Aerocrine NIOX VERO User Manual
  1. Manuals
  2. Brands
  3. Aerocrine Manuals
  4. Medical Equipment
  5. NIOX VERO
  6. User manual

Aerocrine NIOX VERO User Manual

Airway inflammation monitor
Hide thumbs
Table of Contents

Advertisement

Quick Links

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

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the NIOX VERO and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Summary of Contents for Aerocrine NIOX VERO

  • Page 1 NIOX VERO ® Airway Inflammation Monitor User Manual 510(k) 133898 000190-01 (EPM-000165-01) NIOX VERO® User Manual US...
  • Page 2 15, 000 measurements. • Operational life-time NIOX VERO ® Sensor: Maximum 12 months after opening package and installed in NIOX VERO or expiration date as stated on the Sensor, whichever comes first. CAUTION!: Do not use NIOX VERO ®...

  • Page 3: Table Of Contents

    1 Important information ..............3 6.1 Warnings................. 24 6.2 Installation of NIOX® Panel............24 1.1 Before using NIOX VERO® Airway Inflammation Monitor ..3 6.3 Connect to a PC via USB ............25 1.2 About this manual ..............3 6.4 Setup ..................25 1.3 Compliance................
  • Page 4 11.15 Instructions for transport and storage........44 ® 12 NIOX VERO parts and accessories .........45 12.1 Parts included in NIOX VERO® package (Article No. 12-1200)..............45 12.2 Accessories ................46 13 Medical Device Reporting (MDR) ..........46 14 Guidance and manufacturer's declaration - Electromagnetic im-...

  • Page 5: Important Information

    Chapter 1 Important information Important 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. Before using NIOX VERO ®...
  • Page 6 Aerocrine. ® • Use of substances containing alcohol close to the NIOX VERO ® • NIOX VERO should not be used adjacent to or stacked with other instrument may cause erroneous measurement results.

  • Page 7: Indications For Use

    FeNO levels. NIOX VERO is suitable for children, ap- proximately 7 - 17 years, and adults 18 years and older.

  • Page 8: 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 000190-01 NIOX VERO® User Manual US...

  • Page 9: Installation And Set Up

    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.
  • Page 10 Chapter 3 Installation and set up Note: Only use the correct rechargeable battery supplied by Aerocrine. 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.
  • Page 11 AC cord plug. Note: Only use the power adapter supplied by Aerocrine with the instrument. Article No 12-1220. CAUTION! After inserting a new Sensor it is recommended to wait for three hours with the instrument switched on before performing a 9.

  • Page 12: User Interface

    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. 000190-01 NIOX VERO® User Manual US...

  • Page 13: Settings View

    (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 000190-01 NIOX VERO® User Manual US...

  • Page 14: Using Niox Vero

    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. 000190-01 NIOX VERO® User Manual US...
  • Page 15 Note: The procedure is activated by inhaling air from the handle or by pressing the start measurement button. 5.3.2 Measurement 1. Empty the lungs by breathing out thoroughly. 000190-01 NIOX VERO® User Manual US...
  • Page 16 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 000190-01 NIOX VERO® User Manual US...

  • Page 17: Demonstration Mode

    2. Select which animation to use Cloud, Balloon or Meter breathing handle with correct pressure. c. Exhalation through the breathing handle with 3. Select the Demo button. pressure too 4. Select the forward button to move to the following sequence. weak. 000190-01 NIOX VERO® User Manual US...

  • Page 18: Measure Ambient No

    For more details refer to page 9. 5.6.2 Change sound volume 1. Select the Settings button on the main menu. 2. Select the Sound button. 2. Select the Settings button on the main menu. 000190-01 NIOX VERO® User Manual US...
  • Page 19 2. Select the Patient measurements log view button. 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.

  • Page 20: Turn Off The Instrument

    Detailed information about the instrument and Sensor can be viewed. 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. 000190-01 NIOX VERO® User Manual US...

