iRhythm Technologies SR15G ZIO SR ECG GATEWAY User Manual user guide
iRhythm Technologies, Inc. ZIO SR ECG GATEWAY user guide
user guide
PATIENT INSTRUCTIONS
FOR SUPPORT,
CALL 1-888-693-2401
FOR SUPPORT,
CALL 1-888-693-2401
To be completed by patient
TURN OVER FOR BUTTON PRESS LOG
BUTTON PRESS LOG
TURN OVER FOR PATIENT INSTRUCTIONS
Date removed
/ /
Name
Serial #
Enter your symptoms as
shown on the sample page, or
enter them using myZIO™ and
enjoy these additional
features:
• Review and edit your
symptom history
• View Gateway transmissions
• Access and edit your
patient profile
• Find patient instructions
See page 5 to get
started with myZIO
K100A4030.D | September 2015
iRhythm Technologies, Inc.
Clinical Centers
650 Townsend St., Suite 380
San Francisco, CA 94103 U.S.A.
2 Marriott Drive
Lincolnshire, IL 60069 U.S.A.
363 N. Sam Houston Parkway East
Suite 125
Houston, TX 77060 U.S.A.
1-888-693-2401 | irhythmtech.com | @iRhythmTech
FOR SUPPORT, CALL 1-888-693-2401
If the Patch falls o, call 1-888-693-2401.
If you feel severe itching or irritation,
remove the Patch then call
1-888-693-2401.
If you feel the need for immediate
medical care at any time, call 911.
The ZIO® SR device will not provide any
medical assistance and cannot contact
medical personnel for you.
For use in the United States only.
1
Both parts of the ZIO® monitor
were turned on at your
physician’s oce, and are now
recording your heart activity.
The ZIO® SR Patch records
every heartbeat; each time you
press the Patch button, the
ZIO® SR Gateway sends that
information for analysis.
Turn the page for advice on having the
best possible patient experience.
ZIO® PATCH
ZIO® GATEWAY
1
2
USING YOUR ZIO® SR
With the ZIO monitor, you can
sleep, shower and go through
your normal daily activites.
The Patch needs 24 hours to stick to your
skin, so avoid any activities which cause
sweating during this period. (If your skin is
moist, pat it dry with a dry towel or cloth.)
After those first 24 hours, you may resume
normal activities, including moderate
exercise.
The Patch and Gateway will not flash
or make noise when they are working
correctly, but you can check your
transmissions using myZIO.
Turn to the next page
or see the inside back
cover for information
about myZIO.
2
3
TroubleshootingTravelingPatch Removal FAQs Using ZIO SR
1Each time you feel a symptom, press
the button on your Patch. Then note
the date, time, and what you felt in this
booklet or using myZIO.
2Try to keep the
Gateway close by
when you can – set it
down nearby, and when
you are on the move,
carry it with you. The
Gateway is in range if it
remains within 10 feet of
the Patch.
3If the Patch or Gateway lights are
flashing, it does not mean there is
a problem with your heart, only that the
device may have lost its connection.
Turn to the Troubleshooting section or
call 1-888-693-2401 for support.
Three key things to keep in
mind are:
Using ZIO SR
4
Other tips to having the best ZIO
experience possible:
If the Patch feels a little itchy, or
peels or lifts at the edges, it is okay.
Press and hold the Patch to re-stick.
Excessive sweating can cause the
Patch to slide, become loose, fall o,
and shorten wear time – especially
if the sweating occurs in the first 24 hours
after the Patch is put on.
The Patch is water-resistant and
should not be submerged. That
means brief showering is okay,
but no swimming or hot tubs. The
Gateway is NOT waterproof. Please do not
get it wet.
It is okay if the Gateway is
temporarily out of range, but do
not leave it within 6 feet of transmitting
devices (such as wireless routers, baby
monitors and TV senders/transmitters).
Sending heart rhythm data through
the Gateway can take some time.
Recent transmissions may not be
available at myZIO for several hours.
5
TroubleshootingTravelingPatch Removal FAQs Using ZIO SR
Use myZIO to enter and
edit your symptoms
electronically, and view
transmissions from
your Gateway.*
iPhone® users
1. Search for ‘myZIO’ in the App StoreSM
2. Download app
3. Register before entering symptoms
Internet Explorer® users
1. Open internet browser
2. Navigate to myZIO.org
3. Register before entering symptoms
* Recent transmissions may not be
available at myZIO for several hours.
Supported on iPhone 5s, 6 and 6s (iOS 7 and 8).
