Circassia NIOX MINO User manual

US ENGLISH
510(k)
K101034
NIOX MINO®
User Manual

Remember
•Itisimportanttoadheretothespeciedoperatingconditions:
 Ambienttemperature:60to85°F(+16to30°C)
 Humidity:20to60%RH(non-condensing)
•Mobilephonesandcordlessphonesmightinterferewiththeinstrument
andshouldthereforebekeptawayfromtheinstrument.Interference
couldmakeitimpossibletoperformameasurement.
•Whenwithinthespeciedoperatingconditionsitisrecommendedto
keep NIOX MINO®withinstalledSensorconnectedtoapoweroutlet
wheneverpossible.
•ItisrecommendedtoallowaSensortobeconnectedfortwohours
beforetherstmeasurementisdone.
•ItisrecommendednottouseNIOXMINOintheproximityofareas
wherevolatilesubstancessuchasorganicuidsordisinfectantsare
beingused.Specialattentionshouldbepaidtoaerosolsanddisinfection
baths(eitheropenvesselsorultrasonicbaths).
•AlwaysuseaNIOXMINOBag(closed)fortransportationandstorage
ofNIOXMINOwhenitisdisconnectedfromthepoweroutlet.(The
NIOXMINOBagissoldseparately.)
•Shelf-life-NIOXMINOinstrument:Minimum3yearsattimeofdelivery,
or3,000measurements.
NIOXMINOSensor:Maximum12monthswhenmountedinNIOXMINO
orexpirationdateasstatedonthesensor,whichevercomesrst.
Note!
Thismanualisintendedformedicalcarepersonnelandforuse
whenteachingpatientshowtousetheNIOXMINOinstrument.
Toaidthis,ademonstrationmodeisavailableintheinstrument.
Pleaserefertothe"Demonstrationmode"section,page7.

1
Warnings! ........................................................... 2
Intended use ...................................................... 2
Training requirements ....................................... 2
Presentation ....................................................... 3
Installation and set-up ...................................... 4
Measurement ..................................................... 5
EnterpatientID(optional)...................................5
PerformFeNOmeasurement..............................6
View stored results ............................................ 7
Ambient NO measurement ............................... 7
Demonstration mode ......................................... 7
Change settings ................................................. 8
Timeanddate.....................................................8
Soundvolume.....................................................8
Toplightintensity................................................ 8
Modeconguration-QCon/off...........................8
Information menu .............................................. 9
External Quality Control procedure (QC) ...... 10
SelectionandqualicationofQCtesters..........10
QCmeasurement............................................. 11
ViewstoredQCresults..................................... 12
ViewQCinformation.........................................12
ResetQCtester................................................ 12
Turn off NIOX MINO®....................................... 13
MovingNIOXMINO.......................................... 13
General Care .................................................... 13
Preventiveinspections...................................... 13
ChangeSensor.................................................13
ChangeNOscrubber........................................14
Disposalofused/expiredproducts....................14
Returnshipments.............................................14
Support.............................................................14
Limitedwarranty...............................................14
Troubleshooting ............................................... 15
Alert codes........................................................ 16
Technical data .................................................. 17
Displaybuttonsandsymbols............................ 17
Symbolsexplanation.........................................19
Backplate.......................................................... 19
Baselabel........................................................ 19
Dimensionsandweight.....................................19
Electrical data................................................... 19
Noiselevel(standby)....................................... 19
Shelf-life............................................................19
Operatingconditions.........................................19
ExhaledNO-performancedata....................... 20
Linearity............................................................ 20
Precision........................................................... 20
Accuracy........................................................... 20
Method comparison.......................................... 20
Inhalation parameters....................................... 20
Exhalation parameters......................................20
Memory capacity..............................................20
Transportandstorage....................................... 20
Patientlter(mouthpiece)................................. 20
Responsiblemanufacturer................................ 21
NIOX MINO®parts and accessories ............... 21
Connect NIOX MINO®to a PC
using USB ........................................................ 21
NIOX®Panel ...................................................... 21
Cautions ........................................................... 22
NIOX MINO surveillance procedures ............. 24
Clinical documentation ................................... 24
Medical Device Reporting (MDR) ................... 25
Guidance and manufacturer's declaration .... 25
Electromagneticemissions............................... 25
Table of contents
UsermanualEPM-000109,version12,April2017,
for instruments with software version from 2005
to 20XX and 22XX to 23XX.Xcanbeanynumber
between0and9.Theversionnumberforyour
instrumentcanbeseenintheInformationmenu,
seepage9.
Informationinthisdocumentissubjecttochange.
AmendmentswillbemadeavailablebyCircassia,
Inc.astheyoccur.
•NIOXMINOis510(k)cleared,K101034,byFDA.
•NIOXMINOisCE-markedaccordingtoInVitro
DiagnosticDeviceDirective98/79/ECand
approvedforclinicaluseinEECcountries.
•NIOXMINOisRoHScompliant.
•Copyright©2017CircassiaAB,Uppsala,Sweden.
•NIOXMINOandNIOXareregisteredtrademarks
ofCircassiaAB.
•CircassiaisaregisteredtrademarkofCircassia
Limited.

