iRhythm Technologies AT18G Zio AT Gateway User Manual 2

iRhythm Technologies, Inc. Zio AT Gateway 2

User Manual 2

CLINICAL REFERENCE MANUAL
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Description ........................................................2
Indications for Use ..................................................3
Contraindications ...................................................3
Warnings ..........................................................4
Package Contents ..................................................6
Device Diagrams ...................................................7
Account Setup ......................................................8
During Patient Visit .................................................8
Registration .....................................................8
Application Instructions .............................................8
During Monitoring ..................................................8
Reports ...........................................................9
Zio AT Reports ...................................................9
Asymptomatic Arrhythmia Detection .................................10
Troubleshooting ...................................................11
Frequently Asked Questions .......................................11
Healthcare Provider Questions .................................11
Patient Questions .............................................12
Troubleshooting the Patch ........................................17
Troubleshooting the Gateway ......................................18
Zio AT Service Notes ...............................................19
 ................................20
Notice of Privacy Practices (NOPP) ...................................21
Cybersecurity Measures and Controls ................................26
 ..............................................27
Electrical Safety and Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Symbols Glossary .................................................35
TABLE OF CONTENTS
iRhythm Technologies, Inc.
650 Townsend Street, Suite 500
San Francisco, CA 94103 USA
Tel. +1.888.693.2401 (USA Only)
Fax. +1.888.693.2402
irhythmtech.com
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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.
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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.
•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 cross contamination.
•Do not use Zio AT system on patients residing in areas with limited to no
cellular reception.
•Do not modify the Zio AT system.
•The Zio AT system is MR Unsafe!
oDo not expose the Zio AT patch or gateway to a magnetic resonance
(MR) environment.
oThe Zio AT patch or gateway may present a risk of projectile injury
due to the presence of ferromagnetic materials that can be attracted
by the MR magnet core.
oThermal injury and burns may occur due to the metal components
of the Zio AT patch that can heat during MR scanning.
oThe Zio AT patch may generate artifacts in the MR image.
oThe Zio AT patch or gateway may not function properly due to the
        
scanner.
If skin irritation such as severe redness, itching or allergic symptoms
develop, remove the Zio AT patch from the patient’s chest. Call
iRhythm Customer Service at 1.888.693.2401
CAUTION: Federal (USA) law restricts this device to sale by or on the
order of a physician.
ELECTRICAL SAFETY COMPATABILITY
•CAUTION: The Zio AT system needs special precautions regarding EMC
and needs to be utilized according to the EMC information provided in the
following tables.
•
medical electrical equipment.
•WARNING: The Zio AT system should not be used adjacent to or stacked
with other equipment.
•WARNING: The Zio AT system may be interfered with by other equipment,
even if that other equipment complies with CISPR EMISSIONS
requirements.
• WARNING: Portable RF communications equipment (including
peripherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to any part of the Zio AT patch or
gateway. Otherwise, degradation of the performance of this equipment
could result.
PRECAUTIONS
•      
form of pacing therapy has not been established. Paced cardiac rhythms

•          
(younger than 18 years old) has not been established.
•The Zio AT system includes temperature and humidity limitations when
stored/transported. If exposed during storage/transport, patients may
experience degradation of adhesive performance causing the Zio AT

•The Zio AT system 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 AT system if package is damaged. Device may not
perform as intended.
•Keep device and packaging away from young children. Contents may
be harmful if swallowed. Patch contains button cell batteries that are
not accessible during normal use but, if exposed, are known choking
hazards and may cause severe tissue injury if ingested.
•Registration errors may result in limited functionality or erroneous
ECG reporting. Utmost caution should be applied to ensure that patient
registration is accurate and complete.
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PACKAGE CONTENTS
1 Zio AT patch
1 Application instructions 1 Important information pamphlet
1 Zio AT gateway, containing:
• 1 postage-paid return envelope
1 Wearing Your Zio manual &
button press log containing:
• 1 adhesive remover wipe
• 1 patient consent form
• 1 patient survey
1 Skin preparation kit containing:
• 1 patch card template
• 1 disposable razor
• 1 abrader disc
• 4 alcohol wipes
DEVICE DIAGRAMS
Outer Border
Adhesive Wings
Electrode Electrode
Light
Zio Patch
Zio Gateway Exterior
Airplane Mode Light
Outside Status Light
Zio Gateway Interior
Airplane Button Star Button Cell Connection Light
Patch Connection Light
Return Envelope
‘Zio’ Button
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ACCOUNT SETUP
            
