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General| Brand | iRhythm |
|---|---|
| Model | Zio AT |
| Category | Medical Equipment |
| Language | English |
Details the Zio AT system components and its function as a continuous ambulatory monitoring system.
Outlines the intended use of the Zio AT system for capturing, analyzing, and reporting cardiac events.
Lists specific conditions or situations where the Zio AT system should not be used.
Highlights critical warnings related to patient use, reuse, MR environment, and RF interference.
Details precautions regarding pacing therapy, pediatric use, temperature/humidity, shelf life, and damage.
Addresses special precautions needed for EMC and the system's compatibility with electrical equipment.
Lists all components included in the Zio AT package for patient use.
Illustrates the Zio AT patch and gateway with labeled parts for identification.
Ensures clinic account access to iRhythm's patient management system for effective use.
Provides guidance for clinic staff on patient registration and application instructions.
Explains the device's continuous recording and transmission of ECG data for arrhythmia detection.
Defines the parameters used for detecting and transmitting asymptomatic arrhythmia events.
Addresses common questions and provides guidance for troubleshooting the Zio AT system.
Explains what the patch and gateway do and how they record and transmit ECG data.
Provides guidance on checking if the patch and gateway are working correctly.
Advises on correct patch positioning and warns against reapplication if misplaced.
Explains what to do if the gateway is not within range or lacks cellular signal for data transmission.
Covers activities to avoid, how to record symptoms, and handling missed logging.
Addresses patch lifting, detachment, and managing skin irritation.
Explains orange flashing lights on patch/gateway and corrective actions.
Instructs wearing the patch as prescribed by the doctor, up to a maximum of 14 days.
Notes that the patch may flash orange after removal, which is normal for mailing.
Indicates poor patch contact; advises re-pressing the wings or calling support.
Indicates the patch is not recording; advises calling customer service.
Details troubleshooting for lost connection, no cell signal, and general gateway malfunction.
Covers myZio registration/enrollment and patient timeline data display conventions.
Details iRhythm's status as an Independent Diagnostic Testing Facility (IDTF).
Informs users about privacy practices, legal duties, and rights concerning personal information.
Outlines PHI protection measures and provides company contact details.
Details cybersecurity considerations and controls implemented for the Zio AT system.
Details ECG channels, memory capacity, recording format, service life, and shelf life of the Zio AT patch.
Lists technical specifications for the device, including frequency response and input impedance.
Details battery types, service life, dimensions, and weight of the patch and gateway.
Specifies operational and storage temperature and humidity limits.
Covers essential performance, heart rate calculations, and pause determination.
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