iRhythm Technologies AT18G Zio AT Gateway User Manual 2

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Document Description	User Manual 2
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Date Submitted	2018-06-04 00:00:00
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C LIN ICA L REFERENCE M AN UAL
TABLE OF CONTENTS
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
iRhythm Clinical Facility Certification .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 20
Notice of Privacy Practices (NOPP). .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 21
Cybersecurity Measures and Controls. .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 26
Device Specifications .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 27
Electrical Safety and Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Symbols Glossary .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 35
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
1.888.693.2401 • zioreports.com
DESCRIPTION
INDICATIONS FOR USE
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 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 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.
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 autodetection 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 symptomrhythm 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
by iRhythm’s proprietary algorithm before an iRhythm Certified Cardiographic
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.
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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.
•• Do not use Zio AT in combination with external cardiac defibrillators
or high frequency surgical equipment near strong magnetic fields or
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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•• CAUTION: Portable and mobile RF communications equipment can affect
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
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,
use device. Reuse will cause incorrect patient data and patient may
experience cross contamination.
even if that other equipment complies with CISPR EMISSIONS
requirements.
•• Do not use Zio AT system on patients residing in areas with limited to no
•• WARNING: Portable RF communications equipment (including
cellular reception.
•• Do not modify the Zio AT system.
•• The Zio AT system is MR Unsafe!
oo
Do not expose the Zio AT patch or gateway to a magnetic resonance
(MR) environment.
oo
The 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.
oo
Thermal injury and burns may occur due to the metal components
of the Zio AT patch that can heat during MR scanning.
oo
The Zio AT patch may generate artifacts in the MR image.
oo
The Zio AT patch or gateway may not function properly due to the
strong magnetic and radio-frequency fields generated by the MR
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
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
•• Safety and effectiveness of the Zio AT Patch 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.
•• Safety and effectiveness of the Zio AT system on pediatric patients
(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
patch to slip or fall off during the patient wear duration.
•• 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.
•• CAUTION: The Zio AT system needs special precautions regarding EMC
•• Registration errors may result in limited functionality or erroneous
and needs to be utilized according to the EMC information provided in the
following tables.
ECG reporting. Utmost caution should be applied to ensure that patient
registration is accurate and complete.
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1.888.693.2401 • zioreports.com
PACKAGE CONTENTS
DEVICE DIAGRAMS
Zio Patch
1 Zio AT gateway, containing:
• 1 postage-paid return envelope
1 Zio AT patch
Outer Border
Adhesive Wings
Light
Electrode
Electrode
‘Zio’ Button
1 Skin preparation kit containing:
• 1 patch card template
• 1 disposable razor
• 1 abrader disc
• 4 alcohol wipes
1 Application instructions
Zio Gateway Exterior
Airplane Mode Light
Outside Status Light
1 Important information pamphlet
Zio Gateway Interior
Airplane Button
Star Button
Cell Connection Light
Patch Connection Light
1 Wearing Your Zio manual &
button press log containing:
• 1 adhesive remover wipe
• 1 patient consent form
• 1 patient survey
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Return Envelope
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ACCOUNT SETUP
REPORTS
To allow effective use of the Zio system, an account on iRhythm’s patient
management system (www.zioreports.com) is assigned to the clinic.
ZIO AT REPORTS
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
All Zio AT Reports will be available in ZioReports.com.
Note: Transmission time may vary significantly depending on how
effectively the patient maintains patch-gateway proximity and gateway
cellular reception. Transmission reports will be provided after iRhythm
receipt and analysis of ECG strips.
This device is not intended for use in critical care patients
because the reporting timeliness is not consistent with lifethreatening arrhythmias such as ventricular fibrillation.
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.)
