Hydrodebrider

Hydrodebrider Endoscopic Sinus Irrigation System

Indications

The Xomed^® Hydrodebrider^® System is indicated for use whenever irrigation of the paranasal sinuses is desired including post Endoscopic Sinus Surgery and office based irrigation.The Xomed Hydrodebrider is intended to treat such conditions and disorders as rhinitis and acute or chronic sinusitis.

Contraindications

There are no known contraindications.

Warnings

W1. This medical device complies with EN 60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for anesthetized patient.

W2. Disconnect power from the entire system before cleaning to avoid electrical shock.

W3. While using the Xomed Hydrodebrider System with electromechanical devices, maintain BF conditions (insulated, earth-free) to prevent electrical shock.

W4. Verify suction line of the Maxillary Handpiece is working properly to minimize ingestion of irrigation fluid during the procedure.

W5. In cases where the lamina papyracea has been compromised during the surgical procedure, care should be taken not to direct the flow of irrigant through the fistula and into the orbit.

W6. Ensure irrigation tubing clamp is closed when the system is not in use to avoid inadvertent spray.

W7. This equipment is not suitable for use in the presence of flammable mixtures.

W8. Care must be taken prior to and during the procedure to ensure drainage when using the Frontal Handpiece. Occlusion of the frontal ostium from fungal debris, bone chips, or other foreign matter could result in irrigant flowing to the brain.

W9. Always inspect components for damage before and after use. If damage is observed, do not use damaged part until it is repaired or replaced.

W10. To avoid risk of electric shock, this equipment must only be connected to a supply main with protective earth.

W11. Do not modify this equipment without authorization of the manufacturer.

Precautions

P1. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the user manual.

P2. Portable and mobile RF communications equipment can affect Medical Electrical Equipment.

P3. Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this product.

P4. The console should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the console should be observed to verify normal operation in the configuration in which it will be used.