management system (www.zioreports.com) is assigned to the clinic.
Ensure you can access iRhythm patient management system via provided
username and password. If you are unable to access zioreports.com please
contact iRhythm Customer Service at 1.888.693.2401
DURING PATIENT VISIT
REGISTRATION
Register patient online at www.zioreports.com.
iRhythm may contact the patient if any additional information is required.
APPLICATION INSTRUCTIONS
The Zio AT package contains instructions on how to apply the patch and
activate the patch and gateway.
DURING MONITORING
During monitoring the Zio AT device will record continuous beat to beat ECG
information and transmit patient triggered and asymptomatic ECG to provide
accurate arrhythmia detection.
In special circumstances, when patient data needs to be accessed by the
physician during the wear period, a Device Data Request can be made. In
order to make a Device Data Request, the clinician should call iRhythm at
1.888.693.2401. (Note: Device Data Requests are limited by availability of
remaining battery power and may not be successful late in a monitoring
period.)
REPORTS
ZIO AT REPORTS
All Zio AT Reports will be available in ZioReports.com.
        
       
        

          
        

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ASYMPTOMATIC ARRHYTHMIA DETECTION
Asymptomatic arrhythmia events, as detected and transmitted during the

Rhythm Heart Rate Duration
Atrial Fibrillation
 
 
Pause
-
-
Ventricular
Tachycardia
 
 
Complete Heart Block
(day 05:00~23:00) < 50 bpm 
Complete Heart Block
(night 23:00~05:00) < 47 bpm 
Bradycardia  
Tachycardia  
Sensitivity (%) 
AHA  AHA 
98.80 99.33 99.45 99.43
For each of the arrhythmias listed above, the Zio AT patch will transmit up to
two ECG strips per hour.

TROUBLESHOOTING
FOR CUSTOMER SUPPORT, CALL 1.888.693.2401
FREQUENTLY ASKED QUESTIONS
HEALTHCARE PROVIDER QUESTIONS
1. 
A patient can wear the Zio AT patch for up to 14 days or as prescribed.
Note: The Zio AT patch will not record ECG data after 14 days.
Based on individual wear experiences the patient’s actual wear time may
be shorter than prescribed.
2.             

The patient can read the Wearing your Zio Manual & Button Press Log or
call Customer Service at 1.888.693.2401.
3. 
The Zio AT patch records every heartbeat. It also automatically detects
and transmits asymptomatic arrhythmias, even if the patient does not
feel them.
4. 

The patient only needs to keep the gateway within 10 feet of the patch
and within range of good cellular reception. No action is required for the
gateway to send symptomatic heart rhythm data other than pressing the
Zio button on the patch.
5. Are there tests or treatments that are not compatible with the Zio AT

Yes. The following are not recommended during wear of the Zio AT patch:
a. Magnetic Field(s): Magnetic Resonance Imaging (MRI); MRI
Technician; Any job where the patient may be exposed to a large

b. Neuromuscular Stimulators: Brain Stimulator; Neurostimulator;
Spinal Stimulator; TENS Unit

NOTE: Data may not be interpretable during the time the stimulators are
being used. Usage is at physician’s discretion.
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12 13
6.            

No, the Zio AT patch should be removed if the patient requires

PATIENT QUESTIONS
The Zio AT Monitoring System
7. 
The patch is recording every heartbeat. Your doctor will use the heart
rhythm data from the patch to determine the right course of action.
8. 
The gateway wirelessly sends heart rhythm data recorded by your patch
to iRhythm. iRhythm analyzes the data and provides a report to your
doctor.
9. 
     
devices are working. When they are working normally, the patch and

10. 

No. If the Zio AT patch is over the heart in a
slight diagonal as shown, the positioning
should be acceptable.
DO NOT attempt to reapply the Zio AT patch.
11. 

The top label may have separated. Peel the remaining white labels from
the center of the Zio AT patch outward.
12. 

Do your best to keep the gateway in front of you and within 10 feet as
much as possible. The gateway should also be kept in a place with good
cellular connection.
13. 
Yes. However, the gateway will need to be in front of your body and within
10 feet of the patch. You may also use the provided belt clip to carry the
gateway.
14.          