  • Page 21: External Quality Control (Qc) Procedure

    A minimum of one individual (two individuals are recommended) needs to qualify for this procedure. If possible, identify one or two individuals as a ® Note: Always use a closed bag or case (NIOX VERO bag recommended) back-up. for transportation and storage of the instrument.
  • Page 22 2. Select QC Settings to verify which QC IDs are available. Note: Each QC tester must select an individual number. 3. Select an available QC ID. 4. Empty the lungs by breathing out thoroughly. 000190-01 NIOX VERO® User Manual US...
  • Page 23 (A) Control result FeNO value limits (mean value +/- 10 ppb), (B) Control result in ppb, (C) QC Measurement date and time, (D) Measurement se- quence number, (E) QC tester number 12. Remove the handle cap. 13. Press to return to main menu. 000190-01 NIOX VERO® User Manual US...
  • Page 24 Press to return to main menu. Repeat the QC test if the positive and/or the negative control fail. If the QC ® failure persists, discontinue use of NIOX VERO and contact Aerocrine Customer Support. Note: The prompt to QC the device will remain if the QC measurement was performed by a non-qualified QC candidate.
  • Page 25 To add or edit a name to a QC tester number press the Edit button. 4. Select the Return button to return to settings. 5.8.5 Reset QC tester This instruction will delete the data for the selected individual. 000190-01 NIOX VERO® User Manual US...

  • Page 26: Using Niox Vero ® With Niox ® Panel

    • If the equipment is used in a manner not specified by Aerocrine, the protection provided by the equipment may be impaired. 4. Select to accept license agreement for the program.

  • Page 27: Connect To A Pc Via Usb

    1. Plug the USB cable into the instrument and connect it to a PC. Using NIOX ® Panel 2. An enabled USB connection is displayed on NIOX VERO with a symbol Note: The buttons, symbols and views are similar on NIOX Panel and on on the status bar.
  • Page 28 Alerts are stored in the instrument and can be viewed at any time. The alert This allows a QC user (after qualification) to qualify a new instrument codes are for Aerocrine Customer Support use. with just one QC measurement. For instructions how to create QC 1.

  • Page 29: Troubleshooting

    15 seconds from inhaling. Sensor to stabilize. If necessary move the Press Return button, restart the instrument to another location and restart measurement and exhale into the the instrument. instrument directly after inhalation. 000190-01 NIOX VERO® User Manual US...
  • Page 30 Only provided by Aerocrine upon for 30 minutes request. Memory access failure The configuration code entered is incorrect. Enter correct configuration Contact Aerocrine Customer support. code. If this error continues to be shown contact Aerocrine Customer support. 000190-01 NIOX VERO® User Manual US...
  • Page 31 When finished restart the instrument. The measurement value does not fall between 5-50 ppb. Restart the QC tester qualification from Analysis failure day one. Ambient measurement failure. Click the OK button and obtain a new measurement. 000190-01 NIOX VERO® User Manual US...
  • Page 32 Order a new instrument. This alert is visible when less than 500 measurements QC daily result lower than limits from remain or less than 120 days until expiry moving mean. date. Press OK to acknowledge. 000190-01 NIOX VERO® User Manual US...
  • Page 33 All measurements on the Sensor have been used. Replace the Sensor, see page 33. Instrument expiration date has passed It is still possible to view measurements stored in the instrument memory. 000190-01 NIOX VERO® User Manual US...

  • Page 34: Preventive Care

    (see page 38). In the following sections, actions for preventive care and maintenance are If any item is missing or damaged, contact your local Aerocrine represen- described. Do NOT try to repair the instrument. Any attempt will make the tative or Aerocrine Inc.
  • Page 35 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 on the main menu. 6. Select the Breathing handle button. 000190-01 NIOX VERO® User Manual US...

  • Page 36: Operational Life-Time

    Sensor membrane. Note: Only rechargeable batteries supplied by Aerocrine may be used. Type No BJ-G510039AA, Article No 12-1150 WARNING! Be careful when opening the Sensor can. The inside The battery is placed in the compart- of the opening may have sharp ment on the back of the instrument.

  • Page 37: Disposal Of Instrument And Accessories

    Note: There is a LiMnO backup battery inside the instrument in addition The shelf life of the NIOX VERO Patient Filter in its unopened primary pack- to the replaceable and rechargeable battery. age is 2 years from manufacturing date. Note: There is a silver-oxide battery and a LiMnO battery in the Sensor.

  • Page 38: Safety Information

    • The Sensor shall be kept in its original unopened package before installation. For transportation and storage conditions, refer to page 45. • The Sensor is sensitive to changes in ambient temperature and 000190-01 NIOX VERO® User Manual US...

