NIOX MINO User manual

ENGLISH
NIOX MINO®
User Manual

Remember
•Itisofvitalimportancetoadheretothespeciedoperatingconditions:
 Ambienttemperature:+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new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afteropeningpackageand
mountedinNIOXMINO,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
Warning! ........................................................... 2
Intended use (Europe) ..................................... 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
Bluetoothon/off................................................. 8
QCon/off.......................................................... 8
Information menu ............................................ 9
Turn off NIOX MINO®....................................... 9
General care ................................................... 10
Preventive inspections.................................... 10
ChangeSensor............................................... 10
ChangeNOscrubber...................................... 10
Disposalofused/expiredproducts.................. 11
Returnshipments........................................... 11
Support........................................................... 11
Limitedwarranty............................................. 11
Troubleshooting ............................................. 11
Alert codes...................................................... 12
Technical data ................................................ 13
Display buttons and symbols.......................... 13
Symbolsexplanation....................................... 15
Backplate........................................................ 15
Baselabel...................................................... 15
Dimensionsandweight................................... 15
Electrical data................................................. 15
Noiselevel(standby)..................................... 15
Shelf-life.......................................................... 15
Operatingconditions....................................... 15
ExhaledNO-performancedata..................... 16
Linearity.......................................................... 16
Precision......................................................... 16
Accuracy......................................................... 16
Method comparison........................................ 16
Inhalation parameters..................................... 16
Exhalation parameters.................................... 16
Memory capacity............................................ 16
Transportandstorage..................................... 16
Patientlter(mouthpiece)............................... 16
Responsiblemanufacturer.............................. 16
NIOX MINO®parts
and accessories ............................................. 17
Connect NIOX MINO®to a PC using USB .... 18
NIOX®Panel .................................................... 18
Special6sFeNOmeasurement...................... 19
Nasal measurement........................................ 19
Cautions ......................................................... 19
Clinical documentation ................................. 20
Vigilance ......................................................... 20
Guidance and manufacturer's declaration .. 21
Electromagneticemissions............................. 21
UsermanualEPM-000110,version09,April2017,
for instruments with software version 20XX,
22XX and 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ABastheyoccur.
•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510(k)cleared,k101034,byFDA.
•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.
Table of contents

2
Warning!
• Handle the NIOX MINO®instrument as
statedinthismanual.Circassiaacceptsno
responsibilityfordamagedequipmentor
faultyresultsiftheequipmentisnothandled
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"Disposal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 19.
Intended use (Europe)
NIOX MINO®AirwayInammationMonitor
measuresFractionalExhaledNitricOxide(FeNO)
inhumanbreath.ThelevelofNitricOxideis
elevatedwheneosinophilicairwayinammation
ispresentanddecreasesasaresponsetoanti-
inammatorytreatment.TheFeNO concentration
in expired breath can be measured by NIOX MINO
withassurancethatsuchmeasurementsare
repeatableandaccordingtoguidelinesforNO
measurement established jointly by the European
RespiratorySocietyandtheAmericanThoracic
Society1.
Measurement of FeNO by NIOX MINO is a
quantitative,non-invasive,simpleandsafemethod
to measure the FeNO concentration in patients
withasthma-likeairwaysymptomsinorderto
establish and monitor the presence of eosinophilic
airwayinammation.
NIOXMINOissuitableforchildren,approximately
4-17years,andadults18yearsandolder.
FeNO measurements should be used as part
oftheregularassessmentandmonitoringof
asthma patients to improve the patient’s asthma
management.NIOXMINOshouldbeused
asdirectedintheNIOXMINOUserManual.
NIOXMINOmaynotbeusedwithinfantsorby
childrenapproximatelyundertheageof4,as
measurementrequirespatientcooperation.
1Am J Respir Crit Care Med 2005; 171: 912-930.
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18.
Powersupplyunit
NOscrubber,
(page10)
OptionalPCconnection.
Cable(USB)orwireless
(Bluetooth)
NIOXMINOSensor,
(page10)
Mode screen
Standard
measurement mode
(page6)
Nasal measurement
mode
(page19)
Return
Special6s
measurement mode
(page19)
Ambient
measurement
(page7)
Demonstration mode
(page7)
Viewmeasurement
results(page7)
Settingsscreen
Controlledpower
off(page10)
NOscrubber
setup
(page10)
Bluetoothon/off
(page8)
Return
QCon/off
(page8)
Lightandsound
(page8)
Timeanddate
(page8)
Information
(page10)
Main screen Numberofremaining
measurements for
mountedSensor,or
PatientID(optional)
Bluetoothactivated,or
USBcableconnected
Mode status
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. Spreadthelatchesapart,
oneatatime,
(Optionally:Usethered
tooldeliveredwiththe
instrument 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OTHERonthe
display
Note!
Thisscreenisonly
displayedatrststart-
upoftheinstrument.
TheJAPANiconisonly
availableforSW22XX
and23XX.
10.SelectSettings
11.SelectClock
12.Thetimeanddatesettings
areshown
13.Clickthetimeformaticons
tochangebetweenUS
andISOtimeanddate
14.Usetheplusandminus
buttons to set the time and
date
15.Selecttheforwardbutton
tochangebetweenhour,
minute,year,monthand
day
16.SelectOKtoacceptthe
changes
17.SelectNOscrubber

