Overview; Device Description - VivaQuant Rhythm Express RX-1 User Manual

Chapter 2: Overview
2

Overview

This chapter provides an overview of the Rhythm Express RX‐1 ECG Monitor and Arrhythmia Detector. The following
information can be found in this chapter:

Device description

Intended use

Indications for use

Device Description

RX‐1 is a portable battery‐powered wearable recorder for use by trained clinical staff to collect ECG from patients in a
home, clinical, or outpatient setting for up to 30 consecutive days. The device can capture patient activated and auto‐
triggered cardiac events such as bradycardia, tachycardia, pause, and atrial fibrillation via an on‐board ECG waveform
analysis algorithm. The device can automatically deliver the data wirelessly to a server using a built‐in wireless cellular data
modem where it can be reviewed by a physician or other qualified professional. A medical professional can adjust the
device notification criteria and auto triggering parameters using the server and securely communicate the updated device
notification criteria to the device using the cellular network. Device notification parameters include arrhythmia detection
thresholds, monitoring duration, and operating mode.
The RX‐1 consists of a monitor, DIN 40 standard lead wires, and a wall battery charger. The RX‐1 device is intended to be
used only with lead wires supplied by VivaQuant. High quality FDA‐cleared lead electrodes designed for long‐term
ambulatory monitoring should be used, such as 3M 2259 or equivalent.
RX‐1 can record ECG as either an Event Recorder (ER), Mobile Cardiac Telemetry (MCT) or Wireless Holter (WH) device. As
an Event Recorder, the device continuously detects arrhythmias and transmits them at a predetermined interval. Upon
feeling symptoms, as directed by a physician, the patient can press the Red Patient Triggered Event (PTE) button on the
device to mark the time symptoms occurred. The device then prompts the patient to assign a symptom type and will
immediately connect with the cellular network. Once a secure connection is established on the cellular network, the device
will transmit an ECG strip overlapping the time at which the red PTE button was pressed. Once received at a monitoring
center or clinic, the ECG can be evaluation by a physician or other trained professional to aid in diagnosis.
When operating as an MCT device, RX‐1 functions the same as ER mode with the addition that the RX‐1 detects the
location of each heart beat and transmits to the monitoring center for reporting to the physician as an aid in diagnosis. In
addition, while in MCT mode, the server provides for retrieval of any ECG strip during the recording session. When
operating as a WH device, RX‐1 functions the same as MCT mode except that the server automatically retrieves all ECG
strips recorded by the device.
When not actively monitoring a patient, the RX‐1 can be placed in Standby Mode to save battery charge. Standby Mode
essentially puts the device to sleep to preserve the battery and uses only about 1% of remaining battery capacity for each
week the device is in Standby Mode. The device can be charged when in Standby Mode.
6