iRhythm Technologies AT17P Zio AT ECG Patch User Manual

iRhythm Technologies, Inc. Zio AT ECG Patch Users Manual

Users Manual

5
5WEARING
YOUR ZIO
Flip for PRESS BUTTON LOG
Record any events during your wear
period here, the myZio app or at myzio.com.
Return this booklet, your Zio QX patch and
Zio QX gateway after your wear period:
MANUAL
A100A4007.01 4.26.2017 DRAFT
iRhythm Technologies, Inc. — Clinical Centers
650 Townsend St., Suite 500
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.
1.888.6932401 | irhythmtech.com | @iRhythmTech
CALL 1.888.693.2401 IF…
 •TheZioQXpatchfallso.
• You experience severe itching or
irritation.
For all other information please see the
Troubleshooting and Frequently Asked
Questions section of this booklet.
If you feel the need for immediate medical
care at any time, call 911. The Zio QX device
will not provide any medical assistance and
cannot contact medical personnel for you.
For use in the United States only.
1
The Zio® QX System consists of three
components:
1. Zio QX Patch
2. Zio QX Gateway
3. myZioTM App and Website
The Zio QX Patch records every heartbeat.
Each time you press the Patch button or when
Zio QX automatically detects an arrhythmia,
the Zio QX Gateway transmits information
to iRhythm for analysis. myZio is one way
for you to enter your symptoms and verify
that your heart data transmission has been
received by iRhythm.
Zio Patch
Zio Gateway
2
APPLYING YOUR ZIO QX
Follow the instructions in the Zio
QX Application Instructions guide to
apply your Zio QX Patch
It is important that you follow the steps
in the Applications Instructions guide to
ensure that your Patch sticks to your skin
correctly and remains on your skin for the
duration of monitoring.
The Patch should only be applied to healthy,
unbroken skin that was not previously irritated.
3
TROUBLESHOOTINGFAQsPATCH REMOVAL TRAVELING USING ZIO
USING YOUR ZIO QX
With the Zio monitor, you can go
through your normal daily activities
aftertherst24hours.
The Patch needs 24 hours to fully stick to
your skin, we recommend showering briey
with your back to the water, and avoid any
activities that
cause sweating
during this period.
After those rst
24 hours, you
may resume
normal activities,
including
showering
and moderate
exercise.
The Patch and Gateway will not ash
or make noise when they are working
correctly, but you can check your
transmissions using myZio or
www.myzio.com.
4
Remember:
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,
you may enter your symptoms in the myZio
App or on www.myzio.com. See page 6.
2
If the Patch or Gateway lights are
ashing, it does not mean there is a
problem with your heart, only that a
device may have lost its connection. Turn
to the Troubleshooting section or call
1.888.693.2401 for
support.
3
Keep the Gateway
close by when you
can, and when
you are on the move
carry it with you. It is
okay if the Gateway
is temporarily out of
range, but iRhythm
will not receive heart
rhythm data from your
Patch or Gateway while
it is out of range. For
the Gateway to remain
connected it needs to
be kept in front of you
and within 10 feet of
the Patch.
5
TROUBLESHOOTINGFAQsPATCH REMOVAL TRAVELING USING ZIO
Additional tips:
If your skin around the Patch feels
a little itchy, it is okay. If the Patch
peels or lifts at the edges, 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 sweating occurs in the rst 24
hours after the Patch is put on.
The Patch is water-resistant but
should not be submerged. Brief
showering is okay, but no
swimming or hot tubs. The Gateway
is NOT water resistant. Please do
not get it wet.
Do not place the Gateway within 6
feet of transmitting devices, such
as wireless routers, baby
monitors and TV senders/
transmitters. These devices may
cause interference between the
Patch and the Gateway.
Sending heart rhythm data
through the Gateway may take
some time after the Patch button
is pressed. Recent transmissions
may not be viewable on myZio
until several hours later.
