INTENDED USE(IU),
IDENTIFICATION FOR USE(IFU)

The CHART system is for routine patient screening in clinical practice, that helps to bridge “the gap” between primary care and specialized heart care, by assisting clinicians, including family physicians, to better understand and identify, often at an earlier stage, a much broader range of common heart diseases and dysfunctions.

It is an aid to understanding a patient’s cardiac status, which will help clinicians to determine either better treatment options or provide the medical justification needed for referring a patient to a cardiologist for more specialized heartcare; leading to
better patient outcomes.

Intended Use (IU)

Cardio-HART’s (CHART’s) intended use is to provide objective assessment and diagnostic interpretation support to clinicians in patient care situations to aid in the evaluation of cardiac status and prognosis.

Indications for use

  1. The CHART program is a post-processing diagnostic assessment and interpretation software algorithm for the qualitative and quantitative analysis of EMPCG bio-signals previously acquired from a compatible device, including the company’s own FDA cleared Cardio-TriTest™.
  2. The results of the CHART analysis are intended to provide an objective assessment and diagnostic interpretation of resting EMPCG bio-signals for use as an aid in diagnosing commonly recognized cardiac functions and dysfunctions (abnormalities) of a physiological or morphological nature, with mechanical, electrical and structural characteristics in adult populations, age 20+, in patient care situations including primary care settings.
  3. CHART analysis is intended to provide screening and diagnostic indications for conditions that might require further confirmation at a higher level of care.
  4. The CHART program makes use of the patient’s age, gender, race, weight, height, waist diameter, BSA and BMI.
  5. CHART is for use by qualified clinicians in conjunction with the patient’s clinical history, symptoms, physiology and other diagnostic tests as might be available, as well as the clinician’s professional judgment and no treatment or other therapies should be initiated based solely on the indications produced by the CHART Program.
  6. For prescription use only.
  7. CHART program is not intended to diagnose:
    • Infrequent cardiac diseases – excluded as they are rare or require specialist level diagnosis:
      - Pericardial Effusion, Pulmonic Insufficiency or Stenosis, Aortic Root Dilation, Ventricular Septal Defect, Atrial Septal Defect, Thrombus, Paravalvular leak, Ballooning syndrome, Aneurysm, Atherosclerosis, Restrictive Cardiomyopathy, Swinging Heart, Pericardial Cyst, Barlow’s Mitral Valve Disease;
      -Idioventricular Rhythm, Hypocalcemia, Left posterior fascicular block, Ventricular Pre-Excitation, Ventricular tachycardia, Wide-QRS Tachycardia, Early Repolarization, Second-degree AV block, Accelerated Idioventricular Rhythm, Accelerated junctional rhythm, Junctional rhythm, Complete AV block, AV dissociation, Ectopic atrial tachycardia, Sinoatrial Block, Digitalis toxicity or effect, Chronic pulmonary disease, Pulmonary embolism, Acute pericarditis, Left atrial conduction abnormality, Supraventricular Complex, Fusion Complex, Ventricular escape complex, Junctional escape complex, Ventricular Parasystole;
    • Congenital Heart Defects – excluded:
      - Mitral Valve Prolapse (MVP), Congenitally Corrected Transposition, Dextrocardia, Patent ductus arteriosus, etc.
    • Known heart interventions – excluded as they should already be known:
      - Artificial Heart Valve, Percutaneous Coronary Intervention (PCI, STENT), Coronary Artery Bypass Graft (CABG), and all other type of cardiac intervention;
    • Non-cardiac diseases.

Read the Highlights