty System is compatible with the RELIEVA® Spin Sinus Guide Catheter Tips (S-0, F-70, and M-110C), the ACCLARENT® Balloon Inflation Device, the ACCLARENT® SE Inflation Device, the RELIEVA® Extension Tubing
- The RELIEVA SPINPLUS® NAV is compatible with the ACCLARENT® ENT Navigation System.
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.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
This site is published by Acclarent, Inc. which is solely responsible for its contents. It is intended for visitors from the United States.
© Acclarent, Inc. 2020. Last Updated on 09/30/2020