ProvenBP software

Reliable BP estimation in complex patients and in challenging conditions

https://provenbp.com © ProvenBP Partnership, 2022

ProvenBP software is designed to accurately estimate BP and heart rate, including in the presence of mechanical interference and cardiac arrhythmias. ProvenBP software uses cuff pressure records obtained during oscillometric upper arm BP measurements as a data source.

ProvenBP software performs automatic validation (reliability assessment) of calculated BP values

ProvenBP software provides the following additional features:

• Detection of the presence of atrial fibrillation
• Calculation of central aortic pressure and other parameters of central hemodynamics

Fig. 1. Post-processing of data obtained from oscillometric BP Monitor

To get started with ProvenBP software, you can register and run example calculations at https://service.provenbp.com/.

To use ProvenBP software, it is integrated with medical systems, which include automatic BP monitors.

The effect of the ProvenBP solution for manufacturers of automatic BP monitors and 24-hour BP monitors:

• Increasing the competitiveness of devices thanks to additional functions: the ability to measure BP in “difficult” categories of patients and in the presence of interference, automatic exclusion of unreliable BP readings, detection of atrial fibrillation, measurement of central BP. Adding these functions does not require large R&D costs and has almost no effect on the cost of devices.
• New opportunities for promoting devices - using a campaign for advocacy of accurate BP measurements conducted by reputable expert groups in a number of countries.

The effect of the ProvenBP solution for telemedicine service providers:

• Increasing the customer base for telemedicine services for home BP monitoring and ABPM. This is achieved by involving patients in whom it was previously impossible to accurately determine BP or obtain useful ABPM data for analysis.
• Expanding the number of services through the use of new techniques that complement home BP monitoring and ABPM - screening for atrial fibrillation, measuring central BP. A number of countries already provide for reimbursement of costs for such medical services, or this may happen in the foreseeable future

The principles and use of ProvenBP software are described in more detail in the "ProvenBP Software. General Description", as well as in a number of other documents available upon request. The main feature of devices compatible with ProvenBP software is the ability to store a recording of cuff pressure during a BP measurement, and then send this recording through a communication interface. This changes the role of the device in the system. What comes first is not the accurate assessment of BP by the device itself, but its ability to provide high-quality data recording for post-processing. Requirements for devices are described in the document "ProvenBP Software. Compatibility Specifications for BP Monitoring Devices".

The main types of devices that can be data sources for ProvenBP software are:

• Home and professional automatic BP monitors in a “classic” design with its own display
• BP monitors in the form of a smartphone attachment, usually combined with a cuff (“tubeless”)
• 24-hour BP monitors

The following documents describe the practical application of ProvenBP software in medical systems:

• "ProvenBP Software. Solution for Home BP Monitoring and Office BP Measurement" "ProvenBP Software. Solution for 24-hour BP Monitoring (ABPM)"

Examples of using these solutions are shown below.

Fig. 2. An example of a telemedicine system for home BP monitoring

Fig. 3. An example of a PC-based ABPM system integrated with ProvenBP software

For integration, depending on the type of system, you can use several ProvenBP software products. All of them are designed to interact with medical diagnostic systems through the API described in the "ProvenBP Software. Reference Manual" document:

• During the development phase, you can start by using the free web service "ProvenBP SaaS", and then choose the best option for commercial use.
• To organize your own ProvenBP web service, you can use the "ProvenBP for Server" software with unlimited performance.
• The software product "ProvenBP for Windows" has a low cost, and its performance corresponds to the typical workload for a PC-based doctor's workplace.
• Finally, the device manufacturer can, under a separate agreement, order the "ProvenBP OEM" product for distribution as part of its own software.

ProvenBP software was designed to provide estimates of central BP and other central hemodynamic parameters equivalent to the SphygmoCor device. This allows the use in medical systems of ready-made clinical reference values for both office and out-of-office conditions, obtained using SphygmoCor devices and a number of compatible devices. They are described in the document "ProvenBP Software. Clinical Reference Values for Central Hemodynamic Parameters".

Medical equipment and systems are subject to mandatory certification. To simplify certification, a package of documents "ProvenBP Design History File" is supplied with ProvenBP software. It contains preparatory materials for compiling a technical file for a medical device in accordance with the requirements of the main markets.

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ProvenBP technology is designed to remove economic and technological barriers to integrating pulse wave analysis (PWA) techniques into mass produced BP monitoring devices and systems.

There are already necessary conditions for this:

• Low license costs.
• No modification is required to existing built-in BP measurement algorithms.
• Methodological support for device manufacturers.
• Possibility of using ready-made clinical reference values for central hemodynamic parameters.