2
Warnings!
•TheNIOXMINO®instrumentmustalwaysbe
usedandhandledasstatedinthismanual.
Circassiaacceptsnoresponsibilityfordamaged
equipmentorfaultyresults,iftheequipmentis
notusedaccordingtothismanual.
•DonotuseadamagedNIOXMINOinstrument
ordamagedcomponents.
•Useonlythepowersupplyunitprovided.
•Keeptheinstrumentoutofwater.Ensurethatno
liquidisspilledordrippedontheinstrument.
•Donotheatordisposeoftheinstrumentor
Sensorinre.Pleaserefertothe"Handlingof
used/expiredproducts"section.
•Takecarenottodroptheinstrumentorsubjectit
tostrongimpact.
• It is recommended not to use NIOX MINO in the
proximityofareaswherevolatilesubstances
suchasorganicuidsordisinfectantsare
beingused.Specialattentionshouldbepaid
toaerosolsanddisinfectionbaths(eitheropen
vesselsorultrasonicbaths).
•NIOXMINOshouldnotbeusedadjacenttoor
stackedwithotherequipment.
•TheNIOXMINOSensorcontainschemicalsthat
couldbeharmfulifswallowed.
•Touchonlythegreycapwhenexchangingthe
Sensor.
•Donotcleanthesensor.Cleaningofthe
Sensorwithethanolorsimilardisinfectantmight
destabilizeitforanon-predictabletimeperiod.
•KeeptheSensoroutofwater!Ensurethatno
liquidisspilledordrippedontheSensor.
•TheNOscrubbercontainspotassium
permanganateandshouldbedisposedofas
hazardouswasteinaccordancewiththelocal
wastedisposalregulations.
• Whenselectinganaccessoryforyour
NIOX MINO please keep in mind that an
accessorynotrecommendedbyCircassia
mayresultinlossofperformance,damageto
yourNIOXMINO,re,electricshock,injury
ordamagetootherproperty.Theproduct
warrantydoesnotcoverproductfailureor
damageresultingfromusewithnon-approved
accessories.Circassiatakesnoresponsibilityfor
healthandsafetyproblemsorotherproblems
causedbytheuseofaccessoriesnotapproved
byCircassia.
•NomodicationoftheNIOXMINOinstrumentor
theSensorisallowed.
Also see Cautions page 22.
Intended use
NIOX MINO measures Nitric Oxide (NO) in human
breath.NitricOxideisfrequentlyincreasedin
someinammatoryprocessessuchasasthma.
ThefractionalNOconcentrationinexpiredbreath
(FeNO),canbemeasuredbyNIOXMINOaccording
toguidelinesforNOmeasurementestablishedby
theAmericanThoracicSociety.
MeasurementofFeNO by NIOX MINO is a
quantitative,non-invasive,simpleandsafemethod
to measure the decrease in FeNO concentration in
asthmapatientsthatoftenoccursaftertreatment
withanti-inammatorypharmacologicaltherapy,as
anindicationofthetherapeuticeffectinpatientswith
elevatedFeNOlevels.NIOXMINOissuitablefor
childrenapproximately7-17years,andadults18
yearsandolder.
FeNOmeasurementsprovidethephysicianwith
meansofevaluatinganasthmapatient’sresponse
toanti-inammatorytherapy,asanadjuncttothe
established clinical and laboratory assessments
inasthma.NIOXMINOshouldonlybeusedas
directed in the NIOX MINO User Manual and the
NIOXMINOQualityControlTestUserManual,by
trainedphysicians,nurses,respiratorytherapists
andlaboratorytechnicians.NIOXMINOcannotbe
usedwithinfantsorbychildrenapproximatelyunder
theageof7,asmeasurementrequirespatient
cooperation.NIOXMINOshouldnotbeusedin
criticalcare,emergencycareorinanaesthesiology.
Training requirements
NIOX MINO should only be used as directed in this
manual,bytrainedphysicians,nurses,respiratory
therapistsandlaboratorytechnicians.“Trained”
statusisachievedonlyaftercarefulreadingofthis
manual.

