Use Instructions
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January 10, 2019 | v. 3.0
INTENDED USE
The PocketECG transmitter is intended to acquire,
analyze, visualize, record or/and transmit the ECG
and acceleration data. The results of arrhythmia
and ST elevation detection are displayed, stored
or/and transmitted along with the ECG signals. The
acceleration signals are analyzed in order to
determine the physical activity of the patient. It is
assumed that the device can further transmit the
ECG and acceleration signals along with analysis
results using available wireless technologies.
The PocketECG IV is intended for use under the
supervision of a physician or those knowledgeable
in all aspects of ECG morphology, rhythm, and
arrhythmias. Having fulfilled the working conditions
specified in the manual, the device may be used
when the patient is in the following places: clinic,
hospital, outpatient cardiology clinic, house,
business establishment, etc.
CONTRAINDICATIONS
The PocketECG IV is not intended to be used by
patients who have been diagnosed with
life-threatening arrhythmias and require
hospitalization or patients who require inpatient
monitoring using a life-saving device.
The Pocket ECG III is not intended for use in surgical
rooms, intensive care units, intermediate or
step-down units, emergency vehicles. The
PocketECG IV is MR unsafe and should not be used
in any magnetic resonance environment.
COMPLIANCE
The Medicalgorithmics Unified Arrhythmia
Diagnostic System PocketECG IV complies with the
following regulations:
• the essential requirements of the Council
Directive 93/42/EEC,
• the requirements of the United States Food and
Drugs Administration,
• the requirements of the Health Canada Medical
Devices Regulations.
US Federal Law restricts this device to sale by or on
the order of a physician.