Bedfont NObreath FeNO Bedienungsanleitung

NObreath

Aids in the diagnosis & management of asthma,

one breath at a me.

User Manual

FeNO Breath Monitor

0086

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12345!The!NObreath®!should!be!charged!for!a!minimum!of!4!hours!before!first!use.!

12345!The!default!PIN!for!the!NObreath®!is!0000.!Bedfont!strongly!advises!that!this!PIN!is!changed!

upon!installation!and!set-up!of!the!device.!

67-1!185!Please!read!the!manual!before!use.!!

67-1!185!Never!use!alcohol!or!cleaning!agents!containing!alcohol!or!other!organic!solvents!as!

these!vapours!will!damage!the!electrochemical!sensor!inside.!!

67-1!185!Under!no!circumstances!should!the!instrument!be!immersed!or!splashed!with!liquid.!!

67-1!185!Breath!tests!must!only!be!carried!out!with!Bedfont!accessories.!Failure!to!do!so!may!

cause!incorrect!readings.!!

67-1!185!The!mouthpieces!are!single!patient!use!only!and!can!be!used!for!a!maximum!of!3!tests.!

Further!re-use!could!cause!incorrect!readings!and!could!increase!the!risk!of!cross!infection.!The!

mouthpiece!should!be!disposed!of!after!use,!in!accordance!with!local!waste!disposal!guidance.!!

67-1!185!Patients!should!exhale!for!the!duration!of!time!indicated!by!the!monitor!during!a!breath!

test.!Failure!to!do!so!may!cause!incorrect!readings.!!

67-1!185!To!ensure!a!breath!sample!is!taken!at!the!correct!flow!rate,!the!monitor!must!be!held!

upright!at!all!times!during!a!breath!test.!!

67-1!185!Do!not!block!the!exhaust!ports!on!the!device!at!any!time.!Blocking!the!exhaust!ports!may!

cause!erroneous!readings.!!

97:3!215!Ensure!the!monitor!is!used!within!the!stated!operating!temperature!and!humidity!ranges.!

Operating!temperature!is!15-35oC.!Operating!humidity!is!25-80%!RH!(non-condensing).!

97:3!215!Portable!and!mobile!RF!communications!equipment!can!affect!the!NObreath®.!!

97:3!215!It!is!best!practice!to!keep!the!NObreath®!battery!at!2!blocks!charged.!Do!not!keep!the!

NObreath!on!charge!24/7.!Do!not!let!the!NObreath®!battery!run!flat.!

12345!See!Bedfont’s!infection!control!and!maintenance!guidelines!for!further!information!on!

infection!control.!!

12345!Please!do!not!attempt!to!modify!the!equipment!in!any!way!or!use!accessories!not!specified!

by!the!manufacturer.!Any!attempt!to!do!so,!will!invalidate!the!warranty!and!may!compromise!the!

safety!of!the!device.!!

12345!Bedfont®!will!make!available!on!request!service!training!to!appropriately!qualified!personnel.!

! !

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Important!Information/Reminders!....................................................................................................!1!

Introduction!........................................................................................................................................!3!

Definitions!..........................................................................................................................................!3!

Compliance!.........................................................................................................................................!3!

Intended!Use!......................................................................................................................................!3!

Contraindications!...............................................................................................................................!3!

Instrument!Layout!..............................................................................................................................!4!

Installation!and!Set-up!.......................................................................................................................!5!

User!Interface!.....................................................................................................................................!5!

Demo!mode!........................................................................................................................................!8!

Performing!a!Breath!Test!.................................................................................................................!11!

Patient!profiles!.................................................................................................................................!14!

Maintenance!....................................................................................................................................!20!

Settings!.............................................................................................................................................!21!

Data!Reset!........................................................................................................................................!35!

Technical!Specification!.....................................................................................................................!38!

Using!the!NObreath®!with!FeNOchart™!...........................................................................................!39!

Buttons!Explained!.............................................................................................................................!39!

Troubleshooting!...............................................................................................................................!40!

Safety!Information!...........................................................................................................................!42!

Parts!and!accessories!.......................................................................................................................!44!

