NIOX VERO User Manual

NIOX VERO® Nasal User Manual August 2017
002346-02 English

NIOX VERO®

Nasal Measurement Mode

User Manual

Remember

It is important to adhere to the following specified conditions:

• Ambient temperature: +10°C to +35°C

• Humidity: 20% to 80% RH (non-condensing)

• Mobile phones, cordless phones and gas emitting appliances might
interfere with the instrument and should therefore be kept away from
the instrument. Interference could make it impossible to perform a
measurement.

• Exhaled breath contains water vapor which can condense inside the
instrument. When excessively used in a short period, there is a risk
for condensation of water inside NIOX VERO

®

.
Normally a maximum of 10 exhalations/hour can be performed with
NIOX VERO

®

during continuous use. However, it is possible to
perform 20 exhalations in one hour if the instrument is paused for a
minimum of 30 minutes prior to the next session of exhalations.
Exhalations include failed and successful measurements.

• Avoid spilling water or other fluids on the instrument or Sensor.

• Always use a closed case or bag (NIOX VERO

®

bag recommended)

for transportation and storage of NIOX VERO

®

.

• It is recommended, after inserting a new sensor, to wait for three
hours with the instrument switched on before performing a
measurement.

• Operational life-time for NIOX VERO

®

Instrument: Minimum 5 years

at time of delivery, or 15 000 measurements.

• Operational life-time for NIOX VERO

®

Sensor: Maximum 12 months

after opening package and installed in NIOX VERO

®

or expiration

date as stated on the Sensor, whichever comes first.

WARNING!
Use of substances containing alcohol close to the NIOX VERO

®

in-

strument may cause erroneous measurement results.

DO NOT clean the instrument or handle with alcohol or any spray or
wipe containing alcohol!

Do not use substances containing alcohol on or close to the
NIOX VERO

®

instrument. This includes any cleaning agents used to
clean the facility, or other equipment in the area, as well as alcohol
wipes or sprays used on patients.

CAUTION!: Do not use NIOX VERO

®

in the proximity of areas where
volatile substances such as organic fluids or disinfectants are being
used. Special attention should be paid to aerosols and disinfection
baths, either open vessels or ultrasonic baths.

Refer to the NIOX VERO User Manual for complete review of all
cautions, warnings, preventive care and troubleshooting.

Table of contents

NIOX VERO® Nasal NO Measurements User Manual
English 002346-02 1

1 NIOX VERO® Nasal measurement mode ................................... 3

1.1 Before using NIOX VERO®...................................................... 3

1.2 About this manual..................................................................... 3

1.3 Compliance .............................................................................. 3

1.4 Responsible manufacturer and contacts .................................. 3

1.5 Warnings .................................................................................. 3

1.6 Intended Use ............................................................................ 4

2 Product description ..................................................................... 5

2.1 Nasal accessories and parts .................................................... 5

2.2 NIOX VERO

®

accessories and parts........................................ 5

2.3 Main View................................................................................. 6

3 Nasal NO measurements ........................................................... 6

3.1 Preparation for Nasal (nNO) measurement.............................. 6

3.2 Perform Nasal measurement ................................................... 7

3.3 Expiration against Resistance (ER-nNO) ................................. 9

3.4 Tidal Breathing (TB-nNO)....................................................... 11

3.5 Alert codes and actions .......................................................... 11

4 Nasal measurements with NIOX®Panel .................................. 12

4.1 Installation of NIOX® Panel .................................................... 12

4.2 Setup ...................................................................................... 12

4.3 Perform Nasal measurements with NIOX

®

Panel .................. 13

5 Cleaning procedure .................................................................. 19

6 NIOX VERO

®

Nasal Technical Specification ............................ 19

6.1 Performance data................................................................... 19

6.2 Linearity.................................................................................. 19

6.3 Precision ................................................................................ 19

6.4 Accuracy ................................................................................ 19

6.5 Essential performance ........................................................... 20

2

Chapter 1 NIOX VERO® Nasal measurement mode

002346-02 NIOX VERO® Nasal User Manual English 3

1 NIOX VERO® Nasal measurement

mode

1.1 Before using NIOX VERO

®

NIOX VERO® may only be operated as directed in this manual by trained
healthcare professionals. Trained status is achieved only after careful reading
of this manual. Read the entire instructions for use and make certain that you
fully understand the safety information.

This is an amendment to the NIOX VERO User Manual. Carefully read the
NIOX VERO User Manual and the NIOX VERO

®

Nasal Measurement Mode

User Manual before performing NIOX VERO Nasal measurements.