6
Use myZIO to enter your symptoms
electronically and check transmissions sent
from your Gateway.* Through myZio you have
easy access to help instructions and videos.
iPhone® users
1. Search for ‘myZio’ in the App StoreSM
2. Download app
3. Register before entering symptoms
Android™ users
1. Search for ‘myZio’ in the Google Play™
Store
2. Download app
3. Register before entering symptoms
Computer users
1. Open your web browser
2. Navigate to www.myZio.com
3. Register before entering symptoms
* Recent transmissions may not be viewable on myZio until several
hours later.
Supported on iPhone 5 or later (iOS 9+).
Supported on Android 4.4+
iPhone, App Store and the Apple logo are registered trademarks of
Apple Inc.
7
FAQsUSING ZIOPATCH REMOVAL TRAVELING
TROUBLESHOOTING:
GATEWAY
If the light on the outside of your
Gatewayisashing,checkinside.
SLOW FLASHING
(once every 3 seconds):
Indicates that the Gateway has lost the
connection to your Patch.
To reconnect, hold the star buttonfor
3 seconds until the orange light stays on. If
the light then ashes green, the Gateway
has reconnected to the Patch.
Iforangeashingcontinues, call Customer
Service at 1.888.693.2401.
TROUBLESHOOTING
8
SLOW FLASHING
(once every 3 seconds):
Indicates that the Gateway does not have a
cell signal.
To reconnect, 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.
If the light then ashes green, the Gateway
has reconnected. Do not move the Gateway
until the green ashing stops.
If it does not ash green, move the Gateway to
a new place and try again.
Iforangeashingcontinues, call Customer
Service at 1.888.693.2401.
FAST OR FLASHING
(3 times per second):
FastashingindicatesthatyourGateway
is not working. Call Customer Service at
1.888.693.2401.
9
FAQsUSING ZIOPATCH REMOVAL TRAVELING TROUBLESHOOTING
TROUBLESHOOTING: PATCH
SLOW FLASHING
(once every 3 seconds):
Indicates that your Patch is not making
good contact with your skin.
To correct this, press evenly on the wings
of the Patch for 3 to 5 minutes.
Iforangeashingcontinues, call Customer
Service at 1.888.693.2401.
FAST FLASHING
(3 times per second):
Indicates that your Patch is not recording.
Call Customer Service at 1.888.693.2401.
10
FREQUENTLY ASKED
QUESTIONS (FAQS)
The Zio® AT monitoring system
What is the Patch doing?
The Patch is recording every heartbeat.
Your doctor will use the heart rhythm
data from the Patch to 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 and each time the system
automatically detects an arrhythmia. 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 are working normally, the Patch
and Gateway do not ash or make noise.
Do I need to do anything after pressing the
Patch button to send heart rhythm data
wirelessly?
No, you only need to keep the Gateway in
front of you and within 10 feet of the Patch
to stay connected wirelessly after you press
the Patch button. The Gateway should also be
kept in a place with good cell signal.
11
TROUBLESHOOTING USING ZIOPATCH REMOVAL TRAVELING FAQs
Can I carry the Gateway in a purse, bag or
pocket?
Yes. However, when carrying the Gateway
keep it in line of sight of the Patch. The
Gateway will need to be in front of your body
and within 10 feet of the Patch.
What can aect wireless connection
between the Patch and the Gateway?
Wireless devices that use 2.4 GHz signals
such as baby monitors, some cordless
home telephones, 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.
Your activities
Can I exercise while wearing the Patch?
Yes, you may exercise moderately, 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.
12
Can I take a bath?
Yes, but keep the Patch above water. Keep the
Gateway away from all water.
Can I go into a pool or a hot tub?
No. The Patch should not be put under water.
Keep the Gateway away from all water.
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.
Can I y with the Gateway?
Yes, though the Gateway should be placed 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.
Recording symptoms
What should I do if I feel a symptom?
First, press the button on the Patch. Then,
ll out a page of the Button Press Log in this
booklet, use the myZio App or .myzio.com to
enter your symptoms. Please choose only one
option for recording symptoms but not all.