3
Presentation
NIOX®Filter
Disposablepatientlterthatmustbe
exchangedbeforeeachmeasurement
session and patient
Display
NIOX MINO®instrument
Toplight
NIOX Panel PCbased
programthatallows
thepatienttofollowthe
measurementonaPC
screen,seepage21.
Powersupplyunit
NOscrubber,
(page14)
Main screen
OptionalPCconnection.
Cable(USB)
NIOXMINOSensor,
(page13)
Numberofremaining
measurementsfor
mountedSensor,or
PatientID(optional)
PerformQC
(page11)
USBcableconnected
Mode status
Mode screen
Standard
measurement mode
(page6)
QCmeasurement
mode
(page11)
Return
Ambient
measurement
(page7)
Demonstrationmode
(page7)
Viewmeasurement
results
(page7)
Settingsscreen
Controlledpower
off(page13)
NO scrubber
setup
(page14)
Notavailablefor
theUSmarket
Return
Mode
conguration
(page8)
Lightandsound
(page8)
Timeanddate
(page8)
Information
(page9)
SetID
(page5)
USB
connector
Strapholderfor
NIOX MINO Hand
Strap(optional
accessory)

4
Installation and set-up
Caution!
BecarefulwhenopeningtheSensorcan.The
insideoftheopeninghassharpedges.Donot
touchorcleanthewhiteSensormembrane.
1. InserttheSensorintothe
compartment at the base
oftheinstrument
2. Turntheorangeswivel
until locked
3. Gently,spreadthelatches
apart,oneatatime,
(Optionally:Usethered
QCplugtospreadthe
latches apart)
 ...andcarefullypullout
thecover
4. InsertthenewNO
scrubberintothecover
 Makesuretouseanew
NOscrubber,withan
unbroken hole
Unbroken Broken
5. Replacethecoverand
make sure it snaps in
place
6. Attachthepowersupply
unit to the instrument and
toapoweroutlet
7. Waitfortheinstrument
to start up and press the
Forwardbutton
8. Remindertoinsertanew
NOscrubber.Pressthe
Forwardbutton
9. SelectUSAonthedisplay
Note!
Thisscreenisonly
displayedatrststart-up
oftheinstrument.
10.SelectSettings
11.SelectClock
12.Thetimeanddatesettings
areshown
13.Usetheplusandminus
buttons to set the time and
date
14.Selecttheforwardbutton
tochangebetweenhour,
minute,month,day,and
year
15.SelectOKtoacceptthe
changes
16.SelectNOscrubber
17.AgainselectNOscrubber

5
18.Inputthepasscode0000
usingthenumberbuttons
toconrmthatanew
NO scrubber is installed
19.SelectOKtoacceptthe
changes
20.Optional:ConnectaUSB
cable,seepage21
21.SelectReturntogoback
to the Main screen
22.Allowtheinstrumentto
stabilize.
Note!
Stabilizationoftheinstrumentnormallymay
takeupto30minutesfollowingconnection
ofthepowersupplyunittothepoweroutlet.
However,itisrecommendedtoallowthe
NIOX MINO®Sensortobeconnectedfortwo
hoursbeforetherstmeasurementisdone.
Measurement
Dependingonwhatisshownonthedisplay,proceed
asfollows:
Stabilizationinprogress
Wait until ready
Instrument in sleep mode
Touchthedisplay
Readyforuse
Note:
Atwinklingasteriskonthescreen
indicatesthattheexternalQualityControl
(QC)procedureisactivated.AdailyQC
measurementismandatoryforclinicaluse.
Youshouldstartthequalicationprocessof
atleastonestaffmemberforthisprocedure,
seepage11.
Enter patient ID (optional)
Note!
IfPatientIDisused,ithastobeenteredbefore
eachmeasurement(evenifitisthesame
patient).
InputapatientspecicIDnumber,upto10digits.
1. SelecttheIDbuttononthe
main screen
2. InputthepatientspecicID
usingthenumberbuttons to
 Usetheshiftbuttonsto
changebetweendigits0to
4 and 5 to 9
3. SelectOKtoacceptthe
patientID