5
18.AgainselectNOscrubber
19.Inputthepasscode0000
usingthenumberbuttons
toconrmthatanew
NOscrubberisinstalled
20.SelectOKtoacceptthe
changes
21.Optional:Activate
Bluetoothforwireless
communicationwithPCor
connectaUSBcable,see
page18
22.SelectReturntogoback
to the Main screen
23.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anew
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
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)
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18)
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rises
Inhalation time is displayed by
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)
Important!
Alwaysattachanew
patientlterforeach
newpatient

7
View stored results
A 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
uniqueidentication
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week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
11.Thewaitforresultscreenisshown
(staticview)
12.SelectReturntogobacktothe
Mode screen

8
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plusandminusbuttonsto
set the time and date
6. Selecttheforwardbuttonto
changebetweenhour,minute,
year,monthandday
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plusandminus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plusandminusbuttonsto
setthelightintensity
6. SelectOKtoacceptthechanges
Bluetooth on/off
1. SelectSettings
2. SelectBluetooth
3. TheBluetoothsettingisshown
4. Usethebuttonstodeactivateor
activateBluetooth
5. SelectOKtoacceptthechanges
QC on/off
Note!
AnoptionalExternalQualityControl(QC)
procedure is available for NIOX MINO®.
RefertotheNIOXMINOExternalQuality
Controlusermanual.Contactyourlocal
CircassiarepresentativeorCircassia
TechnicalSupportforfurtherinformation.

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
H. AmbientRH(relative
humidity),measuredinside
theinstrument(thevalue
maydifferfromRHmeasured
outsidetheinstrument)
A
B
C
D
E
F
G
H
4. SelectReturntogobacktothe
Settingsscreen
 ...alternativelyselectAlert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
Customersupport
• Date of the alert
•Alertcode(forcustomersupport
purposeonly)
6. SelectReturntogobacktothe
Information screen
Turn off NIOX MINO®
Note!
Whenwithinthespeciedoperating
conditions(seepage15)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

10
General care
•UseanewNIOX®Filter(patientlter)foreach
newpatient.
•Cleantheinstrumentwithaclothdampenedwith
70%ethanol,isopropanolorsimilardisinfectant.
Becarefulwhenusingdisinfectants,asexcessof
alcohol(ethanol)mightpermanentlydamage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your
localCircassiarepresentativeorCircassiaAB.
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
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
tooldeliveredwiththe
instrument 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lidandmake
sure it snaps in place
5. SelectSettings
6. SelectNOscrubber
7. AgainselectNOscrubber

11
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yourlocalCircassiarepresentativeor
CircassiaAB.
Support
PleasecontactyourlocalCircassiarepresentative
or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,andprovidethe
followinginformation:
•Yourname,addressandtelephonenumber.
•SerialNo.(bothinstrumentandSensor).
•Problemdescription(asthoroughaspossible).
•Alertcodesorlists.
Limited warranty
CircassiaABprovidesaLimitedWarrantyforthis
instrumentandoriginalaccessoriesdeliveredwith
thisinstrument.Conditionsaredenedwhenthe
itemsarepurchased.
DoNOTtrytorepairtheinstrument.ItisNOT
permittedtoopentheinstrument.Anyattempt
willmakethewarrantyinvalidandperformance
accordingtothespecicationscannotbe
guaranteed.
Troubleshooting
Warning Action
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are
remaining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page10.
NoSensorconnected-
ConnectaSensor.
Sensoralmostexpired–Order
anewSensor.
Thesymbolisshownwhen
10%ofthemeasurements
areleftor2weeksbefore
expiration date and continue
untiltheSensorhasexpired.
RefertotheChangeSensor
sectionpage10.