Wireless devices that use 2.4 GHz signals such as baby monitors, TV
senders, and wireless routers can interrupt communication between
the patch and gateway if used within 6 feet. Objects placed inside the
gateway can also cause communication problems.
Activities
15. 
Yes, you may exercise moderately, but excessive sweating may shorten
wear time.
16. 
After 24 hours following application, you may take brief showers.
Try to keep your back faced toward the shower. Hold the patch down
while towel drying to prevent accidental removal. Avoid getting the
gateway wet.
17. 
Yes, but keep the patch above water. Keep the gateway away from all
water.
18. 
No. The patch should not be submerged under water. Keep the gateway
away from all water.
19. 
Yes. If questioned during airport security screening, show the statement
in the Traveling section. Note that the gateway will not have cellular
connection outside the United States.
20. 
Yes, the gateway should be placed in “airplane mode.” See Traveling
section.
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14 15
21. 
Avoid activities that cause heavy sweating. Sweat can cause the patch to

water should also be avoided.

22. 
First, press the button on your patch. Then enter your symptoms in the
     
Press Log in this manual. Please choose only one option for recording
your symptoms.
23. 
The patch will still record your heartbeat and the gateway will send any
information that is important for your doctor to know.
24. 
Recording your symptoms and activity gives your physician additional
information about what may have caused the symptom. While this is
useful, it is most important to press the button.
25. 

The patch will store the data until the gateway is in range, then the data
will be sent.
26.            

The gateway will store the data until it has cell signal, then the data will
be sent.
The Patch
27. 
Press evenly on the wings of the patch for 3 to 5 minutes to re-stick.
28. 
Call Customer Service at 1.888.693.2401.
29. 
Call Customer Service at 1.888.693.2401. It is probably due to a small
shaving cut when the patch was applied to your chest.
30. 
Yes. The patch may move slightly from its original position. A blue gel
may be seen under the wings of the patch.
31. 
Yes. The patch may move slightly from its original position. A blue gel
may be seen under the wings of the patch.
32. 

Many patients do not experience skin irritation or itchiness. However,
some patients report minor skin irritation and/or itching while
wearing the patch. If the irritation or itching is severe or hives or
blisters develop, remove the patch and then call Customer Service
at 1.888.693.2401.
Flashing Lights
33. 

noise.
34. 
If you see the patch flashing orange, this does not mean there is
a problem with your heart; it just means that the patch is not well
attached. Press evenly on the wings of the patch for 3 to 5 minutes.
If the flashing continues or comes back, call Customer Service at
1.888.693.2401
35. 
          
problem with your heart; it just means that the patch cannot send
information wirelessly. Turn to Troubleshooting or call Customer Service
at 1.888.693.2401.
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com
16 17

36. 
Wear the patch for as long as your doctor prescribed but no longer than
          
wear time may be shorter than prescribed.
37. 


TROUBLESHOOTING THE PATCH
SLOW FLASHING (once every 3 seconds):
 that the patch is not making good contact.
, press evenly on the wings of the patch for 3 to 5 minutes.
, call Customer Service at 1.888.693.2401.
FAST FLASHING (3 times per second):
 that the patch is not recording. Call Customer Service at
1.888.693.2401.
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com
18 19
TROUBLESHOOTING THE GATEWAY
SLOW (SQUARE) FLASHING (once every 3 seconds):
that the gateway has lost connection to the patch.
   hold the star button for 3 seconds until the orange
            
connection to the Patch.
, call Customer Service at 1.888.693.2401.
SLOW (TRIANGLE) FLASHING (once every 3 seconds):
that the gateway does not have cell signal.
move the gateway to a place with a good cell signal (near
a window or outside) and hold the star button for 3 seconds until the
orange light stays on.



