Exhaled No - Performance Data; Linearity; Precision; Accuracy - Aerocrine NIOX MINO Manuel De L'utilisateur

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
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
®

Inhalation parameters

Inhalation to TLC (Total Lung Capacity) before start
of exhalation, to secure proper activation:
Minimum -3 cm H O (trigger only)
2
≥ 0.998,
2
instrument from Aerocrine.

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
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

Aerocrine AB,
Råsundavägen 18,
SE-169 67 Solna
Sweden
www.aerocrine.com
www.niox.com
E N G L I S H
O, to maintain a fixed flow
2
17