Circassia NIOX VERO User manual

NIOX VERO®User Manual Canada
001504-06 January 2021
NIOX VERO®Airway Inflammation Monitor
User Manual
510(k) 133898

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: Maximum 5 years
in use or 15 000 measurements or the expiration date stated on the
device, whichever comes first.
5 years in use shall be defined as starting from the first NO
measurement taken using the device.
• 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 on or close to the
NIOX VERO®instrument may cause erroneous measurement re-
sults.
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 alco-
hol 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.

Table of contents
NIOX VERO®User Manual
Canada 001504-06 1
1 Important information ...............................................................3
1.1 Before using NIOX VERO®Airway Inflammation Monitor ........ 3
1.2 About this manual..................................................................... 3
1.3 Compliance .............................................................................. 3
1.4 Responsible manufacturer and contacts .................................. 3
1.5 Warnings .................................................................................. 4
1.6 Intended use ............................................................................ 5
2 Product description ..................................................................5
2.1 NIOX VERO®accessories and parts........................................ 5
2.2 Instrument ................................................................................ 6
3 Installation and set up ..............................................................7
4 User interface ..........................................................................10
4.1 Main and settings view ........................................................... 10
4.2 Main View............................................................................... 10
4.3 Settings view .......................................................................... 11
5 Using NIOX VERO® ..................................................................12
5.1 Start the instrument from power save mode .......................... 12
5.2 Register patient ID (optional).................................................. 12
5.3 Measure FeNO....................................................................... 12
5.4 Demonstration mode.............................................................. 15
5.5 Measure ambient NO ............................................................. 16
5.6 Change settings ..................................................................... 17
5.7 Turn off the instrument ........................................................... 19
6 Using NIOX VERO®with NIOX®Panel ...................................20
6.1 Warnings ................................................................................ 20
6.2 Installation of NIOX®Panel .................................................... 20
6.3 Connect to a PC via USB....................................................... 21
6.4 Connect to a PC via Bluetooth............................................... 21
6.5 Setup...................................................................................... 21
6.6 Firmware update .................................................................... 23
6.7 Using NIOX®Panel ................................................................ 23
7 Troubleshooting ...................................................................... 24
7.1 Alert codes and actions.......................................................... 24
8 Preventive care ....................................................................... 29
8.1 General care .......................................................................... 29
8.2 Change disposals .................................................................. 29
8.3 Operational life-time............................................................... 31
8.4 Disposal of instrument and accessories ................................ 32
8.5 Return shipments................................................................... 32
9 Safety information .................................................................. 33
9.1 Warnings................................................................................ 33
9.2 Cautions................................................................................. 33
9.3 Substances disturbing FeNO measurement .......................... 33
9.4 Electromagnetic immunity...................................................... 34
9.5 Electromagnetic emissions .................................................... 34
9.6 Operating conditions .............................................................. 34
10 Reference information .......................................................... 36
10.1 Buttons and descriptions...................................................... 36
10.2 Symbols and descriptions .................................................... 36
10.3 Symbol explanation.............................................................. 37
11 Technical data ....................................................................... 38

Table of contents
NIOX VERO®User Manual
2Canada 001504-06
11.1 Dimensions and weight ........................................................ 38
11.2 Electrical data....................................................................... 38
11.3 Noise level............................................................................ 38
11.4 Exhaled NO - performance data........................................... 38
11.5 Linearity................................................................................ 38
11.6 Precision............................................................................... 38
11.7 Accuracy............................................................................... 38
11.8 Method comparison.............................................................. 38
11.9 Inhalation parameters........................................................... 39
11.10 Exhalation parameters ....................................................... 39
11.11 Essential performance........................................................ 39
11.12 Memory capacity ................................................................ 39
11.13 Patient filter ........................................................................ 39
11.14 Bluetooth ............................................................................ 39
11.15 Rechargeable battery capacity........................................... 40
11.16 Instructions for transport and storage................................. 40
12 NIOX VERO®parts and accessories ....................................41
12.1 Parts included in NIOX VERO®package
(Article No. 12-1260/12-1200/12-1100)........................................ 41
12.2 Accessories .......................................................................... 41
13 Mandatory problem reporting ..............................................42
14 Guidance and manufacturer's declaration - Electromagnetic
immunity and electromagnetic emissions ...............................43

