W Mobile Cardiac Monitor Operator Manual 1
Table of Contents 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21.
1. Description RhythmStar-W is a wearable, battery powered, wireless cardiac monitor that may be worn by a patient to record ECG, bioimpedance, and motion activity level data for up to 30 consecutive days. RhythmStar-W can capture patient activated and auto-triggered events such as Bradycardia, Tachycardia, and Atrial Fibrillation as identified by the existing RhythmStar embedded arrhythmia detection algorithm (K141813). RhythmStar-W is capable to automatically deliver the data to the Cloud server.
. Precautions 1. When viewing ECG data, the presence of pacemaker signals in the ECG trace should NOT be considered true representations of the actual pacemaker stimulus amplitude. CAUTION: No computerized information is completely reliable; physicians should review all ECG results. 2. To receive the best recording results, instruct patients to stay away from heavy electrical equipment or other sources of electromagnetic interference.
Use only RhythMedix supplied charger to charge the RhythmStar-W monitor. 8. Commented [JD1]: One electrode or more than one (electrodes)? Electrodes RhythmStar-W monitor is to be used with third-party electrodes supplied to a patient by a physician or a monitoring center. RhythMedix recommends use of high quality FDA approved lead electrodes, such as the model A10096SG rectangular foam electrodes by Vermed (see http://https://vermed.com/Electrodes/Default.aspx) or equivalent. 9.
To turn on RhythmStar-W, then briefly press and hold the ON/OFF button on the back side of the monitor until monitor briefly vibrates and LED lights on front of device flash one at a time. To turn off RhythmStar-W, press and hold the ON/OFF button for eight (8) seconds until monitor produces a longer vibration and LED lights illuminate for two (2) seconds. ON/OFF button 11. Recharging RhythmStar-W Monitor Step 1: First connect the RhythmStar-W Charger to a USB compliant power adaptor.
12. Operating RhythmStar-W Monitor • When monitor is ON and not connected to patient, the Lead Connection status light will blink yellow every five (5) seconds. • When monitor is ON and properly connected to patient, the Lead Connection status light will discontinue blinking, and then Monitoring status light will begin blinking green every (10) seconds.
15. Troubleshooting Symptom Solution No Power Low battery Noise artifacts on ECG signal Check monitor power and recharge. Recharge monitor. Ensure all electrodes are securely attached to patient and electrodes used are of quality recommended. 16. Meaning of RhythmStar-W Symbols Symbol Description Indicates the medical device manufacturer. Source: ISO 15223-1 Indicates the manufacturer’s catalogue number so that the medical device can be identified.
17. RhythmStar-W Monitor Specifications Characteristics Test Conditions Min. Typical Max. Unit Physical Length Width Thickness Weight 59 50 15 40 With battery mm mm mm gm Functional ECG Channels Accelerometer Resolution Cable selectable 3-Axis 1 8 1 14 2 16 n/a Bits Memory Recording Time Data Retention 30 10 embedded flash media days years Wireless Communication Technology Power Class Output Power LTE CAT-M1 B2, B4, B12, B13 700/1700/1900 3 0.25 MHz n/a W 115 ±32.5 ±650 >1500 ±0.1 0.
warranties of merchantability and fitness. The stated express warranties are in lieu of all obligations of liabilities on the part of RhythMedix for damages, including but NOT limited to special indirect or consequential, arising out of or in connection with the use or performance of RhythMedix products. Any repairs made to the product that are NOT covered by the warranty are billed to the customer. 19.
