Coala Life Coala User manual

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USER MANUAL COALA HEART MONITOR

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“Made for iPhone” mean that an electronic accessory has been designed
to connect specically to iPhone and has been certied by the developer
to meet Apple performance standards. Apple is not responsible for the
operation of this device or its compliance with safety and regulatory
standards. Please note that the use of this accessory with iPhone
may affect wireless performance. iPhone is a trademark of Apple Inc.,
registered in the U.S. and other countries.

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Table of contents
01 Product description .................................................. 5
02 Indication for use...................................................... 9
03 Contraindications ..................................................... 9
04 Cautions ................................................................. 10
05 Warnings................................................................. 13
06 Before using the Coala............................................ 15
07 Getting started ....................................................... 19
08 Best practices ........................................................ 28
09 Record the first measurement ................................ 32
10 My Journal .............................................................. 43
11 My Profile ............................................................... 48
12 My Coala................................................................. 49
13 My Inbox ................................................................. 53
14 Coala LED indications ............................................. 54
15 Coala ECG categorization........................................ 56
16 Troubleshooting ...................................................... 64
17 Storage ................................................................... 71
18 Cleaning and maintenance...................................... 72
19 Electrical safety...................................................... 72

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20 Transceiver properties ............................................ 73
21 Electrical emission ................................................. 74
22 Electrical immunity................................................. 74
23 Warnings related to electromagnetic compatibility. 76
24 Symbols used in system and package label ............ 77
25 Specifications......................................................... 80
26 Contact information to the manufacturer ............... 85

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Introduction
Congratulations on your new Coala. Please read this manual
before use for important safety information about your Coala.
The Coala is paired to the Coala App running on a user
supplied compatible smartphone running iOS or Android.
Compatible smartphones are listed on Coala Life website:
www.coalalife.com/device-compatibility
01 Product description
The Coala Heart Monitor is a patented medical device that
records clinical quality ECG (electrocardiogram) and heart
sounds simultaneously. The device can be used by both
healthcare professionals and health conscious individuals to
record ECG in a home healthcare environment whenever they
are feeling symptoms. The ECG and heart sound recordings
can easily be shared with your Healthcare provider through the
Coala Care Portal.

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The Coala Heart Monitor system consists of the following
parts:
• The Coala Heart Monitor: A small hand-held device that
is pressed against the chest for simultaneous recordings
of ECG and heart sounds through electrodes and a
stethoscope membrane. The chest measurement is always
followed by a thumb ECG recording for the most accurate
detection.
• The Coala App: Installed on a compatible smartphone is
used together with the Coala Heart Monitor to record,
transmit and view measurements directly in your
smartphone. Measurements are transmitted from the app
to the Coala Care Portal server for analysis and the user
reviews the analyzed result within minutes in the Coala
App. The app also features a messaging system where
you can receive messages and notications from your
Healthcare provider.
• The Coala Care Portal:The server that provides the
automatic analysis of measurements, detection of cardiac
rhythm deviations, stores all your recordings and Coala App
account information.

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• The Coala Charge Station: Used to charge the battery in the
Coala Heart Monitor. The Coala can be charged from any
compatible USB source (only use the supplied USB cable).
Fully charge the battery before the rst use and ensure that
the battery is charged regularly.
• The Coala cover and travel bag: Provided to protect the
Coala heart monitor during transportation and storage.
The Coala Heart Monitor is intended to be used by a single
individual to:
• Record simultaneous ECG and heart sounds.
• Annotate each recording with symptoms or free text.
• Wirelessly transfer and receive results from detection of
cardiac rhythm deviation.
• Access previous Coala recordings from the Coala Care Portal
server.
• Print or save ECG recordings to a PDF format, to send to your
Clinician or the recipient of choice.
• Receive messages and notications from your Healthcare
provider. (If accepted as a Healthcare provider with access to
the Coala Care Portal)

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Chest and Thumb ECG
The Coala records ECG measurements on the chest and
thumbs. The chest measurement is recorded by pressing the
Coala membrane to the chest. The thumb measurement is
recorded by rmly pressing both thumbs onto the electrodes
located on the bottom of the Coala.
Simultaneous ECG and Heart Sound
The mechanical movement of valves in the heart create
heart sounds that can be used for assessing the mechanical
condition of the heart. These sounds can be recorded by the
Coala and can be used by a trained medical professional for an
assessment of the heart (when prescribed or used under the
care of a healthcare professional).The unique Coala feature is
the ability to record simultaneous ECG and heart sounds. This
combined information can be used by a trained cardiologist to
give a detailed view of the electrical and mechanical activity
of your heart.