1.2 About this manual

NIOX VERO® Nasal Measurement Mode User Manual - English 002346
version 02, August 2017, for instruments with software version 1D1x-xxxx.
For instruction on how to view the software version number installed in the in­strument, refer to the NIOX VERO User Manual.

Information in this document is subject to change. Amendments will be made
by Circassia AB as they occur.

This User Manual provides instructions on how to operate NIOX VERO

®

in
Nasal Measurement mode.
It contains numbered step-by-step instructions with screens and illustrations.
Choices within steps are displayed with bullet points.

1.3 Compliance

NIOX VERO® and NIOX® Panel are CE-marked according to
In Vitro Diagnostics Device Directive 98/79/EC.
NIOX Patient filter is CE marked according to
Medical Devices Directive 93/42/EEC
NIOX VERO

®

is RoHS compliant.

1.4 Responsible manufacturer and contacts

Mailing address:
Circassia AB, P.O. Box 3006
SE-750 03 Uppsala, Sweden

Visiting address:
Hansellisgatan13
SE-754 50 Uppsala

www.circassia.com
www.niox.com

1.5 Warnings

• Do not use substances containing alcohol on or close to the

NIOX VERO® instrument. This includes any cleaning agents used to
clean the facility, or other equipment in the area, as well as alcohol wipes
or sprays used on patients.

Symbol Description

WARNING

Indicates a potentially hazardous situation that, if not
avoided, can result in bodily harm or injury.

CAUTION

Indicates a potentially hazardous situation that, if not
avoided, can damage a product or system, cause loss
of data or harm to business.

Note Alerts the reader to important information on the proper

use of the product, user expectations, error situations,
and actions related to these.

Chapter 1 NIOX VERO® Nasal measurement mode

4 002346-02 NIOX VERO® Nasal User Manual English

• NIOX VERO® should only be operated by healthcare professionals.

• Operate NIOX VERO® 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.

• When selecting an accessory for your NIOX VERO

®

product keep in
mind that an accessory not recommended by Circassia AB may result in
loss of performance, damage to your NIOX VERO® product, fire, 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
approved by Circassia.

• NIOX VERO

®

should not be used adjacent to or stacked with other

electronic equipment.

• Only use the power supply provided. Pull the plug when disconnecting
NIOX VERO

®

from the power outlet.

• Use only the breathing handle supplied by Circassia.

• No modification of NIOX VERO

®

instrument, handle or Sensor is

allowed.

• Do not drop the instrument or subject it to strong impact.

• Do not use a damaged NIOX VERO

®

instrument or damaged

components.

• Keep the instrument and Sensor out of water. Ensure that no liquid is
spilled or dropped on the instrument or Sensor.

• Do not heat or dispose of the instrument or Sensor in fire. Refer to
“Disposal of instrument and accessories” on.

• NIOX VERO

®

and the NO scrubber in the breathing handle contains
potassium permanganate. Used or expired instruments and breathing
handles should be disposed of as hazardous waste in accordance with
local waste disposal regulations.

• The breathing handle must not be used after expiration date.

• Patient filters should be used immediately after opening.

• NIOX VERO

®

Sensor contains chemicals that could be harmful if

swallowed.

• Be careful when opening the Sensor can. The inside of the opening may
have sharp edges.

• Do not touch or clean the white Sensor membrane.

• After inserting a new Sensor it is recommended to wait for three hours
with the instrument switched on before performing a measurement.

• Make sure to use the correct measurement mode, otherwise incorrect
measurement results might be obtained.

• Do not reuse patient filters.

• Do not use NIOX VERO

®

in the proximity of areas where volatile
substances such as organic fluids or disinfectants are being used.
Special attention should be paid to aerosols and disinfection baths,
either open vessels or ultrasonic baths. Do not use the instrument in the
presence of flammable anesthetic, vapors or liquids.

• Nasal Kit should be used immediately after opening.

• Do not reuse Nasal Kit.

1.6 Intended Use

NIOX VERO® measures Nitric Oxide in human breath (Fractional exhaled
Nitric Oxide, FeNO) and Nasal Nitric Oxide (nNO) in the aspirated air from

the nasal cavity.

FeNO

FeNO is increased in some airway inflammatory processes such as asthma
and decreases in response to anti-inflammatory treatment. FeNO measure­ments with NIOX VERO are quantitative, non-invasive, simple and safe and
should be used as part of regular assessment and monitoring of patients with
these conditions. NIOX VERO is suitable for patients age 4 and above for
FeNO measurements.

