NIOX VERO Airway Inflammation Monitor User Manual 2014

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 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

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Table of contents

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 immunity and electromagnetic emissions ...47

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Chapter 1 Important information

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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. 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.

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.

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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 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 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

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Chapter 1 Important information

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 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.

• 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.

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Chapter 2 Product description

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.

2 2.1

Product description NIOX VERO® accessories and parts

Measurement of FeNO by NIOX VERO is a quantitative, non-invasive, simple and safe method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels. NIOX VERO is suitable for children, approximately 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. (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:

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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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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.

5. Open the battery package.

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Chapter 3 Installation and set up

Note:

Only use the correct rechargeable battery supplied by Aerocrine. Type No BJ-G510039AA, 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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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.

Only use the power adapter supplied by Aerocrine with the instrument. Article No 12-1220.

9. Position the instrument with the stand folded out.

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.

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Chapter 4 User interface

This opens the Time and date setting view.

4 4.1

User interface 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

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.

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

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.

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Chapter 4 User interface

4.2.1

Main menu

4.3

Settings view

(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 (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

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Chapter 5 Using NIOX VERO®

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.

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.

5.2

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.

5.3.1

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.

1. Select the Register patient ID button from the main menu.

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Preparation for measurement

1. Lift the breathing handle from the holder and remove the handle cap.

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Chapter 5 Using NIOX VERO®

Note:

Do not switch OFF the instrument during measurement procedure.

2. Close the lips around the mouthpiece on the patient filter so that no air leakage occurs.

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

3. Inhale deeply through the patient filter to total lung capacity. During inhalation, the cloud on the display moves upwards. Note:

5.3.2

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

Measurement

1. Empty the lungs by breathing out thoroughly.

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Chapter 5 Using NIOX VERO®

4. Exhale slowly through the filter while keeping the cloud within the limits as indicated on the display (the white lines).

6. Exhale until the cloud has passed the flag.

7. The instrument will analyze the sample and generate a result in approximately one minute. 5. The instrument display and audio signals guide the user to the correct exhalation pressure.

Note:

Do not exhale or inhale through the patient filter during the analysis process.

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

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Pressure too strong

Pressure too weak

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Chapter 5 Using NIOX VERO®

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. 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.

5.4

Demonstration mode

Inhalation through the breathing handle.

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, Balloon or Meter

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

3. Select the Demo button. 4. Select the forward button to move to the following sequence.

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Exhalation through the breathing handle with pressure too weak.

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Chapter 5 Using NIOX VERO®

3. Select Ambient Measurement button. d. Exhalation through the breathing handle with pressure too strong.

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.

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 Settings button on the main menu.

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2. Select the Sound button.

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Chapter 5 Using NIOX VERO®

3. The settings for sound and volume opens.

3. The selected log will display the following:

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.

(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.

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

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.

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Chapter 5 Using NIOX VERO®

3. This opens the Instrument information view displaying the following:

3. Select the Return button to return to settings.

(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)

5.6.5

5.7

(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

View instrument information

Detailed information about the instrument and Sensor can be viewed.

Turn off the instrument

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

1. Select the Settings button on the main menu. 2. Select the Instrument button.

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Chapter 5 Using NIOX VERO®

Note: Note:

5.8

Before transportation remove the used patient filter (if still attached) and attach the handle cap. Always use a closed bag or case (NIOX VERO® bag recommended) for transportation and storage of the instrument.

External Quality Control (QC) procedure

5.8.1

Selection and qualification of QC testers

A minimum of one individual (two individuals are recommended) needs to qualify for this procedure. If possible, identify one or two individuals as a back-up. Identify the staff members who will perform the Quality Control and meet the following criteria:

The external Quality Control is one of the procedures that ensures the system is operating within the specifications.

• Over 18 years of age.

Note:

• Non-smoker.

The Quality Control function must always be activated as a daily QC measurement is mandatory when the instrument is clinically used.

A QC icon in the status bar on the screen indicates that a daily external QC assessment is needed or that there are not any currently qualified QC individuals who have completed their initial 4 qualification attempts. The external Quality Control consists of two parts. One positive control from a qualified staff member with a stable FeNO value providing a normal biological FeNO sample and a negative control consisting of a NO free gas sample automatically generated from ambient air. NIOX VERO® will allow for one daily QC measurement that will not affect the number of remaining tests on the NIOX VERO® Sensor. (During the first 20 days of instrument start-up, a maximum of seven QC testers can be qualified without impact to the number of remaining tests on the Sensor.) Note:

It is also possible to store the QC users in a database, see chapter “6.5.6 Perform QC measurement” for information.

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• No ongoing cold or known airway disease. • Expected stable FeNO values between 5 and 40 ppb. • Preferably no allergies (except seasonal, see below) or asthma. A QC tester will be qualified over the course of four days within a seven day period Note:

After a QC tester has been qualified, if the most recent QC measurement is older than 30 days, then the qualification is suspended and the QC tester needs to re-qualify according to the qualification procedure. Perform four QC measurements, one per day within seven days, according to the QC measurement section, in order to qualify a QC tester.

A mean value is calculated from the three qualifying measurements that must be between 5-40 ppb for the QC tester to be qualified. The QC measurement on the fourth day (daily QC) must be within ± 10 ppb from the mean value and the negative control approved. If this has been met the Quality Control has passed for that staff member and the instrument is ready for clinical use. The moving mean value is recalculated when the QC tester performs a QC measurement after seven days.

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