1.888.693.2401 • zioreports.com
1.888.693.2401 • zioreports.com
ASYMPTOMATIC ARRHYTHMIA DETECTION
TROUBLESHOOTING
Asymptomatic arrhythmia events, as detected and transmitted during the
monitoring period, are defined by the following parameters:
FOR CUSTOMER SUPPORT, CALL 1.888.693.2401
Rhythm
Heart Rate
Duration
HEALTHCARE PROVIDER QUESTIONS
≤40 bpm
≥60 seconds
1. How long is the patient supposed to wear the Zio AT patch?
≥180 bpm
≥60 seconds
≥4 seconds
≥3 seconds back-to-back
≥ 120 bpm
≥ 30 seconds
≥150 bpm
≥15 seconds
Atrial Fibrillation
Pause
Ventricular
Tachycardia
FREQUENTLY ASKED QUESTIONS
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. Who should the patient call if they have questions about the Zio AT
patch or gateway?
The patient can read the Wearing your Zio Manual & Button Press Log or
call Customer Service at 1.888.693.2401.
3. What if the patient does not have symptoms?
Complete Heart Block
(day 05:00~23:00)
< 50 bpm
≥6 beats
Complete Heart Block
(night 23:00~05:00)
< 47 bpm
≥6 beats
Bradycardia
≤30 bpm
≥60 seconds
Tachycardia
≥ 200 bpm
≥ 60 seconds
Sensitivity (%) 1
The Zio AT patch records every heartbeat. It also automatically detects
and transmits asymptomatic arrhythmias, even if the patient does not
feel them.
4. Does the patient need to do anything with the Zio gateway to send heart
rhythm data wirelessly?
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.
Positive Predictivity (%) 1
AHA
MIT-BIH
AHA
MIT-BIH
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.
5. Are there tests or treatments that are not compatible with the Zio AT
patch?
Yes. The following are not recommended during wear of the Zio AT patch:
a. M
 agnetic Field(s): Magnetic Resonance Imaging (MRI); MRI
Technician; Any job where the patient may be exposed to a large
magnetic field
b. N
 euromuscular Stimulators: Brain Stimulator; Neurostimulator;
Spinal Stimulator; TENS Unit
c. External Cardioversion/Defibrillation
REP543.B (On file at iRhythm Technologies, Inc.)
10
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NOTE: Data may not be interpretable during the time the stimulators are
being used. Usage is at physician’s discretion.
1.888.693.2401 • zioreports.com
11
6. Can the Zio AT patch be left on a patient during Cardioversion/
Defibrillation?
No, the Zio AT patch should be removed if the patient requires
Cardioversion or Defibrillation.
PATIENT QUESTIONS
The Zio AT Monitoring System
7. What is the patch doing?
13. Can I carry the gateway in a purse, bag or pocket?
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. What can affect wireless connection between the patch and the
gateway?
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.
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. What is the gateway doing?
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. How do I know the patch and the gateway are working?
If you saw green flashes after turning on the patch and gateway, both
devices are working. When they are working normally, the patch and
gateway do not flash or make noise.
10. I think I placed the Zio AT patch in the wrong
position. Can I remove it and reposition it?
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 was peeled off, but there still seems to be a white label
stuck to the wings of the Zio AT patch.
The top label may have separated. Peel the remaining white labels from
the center of the Zio AT patch outward.
12. Do I need to do anything after pressing the patch button to send heart
rhythm data wirelessly?
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.
12
1.888.693.2401 • zioreports.com
Activities
15. Can I exercise while wearing the patch?
Yes, you may exercise moderately, but excessive sweating may shorten
wear time.
16. Can I shower with the patch on?
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. Can I take a bath?
Yes, but keep the patch above water. Keep the gateway away from all
water.
18. Can I go into a pool or a hot tub?
No. The patch should not be submerged under water. Keep the gateway
away from all water.
19. Can I travel with the patch on?
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. Can I fly with the gateway?
Yes, the gateway should be placed in “airplane mode.” See Traveling
section.
1.888.693.2401 • zioreports.com
13
21. What activities should I avoid?
Avoid activities that cause heavy sweating. Sweat can cause the patch to
slide, become loose or fall off. Activities that may submerge the patch in
water should also be avoided.
Recording Symptoms
22. What should I do if I feel a symptom?
First, press the button on your patch. Then enter your symptoms in the
myZio app or in myzio.com. You may also fill out a page of the Button
Press Log in this manual. Please choose only one option for recording
your symptoms.