12
Warning Action
Instrumentalmostexpired–
Orderanewinstrument.
Thesymbolisshown4
months before the
instrumentexpiresorwhen
10%ofthemeasurementsare
remaining.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+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
yourlocalCircassiarepresentativeor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 the
signalforcompletedexhalationisheard.
A12 Noexhalationdetected.Selectreturnand
repeat the measurement and exhale into
theinstrumentdirectlyafterinhalation.
Code Action
A13 Selectreturnandrepeatthe
measurementanddonotbreathethrough
thepatientlterduringanalysis.
A14 WrongpasscodeforNOscrubber
exchange.
Instruments alerts
A20 Checkthatthe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reconnect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 alerts
A30 ChecktheBluetoothconnectiontothe
PC
A31 ChecktheUSBconnectiontothePC
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.
A91 Sensorexpirationdatehaspassedorall
measurementsontheSensorhavebeen
used.ReplacetheSensor.

13
Technical data
Display buttons and symbols
Button Description
Enter patient ID
Measurement modes
Settings
QCsettings
Standard10secondexhalation
FeNO measurement
Special6secondexhalationFeNO
measurement(researchappl.)
Ambient NO measurement
Nasal measurement
(researchapplication)
Storedmeasurementresults
Nasalow2ml/s
(researchapplication)
Nasalow5ml/s
(researchapplication)
Demonstration mode
Clock
Information
Forward
OK
Return
Previous
Next
Decrease
Increase
to Number
Backspace
Button Description
Shifttokeypad0-4
Shifttokeypad5-9
Bluetoothon
Bluetoothoff
UStimeanddatesettings
ISOtimeanddatesettings
Alert info
Soundandtoplight
Sound
Toplight
NOscrubbersetting
Controlledpoweroff

14
Symbol Description
Bluetoothactivated
USBcableconnected
Sleepmode
StandardFeNO measurement
Special6sFeNO measurement
(researchapplication)
Nasal measurement
(researchapplication)
Ambient NO measurement
Attach nasal olive to nostril
(researchapplication)
InsertSensor
NOscrubber
NOscrubber
Generalwarning
Instrumentexpirationwarning
Sensorwarning
Temperaturewarning
NOscrubberwarning
Symbol Description
Wait
Wait,time
Waitfortemperaturestabilization
WaitforSensorstabilization