6
Perform FeNO measurement
Make sure that the instrument is ready
formeasurement(activatebypressing
thedisplayifinsleepmode)
Important!
Alwaysattachanewpatientlterfor
eachnewpatient
Storethepatientltersintheoriginal
boxpriortouse.
Choose one of three options in order to follow the measurement
Listentothesoundsignals
andviewthetoplight.
Look at
the display
usinga
mirror.
IftheoptionalPCbased
NIOX®Panelisused,look
atthePCscreen.(see
page21)
1. Emptylungs
2. Inhaledeeply
throughthelterto
totallungcapacity
Thecloudonthedisplayis
inatedandthetoplightis
turnedoffwhileyouinhale
Thesun/cloudisrising
Inhalation time is displayed
withbuttonsifmeteris
selected
3. Exhaleslowly
throughthelter
untilthetoplight
andsoundturnsoff
Continuoussoundand
steadylight=OK
Intermittenthighfrequency
soundandickeringlight=
exhalation too hard
Intermittentlowfrequency
soundandickeringlight=
exhalationtooweak
4. Waitforresult FeNOvalue
PatientID(ifentered)
Sequencenumber
(each measurement
resultisgivena
uniqueidentication
number)

7
View stored results
Themeasurementresultisautomaticallydisplayed
attheendofameasurement.Allpreviousresultsare
storedintheinstrument,andcanbeviewedatany
time.
1. SelectMode
2. SelectMeasurement
results
3. Thelateststored
measurement is
displayed,showing:
A. FeNOvalue
B. Measurementmode
C. PatientID(ifentered)
D. Sequencenumber
(each measurement
resultisgivena
sequencenumber)
E. Timeanddateof
measurement
A
B
C
D
E
4. Usethepreviousand
next buttons to step
throughthestored
measurements
5. SelectReturntogoback
to the Mode screen
Ambient NO measurement
Note!
A completed ambient NO measurement is
countedasonemeasurementfortheSensor
and NIOX MINO®.
1. Attachanewpatientlter
2. SelectMode
3. SelectAmbient
measurement
4. Waitforresult
(approximately 4 minutes)
Demonstration mode
Usethismodeforanewpatientinorder
todemonstratethedifferentstepsduringa
measurementandthecorrespondingillustrations
onthedisplayaswellaslightandaudiofeed-back.
(Soundvolumehastobeactivated.)
1. SelectMode
2. SelectDemo
3. Theinhalationscreenisshownand
thetoplightisturnedoff
4. UsetheForwardbuttontoadvance
to the next screen
5. Thenormalexhalationscreenis
shown
Correctexhalationpressure:The
cloudinasteadycenteredposition,
thetoplightislit,andtheaudio
emits a constant sound
6. UsetheForwardbuttontoadvance
to the next screen
7. Theexhalationtooweakpressure
screenisshown
8. UsetheForwardbuttontoadvance
to the next screen
9. Theexhalationtoostrongpressure
screenisshown
10.UsetheForwardbuttontoadvance
to the next screen

8
11.Thewaitforresultscreenisshown
(staticview)
12.SelectReturntogobacktothe
Mode screen
Change settings
Time and date
1. SelectSettings
2. SelectClock
3. Thetimeanddatesettingsare
shown
4. Selectthetimeformaticonsto
changebetweenUSandISOtime
and date
5. Usetheminusandplusbuttonsto
set the time and date
6. Selecttheforwardbuttontochange
betweenhour,minute,month,day,
and year
7. SelectOKtoacceptthechanges
Sound volume
1. SelectSettings
2. SelectSoundandLight
3. Thesoundvolumesettingisshown
4. Usetheminusandplusbuttonsto
setthesoundvolume
5. SelectOKtoacceptthechanges
Top light intensity
1. SelectSettings
2. SelectSoundandLight
3. Selecttoplight
4. Thetoplightsettingisshown
5. Usetheminusandplusbuttonsto
setthelightintensity
6. SelectOKtoacceptthechanges
Mode conguration - QC on/off
Note!
Forclinicaluse,theQCmustalwaysbeon!
1. SelectSettings
2. SelectModeConguration
3. SelectQCsettings
4. TheQCsettingsareshown
5. Usethebuttonstodeactivateor
activateQCmeasurement
6. SelectOKtoacceptthechanges

