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

-​ ​Refer​ ​to​ ​appropriate​ ​Instructions​ ​for​ ​Use​ ​and​ ​safety​ ​procedures​ ​when​ ​preparing​ ​and​ ​using​ ​compatible​ ​supplies​ ​or​ ​equipment.

Care​ ​and​ ​Handling ● The​ ​Light​ ​Source​ ​is​ ​constructed​ ​of​ ​sensitive​ ​electronics​ ​and​ ​illumination​ ​components.​ ​Special​ ​care​ ​must​ ​be​ ​taken​ ​to​ ​prevent​ ​damage​ ​to​ ​the​ ​device​ ​and​ ​to maintain​ ​functionality​ ​and​ ​longevity.​ ​ ​Negligent​ ​care​ ​and/or​ ​handling​ ​may​ ​void​ ​warranty.​ ​ ​Refer​ ​to​ ​Section​ ​3.​ ​Cleaning,​ ​Disinfection​ ​&​ ​Maintenance​ ​for additional​ ​information.

2. INSTRUCTIONS​ ​FOR​ ​USE

Using​ ​the​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source​ ​Battery​ ​Charger 1. Plug​ ​the​ ​power​ ​cord​ ​into​ ​a​ ​110V​ ​wall​ ​outlet.​ ​ ​Then​ ​connect​ ​the​ ​AC/DC​ ​power​ ​adapter​ ​to​ ​the​ ​DC​ ​input​ ​jack​ ​of​ ​the​ ​battery​ ​charger. 2. Place​ ​one​ ​or​ ​both​ ​of​ ​the​ ​supplied​ ​battery​ ​cells​ ​into​ ​the​ ​charging​ ​bays​ ​by​ ​aligning​ ​the​ ​negative​ ​end​ ​of​ ​the​ ​battery​ ​cell​ ​with​ ​the​ ​negative​ ​symbol​ ​in​ ​the​ ​charging bay.​ ​Push​ ​on​ ​the​ ​battery​ ​cell​ ​until​ ​it​ ​is​ ​fully​ ​inserted.​ ​The​ ​dual​ ​charging​ ​bays​ ​allow​ ​both​ ​battery​ ​cells​ ​to​ ​be​ ​charged​ ​at​ ​the​ ​same​ ​time. 3. The​ ​charger​ ​indicates​ ​the​ ​charging​ ​status​ ​on​ ​the​ ​LCD​ ​screen.​ ​ ​The​ ​LCD​ ​screen​ ​displays​ ​the​ ​word​ ​“FULL”​ ​when​ ​charging​ ​is​ ​complete.

