Clinical studies show that the cardisiography algorithm can distinguish ischemic heart disease from an undiseased heart with an accuracy of over 90 percent.
In less than 10 percent of the cases on which a clinical study was based, the Cardisio algorithm did not detect ischemic heart disease, even though one was present.
In less than 25 percent of all cases examined in the study, the cardisiography algorithm classified a negative test as positive. This means that in these cases Ischemic heart disease was indicated, although no such was present.
This shows that the results determined by the Cardisio app do under no circumstances replace a personal diagnosis, care, consultation or treatment by a physician or medically trained personnel. The results merely serve for informational purposes and are intended to provide the user with some assistance. However, the Cardisio app neither serves for decision-making in acute circumstances nor for real-time monitoring of vital functions. Furthermore, it also does not interfere at any time with existing, guideline-compliant diagnostic paths or therapeutic measures.
We are continuously working to improve the Cardisio algorithm and depend on the assistance of all users for this: the more information and measurement values the algorithm can process, the more precisely it can identify diseased hearts and distinguish them from healthy hearts.
However, since a slight chance of a misjudgment by the Cardisio algorithm currently exists and is made known to the user, we, as a company, must exclude any claims for damages by users of the Cardisio app, unless outlying evidence is provide. This disclaimer shall apply to legal representatives, as well as vicarious agents of Cardisio GmbH, to the extent that the user asserts any claims against them.
Claims for damages due to an injury of life, limb or health as well as claims for damages arising from a violation of essential contractual obligations shall be excluded from this disclaimer. Essential contractual obligations shall be those whose fulfillment is necessary for achieving the objective of the contract (e.g. provision of the product free from material and legal defects). Liability for damages caused by gross negligence or willful breach of duty by Cardisio GmbH, its legal representatives, or vicarious agents shall also be excluded from the disclaimer. The provisions of the German Product Liability Act (Produkthaftungsgesetz) shall remain unaffected.
Cardisio is the manufacturer of the web service.
The web service is a med. Prod. class 1 according to MDD.
Cardisiography is the method used.
The data recording device is the data collector that has been placed on the market in accordance with the standards and guidelines listed below. It has been tested against IEC 60601 to ensure the electrical safety of medical products and is therefore a medical grade product.
Applied standards and guidelines:
IEC 60950-1, EN 55032: 2015 Class B, EN55024: 2010 + A1: 2015, 47 CFR Part 15.
The cardisiograph is made available to the user for the measurements. An internet-capable laptop or desktop is required for the evaluation, on which the Cardisio APP can be installed (Windows 7 or higher, MacOS 10.5.8 or higher). Commercially available ECG cables and electrodes are used for the measurement (included in the scope of delivery).