Analyser software, application program

Intended purpose

Medis QFR XA is indicated for use in clinical settings where validated and reproducible quantified results are needed to to quantitatively assess X-ray angiographic images the chambers of the heart and of the blood vessels, for use on individual patients with cardiovascular disease. • The QCA measurements can be applied to individual patients with coronary artery disease for measurements in the coronary arteries having a vessel diameter > 1.5mm, • The QLV and QRV measurements can be applied to individual patients with left or right ventricular disfunction as a result of cardiovascular disease or congenital heart disease, • The QVA measurements can be applied to individual patients with peripheral artery disease for measurements in the carotid, femoral, and aortoiliac arteries, they are only intended for use by the responsible clinicians. • The QFR measurements can be applied to intermediate coronary lesions in individual patients with stable angina. The QFR measurement have not been evaluated and therefore should not be applied for non-coronary arteries, in paediatric patients, and cardiac patients with the following conditions: 1) Tachycardia with frequency above 100 bpm,2)Systolic aortic resting blood pressure below 75 mm Hg, 3) Atrial fibrillation.