Preparation​ ​of​ ​the​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source 1. Verify​ ​that​ ​the​ ​Light​ ​Source​ ​has​ ​been​ ​manually​ ​cleaned​ ​and​ ​low-level​ ​disinfected​ ​prior​ ​to​ ​device​ ​preparation​ ​and​ ​use.​ ​Refer​ ​to​ ​Section​ ​3.​ ​Cleaning,​ ​Disinfection &​ ​Maintenance​ ​for​ ​additional​ ​information. 2. Ensure​ ​that​ ​the​ ​battery​ ​has​ ​sufficient​ ​charge​ ​prior​ ​to​ ​initiating​ ​the​ ​ENT​ ​procedure.​ ​ ​If​ ​necessary,​ ​charge​ ​batteries​ ​using​ ​the​ ​supplied​ ​110V​ ​AC​ ​battery​ ​charger. o If​ ​the​ ​Light​ ​Source​ ​power​ ​indicator​ ​is​ ​visibly​ ​lit​ ​blue​ ​and​ ​blinking,​ ​this​ ​indicates​ ​that​ ​the​ ​battery​ ​power​ ​is​ ​low​ ​and​ ​has​ ​at​ ​a​ ​minimum​ ​of​ ​two​ ​minutes​ ​of illumination​ ​time​ ​remaining. o The​ ​Light​ ​Source​ ​equipped​ ​with​ ​a​ ​fully​ ​charged​ ​battery​ ​will​ ​have​ ​enough​ ​power​ ​to​ ​achieve​ ​a​ ​minimum​ ​of​ ​60​ ​minutes​ ​of​ ​illumination​ ​time​ ​using​ ​the​ ​maximum brightness​ ​setting. 3. Unscrew​ ​and​ ​remove​ ​the​ ​rear​ ​battery​ ​cap​ ​and​ ​slide​ ​the​ ​battery​ ​completely​ ​forward​ ​into​ ​the​ ​Light​ ​Source.​ ​Replace​ ​the​ ​rear​ ​battery​ ​cap​ ​and​ ​tighten​ ​to​ ​finger-tight. Note:​ ​the​ ​negative​ ​terminal​ ​of​ ​the​ ​battery​ ​should​ ​line​ ​up​ ​with​ ​the​ ​negative​ ​icon​ ​symbol​ ​located​ ​on​ ​the​ ​Light​ ​Source​ ​towards​ ​the​ ​rear​ ​battery​ ​cap. 4. Attach​ ​the​ ​Light​ ​Source​ ​to​ ​the​ ​Light​ ​Seeker​ ​using​ ​the​ ​following​ ​method: o Grasp​ ​both​ ​the​ ​Light​ ​Source​ ​and​ ​the​ ​Light​ ​Seeker. o Screw​ ​the​ ​Light​ ​Seeker​ ​(clockwise)​ ​until​ ​it​ ​forms​ ​a​ ​tight​ ​seal.​ ​ ​Do​ ​not​ ​overtighten. Portable​ ​Red​ ​LED​ ​Light​ ​Source​ ​Instructions​ ​for​ ​Use​. 1. Power​ ​ON​ ​the​ ​Light​ ​Source​ ​using​ ​the​ ​power​ ​button.​ ​The​ ​Light​ ​Source​ ​power​ ​indicator​ ​will​ ​be​ ​visibly​ ​lit​ ​blue. 2. Push​ ​the​ ​power​ ​button​ ​of​ ​the​ ​Light​ ​Source​ ​1-3​ ​times​ ​to​ ​provide​ ​the​ ​desired​ ​light​ ​intensity. 3. Manipulate​ ​the​ ​device​ ​into​ ​the​ ​desired​ ​anatomy​ ​to​​ ​illuminate​ ​and​ ​transilluminate​ ​across​ ​nasal​ ​and​ ​sinus​ ​structures​ ​during​ ​the​ ​procedure. 4. Remove​ ​the​ ​Light​ ​Seeker​ ​from​ ​the​ ​nasal​ ​cavity. 5. Power​ ​OFF​ ​the​ ​Light​ ​Source 6. Remove​ ​the​ ​Light​ ​Seeker​ ​from​ ​the​ ​Light​ ​Source​ ​by​ ​unscrewing​ ​(counter​ ​clockwise)​ ​until​ ​disengaged.

3. CLEANING,​ ​DISINFECTION​ ​&​ ​MAINTENANCE The​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source​ ​is​ ​not​ ​intended​ ​to​ ​come​ ​into​ ​contact​ ​with​ ​the​ ​patient.​ ​ ​The​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source​ ​may​ ​be​ ​cleaned​ ​and​ ​low​ ​level disinfected,​ ​but​ ​not​ ​sterilized.​ ​Light​ ​Seekers​ ​used​ ​with​ ​the​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source​ ​are​ ​non-sterile​ ​and​ ​shall​ ​be​ ​handled​ ​according​ ​to​ ​their​ ​labeling.