13
TROUBLESHOOTING USING ZIOPATCH REMOVAL TRAVELING FAQs
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 symptom?
Recording your symptoms and activity
gives your physician additional information
about what may have caused the symptom.
While this is useful, the more important
thing is to press the button.
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.
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 to
iRhythm.
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 Service at 1.888.693.2401.
14
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.
Is it normal for the Zio® AT 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 clear gel may be seen
under the wings of the Patch.
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 Service at 1.888.693.2401.
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 ash or make noise.
15
TROUBLESHOOTING USING ZIOPATCH REMOVAL TRAVELING FAQs
What if the Patch ashes orange while I am
wearing it?
If you see the Patch ashing 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 ashing
continues or comes back, call Customer
Service at 1.888.693.2401.
What should I do if my Gateway is ashing
orange?
If you see the Gateway ashing 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.
End of the wear period
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 dierent
and actual wear time may be shorter than
prescribed.
I have removed the Patch and it is ashing
orange. Is this okay?
The Patch may ash orange after removal.
It is okay to mail the device while it is
ashing. Turn to Patch Removal for return
instructions.
16
SECURITY SCREENING
STATEMENT
This person is wearing an iRhythm
Zio QX 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
TROUBLESHOOTINGFAQsUSING ZIOPATCH REMOVAL TRAVELING
TRAVELING WITH YOUR ZIO QX
Flying while wearing a Zio QX is
straightforward. Simply show the
security statement (opposite)
during screening, and remember to
put the Gateway in Airplane Mode.
Refer to
or Call Support
Flashing lights
above?
Your Zio Patch
is not sending us
information
Patient Name
Start Date Rx
Removal Date days
For Support Call:
1.888.693.2401
or visit
myZIO.com
4
3
2
1
Quick Reference
Patient Instructions
Using the ZIO® SR p.2
Troubleshooting p.6
FAQs p.9
Patch Removal p.18
Zio
®
Patch Return Instructions
Lift below to remove return envelope
Remove Patch from skin
Place Patch inside
Gateway as shown
Place Patient booklet
and Gateway in
return envelope
Lift for
Return
Envelope
To turn Airplane Mode ON
Press and hold the airplane button
inside the Gateway for 3 seconds, until the
lights ash orange quickly. The airplane
light on the outside of the Gateway will
ash 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 ash green quickly. The outside
airplane light will stop ashing.
18
REMOVING AND RETURNING
THE PATCH
When you have worn the Patch for
the time prescribed by your doctor,
remove it as described below.
1
Using 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
TROUBLESHOOTINGFAQsUSING ZIOTRAVELINGPATCH REMOVAL
2
Place the Patch inside the Gateway as
shown.
3
Lift panel in the Gateway to remove
4
Place 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.*
ADHESIVE
REMOVER
*You may be held responsible for the cost of the device if both the
Patch and Gateway are not returned.
20
ABOUT THE ZIO QX
Zio QX data analysis
Your Zio QX 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identication
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 identication 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.
21
Indications for use
The Zio QX ECG Monitoring System is intended to capture,
analyze and report symptomatic and asymptomatic cardiac
events and continuous electrocardiogram 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 comprehensive report is generated
based on the entire ECG recording. It is indicated for use on
patients 18 years or older who may suer from transient
symptoms such as palpitations, shortness of breath, dizziness,
light-headedness, pre-syncope, syncope, fatigue, or anxiety
and patients who are asymptomatic. 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 the Zio QX for patients with symptomatic
episodes where variations in cardiac performance could
result in immediate danger to the patient.
• Do not use the Zio QX for patients with known history of
life threatening arrhythmias.
• Do not use the Zio QX in combination with external cardiac
debrillators or high frequency surgical equipment near
strong magnetic elds or devices such as MRI.
• Do not use the Zio QX on patients with neuro-stimulator,
as it may disrupt the quality of ECG data.
• Do not use the Zio QX on patients who do not have
the competency to wear the device for the prescribed
monitoring period.
22
Warnings
• Do not use the Zio QX 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 QX Patch on multiple patients. It is
a single patient use device. Reuse will cause incorrect
patient data and patient may experience skin irritation.