23. What if I forget to press the button when I feel a symptom?
The patch will still record your heartbeat and the gateway will send any
information that is important for your doctor to know.
24. What if I press the button but forget to write down the symptom?
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. What if I press the patch button while the gateway is not within 10 feet
and in line of sight of the patch?
The patch will store the data until the gateway is in range, then the data
will be sent.
26. What happens if I press the patch button while the gateway doesn’t
have cell signal?
The gateway will store the data until it has cell signal, then the data will
be sent.
29. I think I see blood under my patch. What should I do?
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. Is it normal for the Zio® AT patch wings to become cloudy?
Yes. The patch may move slightly from its original position. A blue gel
may be seen under the wings of the patch.
31. Is it normal for the patch to move slightly from its original position?
Yes. The patch may move slightly from its original position. A blue gel
may be seen under the wings of the patch.
32. Is it normal to experience skin irritation or itchiness in the area of the
patch?
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. Will the gateway show any lights or make any sounds?
No. As long as it is able to send data, the gateway will not flash or make
noise.
34. What if the patch flashes orange while I am wearing it?
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. What should I do if my gateway is flashing orange?
The Patch
27. What should I do if the patch peels or lifts at the edges?
Press evenly on the wings of the patch for 3 to 5 minutes to re-stick.
28. What should I do if the patch falls off?
If you see the gateway flashing orange, this does not mean there is a
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.
Call Customer Service at 1.888.693.2401.
14
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15
End of the Wear Period
TROUBLESHOOTING THE PATCH
36. How long am I supposed to wear the patch?
Wear the patch for as long as your doctor prescribed but no longer than
14 days. NOTE: Each person’s wear experience is different and actual
wear time may be shorter than prescribed.
37. I have removed the Patch and it is flashing orange. Is this okay?
The patch may flash orange after removal. It is okay to mail the device
while it is flashing. Turn to Patch Removal for return instructions.
SLOW FLASHING (once every 3 seconds):
Indicates that the patch is not making good contact.
To remedy it, press evenly on the wings of the patch for 3 to 5 minutes.
If orange flashing continues, call Customer Service at 1.888.693.2401.
FAST FLASHING (3 times per second):
Indicates that the patch is not recording. Call Customer Service at
1.888.693.2401.
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TROUBLESHOOTING THE GATEWAY
ZIO AT SERVICE NOTES
Situation
Note
myZio Registration –
Patient Enrollment
In order for a patient to register with myZio they must
first 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 notification 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)
SLOW  (SQUARE) FLASHING (once every 3 seconds):
Indicates that the gateway has lost connection to the patch.
To remedy it, hold the star button for 3 seconds until the orange
light stays on. Then, if you see green flashing, the gateway has found
connection to the Patch.	
If orange flashing continues, call Customer Service at 1.888.693.2401.
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)
SLOW  (TRIANGLE) FLASHING (once every 3 seconds):
Indicates that the gateway does not have cell signal.
To remedy it, 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.
Then, if you see green flashing, the gateway has found a cell signal. Do
not move the gateway until the green flashing stops.
If it does not flash green, move the gateway to a new place and try again.
If orange flashing continues, 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.
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IRHYTHM CLINICAL FACILITY CERTIFICATION
NOTICE OF PRIVACY PRACTICES (NOPP)
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.
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 effect. We reserve the right to revise
this notice and to make the new notice provisions effective 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 Office
- Primary Indication
- ECG Recording
- Symptoms and Activities You Report, by Time and Date
- Activity Level During Monitoring
- Patient Identification 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
How We May Use Your Information
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.
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21
Without Specific Authorization
Does
iRhythm
Share?
Can You
Limit
This
Sharing?
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.
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 benefits 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).
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Yes
Yes
Does
iRhythm
Share?
Can You
Limit
This
Sharing?
For Business
Operations
We may use both De-Identified and Limited
Data Sets (a data set that, per the Health
Insurance Portability and Accountability Act of
1996 regulations, has had patient-identifiable
data removed except for dates of service) for
development of future products, devices or
services.