Cleaning​ ​of​ ​the​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source 1. Power​ ​OFF​ ​the​ ​Light​ ​Source 2. Using​ ​a​ ​wipe​ ​such​ ​as​ ​a​ ​CaviWipe,​ ​thoroughly​ ​wipe​ ​the​ ​Light​ ​Source​ ​for​ ​a​ ​minimum​ ​of​ ​2​ ​minutes,​ ​ensuring​ ​surfaces​ ​remain​ ​visibly​ ​wet​ ​for​ ​the​ ​entire​ ​exposure duration.​ ​ ​Use​ ​new​ ​wipes​ ​as​ ​needed. 3. Allow​ ​the​ ​Light​ ​Source​ ​to​ ​air​ ​dry.​ ​ ​Once​ ​dry,​ ​visually​ ​inspect​ ​the​ ​device​ ​for​ ​any​ ​residual​ ​soil.​ ​ ​Repeat​ ​cleaning​ ​instructions​ ​if​ ​visible​ ​soil​ ​is​ ​present. 4. Proceed​ ​with​ ​disinfection​ ​process Low-level​ ​Disinfection​ ​of​ ​the​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source 1. Low-level​ ​disinfection​ ​should​ ​be​ ​performed​ ​immediately​ ​prior​ ​to​ ​use​ ​in​ ​a​ ​procedure. 2. Ensure​ ​that​ ​the​ ​Light​ ​Source​ ​has​ ​been​ ​cleaned​ ​and​ ​no​ ​residual​ ​soil​ ​remains. 3. Using​ ​a​ ​wipe​ ​such​ ​as​ ​a​ ​CaviWipe,​ ​thoroughly​ ​wipe​ ​the​ ​device​ ​for​ ​a​ ​minimum​ ​of​ ​3​ ​minutes,​ ​ensuring​ ​surfaces​ ​remain​ ​visibly​ ​wet​ ​the​ ​entire​ ​exposure​ ​duration. Use​ ​new​ ​wipes​ ​as​ ​needed. 4. Perform​ ​a​ ​final​ ​wipe​ ​of​ ​all​ ​surfaces​ ​with​ ​70%​ ​IPA​ ​for​ ​a​ ​minimum​ ​of​ ​1​ ​minute. 5. Allow​ ​the​ ​Light​ ​Source​ ​to​ ​air​ ​dry​ ​before​ ​continuing​ ​with​ ​procedure. Additional​ ​Maintenance The​ ​glass​ ​covering​ ​of​ ​the​ ​LED​ ​may​ ​be​ ​cleaned​ ​with​ ​a​ ​lint-free​ ​cloth​ ​as​ ​necessary.

4. STORAGE​ ​&​ ​DISPOSAL The​ ​Light​ ​Source​ ​and​ ​components​ ​may​ ​be​ ​stored​ ​at​ ​normal​ ​room​ ​temperature.​ ​ ​There​ ​are​ ​no​ ​special​ ​storage​ ​requirements. Follow​ ​local​ ​governing​ ​ordinances​ ​and​ ​recycling​ ​plans​ ​regarding​ ​the​ ​recycling​ ​or​ ​disposal​ ​of​ ​the​ ​device​ ​or​ ​components.​ ​ ​Lithium​ ​ion​ ​batteries​ ​in​ ​particular​ ​may have​ ​specific​ ​regional​ ​requirements​ ​for​ ​recycling​ ​or​ ​disposal.

5. MAINTENANCE​ ​OF​ ​QUALITY​ ​OF​ ​SERVICE​ ​&​ ​SECURITY The​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source​ ​is​ ​designed​ ​to​ ​maintain​ ​an​ ​adequate​ ​quality​ ​of​ ​service​ ​during​ ​its​ ​use​ ​in​ ​an​ ​office​ ​environment.

6. TROUBLESHOOTING,​ ​TECHNICAL​ ​SPECIFICATIONS​ ​&​ ​COMPLIANCE Troubleshooting Problem

3844-001-rA​ ​July​ ​2017

Possible​ ​Cause

Action

Entellus​ ​Medical​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source

Page​ ​2​ ​of​ ​5

The​ ​Light​ ​Source power​ ​button​ ​is blinking

Battery​ ​not​ ​charged Battery​ ​not​ ​fully​ ​inserted

The​ ​Light​ ​Source​ ​will not​ ​power​ ​up

Battery​ ​not​ ​charged Battery​ ​Polarity​ ​is​ ​reversed Light​ ​Seeker​ ​not​ ​connected to​ ​Light​ ​Source

