Personal MedSystems CardioSecur Active, User Manual

Page: 33 / 159

V7.2 31
EN
3 Intended Use
CardioSecur is intended to record, evaluate and store 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 reference
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 CardioSecur.
CardioSecur is recommended for individuals with a known or suspected heart condition or risk
factors for cardiac disease (e.g. hypertension, diabetes mellitus or increased cholesterol levels).
Patients and individuals taking precautionary measures may use CardioSecur.
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: