NIOX VERO 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. • 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. 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

1 Important information .................................................................3 1.1 Before using NIOX VERO® Airway Inflammation Monitor .......... 1.2 About this manual ..................................................................... 1.3 Compliance............................................................................... 1.4 Responsible manufacturer and contacts .................................... 1.5 Warnings................................................................................... 1.6 Intended use .............................................................................

3 3 3 3 3 4

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 ............................................................................11 4.1 Main and settings view ............................................................ 11 4.2 Main View............................................................................... 11 4.3 Settings view ........................................................................... 12 5 Using NIOX VERO® ...................................................................12 5.1 Start the instrument from power save mode ............................ 5.2 Register patient ID (optional) .................................................. 5.3 Measure FeNO........................................................................ 5.4 Demonstration mode .............................................................. 5.5 Measure ambient NO.............................................................. 5.6 Change settings ....................................................................... 5.7 Turn off the instrument ............................................................

12 12 13 15 16 17 19

6 Using NIOX VERO® with NIOX® PANEL ...................................20 6.1 Warnings................................................................................. 20 NIOX® VERO User Manual English EPM-000167-01

6.2 Installation of NIOX® PANEL.................................................... 6.3 Connect to a PC via USB ........................................................ 6.4 Connect to a PC via Bluetooth ................................................ 6.5 Setup ...................................................................................... 6.6 Using NIOX Panel ...................................................................

20 21 21 21 22

7 Troubleshooting ........................................................................ 23 7.1 Alert codes and actions........................................................... 23 8 Preventive care .......................................................................... 27 8.1 General care ........................................................................... 8.2 Change disposals .................................................................... 8.3 Operational life-time ............................................................... 8.4 Disposal of instrument and accessories ................................... 8.5 Return shipments ....................................................................

27 27 29 30 30

9 Safety information ..................................................................... 31 9.1 Warnings................................................................................. 9.2 Cautions ................................................................................. 9.3 Substances disturbing FeNO measurement ............................. 9.4 Electromagnetic immunity....................................................... 9.5 Electromagnetic emissions....................................................... 9.6 Operating conditions ..............................................................

31 31 31 31 32 32

10 Reference information ............................................................. 34 10.1 Buttons and descriptions ....................................................... 34 10.2 Symbols and descriptions...................................................... 34 10.3 Symbol explanation............................................................... 35 11 Technical data ......................................................................... 36

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Table of contents

11.1 Dimensions and weight ......................................................... 11.2 Electrical data........................................................................ 11.3 Noise level ............................................................................ 11.4 Exhaled NO - performance data ............................................ 11.5 Linearity ................................................................................ 11.6 Precision ............................................................................... 11.7 Accuracy............................................................................... 11.8 Method comparison .............................................................. 11.9 Inhalation parameters............................................................ 11.10 Exhalation parameters ......................................................... 11.11 Memory capacity ................................................................ 11.12 Patient filter ......................................................................... 11.13 Bluetooth ............................................................................ 11.14 Rechargeable battery capacity............................................. 11.15 Instructions for transport and storage...................................

36 36 36 36 36 36 36 36 36 37 37 37 37 37 37

12 NIOX VERO® parts and accessories .........................................38 12.1 Parts included in NIOX VERO® package (Article No. 12-1100).................................................................... 38 12.2 Accessories ........................................................................... 39 13 Vigilance ..................................................................................39

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NIOX® VERO User Manual English EPM-000167-01

Chapter 1 Important information

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.

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 Directive 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

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.

Visiting address: Råsundavägen 18 SE-169 67 Solna

Note

Alerts the reader to important information on the proper use of the product, user expectations, error situations, and actions related to these.

www.aerocrine.com www.niox.com

1.2

About this manual

NIOX VERO® User Manual - English EPM-000167, version 01, January 2014, for instruments with software version 1D0x-xxxx. For instruction 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.

EPM-000167-01 NIOX VERO® User Manual English

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 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

3

Chapter 1 Important information

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 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 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 30. • 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.

• 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 FeNO results might be obtained. • Use of substances containing alcohol close to the NIOX VERO® instrument may cause erroneous measurement results. • 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.

1.6

Intended use

NIOX VERO® Airway Inflammation Monitor measures Fractional Exhaled Nitric Oxide, FeNO, in human breath. Nitric Oxide is increased in some airway inflammatory processes and decreases as a response to anti-inflammatory treatment. The FeNO concentration in expired breath can be measured by NIOX VERO® with assurance that such measurements are repeatable and according to guidelines for NO measurement established jointly by the European Respiratory Society and the American Thoracic Society1. Measurement of FeNO by NIOX VERO® Airway Inflammation Monitor is a quantitative, non-invasive, simple and safe method to measure the FeNO concentration in patients with asthma-like airway symptoms in order to establish and monitor the presence of airway inflammation responsive to anti-inflammatory treatment.

• Do not touch or clean the white Sensor membrane.