Internet Explorer browser supported on versions IE
8, 9, and 11. iPhone, App Store and the Apple logo are
registered trademarks of Apple Inc.
Using ZIO SR
6
TROUBLESHOOTING:
GATEWAY
Slow flashing
(once every 3 seconds):
Indicates that the Gateway has lost the
connection to your 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 Support at 1-888-693-2401.
If the light on the outside
of your Gateway is flashing,
check inside.
7
TroubleshootingTravelingPatch Removal FAQs Using ZIO SR
Slow flashing
(once every 3 seconds):
Indicates that the Gateway does not
have a 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 or flashing
(3 times per second):
Fast flashing indicates that your
Gateway is not working. Call Customer
Support at 1-888-693-2401.
Troubleshooting
8
TROUBLESHOOTING:
PATCH
Slow flashing
(once every 3 seconds):
Indicates that your 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 Support at 1-888-693-2401.
Fast flashing
(3 times per second):
Indicates that your Patch is not
recording. Call Customer Support at
1-888-693-2401.
9
TroubleshootingTravelingPatch Removal FAQs Using ZIO SR
About the ZIO® SR
recording system
What is the Patch doing?
The Patch is recording every heartbeat.
Your doctor will use the data from the
Patch to look at your heart rhythm and
determine the right course of action.
What is the Gateway doing?
The Gateway wirelessly sends heart
rhythm data from the Patch, each time
the Patch button is pressed. iRhythm
receives and analyzes the data, and
provides a report to your doctor.
How do I know the Patch and the
Gateway are working?
When they were turned on, the sta at
your doctor’s oce made sure that the
Patch and Gateway were working.
When they are working with no
problems, the Patch and Gateway
will not flash or make noise.
FREQUENTLY ASKED
QUESTIONS (FAQs)
FAQs
10
Do I need to do anything with the
Gateway to send heart rhythm data
wirelessly?
No, you only need to keep the Gateway in
arm’s reach and in view to stay connected
wirelessly after you press the Patch button.
The Gateway should also be kept in a place
with good cell signal.
What kinds of devices can aect wireless
connection with the Gateway?
Other wireless devices that use 2.4 GHz
signals such as baby monitors, TV senders/
transmitters, and wireless routers can
interrupt communication between the
Patch and Gateway if used within 6 feet.
About your activities
Can I exercise while wearing the Patch?
Yes, but excessive sweating may shorten
wear time.
Can I shower with the Patch on?
Yes, but showers should be short and try
to keep your back to the shower as much
as possible. Keep soaps and lotions away
from the Patch. When towel-drying, hold
the Patch down with one hand. Press the
Patch against your skin to secure it. Keep
the gateway away from all water.
11
TroubleshootingTravelingPatch Removal FAQs Using ZIO SR
Can I take a bath?
Yes, but keep the Patch above water.
Keep the Gateway away from all water.
Can I go swimming or in a hot tub?
No. The Patch should not be put under
water and heavy sweating will shorten
wear time. Keep the Gateway away from
all water.
Can I travel with the Patch on?
Yes. If questioned during security
screening, show the statement in the
Traveling section. Note that the Gateway
will not have cellular connection outside
the United States.
Can I fly with the Gateway?
Yes, though the Gateway must be in
“airplane mode”. See Traveling.
What activities should I avoid?
Activities that cause heavy sweating
should be avoided. Sweat can cause the
Patch to slide, become loose, fall o, and
shorten wear time.
About recording symptoms
What should I do if I feel a symptom?
Press the button and fill out a page of
the Button Press Log in this booklet or
FAQs
12
using myZIO. Please try to use either the
booklet or myZIO for recording symptoms
and not both.
What if I don’t have symptoms?
That is okay. The Patch records every
heartbeat.
What if I forget to press the button when I
feel a symptom?
While pressing the button is important to
“tag” and wirelessly send an event, the
Patch is recording every heartbeat.
What if I press the button but forget
to write down the information in this
booklet?
While the Button Press Log information is
useful, pressing the button indicates that
you felt your symptoms at that time.
What if I press the Patch button while the
Gateway is not in range?
The Patch will store the data until the
Gateway is in range, then the data will be
sent.
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.
13
TroubleshootingTravelingPatch Removal FAQs Using ZIO SR
About the Patch
What should I do if the Patch peels or
lifts at the edges?
Press and hold along the edges to
re-stick.
What should I do if the Patch falls o?
Call Customer Support at
1-888-693-2401.
I think I see blood under my Patch.
What should I do?
Call Customer Support at
1-888-693-2401. It is probably due to a
small shaving cut when the Patch was
applied to your chest.