Chapter 1 Important information
001504-06 NIOX VERO®User Manual Canada 3
1 Important information
1.1 Before using NIOX VERO®Airway Inflammation
Monitor
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.
1.2 About this manual
NIOX VERO®User Manual - English Canada 001504, version 06, January
2021, for instruments with software version 1D2x-xxxx and 1E2x-xxxx. For in-
struction on how to view the software version number installed in the instru-
ment, see page 18.
Information in this document is subject to change. Amendments will be made
by Circassia as they occur.
The User Manual provides instructions on how to operate NIOX VERO®. It
contains numbered step-by-step instructions with screens and illustrations.
Choices within steps are displayed with bullet points.
1.3 Compliance
NIOX VERO®is CE-marked according to In Vitro Diagnostics Device Direc-
tive 98/79/EC.
NIOX VERO®is RoHS compliant.
NIOX®Panel is CE-marked according to In Vitro Diagnostics Device Directive
98/79/EC.
1.4 Responsible manufacturer and contacts
Mailing address:
Circassia AB, P.O. Box 3006
SE-750 03 Uppsala, Sweden
Visiting address:
Hansellisgatan 13
SE-754 50 Uppsala
www.circassia.com
www.niox.com
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 Important information
4001504-06 NIOX VERO®User Manual Canada
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.
• 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 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 page 32.
• 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.
• 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.
• Make sure to use the correct measurement mode, otherwise incorrect
FeNO results might be obtained.

Chapter 2 Product description
001504-06 NIOX VERO®User Manual Canada 5
1.6 Intended use
NIOX VERO®measures Nitric Oxide (NO) in human breath. Nitric Oxide is
frequently increased in some airway inflammatory processes such as asthma.
The fractional NO concentration in expired breath (FeNO), can be measured
by NIOX VERO according to guidelines for NO measurement established by
the American Thoracic Society.
Measurement of FeNO by NIOX VERO is a quantitative, non-invasive, simple
and safe method to measure the decrease in FeNO concentration in asthma
patients that often occurs after treatment with anti-inflammatory pharmacolog-
ical therapy, as an indication of the therapeutic effect in patients with elevated
FeNO levels. NIOX VERO is suitable for children, 7- 17 years, and adults 18
years and older.
NIOX VERO 10 second test mode is for age 7 and up
NIOX VERO 6 second test mode is for ages 7- 10 only, who cannot
successfully complete a 10 second test.
FeNO measurements provide the physician with means of evaluating an asth-
ma patient's response to anti-inflammatory therapy, as an adjunct to the es-
tablished clinical and laboratory assessments in asthma. The NIOX VERO is
intended for prescription use and should only be used as directed in the
NIOX VERO User Manual by trained healthcare professionals. NIOX VERO
cannot be used with infants or by children under the age of 7, as measure-
ment requires patient cooperation.
NIOX VERO should not be used in critical care, emergency care or in
anesthesiology.
2 Product description
2.1 NIOX VERO®accessories and parts
(A) Breathing handle and handle cap, (B) Sensor (supplied separately),
(C) Instrument (including stand), (D) Rechargeable battery, (E) NIOX®Apps
USB memory stick, (F) USB cable, (G) Power adapter and power cord,
(H) Patient filter (supplied separately)
Note: Only accessories and parts supplied by Circassia may be used.

Chapter 2 Product description
6001504-06 NIOX VERO®User Manual Canada
2.2 Instrument
H) ON/OFF button, (I) Power adapter port, (J) USB port
(K) Battery LED - lit when battery is charging, (L) Standby LED - blinking in
Standby/Sleep mode, (M) Touch panel Display
(N) Breathing handle holder, (O) Breathing handle port

Chapter 3 Installation and set up
001504-06 NIOX VERO®User Manual Canada 7
3 Installation and set up
Open the package with care. Prior to installation, check that the package con-
tains all the parts (see page 5). A screwdriver is required for opening the com-
partment lid and installation of Sensor and battery. Remove the plastic film
from the display.
1. Carefully place the instrument with the display facing down on a flat and
clean surface, then unscrew and remove the compartment lid. There is a
taper on the side of the lid for better grip when opening.
2. Open the Sensor can.
WARNING! Open the Sensor can with care. The inside of the opening may
have sharp edges.
3. Open the Sensor package.
WARNING! Do not touch or clean the white Sensor membrane.
CAUTION! The Sensor should only be stored in its original unopened
package or installed in a NIOX VERO®instrument.
4. Insert the Sensor and turn the swivel clockwise until locked.

Chapter 3 Installation and set up
8001504-06 NIOX VERO®User Manual Canada
5. Open the battery package.
Note: Only use the correct rechargeable battery supplied by Circassia.
(Type No BJ-G510039AA, Article No 12-1150)
6. Insert the rechargeable battery and replace the lid. Tighten the screw by
using a screwdriver.
7. Take the breathing handle tube and push the end of the tube into the
breathing handle port slowly until the triangle is no longer visible.
The breathing handle and the patient filter are Applied parts Type B.
Note: Only attach the breathing handle supplied by Circassia.
Article No 12-1010
Note: Use care not to bend the handle tube.
Note: The triangle should not be visible when assembled correctly.

