NObreath
®
Aids in the diagnosis & management of asthma,
one breath at a me.
User Manual
FeNO Breath Monitor
0086
!
1!
!
!"#$%&'(&)!(*$%"'&+$(,-."+(/.%0)
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!stron g ly!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!electroch emical!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®!batte ry!a t !2!b locks!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.!
! !
! !
2!
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9$(&.(&0)
Important!Informa tio n / R eminders!....................................................................................................!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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3!
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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!an d !its !ca re ,!inc lu d in g!s te p by-step!instructions!with!screens!and!illustrations.!
!
=.*+(+&+$(0)
67-1!185!indicates!a!potentially!hazardous!situatio n ,!w h ich ,!if!n o t! avoided,!may!result!minor!or!
moderate!injury.!!
97:3!215!indicates!a!potentially!haz a rd o u s!s itu a tio n ,!w h ich ,!if!n o t! avoided,!may!result!in!dam a ge !to !
the!device.!!
12345!used!to!call!attention!to!notable!information!that!should!be!followed!during!use.!
!
9$"#>+'(<.)
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®.!
!
!(&.(/./):0.)
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.!
!
9$(&%'+(/+<'&+$(0)
There!are!no!known!contraindications.!
!
! !
4!
!
!(0&%;".(&)?'@$;&)
!
!
1. ON/OFF!switch!
2. Touchscreen!
3. Mouthpiece!aperture!
4. ¼!turn!lock!
5. Manufacturer!label!
6. Exhaust!port!
7. Serial!label!
8. Exhuast!port!
A)B)C)D)E)F)G)
H)
!
5!
!
!
!(0&'>>'&+$()'(/)I.&J;#)
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.!
!
:0.%)!(&.%*'<.)
!
K$".)I<%..()
1.!Information!button!
2.!Battery!status!
3.!Adult!breath!test!
4.!Child!breath!test!
5.!Demo!mode!
6.!Patient!profiles!
7.!Settings!
! !
6!
!
!
The!information!screen!displays!information!about!
the!monitor!and!sensor.!
!
I.&&+(L0)M.(;)N'L.)A)
1.!Date!and!time!options!
2.!Test!log!
3.!Change!PIN!number!
4.!Enable/disable!PIN!use!
5.!Change!flow-meter!style!
6.!Start!ambient!air!test!
7.!Service!Area!
8.!Home!button!
9.!Go!to!Settings!Menu!Page!2!
!
12345)The$Service$Area$must$only$be$accessed$by$
trained$personnel.!
!
7!
!
!
I.&&+(L0)M.(;)N'L.)B)
1.!Increase!screen!brightness!
2.!Decrease!screen!brightness!
3.!Enable/disable!Bluetooth!
4.!Bluetooth!pairing!PIN!
5.!Go!to!Settings!Menu!Page!1!
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! !
8!
!
=."$)"$/.)
!
The!NObreath®!has!an!in-built!
demonstration!video!of!the!breath!test!
process.!It!is!recommended!to!watch!this!
video!prior!to!using!the!device!for!the!first!
time.!This!demo!can!also!be!used!to!explain !
to!patients!how!the!test!will!run,!prior!to!
performing!one.!
!
Press!the!demo!icon!to!begin.!
!
Select!either!the!adult!or!child!patient.!
!
9!
!
!
The!zero!screen!will!briefly!display!as!in!a!
real!test.!
!
)
A!demonstration!will!run!through!the!
breath!test!process.!
!
!
The!whole!test!will!be!shown,!but!at!an!
accelerated!speed.!
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10!
!
!
Only!a!successful!test!will!be!demonstrated.!
!
!
Once!the!result!is!displayed,!the!demo!is!
complete.!
!
Press!the!home!icon!to!return!to!the!home!
screen.!
!
)
!
11!
!
N.%*$%"+(L)')O%.'&P)3.0&)
!
Open!and!insert!a!new!mouthpiece!into!the!
NObreath®!monitor.!!
