Zio AT® Safety Information

The Zio AT device is intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data for long-term monitoring. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety.  It is not intended for use on critical care patients.

• Do not use the Zio AT device for patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient or when real-time or in-patient monitoring should be prescribed
• Do not use the Zio AT device for patients with a known history of life-threatening arrhythmias.
• Do not use the Zio AT device in combination with external cardiac defibrillators or high-frequency surgical equipment near strong magnetic fields or devices such as MRI.
• Do not use the Zio AT device on patients with a neurostimulator, as it may disrupt the quality of ECG data.
• Do not use the Zio AT device on patients who do not have the competency to wear the device for the prescribed monitoring period.

• Do not use the Zio AT patch on patients with known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies. Patients may experience skin irritation.
• Do not reuse the Zio AT patch on multiple patients. It is a single-use device. Reuse will cause incorrect patient data and patient may experience cross contamination.
• Do not use the Zio AT device on patients residing in areas with limited to no cellular service.
• Do not modify the Zio AT device.
• The Zio AT device is MR Unsafe!
  • Do not expose the Zio AT patch or gateway to a magnetic resonance imaging (MRI) environment.
  • The Zio AT patch or gateway may present a risk of projectile injury due to the presence of ferromagnetic materials that can be attracted by the MR magnet core.
  • Thermal injury and burns may occur due to the metal components of the Zio AT patch that can heat during MR scanning.
  • The Zio AT patch may generate artifacts in the MR image.
  • The Zio AT patch or gateway may not function properly due to the strong magnetic and radio-frequency fields generated by the MR scanner.
• The Zio AT device has a maximum limit of transmitting symptomatic (patient-triggered) and asymptomatic (auto-triggered) cardiac events.
  • Asymptomatic cardiac events are transmitted until the maximum limit of 500 transmissions is reached. When the transmission limit is reached, the asymptomatic cardiac events are no longer sent for review during wear.
  • Symptomatic cardiac events are transmitted until the maximum limit of 100 transmissions is reached. When the transmission limit is reached, the symptomatic cardiac events are no longer sent for review during wear.

If a transmission limit is reached, the Zio AT monitor continues to record ECG data, including symptomatic and asymptomatic cardiac events. The data will be fully analyzed and included in the end-of-wear report.

When the patient is approaching a maximum transmission limit, Customer Care contacts the prescribing physician’s office and the patient to send the patient an additional Zio AT device.

• If a Zio AT device is activated before completing patient registration, notifications of clinically actionable arrhythmias will be delayed. To avoid delays, complete the patient registration prior to activating the Zio AT device. A completed patient registration is the prescription order for continuous ambulatory electrocardiogram (ECG) monitoring.
• If skin irritation such as severe redness, itching or allergic symptoms develop, remove the Zio AT patch from the patient’s chest. Call iRhythm Customer Care at 1.888.693.2401.
• CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

• Safety and effectiveness of the Zio AT device on patients receiving any form of pacing therapy has not been established. Paced cardiac rhythms may not be accurately detected and may be incorrectly classified.
• Safety and effectiveness of the Zio AT device on pediatric patients (younger than 18 years old) has not been established.
• The Zio AT device includes temperature and humidity limitations when stored/transported. If exposed during storage/transport, patients may experience degradation of adhesive performance, causing the Zio AT patch to slip or fall off during the patient's wear duration.
• The Zio AT device has a shelf-life date. Use of an expired device may cause a degradation of ECG signal quality and/or a low battery condition.
• Do not use the Zio AT device if the package is damaged. The device may not perform as intended.
• Keep the device and packaging away from young children. Contents may be harmful if swallowed. The patch contains button cell batteries that are not accessible during normal use but, if exposed, are known choking hazards and may cause severe tissue injury if ingested.
• Registration errors may result in limited functionality or erroneous ECG reporting. Utmost caution should be applied to ensure that patient registration is accurate and complete.

Zio AT records and transmits ECG data during wear. Event reports are reviewed by qualified cardiac technicians and provided to the prescribing physician. Reporting timelines may vary.

For questions, contact iRhythm Customer Care at 1-(888)-693-2401.