The Heart Sound Recorder (HSR) is a computer based low risk, general wellness heart stress monitor used to acquire, display, record and save heart sounds.
Certain types of normal heart stress can be monitored by visualizing the rate, rhythm and tone of the heart cycle. The heart’s reaction to certain types of normal stress, such as nutritional or emotional stress can be nearly immediate and its response to a given mitigation technique is often rapid. These changes can be observed by changes of the frequency, ratio, amplitude and characteristics of the heart waveform.
- Maintaining or encouraging a general state of health
- As a general wellness device it relates to a healthy lifestyle by helping to reduce the risk or impact of certain chronic diseases or conditions where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition. As such the intended use is to promote, track and/or encourage choice(s), which, a a part of a healthy lifestyle, may help reduce the risk of certain chronic diseases or conditions and may help with living well with certain chronic diseases or conditions.
- The Heart Sound Recorder is a low risk* non-invasive device that is not implanted and does not involve a technology that may pose a risk to the safety of users or other persons if specific regulatory controls are not applied (such as risks from lasers or radiation exposure).
*as defined by the document issued July 29, 2016, General Wellness: Policy for Low Risk Devices; Guidance for Industry and Food and Drug Administration Staff
- This device is a “General Wellness, Low Risk Device” intended for use to record and display the heart cycle for the purposes of assessing heart stress. It monitors the rate, rhythm and tone of the heart. No treatment or reference to any disease condition is implied.
- Any techniques, treatments, or lifestyle changes suggested after the use of this device should be undertaken only with the guidance of a licensed physician, therapist, or healthcare practitioner.
- The findings from this device can be used to support, but should not be used in place of, sound medical therapies and recommendations.
An internet connection is required to download the software.
To run the HSR software, your system must meet these specifications:
- Laptop personal computer (PC) for software
- Windows 7, Windows 8, Windows 10, 32 or 64-bit
- Intel Pentium 4 compatible or better.
- 512MB of RAM minimum, 1.0GB recommended
- 1024 x 768 graphic display or better
- USB 2 port or higher