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Chapter 2 Product description

NIOX VERO® is suitable for children, approximately 7-17 years, and adults 18 years and older. NIOX VERO® may be suitable for some children from the age of 4, however measurement requires patient cooperation and cannot be used with infants or very young children. FeNO measurements should be used as part of regular assessment and monitoring of airway inflammatory diseases, such as asthma. NIOX VERO® should be used as directed in the NIOX VERO® User Manual. 1 Am

2 2.1

Product description NIOX VERO® accessories and parts

J Respir Crit Care Med 2005; 171: 912-930.

Note:

With additional coaching and encouragement, children as young as age 4 may be able to perform a valid measurement. Even if they are unsuccessful at the first session, their performance may improve at a subsequent visit.

(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:

EPM-000167-01 NIOX VERO® User Manual English

Only accessories and parts supplied by Aerocrine may be used.

5

Chapter 2 Product description

2.2

Instrument

H) ON/OFF button, (I) Power adapter port, (J) USB port

(N) Breathing handle holder, (O) Breathing handle port

(K) Battery LED - lit when battery is charging, (L) Standby LED - blinking in Standby/Sleep mode, (M) Touch panel Display

6

EPM-000167-01 NIOX VERO® User Manual English

Chapter 3 Installation and set up

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.

WARNING! Open the Sensor can with care. The inside of the opening may have sharp edges. 3. Open the Sensor package.

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.

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. 2. Open the Sensor can.

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Chapter 3 Installation and set up

5. Open the battery package. Note:

Only use the correct rechargeable battery supplied by Aerocrine. (Type No BJ-G510039A, Article No 12-1150)

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.

6. Insert the rechargeable battery and replace the lid. Tighten the screw by using a screwdriver.

8

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Chapter 3 Installation and set up

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:

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.

Only use the power adapter supplied by Aerocrine with the instrument. Article No 12-1120.

9. Position the instrument with the stand folded out.

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

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Chapter 3 Installation and set up

11. When the internal check is completed, the main menu appears.

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. 12. Select the Settings button on the main menu. 13. Select Time and date.

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.

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.

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Chapter 4 User interface

4 4.1

User interface

4.2.1

Main menu

Main and settings view

This section describes the main view, settings view, menus and symbols. Buttons and symbols are further described on page 34.

(a) Demo, (b) Patient ID entry, (c) Settings

4.2

4.2.2

Main View

Status bar

(d) Battery status, (e) Bluetooth enabled (in this position a USB 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

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

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Chapter 5 Using NIOX VERO®

4.3

Settings view

5 5.1

Using NIOX VERO® Start the instrument from power save mode

If NIOX VERO® is in standby or sleep mode simply touch the display to activate it.

(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 27, (I) Return to main view

5.2 Note:

Register patient ID (optional) 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.

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Chapter 5 Using NIOX VERO®

2. Enter up to 12 characters (alpha or numeric).

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.

Note:

Do not switch OFF the instrument during measurement procedure.

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

3. Give the breathing handle to the patient and guide the patient to provide a breath sample as described in the next section.

Measure FeNO

Verify proper preparations before performing a measurement with NIOX VERO®. A basic preventive inspection is recommended before each use (see page 27). 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:

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.

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5.3.2 Measurement 1. Empty the lungs by breathing out thoroughly.

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Chapter 5 Using NIOX VERO®

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:

14

The procedure is activated by inhaling air from the handle or by pressing the start measurement button.

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

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Chapter 5 Using NIOX VERO®

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.

8. The result is then displayed: (A) Patient ID - if applicable, (B) FeNO value in ppb (parts per billion), (C) Measurement sequence number, (D) OK - returns to main view.

5.4

Demonstration mode

1. To help professionals in guiding patients, the instrument contains three animated 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, Dora 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.

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Chapter 5 Using NIOX VERO®

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.

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.

b. Exhalation through the breathing handle with correct pressure. c.

Exhalation through the breathing handle with pressure too weak.

2. Select the Settings button on the main menu. 3. Select Ambient Measurement button. 4. Select the Start measurement button.

d. Exhalation through the breathing handle with pressure too strong.

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Chapter 5 Using NIOX VERO®

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.

3. The settings for sound and volume opens.

4. Select decrease/increase to adjust volume. 5. The volume bar indicates the set volume.

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 10.

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.

5.6.2 Change sound volume 1. Select the Settings button on the main menu.

5.6.3 View measurement logs All measurement results are stored in the instrument and can be viewed at any time.

2. Select the Sound button.

1. Select the Settings button on the main menu. 2. Select Patient measurements log view button.

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Chapter 5 Using NIOX VERO®

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) Measurement sequence number, (F) Return to settings (G) Backward, (H) Forward 4. Browse through the measurement logs using the backward and forward buttons. 5. Select the Return button to return to settings.

(A) Alert code (for customer support purpose only), (B) Date and time of alert, (C) Scroll list (blue) (D) Return - returns to previous view, (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.

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.