15
Symbols explanation
Responsiblemanufacturer
Theproductmeetstherequirements
of applicable European directives
ConformstoANSI/AAMIES60601-1
andcertiedtoCAN/CSAC22.2No.
60601-1
ElectricalsafetyTypeBappliedpart
100-240V~50-60Hz
Theproductshouldberecycled
accordingtothelocalprogramfor
electronicequipment.
Consultinstructionsforuse
Refertoinstructionmanual/booklet
Expiration date
Transportandstoragetemperature
limitation
Forsingleuseonly
Invitrodiagnosticmedicaldevice
12M Durability-periodafteropening
Hazardousmaterial
ClassIIequipment
Backplate
NIOX MINO®
Article No 09-1000
Circassia AB
Hansellisgatan 13, SE-754 50, Uppsala, Sweden
www.circassia.com
Use Only Power Supply Unit Art No 09-1005
Rated Supply Voltage 6 V
Maximum Rated Power 20 VA
U.S. Patent: 5,447,165 / 5,922,610 / 6,038,913 / 6,099,480 / 6,723,056 /
6,761,185 / 7,014,692 / D496,667 / D492,035 / D457,231
1 2 3 4 5 6 7
1. Responsiblemanufacturer
2. Refertoinstructionmanual/booklet
3. Invitrodiagnosticmedicaldevice
4. TypeBappliedpart
5. Theproductshouldberecycledaccordingto
thelocalprogramforelectronicequipment
6. Theproductmeetstherequirementsof
applicable European directives
7. ETL-Listed.ConformstoANSI/AAMIES60601-
1andcertiedtoCAN/CSAC22.2No.60601-1.
Base label
2 3
1
1. Instrumentexpirationdate(year:month)
2. Instrumentarticlenumber
3. Instrumentserialnumber
Dimensions and weight
Height:230mm
Width:128mm
Depth:96mm
WeightofinstrumentincludingSensor:0.8kg
Electrical data
Electricalsafetyclassication:Theequipment
complieswiththerequirementsaccordingtoIEC
61010-1and60601-1ClassIITypeB.
NIOX MINO instrument
Secondaryvoltage(externalpoweradapter):6V
Powerconsumption:<15VA
Power supply unit
MainsVoltage:100-240V~50-60Hz
Noise level (stand by)
<35dBA,atadistanceof1m
Shelf-life
NIOX MINO®instrument:Minimum3yearsattime
ofdelivery,or3,000measurements.
NIOXMINOSensor:Maximum12monthswhen
installed in NIOX MINO or expiration date as stated
ontheSensor,whichevercomesrst.
Alwaysusethe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).
Operating conditions
Ambienttemperature:+16to+30°C
Humidity:20to60%RH(non-condensing)*
Atmosphericpressurerange:700to1060hPa
AmbientNOconcentration:<300ppb
Exhaledowrateduringmeasurementsat50
ml/s±10%BTPS(BodyTemperaturePressure
Saturated,37˚C,1013hPa,100%RH)
*TheambientRHintheinstrumentcanbeviewed
intheinformationmenu,seepage10andmay
differfromRHmeasuredoutsidetheinstrument.

16
Exhaled NO - performance data
Performancedatatypicalfortemperaturerange
+16to+30˚C,Humidityrange20-60%RH,
Pressure1013hPa
Measurementrange:
FeNO:5to300ppb
LowestDetectionLimit:5ppb
Determinationbyanalyzinggasconcentrations
aroundandbelowthedetectionlimit.5ppbwas
thelowestdetectablelevel.
Measurementtime:<2min
Temperaturestabilizationtime:≤30min
AmbientNOmeasurementtime:<4min
Linearity
Squaredcorrelationcoefcientr2≥0.998,
slope0.95-1.05,intercept±3ppb.
Determinationbasedonthepooledregression
analysisfrom10instrumentsusingstandardgas
referencesamplesat7differentconcentration
levelscoveringtheoperatingmeasurementrange.
Precision
<3ppbofmeasuredvalue<30ppb,
<10%ofmeasuredvalue≥30ppb.
Expressed as one standard deviation for replicate
measurementswiththesameinstrument,using
acertiedgasconcentrationofNitricOxide
referencestandard.
Accuracy
±5ppbormax10%.
Expressedastheupper95%condencelimit,
basedonabsolutedifferencesforconcentrations≤
50ppbandrelativedifferencesforconcentrations
>50ppb,fromcertiedgasconcentrationofNitric
Oxidereferencestandard.
Method comparison
<10ppbforvalues≤50ppb,
<20%forvalues>50ppb
Expressedasthedifferencebetweena
NIOX MINO®FeNOvalueandthecorresponding
FeNOvaluemeasuredwithNIOX®instrument from
Circassia.
Inhalation parameters
InhalationtoTLC(TotalLungCapacity)beforestart
ofexhalation,tosecureproperactivation:
Minimum-3cmH2O(triggeronly)
Exhalation parameters
Exhalationtime:
Standardmode:10s(clinicaluse)
Special6s.mode:6s(researchuse)
All exhalations are to be performed at an
exhalationpressureof10-20cmH2O,tomaintain
axedowrateof50±5ml/s.
Memory capacity
3000measurements
Transport and storage
NIOX MINO instrument (transport and storage
in its unopened original package)
Relativehumidityrange:10to100%,including
condensation.
Temperaturerange:-20to+60°C
Atmosphericpressurerange:500to1060hPa
NIOX MINO Sensor (transport and storage in
original package)
Relativehumidityrange:10to100%,including
condensation.
Temperaturerange:-20to+60°C
Recommendedtemperaturerange:+2to+25°C
Atmosphericpressurerange:500to1060hPa
NIOX MINO, including sensor (transportation
in NIOX MINO Bag)
Relativehumidityrange:10to95%,non-
condensing
Temperaturerange:+2to+25°C
Atmosphericpressurerange:700to1060hPa
Whentransportingtheinstrumentfromone
locationtoanother,aprolongedstabilization
periodmightberequiredbeforemeasurements
canbeperformed.
Patient lter (mouthpiece)
Disposablelter(NIOXFilter)tobechangedfor
eachnewmeasurementsessionandforeachnew
patient.
Bacterial,virallteraccordingtoMedicalDevice
DirectiveClassIIa.
Responsible manufacturer
CircassiaAB,
Hansellisgatan13,
SE-75450Uppsala
Sweden
www.circassia.com
www.niox.com