Once information is De-Identified through
an approved method, the data is stripped of
individual identifiers, 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
official 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 officials 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
Without Specific Authorization
No
No
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23
Without Specific Authorization
For Workers'
Compensation
We may disclose PHI as permitted by workers'
compensation and similar laws.
Does
iRhythm
Share?
Can You
Limit
This
Sharing?
Yes
No
Without Specific Authorization
Does
iRhythm
Share?
Can You
Limit
This
Sharing?
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 affect any use or disclosure
permitted by your authorization while it was in effect.
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.
Confidential
Communication
You have the right to request that we communicate with you in
confidence 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.
Complaints / Violations
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 staff will assist you
Questions?
Call 1.888.693.2401
Who We Are
Yes
Yes
Who Is Providing
This Notice?
This privacy notice is being provided by iRhythm Technologies, Inc.,
and applies to the diagnostic services offered in connection with
prescribed health care.
What We Do
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 benefit purposes permitted or required by law.
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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 Official
www.irhythmtech.com
Phone:
415.632.5700
Fax:
415.632.5701
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25
CYBERSECURITY MEASURES AND CONTROLS
DEVICE SPECIFICATIONS
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, and to configure encryption of all transmissions between these
devices. Similarly, encryption of all cellular communication between the
Gateway and the cloud is configured during manufacturing.
PATCH PERFORMANCE CHARACTERISTICS
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.
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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
≥ 10 MΩ
ECG Differential Range
±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
Effective Radiated Power < 1mW
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
Effective Radiated Power < 1mW
Gateway
Receive
800 MHz
/ 1900
MHz
750
LTE
CatCDMA
M1
Effective Radiated Power ≤< 300mW
200 mW
Cellular
RF
Transmit/
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27
HEART RATE CALCULATIONS
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
Episode Heart Rates
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
Overall Rhythm 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)
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., durationweighted average of all rhythm episode heart
rates within the record)
ENVIRONMENTAL CHARACTERISTICS
Operational Temperature
41 to 104 degrees
Operational Altitude
-1,000 to 10,000 ft
Operational & Storage Humidity
10% to 95% (non-condensing)
PAUSE DETERMINATION
Shipping (Short-term Storage)
-4 to 104 degrees F
Pause is defined as an RR interval greater than 3 seconds.
Temperature
Long-term Storage Temperature
55 to 85 degrees F
Storage Altitude
-1,000 to 14,000 ft
Patch IP Classification
IP24
Gateway IP Classification
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.
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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.
•• CAUTION: Portable and mobile RF communications equipment can affect
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.
Table 2: Guidance and manufacturer’s declaration—electromagnetic immunity
The Zio AT system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Zio AT system should assure that it is used in such an
environment.
Immunity test
Electrostatic
Discharge (ESD)
IEC 61000-4-2
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
IEC 60601 test
level
±8 kV contact
±15 kV air
30 A/m
Compliance
level
Electromagnetic environment guidance
±8 kV contact
±15 kV air
Floors should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.w
30 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.
Table 1: Guidance and manufacturer’s declaration— electromagnetic emissions
The Zio AT system is intended for use in the electromagnetic environment specified 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 fluctuations/
flicker emissions IEC
61000-3-3
Not applicable
Not applicable
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Table 3: Guidance and manufacturer’s declaration—electromagnetic immunity
Table 3, Continued
The Zio AT system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Zio AT system should assure that it is used in such an
environment.
NOTE 1—At 80 MHz and 800 MHz, the higher frequency range applies.
Immunity test
IEC 60601 test
level
10 V/m
80 MHz to 2.7
GHz
28 V/m
385, 450, 810,
870, 930 MHz
18 Hz pulse
Radiated RF
IEC 61000-4-3
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
32
Compliance
level
10 V/m
28 V/m
9 V/m
28 V/m
9 V/m
Electromagnetic environment guidance
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 fixed 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:
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NOTE 2—These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field 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.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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33
Table 4: Recommended separation distances between portable and mobile RF
communications equipment and the Zio AT system
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
SYMBOLS GLOSSARY
SYMBOL
STANDARD
REFERENCE
STANDARD TITLE
ISO 15223-1
Clause 5.1.1
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
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
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
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
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
ISO 7000-2493
Graphical symbols for
use on equipment
Separation distance according to frequency of transmitter
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
1.2
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
affected by absorption and reflection 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 modifications 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.