Chapter 3 Installation and set up
001504-06 NIOX VERO®User Manual Canada 9
8. Attach the power adapter to the instrument and then to the power outlet.
When installing the unit, either use a socket outlet with a readily
accessible power switch, or connect the AC cord plug to an easily
accessible socket outlet near the equipment. If a fault should occur during
operation of the unit, use the power switch to cut the power supply, or
remove the AC cord plug.
Note: Only use the power adapter supplied by Circassia with the
instrument. Article No 12-1120.
9. Position the instrument with the stand folded out.
10. Start the instrument by sliding the ON/OFF button to ON and allow the
instrument to start up and perform the internal check and measurement
procedures.
CAUTION! After inserting a new Sensor it is recommended to wait for three
hours with the instrument switched on before performing a measurement.
11. When the internal check is completed, the main menu appears.
12. Select the Settings button on the main menu.
13. Select Time and date.

Chapter 4 User interface
10 001504-06 NIOX VERO®User Manual Canada
This opens the Time and date setting view.
14. Select between 12h US and 24h ISO time and date
format.
15. Set time by pressing the button for hour. It changes
color to blue. Change the value to the current hour
by pressing the increase or decrease buttons.
Repeat this procedure for minute, year, month and
day.
16. Select OK to accept the changes and return to the main menu.
The Undo button closes the view without saving any changes.
17. Select the Settings button on the main menu.
18. Select the Breathing handle button. This opens the Breathing
handle view.
19. Select the Reset Breathing handle button. The breathing
handle information view opens to confirm insertion of the
breathing handle.
20. Select the OK button to confirm insertion of a new breathing
handle. This sets the remaining measurements to 1000 and
expiry date one year from the current date.
The Return button returns to Settings view without registering
change.
4 User interface
4.1 Main and settings view
This section describes the main view, settings view, menus and symbols.
Buttons and symbols are further described on page 36.
4.2 Main View
(A) Status bar, (B) Instructive demonstration, (C) Patient ID, (D) Main menu,
(E) Start measurement button

Chapter 4 User interface
001504-06 NIOX VERO®User Manual Canada 11
4.2.1 Main menu
(a) Measurement mode 10s/6s (only shown when 6s is an option, for more
information See “Enable/disable 6s measurement mode” on page -19., (b)
Demo, (c) Patient ID entry, (d) Settings
4.2.2 Status bar
(d) Battery status, (e) USB connection (in this position a Bluetooth
connection may be indicated instead), (f) Breathing handle has expired or is
about to expire - blinking symbol, (g) Instrument has expired or is about to
expire - blinking symbol, (h) Sound disabled, (i) Sensor status and number of
remaining measurements, (j) Temperature outside of specification,
(k) Humidity outside of specification, (l) Time
4.3 Settings view
(A) Modes configuration - see page 19, (B) Volume settings - see page 17,
(C) Alert log see page 18, (D) Instrument & Sensor info - see page 18,
(E) Time and date settings - see page 17, (F) Measurement log - see
page 17, (G) Ambient measurement - see page 16, (H) Breathing handle
status and settings - see page 29, (I) Return to main view

Chapter 5 Using NIOX VERO®
12 001504-06 NIOX VERO®User Manual Canada
5 Using NIOX VERO®
5.1 Start the instrument from power save mode
If NIOX VERO®is in standby or sleep mode simply touch the display to
activate it.
5.2 Register patient ID (optional)
Note: If Patient ID is used, it must be entered before each measurement,
even if it is the same patient. Local Regulations on Patient
information privacy must be considered when using unique patient
identifiers.
1. Select the Register patient ID button from the main menu.
2. Enter up to 12 characters (alpha or numeric).
3. Select the ABC-button to activate a keyboard with the alphabet.
The 123-button changes view back to the numerical keyboard.
4. Select OK button to confirm the registration.
Use the Erase button to erase.
Use the Undo button to undo a registration.
5.3 Measure FeNO
Verify proper preparations before performing a measurement with
NIOX VERO®. A basic preventive inspection is recommended before each
use (see page 29).
WARNING! The patient filter is for single use only.
5.3.1 Preparation for measurement
1. Lift the breathing handle from the holder and remove the handle cap.
2. Obtain a new patient filter. Attach the patient filter to the breathing
handle. Make sure to twist the patient filter in place until it clicks into
place.
Note: Store the patient filters in the
original box prior to use.
Note: Do NOT use sharp objects to
open the patient filter packaging.
Do not touch the filter membrane.
Note: Patient filters should be used
immediately after opening.
Note: There is a risk of leakage if the
filter is not correctly attached to the breathing handle and this may
result in incorrect measurement values.

