MIR SPIROBANK 2.4.8

IMPORTANT NOTE: The application has received regulatory clearance for the U.S. market (FDA), the European market (CE), and in Argentina, Colombia, Ecuador, Mexico, Malaysia, and Taiwan. As such, the intended jurisdictions for this application include the U.S., Canada, Europe, and the aforementioned countries.

It is essential to always seek a doctor's advice in conjunction with using this application and prior to making any medical decisions.

This application facilitates real-time Spirometry and, optionally, Oximetry tests directly on an iPhone. Its user-friendly design caters to the needs of remote patient monitoring and self-management of cardiorespiratory conditions. Additionally, the app integrates with the MIR Live Exam system, allowing healthcare providers to observe and guide patients during testing through a rapid peer-to-peer connection. This feature represents an advancement over traditional home care solutions that lack real-time supervision during the assessment process.

To utilize this application, the MIR Spirobank Smart or MIR Spirobank Oxi Spirometer must be purchased separately. The app connects seamlessly with the spirometer via Bluetooth Low Energy technology.

Spirometry Metrics: PEF, FVC, FEV1, FEV1/FVC ratio, FEF25/75, FEV6, VEXT, PEFTIME, FEF75, FEF25, FEF50

Oximetry Metrics (optional): SpO2 (%), Pulse (BPM)

Main Features:

• The live video exam enables patients to conduct spirometry and oximetry testing remotely with real-time support from a healthcare provider.
• Real-time animations enhance compliance during the spirometry test.
• Access to a real-time plethysmographic curve.
• E-diary functionality allows for symptom tracking and notes for each test.
• Graphical trends facilitate self-monitoring of both spirometry and oximetry metrics.
• Unlimited online updates at no additional cost.
• The app complies with Global Lung Initiative (GLI) predicted sets and utilizes multi-ethnic reference values for spirometry across a 3–95-year age range.

Distinctive Features:

• Compatibility with both disposable and reusable turbine flow meters.
• Comprehensive PDF printouts providing Flow/Volume and Volume/Time curves (Best 3 trials), quality control grades, acceptable trial counts, and variability metrics for FEV1 and FVC.
• The ability to share PDF reports via email, WhatsApp, cloud servers, and other applications.
• Direct printing of PDF reports through Bluetooth printers.

Accuracy:

The app and spirometer are developed by MIR SRL Medical International Research, a leader in innovation with over 25 years of experience in spirometry, oximetry, and mobile health solutions. MIR spirometers adhere to ATS/ERS guidelines as well as ISO standards including ISO 23747:2015 (for Peak Flow), ISO 22782:2009 (for Spirometry), and ISO 80601-2-61 (for Oximetry).

INTEGRATED WITH APPLE HEALTH APP:

• Users can authorize access to data from the Health App including Date of Birth, Gender, Height, and Weight.
• The app can also transmit Peak Expiratory Flow Rate (PEF) and Forced Expiratory Volume in 1 second (FEV1) data to the Health App.
• Data sharing adheres to Apple’s guidelines for privacy protection.

PERSONAL DATA MANAGEMENT:

• User data is stored exclusively on personal iPhones or iPods.
• No data is transmitted to third parties without user consent.
• The collection of personal data (Date of Birth, Height, Weight, Gender, Population Origin) serves solely to calculate target values for spirometry assessments.