Content INTRODUCTION About the ZOLL Cardiac Monitor ..............1 Where Do My Recordings Go? ..............1 This Manual ....................1 What’s In This Manual? ................1 Safety Precautions ..................2 Indications For Use ..................2-3 Contraindications ..................3 DEVICE OVERVIEW System Components ..................
24 hours a day, 7 days a week, or they are downloaded when you return your device to ZOLL at the end of your prescription period. ZOLL provides reports to your prescriber based on your recordings.
• Avoid exposing device to water or excessive moisture. • Do not expose device to extreme temperatures. • Use only the electrodes provided by ZOLL with the ZOLL Cardiac Monitor. • Do not allow conductive parts of the ZOLL Cardiac Monitor patient electrodes to contact other conductive parts including earth.
Data from this device may be used by another device to discover, measure, or report QT interval. The device is not intended to sound any alarms for QT interval changes. Contraindications The ZOLL Cardiac Monitor is not intended for use under the following conditions: • Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
Figure 1 Major components of the system. ITEM DESCRIPTION Monitor Main unit of the ZOLL Cardiac Monitor. Patient Cable Connects the Monitor to the Electrodes to monitor your heart rhythm. Power Charging Recharges the Monitor battery. Plugs into a standard power Cable outlet to provide power to the Monitor (details on page 7).
If the Display Screen is dark, press the Power Button to turn on the Display Screen. Figure 3 Side and back view of the ZOLL Cardiac Monitor Monitor — Side and Back View (Fig. 3) ITEM DESCRIPTION...
Indicates the status of the network connection. The device Indicator periodically turns off its modem to save power. Battery Level Displays the approximate charge remaining in the battery. Serial Number Identification number used if communicating with ZOLL technical support. Also found on the back of the Monitor.
6. Place the Electrodes on your body as indicated in Fig. 9. For more details on Electrode Application see page 12. NOTE: The ZOLL Cardiac Monitor battery cannot be recharged in the device without interrupting the data recording.
Operation Starting a Study 1. Press and hold down the Monitor Power Button to begin powering the device. 2. After approximately three seconds, the Monitor vibrates, briefly displays an ECG (Fig. 7), and then displays the message MONITORING Please connect all electrodes for best results.
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Operation Starting a Study Continued... Figure 10 6. When the Monitor displays the screen above (Fig. 10), it is recording and analyzing ECG data. The Time Remaining on the Display Screen is the number of days remaining for the study; however, the days remaining in your prescription may be less than indicated based on how often you are wearing the device.
Operation Marking an Event During a Study, the ZOLL Cardiac Monitor allows you to indicate symptoms you are feeling for the prescriber to review. 1. To mark an event from this screen, select the Plus Sign (Fig. 11). Figure 11 2.
Operation Marking an Event Continued... 6. A second NEW EVENT screen displays with further instructions (Fig. 14). Select the Right Arrow 7. On the ACTIVITY DIARY screen select the Up or Down Arrows to highlight the activity you are doing (Fig. 15). 8.
Operation Electrode Application Disposable Electrodes are included in the ZOLL Cardiac Monitor box. Only use the Electrodes supplied by ZOLL. Contact your prescriber or ZOLL if you did not receive any Electrodes, experience Electrode fall-off, or you need more Electrodes.
Operation Monitoring a Study Once a Study has started, the ZOLL Cardiac Monitor silently records, detects, and transmits ECG data with no intervention. Briefly press the Monitor Power Button to wake the display or Mark an Event. If the Patient Cable is disconnected from the Electrodes or the Monitor, the device cannot continue recording, the device automatically wakes the display, vibrates, and displays a message.
Maintenance Cleaning • Do not submerge the ZOLL Cardiac Monitor or the Patient Cable in water. Do not hold either the Monitor or the Patient Cable under running water. • Use only a damp cloth with mild detergent diluted with water to clean the device.
System Information Equipment Symbols Consult the Directions For Use Type BF device Electrically Isolated Manufacturer Info RX Only Prescription Only Device has ingress rating of IP22 in accordance with IEC 60529 Recycling Symbol - Do not dispose of this product as unsorted municipal waste.
System Information Wireless Compliance Device may contain FCC ID: ZIMH40L, ZIMH40M or ZIMH41L FCC Compliance Statement This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
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System Information Wireless Compliance Continued... safe exposure. The tests are performed in positions and locations (for example, worn on the body) as required by the FCC for each model. Changes or modifications made to this equipment not expressly approved by TZ Medical may void the FCC authorization to operate this equipment.