• Do not use the Zio QX on patients residing in areas with
limited to no cellular reception.
• No modication of this equipment is allowed.
If skin irritation such as severe redness, itching or
allergic symptoms develop, remove the Zio QX
Patch from the patient’s chest. Call iRhythm
Customer Service at 1.888.693.2401
CAUTION: Federal (USA) law restricts the sale of
this device to or on the order of a physician.
Precautions
• The Zio QX System 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 QX 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 QX System if package is damaged.
Device may not perform as intended.
• Safety and eectiveness of the Zio QX System on pediatric
patients (younger than
• 18 years old) has not been established.
• Keep device and packaging away from young children.
23
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.
• Safety and eectiveness of the Zio QX on patients
receiving any form of pacing therapy has not been
established. Paced cardiac rhythms may not be
accurately detected and may be incorrectly classied.
• 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.
• Device is not intended for infants under 10kg.
The patient is an intended operator
Package Contents
1 Zio QX Patch
1 Zio QX Gateway, containing:
1 postage-paid return envelope
1 Skin Prep & Placement Kit containing:
1 patch card template
1 disposable razor
1 abrader disc
4 alcohol pads
1 Patient Instructions & Button Press Log containing:
1 adhesive remover wipe
1 Zio QX Get Started guide
24
Symbols
Consult Instructions for Use Caution Prescription Use Only
Manufacturer Date of Manufacture Serial Number
Use By Do Not Reuse Zio Patch
Splash-Proof Equipment
Zio Gateway
Drip-proof Equipment Protected
Against Hazardous Parts with
Finger Temperature Limitations
Temperature
Limitations
Humidity
Limitations
Separate Collection Do Not Use if
Package is Damaged Type BF Applied Part
RF Transmitter Net Quantity of Contents Keep Dry
Do Not Open Until
Time of Application
25
Asymptomatic Arrhythmia Detection
Asymptomatic arrhythmia events, as detected and transmitted
during the monitoring period, are dened by the following
parameters:
Rhythm Heart Rate Duration
Atrial Fibrillation
≤40
bpm ≥60 seconds
≤180
bpm ≥60 seconds
Pause - ≥4 seconds
Ventricular
Tachycardia
≥ 120
bpm ≥ 30 seconds
≥150
bpm ≥15 seconds
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
26
PERFORMANCE CHARACTERISTICS
ECG Channels 1 channel
Memory capacity 14 days
Recording Format Continuous
Service Life Up to 14 days
Shelf Life 6 months
Out-of-Pouch Shelf Life 1 day
ELECTRICAL CHARACTERISTICS
Medical Equipment Type BF Applied Part
ECG Frequency Response 0.5Hz to 30Hz
ECG Input Impedance ≥ 10 MΩ
ECG Dierential 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
Eective 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
Eective Radiated
Power < 1mW
Gateway Cellular RF Transmit/
Receive
800 / 1900 MHz CDMA
Eective Radiated
Power ≤300mW
27
POWER CHARACTERISTICS
Patch Battery Type 2 Lithium Manganese
Dioxide Coin Cells
Gateway Battery Type 1 Lithium Polymer Cell
Battery 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 F
Operational Altitude -1,000 to 10,000 ft
Operational & Storage Humidity 10% to 95%
(non-condensing)
Shipping (Short-term Storage)
Temperature
-4 to 104 degrees F
Long-term Storage Temperature 55 to 85 degrees F
Storage Altitude -1,000 to 14,000 ft
Patch IP Classication IPX4
Gateway IP Classication IP22
ESSENTIAL PERFORMANCE
The Zio QX 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 QX alerts the patient
that functionality is impaired.
28
EQUIPMENT CLASSIFICATION
INFORMATION
Patch IEC
Classications
Gateway IEC
Classications
Internally Powered
ME Equipment
Internally Powered
ME Equipment
Type BF Applied Part -
IPX4 - IP 22
Continuous Operation Continuous Operation
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)
29
Pause Determination
Pause is dened as an RR interval greater than 3 seconds.
