NIOX MINO - Performance and Usage Data; Exhaled NO Measurement Performance; Exhalation Parameter Requirements; Transport and Storage Guidelines

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r
2
≥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H
2
O(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H
2
O,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