Cardisio heart screening (Cardisiograph) — Consent and disclaimer · Form CDS-01 v1.2

ProCare Health Services Ltd (BRN C19168909), trading as ProCare Medical Laboratory, offers this test with the Cardisiograph supplied by Halum Heart Ltd (Cardisio Mauritius). Please read this before you sign.

1. About the test

• The Cardisio test is a quick, non-invasive heart screening. A few sensors (electrodes) are placed on my chest and back for a few minutes while I stay still. There are no needles and no radiation.
• Software using artificial intelligence analyses the recording and produces a report. A doctor then reviews it and writes an interpretation.
• The result is an indication that supports my doctor's assessment. It is not a diagnosis and does not replace a consultation, care or treatment by a doctor, nor tests such as a 12-lead ECG, stress test, echocardiogram or coronary angiogram.
• The fee covers the test and a digital report signed by the Reporting Doctor. A medical consultation is not included.
• If my result shows a point of concern, further tests and a visit to a doctor are recommended. A normal result does not rule out heart disease and does not replace regular check-ups, or medical advice if I have symptoms.
• I am responsible for following up my result with my own doctor and for the decisions I take about my health. ProCare staff do not interpret results.
• I take this test voluntarily. I have had the chance to ask questions and they have been answered.

2. How accurate it is

• A UK community study within an NHS cardiovascular-prevention pathway (Rudland, Shah & Nevill, BJGP Open 2025; 628 tests; funded by SBRI Healthcare and Cardisio) reported a positive predictive accuracy of 80% and a negative predictive accuracy of 90.4% compared with a consultant cardiologist's opinion, with under 2% of tests failing.
• An independent hospital study in Heidelberg, Germany (Clin Res Cardiol 2024; 141 patients, compared with stress cardiac MRI) found sensitivity of 44–50% and specificity of 53–54%; 28 recordings could not be analysed by the updated software.
• Studies led by the manufacturer against coronary angiography report higher sensitivity (about 90–97%) and specificity (about 74–90%).
• The UK work was a research study. It is not an approval or endorsement of the test by the NHS.

3. The test can fail

Movement, poor electrode contact, body hair, a pacemaker or defibrillator, an irregular rhythm or a technical fault can make the result unreliable or stop the test. The test may then need to be repeated.

4. Not for emergencies

If I have chest pain, difficulty breathing or other urgent symptoms, I will call 114 (SAMU) or go to the nearest emergency department, whatever this test shows.

5. My data — the test

• I consent to my health information (my name, ID, contact details, test signals and result) being processed by the Cardisiograph and its cloud service, and stored securely, for the purpose of this test.
• I consent to my data being transferred outside Mauritius, including to Germany, to the licensor and the service providers of the Cardisiograph for that purpose.

6. My data — my ProCare record

• As with my blood tests, I consent to ProCare keeping my questionnaire answers, measurements, Cardisio report, doctor's interpretation and this signed consent in my ProCare patient record, so that they can be sent to me, shown in my Patient Hub, compared with my future results and shared with a doctor I consult through ProCare.
• ProCare may use my data in anonymised, combined form to understand the heart health of the people it serves. No one can be identified from these figures.
• I may access my data, ask for it to be corrected, and withdraw my consent, in line with the Data Protection Act 2017, by contacting ProCare on 660 6060.

7. Algorithm — I agree that my data, once anonymised, may be used to improve the Cardisiograph algorithms. This is required to have the test.