No​ ​illumination​ ​or Loss​ ​of​ ​light​ ​from Light​ ​Source

Debris​ ​on​ ​LED​ ​glass​ ​cover Light​ ​intensity​ ​setting​ ​too low

Technical​ ​Specifications​ ​&​ ​Compliance

-Place​ ​the​ ​battery​ ​into​ ​the​ ​charger. -Slide​ ​the​ ​battery​ ​completely​ ​forward​ ​into​ ​the​ ​base​ ​of​ ​the​ ​Light​ ​Source. -Replace​ ​the​ ​rear​ ​battery​ ​cap​ ​and​ ​tighten​ ​to​ ​finger-tight.​ ​ ​Note:​ ​the​ ​negative​ ​terminal​ ​of​ ​the​ ​battery should​ ​line​ ​up​ ​with​ ​the​ ​negative​ ​icon​ ​symbol​ ​located​ ​on​ ​the​ ​Light​ ​Source​ ​towards​ ​the​ ​rear​ ​battery​ ​cap. -Place​ ​the​ ​battery​ ​into​ ​the​ ​charger. -When​ ​the​ ​charger​ ​indicator​ ​blinks​ ​and​ ​the​ ​display​ ​reads​ ​“full”,​ ​the​ ​battery​ ​is​ ​fully​ ​charged​ ​and​ ​ready​ ​for use. Remove​ ​batteries​ ​and​ ​reverse​ ​polarity. -Disconnect​ ​Light​ ​Seeker. -Ensure​ ​Light​ ​Seeker​ ​threads​ ​are​ ​fully​ ​seated​ ​on​ ​Light​ ​Source. -Consult​ ​IFU​ ​for​ ​Light​ ​Seeker. -Disconnect​ ​Light​ ​Seeker. -Clean​ ​glass​ ​covering​ ​at​ ​distal​ ​end​ ​of​ ​Light​ ​Source. -Clean​ ​light​ ​post​ ​of​ ​Light​ ​Seeker. -Ensure​ ​Light​ ​Seeker​ ​threads​ ​are​ ​fully​ ​seated​ ​on​ ​Light​ ​Source. -Adjust​ ​light​ ​setting​ ​to​ ​higher​ ​light​ ​intensity​ ​using​ ​Power​ ​Button.

Item Weight Expected​ ​service​ ​life Battery​ ​type Mode​ ​of​ ​operation Battery​ ​life​ ​at​ ​full​ ​LED​ ​power Battery​ ​lifetime/recharge​ ​cycles Safe​ ​operating​ ​ambient​ ​temperature​ ​range Safe​ ​storage​ ​and​ ​transport​ ​temperature​ ​range Safe​ ​operating,​ ​storage,​ ​&​ ​transport​ ​relative​ ​humidity​ ​range Complies​ ​with​ ​industrial​ ​electrical​ ​standards: Complies​ ​with​ ​medical​ ​safety​ ​standards: Complies​ ​with​ ​medical​ ​EMC​ ​standard:

Specification <​ ​83​ ​grams Minimum​ ​of​ ​1040​ ​hours​ ​of​ ​use Lithium​ ​Ion,​ ​3.6V,​ ​2000​ ​mAh Continuous Minimum​ ​of​ ​60​ ​minutes 250​ ​recharges 15​ ​–​ ​33ºC​ ​(59​ ​-​ ​91ºF) -10​ ​–​ ​50ºC​ ​(14​ ​-​ ​122ºF) 0​ ​–​ ​90%​ ​RH UL,​ ​IEC​ ​60950,​ ​IEC​ ​62133:2012,​ ​RoHS,​ ​WEEE IEC​ ​60601-1:2005/(R)2012;​ ​CAN/CSA-C22.2​ ​No.​ ​60601-1-08 IEC​ ​60601-1-2:2007;​ ​Type​ ​B​ ​Applied​ ​Part

Electromagnetic​ ​Compatibility​ ​(EMC) Medical​ ​Electrical​ ​Equipment​ ​needs​ ​special​ ​precautions​ ​regarding​ ​EMC​ ​and​ ​needs​ ​to​ ​be​ ​installed​ ​and​ ​put​ ​into​ ​service​ ​according​ ​to​ ​the​ ​EMC​ ​information​ ​provided in​ ​this​ ​section.​ ​ ​Portable​ ​and​ ​Mobile​ ​RF​ ​communications​ ​equipment​ ​can​ ​affect​ ​Medical​ ​Electrical​ ​Equipment.

Emission​ ​Test RF​ ​Emissions​ ​CISPR​ ​11 RF​ ​Emissions​ ​CISPR​ ​11 Harmonics​ ​IEC​ ​61000-3-2 Flicker​ ​IEC​ ​61000-3-3

Immunity​ ​Test ESD​ ​EN/IEC​ ​61000-4-2 EFT​ ​EN/IEC​ ​61000-4-4 Surge​ ​EN/IEC​ ​61000-4-5 Voltage​ ​Dips/Dropout EN/IEC​ ​61000-4-11 Power​ ​Frequency 50/60Hz,​ ​Magnetic​ ​Field EN/IEC​ ​61000-4-8

