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DESCRIPTION
The Zio AT connected continuous ambulatory monitoring system (“Zio AT
system”) is an electrocardiogram (ECG) monitoring system. It consists of four
components: (1) Zio AT patch ECG monitor that records continuously through
the entire wear period, (2) Zio AT wireless gateway that provides connectivity
between the patch and the iRhythm monitoring center, (3) Zio arrhythmia
detection algorithm and (4) ZioReports.com clinician portal.
The Zio AT system is a single-patient-use ECG monitor that provides a
continuous, single-channel recording in addition to symptomatic and
asymptomatic data transmission for up to 14 days. The Zio AT patch is
applied and activated by the patient. Once activated, the patch records ECG
without patient interaction, with the goal of improving patient compliance
via simplicity of operation. The Zio AT patch, in conjunction with the wireless
gateway and the Zio arrhythmia detection algorithm, has arrhythmia auto-
detection capabilities. Additionally, patients have the option of pressing a
convenient trigger button which marks the continuous record and initiates
a wireless transfer of a 90 second ECG strip. The wireless transfer of data
is enabled by the Zio AT gateway, which requires proximity and reception
but no patient interaction to transmit to the monitoring center. The patient is
encouraged to document symptomatic events, which will support symptom-
rhythm correlation in the Zio AT reports.
At the conclusion of the wear period (up to 14 days), the patient removes the
Zio AT patch and returns it, along with the gateway, by mail to an iRhythm
data processing center.
Upon receipt of symptomatic/asymptomatic transmissions or downloaded
continuous ECG data at iRhythm’s Clinical Center (iCC), the data is processed
Technician (CCT) reviews the results and generates a report.
Upon explicit request from a clinician responsible for the patient’s healthcare,
segments of ECG data from the continuous recording on the patch can also be
wirelessly retrieved during the wear period.
INDICATIONS FOR USE
The Zio AT ECG monitoring system is intended to capture, analyze and
report symptomatic and asymptomatic cardiac events and continuous
electrocardiogram (ECG) information for long-term monitoring. While
continuously recording patient ECG, both patient-triggered and automatically
detected arrhythmia events are transmitted to a monitoring center for
information from the entire ECG recording. It is indicated for use on patients
transient symptoms such as palpitations, shortness of breath, dizziness,
light-headedness, pre-syncope, syncope, fatigue, or anxiety. The reports are
provided for review by the intended user to render a diagnosis based on
clinical judgment and experience. It is not intended for use on critical care
patients.
CONTRAINDICATIONS
•Do not use Zio AT 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 Zio AT for patients with known history of life threatening
arrhythmias.
•
devices such as MRI.
•Do not use Zio AT on patients with a neuro-stimulator, as it may disrupt
the quality of ECG data.
•Do not use Zio AT on patients who do not have the competency to wear
the device for the prescribed monitoring period.