Chapter 2 Product description

002346-02 NIOX VERO® Nasal User Manual English 5

As measurement requires patient cooperation, some children below the age
of 7 may require additional coaching and encouragement. NIOX VERO
should be used as directed in the NIOX VERO User Manual.

• CAUTION! 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. Incorrect use of the 6s exhalation mode may result
in falsely low FeNO values, which can lead to incorrect clinical decisions.

nNO

Nasal Nitric Oxide has been shown to be decreased in patients with Primary
Ciliary Dyskinesia (PCD), and measurement of nNO 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 non­invasive, 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 manage-

ment

.

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

2 Product description

2.1 Nasal accessories and parts

(A) NIOX VERO® Nasal Kit, Article No 12-1065 Pediatric, 12-1045 Adult,
(B) NIOX VERO® Nasal Restrictor, Article No 12-1033 (for use together with
NIOX VERO® Patient filter)

2.2 NIOX VERO® accessories and parts

(C) NIOX VERO® Breathing Handle, Article No 12-1010 (supplied with
NIOX VERO®)
(D) NIOX VERO® Patient Filter, Article No 12-1018 (supplied separately)

Chapter 3 Nasal NO measurements

6 002346-02 NIOX VERO® Nasal User Manual English

2.3 Main View

(A) Status bar, (B) Instructive demonstration, (C) Patient ID, (D) Main menu,
(E) Start measurement button

2.3.1 Main menu

(a) Measurement mode 10s/6s, (b) Nasal measurement mode, (c) Demo,
(d) Patient ID entry, (e) Settings

3 Nasal NO measurements

Nasal measurements can be performed either using the Tidal Breathing
(TB-nNO) method or by the velum closed with Expiration against Resistance
(ER-nNO) method. Nasal measurements can be performed either on the left
or the right nostril.

3.1 Preparation for Nasal (nNO) measurement

Verify proper preparations before performing a nasal measurement with
NIOX VERO

®

. A basic preventive inspection is recommended before each

use, refer to the NIOX VERO User Manual.

Note: Measurements can be performed without NIOX Panel software,

however, if done, there is no graph available. Only the value will
show on the display screen.

3.1.1 Attach the Nasal Kit to NIOX VERO instrument

1. Place the device on its side on a level secure surface.

2. Disconnect the breathing handle
from the instrument by pushing the
socket into the device and gently
pull out the tube.

Chapter 3 Nasal NO measurements

002346-02 NIOX VERO® Nasal User Manual English 7

3. Take the nasal kit, remove the cap from the end of the tube and push it
into the breathing handle port slowly until the triangle is no longer visible.

Note: There is lubricant on the end of the tube for easier attachment to the

NIOX VERO.

Note: The triangle should not be visible when assembled correctly.

(A), Nasal Olive, (B) Nasal Filter, (C) Nasal Tube, (D) Cap

3.2 Perform Nasal measurement

Nasal measurements can be performed with either Expiration against Resis­tance (ER-nNO) method (see section 3.3) or Tidal Breathing (TB-nNO) meth­od (see section 3.4).

Note: Make sure patient does not inhale by nose during the nasal

measurement.

Note: The patient should not perform nasal NO measurements if there is

evidence of blood in the nostrils.

Note: Prior to performing nasal NO measurements, the patient should be

comfortably seated and have thoroughly cleared the nasal passage.

Note: There are two phases of the nasal measurements. A measurement

period where the instrument aspirates for 30 seconds, and an
analysis period where the instrument analyses the sample for 30
seconds.

Chapter 3 Nasal NO measurements

8 002346-02 NIOX VERO® Nasal User Manual English

Note: Performing a nasal measurement without using the NIOX Panel

(see section 4.3, Perform Nasal measurements with NIOX® Panel)
will not produce a graphical result, it will only give the numerical
result of nasal nitric oxide measurement on the NIOX VERO screen.

CAUTION! Make sure to use the correct size olives, the seal between the
olive and nostril must be airtight to ensure correct measurement result.

(A) Nasal Olive Adult, (B) Nasal Olive Pediatric

CAUTION! Do not insert the Nasal Olive inside the nostril. The larger
part of the Nasal Olive should remain outside the nostril.

CAUTION! Ensure that the sampling hole in the Nasal Olive is aligned
with the nasal passage and not blocked. A blocked sampling hole will in­fluence the measurement result.

Note: If an error occurs see “Alert codes and actions” on page 11.

