Qardio QardioCore User manual

WIRELESS ECG MONITOR
USER MANUAL

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TABLE OF CONTENTS
Introduction 4
Intended use 6
Important safety information 6
Features 8
Requirements 8
Package contents 9
Using QardioCore for the rst time 10
How to turn on/off QardioCore 12
Detailed instructions for the correct
tting of QardioCore 12
Wearing QardioCore upside down 14
Comfortable t for females 15
Taking an ECG/EKG recording 15
Checklist for a correct and accurate
ECG/EKG recording 15
Visualizing your ECG/EKG data 16
Important facts about ECG/EKG and
self-measurement 16
Activity tracking 18
Charging QardioCore 19

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Resetting the pairing 20
Accuracy testing and maintenance 20
Cautions 21
Contraindications 22
User Responsibility 22
General use, safety and precautions,
cleaning 22
Customer service contact 26
Limited warranty 26
Error messages and troubleshooting 28
QardioCore technical specications 30
Disposal 34
Certications 34
FCC Statement 36
RF Statement 39

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INTRODUCTION
Qardio offers a better way of tracking heart health that
ts effortlessly into your life. Our devices are powerful
and smart, have a beautiful design with a delightful
user experience so you can use them anytime,
anywhere.
QardioCore is a clinical-quality wearable
electrocardiogram recorder. It records
electrocardiogram (ECG/EKG) and physical activity.
Health conscious individuals or patients with known
or suspected heart conditions can use QardioCore to
record everyday ECGs, physical activity and medical
symptoms during the day or whenever they feel
like, and share their data with their doctors. Medical
professionals can use the QardioCore to quickly
assess heart rate and rhythm, screen for arrhythmias,
and remotely monitor and manage patients who use
QardioCore.

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QardioCore is the smart way to track your
electrocardiogram with contextual information about
your physical activity. This device was developed in
collaboration with physicians and clinical tests were
conducted to prove its measurement accuracy.
With its ease of use and accuracy, QardioCore is
ideal for monitoring your ECG trace throughout the
day. With this system, you can record your ECG over
extensive periods of time. This allows your doctor
to assess ECG traces accompanying intermittent
or infrequent symptoms difcult to capture with
conventional ECG and Holter systems.
Please read through these instructions carefully so you
understand all functions and safety information.
We want you to be happy with your QardioCore.
If you have any questions, problems or suggestions,
please contact Qardio’s Customer Service at support.
getqardio.com, or visit our website
www.getqardio com for more information.
QardioCore has features that are only available to
those users who are under the care of a physician.
These features are available to prescription users
only and may not be available in all regions or all
languages.

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INTENDED USE
For USA
The QardioCore ECG monitor is intended to capture,
store, transmit and display electrocardiogram (ECG)
information for long term monitoring and evaluation.
It is indicated for use on adult patients 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 QardioCore ECG monitor does not provide
diagnostic interpretation. The QardioCore ECG
monitor is a prescription-only device, and the
reported information is provided for review by a
physician to render a diagnosis based on clinical
judgment and experience.
Caution: Federal law restricts this device
to sale by or on the order of a physician.
For EU
The QardioCore wireless ECG monitor is intended
to record, store and transmit single-channel
electrocardiogram (ECG) rhythms and detects the
presence of atrial brillation and normal sinus rhythm
(when prescribed or used under the care
of a physician).
The QardioCore wireless ECG monitor is intended
for use by healthcare professionals, patients with
known or suspected heart conditions who may
be asymptomatic or who may have chest pain,
palpitations, neurologic symptoms, shortness of
breath, or to monitor response to treatment of cardiac
disorders, and by health conscious individuals.
The device is not intended for pediatric use.

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For CANADA
The QardioCore ECG monitor is a smartphone/tablet
enabled device intended to capture, store, transmit
and display electrocardiogram (ECG) information for
monitoring and evaluation.
It is indicated for use on adult patients 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 device is not intended for
pediatric use.
The QardioCore ECG monitor does not provide
diagnostic interpretation, and the reported analysis
is provided for review by a physician to render a
diagnosis based on clinical judgment and experience.