Guidance​ ​and​ ​Manufacturer’s​ ​Declaration​ ​-​ ​Emissions The​ ​Light​ ​Source​ ​is​ ​intended​ ​for​ ​use​ ​in​ ​the​ ​electromagnetic​ ​environments​ ​specified​ ​below. The​ ​customer​ ​or​ ​the​ ​user​ ​of​ ​the​ ​Light​ ​Source​ ​should​ ​assure​ ​that​ ​it​ ​is​ ​used​ ​in​ ​such​ ​an​ ​environment. Compliance Electromagnetic​ ​Environment​ ​-​ ​Guidance The​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source​ ​uses​ ​RF​ ​energy​ ​only​ ​for​ ​its​ ​internal​ ​function.​ ​ ​Therefore,​ ​its​ ​emissions​ ​are Group​ ​1 very​ ​low​ ​and​ ​are​ ​not​ ​likely​ ​to​ ​cause​ ​any​ ​interference​ ​in​ ​nearby​ ​electrical​ ​equipment. Class​ ​B The​ ​Red​ ​LED​ ​Light​ ​Source​ ​is​ ​suitable​ ​for​ ​use​ ​in​ ​all​ ​establishments,​ ​including​ ​domestic,​ ​and​ ​those​ ​directly N/A connected​ ​to​ ​the​ ​public​ ​low-voltage​ ​power​ ​supply​ ​network​ ​that​ ​supplies​ ​buildings​ ​used​ ​for​ ​domestic​ ​purposes. N/A

Guidance​ ​and​ ​Manufacturer’s​ ​Declaration​ ​–​ ​Immunity The​ ​Light​ ​Source​ ​is​ ​intended​ ​for​ ​use​ ​in​ ​the​ ​electromagnetic​ ​environments​ ​specified​ ​below. The​ ​customer​ ​or​ ​the​ ​user​ ​of​ ​the​ ​Light​ ​Source​ ​should​ ​assure​ ​that​ ​it​ ​is​ ​used​ ​in​ ​such​ ​an​ ​environment. EN/IEC​ ​60601​ ​Test​ ​Level Compliance​ ​Level Electromagnetic​ ​Environment​ ​-​ ​Guidance ±6kV​ ​Contact, Floors​ ​should​ ​be​ ​wood,​ ​concrete,​ ​or​ ​ceramic​ ​tile.​ ​ ​If ±6kV​ ​Contact,​ ​±8kV​ ​Air ±8kV​ ​Air floors​ ​are​ ​synthetic,​ ​the​ ​RH​ ​should​ ​be​ ​at​ ​least​ ​30%. ±2kV​ ​Mains,​ ​±1kV​ ​I/Os ±1kV​ ​Differential,​ ​±2kV​ ​Common N/A >95%​ ​Dip​ ​for​ ​0.5​ ​Cycle (Portable​ ​Red​ ​LED​ ​is​ ​powered N/A 60%​ ​Dip​ ​for​ ​5​ ​Cycles by​ ​an​ ​internal​ ​battery) 30%​ ​Dip​ ​for​ ​25​ ​Cycles >95%​ ​Dip​ ​for​ ​5​ ​Seconds 3​ ​A/m

3​ ​A/m

Power​ ​frequency​ ​magnetic​ ​fields​ ​should​ ​be​ ​that​ ​of​ ​a typical​ ​commercial​ ​or​ ​hospital​ ​environment.

Guidance​ ​and​ ​Manufacturer’s​ ​Declaration​ ​–​ ​Immunity The​ ​Light​ ​Source​ ​is​ ​intended​ ​for​ ​use​ ​in​ ​the​ ​electromagnetic​ ​environments​ ​specified​ ​below. 3844-001-rA​ ​July​ ​2017

