Important Safety Information | NIOX VERO® User Manual (PDF)

For US Healthcare Professionals Only


What is quality control (QC) within the NIOX VERO®?

External quality control (QC) ensures the device is operating within the specifications. A daily, qualified QC measurement is mandatory when the NIOX VERO® is used for clinical measurements.

How do I use the NIOX VERO® quality control (QC)?
The quality control (QC) function must always be enabled in the user settings:

An orange QC icon in the status bar on the screen indicates that a daily external QC measurement needs to be performed by a qualified QC user.

The external QC consists of two parts: One positive control from a qualified QC user with a stable FeNO value to provide a normal biological FeNO sample and one negative control from the breathing handle, consisting of a nitric oxide (NO)-free gas sample, automatically generated from ambient air.

Note: The QC function is performed in the 10-second test mode.

What is a qualified quality control (QC) user?
A qualified quality control (QC) user is an individual who has met the criteria below and completed three measurements over three different days within a 14-day period. After the QC user has been qualified, they can perform a QC measurement to qualify the device for the day.

  1. Over 18 years of age
  2. No ongoing cold or known airway disease
  3. Non-smoker
  4. Expected stable FeNO values between 5 and 40 ppb
  5. Preferably no allergies (except seasonal) or asthma

How do I select quality control (QC) users?
You will need at least one individual (two individuals are recommended) to qualify for the quality control (QC) procedure. If possible, identify one or two individuals as back-up.

What is the quality control (QC) user qualification process?
A quality control (QC) user will qualify themselves by performing three measurements over three different days within a 14-day period. After the QC user is qualified, they can perform a qualified QC measurement to qualify the device for the day.

Each QC user is allowed one QC measurement per day. Multiple QC measurement attempts by the same QC user on the same day will generate alert A51 on the device screen, indicating too many QC attempts have been made.

A mean (average) value is calculated from the three qualifying measurements. This measurement must be between 5-40 ppb for the QC user to be qualified. The qualified QC mean (average) is given a 30-day expiration date.

The qualified QC user’s measurement to qualify the device for the day must be ± 10 ppb from the mean (average) value and the negative control. If this is within specification, the QC has passed for that QC user and the device is ready for clinical use.

The orange QC on the status bar will disappear once the device has been successfully qualified. The orange QC will reappear the next day to indicate that the device needs to be qualified.

Note: It is important to keep the NIOX VERO®’s clock set to the correct time and date. If the clock is set incorrectly, the orange QC could be displayed at the wrong time of day.

Note: The mean (average) value and expiration date are recalculated when the qualified QC user performs a qualified QC measurement every seven days. This happens in the background of the device and requires no action from the user other than performing regular qualifying measurements for the device. Regular qualifying measurements will keep the QC user’s qualification status and FeNO values current. Failure to perform regular qualifying measurements (>30 days) will result in the qualification being discarded. The QC user will need to requalify themselves on the device.

How many users can I qualify?
The device has seven slots ready to assign to your quality control (QC) users. Please assign only one person per slot. Multiple users should not share the same QC slot.

Using NIOX® Apps with a database allows for more QC users to be qualified than the seven slots available on the NIOX VERO® device. Please note that in this case, QC needs to be completed either on the device or on the computer running the database. The data will not be exchanged between the device and the software on the computer.

For new devices only:
After the first qualifying QC measurement is performed on the device, a maximum of five QC users can be qualified without affecting the number of tests remaining on the sensor for a 20-day period. After 20 days, your NIOX VERO® will allow for one daily QC measurement that will not affect the number of remaining tests.

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