getemed CardioMem CM 100 XT, Инструкция по эксплуатации

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6 CardioMem
®
CM 100 XT 78812021-EN
2 Intended use
CardioMem CM 100 XT is intended to continuously analyse and
periodically record ECG data for later evaluation by a medical
professional in order to:

Document arrhythmias on patients whose symptoms oc-
cur infrequently;

Document the impact of an initiating drug therapy for ar-
rhythmias;

Document the recurrence of arrhythmias after discontinu-
ation of a drug therapy;

Document the results after an ablation procedure for ar-
rhythmias;

Evaluate syncopes on patients whose symptoms occur
infrequently.
The ECG recording is triggered either manually by the patient or
automatically by a programmed timer or by way of an algorithm
that can detect the following arrhythmias:

Tachycardia

Bradycardia

Atrial fibrillation

Pause
The device is intended for use in home and clinical environments.
Home environments include rural, urban and suburban residential
areas, as well as schools, offices and retails environments. The
device may also be used during transport. The device is not in-
tended for use near active RF surgical equipment or in shielded
rooms of magnetic resonance imaging (MRI) system. The device
is battery-powered and uses a non-volatile memory to store the
ECG data. The device is not intended for use as a critical care
monitoring system and must not be used in emergency situations.