!
To!start!a!breath!test,!select!either!the!
adult!or!child!patient.!
!
!
As!prompted!onscreen,!take!a!deep!breath.!
!
12345!Do$not$inhale$through$the$
mouthpiece.!
!
Press!the!home!button!at!any!time!to!
cancel!the!breath!test.!
!
!
When!the!exhale!icon!displays,!keep!the!
monitor!upright!and!blow!gently!into!the!
mouthpiece.!
!
12345)Make$sure$the$vent$holes$are$not$
covered.!
!
The!exhalation!time!is!approximately!12!
seconds!for!an!adult!and!10!for!a!child.!
! !
12!
!
The!onscreen!flow!meter!will!guide!the!patient!on!the!exhalation!rate:!
!!!
!
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.!
!
!
A!green!tick!onscreen!indicates!a!successful!
test.!
!
13!
!
!
!
The!results!will!then!be!shown!onscreen!in!
ppb.!
!
Return!to!the!home!screen!by!pressing!the!
home!button!or!save!the!result!to!a!patient!
profile.!
!
!
If!the!patient!exhales!outside!of!the!
exhalation!guidelines,!the!test!will!beep!
before!indicating!a!fail!and!a!red!cross!will!
appear.!
!
Press!the!retry!icon!to!retake!the!test!or!the!
next!arrow!to!view!the!result.!
!
)
) )
! !
14!
!
N'&+.(&)#%$*+>.0)
!
The!NObreath®!is!designed!to!be!capable!of!
storing!results!in!up!to!50!patient!profiles!
!
Press!the!profiles!icon!to!access!patient!
profiles.!
!
!
!
If!the!PIN!has!not!bee n !en t er e d !in !th e !la st!
30!minutes,!the!4-digit!code!will!be!required!
before!the!patient!profiles!can!be!accessed.)
!
NOTE:!If$the$PIN$has$been$forgotten,$p le a se $
contact$Bedfont®$or$its$local$distributor$to$
reset$it.$
!
!
15!
!
!
A!list!of!patient!profiles!will!show!onscreen.!
!
!
!
Create$a$new$patient$profile$
To!create!a!new!profile,!choose!an!empty!
name!slot.!
!
! !
16!
!
!
Use!the!keypad!to!enter!a!name!or!
reference.!
!
Click!the!save!icon!to!create!the!profile.!
!
To!cancel,!press!the!back!arrow!to!return!to!
the!list!of!profiles!or!the!home!icon!to!
return!to!the!main!screen.!
!
Once!the!profile!has!been!created!the!
following!options!will!become!availa ble: !
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!
!
17!
!
!
!
Once!an!adult!or!child!breath!test!has!been!
selected,!the!profile!will!only!offer!that!
breath!test!mode!in!future.!
!
Edit$a$patient$profile$
To!edit!a!patient’s!profile,!select!their!
name/ID!from!the!list.!
! !
18!
!
!
Use!the!keypad!to!edit!the!profile.!
!
Click!the!save!icon!to!save!the!changes.!
!
To!cancel,!press!the!back!arrow!to!return!to!
the!list!of!profiles!or!the!home!icon!to!
return!to!the!main!screen.!
!
Delete$a$patient$profile$
Select!the!patient!that!will!be!deleted!to!
load!their!profile.!
!
!
19!
!
!
Press!the!red!‘x’!to!delete!the!patient!
profile.!
!
Press!the!tick!to!confirm.!
!
The!profile!will!be!deleted!the!profile!screen!
will!be!displayed.!
)
) )
! !
20!
!
M'+(&.('(<.)
Lifetime$of$a$NObreath®$
The!NObreath!has!unlimited!uses.!Subject!to!correct!use,!maintenance!and!service.!Tested!up!to!
30,000!tests.!