9
Information menu
1. SelectSettings
2. SelectInformationmenu
3. Theinformationscreenshows:
A. Numberofremainingsensor
measurements
B. Sensorexpirationdate
C. SensorserialNo.
D. Numberofremaining
instrument measurements
E. Instrumentexpirationdate
F. InstrumentserialNo.
G. Instrumentsoftwareversion
A
B
C
D
E
F
G
4. SelectReturntogobacktothe
Settingsscreen
 ...alternativelyselectAtoview
the alert codes
5. Thealertcodeinformationscreen
isshown,showingthe16latest
alerts
Note!
Thealertcodesinthelistare
onlytobeusedincontactwith
CircassiaPharmaceuticalsInc.
TechnicalSupport
•Dateofthealert
•Alertcode(fortechnicalsupport
purpose only)
6. SelectReturntogobacktothe
Informationscreen

10
TheexternalQualityControlisoneoftheprocedures
thatensuresthesystemisoperatingwithinits
specications.Forfurtherinformationregarding
NIOX MINO®surveillanceprocedures,seepage27.
Note!
TheQualityControlfunctioninNIOXMINO
mustalwaysbeactivatedasadailyQC
measurement is mandatorywhenthe
instrumentisclinicallyused.
TheexternalQualityControlconsistsoftwoparts.
Onepositivecontrolfromaqualiedstaffmember
withastableFeNOvalueprovidinganormal
biologicalFeNOsampleandanegativecontrol
consistingofaNOfreegassample,generated
fromambientair.NIOX MINO will allow for one daily
QC measurement that will not affect the number of
remaining tests on the NIOX MINO Sensor. (During
the rst 20 days of instrument start-up, a maximum
of four QC testers can be qualied without impact to
the number of remaining tests on the Sensor.)
Selection and qualication of QC testers
Aminimumofoneindividual(twoindividualsare
recommended)needstoqualifyforthisprocedure.
Identifyathirdindividualasaback-up,ifpossible.
Identifythestaffmemberswhowillperformthe
QualityControlandmeetthefollowingcriteria:
•Over18yearsofage.
•Noongoingcoldorknownairwaydisease.
•Non-smoker.
• Expected stable FeNOvaluesbetween5and40
ppb.
•Preferablynoallergies(exceptseasonal,see
below)orasthma.
AQCtesterwillbequaliedoverthecourseofthree
days.
Note!
IfthemostrecentQCmeasurementis
olderthan30days,thenthequalicationis
suspendedandtheQCtesterneedstore-
qualifyaccordingtothequalicationprocedure.
PerformthreeQCmeasurements,oneperdaywithin
sevendays,accordingtotheQCmeasurement
section.Ameanvalueiscalculatedfromthethree
measurementsthatmustbebetween5-40ppb.The
followingQCmeasurementonthefourthdaymust
bewithin±10ppbfromthemeanvalueandtheNO
scrubberresult<5ppb.ThentheQualityControlhas
passedandtheinstrumentisreadyforclinicaluse.
Thenextmovingmeanvalueiscalculatedwhenthe
QCtesterperformsaQCmeasurementfollowing7
days.
Result screens for the QC tester qualication
Day 1 Day 2 Day 3
After day 3
Positivecontrolresult:
FeNOvalueandlimits
(meanvalue+/-10ppb)
External Quality Control procedure (QC)

11
QC measurement
Theinstrumentwillpromptfora
daily QCprocedurebyshowinga
twinklingasteriskonthedisplay.
Alwaysconsiderthefollowinginordertoobtain
reliableresults.
Beforeanymeasurement:
•Avoidnitraterichfoodwithin3hrsbeforethe
measurement.
•Avoidstrenuousexerciseatleast1hourbeforethe
measurement.
Preferablydonotperformameasurementincaseof:
•Ongoingcold.
•Acuteseasonalallergy.
1. SelectMode
2. SelectQCmode
3. SelectQCtesternumber
(eachQCtestermust
selectanindividual
number)
4. PerformanormalFeNO
measurementaccordingto
page6.
5. Removethepatientlter
6. ImmediatelyattachtheQC
plug
7. SelecttheForwardiconon
the display
8. Waitfortheanalysistobe
completed and the test
result to be displayed
(approximately 5 minutes)
9. TheQCmeasurement
result is displayed
Note!
Duringthequalication
daysofanewQCtester
the result is displayed as
presentedDay1-3.
Day 1 Day 2 Day 3
A. Positivecontrolresult:
FeNOvalueandlimits
(meanvalue+/-10ppb)
B. QCtesternumber
C. Negativecontrolresult
(should be < 5 ppb)
After day 3
A
B
C
10.RemovetheQCplug
RepeattheQCtestifthepositiveand/orthe
negativecontrolfail.IftheQCfailurepersists,
discontinueuseofNIOXMINO®and contact
CircassiaTechnicalSupport.