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IMPORTANT SAFETY INFORMATION
• Please read the User Manual carefully before using
the QardioCore ECG monitor.
• This device is not to be used by patients who have
a pacemaker. If you have an internal electronic
device, consult your physician before using an ECG
monitor, like QardioCore.
• This device is not designed or intended for
complete diagnosis of cardiac conditions. This
device should never be used as a basis for starting
or modifying treatment without independent
conrmation by professional medical examination.
• Always consult your physician before you begin or
modify any exercise program.
• This device does not detect or measure all heart
rate, heart rhythm and heart waveform changes,
especially those related to ischemic heart
conditions.
• Do not attempt self-diagnosis or self-treatment
based on the recording results and analysis.
• Interpretations made by this device are potential
ndings, not a complete diagnosis
of cardiac conditions. All interpretations should be
reviewed by a medical professional.
• Users should notify their doctor of a possible
change in health: a labeling of the ECG as normal
should not be relied on as a guarantee of absence
of arrhythmias or other health conditions.
• The heart rate analysis is only valid if there is
a valid rhythm (QRS complex visible).

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• Do not use this device during an MRI scan
• Our device will not be performing any
measurements that require validation through
ANSI/AAMI EC 57
• QardioCore relies on sensors that track your
movement and other metrics. The data and
information provided by this device is intended to
be a close estimation of your activity and metrics
tracked, but may not be completely accurate,
including step, distance, and calorie data.
• ECG reports viewed or printed at any
magnication other than 100% may appear
distorted and could lead to misdiagnosis.
• Qardio does not recommend using on
humans less than 20kg.

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FEATURES
The features for QardioCore include: assessment
of symptoms that may be related to arrhythmias
assessment of risk in patients with or without
symptoms of arrhythmia assessment of efcacy of
antiarrhythmic therapy.
QardioCore is intended to record, store and transfer
[single-channel] electrocardiogram (ECG) rhythms.
QardioCore also displays ECG rhythms and is designed
for the assessment of symptoms that may be related to
arrhythmias and the assessment of risk in patients with
or without symptoms of arrhythmia (when prescribed
or used under the care of a physician). QardioCore
is intended for use by healthcare professionals,
individuals with known or suspected heart conditions
and health conscious individuals. The device has not
been tested for and it is not intended for pediatric use.
QardioCore has features that are only available to
those users who are under the care of a physician.
These features are available to prescription users only
and may not be available in all regions or all languages.
OPERATIONAL REQUIREMENTS
QardioCore requires a device with Bluetooth 4.0
(or later) and iOS 10.0 (or later) in order to use your
QardioCore device, you:
• Must download the free Qardio App from the
Apple App Store, or go to www.getqardio.com
• The rst time you use QardioCore, an internet
connection is required. You must sign up for a free
Qardio account, via the Qardio App.
QardioCore works with iPhone, iPod, iPad
and Apple Watch.

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PACKAGE CONTENTS
You will find in your QardioCore package:
a. QardioCore device
b. Three chest straps, to facilitate your everyday use
c. Charging cable
d. Quick guide
e. User manual
List of materials
1. QardioCore Cases: Acrylonitrile butadiene styrene
(ABS) and Thermoplastic vulcanizates (TPV)
2. Connectors (Electrodes): Silver plated brass
3. Strap: 20% Nylon Wooly, 44% Spandex,
and 36% Nylon
4. Buckles on the strap: Acrylonitrile butadiene
styrene (ABS)
5. Rating Label on the strap: 100% Polyester
6. Logo labels on the strap: 100% Nylon.
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5. Adjust the length of the strap to adapt it
for your chest size.
6. Fit the QardioCore to your chest. You should wear
QardioCore directly on your skin, just below your
sternum. Wear your QardioCore with the Qardio
logo to the left. All the electrodes should be
touching your skin and QardioCore should be snug
enough to stay in place during your movement.
7. When you connect the strap to the left side of
QardioCore you should see a green light blink
once to indicate that QardioCore has switched on.
8. While wearing QardioCore with the Qardio App
open, touch and hold your phone or tablet to your
chest to perform the pairing of your QardioCore
with your phone or tablet. When prompted,
accept the pairing request. The green light on your
QardioCore will blink while the device is pairing,
and the Qardio App will indicate your QardioCore
has successfully paired.
USING QARDIOCORE FOR THE
FIRST TIME
1. Download the free Qardio App: On your mobile
phone or tablet go to www.getqardio.com/
download and when prompted, download the app.
Alternatively, go on the iTunes Store.
2. Open the Qardio App on your phone or tablet.
If requested, you should enable Bluetooth on
your device. You can enable Bluetooth under the
Settings menu on your smartphone or tablet.
3. Create a new user login, or login with your existing
user name and password. Follow the on-screen
instructions to register and set up your personal
account.
4. Connect QardioCore to one of the chest straps
provided. Always connect the right side rst.

