Frequently Asked Questions
Is Air Next Spirometer a medical device?
Air Next Spirometer is a CE-certified Class IIa Medical Device and has FDA 510k clearance. It has been validated against the ATS/ISO standard curves.
How can I download the alveofit® Home app?
The alveofit® Home app is available to download for free via Google Play. You can search for alveofit® Home or Air Next. A provider code from your healthcare team is required to use the app.
Troubleshoot
Seeing results
After each trial, you can see the result directly on the screen. The result screen will display the flow-volume curve, FEV1, FVC, the ratio between FEV1/FVC and PEF as well as how long you have exhaled. With alveoair Home, you can add up to 5 tests in one session, for Air MD, up to 8. The app will automatically display the best curve and results for you. Please note that spirometry guidelines recommend at least 3 tests per session.
I have followed the instructions in the app, but my alveoair spirometer is still not working
The alveoair spirometer must be correctly connected to the smartphone via Bluetooth. Make sure the app has permission to access Bluetooth, and that Bluetooth is turned on. If you are using an Android phone, then Location Permission is required for the app to scan for the Air Next.
User Related
How can I delete my account and personal data?
For detailed assistance or inquiries, please feel free to reach out to our Support team by sending an email to support@alveo.fit. They are ready to help you with any questions, concerns, or actions you may need.
Does alveofit® application retain the data after deleting the account?
No, the alveofit® application does not retain any data once the account is deleted.
Is there any time limitation of data retention?
No, the alveofit® application does not retain any data once the account is deleted.
What is the term condition if the device stops working within warranty?
The alveoair device is covered by a one-year warranty, subject to specific conditions. The warranty stipulates that the device should not have water damage or physical breakage for the coverage to be valid. If the device experiences defects in materials or workmanship during the warranty period and has not been subjected to water damage or physical breakage, the manufacturer typically commits to repairing or replacing the device, or providing necessary parts or service at no additional cost to the user. It’s crucial to thoroughly review the terms and conditions of the warranty for a comprehensive understanding of the coverage, limitations, and any actions required on the user’s part to maintain warranty validity.
How do I reset my password?
To reset your password, follow these steps based on your login status:
If Already Logged In:
Navigate to the Profile Screen.
Select “Change Password” to reset your password.
If Not Logged In:
Click on “Forgot Password.”
Verify your Username using the Reset Code sent to your registered Mobile/EmailId.
For an already logged-in session, use the Profile Screen to change the password. If not logged in, initiate a password reset via “Forgot Password,” completing the process by verifying your Username through the Reset Code sent to your registered mobile or email.
What are the predicted values?
Predicted values in a Spirometry test are determined based on individual demographic details such as height, weight, race, age, and gender. These values serve as a benchmark for assessing an individual’s lung function, allowing comparison with actual test results. Predicated values help identify how well a person’s lung function aligns with expected norms, considering their specific characteristics. This comparison aids in evaluating respiratory health and potential deviations from the anticipated lung function for a given demographic profile.
How are spirometry results interpreted?
Interpreting spirometry results involves analyzing various parameters to assess lung function. Here are key components and considerations in interpreting spirometry results:
Forced Expiratory Volume in 1 second (FEV1):
Normal: A healthy individual usually has an FEV1 that is around 80-120% of the predicted value.
Obstructive Lung Disease: A reduced FEV1 suggests difficulty in expelling air quickly, common in conditions like asthma or chronic obstructive pulmonary disease (COPD).
Forced Vital Capacity (FVC):
Normal: FVC should be within the predicted range for a healthy individual.
Restrictive Lung Disease: Reduced FVC may indicate restrictive lung diseases, where the lung expansion is limited, such as pulmonary fibrosis.
FEV1/FVC Ratio:
Normal: A normal ratio is typically around 70-80%.
Obstructive Lung Disease: A lower FEV1/FVC ratio (less than 70%) suggests airway obstruction, common in conditions like COPD.
Peak Expiratory Flow (PEF):
Normal: PEF varies based on age, sex, and other factors.
