Safety Information; Cautions And Warnings - VivaQuant Rhythm Express RX-1 User Manual

Chapter 3: Safety Information
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Safety Information

This chapter provides warnings and cautions relating to use of the RX‐1 device. All personnel that use this device should
read and be familiar with the content of this section prior to use.
VivaQuant asserts that the product covered by this manual is safe, reliable, and effective provided that the product is used
in accordance with the instructions for use, as provided in this manual. Observance of all safety messages will help protect
the user and the patient against those hazards.

Cautions and Warnings

WARNING: Wear the device and lanyard under a shirt or other garment to avoid becoming entangled in your surroundings.
:
WARNING Disconnect Patient leads from electrodes before defibrillation. Exposure to defibrillation may damage the RX‐1
device or may interfere with operation of the defibrillator.
WARNING: RX‐1 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 long 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 device is designed for use with standard electrodes. Some people are sensitive to the 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 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 ECG leads to contact an electrical power source. Contact could cause electrocution of
the patient.
CAUTION: Disconnect the lead wires from the electrodes prior to charging. Although the charger has been tested to assure
that it meets safety standards, failure could result in electrical shock.
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