12
Note!
IfthedailyQualityControlis
notsuccessfullyperformed,
oriftheresultsfromthe
QCareoutsidelimits,an
asteriskwillbedisplayed
besideeverymeasurement
value
Note!
TheprompttoQCthe
devicewillremainifthe
QCmeasurementwas
performedbyanon-
qualiedQCcandidate.It
isnotanindicationofan
unsuccessful(failed)QC
measurement.
View stored QC results
AllpreviousQCresultsarestoredintheinstrument
andcanbeviewedatanytimebyusingthefollowing
procedure:
1. SelectMode
2. SelectQC
3. SelectQCmeasurement
results
4. Thelateststored
measurement is displayed
A. Positivecontrolresult:
FeNOvalueandlimits
(meanvalue+/-10ppb)
B QCtesternumber
C. Negativecontrolresult
(should be < 5 ppb)
D. QCsequencenumber
E. Timeanddateof
measurement
A
B
C
D
E
 Thequalicationresults
can also be displayed
A. QCtesterqualifying
result
B QCtesternumber
C. QCsequencenumber
A
B
C
5. Usethepreviousandnext
buttonstostepthroughthe
results
6. SelectReturntogobackto
the Mode screen
View QC information
QCtesterinformationisstoredintheinstrument.
1. SelectMode
2. SelectQC
3. SelectQCinfo
4. TheQCinformationis
displayed:
A. MeanQCFeNOvalue
andlatestmovingmean
dateforQCtesters1
and2
B. Ongoingqualication,
positioninQC
measurementsequence
forQCtester3,and
latestqualication
measurement date
C. TheQCtester4isnot
qualied
A
B
C
Reset QC tester
Thisprocedurewilldeletethedatafortheselected
individual
1. SelectSettings
2. SelectModeConguration
3. SelectQCsettings
4. SelectResetQCtester
5. SelecttheQCtestertobe
reset
6. Selectthecrossed-out
numbertoconrmresetof
desireduserID

13
Turn off NIOX MINO®
Note!
Whenwithinthespeciedoperatingconditions
(seepage16)itisrecommendedtokeep
NIOXMINOwithinstalledSensorconnectedto
apoweroutletwheneverpossible.
1. Pulloutthepowersupplyunitconnectorfrom
NIOX MINO
Moving NIOX MINO
Theinstrumentcanbemovedtoanotherpower
outletwithoptimizedinitiatingstartup.
Note!
Theinstrumentmustbeconnectedtothenew
poweroutletwithinafewminutes.
1. SelectSettings
2. SelectControlledpoweroff
3. SelectOKtoconrm
4. Movetheinstrumentand
connectittoapoweroutlet
5. Waituntiltheinstrumentis
ready to use
General Care
•UseanewNIOX®Filter(patientlter)foreachnew
patient.
•Onlycleantheinstrumentwithaclothdampened
with70%ethanol,isopropanolorsimilar
disinfectant.Becarefulwhenusingdisinfectants
asexcessalcohol(ethanol)mightpermanently
destroytheSensor.Donotusespraydetergents.
Note!
Neverattempttoopenorservicethe
NIOXMINOinstrumentorSensor.
Preventive inspections
Beforeeachmeasurement,visuallyinspect:
•thatNIOXMINOisnotdamaged
•thattheSensorisinplace
•thataNIOXFilterisattached
•thatthepowersupplycordisundamagedand
correctly connected to the instrument and to the
poweroutlet.
IfanyitemismissingordamagedcontactCircassia
PharmaceuticalsInc.
Change Sensor
Caution!
BecarefulwhenopeningtheSensorcan.The
insideoftheopeninghassharpedges.
DonottouchorcleanthewhiteSensor
membrane.
1. Pressandholdtheblue
button...
 ...whileturningtheorange
swivel
2. RemovetheSensor

