Bedfont NObreath FeNO User manual

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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=.*+(+&+$(0)
67-1!185!indicates!a!potentially!hazardous!situation,!which,!if!not!avoided,!may!result!minor!or!
moderate!injury.!!
97:3!215!indicates!a!potentially!hazardous!situation,!which,!if!not!avoided,!may!result!in!damage!to!
the!device.!!
12345!used!to!call!attention!to!notable!information!that!should!be!followed!during!use.!
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9$"#>+'(<.)
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!
A)
B)
C)
D)
E)
F)
G)
H)

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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!

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The!information!screen!displays!information!about!
the!monitor!and!sensor.!
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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!
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12345)The$Service$Area$must$only$be$accessed$by$
trained$personnel.!

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7!
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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.!
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Press!the!demo!icon!to!begin.!
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Select!either!the!adult!or!child!patient.!

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The!zero!screen!will!briefly!display!as!in!a!
real!test.!
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A!demonstration!will!run!through!the!
breath!test!process.!
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The!whole!test!will!be!shown,!but!at!an!
accelerated!speed.!

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Only!a!successful!test!will!be!demonstrated.!
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Once!the!result!is!displayed,!the!demo!is!
complete.!
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Press!the!home!icon!to!return!to!the!home!
screen.!
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N.%*$%"+(L)')O%.'&P)3.0&)
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Open!and!insert!a!new!mouthpiece!into!the!
NObreath®!monitor.!!
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To!start!a!breath!test,!select!either!the!
adult!or!child!patient.!
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As!prompted!onscreen,!take!a!deep!breath.!
!
12345!Do$not$inhale$through$the$
mouthpiece.!
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Press!the!home!button!at!any!time!to!
cancel!the!breath!test.!
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When!the!exhale!icon!displays,!keep!the!
monitor!upright!and!blow!gently!into!the!
mouthpiece.!
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12345)Make$sure$the$vent$holes$are$not$
covered.!
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The!exhalation!time!is!approximately!12!
seconds!for!an!adult!and!10!for!a!child.!

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The!onscreen!flow!meter!will!guide!the!patient!on!the!exhalation!rate:!
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Keep!the!
car!in!the!middle!
of!the!road.!
Keep!the!dial!
in!the!green!area.!
Keep!the!
car!in!the!middle!
of!the!road.!
Follow!the!bubbles.!
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A!green!tick!onscreen!indicates!a!successful!
test.!

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The!results!will!then!be!shown!onscreen!in!
ppb.!
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Return!to!the!home!screen!by!pressing!the!
home!button!or!save!the!result!to!a!patient!
profile.!
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If!the!patient!exhales!outside!of!the!
exhalation!guidelines,!the!test!will!beep!
before!indicating!a!fail!and!a!red!cross!will!
appear.!
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Press!the!retry!icon!to!retake!the!test!or!the!
next!arrow!to!view!the!result.!
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N'&+.(&)#%$*+>.0)
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The!NObreath®!is!designed!to!be!capable!of!
storing!results!in!up!to!50!patient!profiles!
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Press!the!profiles!icon!to!access!patient!
profiles.!
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If!the!PIN!has!not!been!entered!in!the!last!
30!minutes,!the!4-digit!code!will!be!required!
before!the!patient!profiles!can!be!accessed.)
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NOTE:!If$the$PIN$has$been$forgotten,$please$
contact$Bedfont®$or$its$local$distributor$to$
reset$it.$
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A!list!of!patient!profiles!will!show!onscreen.!
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Create$a$new$patient$profile$
To!create!a!new!profile,!choose!an!empty!
name!slot.!
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Use!the!keypad!to!enter!a!name!or!
reference.!
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Click!the!save!icon!to!create!the!profile.!
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To!cancel,!press!the!back!arrow!to!return!to!
the!list!of!profiles!or!the!home!icon!to!
return!to!the!main!screen.!
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Once!the!profile!has!been!created!the!
following!options!will!become!available:!
1. See!a!graph!of!results!
2. Delete!the!patient!profile!
3. Take!an!adult!breath!test!
4. Take!a!child!breath!test!
5. Return!to!the!profile!list!
6. Return!to!the!main!screen!

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Once!an!adult!or!child!breath!test!has!been!
selected,!the!profile!will!only!offer!that!
breath!test!mode!in!future.!
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Edit$a$patient$profile$
To!edit!a!patient’s!profile,!select!their!
name/ID!from!the!list.!

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Use!the!keypad!to!edit!the!profile.!
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Click!the!save!icon!to!save!the!changes.!
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To!cancel,!press!the!back!arrow!to!return!to!
the!list!of!profiles!or!the!home!icon!to!
return!to!the!main!screen.!
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Delete$a$patient$profile$
Select!the!patient!that!will!be!deleted!to!
load!their!profile.!
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Press!the!red!‘x’!to!delete!the!patient!
profile.!
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Press!the!tick!to!confirm.!
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The!profile!will!be!deleted!the!profile!screen!
will!be!displayed.!
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