2. Select the Instrument button. 3. This opens the Instrument information view displaying the following:

1. Select the Settings button on the main menu. 2. Select Alert log button.

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Chapter 5 Using NIOX VERO®

5.7

Turn off the instrument

1. To turn off the instrument, slide the ON/OFF button to OFF.

(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)

5.6.6 Note:

Note:

Before transportation remove the used patient filter (if still attached) and attach the handle cap.

Note:

Always use a closed bag or case (NIOX VERO® bag recommended) for transportation and storage of the instrument.

Turn QC functionality on or off An optional External Quality Control (QC) procedure is available for NIOX VERO®. Refer to the NIOX VERO® External Quality Control user manual. Contact your local Aerocrine representative for further information.

1. Select the Settings button on the main menu. 2. Select the Modes configuration button. 3. Select the check box to activate QC functionality.

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Chapter 6 Using NIOX VERO® with NIOX® PANEL

6

Using NIOX VERO® with NIOX® PANEL

Your NIOX VERO® instrument can be used together with NIOX® PANEL. NIOX® PANEL is a PC application and visual aid allowing you to operate the instrument from your PC.

6.1

Warnings

• NIOX® PANEL shall only be operated by trained healthcare professionals. • Operate NIOX® PANEL 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® PANEL product keep in mind that an accessory not recommended by Aerocrine AB may result in loss of performance, damage to your NIOX® PANEL 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. • If the equipment is used in a manner not specified by Aerocrine, the protection provided by the equipment may be impaired.

6.2

Installation of NIOX® PANEL

NIOX® Panel System requirements • Windows® XP*(32 bit), Windows® Vista(32 bit), Windows® 7 (32 or 64 bit) or Windows® 8 Pro (32 or 64 bit) • NET Framework 4.0 or higher • 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** *

Service Pack 3 Needed for Bluetooth communication

**

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.

• Modification of NIOX® PANEL application is not allowed.

3. If .NET Framework 4.0, VC++ 2010, XNA or SQL Server Compact is not installed, an installation wizard for each of the programs opens, one at the time.

• Do not use damaged components.

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 opens. 7. Follow the instructions and install the program. 8. When the installation is complete, click Close.

20

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Chapter 6 Using NIOX VERO® with NIOX® PANEL

9. The application is now available on the start menu.

6.4

6.3

6.4.1 Activate Bluetooth functionality 1. Select the Settings button on the main menu.

Connect to a PC via USB

In order for NIOX VERO® to be able to communicate with a PC, you may use a USB cable. An alternative option is Bluetooth communication (see how to enable Bluetooth in the next section). Note:

Only USB cables supplied by Aerocrine may be used. Article no 121002

1. Plug the USB cable into the instrument and connect it to a PC.

Connect to a PC via Bluetooth

2. Select the Measurement Mode button. This opens the Configuration modes view. 3. To enable Bluetooth, check the checkbox. (Unchecking the box disables Bluetooth communication.) Select OK to confirm change. This returns to the Settings view. An enabled Bluetooth function is indicated by a symbol on the status bar (provided that the instrument is not connected to a PC via cable).

6.4.2

Connect by Bluetooth in NIOX® Panel

1. Select

in the NIOX Panel window

2. A search view opens, select to search for devices. 3. Select the instrument and click OK. Note:

If the instrument is in power saving mode no connection will be established.

2. An enabled USB connection is indicated on NIOX VERO® by a symbol on the status bar.

6.5

Note:

1. Turn on the PC and monitor.

If the instrument is in power saving mode no connection will be established.

Setup

2. Turn on the instrument 3. Select the Start or the Windows button normally found in the left lower hand corner of your monitor.

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Chapter 6 Using NIOX VERO® with NIOX® PANEL

4. Select NIOX® PANEL from the program list. VERO®

5. Plug the USB cable into the USB port on the NIOX 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.

6.6.3 Change settings See “Change settings” on page 17 6.6.4 View measurement logs See “View measurement logs” on page -17.

6. The NIOX® PANEL application opens and you can start to operate your NIOX VERO® instrument via your PC.

6.6 Note:

Using NIOX Panel The buttons, symbols and views are similar on NIOX® Panel and on NIOX VERO®.

6.6.1 Measure FeNO See “Measure FeNO” on page 13 CAUTION! Do not disconnect the instrument from the PC during measurement and analyzing process.

6.6.2 Demonstration mode See “Demonstration mode” on page 15

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EPM-000167-01 NIOX VERO® User Manual English

Chapter 7 Troubleshooting

7 7.1

Troubleshooting Alert codes and actions

Alert messages and other information are shown as a code on the instrument display. The tables below provide the alert codes and recommended actions to be taken for an alert code. If the alert persists, contact your local Aerocrine representative or Aerocrine Customer Support. User alerts

Screen

User alerts

Exhalation too strong Press Redo measurement and repeat the measurement with less exhalation force.

A11

Exhalation too weak Press Redo measurement and repeat the measurement with greater exhalation force.

Analysis interrupted Repeat the measurement and do not breathe through the handle during analysis.

