INTENDED USE
The HydroCleanse™ sinus wash delivery system is intended to irrigate and suction within the paranasal sinuses.
INDICATIONS FOR USE
The HydroCleanse™ sinus wash delivery system is indicated for use whenever irrigation of the paranasal sinuses is desired.
DEVICE DESCRIPTION
The HydroCleanse™ sinus wash delivery system is a manual device that enables a user to simultaneously and continuously deliver pressurized saline irrigation to the paranasal sinuses and suction out excess fluid. The system consists of three major components: suction catheter tip, irrigator handle system, and syringe system.
The suction catheter tips include three different angles: 13°, 70°, 120°. The irrigator handle system includes an irrigation catheter with a fan-shaped spray nozzle and a rotating dial wheel for larger spray coverage, a spin lock for suction catheter tip attachment, and a suction connector that connects to a vacuum pump to provide suction. The syringe system includes a syringe with self-returning handgrip, a 3-way luer connector with check valves to prevent fluid backflow, and a spike for direct insertion into the saline bag. Spray action is initiated by depressing the handgrip and the syringe refills when the handgrip self-returns.
CONTRAINDICATIONS
None known.
WARNINGS
- Do not irrigate if the sinus cavity is compromised either intraoperatively or prior to surgery (for example, dehiscence, erosion, or fistula), or an anatomical anomaly is known or suspected.
- Do not use if the sterile package has been opened, or is damaged.
PRECAUTIONS
- Do not attempt to re-sterilize or reuse single use disposable device. Re-sterilization or reuse may result in device damage and patient injury.
- Dispose of the used HydroCleanse™ sinus wash delivery system following healthcare facility guidelines on proper disposal of contaminated materials.
- It is important to monitor the orbit for pressure changes and/or swelling during irrigation and to monitor for changes to vital signs that could be suggestive of increased ocular or cerebral pressure.
Verify the suction line is working properly to minimize ingestion of irrigation fluid during the procedure. The device may be configured to a suction only instrument when a higher suction rate is needed.