, call Customer Support at 1.888.693.2401.
FAST (SQUARE) OR (TRIANGLE) FLASHING (3 times per second):
Indicates that the gateway is not working. Call Customer Support at
1.888.693.2401.
Situation Note
myZio Registration –
Patient Enrollment
In order for a patient to register with myZio they must
rst be enrolled by the clinic in www.zioreports.com. In
the event that the patient attempts to register prior to
completion of enrollment by the clinic they will receive
a notication indicating “This Zio patch is currently not
available for use. Please call Customer Service at
1.888.693.2401.”, until enrollment has been completed.
(SYS-2281)
Patient Timeline –
Paper Booklet Diary
Entries
For patients with the Zio AT Patch, ZioReports provides
a timeline screen that displays along with Transmission,
DDR, Daily, and Final reports, patient provided diary entries.
For each diary entry the date and time of the symptom
reported is displayed. In the event that a patient does not
provide the date/time for a symptom on the paper booklet,
the timeline will display a date with a year starting in 3000.
Dates that have a year of 3000 or greater indicate that
the patient did not provide the timestamp of the symptom
experienced.
(SYS-2315)
ZIO AT SERVICE NOTES
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com
20 21
IRHYTHM CLINICAL FACILITY CERTIFICATION
The Zio AT monitoring system is analyzed at the iRhythm Clinical Center.
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.
NOTICE OF PRIVACY PRACTICES (NOPP)
iRhythm is committed to protecting the privacy of your personal information.
We are required by the U.S. - EU Safe Harbor Framework to maintain the
privacy of your personal information, and to notify you of our privacy practices,
our legal duties, and your rights concerning your personal information.
Why?
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"). This notice describes our privacy practices, our legal duties, and
your rights concerning your PHI. We will follow the privacy practices
described in this notice while it is in eect. We reserve the right to revise
this notice and to make the new notice provisions eective for all PHI we
maintain. If we revise this notice, we will post the revised notice on this
page.
Why?
In providing diagnostic services, the types of information we collect may
include:
- Name
- Gender
- Date of Birth
- Medicare and Secondary Insurance Information
- Address and Phone Number
- Prescribing Physician and Oce
- Primary Indication
- ECG Recording
- Symptoms and Activities You Report, by Time and Date
- Activity Level During Monitoring
- Patient Identication Number
- Clinical Information and Diagnostic Results
How?
By providing diagnostic services to our patients, we regularly collect
information through:
- Phone conversations
- Patient submitted documents
- Prescribing physician submitted documents
- ZioEvent card transmissions
- Return of Zio XT or Zio AT Patches

We have the right to use and disclose health information for your treatment, to secure
payment for your health care, and to operate our business.
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com
22 23

Does
iRhythm

Can You
Limit
This

To You We must disclose your PHI to you, as described
in the "Your Rights" section of this notice. Yes Yes
For Payment
We may use and disclose PHI to obtain payment
for services provided to you. We may also
disclose your PHI to a health care provider or
health plan so that the provider or plan may
obtain payment of a claim or engage in other
payment activities.
Yes Yes
For Treatment
We may use and disclose PHI to provide and
manage your diagnostic services. That may
include consulting with other health care
providers about your diagnostic services.
For example, we will release the results of
your diagnostic services to your prescribing
physician, to the physician treating you, or in a
medical emergency, if applicable.
Yes No
For Health Care
Operations
We may use or disclose PHI to conduct quality
assessment and improvement activities,
to conduct fraud and abuse investigations,
to engage in care coordination or case
management, or to communicate with you
about health related benets and services or
treatment alternatives that may be of interest
to you. We may also disclose PHI to a health
care provider or health plan subject to federal
privacy laws, as long as the provider or plan
has or had a relationship with you and the
PHI is disclosed only for certain health care
operations of that provider or plan. We may
also disclose PHI to other entities with which
we have contracted to perform or provide
certain services on our behalf (e.g.,business
associates).
Yes No

Does
iRhythm

Can You
Limit
This

For Business
Operations
We may use both De-Identied and Limited
Data Sets (a data set that, per the Health
Insurance Portability and Accountability Act of
1996 regulations, has had patient-identiable
data removed except for dates of service) for
development of future products, devices or
services. 
Once information is De-Identied through
an approved method, the data is stripped of
individual identiers, at which point iRhythm
may share this information without restriction
externally to support research, market
development, trend analysis, etc.
Information containing Limited Data Sets may
be provided externally to support market and
product development. However, iRhythm will
obtain the required data use agreements when
transferring Limited Data Sets to external
parties.
Yes Yes
For Public
Health And
Safety
We may use or disclose PHI to the extent
necessary to avert a serious and imminent
threat to the health or safety of you or others.
We may also disclose PHI for public health and
government health care oversight activities and
to report suspected abuse, neglect or domestic
violence to government authorities.
Yes No
As Required By
Law
We may use or disclose PHI when we are
required to do so by law. Yes No
For Process
And
Proceedings
We may disclose PHI in response to a court
or administrative order, subpoena, discovery
request, or other lawful process.
Yes No
For Law
Enforcement
We may disclose PHI to a law enforcement
ocial with regard to crime victims and
criminal activities.
Yes No
Special
Government
Functions
We may disclose the PHI of military personnel
or inmates or other persons in lawful custody
under certain circumstances. We may disclose
PHI to authorized federal ocials for lawful
national security activities.
Yes No
For Research,
Death, And
Organ Donation
We may use or disclose PHI in certain
circumstances related to research, death or
organ donation.
Yes No
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com
24 25