A21

Measurement failed Remove any sources of disturbance (such as cordless phones/mobile phones or gas emitting appliances). Then press Redo measurement. Repeat the procedure. When the instrument is ready for use repeat the measurement. If the alert persists, restart the instrument.

Instrument alerts A01

Measurement failed No exhalation detected or the user failed to exhale within 15 seconds of inhaling. Press Redo measurement button. Repeat the procedure and exhale into the instrument directly after inhalation.

EPM-000167-01 NIOX VERO® User Manual English

Action

A13

Action

A10

A12

Screen

Screen

Action Unstable temperature Make sure that the ambient temperature is between +10°C and +35°C. Wait for the Sensor to stabilize. If necessary move the instrument to another location and restart the instrument.

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Chapter 7 Troubleshooting

Instrument alerts

Action

Instrument alerts

A02

Sensor stabilization Remove any sources of disturbances (such as cordless phones, mobile phones or gas emitting appliances). Wait for the Sensor to stabilize.

A06

A03

Unstable system Remove any sources of disturbances (such as cordless phones, mobile phones or gas emitting appliances). Wait for the System to stabilize.

Configuration code error Only provided by Aerocrine upon request. The configuration code entered is incorrect. Enter correct configuration code. If this error continues to be shown, contact Aerocrine Customer support.

A07

Lid open warning Check if the battery or sensor lid is open and close if needed. Click the OK button when finished.

A08

Battery problem Low power in battery or other failure. Change the battery and click the OK button when finished.

A22

Memory access failure Contact Aerocrine Customer support.

A04

A05

24

Screen

Count down time The remaining time until the instrument is ready to use.

Lock MMI When the instrument is connected to a PC the main view buttons will be locked.

Screen

Action

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Chapter 7 Troubleshooting

Instrument alerts

Screen

Action

Instrument alerts

A25

Temperature or base line failed to stabilize within 30 minutes Check that the ambient temperature and relative humidity is within specification. If necessary, move the instrument to another location and restart the instrument.

A30

Bluetooth connection error Check the Bluetooth connection with the PC. When finished click the OK button.

A26

Self test failure The self test of the instrument failed. Restart the instrument. If alert code persists contact Aerocrine Customer support.

A31

USB connection error Check the USB connection with the PC. When finished click the OK button.

A27

Internal hardware error unrecoverable

A40

No Sensor inserted Insert Sensor. See page 28 (replacement of sensor) or page 7 (initial placement of sensor).

A41

Sensor error Remove any sources of disturbance (such as cordless/mobile telephones or gas emitting appliances). When the instrument is ready for measurement try to repeat the measurement. If alert persists, power off the instrument, remove and insert the Sensor and restart the instrument.

Contact Aerocrine Customer support.

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.

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Screen

Action

25

Chapter 7 Troubleshooting

Instrument alerts

Action

Instrument alerts

A80

The instrument is about to expire Order a new instrument. This alert is visible when less than 500 measurements remain or less than 120 days until expiry date. Press OK to acknowledge.

A92

Instrument expiration date has passed It is still possible to view measurements stored in the instrument memory.

A81

The Sensor is about to expire Order a new Sensor. This alert is visible when less than 10% of the measurements remain or less than 2 weeks until expiry date. Press OK to acknowledge.

A93

Sensor expiration date has passed. Replace the sensor, see page 28.

A82

The breathing handle is about to expire This alert is visible when less than 100 measurements remain or less than 2 weeks until expiry date. Press OK. Prepare to change breathing handle.

A94

A90

All measurements on the instrument have been used It is still possible to view measurements stored in the instrument memory.

The breathing handle has expired Press OK. Change breathing handle. See page 27. CAUTION! The breathing handle’s NO scrubber contains potassium permanganate and should be disposed of as hazardous waste in accordance with local waste disposal regulations.

A95

Breathing handle expiration date has passed Replace the handle, see page 27. It is still possible to view measurements stored in the instrument memory.

A91

26

Screen

All measurements on the sensor have been used. Replace the sensor, see page 28.

Screen

Action

EPM-000167-01 NIOX VERO® User Manual English

Chapter 8 Preventive care

8 8.1

Preventive care General care

In the following sections, actions for preventive care and maintenance are described. Do NOT try to repair the instrument. Any attempt will make the warranty invalid and performance according to the specifications cannot be guaranteed. 1. Clean the instrument with a cloth dampened with soap solution. If needed, use a dampened cloth with 70% ethanol, isopropanol or similar disinfectant. CAUTION! Minimize use of solvents 2. Clean the breathing handle with a cloth dampened with water, alcohol or soap solution. Note:

8.1.1 Preventive inspections Before each measurement verify that NIOX VERO® is working properly, is not damaged and that normal operating conditions are fulfilled (see page 32). If any item is missing or damaged, contact your local Aerocrine representative or Aerocrine AB Customer support.

8.2

Change disposals

8.2.1 Change breathing handle The breathing handle contains a NO scrubber which can be used for 1000 measurements or one year, whichever comes first. The breathing handle view is used for viewing the status of the breathing handle and for resetting breathing handle usage parameters.

