Related Manuals for NIOX FeNo VERO
Summary of Contents for NIOX FeNo VERO
- Page 1 NIOX VERO Airway Inflammation Monitor ® User Manual NIOX VERO User Manual English ® 000191-16 May 2023...
- Page 2 30 minutes prior to the next session of exhalations. Exhalations include failed and successful measurements. CAUTION!: Do not use NIOX VERO® in the proximity of areas where • Avoid spilling water or other fluids on the instrument or sensor.
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Page 3: Table Of Contents
1 Important information ................3 6.1 Warnings ....................... 20 6.2 Installation of NIOX® Panel ..............21 1.1 Before using NIOX VERO® Airway Inflammation Monitor....3 6.3 Connect to a PC via USB................21 1.2 About this manual ..................3 6.4 Connect to a PC via Bluetooth ............... 21 1.3 Compliance...................... - Page 4 11.13 Patient filter ....................39 11.14 Bluetooth..................... 39 11.15 Rechargeable battery capacity ............39 11.16 Instructions for transport and storage ..........40 12 NIOX VERO® parts and accessories ..........41 12.1 Parts included in NIOX VERO® package (Article No. 12-1100) .................... 41 12.2 Accessories....................41 13 Vigilance .....................42...
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Page 5: Important Information
Before using NIOX VERO® Airway Inflammation NIOX VERO® is RoHS compliant. Monitor NIOX VERO® may only be operated as directed in this manual by trained Responsible manufacturer and contacts healthcare professionals. Trained status is achieved only after careful reading Mailing address: of this manual. -
Page 6: Intended Use
Nitric Oxide, FeNO) and Nasal Nitric Oxide (nNO) in the aspirated air from the spilled or dropped on the instrument or sensor. nasal cavity. NIOX VERO® is for use only as an In Vitro Diagnostic Device (IVD) • Do not heat or dispose of the instrument or sensor in fire. Refer to section and intended for near patient testing. -
Page 7: Principals Of Operation
The device requires no maintenance or Measurement of nNO with the NIOX VERO® Nasal Measurement Mode is non- scheduled servicing. invasive, simple, safe and repeatable in patients age 5 and above when measured according to the NIOX VERO®... -
Page 8: Product Description
(H) ON/OFF button, (I) Power adapter port, (J) USB port (A) Breathing handle and handle cap, (B) Sensor (supplied separately), (C) Instrument (including stand), (D) Rechargeable battery, (E) NIOX Panel USB memory stick, (F) USB cable, (G) Power adapter and power cord, (H) Patient filter (supplied separately) Note: Only accessories and parts supplied by Circassia may be used. -
Page 9: Installation And Set Up
There is a taper on the side of the lid for better grip when opening. Open the sensor can. (N) Breathing handle holder, (O) Breathing handle port 000191-16 NIOX VERO ® User Manual English... - Page 10 CAUTION! The sensor should only be stored in its original unopened package 6. Insert the rechargeable battery and replace the lid. Tighten the screw by or installed in a NIOX VERO® instrument. using a screwdriver. Insert the sensor and turn the swivel clockwise until locked.
- Page 11 The triangle should not be visible when assembled correctly. 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. 000191-16 NIOX VERO ® User Manual English...
- Page 12 20. Select the OK button to confirm insertion of a new breathing 13. Select Time and date. 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. 000191-16 NIOX VERO ® User Manual English...
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Page 13: User Interface
(i) Sound disabled, (j) Sensor status and number of remaining measurements, (k) Temperature outside of specification, (l) Humidity outside of specification, (m) Time (A) Status bar, (B) Instructive demonstration, (C) Patient ID, (D) Main menu, (E) Start measurement button 000191-16 NIOX VERO ® User Manual English... -
Page 14: Settings View
Chapter 5 Using NIOX VERO® Using NIOX VERO® Settings view 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 section 5.6.6, Register patient ID (optional) (B) Volume settings - see section 5.6.2, (C) Alert log - see section 5.6.4,... -
Page 15: Measure Feno
Verify proper preparations before performing a measurement with Note: There is a risk of leakage if the NIOX VERO®. A basic preventive inspection is recommended before each use filter is not correctly attached to the breathing handle and this may (see section 8.1.1). - Page 16 Chapter 5 Using NIOX VERO® 5.3.2 Measurement Exhale slowly through the filter while keeping the cloud within the limits as indicated on the display (the white lines). Empty the lungs by breathing out thoroughly. Close the lips around the mouthpiece on the patient filter so that no air leakage occurs.
