V6.0
5
EN
3
Intended Use
CardioSecur is intended to record, evaluate and store a resting electrocardiograms (ECG) for
adults.
CardioSecur is a medical electronic system, comprising an ECG cable and an app for a
smartphone. CardioSecur can record, evaluate and store a complete 15-lead ECG using 4
electrodes. CardioSecur is able to detect arrhythmias and ischemia of the heart by comparing
a reference reading to a control reading. CardioSecur serves the purpose of self-monitoring
heart activity.
The user is required to record a personal reference reading when symptom-free. The refer-
ence reading is stored in the CardioSecur app. The user may perform the reading himself or
under medical supervision. A control reading may be performed immediately in the case of
symptoms or at regular intervals (e.g. every other day), independent of symptoms.
The user is not required to have previous medical knowledge or special training to use Cardi-
oSecur. CardioSecur is recommended for individuals with a known or suspected heart condi-
tion or risk factors for cardiac disease (e.g. hypertension, diabetes mellitus or increased
cholesterol levels). Patients and individuals taking precautionary measures may use CardioSe-
cur.
In order to record an ECG (reference and control ECG), disposable electrodes need to be
positioned on the user’s thorax according to the following diagram:
