iRhythm Zio AT Reference Manual
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iRhythm Zio AT Reference Manual

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C L INI CAL REF ERENCE MAN UAL

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  • Page 1 C L INI CAL REF ERENCE MAN UAL...

  • Page 2: Table Of Contents

    Clinical Facility Certification . . . . . . . . . . . . . . . . . .

  • Page 3: Description

    • Do not use Zio AT in combination with external cardiac defibrillators Zio AT patch and returns it, along with the gateway, by mail to an iRhythm or high frequency surgical equipment near strong magnetic fields or data processing center .

  • Page 4: Warnings

    Do not use Zio AT system on patients residing in areas with limited to no peripherals such as antenna cables and external antennas) should be cellular reception . used no closer than 30 cm (12 inches) to any part of the Zio AT patch or • Do not modify the Zio AT system .

  • Page 5: Package Contents

    PACKAGE CONTENTS DEVICE DIAGRAMS Zio Patch 1 Zio AT gateway, containing: 1 Zio AT patch Outer Border • 1 postage-paid return envelope Adhesive Wings Light Electrode Electrode ‘Zio’ Button 1 Skin preparation kit containing: Zio Gateway Exterior • 1 patch card template •...

  • Page 6: Account Setup

    Register patient online at www.zioreports.com . iRhythm may contact the patient if any additional information is required . APPLICATION INSTRUCTIONS The Zio AT package contains instructions on how to apply the patch and activate the patch and gateway . DURING MONITORING...

  • Page 7: Asymptomatic Arrhythmia Detection

    ≥60 seconds 1. How long is the patient supposed to wear the Zio AT patch? Atrial Fibrillation A patient can wear the Zio AT patch for up to 14 days or as prescribed . ≥180 bpm ≥60 seconds Note: The Zio AT patch will not record ECG data after 14 days .

  • Page 8: Patient Questions

    6. Can the Zio AT patch be left on a patient during Cardioversion/ 13. Can I carry the gateway in a purse, bag or pocket? Defibrillation? Yes . However, the gateway will need to be in front of your body and within No, the Zio AT patch should be removed if the patient requires 10 feet of the patch .
  • Page 9 29. I think I see blood under my patch. What should I do? 21. What activities should I avoid? Call Customer Service at 1 .888 .693 .2401 . It is probably due to a small Avoid activities that cause heavy sweating . Sweat can cause the patch to shaving cut when the patch was applied to your chest .

  • Page 10: Troubleshooting The Patch

    TROUBLESHOOTING THE PATCH End of the Wear Period 36. How long am I supposed to wear the patch? Wear the patch for as long as your doctor prescribed but no longer than 14 days. NOTE: Each person’s wear experience is different and actual wear time may be shorter than prescribed .

  • Page 11: Troubleshooting The Gateway

    Please call Customer Service at 1.888.693.2401.”, until enrollment has been completed. (SYS-2281) Patient Timeline – For patients with the Zio AT Patch, ZioReports provides Paper Booklet Diary a timeline screen that displays along with Transmission, Entries DDR, Daily, and Final reports, patient provided diary entries.

  • Page 12: Irhythm Clinical Facility Certification

    Independent Diagnostic Testing Facility Performance Standards . A link our legal duties, and your rights concerning your personal information . to these standards (42 C .F .R . section 410 .33) can be found at the iRhythm website www .irhythmtech .com .
  • Page 13 Once information is De-Identified through payment activities. an approved method, the data is stripped of For Business individual identifiers, at which point iRhythm We may use and disclose PHI to provide and Operations may share this information without restriction manage your diagnostic services.  That may...
  • Page 14 What We Do Your Rights To protect your PHI from unauthorized access and use, iRhythm has How Does iRhythm implemented security safeguards that comply with federal law to Protect My PHI? With limited exceptions, you have the right to review in person, or secure physical and electronic information.

  • Page 15: Cybersecurity Measures And Controls

    CYBERSECURITY MEASURES AND CONTROLS DEVICE SPECIFICATIONS As a connected medical device, the Zio AT patch was developed with careful PATCH PERFORMANCE CHARACTERISTICS consideration of cybersecurity risks and their compensating controls . Key measures include manufacturing steps to exclusively pair one AT patch...
  • Page 16 ESSENTIAL PERFORMANCE The Zio AT device records and transmits ECG for analysis after receipt of data . In the event it cannot record or transmit in a timely fashion, the Zio AT alerts the patient that functionality is impaired .

  • Page 17: Electrical Safety And Compatibility

    EMC information provided in the The Zio AT system is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio AT system should assure that it is used in such an following tables .
  • Page 18 The Zio AT system is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio AT system should assure that it is used in such an NOTE 2—These guidelines may not apply in all situations. Electromagnetic propagation is environment.

  • Page 19: Symbols Glossary

    The Zio AT system is intended for use in an electromagnetic environment in which radiated TEXT RF disturbances are controlled. The customer or the user of the Zio AT system can help Medical devices — prevent electromagnetic interference by maintaining a minimum distance between...
  • Page 20 DESCRIPTION / DESCRIPTION / STANDARD STANDARD SYMBOL STANDARD TITLE SYMBOL TITLE EXPLANATORY SYMBOL STANDARD TITLE SYMBOL TITLE EXPLANATORY REFERENCE REFERENCE TEXT TEXT Medical devices — Medical devices — Indicates the Symbols to be used Symbols to be used manufacturer’s ISO 15223-1 with medical device ISO 15223-1 with medical device...
  • Page 21 DESCRIPTION / DESCRIPTION / STANDARD STANDARD SYMBOL STANDARD TITLE SYMBOL TITLE EXPLANATORY SYMBOL STANDARD TITLE SYMBOL TITLE EXPLANATORY REFERENCE REFERENCE TEXT TEXT Marking of electrical Manufacturer- To indicate and electronic determined that the equipment in degree of BS EN Separate product shall accordance with particle and...
  • Page 22 This page intentionally left blank This page intentionally left blank 1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com...
  • Page 23 Technologies, Inc. 650 Townsend St ., Suite 500 San Francisco, CA 94103 USA 1 .888 .693 .2401 irhythmtech.com ALB0031.01 • 2018-04-11...

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