iRhythm Technologies Inc. AT18G User Manual
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ABOUT THE ZIO AT
Zio AT data analysis
Your Zio AT data is analyzed at the iRhythm Clinical Centers.
iRhythm is an Independent Diagnostic Testing Facility (IDTF)
dedicated to providing world-class diagnostic service. As an
IDTF, we adhere to Medicare Independent Diagnostic Testing
Facility Performance Standards.
iRhythm is an Independent Diagnostic Testing Facility (IDTF)
dedicated to providing world-class diagnostic service. As an
IDTF, we adhere to Medicare Independent Diagnostic Testing
Facility Performance Standards.
A link to these standards (42 C.F.R. Section 410.33) can be
found at the iRhythm website www.irhythmtech.com.
found at the iRhythm website www.irhythmtech.com.
Patient identification
Before placing your device in the prepaid envelope, please
write your name on the line above the return address. By
writing your name on the envelope you are providing another
method of identification for the Patch and Gateway and are
consenting to the potential viewing of your name on the
envelope. You may choose to not write your name on the
envelope.
write your name on the line above the return address. By
writing your name on the envelope you are providing another
method of identification for the Patch and Gateway and are
consenting to the potential viewing of your name on the
envelope. You may choose to not write your name on the
envelope.
Notice of privacy practices
As participants in your health care, we are required by
applicable federal and state law to maintain the privacy of
your Protected Health Information (PHI).
applicable federal and state law to maintain the privacy of
your Protected Health Information (PHI).
Our full Notice of Privacy Practices, found at www.irhythmtech.
com, describes our privacy practices, our legal duties, and
your rights concerning your PHI.
com, describes our privacy practices, our legal duties, and
your rights concerning your PHI.
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
reporting. After wear, a final report is generated based on
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
reporting. After wear, a final report is generated based on
beat-to-beat information from the entire ECG recording. It is
indicated for use on patients 18 years or 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. 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.
indicated for use on patients 18 years or 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. 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.
immediate danger to the patient or when real-time or in-
patient monitoring should be prescribed.
• Do not use the Zio AT for patients with known history of
life threatening arrhythmias.
• Do not use the Zio AT in combination with external cardiac
defibrillators or high frequency surgical equipment near
strong magnetic fields or devices such as MRI.
strong magnetic fields or devices such as MRI.
• Do not use the Zio AT on patients with neuro-stimulator,
as it may disrupt the quality of ECG data.
• Do not use the Zio AT on patients who do not have the
competency to wear the device for the prescribed
monitoring period.
monitoring period.
Warnings
• Do not use the Zio AT Patch on patients with known
allergic reaction to adhesives or hydrogels or with family
history of adhesive skin allergies. Patient may experience
skin irritation.
history of adhesive skin allergies. Patient may experience
skin irritation.
• Do not reuse the Zio AT Patch on multiple patients. It is
a single patient use device. Reuse will cause incorrect
patient data and patient may experience skin irritation.
patient data and patient may experience skin irritation.
• Do not use the Zio AT on patients residing in areas with
limited to no cellular reception.
• Do not modify the Zio AT system.