The breathing handle and patient filter are not intended for sterilization.

WARNING! • The breathing handle and the instrument can not be cleaned with an aerosol • Be careful when using disinfectants as excess of alcohol (ethanol) might permanently damage the Sensor. Do not use spray detergents. • Use a new patient filter for each patient. • Never attempt to open the instrument (other than the Sensor and battery compartment) or to perform service of the instrument or Sensor. • Do not modify the handle tube. (A) Breathing handle symbol, (B) Remaining number of measurements,

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Chapter 8 Preventive care

(C) Expiration date, (D) Breathing handle reset button, (E) Return button Note: The breathing handle status icon appears blinking in the status bar two weeks prior to expiration or when 10% of its capacity is left. Perform the following steps to change the breathing handle: 1. Place the device on its side on a level secure surface. 2. Remove the used handle from the instrument by pushing the socket into the device and gently pull out the tube. 3. Discard the breathing handle.

7. Select the Reset Breathing handle button. 8. The breathing handle information view opens to confirm replacement of the breathing handle. Select the OK button to confirm insertion of a new breathing handle and to set the remaining measurements to 1000 and expiration date one year from the current date. Note:

The Return button returns to settings view without registering change.

8.2.2 Exchange of NIOX VERO® Sensor 1. Turn off the instrument. 2. Open the compartment on the back of the instrument using a screwdriver. Turn the swivel to release the Sensor.

CAUTION! The breathing handle contains potassium permanganate and should be disposed of as hazardous waste in accordance with local waste disposal regulations. Do not re-use an expired breathing handle. 4. Attach a new breathing handle to the instrument by pushing the tube into the socket until the triangle is no longer visible. 5. Select the Settings button in the main menu. 6. Select Breathing handle button.

28

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Chapter 8 Preventive care

3. Remove the old Sensor. 4. Replace with a new Sensor. WARNING! Make sure to not touch or clean the white Sensor membrane. WARNING! Be careful when opening the Sensor can. The inside of the opening may have sharp edges. 5. Turn the swivel to lock.

8.2.3 Change battery If the rechargeable battery is no longer charging properly, malfunctioning, or requires charging more frequently than normal, then it needs to be replaced. Note:

Only rechargeable batteries supplied by Aerocrine may be used. (Type No BJ-G510039A, Article No 12-1150)

The battery is placed in the compartment on the back of the instrument.

6. Replace the compartment lid.

1. Turn off the instrument.

CAUTION! Make sure there is no foreign material or particles in the Sensor compartment before closing it.

2. Open the compartment lid (see page 28). 3. Remove the old battery and insert a new battery. 4. Close the compartment lid. CAUTION! Used batteries should be recycled according to the local recycling program for rechargeable batteries.

8.3

Operational life-time

8.3.1 NIOX VERO® instrument Minimum 5 years at time of delivery or 15 000 measurements, whichever comes first. The user is prompted for expiry parameters via the device display. It is not possible to perform further measurements after expiry, although stored measurement data can still be retrieved.

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Chapter 8 Preventive care

8.3.2 NIOX VERO® Sensor Operational life-time is maximum 12 months after opening package and installation in NIOX VERO® or until expiration date as stated on the Sensor, whichever comes first. The Sensor will expire after the pre-programmed number of measurements have been depleted, or after one year (whichever comes first). When there is less than 10% of the number of the measurements left, or less than two weeks of use remaining, a message is shown on the display.

inside the instrument in addition to the replaceable and rechargeable battery. Note:

There is a silver-oxide battery and a LiMnO2 battery in the Sensor.

NIOX VERO® is RoHS compliant.

8.5

Return shipments

For return shipments, contact your local Aerocrine representative or Aerocrine AB.

8.3.3 NIOX VERO® Patient filter The shelf life of the NIOX VERO Patient Filter in its unopened primary package is two years from manufacturing date. NIOX VERO Patient Filter is for single use and must be replaced for every patient and measurement occasion.

8.4

Disposal of instrument and accessories

WARNING! NIOX VERO® and the breathing handle contain potassium permanganate. Used or expired instruments and handles should be disposed of as hazardous waste in accordance with local waste disposal regulations. Used or expired Sensors should be recycled according to the local recycling program for electronic equipment. Used batteries should be recycled according to the local recycling program for rechargeable batteries.

Note:

30

There is a Lithium Manganese Dioxide (LiMnO2) backup battery

EPM-000167-01 NIOX VERO® User Manual English

Chapter 9 Safety information

9

Safety information

• Make sure that the gas outlet (four parallel slots to the left of the lid) on the rear side of the device is not covered.

See “Warnings” on page 3

• The device contains a Lithium-ion Battery which may cause an increased risk of heat, smoke or fire if handled incorrectly; do not open, crush, heat above 60°C or incinerate.