)
Routine$maintenance$$
1. Mouthpieces!are!to!be!replaced!after!every!patient.!!
2. Hands!should!be!washed!regularly!in!accordance!with!infection!control!practice.!
97:3!215)=$)($&);0.)0'(+&+0+(L)#%$/;<&0)<$(&'+(+(L)'><$P$>)'0)&P+0)"'@)/'"'L.)&P.)
0.(0$%0Q)
3. Only!use!accessories!approved!by!Bedfont®.!
97:3!215):0.)$*)'<<.00$%+.0)($&)'##%$R./)S@)&P.)"'(;*'<&;%.%)T+>>)+(R'>+/'&.)&P.)
T'%%'(&@!'(/)"'@)<$"#%$"+0.)&P.)0'*.&@)$*)&P.)/.R+<.Q!
4. It!is!best!practice!to!not !let !th e !b a tte ry !ru n !f lat .!If!th is !o c cu r s,!th e !d e vic e !m a y !n ee d !
calibration.!Please!contact!Bedfont!or!its!local!distributor!for!advice.!
!
Servicing$
1. The!NObreath®!should!be!calibrated!annually!or!the!NO!sensor!should!be!replaced.!
2. The!NO!scrubber!should!be!replaced!annually.!
3. The!NO!sensor,!breath!drying!cartridge!and!the!pump!should!be!replaced!every!5!years!
!
67-1!185)=$)($&)$#.()&P.)12S%.'&PU)/.R+<.Q)3P+0)<$;>/)%.0;>&)+()S$/+>@)P'%")'(/)')R$+/)+()
T'%%'(&@Q)I.%R+<+(L)0P$;>/)$(>@)S.)<'%%+./)$;&)S@)')O./*$(&U)&%'+(./)%.#%.0.(&'&+R.Q)
)
Cleaning$
1. Bedfont®!recommends!wiping!the!instrument’s!external!surfaces!with!a!product!
specifically!developed!for!this!purpose.!Bedfont®!provides!instrument!cleanin g!w ipe s.!
The!device!or!consumables!cannot!be!sterilised.!It!is!recommended!that!wipes!are!used!
once!and!for!one!surface!only.!The!NObreath®!device!should!be!cleaned!for!initial!use!
and!after!each!patient!use.!
97:3!215)=$)($&);0.)'(@)0;S0&'(<.0)<$(&'+(+(L)'><$P$>)$()$%)(.' %)&P. )12 S %. '&P UQ))
Under!no!circumstances!should!the!instrument!be!immersed!in!liquid!or!splashed!with!liquid.!
! !
!
21!
!
I.&&+(L0)
!
!
Change$the$date/time$
To!change!the!date!or!time,!press!the!edit!
date/time!icon!on!the!1st!page!of!the!settings!
menu.!
!
Select!either!/J"J@!or!"J/J@)for!the!d ate!fo rm at!
and!ABP!or!BDP!for!the!time!format.!The!purple!
circle,! ,!indicates!the!select e d !o p ti o n .!
!
To!adjust!the!date/time,!select!the!number!and!it!
will!become!highlighted.!Use!the!arrows!to!change!
as!desired.!
!
Press!the!save!button!to!keep!the!changes.!
!
To!cancel,!press!the!back!arrow!to!return!to!the!
settings!menu.!
! !
22!
!
!
Test$log$
To!access!the!test!log,!press!the!log!icon!on!the!1st!
page!of!the!settings!menu.!
!
!
!
The!most!recent!test!results!are!automatically!
saved!in!the!log!and!the!NObreath!can!store!150!
at!a!time.!
!
Use!the!arrows!to!scroll!through!the!log.!
!
Press!the!back!arrow!to!return!to!the!settings!
menu!or!the!home!icon!to!return!to!the!main!
screen.!
!
23!
!
!
Change$PIN$
Each!device!is!pre-set!to!the!PIN!code!0000.!It!is!
highly!recommended!that!the!PIN!is!changed!to!a!
memorable!4!digit!number.!
!
To!change!the!PIN!number,!press!the!change!PIN!
icon!from!the!1st!page!of!the!settings!menu.!
!
