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FAQ - Frequently asked questiones

General

What is FeNO?

FeNO stands for “fractional exhaled nitric oxide (NO)” and is used as a biomarker for diagnostic support and monitoring of bronchial asthma.

Why is FeNO measured?

FeNO is produced in the respiratory tract by epithelial cells, among others. The NO concentration in the exhaled breath therefore reflects the degree of allergic inflammation in the respiratory tracts. Increased FeNO values indicate a worsening of the disease even before a conspicuous pulmonary function test result and therefore allow early therapeutic countermeasures to be taken. [Bodini A et al. 2017]

Increasing FeNO values show a worsening of the disease even before a pulmonary function test and therefore allow early therapeutic countermeasures. [Bodini A et al. 2017]

What are the advantages of FeNO measurement?

FeNO measurement offers numerous advantages:

  • It supports asthma diagnosis and gives a prognosis on the response to inhaled corticosteroids (ICS) [Dweik et al. 2011, Karrasch et al. 2017, Taylor et al. 2006]
  • It allows better monitoring of the airway inflammation and acute asthma episodes can be reduced through treatment control with FeNO [Petsky et al. 2016, Essat et al. 2016]
  • It allows early therapeutic countermeasures in case of a worsening of the disease [Bodini A et al. 2017]

When is a FeNO measurement carried out?

FeNO measurement (inflammometry) is usually used in primary diagnostics in addition to the pulmonary function test, and for follow-up monitoring of asthma. The diagnostic value of FeNO testing for asthma diagnosis is comparable to the bronchoprovocation, or bronchial challenge, test [Schneider et al. 2014]. According to the new NICE Guideline on Asthma Diagnosis and Monitoring (2017), a conclusive FeNO test and proven reversible bronchodilation can even eliminate the need for a bronchoprovocation test for asthma diagnosis.

How widespread and recognized is FeNO measurement?

The guidelines of the American Thoracic Society (ATS) recommend this method for diagnosis, therapy management, and monitoring of asthma patients. [ATS, Dweik et al. 2011] The NICE Clinical Guideline on Asthma has included FeNO measurement in the diagnosis algorithm in order to improve diagnostic quality, and considers the FeNO value to be an important parameter for long-term asthma management. FeNO measurement can also help to increase cost effectiveness. The German Guidelines for Diagnosis and Treatment of Asthma Patients also recommend using the FeNO value as an additional marker for confirming the asthma diagnosis.

When is a FeNO value critical?

FeNO threshold values depend, among other things, on height and gender; women have lower values than men, children lower values than adults. The guidelines of the American Thoracic Society (ATS) state that values between 0 and 25 ppb are low, between 25 and 50 ppb medium and above 50 ppb high. As a guide, values below 25 ppb can be considered normal (children below 20 ppb). Values above 50 ppb (children above 35 ppb) indicate active inflammation of the respiratory tract. However, the final diagnosis is up to the doctor, who makes the diagnosis based on known reference values. Since these can vary from country to country, we refrain from storing the reference values, especially with the Vivatmo pro device for physicians.

Product

Does Vivatmo require regular maintenance or calibration?

Vivatmo is calibrated by the manufacturer and due to the unique sensor technology, this calibration remains stable for the entire specified service life. The innovative measuring principle prevents the sensor from becoming depleted during the permissible number of measurements. During each regeneration period, the sensor surface is cleaned of the different contaminants from the exhaled breath and thus optimally prepared for the next measurement. This ensures an accurate measuring result at all times. Recalibration by the user is therefore not necessary. However, in the case of Vivatmo pro, we recommend QC testing at regular intervals (see instructions for use).

How should the handhelds be cleaned and disinfected?

Wipe disinfection is sufficient and eliminates the need for reconditioning or cleaning. If you use disinfection wipes that contain alcohol, the alcohol percentage should not exceed 30%. A higher percentage can cause damage to the display and remove labels. The following products have been verified for wipe disinfection by the manufacturer: mikrozid® universal wipes (Schülke).

Are the costs for FeNO measurement reimbursed by health insurers?

The costs for home measurement with Vivatmo me are not (yet) covered by health insurance. In some countries, FeNO measurement is reimbursed in the medical practice; in Germany, for example, by private health insurance companies. As a rule, private health insurance companies reimburse the costs for FeNO measurement according to an analog number to the current scale of fees for physicians with € 35.77 (GOÄ Number 617). The statutory health insurance funds do not currently reimburse the service, so that most doctors consider it to be an individual healthcare service (IGeL).

Can Vivatmo pro be incorporated into the hospital network or the software of a doctor’s office?

Vivatmo pro can be incorporated into administration systems via the HL7 or GDT interface.

Which printers are supported by the Vivatmo pro basestation?

All HP printers which can be controlled with the drivers “hpcups 3.12.6” and “hpcups 3.18.3” are currently supported.

Does ambient NO influence measurements with Vivatmo?

The influence of significantly increased NO and NO2 is minimized through the regeneration process, sample processing in the oxycap and fractionation. Before each measurement, the Vivatmo measuring system, including the sensor, is cleaned in the regeneration process in order to eliminate effects of previous measurements or ambient influences.

How and where can I dispose of my Vivatmo at the end of its useful life?

Vivatmo can be disposed of after the end of its useful life at a recycling depot together with small electrical appliances. Vivatmo must not be disposed of with household waste.

Why does the respiratory flow have to be kept constant for several seconds during the measuring maneuver?

Nitric oxide (NO) from the mouth and throat has to be separated from the breath sample (fractionated exhaled NO) so that the pure NO from the bronchial tubes is measured. This is ensured by a defined bypass phase before the measurement. Since the NO concentration also depends on the respiratory flow, this is controlled during the breathing maneuver.

Do software updates have to be carried out and do they cost anything?

Software updates for the pro base station ensure that your system is always up to date. These are naturally provided free of charge.

Does the device have to be calibrated?

The Vivatmo pro is calibrated by the manufacturer and does not require any further calibration by the user. However, it is recommended to perform a QC test at regular intervals (see IFU).

Is patient data protected on the device?

Access to patient data can be protected through access control with a user name and passcode. When measurement orders are transmitted through the network, access should be protected with a user ID and password. The organization that uses Vivatmo is responsible for data security.

May an oxycap (mouthpiece) be used several times?

The oxycap is a complex system for processing breath samples and is not suitable for multiple use. After removal from the outer packaging, it can be used for 15 minutes. Thus, a maximum of five measurement attempts can be conducted until a valid value is obtained.

How are oxycaps disposed of?

Oxycaps can be disposed of in household waste.