9.2

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

9.1

Warnings

Cautions

• Mobile phones, cordless phones and gas emitting appliances might interfere with the instrument and could make it impossible to perform a measurement. • The instrument might produce some heat during normal operation. The temperature could increase up to 5°C above the ambient temperature. Make sure that the ventilation slots are not blocked. Do not place the instrument on a bed, sofa, carpet or other soft surface. • Normally a maximum of 10 measurements/hour 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. • The Sensor shall be kept in its original unopened package prior to installation. For transportation and storage conditions, refer to page 38. • The Sensor is sensitive to changes in ambient temperature and humidity. Best performance is achieved if the ambient conditions are stable. Refer to the recommended environmental conditions on page 32. Keep the unit away from windows, direct sun, radiators, stoves or open fire in order to avoid unstable conditions. • When transporting the unit from one location to another a prolonged stabilization period before measurement might be required. Refer to the recommended transportation conditions in the “Transport and Storage” section on page 37. Always use a bag for transportation.

EPM-000167-01 NIOX VERO® User Manual English

• Keep the Sensor out of reach of children. • Any person who connects external equipment to signal input and signal output ports of this device has formed a Medical Electric System and is therefore responsible for the system to comply with the requirements of IEC 60601-1. • A PC connected to the USB connector has to be certified for one of the standards IEC 60601-1, IEC 60950 or comparable with safety extra low voltage on the USB ports. • The connected PC should be placed out of reach from the patient. Do not, simultaneously, touch the connected PC and the patient.

9.3

Substances disturbing FeNO measurement

Known patient factors that could interfere with FeNO measurements are described in the ATS/ERS Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005 (Am j Respir Crit Care Med 2005; 171:912-930)

9.4

Electromagnetic immunity

NIOX VERO® has been tested to comply with the emission and immunity requirements described in the parts of the IEC 61326 series for electrical equipment for measurement, control and laboratory use, and found to com-

31

Chapter 9 Safety information

ply with IEC 60601-1-2:2007 General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibilityRequirements and tests.

• NO in ambient air up to 300 ppb

CAUTION! The test limits are designed to provide protection against harmful interference in a typical medical installation. However, because of the increased use of radio-frequency transmitting equipment and other sources of electrical noise emitters in the healthcare and home environments, such as base stations for radio, cellular/cordless telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast, it is possible that high levels of such interferences due to close proximity or strength of a source, may result in disruption of performance of the instrument. If abnormal performance is observed, it may be necessary to reorient or relocate the NIOX VERO®.

• Temperature range of +10°C to +35°C

WARNING! NIOX VERO® should not be used adjacent to or stacked with other electronic equipment.

9.6.1 Limited warranty Aerocrine AB provides a Limited Warranty for this instrument and original accessories delivered with the instrument. Conditions are defined when the items are purchased.

9.5

Electromagnetic emissions

To verify NO in ambient air, perform an ambient measurement, see page 16

• A relative humidity range of 20% to 80%, non condensing • An atmospheric pressure range of 700 hPa to 1060 hPa Performance shall be sustained when measuring continuously at a pace of up to 10 measurements / hour. Measurement cycle groups of 20 measurements / hour with sustained performance for one hour, with a minimum of 30 minutes in between each measurement cycle group of 20 measurements / hour. See also page 31.

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.

Do NOT try to repair the instrument. Any attempt will make the warranty invalid and performance according to the specifications cannot be guaranteed.

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

9.6.2 Support Contact your local Aerocrine representative or Aerocrine Customer Support if you encounter problems which you cannot solve with the information in this manual.

9.6

Operating conditions

Ensure stable operating conditions by avoiding placement of the instrument in direct sunlight, near sources radiating heat, or ventilation. NIOX VERO® operates within specification at the following conditions:

32

For contact details, see back cover, and provide the following information: • Your name, address and telephone number.

EPM-000167-01 NIOX VERO® User Manual English

Chapter 9 Safety information

• Serial number for both the instrument, handle and Sensor. • Problem description (as thorough as possible) • Alert codes or lists.

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33

Chapter 10 Reference information

10 Reference information 10.1

Buttons and descriptions

10.1.1

Control buttons

10.1.2

OK - accept changes/verify result

Delete

Undo - closes view without saving changes

Edit

Return

Set configuration

Erase button

Demo

Skip

Reset handle

Decrease/step downwards

Time/date (active for resetting)

Increase/step upwards

Time/date

Check box (not active)

Start ambient measurement

Check box (active)

Start measurement

Settings view buttons Configuration

Patient measurements

Volume

Ambient measurements

Alert logs

Breathing handle status

Instrument status

Enable Bluetooth

Time and date

Main menu buttons Demo

10.1.3

Settings

10.2

Symbols and descriptions

10.2.1

Status bar Battery - fully charged

Breathing handle - about to expire or has expired (blinking)

Battery < 87% charge

Instrument - about to expire or has expired (blinking)