Electrical Safety and Compatibility
• CAUTION: The Zio QX 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 aect medical electrical equipment.
• WARNING: The Zio QX should not be used adjacent to or
stacked with other equipment.
• WARNING: The Zio QX 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 QX Patch.
Otherwise, degradation of the performance of this
equipment could result.
Table 1: Guidance and manufacturer’s declaration—
electromagnetic emissions
The Zio QX device is intended for use in the electromagnetic
environment specied below. The customer or the user of
the Zio QX device should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic
environment -
guidance
30
RF emissions
CISPR 11 Group 1
The Zio QX device
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 QX
device 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
Not applicable Not applicable
Table 2: Guidance and manufacturer’s declaration—
electromagnetic immunity
The Zio QX device is intended for use in the electromagnetic
environment specied below. The customer or the user of
the Zio QX device should assure that it is used in such an
environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic
environment -
guidance
31
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 %.
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.
Table 3: Guidance and manufacturer’s declaration—
electromagnetic immunity
The Zio QX device is intended for use in the electromagnetic
environment specied below. The customer or the user of
the Zio QX device should assure that it is used in such an
environment.
Immunity
test
IEC 60601
test level
Com-
pliance
level
Electromagnetic
environment -
guidance
32
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
QX device, 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:
33
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 QX is used exceeds the applicable
RF compliance level above, the Zio QX 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 QX Patch.
b Over the frequency range 150 kHz to 80 MHz, eld
strengths should be less than 3 V/m.
Table 4: Recommended separation distances between
portable and mobile RF communications equipment and the
Zio QX
The Zio QX is intended for use in an electromagnetic
environment in which radiated RF disturbances are
controlled. The customer or the user of the Zio QX can
help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Zio QX
as recommended below, according to the maximum output
power of the communications equipment.
34
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
1 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 aected by absorption and
reection from structures, objects, and people.
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.
For body worn operation, this device 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 ensure
compliance with FCC RF exposure guidelines.
35
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.
because I felt…
I pressed the button on:
while I was…
for this duration…
:
m d y mhm d y mh
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
uttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
because I felt…
I pressed the button on:
while I was…
for this duration…
:
m d y mhm d y mh
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
uttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
because I felt…
I pressed the button on:
while I was…
for this duration…
:
m d y mhm d y mh
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
uttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
because I felt…
I pressed the button on:
while I was…
for this duration…
:
m d y mhm d y mh
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
uttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
because I felt…
I pressed the button on:
while I was…
for this duration…
:
m d y mhm d y mh
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
uttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
because I felt…
I pressed the button on:
while I was…
for this duration…
:
m d y mhm d y mh
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
uttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
because I felt…
I pressed the button on:
while I was…
for this duration…
:
m d y mhm d y mh
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
uttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
because I felt…
I pressed the button on:
while I was…
for this duration…
:
m d y mhm d y mh
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
uttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
because I felt…
I pressed the button on:
while I was…
for this duration…
:
m d y mhm d y mh
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
uttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
because I felt…
I pressed the button on:
while I was…
for this duration…
:
m d y mhm d y mh
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
uttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
because I felt…
I pressed the button on:
while I was…
for this duration…
:
m d y mhm d y mh
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
uttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
because I felt…
I pressed the button on:
while I was…
for this duration…
:
m d y mhm d y mh
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
uttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
because I felt…
I pressed the button on:
while I was…
for this duration…
:
m d y mhm d y mh
AM
PM
describe
activity
1 minute or less
10 minutes or less
1 hour or less
More than 1 hour
anxious
arm or neck pain/tingling
chest pain or pressure
dizziness
faint
light headed
pounding
uttering or racing
short of breath
skipped or irregular beat(s)
other:
describe
SAMPLE
Enter your symptoms as shown on
the sample page, or enter them using
myZio™ or www.myzio.com website
and enjoy these additional features:
• Review and edit your symptom history
• Have easy access to help instructions
and videos
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