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Page 17: Demonstration Mode
Exhale until the cloud has passed the flag. • NIOX VERO® can be operated with two different exhalation times, 10 seconds and 6 seconds. The 10 second test is the preferred mode. For children who are not able to perform the 10 second test, the 6 second test is an alternative. -
Page 18: Measure Ambient No
The Undo button returns to the main menu without saving changes. during troubleshooting. Inhalation Note: An ambient measurement is counted as one measurement on through the NIOX VERO® Sensor and the instrument. breathing handle. Attach a patient filter to the breathing handle until it clicks into place. Exhalation through the... -
Page 19: Change Settings
Chapter 5 Using NIOX VERO® 5.6.2 Change sound volume Select the Settings button on the main menu. Select Ambient Measurement button. Select the Settings button on the main menu. Select the Sound button. Select the Start measurement button. The settings for sound and volume opens. - Page 20 Chapter 5 Using NIOX VERO® The selected log will display the following: (A) Alert code (for technical support purpose only), (B) Date and time of alert, (A) Patient ID - if defined, (B) FeNO value, (C) Measurement date and time,...
- Page 21 Contact your local Circassia representative for further 5.6.8 Activate Nasal measurement mode information. To unlock Nasal measurement mode in NIOX VERO® a configuration code is Select the Settings button on the main menu. required. Select the Modes configuration button.
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Page 22: Turn Off The Instrument
To turn off the instrument, slide the ON/OFF button to OFF. The 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 a PC. -
Page 23: Installation Of Niox® Panel
Chapter 6 Using NIOX VERO® with NIOX® Panel Installation of NIOX® Panel 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. NIOX® Panel System requirements •... -
Page 24: Setup
Chapter 6 Using NIOX VERO® with NIOX® Panel Select the Measurement Mode button. 6. The NIOX® Panel application opens and you can start to operate your NIOX VERO® instrument via your PC. This opens the Configuration modes view. Note: When starting NIOX® Panel for the first time the connectivity details To enable Bluetooth, check the dialog box opens. -
Page 25: Firmware Update
To decide at a later stage to allow Circassia to collect data, press cancel and the dialog box will open again next time NIOX® Panel is started, or click on the cloud icon in the status bar. -
Page 26: Using Niox® Panel
Chapter 6 Using NIOX VERO® with NIOX® Panel Using NIOX® Panel Select Alert log button. Note: The buttons, symbols and views are similar on NIOX® Panel and on NIOX VERO®. 6.7.1 Measure FeNO See section 5.3, Measure FeNO CAUTION! Do not disconnect the instrument from the PC during measurement and analysing process. -
Page 27: Troubleshooting
Press Return button. Repeat the procedure and exhale into the instrument Sensor stabilization directly after inhalation. Remove any sources of disturbances (such as cordless phones, mobile phones or gas emitting appliances). Wait for the sensor to stabilise. 000191-16 NIOX VERO User Manual English ®... - Page 28 If this error continues to be shown, contact Circassia Technical support. Lid open warning Check if the battery or sensor lid is open and close if needed. Click the OK button when finished. 000191-16 NIOX VERO User Manual English ®...
- Page 29 (replacement of sensor) or section 3 Check that the sensor, battery and lid is (initial placement of sensor). in its correct position, also make sure that the tube is not folded. When finished restart the instrument. 000191-16 NIOX VERO ® User Manual English...
- Page 30 Order a new sensor. This alert is visible when less than 10% of the measurements remain or less than 2 Sensor expiration date has passed. weeks until expiry date. Replace the sensor, see section 8.2.2. Press OK to acknowledge. 000191-16 NIOX VERO User Manual English ®...