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9. After a few seconds, QardioCore will automatically
start recording your electrocardiogram. Your ECG
can be affected by the position of QardioCore on
your chest and your physiological condition. It is
very important that QardioCore is correctly placed.
Please read the “Detailed instructions for the
correct tting of QardioCore” and the “Checklist
For a Correct and Accurate ECG/EKG Recording”
sections on the User Manual with particular care.
10. The ECG recording can be stopped at any time
by detaching the left clip from QardioCore and
removing it from the chest.
For the rst time use only:
With the Qardio App open
hold your iOS device near
your QardioCore to pair it.
Adjust length of strap
QardioCore should be snug
enough to stay in place
during your movement.
Slide the clip into place
Make sure QardioCore is
fully touching your body,
with all electrodes in contact
with the skin, and the strap
ts comfortably.

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HOW TO TURN ON/OFF QARDIOCORE
QardioCore turns itself on when you attach the chest
strap to its left side and it turns off when you unclip
the left side of the strap. When QardioCore is not
being worn, if the strap is left attached to the device,
QardioCore will remain in a low power mode to
preserve battery life.
To check if your device is switching on, look for the
short blink of a green light on the top of the device
when connecting the chest strap to the left side of
QardioCore. The green light will blink twice when
QardioCore is disconnected. Always store QardioCore
with the chest strap detached from the device.
DETAILED INSTRUCTIONS FOR THE
CORRECT FITTING OF QARDIOCORE
1. Wearing your QardioCore with the right t will keep
you comfortable: the device should be snug but
comfortable, and it should remain in place during
your movements. You should wear QardioCore
directly on your skin, just below your sternum.
An overly tight strap can be annoying or even
cause skin irritation, while a strap that’s too loose
can cause rubbing and affect the performance of
QardioCore. Before tting QardioCore to your
chest, connect the device to one of the chest straps
provided. Always connect the right side (when
viewing QardioCore from the sensor side) rst.
2. Adjust the length of the strap to adapt it for your
strap size.
3. Position QardioCore on your chest with the Qardio
logo to the left. You should wear QardioCore
directly on your skin, just below the sternum.

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5. In order to obtain an accurate measurement, it is
essential that all of QardioCore’s electrodes remain
in contact with your skin at all times. We have
designed QardioCore to suit a multitude of body
shapes and chest types, allowing for you to make
slight modications to how QardioCore is worn to
maximize the recording quality and comfort on an
individual level. If the ECG data is erratic or does
not appear, you can try these tips:
• Clean and dry your chest before putting
on the device.
• Avoid wearing sunscreen under the device.
• Wear the device below your sternum bone.
• The device should be snug but comfortable.
• You can try wearing the device lower on your
chest.
Wrap the strap around your body and connect it to
the left side of QardioCore. All of the electrodes
should be touching your skin and QardioCore
should be tted securely enough to stay in place
during your movement.
4. After you put on QardioCore, it switches
on automatically and starts recording the
electrocardiogram after a few seconds. When you
connect the strap to the left side of QardioCore,
you should see a green light blink once to indicate
that QardioCore has switched on.

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6. Tips to avoid skin irritation, or if you have
allergies or skin sensitivities.
• Keeping your QardioCore and straps—as
well as your skin—clean and dry will maximize
comfort and prevent long-term damage to
the device. This is especially important after
workouts or exposure to liquids such as sweat,
soap, sunscreen, and lotions that can cause
skin irritations.
• These irritants can make skin reactions more
likely if found between QardioCore and your
skin.
• If you have known allergies or sensitivities
to substances like metals or plastics, check
the materials in QardioCore and its straps on
support.getqardio.com.
• If you experience redness, swelling, itchiness,
or any other irritation, immediately remove
QardioCore and consult your physician before
you put QardioCore back on.
• Ensure you allow your skin to breathe for a few
hours a day by not wearing QardioCore.
• Individuals with sensitive skin or in poor
physical condition may experience skin
irritation when wearing QardioCore. Such
individuals should keep their QardioCore and
straps particularly clean.

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WEARING QARDIOCORE UPSIDE DOWN
If you have a more concave chest, or are consistently
nding it difcult for the top electrode to remain in
contact with the skin, we recommend that you wear
QardioCore upside down. Unclip the strap from the
left side of QardioCore and ip the device around
so the Qardio logo is on the right side. Re-position
QardioCore and re-attach the strap. Then, while in
the QardioCore section of the Qardio App, open
“Settings.” Click the button to turn on “Upside down
wearing mode” before checking your ECG timeline
for an improvement in recording quality.
COMFORTABLE FIT FOR FEMALES
QardioCore should be worn underneath the bra for an
accurate reading. To ensure the most comfortable t,
QardioCore should be used with a wire-free bra or a
sport bra.
TAKING AN ECG/EKG RECORDING
When you wear a fully charged QardioCore, it will
automatically start recording your electrocardiogram
after approximately one minute.
It is very important that QardioCore is correctly
placed. Please read the “Detailed instructions for
the correct fitting of QardioCore” and the “Checklist
For a Correct and Accurate ECG/EKG Recording”
sections of the User Manual with particular care.
The ECG recording can be stopped at any time by
detaching the left clip from QardioCore and removing
it from the chest.