Warranty!..........................................................................................................................................!45!

Returns!.............................................................................................................................................!45!

Responsible!Manufacturer!and!Contacts!.........................................................................................!45!

! !

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The!User!Manual!provides!instructions!on!how!to!operate!NObreath®!FeNO!monitor!and!its!

accessories.!It!contains!relevant!information!about!the!monitor,!its!uses!and!its!care,!including!step-

by-step!instructions!with!screens!and!illustrations.!

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67-1!185!indicates!a!potentially!hazardous!situation,!which,!if!not!avoided,!may!result!minor!or!

moderate!injury.!!

97:3!215!indicates!a!potentially!hazardous!situation,!which,!if!not!avoided,!may!result!in!damage!to!

the!device.!!

12345!used!to!call!attention!to!notable!information!that!should!be!followed!during!use.!

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NObreath®!is!CE!marked!according!to!the!Medical!Device!Directive!93/42/EEC.!

Please!refer!to!the!‘Safety!Information’!section!of!this!manual!for!more!information!on!the!

compliance!of!the!NObreath®.!

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The!NObreath®!is!a!breath!nitric!oxide!(NO)!test!system!intended!to!measure!fractional!exhaled!

nitric!oxide!(FeNO)!in!parts!per!billion!(ppb)!in!exhaled!breath.!

The!measurement!is!taken!to!evaluate!airway!inflammation!and!should!be!used!in!conjunction!with!

other!clinical!and!laboratory!evaluations!where!appropriate!when!making!a!diagnosis!or!treatment!

plan.!!

The!measurements!are!intended!for!interpretation!by!healthcare!professionals!and!for!use!in!a!

healthcare!environment,!where!patients!will!complete!measurements!under!supervision.!

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There!are!no!known!contraindications.!

! !

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1. ON/OFF!switch!

2. Touchscreen!

3. Mouthpiece!aperture!

4. ¼!turn!lock!

5. Manufacturer!label!

6. Exhaust!port!

7. Serial!label!

8. Exhuast!port!

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12345)The$NObreath®$should$not$be$operated$in$an$environment$outside$of$the$temperature$or$

humidity$ranges$stated$in$the$technical$specification.!

The!NObreath®!should!be!charged!for!4!hours!prior!to!first!use.!

The!default!PIN!is!0000.!It!is!strongly!recommended!to!change!this!prior!to!first!use!–!please!refer!to!

the!‘Change!PIN’!section!of!this!manual!for!instructions.!

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1.!Information!button!

2.!Battery!status!

3.!Adult!breath!test!

4.!Child!breath!test!

5.!Demo!mode!

6.!Patient!profiles!

7.!Settings!

! !

The!information!screen!displays!information!about!

the!monitor!and!sensor.!

I.&&+(L0)M.(;)N'L.)A)

1.!Date!and!time!options!

2.!Test!log!

3.!Change!PIN!number!

4.!Enable/disable!PIN!use!

5.!Change!flow-meter!style!

6.!Start!ambient!air!test!

7.!Service!Area!

8.!Home!button!

9.!Go!to!Settings!Menu!Page!2!

12345)The$Service$Area$must$only$be$accessed$by$

trained$personnel.!

I.&&+(L0)M.(;)N'L.)B)

1.!Increase!screen!brightness!

2.!Decrease!screen!brightness!

3.!Enable/disable!Bluetooth!

4.!Bluetooth!pairing!PIN!

5.!Go!to!Settings!Menu!Page!1!

! !

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The!NObreath®!has!an!in-built!

demonstration!video!of!the!breath!test!

process.!It!is!recommended!to!watch!this!

video!prior!to!using!the!device!for!the!first!

time.!This!demo!can!also!be!used!to!explain!

to!patients!how!the!test!will!run,!prior!to!

performing!one.!

Press!the!demo!icon!to!begin.!

Select!either!the!adult!or!child!patient.!

The!zero!screen!will!briefly!display!as!in!a!

real!test.!

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A!demonstration!will!run!through!the!

breath!test!process.!

The!whole!test!will!be!shown,!but!at!an!

accelerated!speed.!

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