Obstructive Lung Disease: Reduced PEF may indicate airway narrowing or obstruction.
Interpretation Based on Patterns:
Obstructive Pattern: Reduced FEV1 and FEV1/FVC ratio, typical in asthma or COPD.
Restrictive Pattern: Reduced FVC with a normal or increased FEV1/FVC ratio, common in conditions limiting lung expansion.
Comparison with Predicted Values:
Results are compared with predicted values based on demographic factors (age, gender, height, etc.).
Deviations from predicted values help identify abnormalities or diseases.
Interpretation is complex and should consider the patient’s medical history, symptoms, and other diagnostic tests. Consulting with a healthcare professional, typically a pulmonologist or respiratory therapist, is crucial for a comprehensive understanding and accurate diagnosis.
How many Languages are supported by alveofit® Application?
The alveofit® application primarily supports the English language. This means that the user interface, features, and communication within the application are predominantly in English. It’s important to note that language support in applications can evolve over time, so users are encouraged to check official updates, and documentation, or contact the application’s support team for the most current information on language options and any potential expansions to language support.
Do you have an open API to integrate the application with another system?
Yes, we have an open API that facilitates integration with third-party applications or institutions. Our application supports Fast Healthcare Interoperability Resources (FHIR) APIs for seamless integration. Additionally, we offer Software Development Kits (SDKs) specifically designed for Android application integration. These tools provide flexibility and compatibility for a smoother integration experience with external systems. For detailed information or assistance with the integration process, please contact our support team. support@alveo.fit
Is there any indication in the device, if the device is connected to a mobile application?
Certainly, the alveoair device features clear indicators for its wireless connection with the alveoMD® application. Users can observe LED light blinks on the device, and on the alveofit® application screen, there are visual cues confirming the successful connection. These indicators serve to easily communicate the device’s connectivity status to the user.
Can I associate one device with multiple users?
No, each alveoair device is associated with a single user. However, the alveoMD® application can be installed on multiple mobile devices, allowing the same user to perform tests using different devices.
Which type of battery alveoair supports?
The AlveoAir device supports AAA batteries.
Can I get the PDF report of my spirometry test over email?
Certainly. You can generate a PDF report of your spirometry test within the alveoMD® application. After generating the report, you can view it using a PDF viewer and share it via email, WhatsApp, or other sharing options as needed.
When does the warranty period for alveoair devices begin?
The warranty period for the AlveoAir device commences from the date of device registration and extends for a duration of one year. During this period, users are entitled to warranty coverage, which typically includes repair or replacement of the device for eligible issues. It is crucial for users to carefully review the terms and conditions specified in the warranty policy, as well as any requirements or limitations outlined by the manufacturer. For comprehensive details regarding warranty coverage, initiation, and any potential extensions, users should refer to the official documentation provided by the manufacturer or contact the customer support team for accurate and up-to-date information.
Is my health information secure on the alveofit® app?
Certainly, your health information on the alveoMD® app is secure. We adhere to HIPAA compliance standards, ensuring the confidentiality and protection of all personal and health-related data.
Is your device FDA-approved?
Thank you for the clarification. Based on your information:
Yes, the AlveoAir Spirometer is FDA-approved with 510(k) clearance.
The 510(k) clearance from the United States Food and Drug Administration (USFDA) indicates that the AlveoAir Spirometer has been reviewed and found to be substantially equivalent to another legally marketed device. This clearance is a significant milestone, ensuring that the device meets strict standards for safety and effectiveness set by the FDA.
What does this mean?
Safety and Effectiveness: The 510(k) clearance affirms that the AlveoAir Spirometer is safe and effective for its intended use.
Regulatory Compliance: This approval also means that the device complies with regulatory requirements for medical devices in the United States.
Quality Assurance: Users and healthcare professionals can have confidence in the quality and reliability of the AlveoAir Spirometer.
For Users:
If you’re considering using the AlveoAir Spirometer, this FDA approval provides assurance of its quality and safety standards, making it a trustworthy choice for spirometry testing.
It’s always recommended to check the latest documentation provided with the device for any updates or changes in its regulatory status.