NIOX VERO User Manual

Table of contents

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 Intended use ... 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 ... 12 5.2 Register patient ID (optional) ... 12 5.3 Measure FeNO... 13 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 NIOX® VERO User Manual English EPM-000167-01

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 Using NIOX Panel ... 22 7 Troubleshooting ... 23 7.1 Alert codes and actions... 23 8 Preventive care ... 27 8.1 General care ... 27 8.2 Change disposals ... 27 8.3 Operational life-time ... 29 8.4 Disposal of instrument and accessories ... 30 8.5 Return shipments ... 30 9 Safety information ... 31 9.1 Warnings... 31 9.2 Cautions ... 31 9.3 Substances disturbing FeNO measurement ... 31 9.4 Electromagnetic immunity... 31 9.5 Electromagnetic emissions... 32 9.6 Operating conditions ... 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 ... 36 11.2 Electrical data... 36 11.3 Noise level ... 36 11.4 Exhaled NO - performance data ... 36 11.5 Linearity ... 36 11.6 Precision ... 36 11.7 Accuracy... 36 11.8 Method comparison ... 36 11.9 Inhalation parameters... 36 11.10 Exhalation parameters ... 37 11.11 Memory capacity ... 37 11.12 Patient filter ... 37 11.13 Bluetooth ... 37 11.14 Rechargeable battery capacity... 37 11.15 Instructions for transport and storage... 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

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Important information

1.1

Before using NIOX VERO® Airway Inflammation Monitor

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® 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.

NIOX VERO® is CE-marked according to In Vitro Diagnostics Device Directive 98/79/EC. NIOX VERO® is RoHS compliant.

Symbol

Description

WARNING

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

Mailing address: Aerocrine AB, P.O. Box 1024 SE-171 21 Solna, Sweden

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

1.4

1.5

Responsible manufacturer and contacts

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

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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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EPM-000167-01 NIOX VERO® User Manual English

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.

2 2.1

Product description NIOX VERO® accessories and parts

1 Am 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.

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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

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EPM-000167-01 NIOX VERO® User Manual English

Chapter 3 Installation and set up

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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.

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EPM-000167-01 NIOX VERO® User Manual English

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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EPM-000167-01 NIOX VERO® User Manual English

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

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.

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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:

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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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