Is it normal for the ZIO® SR Patch wings
to become cloudy?
Yes, the wings of the Patch may become
cloudy after a few days of wear.
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.
FAQs
14
Is it normal to experience skin irritation
or itchiness in the area of the Patch?
Most patients do not experience skin
irritation or itchiness. However, some
patients have reported 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, then
call Customer Support at 1-888-693-2401.
About flashing lights
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.
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 Support at 1-888-693-2401.
15
TroubleshootingTravelingPatch Removal FAQs Using ZIO SR
What should I do if my Gateway is
flashing orange?
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 Support at 1-888-693-2401.
About returning the Patch
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 dierent and actual wear
time may be shorter than prescribed.
How do I return the Patch and Gateway?
You can drop o the sealed envelope at
the Post Oce, in a USPS (blue) mailbox
or give it to your mail carrier. Turn to
Patch Removal for return instructions.
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 the Patch
Removal for return instructions.
FAQs
16
SECURITY SCREENING
STATEMENT
This person is wearing an
iRhythm ZIO® SR Patch prescribed
by their physician. This device is
currently adhered to the patient’s
chest and is monitoring their heart.
It can only be removed under the
direction of their physician.
If you have any questions, please
contact the iRhythm Clinical Center at
1-888-693-2401
24 hours/day, 7 days/week.
17
TroubleshootingTravelingPatch Removal FAQs Using ZIO SR
TRAVELING WITH
YOUR ZIO® SR
Flying while wearing a ZIO®
SR is straightforward. Simply
show the security statement
(opposite) during screening,
and remember to put the
Gateway in Airplane Mode.
To turn Airplane Mode ON
Press and hold the airplane button
inside the Gateway for 3 seconds,
until the lights flash orange quickly.
The airplane light on the outside of
the Gateway will flash as long as it
is in “Airplane Mode.”
To turn Airplane Mode OFF
Press and hold the airplane button
inside the Gateway for 3 seconds,
until the lights flash green quickly.
The outside airplane light will stop
flashing.
Traveling
18
REMOVING AND
RETURNING THE PATCH
When you have worn the
Patch for the time prescribed
by your doctor, remove it as
described below.
1Using the adhesive remover from the
opposite page, tilt the center of the
Patch up and sweep between your skin and
the Patch – while lifting one side from the
center out. Repeat for the other side, lifting
from the center out. Wash the skin with
mild soap, rinse with water, and pat dry.
19
TroubleshootingTravelingPatch Removal FAQs Using ZIO SR
2Place the Patch inside the Gateway
as shown.
3Lift panel in the Gateway to remove
the return envelope.
ADHESIVE
REMOVER
4Place only the Patch, Gateway and
this booklet inside the envelope
and seal. Mail it back via the U.S. Postal
Service as soon as possible.
Patch Removal
20
ZIO® SR data analysis
Your ZIO® SR data is analyzed at the iRhythm
Clinical Centers. iRhythm is an Independent
Diagnostic Testing Facility (IDTF) dedicated
to providing world-class diagnostic service. As
an IDTF, we adhere to Medicare Independent
Diagnostic Testing Facility Performance
Standards.
A link to these standards (42 C.F.R. Section
410.33) can be found at the iRhythm website
www.irhythmtech.com.
Patient identification
Before placing your device in the prepaid
envelope, please write your name on the line
above the return address. By writing your name
on the envelope you are providing another
method of identification for the Patch and
Gateway and are consenting to the potential
viewing of your name on the envelope. You may
choose to not write your name on the envelope.
Notice of privacy practices
As participants in your health care, we are
required by applicable federal and state law to
maintain the privacy of your Protected Health
Information (PHI).
Our full Notice of Privacy Practices, found at
www.irhythmtech.com, describes our privacy
practices, our legal duties, and your rights
concerning your PHI.
Indications for use
The ZIO® SR is a prescription-only, single patient
use, continuously recording ECG monitor with
wireless patient event transmission that can be
worn up to patients 18 years or older, patients
ABOUT THE ZIO® SR
21
who may be asymptomatic or who may suer
from transient symptoms such as palpitations,
shortness of breath, dizziness, light-headedness,
pre-syncope, syncope, fatigue, or anxiety.
Contraindications
• Do not use the ZIO® SR for patients with
symptomatic episodes where instance
variations in cardiac performance could result
in immediate danger to the patient.
• Do not use the ZIO® SR for patients with
known history of life threatening arrhythmias.
• Do not use the ZIO® SR in combination
with external cardiac defibrillators or high
frequency surgical equipment near strong
magnetic fields or devices such as MRI.