Entellus​ ​Medical​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source

Page​ ​3​ ​of​ ​5

Immunity​ ​Test Conducted​ ​RF EN/IEC​ ​61000-4-6

Radiated​ ​RF EN/IEC​ ​61000-4-3

The​ ​customer​ ​or​ ​the​ ​user​ ​of​ ​the​ ​LED​ ​Light​ ​Source​ ​should​ ​assure​ ​that​ ​it​ ​is​ ​used​ ​in​ ​such​ ​an​ ​environment. EN/IEC​ ​60601​ ​Test Compliance​ ​Level Electromagnetic​ ​Environment​ ​-​ ​Guidance Level N/A Portable​ ​and​ ​mobile​ ​RF​ ​communications​ ​equipment​ ​should​ ​be​ ​used​ ​no​ ​closer​ ​to​ ​the 3Vrm,​ ​150kHz​ ​to (Portable​ ​Red​ ​LED Light​ ​Source​ ​than​ ​the​ ​distances​ ​calculated​ ​or​ ​listed​ ​below. 80MHz is​ ​powered​ ​by​ ​an Recommended​ ​Separation​ ​Distance internal​ ​battery) d​ ​=​ ​1.2​√​P​ ​80MHz​ ​to​ ​800MHz d​ ​=​ ​2.3​√​P​ ​800MHz​ ​to​ ​2.7MHz Where​ ​P​ ​is​ ​the​ ​maximum​ ​output​ ​power​ ​rating​ ​of​ ​the​ ​transmitter​ ​in​ ​watts​ ​and​ d ​ ​ ​is​ ​the recommended​ ​separation​ ​distance​ ​in​ ​meters. 3V/m​ ​(E1) Field​ ​strengths​ ​from​ ​fixed​ ​transmitters,​ ​as​ ​determined​ ​by​ ​an​ ​electromagnetic​ ​site​ ​survey, should​ ​be​ ​less​ ​than​ ​the​ ​compliance​ ​level​ ​(E1). 3Vm,​ ​80MHz​ ​to Interference​ ​may​ ​occur​ ​in​ ​the​ ​vicinity​ ​of​ ​equipment​ ​containing​ ​a​ ​transmitter​ ​or​ ​marked 2.7GHz with​ ​the​ ​following​ ​symbol:

Recommended​ ​Separation​ ​Distances​ ​between​ ​portable​ ​and​ ​mobile​ ​RF​ ​communications​ ​equipment​ ​and​ ​the​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source The​ ​Light​ ​Source​ ​is​ ​intended​ ​for​ ​use​ ​in​ ​the​ ​electromagnetic​ ​environment​ ​in​ ​which​ ​radiated​ ​RF​ ​disturbances​ ​are​ ​controlled.​ ​ ​The​ ​customer​ ​or​ ​user​ ​of​ ​the​ ​Light Source​ ​can​ ​help​ ​prevent​ ​electromagnetic​ ​interference​ ​by​ ​maintaining​ ​a​ ​minimum​ ​distance​ ​between​ ​portable​ ​and​ ​mobile​ ​RF​ ​Communications​ ​Equipment (transmitters)​ ​and​ ​the​ ​device​ ​as​ ​recommended​ ​below,​ ​according​ ​to​ ​the​ ​maximum​ ​output​ ​power​ ​of​ ​the​ ​communications​ ​equipment. Separation​ ​distance​ ​according​ ​to​ ​frequency​ ​of​ ​transmitter​ ​(m) Max​ ​Output​ ​Power​ ​of 150kHz​ ​to​ ​80MHz 80MHz​ ​to​ ​800MHz 800MHz​ ​to​ ​2.7GHz Transmitter​ ​(Watts) d​ ​=(1.2)(​√​P​) d​ ​=(1.2)(​√​P​) d​ ​=(2.3)(​√​P​) N/A 0.01 0.12 0.23 0.1 1 10

(Portable​ ​Red​ ​LED​ ​ ​ ​is​ ​powered by​ ​an​ ​internal​ ​battery)

0.38

0.73

1.2

2.3

Conducted​ ​RF​ ​Immunity​ ​testing does​ ​not​ ​apply,​ ​resulting​ ​in​ ​no separation​ ​data​ ​from​ ​150kHz​ ​to 80MHz.

