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3 Intended Use
Intended purpose
CardioSecur is intended to record, display and document a resting electrocardiogram (ECG) for
adult males and females.
CardioSecur is a medical electrical system comprising an ECG cable, an iOS device and an app
for an iOS device. CardioSecur records a 22-lead ECG using 4 electrodes.
Indications
Diagnoses that can be made with the standard placement of a 10-electrode ECG (ischemia,
rhythm disturbances).
Contraindications
Non-standard placement of electrodes (e.g. Brugada syndrome).
Information for use
Only medically trained personnel may use CardioSecur. When in automatic mode, CardioSecur
may also be used by untrained personnel.
To record an ECG with CardioSecur, the disposable electrodes need to be positioned on the
patient's thorax according to the following diagram:
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