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Not a medical device: the Apnealytics medical disclaimer

Apnealytics is a tracking and coaching tool. It reads the data your CPAP machine, oximeter and phone already record and presents it clearly. It is not a medical device, it does not diagnose sleep apnea or any other condition, and it does not treat, change or recommend therapy settings. This page is the Apnealytics medical disclaimer, written to be understood rather than skimmed.

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Not a medical device: the Apnealytics medical disclaimer

What Apnealytics is

A way to read the SD card from your ResMed machine and see your nights in plain English.
A place to put your oximeter data, your Apple Health or Health Connect vitals and your gear beside your therapy.
A set of reports and share links that help you have better conversations with your clinician.
A Knowledge Hub that explains the terms your machine uses.

What Apnealytics is not

Not a diagnostic tool. Apnealytics does not determine whether you have sleep apnea, how severe it is, or what kind.
Not a treatment. It does not deliver therapy, adjust your machine or tell you which setting to use.
Not a substitute for a sleep study or a clinician. A polysomnogram or home sleep test, read by a qualified professional, is how sleep apnea is diagnosed and staged.
Not an emergency service. If you are unwell, contact your doctor or emergency services, not an app.
Not regulated as a medical device. Apnealytics has not been cleared or approved by the FDA or any other regulator for a medical purpose, and does not claim to be.

About machine-estimated AHI

Your CPAP machine estimates events from airflow at the mask. It does not measure brain activity, oxygen or effort, and it cannot know whether you were asleep. That means:

Machine AHI is an estimate. It is useful for watching your own trend over time; it is not the same as the AHI from a sleep study and should not be compared directly to one.
Event types are inferred. Obstructive, central, hypopnea and unclassified labels come from the machine's algorithm, which can misclassify, especially around leak and arousals.
Different machines score differently. A change in machine can change your numbers without any change in you.
Leak affects everything. High leak can cause both missed and spurious events.

Apnealytics shows bands such as Great, Mild, Moderate and High to make your own trend readable. The bands are descriptive labels for your numbers; they are not a clinical severity classification and they are not advice.

About the other figures

The Sleep Score, Heads up alerts, What changed? notes, trigger-journal correlations and Ask your data answers are all derived from the figures above. They describe patterns in your data. They do not establish cause, and they do not replace a clinician's judgement. Oximetry metrics such as ODI₃, ODI₄ and T90 are calculated from your oximeter's export and depend entirely on that device's accuracy and fit.

What we ask of you

Talk to your clinician before changing any setting, mask, or part of your therapy, and bring your Apnealytics data to that conversation rather than acting on it alone.
Do not stop therapy because a number looks good, and do not panic because a number looks bad. Ask.
Treat Ask your data as a reading assistant, not a doctor. It is designed to point you back to your clinician for anything that sounds like a medical decision.
Keep your prescription and your clinician's instructions as the authority on your therapy.

Why we are this direct

Honest framing is part of how Apnealytics is built, not a legal afterthought. Data is only useful if you know what it can and cannot tell you. We would rather you understand the limits of machine-estimated figures and use Apnealytics well than believe it is more than it is.

FAQ

Questions people ask

Help center →

Is Apnealytics FDA approved or cleared?

No. Apnealytics is not a medical device and has not been submitted to, cleared or approved by the FDA or any other regulator. It is a consumer tracking and coaching tool that presents data your own devices already record.

Is machine AHI accurate?

It is a consistent estimate, which makes it good for watching your own trend. It is not a diagnostic measurement. CPAP machines infer events from airflow alone, cannot tell sleep from wakefulness and can misclassify events, particularly when leak is high. Compare your machine AHI with itself over time, and leave comparisons with a sleep study to your clinician.

Can I use Apnealytics to adjust my own pressure?

Apnealytics will show you clearly what happened after any change, but it does not recommend settings and we ask you not to change your prescription without your clinician. Pressure, EPR and mode decisions depend on your diagnosis and history, which your clinician knows and an app does not.

Is Apnealytics' Sleep Score medically validated?

No. The Sleep Score is a 0 to 100 summary of your therapy night built from your machine's figures so you can compare your own nights. It is not a validated clinical instrument and should not be read as one. The underlying figures are always shown beside it.

Does the disclaimer mean the data is not useful?

Not at all. Trend data from your machine is exactly what clinicians look at between visits, and understanding it helps you ask better questions and notice problems such as leak early. The disclaimer is about who makes the medical decisions, not about whether the data matters.