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1.2 Indication for Use
The QT ECG System is intended to acquire, record and process an
electrocardiographic signal so that it can be transmitted digitally via Bluetooth
technology to a cell-phone or mobile device, then to a remote location.The
QT ECG System is indicated for use on adult patients and pediatric patients
age 18 – 22 years. It is designed to be used by a patient or other layperson in
the home, or by healthcare workers in non-acute care clinical facilities (such
as nursing homes, skilled nursing facilities), to record and transmit a 12-lead
ECG and rhythm strip in near real-time to enable review at a physician's office,
hospital or other medical centers.
1.3 Intended Use
The QT ECG System is intended to condition an electrocardiographic signal
so that it can be transmitted digitally via Bluetooth technology and cell-
phone or communication device to a remote location.. The QT ECG System is
designed to be used by a patient or another layperson or a healthcare worker
to transmit a 12-lead ECG and rhythm strip in near real-time to enable review
at a physician’s office, hospital, or other medical centers.
1.4 Contraindications
Sensitive skin, allergy, or open wound.
1.5 Environment
The QT ECG system is designed for home use and for use in non-acute
care clinical settings. No professional medical training is required to use this
system.