17
NIOX MINO®parts
and accessories
Warning!
Whenselectinganaccessoryforyour
NIOX MINO product please keep in mind that
anaccessorynotrecommendedbyCircassia
ABmayresultinlossofperformance,
damagetoyourNIOXMINOproduct,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ABtakesnoresponsibilityfor
health and safety problems or other problems
caused by the use of accessories not
approvedbyCircassia.
Parts included in NIOX MINO package
(Item No. 09-1000)
NIOXMINOinstrument(09-1100)
NIOXMINOPowerSupplyUnit(incl.4supply
adapters)(09-1005)
NIOXMINOUSBcable(09-1010)
NIOXMINOQCplug(09-1015)
NIOXPanel(onUSBstick)
(12-1003)
Parts delivered separately
NIOXMINONOscrubber(09-1300)
NIOXMINOUserManual(EPM-000110)
Accessories
NIOXMINOTestKit100(03-4000)
(contains:1NIOXMINOSensor*for100
measurementsand100NIOX®Filters**)
NIOXMINOTestKit300,(03-4001)
(contains:1NIOXMINOSensor*for300
measurementsand300NIOXFilters**)
NIOXMINOTestKit500,(03-4007)
(contains:1NIOXMINOSensor*for500
measurementsand500NIOXFilters**)
NIOXMINOTestKit1000,(03-4010)
(contains:1NIOXMINOSensor*for1000
measurementsand1000NIOXFilters**)
NIOXMINOBag(09-1020)
* NIOXMINOSensor
Pre-calibrateddisposablesensorfor100,
300,500or1000measurements.Shelf-
life:Maximum12monthswheninstalledin
NIOX MINO or expiration date as stated on
theSensor,whichevercomesrst.(Useonly
NIOXMINOSensorswithCircassiaitem
number03-2005,03-2010,03-2030,03-2050
or03-2100.)
** NIOXFilter
Disposableltertobechangedforevery
patient.Bacterial,virallteraccordingto
MedicalDeviceDirectiveClassIIa.

18
Connect NIOX MINO®to a PC
using USB
Caution!
• APCconnectedtotheUSBconnector
hastobecertiedforoneofthe
standardsIEC60601-1,IEC61010-1,
IEC60950orcomparablewithsafety
extralowvoltageontheUSBports.
• TheconnectedPCshouldbeplaced
outofreachfromthepatient.Donot,
simultaneously,touchtheconnectedPC
andthepatient.
1. ConnecttheUSBcablefromtheinstrumentto
thePC
USBcablefromPC
2. TheUSBicon isshownonthe
NIOXMINOdisplaytoindicatethataUSB
connection is established
Connect NIOX MINO to a PC
using Bluetooth
1. SelectSettings
2. SelectBluetooth
3. TheBluetooth
settingisshown
4. Usethebuttonto
activateBluetooth
5. SelectOKtoaccept
thechanges
6. FollowtheinstructionsdeliveredwiththePC
orfromtheBluetoothdevicemanufacturerfor
howtosetupaBlutetoothconnection:
• CreateanewBluetoothconnection
•SelectNIOXMINO
• Enter passcode 0000
NIOX®Panel
AUSBmemorystickisdeliveredwithNIOXMINO
containingtheNIOXPanelprogram.
Forinstructionsonhowtoinstallandusethe
programrefertotheNIOXPanelUserManual.