Zio XT Indications, Safety & Warnings

Indications for Use

The Zio XT monitor is a prescription-only, single-patient-use, continuously recording ECG monitor that can be worn up to 14 days. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, presyncope, syncope, fatigue, or anxiety.

Contraindications

• Do not use the Zio XT monitor for patients with symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the patient.
• Do not use the Zio XT monitor 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 XT monitor on patients with neuro-stimulator, as it may disrupt the quality of ECG data.
• Do not use the Zio XT monitor on patients who do not have the competency to wear the device for the prescribed monitoring period.

Warnings

• Do not use the Zio XT monitor on patients with known allergic reaction to adhesives or hydrogels or with a family history of adhesive skin allergies. Your patient may experience skin irritation.
• Do not reuse the Zio XT monitor on multiple patients. It is a single patient use device. Reuse will cause incorrect patient data and may experience skin irritation.

If skin irritation such as severe redness, itching or allergic symptoms develop, remove the Zio XT monitor from the patient’s chest.

Caution: Federal (USA) law restricts the sale of this device to or on the order of the physician.

PRECAUTIONS

• The Zio XT monitor includes temperature and humidity limitations. If exposed, patients may experience degradation of adhesive performance causing the device to slip or fall of during the patient wear duration.
• The Zio XT monitor has a shelf-life date. Use of expired device may cause a degradation of ECG signal quality and/or low battery condition.
• Do not use the Zio XT monitor if package is damaged. Device may not perform as intended.
• Safety and effectiveness of the Zio XT monitor on pediatric patients (younger than 18 years old) has not been established.
• Safety and effectiveness of the Zio XT monitor 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.