entellus Medical

Entellus Medical 3844-001-Portable Red LED Light Source Instructions for Use Rev A July 2017

Instructions for Use

5 Pages

​​​​​  INSTRUCTIONS​ ​FOR​ ​USE  Portable​ ​Red​ ​LED​ ​Light​ ​Source Read​ ​all​ ​instructions​ ​prior​ ​to​ ​use  Caution:​ ​ ​Federal​ ​(USA)​ ​law​ ​restricts​ ​this​ ​device​ ​to​ ​sale​ ​by​ ​or​ ​on​ ​the​ ​order​ ​of​ ​a​ ​physician.  1. INTRODUCTION Intended​ ​Use  The​ ​Entellus​ ​Medical​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source™​ ​is​ ​intended​ ​for​ ​use​ ​in​ ​a​ ​physician’s​ ​office​ ​during​ ​endoscopic​ ​procedures.​ ​ ​The​ ​Light​ ​Source​ ​is​ ​not intended​ ​for​ ​use​ ​in​ ​the​ ​sterile​ ​field. Indication​ ​for​ ​Use  The​ ​Light​ ​Source​ ​is​ ​indicated​ ​for​ ​use​ ​in​ ​endoscopic​ ​procedures​ ​to​ ​locate,​ ​illuminate​ ​within,​ ​and​ ​transilluminate​ ​across​ ​nasal​ ​and​ ​sinus​ ​structures​ ​when​ ​used with​ ​the​ ​Entellus​ ​Medical​ ​MiniFESS™​ ​Light​ ​Seeker™. Description  The​ ​Light​ ​Source​ ​is​ ​a​ ​non-sterile,​ ​reusable​ ​device​ ​that​​ ​is​ ​designed​ ​to​ ​be​ ​attached​ ​to​ ​the​ ​Light​ ​Seeker.​ ​The​ ​internal​ ​red​ ​LED​ ​provides​ ​sufficient​ ​light​ ​to​ ​allow​ ​the Light​ ​Seeker​ ​to​ ​locate,​ ​illuminate​ ​and​ ​transilluminate​ ​across​ ​nasal​ ​and​ ​sinus​ ​structures​ ​by​ ​providing​ ​three​ ​levels​ ​of​ ​intensity.​ ​ ​The​ ​Light​ ​Source​ ​is​ ​powered​ ​by​ ​an internal​ ​lithium-ion​ ​rechargeable​ ​battery. The​ ​Light​ ​Source​ ​package​ ​includes​ ​the​ ​Light​ ​Source​ ​(with​ ​ACMI​ ​connector),​ ​battery​ ​charger​ ​(with​ ​AC/DC​ ​adapter),​ ​and​ ​two​ ​lithium​ ​ion​ ​battery​ ​cells.​ ​ ​Refer​ ​to Figure​ ​1​ ​below.  Figure​ ​1​ ​–​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source​ ​(Catalog​ ​Number​ ​PRLS-100) Contraindications None​ ​known  Warnings ● Do​ ​not​ ​use​ ​the​ ​Light​ ​Source​ ​within​ ​a​ ​sterile​ ​field​ ​as​ ​this​ ​may​ ​result​ ​in​ ​cross​ ​contamination,​ ​since​ ​the​ ​device​ ​is​ ​unable​ ​to​ ​be​ ​sterilized. ● Use​ ​only​ ​the​ ​supplied​ ​battery​ ​charger​ ​(RLC-100)​ ​with​ ​the​ ​Entellus​ ​Medical​ ​(RLB-100)​ ​battery​ ​cells.​ ​ ​Use​ ​of​ ​another​ ​battery​ ​may​ ​present​ ​a​ ​risk​ ​of​ ​fire​ ​or explosion. ● Do​ ​not​ ​attempt​ ​to​ ​modify​ ​or​ ​disassemble​ ​the​ ​Light​ ​Source​ ​or​ ​any​ ​component.​ ​ ​Doing​ ​so​ ​may​ ​damage​ ​the​ ​device​ ​or​ ​create​ ​a​ ​safety​ ​hazard. ● Do​ ​not​ ​use​ ​if​ ​rear​ ​battery​ ​cap​ ​is​ ​not​ ​completely​ ​tightened​ ​to​ ​the​ ​Light​ ​Source.​ ​ ​Operating​ ​with​ ​the​ ​rear​ ​cap​ ​loose​ ​may​ ​increase​ ​the​ ​risk​ ​of​ ​electric​ ​shock. Precautions ● Clean​ ​and​ ​low-level​ ​disinfect​ ​the​ ​Light​ ​Source​ ​prior​ ​to​ ​use​ ​and​ ​after​ ​every​ ​subsequent​ ​use,​ ​employing​ ​only​ ​the​ ​procedures​ ​listed​ ​in​ ​this​ ​manual. ● Do​ ​not​ ​sterilize​ ​the​ ​Light​ ​Source​ ​using​ ​any​ ​method,​ ​as​ ​this​ ​will​ ​destroy​ ​the​ ​Light​ ​Source. ● Do​ ​not​ ​submerge​ ​or​ ​allow​ ​liquids​ ​to​ ​enter​ ​the​ ​Light​ ​Source​ ​as​ ​it​ ​is​ ​not​ ​waterproof​ ​and​ ​this​ ​will​ ​destroy​ ​the​ ​device. ● Use​ ​only​ ​the​ ​supplied​ ​AC/DC​ ​adapter​ ​with​ ​the​ ​battery​ ​charger. ● Test​ ​the​ ​Light​ ​Source​ ​prior​ ​to​ ​any​ ​procedure​ ​to​ ​ensure​ ​functionality. ● Do​ ​not​ ​stare​ ​directly​ ​at​ ​the​ ​Light​ ​Source​ ​or​ ​point​ ​it​ ​directly​ ​at​ ​anyone’s​ ​eyes​ ​while​ ​illumination​ ​is​ ​active. Recommended​ ​Supplies​ ​and​ ​Compatible​ ​Equipment The​ ​following​ ​supplies​ ​and/or​ ​equipment​ ​are​ ​not​ ​provided​ ​but​ ​are​ ​required​ ​to​ ​use​ ​the​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source: ● Compatible​ ​ENT​ ​equipment​ ​such​ ​as​ ​the​ ​Entellus​ ​Medical​ ​MiniFESS​ ​Light​ ​Seeker. ● CaviWipes​ ​low-level​ ​disinfectant,​ ​or​ ​equivalent​ ​product ● 70%​ ​Isopropyl​ ​alcohol​ ​(IPA) ● Lint-free​ ​cloths 3844-001-rA​ ​July​ ​2017  Entellus​ ​Medical​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source  Page​ ​1​ ​of​ ​5
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