A!prompt!will!ask!for!the!current!PIN!to!be!
entered.!
)
If!the!PIN!has!been!forgotten,!please!contact!
Bedfont®!or!its!local!distributor!to!reset!it.!
!
! !
24!
!
!
Enter!the!current!PIN!and!press!the!next!
arrow!to!proceed.!
!
!
A!prompt!will!then!ask!for!a!new!PIN!number!
to!be!entered.!
!
!
!
25!
!
!
Enter!a!new!memorable!4!digit!code!and!press!
the!next!arrow!!to!continue!
!
!
A!prompt!will!ask!for!the!new!PIN!number!to!
be!re-entered!for!confirmation.!
! !
26!
!
!
Re-enter!the!PIN!to!confirm!the!new!4!digit!
code!and!press!the!tick!to!register!the!change.!
!
!
To!cancel,!press!the!back!arrow!to!return!to!
the!settings!menu!or!the!home!icon!to!retu rn!
to!the!main!screen.!
!
Enable/disable$PIN$
To!disable!the!PIN,!press!the!enable/disable!PIN!
icon!on!the!1st!page!of!the!settings!menu.!
!
27!
!
!
A!prompt!will!ask!for!the!PIN!number!to!be!
entered!in!order!to!disable!the!PIN!function.!
!
Once!the!PIN!function!is!disabled,!it!will!be!
crossed!out!in!the!settings!menu.!
!
To!re-enable!the!PIN!function,!simply!press!
the!enable/disable!button!again!and!re-enter!
the!PIN!to!confirm.!
! !
28!
!
!
Change$flow-meter$style$
To!change!the!flow-meter!style,!press!the!flowmeter!button!on!the!1st!page!of!the!settings!menu.!
!
Select!either!the!adult!or!child!test!mode!to!
change!the!flow-meter!style.!
!
29!
!
!
The!current!flow-meter!style!will!be!highlighted.!
!
Select!the!new!style!and!press!the!save!icon!to!
register.!
! !
30!
!
!
The!new!flow-meter!style!will!now!be!used!for!
that!breath!test!mode!and!the!relevant!de m o!
mode.!
!
Press!the!back!arrow!to!return!to!the!settings!
menu!or!the!home!icon!to!return!to!the!main!
screen.!
!
Ambient$air$test$
To!perform!an!ambient!air!test,!press!the!ambient!
test!icon!on!the!1st!page!of!the!settings!menu.!
!
31!
!
!
The!NObreath®!will!begin!sampling!the!
atmosphere!and!an!hourglass!be!shown!onscreen.!
!
The!result!will!be!shown!onscreen.!
!
Press!the!back!arrow!to!return!to!the!settings!
menu!or!the!home!icon!to!return!to!the!main!
screen.!
! !
32!
!
!
To!adjust!the!brightness!of!the!display,!go!to!the!
2nd!page!of!the!settings!menu!and!use!the!arrows!
to!increase/decrease!the!brightness!of!the!scre en .!
!
Enable/disable$Bluetooth$
To!enable!Bluetooth,!go!to!the!2nd!page!of!the!
settings!menu!and!press!the!enable/disable!
Bluetooth!button.!
!
33!
!
!
Once!Bluetooth!is!enabled,!the!Bluetooth!symbol!
will!no!longer!be!crossed!out!on!the!2nd!page!of!
the!settings!menu!and!a!Bluetooth!sym b ol!will!
appear!next!to!the!battery!status!icon.!
!
Press!the!icon!again!to!switch!Bluetooth!off.!
!
Press!the!back!arrow!to!return!to!the!settings!
menu!or!the!home!icon!to!return!to!the!main!
screen.!
!
Bluetooth$pairing$
To!pair!a!device!with!the!NObreath®,!go!to!the!2nd!
page!of!the!settings!menu!and!press!the!Bluetooth!
pairing!icon.!
! !
34!
!
!
The!screen!will!display!the!Bluetooth!pairing!PIN.!