3.8

7.3

12

23

100

7. WARRANTY​ ​&​ ​REPAIR​ ​SERVICE Limited​ ​Warranty Entellus​ ​Medical,​ ​Inc.​ ​warrants​ ​for​ ​a​ ​period​ ​of​ ​one​ ​(1)​ ​year​ ​following​ ​purchase​ ​of​ ​the​ ​product​ ​that​ ​the​ ​product​ ​will​ ​be​ ​free​ ​from​ ​defects​ ​in​ ​material​ ​and​ ​workmanship. Within​ ​the​ ​warranty​ ​period,​ ​upon​ ​receipt​ ​of​ ​Customer’s​ ​prior​ ​written​ ​notice,​ ​Entellus​ ​may​ ​either​ ​repair​ ​or​ ​replace​ ​defective​ ​parts/products​ ​at​ ​no​ ​charge​ ​to​ ​Customer. Entellus​ ​Medical​ ​warrants​ ​that​ ​reasonable​ ​care​ ​has​ ​been​ ​used​ ​in​ ​the​ ​design​ ​and​ ​manufacture​ ​of​ ​this​ ​device.​ ​ ​Entellus​ ​Medical​ ​excludes​ ​all​ ​other​ ​warranties, whether​ ​expressed​ ​or​ ​implied,​ ​by​ ​operation​ ​of​ ​law​ ​or​ ​otherwise​ ​including,​ ​but​ ​not​ ​limited​ ​to,​ ​any​ ​implied​ ​warranties​ ​of​ ​merchantability​ ​or​ ​fitness​ ​since​ ​handling​ ​and storage​ ​as​ ​well​ ​as​ ​other​ ​factors​ ​relating​ ​to​ ​the​ ​patient,​ ​diagnosis,​ ​treatment,​ ​medical​ ​procedures,​ ​and​ ​other​ ​matters​ ​beyond​ ​Entellus​ ​Medical’s​ ​control​ ​directly​ ​affect the​ ​device​ ​and​ ​the​ ​results​ ​obtained​ ​from​ ​its​ ​use.​ ​ ​Entellus​ ​Medical​ ​shall​ ​not​ ​be​ ​liable​ ​for​ ​any​ ​incidental​ ​or​ ​consequential​ ​loss,​ ​damage​ ​or​ ​expense,​ ​directly​ ​or indirectly​ ​arising​ ​from​ ​the​ ​use​ ​of​ ​this​ ​device.​ ​ ​Entellus​ ​Medical​ ​neither​ ​assumes​ ​nor​ ​authorizes​ ​any​ ​other​ ​person​ ​to​ ​assume​ ​for​ ​it​ ​any​ ​other​ ​or​ ​additional​ ​liability​ ​or responsibility​ ​in​ ​connection​ ​with​ ​this​ ​device.​ ​ ​Refer​ ​to​ ​Entellus​ ​Medical,​ ​Inc.​ ​Standard​ ​Terms​ ​and​ ​Conditions.

8. SYMBOL​ ​DESCRIPTIONS​ ​&​ ​MANUFACTURER​ ​INFORMATION

LOT Consult​ ​Instructions for​ ​Use ISO​ ​15223-1:5.4.3

Lot​ ​Number

ISO​ ​15223-1:5.1.5

REF

MODE L Model​ ​Number

Catalog​ ​Number ISO​ ​15223-1:5.1.6

Manufacturer

Caution

Quantity

ISO​ ​15223-1:5.4.4

ISO​ ​15223-1:5.1.1

Standy​ ​-​ ​Power On/Off​ ​Switch IEC​ ​60417-5009

Symbols​ ​Reference

SN Non-ionizing radiation

IEC/TR​ ​60878-5140

Type​ ​B​ ​Applied Part IEC​ ​60417:5840

3844-001-rA​ ​July​ ​2017

Lithium-ion Battery​ ​–​ ​recycle

Device​ ​Is​ ​Non Sterile

ISO​ ​15223-1:5.2.7

Serial​ ​Number

ISO​ ​15223-1:5.1.7

Rx​ ​Only

Prescription​ ​Use Only 21​ ​CFR​ ​801.109

Entellus​ ​Medical​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source

ISO​ ​15223-1:2012​ ​–​ ​Medical​ ​Devices​ ​– Symbols​ ​to​ ​be​ ​used​ ​with​ ​medical​ ​device labels,​ ​labelling​ ​and​ ​information​ ​to​ ​be supplied​ ​Part​ ​1:​ ​General​ ​Requirements IEC​ ​60417:2002​ ​–​ ​Graphical​ ​symbols​ ​for use​ ​on​ ​equipment IEC/TR​ ​60878:2015​ ​–​ ​Graphical​ ​symbols​ ​for electrical​ ​medical​ ​practice

Not​ ​made​ ​with​ ​natural​ ​rubber​ ​latex

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per​ ​local regulations CaviWipes​ ​are​ ​a​ ​registered​ ​trademark​ ​of​ ​Metrex​ ​Research​ ​LLC.

Manufactured​ ​by: Entellus​ ​Medical​ ​Inc. 3600​ ​Holly​ ​Lane​ ​North,​ ​Suite​ ​40 Plymouth,​ ​MN​ ​ ​55447​ ​USA +​ ​1​ ​866-620-7615​ ​(f)​ ​+1​ ​866-620-7616 www.entellusmedical.com

3844-001-rA​ ​July​ ​2017

Entellus​ ​Medical​ ​Portable​ ​Red​ ​LED​ ​Light​ ​Source

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