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Vivatmo

FAQ

Frequently asked questiones

People affected with asthma

FeNO stands for “fractional exhaled nitric oxide”, and is a standardized breath sample obtained from the bronchi. The NO that thus becomes measurable is used as a biomarker for the diagnosis and follow-up of bronchial asthma.

Following an allergic reaction, the epithelial cells* in the lower respiratory tract produce increased amounts of NO. The nitric oxide or NO concentration in the exhaled breath therefore reflects the degree of allergic inflammation in the respiratory tract. The more severe the inflammation is, the more NO is produced and measured as FeNO.

*Epithelial cells lie together in single or multiple cell layers and cover all inner and outer surfaces of the human body.

Measuring FeNO at home helps you monitor the progression of the airway inflammation. Controlling asthma treatment by means of regular FeNO measurements can help to reduce the frequency of acute asthma episodes. A worsening of the inflammation is indicated by increased FeNO values, enabling your doctor to take therapeutic countermeasures at an early stage.

No. The costs for the Vivatmo me home monitoring device are not covered by the statutory health insurance funds in Germany. In some countries, FeNO measurement is reimbursed in the medical practice; in Germany, for example, by private health insurance companies.

Children with asthma

Measurement with Vivatmo me requires the patient to cooperate by breathing out into the device through a disposable mouthpiece. The patient should be at least 7 years old and able to manage the breathing maneuver.

FeNO measurement is simple, non-invasive and stress-free for your child. Initially, they may need to practice the breathing maneuver a couple of times to get it right. But they’ll soon get the hang of it. All they need to do is breathe out evenly for 10 seconds through the single-use mouthpiece into the device. This measures the inflammatory market NO (nitric oxide) in their exhaled breath and doesn’t pose any risk to your child. Even if they inadvertently breathe in again via the mouthpiece no harmful chemicals or germs can enter their airways.

If possible, take the measurement at the same time of day, preferably in the morning before taking any medication. Under https://youtu.be/0HdDxeMzDBE you will find a video guide to using the device.

We recommend performing the measurement sitting down. The following conditions can influence the measurement results or cause problems or malfunction of the Vivatmo me device or the mouthpiece:

  • Smoking or tobacco consumption up to 30 minutes prior to measurement
  • Eating or drinking just before taking the measurement
  • High levels of physical exertion
  • Rooms with high air pollution, open flames (e.g. gas cooker) or smoke (e.g. from the consumption of tobacco)
  • Contact and penetration of moisture or liquids

Regular medical check-ups are the basis of any good asthma treatment and the Vivatmo me device cannot be a substitute for a doctor. However, well-managed and individually adjusted asthma therapy should be able to keep exacerbations and acute flare-ups at bay, avoiding the need for unplanned or emergency doctor’s visits.

Pregnant women with asthma

FeNO measurment is simple and non-invasive. All you need to do is breathe out evenly for 10 seconds through the single-use mouthpiece into the measuring device to measure the inflammatory marker NO (nitric oxide) in your exhaled breath. This does not pose any risk either to you or your baby. Even if you inadvertently breathe in again via the mouthpiece no harmful chemicals or germs can enter your airways.

When you’re pregnant it’s especially important that your asthma is well controlled. It goes without saying that an asthma attack during pregnancy poses greater risks for you and your unborn baby than appropriate, if necessary more intensive, asthma management. What’s more, most asthmatics experience a change in their asthma patterns during pregnancy, making it necessary to either reduce or intensify their basic anti-inflammatory therapy.

It’s therefore especially important to monitor your asthma carefully and closely during this time and adapt your treatment where appropriate. Regular FeNO measurement provides you and your doctor with valuable information about the present degree of inflammation of your airways, providing a feeling of security for you and your baby!

The FeNO values show you whether your asthma medication (usually inhaled corticosteroids) is effective and how severe the allergic inflammatory response of your lungs currently is. Like this, the degree of inflammation can be closely controlled and your treatment adjusted accordingly in consultation with your doctor. To supplement your Vivatmo me you can also download the Vivatmo app. This digital asthma diary is an easy way to manage your measured FeNO results. With the Vivatmo app you are always optimally informed and have a handle on the progression of your asthma.