!
Please!make!sure!the!Bluetooth!on!the!NObreath®!
and!the!other!device!is!switched!on!in!order!to!
pair!with!the!NObreath®.!
!
Press!the!back!arrow!to!return!to!the!settings!
menu!or!the!home!icon!to!return!to!the!main!
screen.!
!
! !
!
35!
!
='&')-.0.&)
!
To!access!the!Data!Reset!button,!first!remove!the!
back!cover!and!the!breath!drying!cartridge.!
!
This!will!reveal!the!Data!Reset!button!at!the!top!
right!of!the!NObreath®.!
!
Press!and!hold!the!Data!Reset!button!for!5!
seconds!and!the!screen!will!reveal!the!reset!icon.!!
!
12345!A$data$reset$will$erase$all$patient$data$from$
the$device$the$PIN$will$be$reset$to$the$default,$
0000.$
$
Press!the!tick!to!confirm!the!data!reset!or!cross!to!
cancel.!
! !
36!
!
!
An!egg!timer!will!display!onscreen!as!the!
NObreath®!begins!erasing!all!data.!
$
NOTE:!This$can$take$up$to$5$minutes$to$complete.!
!
Once!complete,!the!screen!will!prompt!you!to!add!
the!back!cover!again.!
!
Ensure!that!you!have!re-inserted!the!breath!
drying!cartridge!and!then!reattach!the!back!cover.!
!
37!
!
!
All!data!will!be!erased!and!the!home!screen!will!
display!once!more.!
!
! !
! !
38!
!
3.<P(+<'>)I#.<+*+<'&+$()
NObreath®$monitor$and$dock$
9$(<.(&%'&+$()%'(L.)
0-500ppb!
=+0#>'@)
Full!colour!touchscreen!
=.&.<&+$()#%+(<+#>.)
Electrochemical!sensor!
-.#.'&'S+>+&@)
±5ppb!of!measured!value!≤!50ppb!
±10%!of!measured!value!>!50ppb!
7<<;%'<@)
±5ppb!of!measured!value!≤!50ppb!
±10%!of!measured!value!>!50ppb!
N$T.%)
12S%.'&PU)"$(+&$%)
1!x!main!rechargeable!Li-ion!battery!–!Approx.!100!
uses!on!fully!charged!battery!
2!x!Li-ion!coin!cell!battery!–!Approx.!5!years!
Input:!5V,!0.5A!
12S%.'&PU)=$<V!
Mains!powered!
Input:!5V,!0.5A!
Output:!5V,!0.5A!
N>;L!
Input:!100-240V!~!50/60Hz.,!0.2A!
Output:!5.0V,!1.0A!
3
WX)
%.0#$(0.)&+".!
≤10!seconds!
3."#.%'&;%.)
2#.%'&+(L)
15-35oC!
I&$%'L.,&%'(0#$%&!
0-50°C!
K;"+/+&@)
2#.%'&+(L)
25-80%!RH!(non-condensing)!
I&$%'L.,&%'(0#$%&!
5-95%!RH!(non-condensing)!
2#.%'&+(L,&%'(0#$%&,0&$%'L.)#%.00;%.)
Atmospheric!±10%!
I.(0$%)$#.%'&+(L)>+*.)
5!years!(subject!to!servicing)!!
I.(0$%)0.(0+&+R+&@)
1ppb!
I.(0$%)/%+*&)
<5%!per!annum!
=+".(0+$(0)
Approx.!90!x!159!x!59!mm!
6.+LP&)
Approx.!400g!
M'&.%+'>0)
12S%.'&PU)"$(+&$%)
Case:!polycarbonate/ABS!blend!
SteriTouch®!anti-microbial!additive!
12S%.'&PU)=$<V!
O%.'&P)&.0&)&+".)
7/;>&)
12!seconds!
9P+>/!
10!seconds!
7"S+.(&!
30!seconds!
6'%"J;#)&+".)
≤60!seconds!
