VOCARE vitals360, Руководство пользователя

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Instructions for Use Page 74 of 117
device ECG Recording function.
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This device is NOT intended for treatment.
CAUTION
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DO NOT use the device in the bathroom or moist environments.
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DO NOT take ECG Recording s in areas where the device could be exposed to strong
electromagnetic forces.
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DO NOT take ECG Recording s in close vicinity to other equipment emitting ultrasonic
acoustics.
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DO NOT take ECG Recording s while using other electrical devices.
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DO NOT use radio systems or cellular phones near the device when taking ECG Recordings.
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Upper-frequency electrosurgical interference may cause inaccurate readings.
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DO NOT use on patients with significant resting tremors.
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DO NOT use with a cardiac pacemaker, ICDs, or other implanted electronic devices.
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DO NOT use the device for any purpose other than obtaining an electrocardiograph or other
function in this device.
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DO NOT attempt to use the device over or through clothing.
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DO NOT connect the device to the USB Cable when acquiring.
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As in all ECG measurement procedures that use electrode contact to the skin, body
movements, muscle activities, or loose contact between the electrodes and the skin are
expected to influence the quality of the measurements.
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DO NOT take a recording if the electrodes are dirty. Clean them first.
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DO NOT pour liquid on to the device or the electrodes.
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This device monitors and records ECG waveforms, it DOES NOT detect or measure all heart
rate, heart rhythm and heart waveform changes, especially those related to ischemic heart
conditions.
NOTES
The device is susceptible to interference from RF energy sources (lowered RF immunity) which
exceeds the IEC 60601-1-2 limits, such as power line bursts, other medical devices, and certain cellular
products, information technology equipment and radio/television transmission. Portable RF
communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm to any part of the device, including cables specified by the
manufacturer. The ECG subsystem cannot record ST-segment shift.
FOR PATIENTS WITH PACEMAKER. The heart rate measurement may continue to count the
pacemaker rate during occurrences of cardiac arrest or some arrhythmias since this device has NO
capability of pacemaker pulse inhibition. DO NOT rely upon the heart rate reading in this situation.
It is recommended to use a soft cloth with medical alcohol to wipe the metal electrode when the
measuring signal is too weak.