14
3. InsertthenewSensor
4. Turnbacktheorange
swiveluntillocked
Change NO scrubber
1. Spreadthelatchesapart,
oneatatime,
(Optionally:Usethered
QCplugtospreadthe
latches apart)
 ...andcarefullypulloutthe
cover
2. Removetheused
NOscrubberfromthe
cover
3. InsertthenewNO
scrubberintothecover
 Makesuretouseanew
NOscrubber,withan
unbroken hole
Unbroken Broken
4. Replacethecoverand
make sure it snaps in
place
5. SelectSettings
6. SelectNOscrubber
7. AgainselectNOscrubber
8. Inputthepasscode0000
usingthenumberbuttons
toconrmthatanew
NO scrubber is installed
9. SelectOK
Disposal of used/expired products
• Used or expired NIOX MINO®Sensorsshouldbe
recycledaccordingtothelocalrecyclingprogram
forelectronicequipment.Notethatthereisa
LiMnO2batteryinsidetheSensorunit*.
•AnexpiredNIOXMINOshouldberecycled,
accordingtothelocalprogramforelectronic
equipment.NotethatthereisaLiMnO2backup
batteryinsidetheinstrument*.
•TheNOscrubbercontainspotassium
permanganateandshouldbedisposedofas
hazardouswasteinaccordancewiththelocal
wastedisposalregulations.
•NIOXMINOisRoHScompliant.
*Thebatteriesarenotuser-replaceableparts.
Return shipments
ContactCircassiaTechnicalSupportbeforereturning
anyinstrumentoraccessory.Seecontactinformation
attheendofthisUserManual.
Support
PleasecontactCircassiaTechnicalSupportifyou
encounterproblems,whichyoucannotsolvewith
theactionsstatedinthismanual.
Forcontactdetails,seeback-pageofthismanual,
andprovidethefollowinginformation:
•Yourname,addressandtelephonenumber.
•SerialNo.(bothinstrumentandSensor).
•Alertdescription(asthoroughaspossible).
•Alertcodesorlists.

15
CircassiaPharmaceuticalsInc.providesaLimited
Warrantyforthisinstrumentandoriginalaccessories
deliveredwiththisinstrument.Conditionsaredened
atthetimeofpurchase.
DoNOTtrytorepairtheinstrument.ItisNOT
permittedtoopentheinstrument.Anyattemptto
opentheinstrumentwillvoidthewarrantyand
performancetospecicationscannotbeguaranteed.
Troubleshooting
Warning Action
Asteriskshown.
Theinstrumenthasnotbeen
veriedbyadailyQC.Performa
QCmeasurement.
DailyQCmeasurementoutside
limits.RestartthedailyQC
measurementwithanotherQC
tester.
Theinhalationwastooweakto
initiate a measurement or an
exhalation into the instrument
wasperformedpriortoan
inhalation.Stoptheprocedure
immediatelywhenthiswarning
appears.Waituntilthemain
menu screen is displayed and
repeattheinhalationwitha
strongerinhalationforce.
NOscrubberreminder.
Thesymbolisshownatrst
start-upoftheinstrumentasa
reminder to insert and set the
softwareforanewNOscrubber.
SeeInstallation and set-up
sectionpage4.
NOscrubberalmostexpired.
OrderanewNOscrubber.
Thesymbolisshownwhen10%
ofthemeasurementsremain
or2weeksbeforeexpiration
date and continue until the NO
scrubberhasexpired.ANO
scrubbercanbeusedfor1000
measurementsor1year.Refer
totheChangeNOscrubber
sectiononpage14.
Limited warranty

16
Warning Action
NoSensorconnected.Inserta
Sensor.
Sensoralmostexpired.Ordera
newSensor.
Thesymbolisshownwhen10%
ofthemeasurementsremain
or2weeksbeforeexpiration
dateandwillbeshownuntilthe
Sensorhasexpired.Refertothe
ChangeSensorsectionpage
13.
Instrumentalmostexpired.
Orderanewinstrument.
Thesymbolisshown4months
beforetheinstrumentexpiresor
when10%ofthemeasurements
remain.Theinstrumentwillnot
workaftertheindicateddate,
oraftertheindicatednumberof
measurements.Itisstillpossible
toviewmeasurementsstored
in the instrument memory and
downloaddatatoaPC.
Make sure that the ambient
temperatureisbetween60and
85°F(+16and+30°C).
WaitfortheSensortostabilize.
Removeanysourcesof
disturbance (such as cordless
ormobiletelephones,orgas
emittingappliances).Waitforthe
Sensortostabilize.
WaitfortheSensortostabilize.
<4minutes(countdown
started).
Alert codes
Alertmessagesandotherinformationareshown
ascodesatthetopoftheinstrumentdisplay.The
tablebelowprovidestherecommendedactionsto
betakenforanalertcode.Ifalertpersists,contact
CircassiaTechnicalSupport.
Code Action
User alerts
A10 Exhalationtoostrong.SelectReturnand
repeatthemeasurementwithlessforce.
A11 Exhalationtooweak.SelectReturnand
repeatthemeasurementwithgreater
exhalationforceandexhaleuntilsignalfor
completedexhalationisheard.
A12 Noexhalationdetected.SelectReturnand
repeat the measurement and exhale into
theinstrumentdirectlyafterinhalation.
A13 SelectReturnandrepeatthe
measurement.Donotbreathethroughthe
patientlterduringanalysis.
A14 WrongpasscodeforNOscrubber
exchange.
Instruments alerts
A20 Checkthatambienttemperatureis
withinspecication.Ifnecessary,shut
theinstrumentdown,moveittoanother
locationandrestarttheinstrument.
A21 Removeanysourcesofdisturbance(such
ascordless/mobiletelephones,orgas
emittingappliances).Whentheinstrument
isreadytrytorepeatthemeasurement.If
thealertpersists,unplugandreconnectthe
powersupplyunittorestarttheinstrument.
A22 Unplugandconnectthepowersupplyunit
torestarttheinstrument.
A23 Removeanysourcesofdisturbance(such
ascordless/mobiletelephones,orgas
emittingappliances).Whentheinstrument
isreadytrytorepeatthemeasurement.If
thealertpersists,unplugthepowersupply
unit,removeandreinserttheSensor,
reconnectthepowersupplyunitandrestart
theinstrument.
A24 Checkthatthesupplyvoltageiswithin
specication.Ifnecessaryreplacethe
powersupplyunit.
Connection alert
A31 ChecktheUSBconnectiontothePC