M'Y+";")'"S+.(&)$#.%'&+(L)>.R.>)
350!ppb!NO!
92)<%$00)+(&.%*.%.(<.))
45!ppm!≤17.6!ppb!
12345!Exhaled$flow$during$FeNO$measurement$at$50ml/sec$±10%$at$10cm$H20
!
NObreath®$mouthpiece$
!(*.<&+$()<$(&%$>)
An!integrated!infection!control!filter!removes!and!
traps!>98%!of!airborne!bacteria!and!>96%!of!viruses.!!
=+".(0+$(0)
Approx.!180!x!25!x!15!mm!
6.+LP&)
Approx.!11g!
M'&.%+'>0)
Polypropylene!
!
!
39!
!
:0+(L)&P.)12S%.'&PU)T+&P)Z.12<P'%&[)
The!NObreath®!monitor!is!supplied!with!FeNOchart™!software,!which!allows!patient!data!to!be!
synchronised!from!the!device!to!a!computer,!where!results!can!be!safely!stored!and!analysed.!
FeNOchart™!can!be!downloaded!directly!from!www.nobreathfeno.com.!
Insert!the!USB!lead!int o !th e !P C ,!and!connect!the!othe r!e n d !to !t h e!r ea r!of!the!docking!station.!P la c e!
the!NObreath®!into!the!docking!station,!co nn ectin g!it!to!the!m icro !US B!in!the !bas e.!Altern ative ly,!the!
micro!USB!lead!can!be!directly!connected!to!the!base!of!the!NObreath®!unit!itself.!
Before!starting!the!software,!ensure!that!the!NObreath®!is!connected!to!the!PC!and!switched!on.!
Double!click!the!FeNOchart!™!icon!on!the!PC!to!start!the!programme.!Refer!to!the!FeNOchart!™!
manual!for!how!to!operate!the!FeNOchart!™!software.!
!
O;&&$(0)4Y#>'+(./)
Information!
!
Retry!
!
Change!PIN!
!
Adult!test!
!
Save!!Disable!PIN!
!
Child!test!
!
Next!screen!
!
Enable!PIN!
!
Demo!mode!
!
Previous!screen!
!
Change!flow!meter!
style!
!
Patient!profiles!
!
Settings!
!
Ambient!test!
!
Home!button!
!
Date!&!time!
!
Disable!Bluetooth!
!
Graph!of!results!
!
Selected!
!
Enable!Bluetooth!
!
Delete!patient!
!
Increase!
!
Service!Area!
(See!service!manual)!
!
Confirm!
!
Decrease!
!
!!Cancel!
!
Test!log!
!
!
!
! !
! !
40!
!
3%$;S>.0P$$&+(L)
!
The!service!date!is!due!in!≤!30!days.!
!
This!will!be!displayed!every!day!until!it!has!been!
reset!by!performing!a!calibration!or!sensor!
change.!
!
365!days!has!elapsed!since!the!last!service.!
!
This!will!be!displayed!every!day!until!395!days!has!
surpassed!or!it!has!been!reset!by!performing!a!
calibration!or!sensor!change.!
!
395!days!has!elapsed!since!the!last!service.!
!
This!will!be!displayed!every!day!until!it!has!been!
reset!by!performing!a!calibration!or!sensor!
change.!
!
No!tests!can!be!performed!until!the!monitor!has!
been!serviced.!
!
41!
!
!
The!back!of!the!monitor!is!open.!
!
Make!sure!the!back!of!the!unit!is!secure!and!the!¼!
turn!lock!is!closed!to!continue.!
!
No!sensor!detected.!
!
Verify!the!sensor!is!correctly!inserted!to!continue.!
!
The!battery!is!flat.!!
!
Place!the!monitor!in!the!charging!dock!or!connect!
directly!to!the!mains.!
!
The!NObreath®!takes!8!hours!to!charge!fully.!
!
! !
! !
42!
!