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Page 31: Preventive Care
Breathing handle expiration date has WARNING! DO NOT clean area immediately surrounding the passed NIOX VERO® with products containing alcohol. This includes sprays Replace the handle, see section 8.2.1. or wipes containing alcohol. It is still possible to view measurements stored in the instrument memory. -
Page 32: Change Disposals
Do not modify the handle tube. 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 section 9.6). If any item is missing or damaged, contact your local Circassia representative or Circassia Technical support. - Page 33 If the rechargeable battery is no longer charging properly, malfunctioning, or requires charging more frequently than normal, then it needs to be replaced. 8.2.2 Exchange of NIOX VERO® Sensor Note: Only rechargeable batteries supplied by Circassia may be used. Turn off the instrument.
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Page 34: Operational Life-Time
NIOX VERO® Patient filter battery placed compartment on the back of the The shelf life of the NIOX VERO® Patient Filter in its unopened primary instrument. package is three years from manufacturing date. Turn off the instrument. The NIOX VERO® Patient Filter must be replaced for every patient. Reuse... -
Page 35: Safety Information
Normally a maximum of 10 exhalations/hour can be performed with voltage on the USB ports. NIOX VERO® during continuous use. However, it is possible to perform 20 • The connected PC should be placed out of reach from the patient. Do not, exhalations in one hour if the instrument is paused for a minimum of 30 simultaneously, touch the connected PC and the patient. -
Page 36: Electromagnetic Immunity
Chapter 9 Safety information Electromagnetic immunity Operating conditions NIOX VERO® has been tested to comply with the emission and immunity Ensure stable operating conditions by avoiding placement of the instrument requirements described in the parts of the IEC 61326 series for electrical in direct sunlight, near sources radiating heat, or ventilation. -
Page 37: Information Security
The NIOX VERO® device does not connect to hospital networks or the internet when operating as intended in the healthcare providers setting. It The patient ID is optional information that can be entered by users and used to communicates with connected NIOX®... -
Page 38: 10 Reference Information
Main menu buttons within operating conditions range Bluetooth enabled Warning - humidity is not within Measurements mode 10s Demo operating conditions range Instrument connected via Time Measurements mode 6s Patient ID Audio - mute Settings 000191-16 NIOX VERO ® User Manual English... -
Page 39: Symbol Explanation
Connected to Microsoft Not connected to Microsoft Azure European Commission Directive 2006/66/EC related to all batteries Azure (Only shown in (Only shown in NIOX® Panel and accumulators applies to this product. The battery in this product NIOX® Panel status bar) status bar) should be recycled according to the local program for batteries. -
Page 40: Technical Data
Noise level < 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 < 65 dBA, at a distance of 1 m value measured with NIOX VERO®... -
Page 41: Exhalation Parameters
Charging time: <8 hours under normal conditions. Lowered capacity, and/or when 8 hours of charging time does not charge the The NIOX VERO® Patient Filter is labeled for single use only and must be battery fully, indicates that the battery should be replaced. -
Page 42: Instructions For Transport And Storage
Place the instrument and accessories in the bag and close bag. NIOX VERO® 10-35 °C 20-80% 700-1060 hPa Sensor Verify that the storage environment conditions are appropriate see recommendations for NIOX VERO® including sensor. 11.16.1 Transport and storage in unopened original package Temperature Relative humidity Atmospheric (non condensing) pressure NIOX VERO®... -
Page 43: 12 Niox Vero® Parts And Accessories
Accessories NIOX VERO® Test Kit 100 (12-1810) CAUTION! When selecting an accessory for your NIOX VERO® keep in mind Contains: 1 Sensor* for 100 tests and 100 NIOX VERO® Filters that an accessory not recommended by Circassia may result in loss of NIOX VERO®... -
Page 44: 13 Vigilance
• 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 patient benefit? 000191-16 NIOX VERO ® User Manual English... -
Page 45: 14 Revision History
Chapter 14 Revision History 14 Revision History Clarified point on instrument operational life / Added NIOX® Panel CE marking /Added statement on NIOX® Panel SW / Updated firmware revision reference/ Updated phone number on cover Revision Changes Updated firmware revision referenced / Modified note in 6.6 / Added... - Page 48 Patents: NIOX® products are protected by a number of patents in the US, Europe and a range of other countries. Circassia AB, an ISO 13485 certified company Circassia AB, Hansellisgatan 13, SE-754 50 Uppsala, Sweden Phone: +46 18 32 88 37, Fax: +46 18 32 88 38, E-mail: nioxtechsupport@circassia.com...