Does
iRhythm

Can You
Limit
This

For Workers'
Compensation
We may disclose PHI as permitted by workers'
compensation and similar laws. Yes No

Does
iRhythm

Can You
Limit
This

You may give us written authorization to use your PHI or disclose it
to anyone for any purpose not otherwise permitted or required by
law. If you give us such authorization, you may revoke it in writing
at any time. Your revocation will not aect any use or disclosure
permitted by your authorization while it was in eect.
Yes Yes
While the law permits us in certain circumstances to disclose
your PHI to family, friends and others, we will do so only with
your authorization. In the event you are unable to authorize such
disclosure, but emergency or similar circumstances indicate that
disclosure would be in your best interest, we may disclose your PHI
to family, friends or others to the extent necessary to help with your
health care coverage arrangements.
Yes Yes
Your Rights
Access
With limited exceptions, you have the right to review in person, or
obtain copies of, your PHI. We may charge you a reasonable fee as
allowed by law to obtain this information.
Amendment With limited exceptions, you have the right to request that we amend
your PHI.
Disclosure
Accounting
You have the right to request and receive a list of certain disclosures
made of your PHI. If you request this list more than once in a
12-month period, we may charge you a reasonable fee as allowed by
law to respond to any additional request.
Use/Disclosure
Restriction
You have the right to request that we restrict our use or disclosure
of your PHI for certain purposes. We are not required to agree to a
requested restriction. We will agree to restrict use or disclosure of
your PHI provided that the law allows and we determine the restriction
does not impact our ability to operate our business, provide diagnostic
services, and comply with the law. Even when we agree to a restriction
request, we may still disclose your PHI in a medical emergency and
use or disclose your PHI for public health and safety and other similar
public benet purposes permitted or required by law.
Condential
Communication
You have the right to request that we communicate with you in
condence about your PHI at an alternative address.
Privacy Notice
You have the right to request and receive a copy of this notice at any
time. For more information or if you have questions about this notice,
please contact us using the information listed at the end of this notice.

If you are concerned that we may have violated your privacy rights, you may inquire with us
using the contact information listed at the end of this notice. You may also submit a written
complaint to the U.S. Department of Health and Human Services. We will provide you with
the address for the U.S. Department of Health and Human Services upon request.
To Limit Our
Sharing Or Submit
Complaints
Call 1.888.693.2401 - our Customer Service sta will assist you
Questions? Call 1.888.693.2401
Who We Are
Who Is Providing
This Notice?
This privacy notice is being provided by iRhythm Technologies, Inc.,
and applies to the diagnostic services oered in connection with
prescribed health care.
What We Do
How Does iRhythm
Protect My PHI?
To protect your PHI from unauthorized access and use, iRhythm has
implemented security safeguards that comply with federal law to
secure physical and electronic information.
Company Contact Details
Address:
iRhythm Technologies, Inc.
650 Townsend Street
Suite 500
San Francisco, CA 94103
Attn: Privacy Ocial
www.irhythmtech.com
Phone: 415.632.5700
Fax: 415.632.5701
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com
26 27
CYBERSECURITY MEASURES AND CONTROLS
As a connected medical device, the Zio AT patch was developed with careful
consideration of cybersecurity risks and their compensating controls. Key
measures include manufacturing steps to exclusively pair one AT patch
with one Gateway, thus preventing Bluetooth communication with any other
         