17
Code Action
QC alerts
A50 Themeanvalueofthethreequalication
resultsdoesnotfallbetween5-40ppb.
RestarttheQCtesterqualicationfrom
qualicationday1.
A51 Therehasbeenanattempttoperform
severalQCmeasurementsatthesameday
withthesametestperson.Waitoneday
andperformthenextQCmeasurement.
A52 Movingmeanvalueoutofrange.
RestarttheQCtesterqualicationfrom
qualicationday1.
A53 NOscrubberresultover5ppb.Check
thattheQCPlugwasattachedwhen
instructed.RestarttheQCmeasurement.
IfcontinuouslyshownreplacetheNO
scrubber.
A54 DailyQCresultlowerthan5ppb.Restart
themeasurementwithatestpersonwho
has a FeNOvaluehigherthan5ppb.
A55 DailyQCresulthigherthan40ppb.Restart
themeasurementwithatestpersonwho
has a FeNOvaluelowerthan40ppb.
A56 FailuretopresstheQCplugforwardbutton
intime(within1:30min).RepeattheQC
measurement and make sure to press
theforwardbuttonaftertheQCplugis
inserted.
Instrument and Sensor expiration alerts
A90 Instrument expiration date has passed
orallinstrumentmeasurementshave
beenused.Itisstillpossibletoview
measurements stored in the instrument
memoryanddownloaddatatoaPC.
ContactCircassiaTechnicalSupport.
A91 Sensorexpirationdatehaspassedorall
measurementsontheSensorhavebeen
used.ReplacetheSensor.
Technical data
Display buttons and symbols
Button Description
EnterpatientID
ModeConguration
Measurement modes
Settings
QCsettings
Standard10secondexhalation
FeNO measurement
NotavailablefortheUSmarket,
research application
QCmeasurement
Ambient NO measurement
NotavailablefortheUSmarket,
research application
Storedmeasurementresults
StoredQCmeasurementresults
NotavailablefortheUSmarket,
research application
NotavailablefortheUSmarket,
research application
Demonstrationmode
Clock
Information
QCinfo
Forward
OK
Return

18
Button Description
Previous
Next
Decrease
Increase
to Number
Backspace
Shifttokeypad0-4
Shifttokeypad5-9
NotavailablefortheUSmarket
NotavailablefortheUSmarket
UStimeanddatesettings
ISOtimeanddatesettings
Alertinfo
ExternalQCon
ExternalQCoff
ResetQCtester
ConrmQCtesterreset
Soundandtoplight
Sound
Toplight
NOscrubbersetting
Controlledpoweroff
Symbol Description
NotavailablefortheUSmarket
USBcableconnected
Theinstrumenthasnotbeenveried
byadailyQC
Sleepmode
StandardFeNO measurement
NotavailablefortheUSmarket,
research application
NotavailablefortheUSmarket,
research application
Ambient NO measurement
NotavailablefortheUSmarket,
research application
InsertQCplug
InsertSensor
NO scrubber
NO scrubber
Generalwarning
Instrumentexpirationwarning