Intended Use; Intended Purpose - Cardiosecur Pro Benutzerhandbuch

Please read the user manual
Warning
Warning concerns safety-relevant information
Information
Information concerns details that are worth knowing
Manufacturer's data
Store at indicated temperature with unbroken seal.
For single use only
Latex-free
CardioSecur and its accessories - like any other electronic device – contain metal and
plastic parts, which need to be disposed of separately after the operating life to
prevent a negative environmental impact. Send CardioSecur and its associated
accessories with sufficient postage, if possible, in its original packaging, to Personal
MedSystems GmbH for disposal free of charge.
Application unit of type BF. An application unit of type BF grants protection against
electric shock, in particular with regard to permissible discharge current, according to
the requirements of norm EN 60601-1.

3 Intended Use

3.1

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.
3.2 Indications
Diagnoses that can be made with the standard placement of a 10-electrode ECG (ischemia, rhythm
disturbances).
3.3 Contraindications
Non-standard placement of electrodes (e.g. Brugada syndrome).
3.4 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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