I'*.&@)!(*$%"'&+$()
=.L%..)$*)#%$&.<&+$()'L'+(0&).>.<&%+<)0P$<V)
!
Type!BF!applied!part!
3@#.)$*)#%$&.<&+$()'L'+(0&).>.<&%+<)0P$<V)
Internally!powered!e q u ip ment!
=.L%..)$*)#%$&.<&+$()'L'+(0&)+(L%.00)$*)>+\;+/!
IPX0!–!not!protected!against!water!ingress)
=.L%..)$*)0'*.&@)'##>+<'&+$()+()&P.)#%.0.(<.)$*)')
*>'""'S>.)'('.0&P.&+<)"+Y&;%.)T+&P)' +%])$Y@L. ()$%)
(+&%$;0)$Y+/.)
Equipment!not!suitable!for!use!in!the!presence!of!
flammable!mixtures.!
-.*.%)&$)"'(;'>)
!
3P.)/.R+<.)+(<>;/.0)')-'/+$)Z%.\;.(<@)^-Z_)
&%'(0"+&&.%)^O>;.&$$&P_)
!
94)"'%V)
!
=+%.<&)<;%%.(&)
!
=+0#$0.)$*)'<<$%/+(L)&$)6444)
!
I.%+'>)(;"S.%)
!
M'(;*'<&;%./)S@)
!
M'(;*'<&;%.)/'&.)
!
O./*$(&U)>$L$)
!
!
! !
!
43!
!
Electromagnetic$Immunity$
The!NObreath®!and!NObreath®!Dock!comply!with!the!directive!EN60601-1-2:2015!4th!edition!
electromagnetic!compatibility.!
8;+/'(<.)'(/)"'(;*'<&;%.%`0)/.<>'%'&+$(5)4>.<&%$"'L(.&+<)+"";(+&@)
The!NObreath®!is!intended!for!use!in!the!electromagnetic!environment!specified !be low .!Th e!cu sto m er!or!th e!u ser!o f!the!
NObreath®!should!ensure!that!it!is!used!in!such!an!environment.!
Immunity!test!
IEC!60601!test!level!
Compliance!level!
Electromagnetic!environment!
guidance!
Electrostatic!
Discharge!(ESD)!
IEC!61000-4-2!
±8kV!contact!
±15kV!air!!
±8kV!contact!
±15kV!air!
Floor!should!be!wood,!concrete!or!
ceramic!floor!tile.!If!floors!are!
covered!with!synthetic!material!the!
relative!humidity!should!be!at!least!
30%.!
Electrical!fast!
transient/burst!
IEC!61000-4-5!
–!–!–!
Surge!
IEC61000-4-5!
–!–!–!
Voltage!dips,!
short!
interruptions!
and!voltage!
variations!on!
power!supply.!
IEC!61000-4-11!
–!–!–!
Power!
frequency!
(50/60Hz)!
Magnetic!field!
IEC!61000-4-8!
30!A/m!
30!A/m!
Power!frequency!magnetic!fields!
should!be!at!levels!characteristic!of!
a!typical!location!environment.!
Conducted!RF!
IEC!61000-4-6!
Radiated!RF!
IEC!61000-4-3!
10V/m!(1kHz!80%)!80MHz-2.7GHz!
10V/m!(1kHz!80%)!80MHz-2.7GHz!
Portable!and!mobile!RF!
communications!equipment!should!
be!used!no!closer!to!the!NObreath®!
than!the!recommended!separation!
distance!calculated!from!the!
equation!appropriate!to!the!
frequency!of!the!transmitter.!
Interference!may!occur!in!the!
vicinity!of!equipment!marked!with!
the!following!symbol:!
!
385!MHz!
27!V/m!
385!MHz!
27!V/m!
450!MHz!
28!V/m!
450!MHz!
28!V/m!
710!MHz!
9!V/m!
710!MHz!
9!V/m!
745!MHz!
9!V/m!
745!MHz!
9!V/m!
780!MHz!
9!V/m!
780!MHz!
9!V/m!