devices. Similarly, encryption of all cellular communication between the

iRhythm regularly evaluates the integrity of our cloud-based infrastructure
through both vulnerability and penetration testing of all internet-accessible
servers. Industry-standard encryption is employed for all data transfers to,
from and within the Cloud, and for protecting data at rest.
Patient data is protected during wear through use of proprietary data storage
formats and access methods, and physically protected data ports. Once
returned to iRhythm for processing, data integrity checks are used to ensure
the integrity of all recorded data.
DEVICE SPECIFICATIONS
PATCH PERFORMANCE CHARACTERISTICS
ECG Channels 1 channel
Memory capacity 14 days
Recording Format Continuous
Service Life Up to 14 days
Shelf Life 2 months
ELECTRICAL CHARACTERISTICS
Medical Equipment Type BF Applied Part
ECG Frequency Response 0.5Hz to 30Hz
ECG Input Impedance 
 ±1.65 mV
ECG A/D Sampling Rate 200 Hz
ECG Resolution 10 bits
Patch Short-range RF Transmit/
Receive
2.4 GHz Bluetooth Low Energy

Frequency Band of Transmission 2.4 GHz
Bandwidth of the Receiver 2400-2480 MHz
Type and Frequency of Modulation 1-Mbps GFSK
Gateway Short-range RF Transmit/
Receive
2.4 GHz Bluetooth Low Energy

Gateway Cellular RF Transmit/
Receive
800 / 1900 MHz CDMA

< 200 mW
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POWER CHARACTERISTICS
Patch Battery Type 2 Lithium Manganese Dioxide Coin
Cells
Gateway Battery Type 1 Lithium Polymer Cell
Battery Life Continuous
Service Life 14 days
PHYSICAL CHARACTERISTICS
Patch Dimensions 5.2 x 2.0 x 0.5 inches
Patch Weight 24.7 g
Gateway Dimensions 6.2 x 3.4 x 0.8 inches
Gateway Weight 158 g
ENVIRONMENTAL CHARACTERISTICS
Operational Temperature 41 to 104 degrees
Operational Altitude -1,000 to 10,000 ft
Operational & Storage Humidity 10% to 95% (non-condensing)
Shipping (Short-term Storage) -4 to 104 degrees F
Temperature
Long-term Storage Temperature 55 to 85 degrees F
Storage Altitude -1,000 to 14,000 ft
 IP24
 IP22
ESSENTIAL PERFORMANCE
The Zio AT device records and transmits ECG for analysis after receipt of
data. In the event it cannot record or transmit in a timely fashion, the Zio AT
alerts the patient that functionality is impaired.
HEART RATE CALCULATIONS
Episode Heart Rates
Max The maximum episode heart rate (i.e., maximum
of all instantaneous heart rates within the episode)
Min The minimum episode heart rate (i.e., minimum of
all instantaneous heart rates within the episode)
Avg The average episode heart rate (i.e., average of all
instantaneous heart rates within the episode)
Overall Rhythm Heart
Rates
Max
The maximum overall heart rate (i.e., maximum of
all rhythm episode maximum heart rates within
the record)
Min
The minimum overall heart rate (i.e., minimum of
all rhythm episode minimum heart rates exclusive
of Pause heart rates within the record)
Avg
The average overall heart rate (i.e., duration-
weighted average of all rhythm episode heart
rates within the record)
PAUSE DETERMINATION
ned as an RR interval greater than 3 seconds.
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ELECTRICAL SAFETY AND COMPATIBILITY
•CAUTION: The Zio AT system needs special precautions regarding EMC
and needs to be utilized according to the EMC information provided in the
following tables.
•
medical electrical equipment.
•WARNING: The Zio AT system should not be used adjacent to or stacked
with other equipment.
•WARNING: The Zio AT system may be interfered with by other equipment,
even if that other equipment complies with CISPR EMISSIONS
requirements.
• WARNING: Portable RF communications equipment (including
peripherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to any part of the Zio AT patch or
gateway. Otherwise, degradation of the performance of this equipment
could result.