Chapter 3 Nasal NO measurements

002346-02 NIOX VERO® Nasal User Manual English 9

3.3 Expiration against Resistance (ER-nNO)

ER-nNO Nasal measurements shall be performed while exhaling through the
mouth towards a restrictor (breathing handle), this generates a pressure that
makes sure the velum is closed. The NIOX VERO Breathing Handle with a
patient filter and the NIOX VERO restrictor is used as the restrictor in this
breathing method. The breathing handle is NOT connected to the
NIOX VERO when used in this manner.

1. Open a new Patient Filter and insert an new Nasal Restrictor into the
Patient Filter, so that it rests on top of the white filter pad.

Note: Do not use the Patient Filter without the NIOX VERO Nasal

Restrictor.

Note: Use the Patient Filter directly after it has been opened.

Note: The Patient filter and the restrictor is for single patient use only.

2. Attach the Patient Filter to the Breathing Handle until it clicks into place.

3. Give the breathing handle to the patient, put the Olive to the selected
nostril and instruct the patient to inhale to total lung capacity and to begin
exhaling into the patient filter once their lips are tightly sealed around it.
The patient will have to exhale steadily and continuously for 30 seconds.

Chapter 3 Nasal NO measurements

10 002346-02 NIOX VERO® Nasal User Manual English

4. Start Nasal measurement by selecting the Nasal icon (A)

5. Enter patient ID (optional) and then start the nasal measurement by
pressing the start measurement button (B)

Note: If measurement is started before patient is ready, there is an option

to abort measurement, it is not recorded as a measurement on
sensor or instrument.

6. The instrument will aspirate for 30 seconds, and then will start to analyze
the sample. After the aspiration is complete, remove nasal olive from the
nostril and wait for the result.

Chapter 3 Nasal NO measurements

002346-02 NIOX VERO® Nasal User Manual English 11

3.4 Tidal Breathing (TB-nNO)

TB-nNO measurements shall be performed while breathing normally through
an open mouth.

1. Put the Olive to the selected nostril and instruct the patient to slowly inhale
and exhale through the mouth.

2. Start Nasal measurement by selecting the Nasal icon (A)

3. Enter patient ID (optional) and then start the nasal measurement by
pressing the start measurement button (B)

Note: If the measurement is started before patient is ready, there is an

option to abort measurement, it is not recorded as a measurement on
sensor or instrument.

4. The instrument will aspirate for 30 seconds and then will start to analyze
the sample. After the aspiration is complete, remove nasal olive from the
nostril and wait for the result.

3.5 Alert codes and actions

For additional alert codes, refer to the NIOX VERO User Manual.

User alerts Screen Action

A28 Internal hardware error recoverable

Check that the Sensor, battery and lid is
in its correct position, also make sure that
the tube is not folded. When finished
restart the instrument.

A29 Analysis failure

Ambient measurement failure.
Click the OK button and obtain a new

measurement.

Chapter 4 Nasal measurements with NIOX®Panel

12 002346-02 NIOX VERO® Nasal User Manual English

4 Nasal measurements with

NIOX®Panel

Using NIOX Panel provides the ability to see the nNO measurement graphi­cally, produce the file and print the results.

4.1 Installation of NIOX® Panel

The NIOX® Panel software is supplied on a USB storage device.

1. Insert the USB storage device in the computer’s USB port.

2. Select the file named setup.exe.

3. If .NET Framework 4.5, VC++ 2013 or SQL Server Compact is not
installed, an installation wizard for each of the programs opens, one at
the time.

4. Select to accept license agreement for the programs.

5. Follow the instructions and wait for the programs to install.

6. The Installation wizard for NIOX

®

Panel Nasal opens.

7. Follow the instructions and install the program.

Note: Last step of installation “Removing backup files” takes a few

minutes.

8. When the installation is complete, click Close.
The application is now available on the start menu.

4.2 Setup

1. Turn on the PC and monitor.

2. Turn on the instrument.

3. Select the Start or the Windows button normally found in the left lower
hand corner of the monitor.

4. Select NIOX® Panel from the program list.

5. Plug the USB cable into the USB port on the NIOX VERO® and connect
it to the USB port on the PC or connect by Bluetooth. This icon is shown
on the display to indicate that a connection is established and
NIOX VERO® is running remote controlled.

