Zio XT - User Manual

Enroll the patient.
Online: www.ZioSuite.com
Phone: 1.888.693.2401
Write in Name, Physician, Start Date
and Time on cover of Patient Instructions
& Button Press Log.
Determine position:
Patient should stand with arms
relaxed at side.
Skin should be free of perspiration.
1. Plan & position
Start Guide
Determine placement area without
removing backing.
Place on attest part of upper left chest:
• 1 nger width below collarbone,
centered over left pectoral muscle
• Edge of the Zio XT Patch next to sternum
• Angle so arrow on top label
points upward
• Avoid armpit and breast tissue
Prepare a large area:
Shave area.
Abrade skin, applying pressure for 40
broad strokes—10 times in the direction
2. Prep skin
of each arrow in 2a & 2b (important for
adhesion and ECG signal quality).
Clean skin thoroughly with all alcohol
pads. Let dry for 1 minute.
1
2a 2b
3
4c
4b
4a
Hold device in the center and remove
clear backings. Keep top label on. Do not
touch adhesive.
3. Apply patch
Place Zio XT Patch in the recommended
position.
Press rmly across the entire device for
2 minutes (see image 3).
Peel o the 2 parts of the top label
(see image 4a).
Press rmly across the entire device for
2 minutes, working adhesive into the skin.
Emphasize pressing on the dotted areas
shown in gure 4b.
4. Finish & activate
Firmly press the ‘Zio’ button and release
(see image 4c). The green light will ash
5 times indicating that the monitoring
has started.
Help patient get familiar with the location
of the button.
Ask your patients to download the
MyZio™ symptom tracking app.
5. Download & register

Summary

Plan and Position Zio XT Patch

Determine Patient Position

Patient should stand with arms relaxed at side. Skin should be free of perspiration.

Determine Placement Area

Place on flattest part of upper left chest, 1 finger width below collarbone.

Prepare and Apply Zio XT Patch

Prepare Skin

Shave area, abrade skin with 40 broad strokes, clean with alcohol pads.

Apply Patch

Hold device center, remove clear backings, press firmly for 2 minutes.

Finish and Activate Zio XT Patch

Peel Top Label

Peel off the 2 parts of the top label.

Activate Monitoring

Press the 'Zio' button; green light flashes 5 times.

Download and Register Patient App

MyZio App Download

Ask patients to download the MyZio™ symptom tracking app.

Using the Zio XT Patch and Button Log

Wear Duration and Button Press

Wear up to prescribed duration. Press 'Zio' button for symptoms, write in log.

Returning the Zio XT Patch

Write 'Date Removed' on cover and return in postage-paid box.

Frequently Asked Questions

Patch Wear Time and Activities

Wear up to 14 days. Shower after 24 hrs. Avoid excessive sweating initially.

Patch Status and Troubleshooting

Device is silent. Call Customer Care if patch falls off.

Important Warnings and Precautions

Contraindications and Restrictions

Do not use with adhesive allergies, magnetic fields, neurostimulators, or defibrillators.

Overview

1. Function Description
2. Usage Features
3. Patient Enrollment and Preparation
4. Positioning the Patch
5. Skin Preparation
6. Applying the Patch
7. Finishing and Activation
8. Symptom Tracking
9. Wear Duration
10. Daily Activities and Water Exposure
11. Device Status
12. Maintenance Features
13. Skin Care During Wear
14. Troubleshooting Adhesion Issues
15. Returning the Device
16. Customer Support
17. Warnings and Contraindications

The Zio XT Patch is a compact, wearable, and disposable electrocardiogram (ECG) monitoring device designed for continuous, long-term cardiac rhythm assessment. It is intended for use in patients who require extended monitoring for the detection of cardiac arrhythmias. The device is applied directly to the skin on the upper left chest and records ECG data over several days, providing a comprehensive view of the patient's heart activity during their normal daily routine.

Function Description:

The primary function of the Zio XT Patch is to continuously record and store ECG data for subsequent analysis by healthcare professionals. It captures every heartbeat, allowing for the detection of both symptomatic and asymptomatic cardiac events. The device is designed to be unobtrusive, enabling patients to maintain their regular activities while being monitored.

A key feature of the Zio XT Patch is its integrated event button, referred to as the "Zio button." Patients are instructed to press this button whenever they experience a cardiac symptom, such as chest pain, dizziness, palpitations, or shortness of breath. Pressing the button marks the ECG data at that specific time, correlating the patient's subjective symptoms with objective ECG findings. This correlation is crucial for accurate diagnosis and treatment planning. The device provides visual feedback (a green light flashing 5 times) to confirm that monitoring has started after activation.

The Zio XT Patch is engineered for ease of use, from application to data collection. Its adhesive backing ensures secure attachment to the skin, while its discreet design minimizes interference with daily life. The device is designed to be worn for a prescribed duration, typically up to 14 days, though the actual wear time may vary based on individual patient experiences and physician recommendations.

