Visual and Audible Indicators “RECORD” button only works when the device is attached to electrodes “SEND” button only works when the device is not attached to electrodes NORMAL CONDITIONS Patient Instructions Prescribing Physician: Device Action Audible Indicator Visual Indicator Device Activated for First Time 1 upward tone Green flashing light (3 sec) Monitoring Start date: Leads Snapped to Electrodes (any time after initial activation) 1 upward tone Green flashing light (3 sec) Monitoring Completion date: Recording Started 3 short beeps Green flashing light (15 sec) Recording Finished 1 short beep Green flashing light stops Leads Unsnapped from Electrodes 1 downward tone Orange flashing light (3 sec) SEND an Event 1 upward tone, pause, continuous warbling transmission tone Green flashing light (3 sec) Sending Complete End of warbling transmission tone None Memory Full none Orange flashing light (every 10 sec) Your physician has prescribed long term monitoring of the electrical activity of your heart. This common procedure is referred to as event monitoring. For the best possible results, wear the Zio™ Event Card continuously during your normal daily activities. Avoid contact with water while wearing the monitor. The monitor is not waterproof! If at any time your symptom is severe or you feel the need for immediate care, call 911. The Zio™ Event Card will not provide any medical assistance and cannot contact medical personnel for you. When monitoring is completed, return the Zio™ Event Card for recycling to iRhythm Technologies, Inc. using the enclosed postage-paid envelope. iRhythm recycles 100% of each device that is returned to us. No part of the device will end up in a landfill. ERROR CONDITIONS Device Action Audible Indicator Visual Indicator SEND button pressed, but no recordings stored 1 downward tone Orange flashing light (1 sec) SEND button pressed, but leads are attached 1 downward tone Orange flashing light (1 sec) RECORD button pressed, but leads are not attached 1 downward tone Orange flashing light (1 sec) RECORD button pressed while device transmitting none Orange flashing light (1 sec) SEND button pressed again if device transmitting none Orange flashing light (1 sec) Low battery (replace device) none Orange flashing light (continuous) iRhythm Technologies, Inc., the provider of Zio™ products and services, markets Zio™ in collaboration with St. Jude Medical, Inc. iRhythm Technologies, Inc. 650 Townsend Street, Suite 380 | San Francisco, CA 94103 | www.irhythmtech.com ST. JUDE MEDICAL, the nine-squares symbol, and MORE CONTROL. LESS RISK. are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies. Zio™ is a trademark of iRhythm Technologies, Inc. ©2010 iRhythm Technologies, Inc. All rights reserved. For support, contact the IRhythm national clinical center 1-888-693-2401 Connect the Zio™ Event Card A. Shave electrode area if hair is present. Clean area on skin with alcohol. Abrade skin in ‘x’ and ‘+’ motion. B. Remove 2 electrodes from package. Re-seal electrode package to keep remaining electrodes fresh. C. Snap wires of Zio™ Event Card to electrodes (Fig. 1). D. Position electrodes on chest (Fig. 2) (white on right side of chest; black on left). 3 2 1 E. Ensure that electrodes are securely stuck to your chest. Record an Event A. When symptomatic, press the ‘RECORD’ button (Fig. 3). The device will beep 3 times. If an orange light flashes, check connections and replace electrodes as necessary. 3 B. Wait 20 seconds while the green light flashes. You should remain quiet and still. Leave device undisturbed. C. When the recording is complete the device will beep and the green light will stop flashing. When you press the button, the device stores the previous 45 seconds of ECG in memory plus the first 15 seconds after the button is pressed. Transmit A. Find a quiet location. Loud noise can interfere with transmission. SEND SEND RECO RD 4 B. Call 1-888-693-2401 and press “1” to speak with a technician. Use a landline or portable phone. Cell phones will not transmit data properly. TIPS FOR USE C. Unsnap wire(s) from electrodes. D. Place Zio™ Event Card face up on a flat stable surface. • E. Place phone mouthpiece directly over the phone icon on the device (Fig. 4). • F. Press ‘SEND’ button until the device beeps and flashes green (Fig. 5). • G. When tone ends, pick up phone and speak with technician. Do not reconnect device to electrodes until confirming a successful transmission. • • Reconnecting Device A. Snap wires back onto electrodes (Fig. 6). If device had 2 recordings stored, it will flash orange until reconnected. B. When device is reattached, it is ready to record again. The memory will be cleared. 5 • Remove Zio™ Event Card before bathing or showering (you may leave on the electrodes). Do not use lotion or moisturizer near electrodes. Lotions prevent electrode contact. Change electrodes every 2 to 3 days or when they start to peel away. To avoid skin irritation, when changing electrodes move them slightly from their previous position The device can store up to 2 recordings. If the memory is full, an orange light will flash and you cannot record more events until you have transmitted the data. Remain still and refrain from talking during recording and transmission E100A4030.07 | Nov. 2010