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Precision in Practice

Zio service: Proven Accuracy in Ambulatory Cardiac Monitoring1-4

Discover discreet1,5,6, comfortable7-8, and reliable arrhythmia detection1-4 trusted by millions.

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How does the Zio service work?

 

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Zio ambulatory ECG monitor is applied to the patient in-clinic.2-1

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Patient wears Zio monitor for up to 14 days and mails it back to iRhythm. 1,4,10

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iRhythm analyzes
the data.

 
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Physician receives a high-quality, actionable, end-of-wear report. 7, 11

 

 

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No need for retest 2 (1)

The results stand out.

The monitor doesn’t.

Industry-leading technology designed in Silicon Valley

  • Created with patients in mind, the  Zio monitor is discreet, 1, 5 breathable, and features waterproof housing 12, 13  to deliver an astounding 99% patient compliance. 4,14  
  • Backed by years of expertise in cardiac monitoring, the Zio monitor utilizes proprietary biosensor technology, ensuring accurate and reliable results. 7, 15, 16

Zio report, accurate and actionable 

Our succinct report is designed to reduce the time spent reviewing ECG data. We use a CE-marked deep learned algorithm that detects 13 types of arrhythmia classes.17-20

ZIO MONITOR PATIENT REPORT SAMPLE #1.PDF

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The Zio service is a long-term continuous ambulatory cardiac monitoring service. It consists of the Zio monitor that collects beat-to-beat ECG data and can be worn for up to 14 days; the ZEUS deep learned algorithm which produces reports; and the final review by a team of Cardiac Physiologists. Preliminary findings from the Zio report are intended for use by clinicians as an aid in arrhythmia diagnosis and management.

Indications for Use: the Zio monitor is a prescription-only, single-use ambulatory ECG monitor that continuously records data for up to 14 days. It is indicated for use on patients 18 years and 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.

Contraindications: Do not use the Zio monitor for critical care patients or for patients with symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the patients or when real-time or in-patient monitoring should be prescribed. (Refer to the Zio monitor Instructions for Use for the full list of contraindications.)

Zio monitor, ZEUS and Zio service are currently available in Austria, Netherlands, Spain, Switzerland, UK and USA. Zio monitor and ZEUS are CE-marked. 

Zio and ZioSuite are registered trademarks of iRhythm Technologies, Inc. in the United States of America.

Studies and data represent the US patient population only. Results may not apply to UK, EU and other populations.


 

References

1. Data on file. iRhythm Technologies, 2022-2023.

2. Analyzable time is based off 14-day prescription.

3. Zio™ LTCM devices refers to Zio monitor device.

4. Based on the US data.

5. Based on the US and UK data using Zio™ ECG monitors.

6. Zio service provides continuous, uninterrupted recording and a comprehensive end-of-wear report.

7. Zio monitor Instructions for Use. iRhythm Technologies, 2023.

8. Zio LTCM service refers to the Zio monitor service.

9. Data on file. iRhythm Technologies, 2023.

10. Tsang et al. Benefits of monitoring patients with mobile cardiac telemetry (MCT) compared with the event or Holter Monitors. Medical Devices: Evidence and Research. Published online December 2013:1. doi:10.2147/mder.s54038

11. Clinical Reference Manual. iRhythm Technologies, 2019.

12. Data on file. iRhythm Technologies, 2017, 2023.

13. The Zio monitor device should not be submerged in water. During a bath, keep the device above water. Please refer to the Zio monitor labeling instructions or Patient Guide for the full set of details.

14. Data on file. iRhythm Technologies, 2022.

15. Clinical Reference Manual. iRhythm Technologies, 2022.

16. Continuous, uninterrupted refers to the recording of ECG data. Zio Gateway transmissions may be impacted. See Product Labeling for more information.

17. Data on file. iRhythm Technologies 2020.

18. Hannun et al. Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network. Nat Med. 2019;25:65-69.https://doi.org/10.1038/s41591-018-0268-3

19. Deep-learned algorithm is only available in the United States, European Union, and United Kingdom.

20. FDA 510K clearance, CE mark, and UKCA mark.

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