Aerocrine NIOX VERO User manual

000190-01 (EPM-000165-01) NIOX VERO® User Manual US
NIOX VERO®Airway Inflammation Monitor
User Manual
510(k) 133898

Remember
It is important to adhere to the following specified conditions:
• Ambient temperature: 50°F to 95°F
• 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.
• Normally a maximum of 10 measurements can be performed during
continuous use. However, it is possible to perform 20 measurements
in one hour if the instrument is paused for a minimum of 30 minutes
prior to the next session of 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 NIOX VERO®Instrument: Minimum 5 years at
time of delivery, or 15, 000 measurements.
• Operational life-time 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.
CAUTION!: Do not use NIOX VERO®in the proximity of areas where vol-
atile substances such as organic fluids or disinfectants are being used. Spe-
cial attention should be paid to aerosols and disinfection baths, either
open vessels or ultrasonic baths.

Table of contents
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................................................................................... 3
1.6 Indications for 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 ....................................................................... 16
5.7 Turn off the instrument............................................................ 18
5.8 External Quality Control (QC) procedure ................................ 19
6 Using NIOX VERO®with NIOX®Panel .....................................24
6.1 Warnings................................................................................. 24
6.2 Installation of NIOX® Panel...................................................... 24
6.3 Connect to a PC via USB ........................................................ 25
6.4 Setup ...................................................................................... 25
6.5 Using NIOX® Panel.................................................................. 25
7 Troubleshooting ........................................................................ 27
7.1 Alert codes and actions........................................................... 27
8 Preventive care ..........................................................................32
8.1 General care ........................................................................... 32
8.2 Change disposables................................................................. 32
8.3 Operational life-time ............................................................... 34
8.4 Disposal of instrument and accessories ................................... 35
8.5 Return shipments .................................................................... 35
9 Safety information ..................................................................... 36
9.1 Warnings................................................................................. 36
9.2 Cautions.................................................................................. 36
9.3 Substances disturbing FeNO measurement ............................. 37
9.4 Electromagnetic immunity....................................................... 38
9.5 Emission of electromagnetic energy......................................... 38
9.6 Operating conditions .............................................................. 38
10 Reference information ............................................................. 40
10.1 Buttons and descriptions....................................................... 40
10.2 Symbols and descriptions...................................................... 40
10.3 Symbol explanation............................................................... 41
11 Technical data ......................................................................... 42

Table of contents
2
11.1 Dimensions and weight ......................................................... 42
11.2 Electrical data........................................................................ 42
11.3 Noise level ............................................................................ 42
11.4 Exhaled NO - performance data ............................................ 42
11.5 Linearity ................................................................................ 42
11.6 Precision ............................................................................... 42
11.7 Accuracy............................................................................... 42
11.8 Method comparison .............................................................. 42
11.9 Inhalation parameters............................................................ 42
11.10 Exhalation parameters ......................................................... 43
11.11 Memory capacity ................................................................ 43
11.12 Patient filter......................................................................... 43
11.13 Bluetooth ............................................................................ 43
11.14 Rechargeable battery capacity............................................. 44
11.15 Instructions for transport and storage................................... 44
12 NIOX VERO®parts and accessories .........................................45
12.1 Parts included in NIOX VERO® package
(Article No. 12-1200).................................................................... 45
12.2 Accessories ........................................................................... 46
13 Medical Device Reporting (MDR) ............................................46
14 Guidance and manufacturer's declaration - Electromagnetic im-
munity and electromagnetic emissions .........................................47

Chapter 1 Important information
000190-01 NIOX VERO® User Manual US 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 read-
ing 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 - US 000190 (EPM-000165), version 01,
November 2014, for instruments with software version 1D1x-xxxx. X can
be any number between 0 and 9 or a character. For instructions on how to
view the software version number installed in the instrument, see page 18.
Information in this document is subject to change. Amendments will be
made by Aerocrine AB 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.
For clinical and performance characteristics, refer to the NIOX VERO®
Labeling Summary/Package Insert (EPS-000069).
1.3 Compliance
NIOX VERO® is CE-marked according to In Vitro Diagnostics Device Direc-
tive 98/79/EC. NIOX VERO®is RoHS compliant.
1.4 Responsible manufacturer and contacts
Mailing address:
Aerocrine AB, P.O. Box 1024
SE-171 21 Solna, Sweden
Visiting address:
Råsundavägen 18
SE-169 67 Solna
www.aerocrine.com
www.niox.com
1.5 Warnings
• NIOX VERO®should only be operated by healthcare professionals.
• Operate NIOX VERO®as stated in this manual. Aerocrine 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 Aerocrine may result in
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
4 000190-01 NIOX VERO® User Manual US
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. Aerocrine takes no responsibility for
health and safety problems or other problems caused by the use of
accessories not approved by Aerocrine.
• NIOX VERO®should not be used adjacent to or stacked with other
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 Aerocrine.
• 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 35.
• 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 the expiration date.
• Patient filters should be used immediately after opening.
• NIOX VERO®Sensor contains chemicals that could be harmful if
swallowed.
• Do not touch or clean the white Sensor membrane.
• Do not clean the sensor. Cleaning of the Sensor with ethanol or similar
disinfectant might destabilize it for a non-predicable time period.
• After inserting a new Sensor it is recommended to wait for three hours
with the instrument switched on before performing a measurement.
• Use of substances containing alcohol close to the NIOX VERO®
instrument may cause erroneous measurement results.
• Do not reuse the 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.

