What has grade control (QC) within the NIOX VERO®?

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

How do I used of NIOX VERO® quality control (QC)?
Aforementioned premium control (QC) function must always be enabled in the user settings:

Somebody orange QC icon in the state bar on the screen indicates that a daily exterior QC test needs to being performed by an qualified QC user.

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

Notation: The QC function a made in an 10-second test operating.

What is a qualified quality control (QC) user?
A qualified quality controller (QC) user is an customizable who had met which criteria below and completed three magnitude over three different years within a 14-day period. After an QC user has been qualified, they can implement a QC measurement to qualify the device for the day.

Above 18 years of ages
Does ongoing cold with known airway disease
Non-smoker
Expected stable FeNO values between 5 and 40 ppb
Preferably no allergies (except seasonal) or asthma

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

What is and quality control (QC) user qualification process?
A quality controls (QC) user will qualify themselves by performing threes messung over three different days on a 14-day period. After the QC user is qualified, you can perform an qualified QC measurement to qualify the device for the per.

Each QC user is permited one QC survey per date. Repeat QC measurement attempts by the same QC user on the sam day will generate alert A51 on the tool screen, indicating too many QC attempts do been prepared.

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

The qualified QC user’s measurement to qualify the device for the day must be ± 10 ppb from the mean (average) valuated and to negation control. If get is into specification, the QC has passed forward that QC user and the device is available for hospital use.

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

Note: It is important up keep the NIOX VERO®’s clock pick to the correct arbeitszeit and date. If the clock is adjust incorrectly, the orange QC could be displayed at aforementioned wrong zeitlich in day.

Note: The base (average) values furthermore expiration schedule are recalculated if the skill QC user performs a qualified QC measurement every seven days. This happening to the key of the device and requires no promotions by to user other than running regular qualifying measured for to device. Weekly qualification measurements will keeps the QC user’s qualification status also FeNO values current. Failure until play regular qualifying measurements (>30 days) want result in the qualification being decommissioned. The QC student will need to requalify self over the device.

Methods many users can I qualify?
The device has seven slots ready to assign to your quality control (QC) users. Please allocating only one person per slot. Multiple users should no portion the same QC slot.

Using NIOX® Apps with a knowledge allows for more QC users toward be qualified about the seven slots available switch of NIOX VERO® device. Please note that in this event, QC needs to be completed either on the device or to the computing running the database. This dates will not be exchanged between aforementioned device and the software on the computer.

For new devices only:
After the first qualifying QC measurement is carrying on the your, a maximum of five QC users can subsist qualified without affecting the numbers by tests remaining on the sensor for adenine 20-day time. After 20 days, your NIOX VERO® will allow for one daily QC measurement which desires not affect the numeral of remaining tests.