Chapter 5 Using NIOX VERO®
001504-06 NIOX VERO®User Manual Canada 13
Note: Do not switch OFF the instrument during measurement procedure.
3. Give the breathing handle to the patient and guide the patient to provide
a breath sample as described in the next section.
5.3.2 Measurement
1. Empty the lungs by breathing out thoroughly.
2. Close the lips around the mouthpiece on the patient filter so that no air
leakage occurs.
3. Inhale deeply through the patient filter to total lung capacity. During
inhalation, the cloud on the display moves upwards.
Note: The procedure is activated by inhaling air from the handle or by
pressing the start measurement button.

Chapter 5 Using NIOX VERO®
14 001504-06 NIOX VERO®User Manual Canada
4. Exhale slowly through the filter while keeping the cloud within the limits
as indicated on the display (the white lines).
5. The instrument display and audio signals guide the user to the correct
exhalation pressure.
A continuous sound indicates correct pressure with a frequency proportional
to the pressure.
An intermittent high frequency sound - too strong pressure
An intermittent low frequency sound - too weak pressure
Exhalation with:
Pressure correct Pressure too strong Pressure too weak
6. Exhale until the cloud has passed the flag.
7. The instrument will analyze the sample and generate a result in
approximately one minute.
Note: Do not exhale or inhale through the patient filter during the analysis
process.

Chapter 5 Using NIOX VERO®
001504-06 NIOX VERO®User Manual Canada 15
8. The result is then displayed: (A) Patient ID - if applicable, (B) FeNO value
in ppb (parts per billion), (C) Measurement mode 10s/6s,
(D) Measurement sequence number, (E) OK - returns to main view.
5.3.3 Perform 6s NO measurement
• The NIOX VERO can be operated with two different exhalation times. 10
seconds and 6 seconds. The 10 second test is the preferred mode for all
ages.
The 6 second test is for children ages 7 - 10 years old who are not able to
complete a 10 second mode test. The 6 second mode should not be used
with patients over the age of 10.
6s measurement mode is not activated by default, refer to “Enable/disable 6s
measurement mode” on page 19.
1. Change to 6s Measurement mode by selecting the 10s button
(green man symbol) on the main menu.
2. The button changes to 6s measurement mode (orange, small
child symbol).
3. The 6s measurement mode is illustrated with an orange start
button.
4. Perform measurement as instructed in the “5.3.2 Measurement”
section.
5. Wait for the result.
6. The result screen displays the icon for 6s measurement.
Note: The device will always return to the default 10s mode after a
6s measurement.
5.4 Demonstration mode
To help professionals in guiding patients, the instrument contains three ani-
mated demonstrations with visual and audio guides of the different stages of a
measurement procedure.
1. Select the Animation button on the main menu.
2. Select which animation to use (Cloud, Balloon or Meter)
3. Select the Demo button.
4. Select the forward button to move to the following sequence.
5. The undo button closes the demonstration and returns to animation
select.
6. Select OK button to confirm the changes
7. The undo button returns to the main menu without saving changes.

Chapter 5 Using NIOX VERO®
16 001504-06 NIOX VERO®User Manual Canada
5.5 Measure ambient NO
Note: An ambient measurement may be requested by customer support
during troubleshooting.
Note: An ambient measurement is counted as one measurement on
NIOX VERO®Sensor and the instrument.
1. Attach a patient filter to the breathing handle until it clicks into place.
2. Select the Settings button on the main menu.
3. Select Ambient Measurement button.
4. Select the Start measurement button.
a. Inhalation
through the
breathing
handle.
b. Exhalation
through the
breathing
handle with
correct
pressure.
c. Exhalation
through the
breathing
handle with
pressure too
weak.
d. Exhalation
through the
breathing
handle with
pressure too
strong.

Chapter 5 Using NIOX VERO®
001504-06 NIOX VERO®User Manual Canada 17
5. The progress bar is visible until the measurement is finished and the
result is displayed: Ambient measurement value (in ppb), measurement
mode and measurement sequence number.
5.6 Change settings
5.6.1 Change time and date
1. Select the Settings button on the main menu.
2. Select the Time and Date button.
For more details refer to page 9.
5.6.2 Change sound volume
1. Select the Settings button on the main menu.
2. Select the Sound button.
3. The settings for sound and volume opens.
4. Select decrease/increase to adjust volume.
5. The volume bar indicates the set volume.
6. Select the OK button to save settings and return to the Settings
view.
The Undo button closes the view without saving changes.
7. The status bar indicates mute status when the sound volume is set
to zero.
5.6.3 View measurement logs
All measurement results are stored in the instrument and can be viewed at
any time.
1. Select the Settings button on the main menu.
2. Select Patient measurements log view button.