• Do not use the ZIO® SR on patients with
neuro-stimulator, as it may disrupt the quality
of ECG data.
• Do not use the ZIO® SR on patients who do
not have the competency to wear the device
for the prescribed monitoring period.
Warnings
• Do not use the ZIO® SR 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® SR. It is a single
patient use device. Reuse will cause incorrect
patient data and patient may experience skin
irritation.
• Do not use the ZIO® SR on patients residing in
areas with limited to no cellular reception.
If skin irritation such as severe redness, itching
or allergic symptoms develop, remove the
Patch.
22
CAUTION: Federal (USA) law restricts the sale
of this device to or on the order of a physician.
Precautions
• The ZIO® SR includes temperature and
humidity limitations. If exposed, patients
may experience degradation of adhesive
performance causing the device to slip or fall
o during the patient wear duration.
• The ZIO® SR 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® SR if package is
damaged. Device may not perform as
intended.
• Safety and eectiveness of the ZIO® SR on
pediatric patients (younger than
18 years old) has not been established.
• Safety and eectiveness of the ZIO® SR 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.
Type BF
applied part
Separate
collection
Consult
Instructions
for Use
RF
Transmitter
Keep DryPrescription-
Use Only
23
This device complies with part 15 of the FCC
Rules. Operation is subject to the following
two conditions: (1) this device may not cause
harmful interference, and (2) this device must
accept any interference received, including
interference that may cause undesired
operation.
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 it’s intended purpose and as
instructed in the manual.
because I felt…
I pressed the button on:
while I was…
for this duration…
h m mh
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
fluttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
m d y
mdy
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
because I felt…
I pressed the button on:
while I was…
for this duration…
h m mh
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
fluttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
m d y
m d y
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
because I felt…
I pressed the button on:
while I was…
for this duration…
h m mh
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
fluttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
m d y
mdy
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
because I felt…
I pressed the button on:
while I was…
for this duration…
h m mh
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
fluttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
m d y
m d y
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
because I felt…
I pressed the button on:
while I was…
for this duration…
h m mh
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
fluttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
m d y
mdy
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
because I felt…
I pressed the button on:
while I was…
for this duration…
h m mh
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
fluttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
m d y
m d y
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
because I felt…
I pressed the button on:
while I was…
for this duration…
h m mh
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
fluttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
m d y
mdy
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
because I felt…
I pressed the button on:
while I was…
for this duration…
h m mh
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
fluttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
m d y
m d y
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
because I felt…
I pressed the button on:
while I was…
for this duration…
h m mh
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
fluttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
m d y
mdy
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
because I felt…
I pressed the button on:
while I was…
for this duration…
h m mh
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
fluttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
m d y
m d y
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
because I felt…
I pressed the button on:
while I was…
for this duration…
h m mh
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
fluttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
m d y
mdy
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
because I felt…
I pressed the button on:
while I was…
for this duration…
h m mh
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
fluttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
m d y
m d y
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
because I felt…
I pressed the button on:
while I was…
for this duration…
h m mhm d y
mdy
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
x
getting out of bed
0 5
x
x
x
2 2 1 5
x
1 0 1 5
S
A
M
P
L
E
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
fluttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
Enter your symptoms as
shown on the sample page, or
enter them using myZIO™ and
enjoy these additional
features:
• Review and edit your
symptom history
• View Gateway transmissions
• Access and edit your
patient profile
• Find patient instructions
See page 5 to get
started with myZIO
K100A4030.D | September 2015
iRhythm Technologies, Inc.
Clinical Centers
650 Townsend St., Suite 380
San Francisco, CA 94103 U.S.A.
2 Marriott Drive
Lincolnshire, IL 60069 U.S.A.
363 N. Sam Houston Parkway East
Suite 125
Houston, TX 77060 U.S.A.
1-888-693-2401 | irhythmtech.com | @iRhythmTech
FOR SUPPORT, CALL 1-888-693-2401
If the Patch falls o, call 1-888-693-2401.
If you feel severe itching or irritation,
remove the Patch then call
1-888-693-2401.
If you feel the need for immediate
medical care at any time, call 911.
The ZIO® SR device will not provide any
medical assistance and cannot contact
medical personnel for you.
For use in the United States only.
PATIENT INSTRUCTIONS
FOR SUPPORT,
CALL 1-888-693-2401
FOR SUPPORT,
CALL 1-888-693-2401
To be completed by patient
TURN OVER FOR BUTTON PRESS LOG
BUTTON PRESS LOG
TURN OVER FOR PATIENT INSTRUCTIONS
Date removed
/ /
Name
Serial #