Qardio QardioCore, Руководство пользователя

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INTENDED USE
For USA
The QardioCore ECG monitor is intended to capture,
store, transmit and display electrocardiogram (ECG)
information for long term monitoring and evaluation.
It is indicated for use on adult patients who may
be asymptomatic or who may suffer from transient
symptoms such as palpitations, shortness of breath,
dizziness, light headedness, pre syncope, syncope,
fatigue, or anxiety.
The QardioCore ECG monitor does not provide
diagnostic interpretation. The QardioCore ECG
monitor is a prescription-only device, and the
reported information is provided for review by a
physician to render a diagnosis based on clinical
judgment and experience.
Caution: Federal law restricts this device
to sale by or on the order of a physician.
For EU
The QardioCore wireless ECG monitor is intended
to record, store and transmit single-channel
electrocardiogram (ECG) rhythms and detects the
presence of atrial fibrillation and normal sinus rhythm
(when prescribed or used under the care
of a physician).
The QardioCore wireless ECG monitor is intended
for use by healthcare professionals, patients with
known or suspected heart conditions who may
be asymptomatic or who may have chest pain,
palpitations, neurologic symptoms, shortness of
breath, or to monitor response to treatment of cardiac
disorders, and by health conscious individuals.
The device is not intended for pediatric use.