810!MHz!
28!V/m!
810!MHz!
28!V/m!
870!MHz!
28!V/m!
870!MHz!
28!V/m!
930!MHz!
28!V/m!
930!MHz!
28!V/m!
1720!MHz!
28!V/m!
1720!MHz!
28!V/m!
1845!MHz!
28!V/m!
1845!MHz!
28!V/m!
1970!MHz!
28!V/m!
1970!MHz!
28!V/m!
2450!MHz!
28!V/m!
2450!MHz!
28!V/m!
5240!MHz!
9!V/m!
5240!MHz!
9!V/m!
5500!MHz!
9!V/m!
5500!MHz!
9!V/m!
5785!MHz!
9!V/m!
5785!MHz!
9!V/m!
!
! !
! !
44!
!
N'%&0)'(/)'<<.00$%+.0)
!
!
!
1. NObreath®!Dock!
2. USB!cable!
3. Mains!plug!and!universal!adaptors!
4. NObreath®!Forum!information!
5. Interpretation!chart!
6. NObreath®!mouthpiece!
7. Microfiber!cloth!
8. Quick!Start!Guide!
9. Screwdriver!
10. Infection!Con t ro l!Maintenance!Guidelin e s!
11. Patient!Preparation!
!
! !
A)
Quick!Start!
H)B)W)C)F)
G)
Infection !Control!Ma intenance!
Guidelines!
NObreath®!Forum!
D)
E)
AX)
AA)
!
45!
!
6'%%'(&@)
Bedfont®!Scientific!Limited!warrants!the!NObreath®!monitor,!sensors!and!batteries!excepted,!to!be!
free!of!defects!in!materials!and!workm an ship !for!a!p erio d!of!2 !years !from !th e!da te!o f!ship m en t,!
subject!to!service!and!maintenance!requirements.!
The!NO!sensor!is!guaranteed!for!a!period!of!6!months!only!from!the!date!of!shipment!from!
Bedfont®.!
Bedfont’s!sole!obligation!under!this!warranty!is!limited!to!repairing!or!replacing,!at!its!choice,!any!
item!covered!under!this!warranty!when!such!an!item!is!returned!intact!and!prepaid,!to!Bedfont®!or!
the!local!representative.!
This!warranty!is!automatically!invalidated!if!the!products!are!altered!or!tampered!with!by!
unauthorised!personnel,!or!have!been!subject!to!misuse,!neglect!or!accident.!At!the!end!of!the!
product’s!life,!contact!Bedfont®!or!its!distributor!for!disposal!instructions.!
Single!use!consumables!and!accessories!should!be!disposed!of!in!line!with!local!clinical!waste!
guidelines.!
Never!dispose!of!any!electronic!instrument!or!batteries!in!domestic!waste.!At!the!end!of!the!
product’s!life,!contact!Bedfont®!or!its!distributor!for!disposal!instructions.!
!
-.&;%(0)
Please!contact!Bedfo n t® !or!its!local!distributor!for!instructions!on!returning!goods.!
!
-.0#$(0+S>.)M'(;*'<&;%.%)'(/)9$(&'<&0)
Bedfont!Scientific!Ltd.!
Station!Yard,!Station!Road,!
Harrietsham,!
Maidstone,!Kent,!
ME17!1JA!
United!Kingdom!
www.bedfont.com!
www.nobreathfeno.com!
!
ask@bedfont.com!
0044!1622!851122!
!
Bedfont® Scientic Ltd.
Station Road, Harrietsham, Maidstone,
Kent, ME17 1JA England
Tel: +44 (0)1622 851122 Fax: +44 (0)1622 854860
Email: ask@bedfont.com
www.bedfont.com
Issue 5- January 2019, Part No: LAB759
Bedfont® Scientic Limited reserves the right to change or update this literature without prior notice.
Registered in: England and Wales. Registered No: 1289798
© Bedfont® Scientic Limited 2019
Our family, innovang health, for yours.
est. 1976
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