  • Page 39: Substances Disturbing Feno Measurement

    FeNO levels. It is • Other factors - The manipulation of physiologic parameters has been possible that a mouthwash may reduce the effect of nitrate-containing 000190-01 NIOX VERO® User Manual US...

  • Page 40: Electromagnetic Immunity

    FeNO remains stable after exercise. It would seem prudent to ® may be necessary to reorient or relocate the NIOX VERO avoid strenuous exercise for 1 hour before the measurement. • Ethnic differences in ‘healthy’ FeNO levels have been observed. In ®...
  • Page 41 20 measurements / hour. 9.6.1 Limited warranty Aerocrine provides a Limited Warranty for this instrument and original ac- cessories delivered with the instrument. Conditions are defined when the items are purchased. Do NOT try to repair the instrument. Any attempt will make the warranty invalid and performance according to the specifications cannot be guaran- teed.

  • Page 42: 10 Reference Information

    Warning - temperature is not within operating conditions range Radio button - on/QC performed Warning - humidity is not within operating conditions range 10.1.2 Main menu buttons Instrument connected via Time Demo Settings Audio - mute Patient ID 000190-01 NIOX VERO® User Manual US...

  • Page 43: Symbol Explanation

    Chapter 10 Reference information 10.2.2 Display Expiration date Analysis progress bar Transport and storage temperature limitation Volume bar For single use only General warning In Vitro Diagnostic Device Screen code - correct Transport and storage humidity limitation Screen code - incorrect Transport and storage atmospheric pressure limitation Result screen - Ambient measurement Equipment protected throughout by DOUBLE INSULATION or...

  • Page 44: 11 Technical Data

    < 10 ppb for values ≤ 50 ppb, < 20% for values > 50 ppb. Expressed as the ® < 65 dBA, at a distance of 1 m difference between a NIOX MINO FeNO value and the corresponding ® FeNO value measured with NIOX VERO instrument from Aerocrine. 11.4 Exhaled NO - performance data 11.9 Inhalation parameters The instrument is verified to fulfill the specified performance under the temperature range within 50 to 95 °F, relative humidity range of 20-80%...

  • Page 45: Exhalation Parameters

    11.10 Exhalation parameters 11.13.1 R&TTE Directive Hereby, Aerocrine AB, declares that this NIOX VERO is in compliance Exhalation time: Standard mode: 10 s (clinical use) with the essential requirements and other relevant provisions of Directive All exhalations are to be performed at an exhalation pressure of 10 - 20 cm 1999/5/EC.

  • Page 46: Rechargeable Battery Capacity

    This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: Only use the power adapter or USB cable supplied by Aerocrine to charge the battery. (1) This device may not cause harmful interference, and Capacity: Approx.

  • Page 47: Niox Vero ® Parts And Accessories

    Aerocrine may result before measurements can be performed. in loss of performance, damage to your NIOX VERO product, fire, electric shock, injury or damage to other property. The product warranty does not 11.15.2 NIOX VERO...

  • Page 48: Accessories

    FDA. Any user of Aerocrine's products, first. who experience an adverse event related to the product, must therefore ® immediately report this to Aerocrine Inc. The report should contain the fol- ** NIOX VERO Filter Disposable filter to be changed for every patient. lowing: Bacterial, viral filter according to Medical Device Directive Class I.

  • Page 49: Guidance And Manufacturer's Declaration - Electromagnetic Im- Munity And Electromagnetic Emissions

    The NIOX VERO ® is intended for use in the electromagnetic environment specified below. ® The customer or the user of the NIOX VERO should assure that it is used in such an environment. Immunity test Compliance Electromagnetic environment -...
  • Page 50 NIOX and voltage cycle VERO, including cables, than the ® If the user of the NIOX VERO requires variations on recommended separation distance 40% U_T continued operation during power power supply...
  • Page 51 NIOX VERO is used exceeds the applicable 3.689 3.689 7.379 ® RF compliance level above, the NIOX VERO should be observed to 11.667 11.667 23.333 verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or For transmitters rated at a maximum output power not listed above, the ®...
  • Page 52 ® The NIOX VERO is intended for use in the electromagnetic environment specified below. ® The customer or the user of the NIOX VERO should assure that it is used in such an environment Emission test Compliance Electromagnetic environment - guidance ®...
  • Page 54 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.

Table of Contents