The Zio AT system is intended for use in the electromagnetic environment specied below.
The customer or the user of the Zio AT system should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1
The Zio AT system uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11 Class B
The Zio AT system is suitable for use in
all establishments, including domestic
establishments.
Harmonic emissions
IEC 61000-3-2 Not applicable Not applicable
Voltage uctuations/
icker emissions IEC
61000-3-3
Not applicable Not applicable

The Zio AT system is intended for use in the electromagnetic environment specied below.
The customer or the user of the Zio AT system should assure that it is used in such an
environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic environment -
guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete,
or ceramic tile. If oors are
covered with synthetic material,
the relative humidity should be at
least 30 %.w
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic elds
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.
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
The Zio AT system is intended for use in the electromagnetic environment specied below.
The customer or the user of the Zio AT system should assure that it is used in such an
environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic environment -
guidance
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.7
GHz
28 V/m
385, 450, 810,
870, 930 MHz
18 Hz pulse
9 V/m
710, 745,
780 MHz
217 Hz pulse
28 V/m
1720, 1845,
1970,
2450 MHz
217 Hz pulse
9 V/m
5240, 5500,
5783 MHz
217 Hz pulse
10 V/m
28 V/m
9 V/m
28 V/m
9 V/m
Portable and mobile RF
communications equipment should
be used no closer to any part of the
Zio AT system , including cables,
than the recommended separation
distance calculated from the
equation applicable to the frequency
of the transmitter.
Recommended separation distance
d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.5 GHz
where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m).
Field strengths from xed RF
transmitters, as determined by an
electromagnetic site survey,a should
be less than the compliance level in
each frequency range.b
Interference may occur in the
vicinity of equipment marked with
the following symbol:

NOTE 1—At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2—These guidelines may not apply in all situations. Electromagnetic propagation is
aected by absorption and reection from structures, objects, and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to xed RF transmitters, an electromagnetic site survey should be
considered. If the measured eld strength in the location in which the Zio AT system
is used exceeds the applicable RF compliance level above, the Zio AT system should
be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Zio AT patch or
gateway.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
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

