Chapter 1 Important information
000191-16 NIOX VERO
®
User Manual English 5
NIOX VERO® for FeNO measurement can be operated with two different
exhalation times, 10 seconds and 6 seconds. The 10 second test is the
preferred mode. For children who are not able to perform the 10 second test,
the 6 second test is an alternative. The 6 second test should be used with
caution in patients over the age of 10 years. It should not be used in adult
patients.
nNO
Nasal Nitric Oxide has been shown to be decreased in patients with Primary
Ciliary Dyskinesia (PCD). Measurement of nNO is a screening tool that can
assist in the identification of cases of PCD according to ERS guidelines
1
.
Measurement of nNO with the NIOX VERO® Nasal Measurement Mode is non-
invasive, simple, safe and repeatable in patients age 5 and above when
measured according to the NIOX VERO® Nasal Measurement Mode User
Manual. Suspected cases of PCD following screening with nNO should be
confirmed according to published recommendations for PCD diagnosis and
management.
1
. Lucas JS, Barbato A, Collins SA, et al. European Respiratory Society guidelines
for the diagnosis of primary ciliary dyskinesia. Eur Respir J 2017; 49: 1601090.
1.7 Principals of Operation
NIOX VERO® is a small, portable system for the non-invasive, quantitative
measurement of the fractional nitric oxide (NO) concentration in expired
human breath (FeNO), a marker of airway inflammation and Nasal Nitric Oxide
(nNO) in the aspirated air from the nasal cavity as a screening tool to assist in
the identification of Primary Ciliary Dyskinesia.
The NIOX VERO® hand-held device includes a sampling and gas conditioning
system and a man-machine interface (MMI). The user is guided through the
breathing maneuver with the built-in touch-screen display by use of an
interactive MMI. The valves and pumps of the instrument are automatically
controlled to manage the inhaled sample appropriately via the instrument
electronics and software program. Filtering of inhaled air eliminates
contamination from ambient NO levels.
A built-in flow control keeps exhalation at 50 ml/s so that it is standardized for
all patients. Results are processed using dedicated software and are
expressed as Nitric Oxide concentration in parts per billion (ppb).
Each NIOX VERO® sensor is individually calibrated during manufacture. The
sensor maintains its calibration during the sensor lifetime, no additional
calibration is needed by the user. The device requires no maintenance or
scheduled servicing.
There are international and country specific guidelines on the interpretation of
results. For FeNO, the most commonly used is the American Thoracic Society
guidelines: Dweik RA, Boggs PB, Erzurum SC, et al. Interpretation of exhaled
nitric oxide levels (FeNO) for clinical applications: an official ATS clinical
practice guideline, 2011. Am J Respir Crit Care Med. 2011; 184: 602-615.
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