NIOX® Panel System requirements

• Windows

®

7, Windows® 8 (RT versions excluded) or

Windows

®

10

• .NET Framework 4.5

• 1 GHz or faster processor

• 256 MB RAM (512 MB RAM recommended)

• 250 MB of video graphics RAM

• 250 MB of available hard-disc space

• 1024x768 screen resolution

• Generic Microsoft Bluetooth driver

*

*

Needed for Bluetooth communication

Chapter 4 Nasal measurements with NIOX®Panel

002346-02 NIOX VERO® Nasal User Manual English 13

6. The NIOX® Panel application opens and it is possible to perform Nasal
NO measurements.

4.3 Perform Nasal measurements with NIOX® Panel

Note: The buttons, symbols and views are similar on NIOX® Panel and on

NIOX VERO®.

1. To enter patient ID, select patient id button. (A)

2. Select Nasal button. (B)

3. Select which expiration method to use, ER-nNO (see section 4.3.1) or TB­nNO (see section 4.3.2) and which nostril, left or right, patient age is
optional.

4. Select which file format to save measurement curve, .xlsx, pdf or both. If
the pdf file is chosen, an excel file is saved in the NIOX Nasal
Measurements folder on the computers Desktop.

Chapter 4 Nasal measurements with NIOX®Panel

14 002346-02 NIOX VERO® Nasal User Manual English

4.3.1 Expiration against Resistance (ER-nNO)

ER-nNO Nasal measurements shall be performed while exhaling through
the mouth towards a restrictor (breathing handle), this generates a pressure
that makes sure the velum is closed. The NIOX VERO Breathing Handle with
a patient filter and the NIOX VERO restrictor is used as the restrictor in this
breathing method. The breathing handle is NOT connected to the
NIOX VERO when used in this manner.

1. Open a new Patient Filter and insert an new Nasal Restrictor into the
Patient Filter, so that it rests on top of the white filter pad.

2. Attach the Patient Filter to the Breathing Handle until it clicks into place

3. Give the breathing handle to the patient, put the Olive to the selected
nostril and instruct the patient to inhale to total lung capacity and to begin
exhaling into the patient filter once their lips are tightly sealed around it.
The patient will have to exhale steadily and continuously for 30 seconds.

4. Select start measurement button (A) to start a ER-nNO Nasal
measurement with NIOX Panel.

Note: If measurement is started before patient is ready, there is an option

to abort measurement, it is not recorded as a measurement on
sensor or instrument.

Note: The y-axis does not show a nitric oxide value during the

measurement and analysis periods. This is due to the entire sample
having to cycle through the sensor (delayed analysis).

5. The instrument will aspirate for 30 seconds and then will start to analyze
the sample. After the aspiration is complete, remove nasal olive from the
nostril and wait for the result.

Note: By selecting the abort button (A) the measurement is canceled. This

can be pressed in the measurement or analysis period to abort the
measurement.

Chapter 4 Nasal measurements with NIOX®Panel

002346-02 NIOX VERO® Nasal User Manual English 15

6. When selecting the OK button (B) an option to save the file will be shown.

Note: The measurement result will always be saved in the instrument

memory.

Note: If the option “No” is selected the file won’t be saved.

7. A save dialog will be shown and an option to view the file.

Note: The Excel file has options to adjust width of the calculation area, or

change the range of seconds used to calculate the measurement
result.

Note: The pdf-file shows the graph.

Chapter 4 Nasal measurements with NIOX®Panel

16 002346-02 NIOX VERO® Nasal User Manual English

(A) Complete nNO curve data

• Blue line of graph

• 30 second aspiration measurement

• 30 second baseline measurement

(B) nNO calculation Range

• Orange section of graph

• nNO as calculated by NIOX VERO using clinically validated method

(C) Adjustable Calculation Area

• Grey section of graph

(D) nNO Value and Measurement information

• nNO in ppb

• Measurement Method (TB or ER)

• Nostril (L or R)

(E) User defined nNO Value

• Can change the adjustable calculation area

• Output is displayed in ‘red’ text

(F) Patient Information

• Patient ID

•Age

• Aspiration time (always 30sec)

• Date of Measurement

Chapter 4 Nasal measurements with NIOX®Panel

002346-02 NIOX VERO® Nasal User Manual English 17

4.3.2 Tidal Breathing (TB-nNO)

TB-nNO measurements shall be performed while breathing normally through
an open mouth.

1. Before selecting the start measurement button make sure to instruct the
patient to slowly inhale and exhale though the mouth.

2. Select start measurement button to start a TB-nNO Nasal
measurement with NIOX Panel.

Note: If measurement is started before patient is ready, there is an option

to abort measurement, it is not recorded as a measurement on
sensor or instrument.