Usage Features:

Patient Enrollment and Preparation:

Before application, patients are enrolled through the ZioSuite.com online portal or by phone. Essential patient and physician information, along with the start date and time, are recorded on the accompanying Patient Instructions & Button Press Log.

Positioning the Patch:

Accurate placement is critical for optimal ECG signal quality. The patient should stand with arms relaxed at their side. The device is positioned on the flattest part of the upper left chest, specifically:

• One finger width below the collarbone, centered over the left pectoral muscle.
• The edge of the Zio XT Patch should be next to the sternum.
• The arrow on the top label should point upward.
• Areas to avoid include the armpit and breast tissue. The placement area is determined without removing the adhesive backing initially.

Skin Preparation:

Thorough skin preparation is essential for good adhesion and ECG signal quality. A large area of skin is prepared by:

1. Shaving: The area where the patch will be applied is shaved.
2. Abrasion: The skin is abraded using firm pressure, applying 40 broad strokes (10 strokes in each direction of the arrows shown in the instructions). This step is crucial for both adhesion and ECG signal quality.
3. Cleaning: The skin is thoroughly cleaned with all provided alcohol pads and allowed to air dry for one minute. The skin must be free of perspiration before application.

Applying the Patch:

1. The device is held in the center, and the clear backings are removed, leaving the top label on. Care is taken not to touch the adhesive.
2. The Zio XT Patch is placed in the recommended position.
3. The device is pressed firmly across its entire surface for 2 minutes to ensure proper adhesion.

Finishing and Activation:

1. The two parts of the top label are peeled off.
2. The device is pressed firmly across its entire surface again for 2 minutes, working the adhesive into the skin. Particular emphasis is placed on pressing the dotted areas indicated in the instructions.
3. The "Zio" button is pressed firmly and then released. A green light will flash 5 times, indicating that monitoring has successfully started.
4. Patients are encouraged to familiarize themselves with the location of the button for easy access during symptomatic events.

Symptom Tracking:

Patients are advised to download the MyZio™ symptom tracking app to log their symptoms. Additionally, each time a symptom is felt and the Zio button is pressed, the patient should record the symptom, date, and time in the provided Button Press Log.

Wear Duration:

Patients wear the Zio XT Patch according to their physician's prescribed wear time, up to a maximum of 14 days. Actual wear time may be shorter based on individual experiences.

Daily Activities and Water Exposure:

• Patients can engage in most daily activities. However, activities that cause excessive sweating may affect patch adhesion, potentially leading to loosening, falling off, or shortening wear time, especially during the first 24 hours.
• Showering is permitted after the first 24 hours of wear. Patients should shower with their back facing the shower head and keep soaps and lotions away from the patch.
• Swimming and hot tub use are not permitted while wearing the Zio XT Patch.

Device Status:

When working properly, the Zio XT Patch will not flash or make noise, ensuring discreet operation.

Maintenance Features:

Skin Care During Wear:

While wearing the patch, patients should avoid applying soaps, lotions, or other skin products directly to the patch or the surrounding skin, as this can compromise adhesion. If skin irritation occurs, patients should contact their healthcare provider.

Troubleshooting Adhesion Issues:

If the patch begins to loosen or fall off, patients are instructed to contact Customer Care. The initial 2-minute firm press during application and the subsequent 2-minute press after label removal are crucial for maximizing adhesion. Proper skin preparation, including shaving and abrasion, also contributes significantly to patch longevity.

Returning the Device:

Upon completion of the monitoring period, the Zio XT Patch (along with the Patient Instructions & Button Press Log) is placed in the original postage-paid box. It can then be dropped off at the Post Office, in a USPS (blue) mailbox, or given to a mail carrier. The "Date Removed" should be written on the cover of the Patient Instructions.

Customer Support:

Customer Care is available 24 hours a day, 7 days a week, for any questions or issues, including if the patch falls off or if the patient has no symptoms during the wear period.

Warnings and Contraindications:

• The Zio XT Patch should not be used on patients with known allergic reactions to adhesives or hydrogels, or those with a family history of adhesive skin allergies.
• It should not be used in combination with external cardiac defibrillators or high-frequency surgical equipment.
• Avoid use near strong magnetic fields or devices such as MRI.
• Do not use on patients with a neuro-stimulator, as it may disrupt ECG data quality.
• The device is not intended for patients who lack the competency to wear it for the prescribed monitoring period.

The Zio XT Patch is a prescription device, and its sale is restricted by Federal (USA) law to or on the order of a physician. This ensures that the device is used under appropriate medical supervision for diagnostic purposes.

Zio XT Specifications

General

Charging Time	4 hours
Timer	2-minute timer with 30-second intervals
Waterproof Rating	IPX7
Battery Type	Lithium-ion
Cleaning Modes	Sensitive
Usage Time per Charge	Up to 30 days