for manufacturers
Your device — our path to a signed document
An embeddable deterministic core that analyzes a recording of any length — from 30 seconds on a wearable device to a 24-hour Holter — with rules that carry a version, and with a path to a structured document signed by a physician. The manufacturer keeps the device and the signal; the layer of “document, registry, dictionary and evidence” is taken ready-made, together with an explicit division of responsibility.
Division of responsibility
| The manufacturer | HealthOS Cardio | |
|---|---|---|
| The registration certificate for the device | held by the manufacturer; the core inside their device is part of their dossier | licensor |
| The clinical decision | the physician authorizes; neither the device nor the core takes it | a draft always stays a draft |
| Transport into the registry | the operator of the clinic that buys the device | forming the document and tracking its states |
| Personal data | the clinic’s perimeter or a cloud on Russian territory | the boundary of personal data is set by the storage schema |
Who this is for
Who this is for
Manufacturers of electrocardiographs and Holter recorders · of wearable recorders without a physician layer · of telemedicine complexes · platforms that hold a fleet of devices.
How it is built
What gets embedded
Programming interface. Your device calls a stable programming interface. The reading pipeline is packed into a container. The container runs when a hardware key with a license is present.
Library. A dynamic C++20 library with a stable binary interface. It runs when a key with a license is present.
- Input formats. EDF and others. The format of your recorder is the subject of a pilot with a fixed scope of integration.
- Reproducibility. The same input and the same rule package give the same result.
What backs it up
The dictionary and versioned rules
The place of a training base is taken by the curated dictionary of the cardiology dialect: descriptors across seven layers of analysis, bound to the electrocardiographic subsets of international terminologies. A rule is changed by an act over the graph, with a version and an author, and not by a new firmware release; the core needs no infrastructure for serving models.
What backs it up
Evidence and the audit trail
Behind every finding stand a versioned rule, the signal window, the term and the recording-quality assessment. The audit trail of the analysis comes out as a separate kind of report — a ready log for the regulatory dossier and for the post-market surveillance carried out by the holder of the registration certificate.
What backs it up
The path to the document
The findings are formed into an instrumental examination protocol — a structured medical document; the completeness of the mandatory fields is checked before submission, and the registration states are tracked. Submission to the registry — once the operator’s loop is ready. Today this is the full loop as a draft for the physician’s signature.
What backs it up
License
The core is supplied under a proprietary OEM license with the right to embed. The licensor is RTLAB LLC. The terms of embedding, of distribution as part of a device and of remuneration are set out in the OEM agreement with the licensee; the text of the terms is provided on request.
What backs it up
Test bench
Synthetic and de-identified recordings, a run of “same input — same output”, an emulator of the registry operator. There are no patient data on the bench.
Limits
Limits
HealthOS Cardio is not a medical device. The machine does not make a diagnosis and does not sign the document. The product processes a recording, it does not take the place of a recorder: a substitute for a Holter monitor, a patch or an implantable monitor is not sold. More — “Limits and responsibility”.
Who else
Other doors
For clinicians
Many can read an electrocardiogram — almost no one closes the case with a document. What the workplace includes and where it works.
Open →For private physicians
A physician in their own practice or a remote reader
Open →For partners
A medical-system vendor, an operator or an integrator
Open →For you and your family
You want to work it out yourself or to record someone close to you
Open →The first pilot is an analysis container inside your own loop, on the recordings of your own recorder.
Request an OEM pilot For partners