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CHECKLIST FOR A CORRECT AND
ACCURATE ECG/EKG RECORDING
• Adjust the length of the strap to adapt it for your
chest size. Wear your QardioCore with the Qardio
logo to the left.
• Fit the QardioCore to your chest. When you
connect the strap to the left side of QardioCore
you should see a green light blink once to indicate
that QardioCore has switched on.
• You should wear QardioCore directly on your skin,
just below your sternum. Ensure all the electrodes
are touching your skin. Ensure QardioCore fits
securely enough to stay in place during your
movement.
• Ensure the Qardio App is running on your iOS
device
• You can stop the recording at any time by pressing
the clip and detaching QardioCore from your
chest. The green light will blink twice to indicate
QardioCore has disconnected.
VISUALIZING YOUR ECG/EKG DATA
Press the ECG button while in the QardioCore section
of Qardio App to see your ECG trace and heart rate
data to see your ECG trace and heart rate data.
The ECG trace is visualized by default at 25mm/s and
10mm/mV. You can pinch and zoom when viewing the
recording.
The ECG visualization can also be set to 25mm/s or
50mm/s, and 5mm/mV, 10mm/mV or 20mm/mV. These
options are only available to health professionals.

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NOTE: ECG recording viewed or printed at any
magnification other than 100% may appear distorted
and could lead to misdiagnosis.
NOTE: You will not be able to view your recordings or
utilize any of QardioCore’s analytical tools until you are
under the care of a physician. To gain access to these
features, you must create an account on the Qardio
App. One minute of your first recording will then be
automatically sent for analysis. Once you have received
the ECG analysis, you will have an access to viewing
that recording and subsequent recordings. This
service is not intended to replace medical advice, and
please seek professional medical assistance if you are
suffering from any medical problem.
IMPORTANT FACTS ABOUT ECG/EKG
AND SELF-MEASUREMENT
What is an electrocardiogram?
An electrocardiogram – often abbreviated as ECG
or EKG – is a test that measures the electrical activity
of the heartbeat. With each heartbeat, an electrical
impulse (or “wave”) travels through the heart.
This wave causes the muscle to squeeze and pump
blood from the heart.
Why is it done?
An ECG gives two major kinds of information. First,
by measuring time intervals on the ECG, a doctor can
determine how long the electrical wave takes to pass
through the heart. Finding out how long the wave takes
to travel from one part of the heart to the next shows if
the electrical activity is normal or slow, fast or irregular.
Second, by measuring the amount of electrical activity
passing through the heart muscle, a cardiologist may

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be able to nd out if parts of the heart are too large or
are overworked. During an ECG, several sensors, called
electrodes, capture the electrical activity of the heart.
Wearing QardioCore during exercise
During exercise the body requires more oxygen.
As the level of physical activity increases, the heart has
to work harder to deliver more oxygen-rich blood to
the exercising muscles, so the heart beats faster. By
monitoring the electrical signals of the heart as it beats
faster, it is often possible to detect coronary problems
that cannot be seen when the body is at rest. As the
intensity of the exercise increases, your heart rate
will increase. You should stop your physical exercise
if you experience dizziness, fatigue, chest pain, or
other symptoms. Normally you should maintain your
heart rate below your target level (85% of a predicted
maximum heart rate, based on your age, and your any
known medical conditions). You should consult your
doctor before exercising and about your target
heart rate level.
Target heart rate
While using QardioCore, the Qardio App displays
the current heart rate and the target heart rate
during recording, in the overview area.
The target heart rate can be adjusted at any time in
the settings
You can either set the target heart rate directly, or set
it as a percentage of the predicted maximum heart
rate. By default, the target heart rate value is set as
85% of the predicted maximum HR.
The predicted maximum heart rate is calculated with
the following formula: Predicted Maximum Heart
Rate = (220 – user’s age in years).
Heat rate detection method
1. ECG signal is filtered with a set of filters to
amplify QRS parts of the signal and detect QRS