Important Messages; Warnings And Cautions - VivaQuant Rhythm Express RX-1 mini Use Manual

Important Messages

Safety messages are indicated throughout this guide to draw attention to safety and
other important information.

Warnings and Cautions

The following section contains a list of the warnings and cautions relevant to the RX-1 mini device.
WARNING: Disconnect device from patient before defibrillation. Exposure to defibrillation may
damage the RX-1 mini device or may interfere with operation of the defibrillator.
WARNING: RX-1 mini is not intended for use as an emergency medical response system.
WARNING: Keep out of reach of children. This device includes use of small parts and
wires/cords which could pose a choking or strangulation hazard to unattended
children.
CAUTION: This device captures and presents data reflecting a patient's physiological condition
that, when reviewed by a trained medical professional, can be useful in determining
a diagnosis. However, the data should not be used as the sole means for
determining a patient's diagnosis.
CAUTION: The RX-1 mini device is designed for use with standard electrodes. Some people are
sensitive to materials used in skin electrodes. If a reaction occurs, remove the
device and electrodes from the body.
CAUTION: This device is not intended for use during an MRI.
CAUTION: Use only specified parts and accessories to maintain operator and patient safety.
CAUTION: The RX-1 mini is designed to meet or exceed requirements for electromagnetic
compatibility, however, some environmental electrical interference may cause
an artifact in the ECG. The quality of ECG signals may be adversely affected by
electromagnetic interference from heavy machinery, electric blankets, and
similar apparatus, resulting in non-physiological waveforms with the potential
for misinterpretation.
CAUTION: Do not allow electrodes or leads to contact an electrical power source or ground
when in use on a patient. Contact in this manner could cause electrical shock of
the patient.
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Rhythm Express® RX-1 mini Patient Use Guide LP-015 Rev J