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SYMBOL TITLE
DESCRIPTION /
EXPLANATORY
TEXT
Manufacturer
Indicates the
medical device
manufacturer.
Date of
manufacture
Indicates the date
when the medical
device was
manufactured
Use-by date
Indicates the date
after which the
medical device is
not to be used.
Batch code
Indicates the
manufacturer’s
batch code so
that the batch
or lot can be
identified.
Catalogue
number
Indicates the
manufacturer’s
catalogue
number so that
the medical
device can be
identified.
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SYMBOL
36
STANDARD
REFERENCE
STANDARD TITLE
ISO 15223-1
Clause 5.1.7
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
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
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
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
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
ISO 7000-1051
Graphical symbols for
use on equipment
SYMBOL TITLE
DESCRIPTION /
EXPLANATORY
TEXT
Serial number
Indicates the
manufacturer’s
serial number
so that a
specific medical
device can be
identified.
Keep dry
Indicates a
medical device
that needs to be
protected from
moisture.
Temperature
limit
Indicates the
temperature
limits to which
the medical
device can be
safely exposed.
Humidity
limitation
Indicates
the range of
humidity to
which the
medical device
can be safely
exposed.
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.
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SYMBOL
STANDARD
REFERENCE
STANDARD TITLE
ISO 15223-1
Clause 5.4.3
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
ISO 7000-1641
Graphical symbols for
use on equipment
IEC 606011 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
ISO 7000-0434
Graphical symbols for
use on equipment
IEC 606011 Table D.1,
Symbol 10
SYMBOL TITLE
DESCRIPTION /
EXPLANATORY
TEXT
Consult
instructions
for use
Indicates the
need for the
user to consult
the instructions
for use.
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.
Medical electrical
equipment — Part 1:
General requirements
for basic safety and
essential performance
1.888.693.2401 • zioreports.com
37
SYMBOL
38
STANDARD
REFERENCE
STANDARD TITLE
BS EN
50419:2006
Marking of electrical
and electronic
equipment in
accordance with
article 11(2) of
Directive 2002/96/EC
(WEEE)
SYMBOL TITLE
DESCRIPTION /
EXPLANATORY
TEXT
Separate
Collection
To indicate
that the
product shall
be separated
when
disposed.
IEC 60417-5140
Graphical symbols for
use on equipment
IEC 60601-12:2007, Clause
5.1.1
Medical electrical
equipment — Part 1-2:
General requirements Non-ionizing
for basic safety and
electromagnetic
essential performance radiation
— Collateral standard:
Electromagnetic
compatibility —
Requirements and
tests
IEC 60417-5333
Graphical symbols for
use on equipment
IEC 606011, Table D.1,
Symbol 20
Medical electrical
Type BF Applied
equipment — Part 1:
Part
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
1.888.693.2401 • zioreports.com
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
SYMBOL
STANDARD
REFERENCE
STANDARD TITLE
SYMBOL TITLE
IEC 606011, Table D.3
Symbol 2
IEC 60529
Medical electrical
equipment — Part 1:
General requirements
Degrees of
for basic safety and
protection
essential performance
provided by
enclosure
Degrees of Protection
Provided by
Enclosures (IP Code)
Manufacturerdetermined
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°
To identify
a type BF
applied part
complying
with IEC
60601-1.
Keep away
from magnetic
resonance
imaging (MRI)
equipment.
DESCRIPTION /
EXPLANATORY
TEXT
Labeling-Medical
21 CFR 801.15(c) devices; prominence
(1)(i)F
of required label
statements
Prescription
only
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Requires
prescription
in the United
States
39
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1.888.693.2401 • zioreports.com
1.888.693.2401 • zioreports.com
41
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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