The app also provides regional pollen flight information, which you can display in a monthly overview together with your FeNO values and other health data and share with your physician. Like this, you and your doctor have all the relevant information for managing your therapy.

Australian studies have shown the benefits of FeNO-adjusted therapy management for pregnant asthmatics and their children (Powell et al. Lancet 2011, Morten et al. J Allergy Clin Immunol 2018). The group taking regular FeNO measurements suffered 50 percent fewer asthma attacks. Furthermore, their children developed early childhood asthma 40 percent less often.

Regular medical check-ups are the basis of any good asthma treatment and the Vivatmo me device cannot be a substitute for a doctor. However, well-managed and individually adjusted asthma therapy should be able to keep exacerbations and acute flare-ups at bay, avoiding the need for unplanned or emergency doctor’s visits.

General

FeNO stands for “fractional exhaled nitric oxide”, and is a standardized breath sample obtained from the bronchi. The NO that thus becomes measurable is used as a biomarker for the diagnosis and follow-up of bronchial asthma.

Following an allergic reaction, the epithelial cells* in the lower respiratory tract produce increased amounts of NO. The nitric oxide or NO concentration in the exhaled breath therefore reflects the degree of allergic inflammation in the respiratory tract. The more severe the inflammation is, the more NO is produced and measured as FeNO.

*Epithelial cells lie together in single or multiple cell layers and cover all inner and outer surfaces of the human body.

FeNO measurement helps your doctor to diagnose allergic asthma. In addition, it is very likely that asthmatics with elevated FeNO levels will respond well to inhaled corticosteroids (ICS). [Dweik et al. 2011, Karrasch et al. 2017, Taylor et al. 2006] FeNO measurement can be used to monitor the progression of airway inflammation. Controlling asthma treatment by means of regular FeNO measurements can help to reduce the frequency of acute asthma episodes. [Petsky et al. 2016, Essat et al. 2016] A worsening of the inflammation is indicated by increased FeNO values, enabling your doctor to take therapeutic countermeasures at an early stage. [Bodini A et al. 2017]

FeNO measurement (inflammometry) is usually used to confirm a diagnosis of asthma in addition to the pulmonary function test. Regular FeNO measurements are also used 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].

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 British NICE Clinical Guideline on Asthma has recommended including 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.

NO concentration in the air is measured in ppb (parts per billion), i.e. a concentration of 10 ppb is equivalent to 10 nitric oxide molecules per billion air particles. (Factsheet of the Deutsche Atemwegsliga e.V.: FeNO measurement)

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. In general, you and your doctor will determine your personal threshold value together. (Factsheet of the Deutsche Atemwegsliga e.V.: FeNO measurement)

Product

Please follow this link to get to our onlineshop where you can buy Vivatmo me and disposable mouthpieces (oxycaps):

You can order disposable mouthpieces (oxycap) in our onlineshop. Please follow this link:

Vivatmo me 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. Before each use, the device cleans the sensor surface of various impurities from the exhaled breath and thus optimally prepares it for the next measurement. This ensures you always get an accurate measuring result. There is therefore no need for you to recalibrate the device.

Instructions on how to use the Vivatmo me can be found here.

Regularly wipe the device with a disinfection wipe that contains alcohol. Please note that 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).

Due to the current coronavirus crisis, we are receiving an increasing number of queries related to the virus filtration rate of Vivatmo oxycaps (disposable mouthpieces).
During the entire service life of three (Vivatmo me) or five years (Vivatmo pro), the bacteria and virus filter of the mouthpiece (99.9978% BFE and 99.960% VFE) counteracts any contamination of the inner workings of the device.
In addition, after the bacteria and virus filter the exhaled air passes through a drying filter, which removes moisture from the exhaled air flowing through it and thus counteracts the growth of microorganisms in the device. The use of a valve in the gas pipe system also prevents the inhalation of air from the unit. This reduces the probability of infection to a minimum. Based on these measures, the product can be classified as low microbiological risk.
If more than one person is using the Vivatmo device, we recommend wearing disposable gloves (CE category II), as well as disposing of mouthpieces immediately after measurement.