Chapter 2 Product description
000190-01 NIOX VERO® User Manual US 5
1.6 Indications for use
NIOX VERO®measures Nitric Oxide (NO) in human breath. Nitric Oxide is
frequently increased in some 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, sim-
ple and safe method to measure the decrease in FeNO concentration in
asthma patients that often occurs after treatment with anti-inflammatory
pharmacological therapy, as an indication of the therapeutic effect in pa-
tients with elevated FeNO levels. NIOX VERO is suitable for children, ap-
proximately 7 - 17 years, and adults 18 years and older.
FeNO measurements provide the physician with means of evaluating an
asthma patient’s response to anti-inflammatory therapy, as an adjunct to the
established 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 approximately under the age of
7, as measurement 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®Panel
USB memory stick, (F) USB cable, (G) Power adapter and power cord,
(H) Patient filter (supplied separately)
Note: Only accessories and parts supplied by Aerocrine may be used.

Chapter 2 Product description
6 000190-01 NIOX VERO® User Manual US
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
000190-01 NIOX VERO® User Manual US 7
3 Installation and set up
Open the package with care. Prior to installation, check that the package
contains all the parts. (See page 5). A screwdriver is required for opening
the compartment 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.
5. Open the battery package.

Chapter 3 Installation and set up
8 000190-01 NIOX VERO® User Manual US
Note: Only use the correct rechargeable battery supplied by Aerocrine.
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 Aerocrine.
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
000190-01 NIOX VERO® User Manual US 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 Aerocrine with the
instrument. Article No 12-1220.
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.
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 000190-01 NIOX VERO® User Manual US
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 the 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 40.
4.2 Main View
(A) Status bar, (B) Instructive demonstration, (C) Patient ID, (D) Start
measurement button

Chapter 4 User interface
000190-01 NIOX VERO® User Manual US 11
4.2.1 Main menu
(a) QC Users (b) Demo, (c) Patient ID entry, (d) Settings
4.2.2 Status bar
(e) Battery status, (f) USB connection, (g) QC warning, (h) Breathing handle
has expired or is about to expire - blinking symbol, (i) Instrument has
expired or is about to expire - blinking symbol, (j) Sound disabled,
(k) Sensor status and number of remaining measurements, (l) Temperature
outside of specification, (m) Humidity outside of specification, (n) Time
4.3 Settings view
(A) Modes configuration - see page 16, (B) Volume settings - see page 16,
(C) Alert log see page 17, (D) Instrument & Sensor info - see page 18,
(E) QC log - see page 22, (F) Time and date settings - see page 16,
(G) Measurement log - see page 17, (H) Ambient measurement - see
page 16, (I) Breathing handle status and settings - see page 32, (J) QC tester
info - see page 22, (K) Return to main view

Chapter 5 Using NIOX VERO®
12 000190-01 NIOX VERO® User Manual US
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 ac-
tivate 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 32).
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.
Note: Do NOT use sharp objects to
open the packaging for the
patient filter. 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®
000190-01 NIOX VERO® User Manual US 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 000190-01 NIOX VERO® User Manual US
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®
000190-01 NIOX VERO® User Manual US 15
8. The result is then displayed: (A) Patient ID - if applicable, (B) FeNO
value in ppb (parts per billion), (C) Measurement mode,
(D) Measurement sequence number, (E) OK - returns to main view.
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 the animation
select.
6. Select OK button to confirm the changes.
7. The undo button returns to the main menu without saving
changes.
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.

Chapter 5 Using NIOX VERO®
16 000190-01 NIOX VERO® User Manual US
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.
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.
d. Exhalation
through the
breathing
handle with
pressure too
strong.

Chapter 5 Using NIOX VERO®
000190-01 NIOX VERO® User Manual US 17
3. The settings for sound and volume opens.
4. Select increase/decrease 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 the Patient measurements log view button.
3. The selected log will display the following:
(A) Patient ID - if defined, (B) FeNO value, (C) Measurement date and time,
(D) Measurement mode, (E) Return to settings, (F) Backward, (G) Forward,
(H) Measurement sequence number, (I) QC Warning, only shown if the
daily QC measurement is not performed or if the results from the QC are
outside limits
4. Browse through the measurement logs using the backward and forward
buttons.
5. Select the Return button to return to settings.
5.6.4 View alert logs
Alerts are stored in the instrument and can be viewed at any time. The alert
codes are for Aerocrine Customer Support use.
1. Select the Settings button on the main menu.
2. Select Alert log button.

Chapter 5 Using NIOX VERO®
18 000190-01 NIOX VERO® User Manual US
(A) Alert code (for customer support purpose only), (B) Return - returns to
previous view, (C) Date and time of alert, (D) Scroll list (blue),
(E) Backward (F) Forward
3. Select the Return button to return to settings.
5.6.5 View instrument information
Detailed information about the instrument and Sensor can be viewed.
1. Select the Settings button on the main menu.
2. Select the Instrument button.
3. This opens the Instrument information view displaying the following:
(A) Numbers of remaining measurements on the instrument,
(B) Instrument serial number, (C) Software version number (D) Instrument
expiration date, (E) Return to settings, (F) Numbers of remaining
measurements on the Sensor, (G) Sensor serial number, (H) Sensor
expiration date, (I) Enter configuration code (only used on request from
Aerocrine)
5.7 Turn off the instrument
1. To turn off the instrument, slide the ON/OFF button to OFF.