Intended Use - Cardiosecur ACTIVE Benutzerhandbuch

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Intended Use

CardioSecur is intended to record, evaluate, document and diagnose a resting ECG of adults.
CardioSecur is a medical electrical system, comprising an ECG cable, an App for iPhone, iPod
touch or iPad. CardioSecur can record, evaluate and store a complete 15-lead ECG with four
electrodes. CardioSecur is able to detect arrhythmia and ischemia of the heart by comparing a
reference reading with a control reading. CardioSecur serves the purpose of self-monitoring
heart activity.
The user is required to record a personal reference reading in a state free of health problems
and discomfort. The reference reading is stored in CardioSecur. The user may perform the
reading himself or under medical supervision. A control reading may be performed either imme-
diately in case of discomforting symptoms or in regular intervals (e.g. every other day) inde-
pendently of discomforting symptoms.
The user is not required to have previous medical knowledge or special training for using Cardi-
oSecur. CardioSecur is recommended to individuals with a known or suspected heart condition
or bearing 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 reading), electrodes need to be positioned on
the user's thorax according to the following diagram:
White electrode:
Yellow electrode:
Red electrode:
Green electrode:
V4.0
At the upper end of the sternum
At the lower end of the sternum in the middle of the thorax
In the middle of the right shoulder at the height of the lower end of
the sternum (the same height as the yellow electrode)
In the middle of the left shoulder at the height of the lower end of
the sternum (the same height as the yellow electrode)
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