Battery < 62% charge

Sensor status - followed by number of measurements remaining

Battery < 37% charge

Sensor status - no sensor

Battery < 12% charge

Warning - temperature is not within operating conditions range

Bluetooth enabled

Warning - humidity is not within operating conditions range

Instrument connected via USB

Time

Patient ID

Audio - mute

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Chapter 10 Reference information

10.2.2

Display Analysis progress bar

Expiration date Transport and storage temperature limitation

Volume bar General warning Screen code - correct

For single use only In Vitro Diagnostic Device Transport and storage relative humidity limitation

Screen code - incorrect Transport and storage atmospheric pressure limitation Result screen - Ambient measurement Cloud - pressure within limits Cloud - goal reached

Equipment protected throughout by DOUBLE INSULATION or REINFORCED INSULATION The Device includes a Radio Frequency (RF) transmitter (Bluetooth)

Cloud - warning pressure too high or too low

10.3

Symbol explanation Responsible manufacturer The product meets the requirements of applicable European directive Electrical safety Type B applied parts: Breathing handle and patient filter The product should be recycled according to the local program for electronic equipment. Consult instructions for use

EPM-000167-01 NIOX VERO® User Manual English

35

Chapter 11 Technical data

11 Technical data 11.1

Dimensions and weight

Height: 145 mm Width: 185 mm Depth: 41 mm Weight of instrument including Sensor: 1kg

11.2

Electrical data

Electrical safety classification:

The equipment complies with the requirements according to IEC 60601-1 and IEC 61010-1. Class II ME EQUIPMENT while externally powered, and as INTERNALLY POWERED ME EQUIPMENT while powered by battery.

Mains Voltage:

100-240 V ~47-63 Hz

Secondary voltage (external power adapter):

5V

Power consumption:

< 15 VA

11.3

Noise level

< 65 dBA, at a distance of 1 m

11.4

11.5

Linearity

Squared correlation coefficient r2 ≥ 0.998, slope 0.95 -1.05,intercept ±3 ppb.

11.6

Precision

< 2ppb of measured value for values < 50 ppb, < 4% of measured value for values ≥ 50 ppb. Expressed as one standard deviation for replicate measurements with the same instrument, using a certified gas concentration of Nitric Oxide reference standard.

11.7

Accuracy

±5 ppb or maximum 10% of measured value. Expressed as the upper 95% confidence limit, based on absolute mean of differences from certified gas concentration of Nitric Oxide.

11.8

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 VERO® instrument from Aerocrine.

Exhaled NO - performance data

The instrument is verified to fulfill the specified performance under a temperature range of +10 to +35 °C, relative humidity range of 20-80% and pressure range of 700-1060 hPa.

36

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.

11.9

Inhalation parameters

Inhale to TLC (Total Lung Capacity) before start of exhalation. Inhalation in instrument is triggered by a pressure of -3 cm H20.

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Chapter 11 Technical data

11.10

Exhalation parameters

Exhalation time: Standard mode: 10 s (clinical use) All exhalations are to be performed at an exhalation pressure of 10 - 20 cm H2O, to maintain a fixed flow rate of 50 ±5 ml/s. The instrument stops the measurement at pressures outside the interval. Warning alerts sounds at 10 - 12 and 18-20 cm H2O.

11.11

Memory capacity

Up to 15 000 measurements, depending on the size of the measurement files.

11.12

Patient filter

Disposable filter to be changed for each new measurement session and for each patient.

11.13.1 R&TTE Directive Hereby, Aerocrine AB, declares that this NIOX VERO is in compliance with the essential requirements and other relevant provisions of Directive 1999/ 5/EC.

11.14

Only use the power adapter or USB cable supplied by Aerocrine to charge the battery. Capacity: Approx. 30 measurements per day or 36 hours stand-by in 25°C environment condition. Lifetime: At least one year with normal use. Charging time: <8 hours under normal conditions. Lowered capacity, and/or when 8 hours of charging time does not charge the battery fully, indicates that the battery should be replaced. Battery Type No BJ-G510039A, Article No 12-1150.

Bacterial, viral filter, CE marked according to Medical Device Directive Class I.

Note:

11.13

11.15

Bluetooth

NIOX VERO® has a Bluetooth class 2 receiver/transmitter with: • Frequency band of 2402MHz~2480 MHz. • Modulation method • 0,5BT Gaussian Filter 2 FSK modulation index: 0.28~0.35 (Basic Rate 1Mbps) • π/4-DQPSK (EDR 2Mbps) • 8DPSK (EDR 3Mbps) • ERP • Power class 2

EPM-000167-01 NIOX VERO® User Manual English

Rechargeable battery capacity

To charge the battery by USB cable, the instrument needs to be powered off.

Instructions for transport and storage

CAUTION! Always use a closed bag or box for transportation and storage of NIOX VERO®. 1. Verify that the instrument is turned off and disconnected from the power supply. 2. Remove the patient filter and attach the protective cap on the handle. 3. Place the instrument and accessories in the bag and close bag. 4. Verify that the storage environment conditions are appropriate see recommendations for NIOX VERO® including sensor.

