Zio® monitor Safety Information

The Zio monitor is intended to capture symptomatic and asymptomatic cardiac events in a continuous electrocardiogram (ECG) record for long-term monitoring. 

The Zio monitor is a prescription-only, single-use 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 experience transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety.

• Do not use the Zio monitor on critical care patients because the reporting timeliness is not consistent with life-threatening arrhythmias such as ventricular fibrillation.
• The Zio monitor is not intended for use on patients under 18 years old.
• Do not use the Zio monitor for patients with symptomatic episodes where instance 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 monitor in combination with external cardiac defibrillators.
• Do not use the Zio monitor on patients with neurostimulator, as it may disrupt the quality of ECG data.
• Do not use the Zio monitor on patients who do not have the competency to wear the device for the prescribed wear period.

• Do not use the Zio monitor on patients with known allergic reactions to adhesives or hydrogels or with a family history of adhesive skin allergies. If allergic symptoms, severe skin irritation, or signs of skin infection develop, remove the device from the patient’s chest and discontinue wear. Reaction to adhesives may include severe redness and itching, hives, and blisters. Contact your healthcare provider and Customer Care to report the reaction.
• The Zio monitor is not designed for use on patients with pacing therapy or implantable cardioverter defibrillators. Paced cardiac rhythms may not be accurately detected and may be incorrectly classified. The shocks from implantable cardioverter defibrillators may damage the Zio monitor.
• Do not expose the Zio monitor to a magnetic resonance imaging (MRI) environment.
  • The MRI device’s magnet core can attract the ferromagnetic materials in the Zio monitor, creating a risk of projectile injury to the patient and others in proximity to the Zio monitor and MRI device.
  • Metal components in the Zio monitor can heat during MRI scanning, resulting in the potential for thermal injury and burns.
• Do not reuse the Zio monitor on the same patient or on multiple patients. It is a single-use device.

     Reuse of the device may result in mixed patient results, poor adhesion, and poor ECG signal.

• Do not modify this equipment without authorization from the manufacturer.

• During storage and prior to prescription for a patient, do not exceed the temperature and humidity limitations for the Zio monitor. Devices exposed to environmental conditions outside the specified range may have degraded adhesive and battery performance.  Observe the temperature and humidity specifications for transportation and storage listed on the box and in the instructions for use.

Refer to Environmental Specifications in the Instructions for Use for temperature and humidity specifications.

• Confirm the expiration date for the Zio monitor listed on the device box or pouch. Use of an expired device may cause a degradation of ECG signal quality and a low battery condition. Apply the device on or before the expiration date.
• Registration errors may result in limited functionality or erroneous ECG reporting. Utmost caution should be taken to ensure that the patient registration is accurate and complete.
• Recorded ECG data cannot be retrieved for analysis unless you return your Zio monitor. Keep the original box. The box is designed to protect the Zio monitor and Symptom Log in the return mail when properly sealed. Follow the return instructions in this manual.

If the box is damaged during opening or handling or lost, contact Customer Care.

• Carefully prepare the skin on the patient’s upper left chest prior to applying the Zio monitor. Observe the instructions for proper shaving, exfoliating, and cleaning. Proper placement and alignment of the Zio monitor on the patient’s chest is important for recording ECG data.

Carefully follow the sequence of all steps in the application instructions to ensure the device is properly positioned and securely adhered to the patient’s chest.

• Avoid delays in recording ECG data. After applying the Zio monitor to the patient’s chest, follow the instructions in this manual to activate recording of ECG data. If the light on the Zio monitor does not flash green after a second activation attempt, contact Customer Care.
• Exposing the Zio monitor to any sources of infrared light (greater than 780 nanometers), such as direct sunlight or infrared saunas, can disrupt the recording of ECG data. Wear clothing if exposure to infrared light, such as direct sunlight, cannot be avoided.
• To avoid electromagnetic interference in the Zio monitor ECG recording, maintain a distance from electronic or surgical equipment with strong electromagnetic fields. The Zio monitor is suitable for use in a home healthcare environment.
• If the patient has a known allergic reaction to limonene, the active ingredient in the adhesive remover, use a pure brand of baby oil or a pure brand of petroleum jelly to aid removal instead of the adhesive remover wipe.

The Zio monitor continuously records ECG data during wear. After the prescribed wear period, the device is returned for data extraction and clinical analysis.

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