No. The costs for the Vivatmo me home monitoring device are not covered by the statutory health insurance funds. In some countries, FeNO measurement is reimbursed in the medical practice; in Germany, for example, by private health insurance companies.

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

Oxycaps can be disposed of in household waste.

The Vivatmo app is a digital asthma diary. The Vivatmo app enables you to retrieve all important information relating to your asthma at a glance: FeNO values, symptoms, medication and pollen count. The FeNO results measured with the Vivatmo me device are transmitted to your smartphone via Bluetooth. The app automatically retrieves pollen data for your current location, keeping you constantly informed about possible triggers that can affect the course of the disease. You can also enter medication doses and personal wellbeing. Together with pollen and medication data, a monthly PDF report can be generated and printed or sent by e-mail for your records or to your physician. Regular reporting can help you and your doctor optimize your individual asthma therapy.

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.

The Vivatmo app is available from the Google Play Store as well as the App Store and can be downloaded for free.

The Vivatmo app is available for android in the Play Store and for iOS in the App Store.

The Vivatmo app is completely free. There are also no in-app costs incurred.

The Vivatmo app is available in almost every country in which Vivatmo me is available.

The Vivatmo app is available in German, English, Italian, French, Portuguese and Spanish

Pollen is a frequent symptom trigger for many asthma patients. By activating the location feature, you allow the app to retrieve the current pollen count for your region.

Your position is only transmitted if you open the app to check the current local pollen forecasts and is deleted immediately afterwards.

The error message E-4 indicates that the ambient temperature or air pressure is outside the specified range. Please check the ambient conditions and take a new mouthpiece if this error message is displayed. For further information on how to attach the mouthpiece correctly, see chapter “2.1 Attaching the disposable mouthpiece” in the instruction for use.

If the error persists or the device shows unexpected operations, contact the Vivatmo me customer service center at service@vivatmo.com.

The error message E-5 indicates that the humidity is too high. Please use the Vivatmo me in location with permissible ambient conditions. When transporting the device from one place to another, a stabilization period of min. 20 minutes should be allowed before use.

If the error persists or the device shows unexpected operations, contact the Vivatmo me customer service center at service@vivatmo.com.

The error message E-6 indicates that the batteries are too weak for measurement. Please replace the batteries with new ones. For further information on how to replace the batteries correctly, see chapter “1.2 Activate your Vivatmo me” in the instruction for use.

If the error persists or the device shows unexpected operations, contact the Vivatmo me customer service center at service@vivatmo.com.

There may be two reasons why your Vivatmo me device will not turn on:

Batteries are empty. Please replace the batteries with new ones. For further information on how to replace the batteries correctly, see chapter “1.2 Activate your Vivatmo me” in the instruction for use.

Batteries are inserted the wrong way. Please ensure that the batteries are inserted with correct polarity.

If the error persists or the device shows unexpected operations, contact the Vivatmo me customer service center at service@vivatmo.com.

Notifiable substances:

The pump in our product contains lead monoxide

The product contains 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol (CAS 119-47-1)

Product Lifetime

You can take 1,000 (successful) measurements with your Vivatmo me. The device has a service life of three years from the date of manufacture.

We generally recommend taking one to two measurements a week during the allergy season. More or fewer measurements can be taken as required.

Currently, there is no clinical data available on the frequency of FeNO home measurement. We advise that you speak with your pulmonary specialist and decide on the frequency of your FeNO home measurements together. We generally recommend taking one to two measurements a week during the allergy season. More or fewer measurements can be taken as required.

The Vivatmo me device and the mouthpieces (Vivatmo oxycap) are manufactured in Germany.