The Zio AT system is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the Zio AT system can help
prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the Zio AT system
as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to
80 MHz 80 MHz to 800 MHz 80 MHz to
2.5 GHz
d = 1.2√P d = 1.2√P d = 2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be determined using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1—At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2—These guidelines may not apply in all situations. Electromagnetic propagation is
aected by absorption and reection from structures, objects, and people.
• This system complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This system may not cause harmful interference, and (2) this device must
accept any interference received, including interference that may cause undesired operation.
• For body worn operation, this system has been tested and meets FCC RF exposure guidelines
when used with an accessory that contains no metal, such as the belt clip provided, and that
positions the Gateway a minimum 1 cm from the body. Use of other accessories may not
ensurecompliance with FCC RF exposure guidelines.
• Changes or modications not expressly approved by the party responsible for compliance
could void the user's authority to operate the equipment.
• The gateway has been tested and meets FCC RF exposure guidelines when used and
operated for its intended purpose and as instructed in the manual.
SYMBOL STANDARD
REFERENCE STANDARD TITLE SYMBOL TITLE
DESCRIPTION /
EXPLANATORY
TEXT
ISO 15223-1
Clause 5.1.1
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Manufacturer
Indicates the
medical device
manufacturer.
ISO 7000-3082 Graphical symbols for
use on equipment
ISO 15223-1
Clause 5.1.3
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Date of
manufacture
Indicates the date
when the medical
device was
manufactured
ISO 7000-2497 Graphical symbols for
use on equipment
ISO 15223-1
Clause 5.1.4
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Use-by date
Indicates the date
after which the
medical device is
not to be used.
ISO 7000-2607 Graphical symbols for
use on equipment
ISO 15223-1
Clause 5.1.5
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Batch code
Indicates the
manufacturer’s
batch code so
that the batch
or lot can be
identied.
ISO 7000-2492 Graphical symbols for
use on equipment
ISO 15223-1
Clause 5.1.6
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Catalogue
number
Indicates the
manufacturer’s
catalogue
number so that
the medical
device can be
identied.
ISO 7000-2493 Graphical symbols for
use on equipment
SYMBOLS GLOSSARY
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36 37
SYMBOL STANDARD
REFERENCE STANDARD TITLE SYMBOL TITLE
DESCRIPTION /
EXPLANATORY
TEXT
ISO 15223-1
Clause 5.1.7
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Serial number
Indicates the
manufacturer’s
serial number
so that a
specic medical
device can be
identied.
ISO 7000-2498 Graphical symbols for
use on equipment
ISO 15223-1
Clause 5.3.4
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Keep dry
Indicates a
medical device
that needs to be
protected from
moisture.
ISO 7000-0626 Graphical symbols for
use on equipment
ISO 15223-1
Clause 5.3.7
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Temperature
limit
Indicates the
temperature
limits to which
the medical
device can be
safely exposed.
ISO 7000-0632 Graphical symbols for
use on equipment
ISO 15223-1
Clause 5.3.8
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Humidity
limitation
Indicates
the range of
humidity to
which the
medical device
can be safely
exposed.
ISO 7000-2620 Graphical symbols for
use on equipment
ISO 15223-1
Clause 5.4.2
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Do not re-use
Indicates a
medical device
that is intended
for one use, or
for use on a
single patient
during a single
procedure.
ISO 7000-1051 Graphical symbols for
use on equipment
SYMBOL STANDARD
REFERENCE STANDARD TITLE SYMBOL TITLE
DESCRIPTION /
EXPLANATORY
TEXT
ISO 15223-1
Clause 5.4.3
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied Consult
instructions
for use
Indicates the
need for the
user to consult
the instructions
for use.
ISO 7000-1641 Graphical symbols for
use on equipment
IEC 60601-
1 Table D.1,
Symbol 11
Medical electrical
equipment — Part 1:
General requirements
for basic safety and
essential performance
ISO 15223-1
Clause 5.4.4
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Caution
Indicates the
need for the
user to consult
the instructions
for use for
important
cautionary
information
such as
warnings and
precautions
that cannot,
for a variety
of reasons, be
presented on
the medical
device itself.
of reasons, be
presented on
the medical
device itself.
ISO 7000-0434 Graphical symbols for
use on equipment
IEC 60601-
1 Table D.1,
Symbol 10
Medical electrical
equipment — Part 1:
General requirements
for basic safety and
essential performance
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SYMBOL STANDARD
REFERENCE STANDARD TITLE SYMBOL TITLE
DESCRIPTION /
EXPLANATORY
TEXT
BS EN
50419:2006
Marking of electrical
and electronic
equipment in
accordance with
article 11(2) of
Directive 2002/96/EC
(WEEE)
Separate
Collection
To indicate
that the
product shall
be separated
when
disposed.
IEC 60417-5140 Graphical symbols for
use on equipment
Non-ionizing
electromagnetic
radiation
To indicate
generally
elevated,
potentially
hazardous,
levels of
nonionizing
radiation, or
to indicate
equipment or
systems e.g.
in the medical
electrical area
that include RF
transmitters
or that
intentionally
apply RF
IEC 60601-1-
2:2007, Clause
5.1.1
Medical electrical
equipment — Part 1-2:
General requirements
for basic safety and
essential performance
— Collateral standard:
Electromagnetic
compatibility —
Requirements and
tests
IEC 60417-5333 Graphical symbols for
use on equipment
Type BF Applied
Part
To identify
a type BF
applied part
complying
with IEC
60601-1.
IEC 60601-
1, Table D.1,
Symbol 20
Medical electrical
equipment — Part 1:
General requirements
for basic safety and
essential performance
ASTM F2503-13
Standard Practice
for Marking Medical
Devices and Other
Items for Safety in the
Magnetic Resonance
Environment
Magnetic
Resonance (MR)
unsafe
Keep away
from magnetic
resonance
imaging (MRI)
equipment.
SYMBOL STANDARD
REFERENCE STANDARD TITLE SYMBOL TITLE
DESCRIPTION /
EXPLANATORY
TEXT
IEC 60601-
1, Table D.3
Symbol 2
IEC 60529
Medical electrical
equipment — Part 1:
General requirements
for basic safety and
essential performance
Degrees of Protection
Provided by
Enclosures (IP Code)
Degrees of
protection
provided by
enclosure
Manufacturer-
determined
degree of
particle and
water ingress
protection,
where:
N1 = Degrees
of protection
against access
to hazardous
parts N2 =
Degrees of
protection
against water
Protected
against solid
foreign objects
of 12,5 mm
diameter and
greater, and
protected
against
splashing
water
Protected
against solid
foreign objects
of 12,5 mm
diameter
and greater,
and protected
against
vertically
falling water
drops when
enclosure
tilted up to 15°
21 CFR 801.15(c)
(1)(i)F
Labeling-Medical
devices; prominence
of required label
statements
Prescription
only
Requires
prescription
in the United
States
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iRhythm Technologies, Inc.
650 Townsend St., Suite 500
San Francisco, CA 94103 USA
1.888.693.2401
irhythmtech.com
ALB0031.01 • 2018-04-11

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