Professionisti del settore sanitario
Hydrodebrider
Endoscopic Sinus Irrigation System
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Si, sono un operatore sanitario
Note: Ai sensi e per gli effetti dell’Art. 76 D.P.R. 445/2000 consapevole della responsabilità e delle conseguenze civili e penali previste in caso di dichiarazioni mendaci e/o formazione od uso di atti falsi, nonché in caso di esibizione atti contenenti dati non più corrispondenti a verità e consapevole altresì che qualora emerga la non veridicità del contenuto della presente decadranno i benefici per i quali la stessa è rilasciata confermo di essere un OPERATORE SANITARIO.
I contenuti presenti in questo sito contengono informazioni rivolte agli operatori sanitari, in quanto si riferiscono a prodotti rientranti nella categoria dei dispositivi medici che richiedono l’impiego o l’intervento da parte di professionisti del settore medico-sanitario.
Professionisti del settore sanitario
Hydrodebrider
Endoscopic Sinus Irrigation System
This website provides excerpts from our user manuals. It is important to consult the full system manuals for the most updated information. The most current version of each manual is located on our Medtronic Manual Library website.
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.
There are no known contraindications.
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.
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.
View the indications, safety, and warnings for the Integrated Power Console (IPC® System).
The Straightshot® M4 and M5 Microdebriders are part of the IPC® System and XPS® 3000 System.
View the indications, safety, and warnings for the Straightshot M4 and M5 Microdebriders.
View the indications, safety, and warnings for the Fusion® ENT Navigation System.
View the indications, safety, and warnings for the Endo-Scrub® 2 Lens Cleaning Sheaths.
View indications, safety, and warnings for Medtronic Xomed MeroGel® Nasal Dressing/Sinus Stent.
Medtronic Italia S.p.A. Società a socio unico soggetta ad attività di direzione e coordinamento da parte di Medtronic PLC.
Cap. soc. € 1.200.487,00 - Codice fiscale, partita IVA e numero di iscrizione al Registro delle Imprese di Milano-Monza-Brianza-Lodi 09238800156 – REA MI – 1275682. Sede Legale e Uffici Via Varesina, 162 Edificio Raimondi - 20156 Milano.