Note: The y-axis does not show a nitric oxide value during the

measurement and analysis periods. This is due to the entire sample
having to cycle through the sensor (delayed analysis).

3. The instrument will aspirate for 30 seconds and then will start to analyze
the sample. After the aspiration is complete, remove nasal olive from the
nostril and wait for the result.

Note: By selecting the abort button (A) the measurement is canceled. This

can be pressed in the measurement or analysis period to abort the
measurement.

4. When selecting the OK button (B) an option to save the file will be shown.

5. A save dialog will be shown and an option to view the file.

Chapter 4 Nasal measurements with NIOX®Panel

18 002346-02 NIOX VERO® Nasal User Manual English

Note: The measurement result will always be saved in the instrument

memory.

Note: The pdf-file shows the graph.

(A) Complete nNO curve data

• Blue line of graph

• 30 second aspiration measurement

• 30 second baseline measurement

(B) nNO calculation Range

• Orange section of graph

• nNO as calculated by VERO using clinically validated method

(C) Adjustable Calculation Area

• Grey section of graph

(D) nNO Value and Measurement information

• nNO in ppb

• Measurement Method (TB or ER)

• Nostril (L or R)

(E) User defined nNO Value

• Can change the adjustable calculation area

• Output is displayed in ‘red’ text

(F) Patient Information

• Patient ID

•Age

• Aspiration time (always 30sec)

• Date of Measurement

Chapter 5 Cleaning procedure

19

5 Cleaning procedure

WARNING! DO NOT clean the instrument or handle with
products containing alcohol. This includes sprays or wipes
containing alcohol!

WARNING! DO NOT clean area immediately surrounding the
NIOX VERO

®

with products containing alcohol. This includes

sprays or wipes containing alcohol.

For cleaning of the instrument see NIOX VERO User Manual.

Note: NIOX Nasal Kit are disposable items for single patient use only.

• If the any part of the Nasal Kit appears clogged, replace the Nasal Kit

• The NIOX Nasal Kit is for single patient use and do not need any

cleaning.

6 NIOX VERO® Nasal

Technical Specification

6.0.1 Electromagnetic emissions

CAUTION! This equipment has been designed and tested to CISPR 11
Class A. In a domestic environment it may cause radio interference, in which
case, you may need to take measures to mitigate the interference.

For guidance and manufacturer’s declaration - electromagnetic emissions
see www.niox.com

6.1 Performance data

Measurement range: 5 to 2000 ppb
Lowest detection limit: 5 ppb
Sampling flow rates: 5 ml/s

6.2 Linearity

Squared correlation coefficient r2 ≥ 0.998

6.3 Precision

< 3ppb of measured value for values < 30 ppb, < 10% of measured value for
values ≥ 30 ppb. Expressed as one standard deviation for replicate mea­surements with the same instrument, using a certified gas concentration of
Nitric Oxide reference standard.

6.4 Accuracy

±10 ppb for measured values < 50ppb or 20% of measured value for values
≥ 50 ppb. Expressed as the upper 95% confidence limit, based on absolute
mean of differences from certified gas concentration of Nitric Oxide.

Chapter 6 NIOX VERO® Nasal Technical Specification

20

For FeNO technical specification refer to the NIOX VERO User Manual.

6.5 Essential performance

Essential performance for NIOX VERO Nasal Measurement Mode consists
of

1. The measurement of the NO concentration of air aspirated from the
nasal cavity

2. The measurement of nasal NO for screening of diseases such as
primary ciliary dyskinesia according to ATS/ERS

NIOX VERO contains internal monitoring functionality for safety and essen­tial performance parameters. Recurrent testing is not necessary to maintain
essential performance or basic safety.

Information in this document is subject to change.

Amendments will be made available by Circassia AB as they occur.

Based on the company’s intellectual property, Circassia develops and commercializes

products for the monitoring of nitric oxide (NO) as a marker of airway inflammation,

to improve the management and care of patients with inflammatory disease in the airways.

Patents:

Circassia’s NIOX products are protected by a number of patents in the US, Europe and a range of other countries.

Circassia AB, Hansellisgatan 13, SE-754 50 Uppsala, Sweden

Phone: [phone], Fax: [phone], E-mail: [email protected]

www.niox.com

Copyright 2017 Circassia AB, Uppsala, Sweden.

Circassia is a registered trademark of Circassia Limited

NIOX, NIOX MINO and NIOX VERO are registered trademarks of Circassia AB.