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Chapter 12 NIOX VERO® parts and accessories

11.15.1 NIOX VERO®, including sensor (transportation and storage) • Relative humidity range: 20% to 80%, non condensing. • Temperature range: +10 to +35 °C • Atmospheric pressure range: 700 to 1060 hPa When transporting the instrument from one location to another with different ambient conditions, a prolonged stabilization period might be required before measurements can be performed. 11.15.2 NIOX VERO® instrument (transport and storage in its unopened original package without Sensor) • Relative humidity range: 10% to 90%, non condensing (maximum 1 week when outside relative humidity range 10% to 80%). • Temperature range: -20°C to +60°C (maximum 1 week when outside temperature range +10°C to +35°C). • Atmospheric pressure range: 500 to 1070 hPa 11.15.3 NIOX VERO® Sensor (transport and storage in original package) • Relative humidity range: 10% to 99%, non condensing. • Recommended temperature range: +5°C to +25°C (maximum 24h for the ranges -20°C to +5°C and + 35°C to +60°C) • Atmospheric pressure range: 700 to 1070 hPa

12 NIOX VERO® parts and accessories CAUTION! When selecting an accessory for your NIOX VERO® keep in mind that an accessory not recommended by Aerocrine 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. Aerocrine takes no responsibility for health and safety problems or other problems caused by the use of accessories not approved by Aerocrine.

12.1

Parts included in NIOX VERO® package (Article No. 12-1100)

NIOX VERO® Instrument (12-1000) NIOX VERO® Breathing Handle (12-1010) NIOX VERO® Handle Cap (12-1009) NIOX VERO® Power Adapter (12-1120) NIOX VERO® Power Cord (12-1130) NIOX VERO® USB Cable (12-1002) NIOX VERO® Battery (Type No BJ-G510039A, Article No 12-1150) NIOX VERO® Stand (12-1001) NIOX VERO® User Manual (EPM-000167) NIOX® Panel USB Memory stick (12-1003)

38

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Chapter 13 Vigilance

12.2

Accessories

NIOX VERO® Test Kit 100 (12-1810) Contains: 1 Sensor* for 100 tests and 100 NIOX VERO® Filters** NIOX VERO® Test Kit 300 (12-1830) Contains: 1 Sensor* for 300 tests and 300 NIOX VERO® Filters** NIOX VERO® Test Kit 500 (12-1850) Contains: 1 Sensor* for 500 tests and 500 NIOX VERO® Filters** NIOX VERO® Test Kit 1000 (12-1900) Contains: 1 Sensor* for 1000 tests and 1000 NIOX VERO® Filters** * NIOX VERO® Sensor Pre-calibrated disposable sensor for 100, 300, 500 or 1000 measurements. Operational life-time: Maximum 12 months when installed in NIOX VERO® or expiration date as stated on the Sensor, whichever comes first. ** NIOX VERO® Filter Disposable filter to be changed for every patient. Bacterial, viral filter according to Medical Device Directive Class I.

13 Vigilance Aerocrine, as a medical device manufacturer, must have a Vigilance system in place to report to health authorities, any adverse incidents that have occurred with its medical products. The purpose of the Vigilance system is to ensure the health and safety of patients, users and others using medical products by reducing the likelihood of the same type of adverse incident being repeated. This is achieved by immediate notification of incidents to enable corrective and preventive actions. An adverse incident is defined as: Any malfunction or deterioration in the characteristics and/or performance of a instrument, or any inadequacy in the labeling or instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his/her state of health. Manufacturers of medical devices are obliged to report adverse incidents to national health authorities within 10 or 30 days, dependent on the severity of the incident. Any user of Aerocrine's products, who experience an adverse incident related to the product, must therefore immediately report this to Aerocrine or Aerocrine's local market representative. The report can be made by e-mail, fax, or telephone. The report should contain the following information: • When and where did the incident occur? • What product / accessory was involved? • Was the incident related to instructions for use of the product? • Was the risk foreseeable and clinically acceptable in view of potential

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Chapter 13 Vigilance

patient benefit? • Was the outcome adversely affected by a patient's pre-existing condition? The report should be forwarded to Aerocrine's local representative in the country where the incident occurred.

40

Information in this document is subject to change. Amendments will be made available by Aerocrine AB as they occur. Copyright© 2014 Aerocrine AB, Solna, Sweden. Based on the company’s intellectual property, Aerocrine develops and commercializes products for the monitoring of nitric oxide (NO) as a marker of inflammation, to improve the management and care of patients with inflammatory disease in the airways. Patents: For information about patents relating to Aerocrine products see www.aerocrine.com

An ISO 13485 certified company

Aerocrine AB, Råsundavägen 18, SE-169 67, Sweden Phone: +46 8 629 07 80, Fax: +46 8 629 07 81, E-mail: [email protected] www.aerocrine.com Copyright© 2014 Aerocrine AB, Solna, Sweden. Aerocrine, NIOX®, NIOX MINO® and NIOX VERO® are registered trademarks of Aerocrine AB.