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 coefficient 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 certified gas concentration of Nitric Oxide
reference standard.
Accuracy
±5 ppb or max 10%.
Expressed as the upper 95% confidence limit,
based on absolute differences for concentrations ≤
50 ppb and relative differences for concentrations
> 50 ppb, from certified 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 fixed flow 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 filter (mouthpiece)
Disposable filter (NIOX Filter) to be changed for
each new measurement session and for each new
patient.
Bacterial, viral filter according to Medical Device
Directive Class IIa.
Responsible manufacturer
Circassia AB,
Hansellisgatan 13,
SE-754 50 Uppsala
Sweden
www.circassia.com
www.niox.com