Related Manuals for VivaQuant Rhythm Express RX-1 mini
Summary of Contents for VivaQuant Rhythm Express RX-1 mini
- Page 1 Rhythm Express® RX-1 mini Remote Cardiac Monitoring System PATIENT USE GUIDE VivaQuant, Inc. 1265 Grey Fox Rd., Suite 400 Arden Hills, MN 55112 Tel. 1-866-ECG-TRUE (1-866-324-8783) LP-015 Rev J...
- Page 2 CAUTION: Carefully read all instructions prior to use. Observe all warnings and cautions in these directions. Failure to do so may result in patient complications. INTENDED USE The Rhythm Express remote cardiac monitoring system is intended for use by patients greater than 10 kg who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis.
-
Page 3: Battery Icon
About the RX-1 mini Device RX-1 mini is a portable, battery-powered device that is used to monitor your heart rhythm continuously. When RX-1 mini detects an abnormal heart rhythm, it saves the electrocardiogram (ECG) in its memory. RX-1 mini is connected to a monitoring center using a secure, private cellular connection. - Page 4 RX-1 mini Important Features and Controls Direct current 5 V dc 1.5 Amp RX-1 mini Type BF electrical isolation, device is not defibrillator proof. Electrodes are the applied parts. Not MRI safe Follow Instructions for use! This is the FCC logo indicating compliance with the FCC rules for wireless devices. Emits non-ionizing radiation Caution: Federal law restricts this device to sale by or on the order of a physician IP64...
-
Page 5: Important Messages
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. - Page 6 CAUTION: The user of this product is responsible for routine maintenance. Failure to do so may cause undue failure and possible health hazards. CAUTION: VivaQuant equipment is identified by the UDI, Model, and serial number on the back of the device. Take care not to deface these numbers.
- Page 7 RX-1 mini device – Gathers data on your heart rhythm and forwards to the monitoring center. RX-1 mini Components Before connecting your device, locate the components. Charger – Charges the battery in the RX-1 mini device. Inside Case Label ECG electrodes – Senses the electrical signals of the heart on the skin. The silver snap connects to the RX-1 mini leads.
- Page 8 Using the RX-1 mini Prepare Your Skin The figure below shows the approximate location of the device on chest. 1. Prepare the skin at this location by trimming any hair. 2. Following the instructions for skin preparation provided by your physician. NOTE: Do not use lotions or creams before applying the electrodes.
- Page 9 Changing Electrodes Change electrodes as instructed by clinic staff. To remove electrodes, gently grasp the edge/tab and peel back in a slow, continuous motion. A wet, warm washcloth may aid in removal of the electrodes. To avoid skin damage, do not rapidly remove the electrodes. Note: To avoid excessive skin irritation, we suggest that when you change electrodes, place them next to the prior location.
- Page 10 Charging Your Device 1. Disconnect the lead snaps from the skin electrodes. Do not wear device while charging. 2. Remove any debris or moisture from device connector using a cotton swab. 3. Plug the charger into a wall outlet. Place the device and connector on a flat surface as shown below and bring the connector to the device until it snaps in place as shown in the middle figure below.
-
Page 11: Troubleshooting
Completing Your Study Your physician has prescribed the duration of your recording of several days to a few weeks. When the recording has been completed, the heart icon will blink green on and off when Red button is briefly pressed. Disconnect the leads from the electrodes, remove the electrodes from your skin, and discontinue wearing the monitor. - Page 12 Factory Authorized Technicians only. Do not attempt to repair, modify, or service the VivaQuant Rhythm Express RX-1 mini device. Do not attempt to open or tamper with the device housing. Opening the housing will void this warranty.
- Page 13 Publication Information The information in this manual only applies to the VivaQuant Model RX-1 mini device. Due to ongoing product improvements, specifications in this manual are subject to change without notice. VivaQuant® and Rhythm Express® are trademarks of VivaQuant, Inc. All other marks referenced in this guide are owned by their respective owners.
- Page 14 • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult VivaQuant for help. Federal Communication Commission (FCC) Radiation Exposure Statement: The RX-1 mini is in compliance with SAR for general population/uncontrolled exposure limits in ANSI/IEEE C95.1-1999 and has been tested in accordance with the measurement methods...
- Page 15 EMC Standard or Test Phenomenon Level of Performance Method ±8 kV contact, ±2 kV, ±4 kV, ±8 Electrostatic Discharge IEC 61000-4-2 ±15 kV air 10 V/m from 80 MHz – 2.7 GHz Radiated RF EM fields IEC 61000-4-3 80% AM at 1 kHz Proximity Fields from RF IEC 61000-4-3 IEC 60601-1-2 Table 9...
- Page 16 1-866-ECG-TRUE (1-866-324-8783) www.rhythmexpressecg.com 1265 Grey Fox Rd. Suite 400, Arden Hills, MN 55112 VivaQuant and Rhythm Express are trademarks of VivaQuant, Inc. L P - 003 R h y t h m Express® RX-1 mini Patient Use Guide LP-015 Rev H...
Need help?
Do you have a question about the Rhythm Express RX-1 mini and is the answer not in the manual?
Questions and answers
What does it mean when red light flashed