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02 Indication for use
The Coala Heart Monitor is intended for self-testing by
patients to record, store, transfer and display surface ECG and
sound to aid the detection of heart and respiratory conditions.
The Coala Heart Monitor is intended for use by; healthcare
professionals, individuals with known or suspected heart
conditions and health conscious individuals.
The Coala Heart Monitor is not intended for use for vital
monitoring as in intensive care.
03 Contraindications
There are no known contraindications for Coala Heart Monitor.

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04 Cautions
• Do not use for any purpose other than to obtain ECG and
sound recordings.
• The Coala should be applied only to intact, clean skin (e.g.,
not over open wounds, lesions, infected, or inamed areas).
• Not suitable for direct cardiac application (intact skin only).
• Not recommend for use on individuals with a cardiac
pacemaker, ICDs or other implanted electronic devices.
• Not to be used with a pacemaker. If the Coala is used with a
pacemaker, pacing pulses may be detected and counted by
the heart rate display but may not be displayed in the ECG
graphs.
• The Coala Heart Monitor has not been tested for use on
infants less than 12 months old. Due to chest size and
electrode placement Coala Life does not recommend use on
humans weighing less than 10 kg.
• A successful chest recording may not be possible if the
device is applied to a chest which has too much body hair,
body fat or very dry skin. Try to apply moisture to the skin
and shave off any body hair to obtain successful recordings.
• Do not use a device that shows signs of mechanical damage
or loose parts.

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• Do not disassemble, repair or modify the device in any way.
• Do not take recordings if the ECG electrodes are dirty. Clean
them rst.
• Do not sterilize this device with an autoclave, gas sterilizer
or using radiation such as gamma or E-beam sterilization.
• Do not use device in locations subject to extreme high or
low temperatures or humidity. For this reason, do not leave
the device in vehicle.
• Do not use device in wet environments. Do not use device
that has been submerged in water. The Coala device
carries an Ingress Protection (IP) rating of IP22 meaning
that vertically dripping water has no harmful effect when
the enclosure is tilted at an angle up to 15° relative to its
Normal mode (in at position with stethoscope membrane
turned down). Note: The Charge Station and USB cable
do not carry an IP rating and are only to be used in a dry
environment.
• Do not expose the device to strong shocks or vibrations.
• Recordings may be interrupted by strong electromagnetic
interference, shocks and vibrations.
• Do not take recordings in the presence of strong
electromagnetic elds such as near an arc welder,

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high power radio transmitter etc as these can cause
disturbances to recorded signals. Note that recordings
performed in vehicles (cars, buses, trains, aircraft etc) may
see disturbances due to electromagnetic interference as
from motors and ignition systems.
• Do not use this device in dusty environments such as
machine shops. Use the protective cover and bag to keep
the device clean. Note that the IP22 rating of the Coala
device does not mean that it is dust proof.
• To avoid intrusion and leaks of personal data to
unauthorized persons lock the smartphone or logout from
the Coala App between measurements.
• Contact Coala Life of any signs of malicious system
behavior, suspicions of malware or system cybersecurity
violations.
• ECG-lters may distort baseline properties and high-
frequency response of the ECG signal. The full signal
without lters is available for healthcare professionals in
the Coala Care Portal. Signal amplitudes for the chest ECG
measurement are typically lower (0.1 to 0.4 mV) than on
conventional chest leads due to close electrode spacing
on the Coala. Chest signal morphology is also affected by
positioning of the Coala on the chest and may not resemble

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conventional chest leads.
• Maximum T-wave amplitude is 1.5 times the QRS amplitude
for correct display of heart rate.
05 Warnings
• This device is not 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 medical examination.
• This device does not detect or measure all heart rate, heart
rhythm and heart waveform changes, especially those
related to ischemic heart conditions or life threatening
arrhythmias. Always consult your Healthcare Professional if
you experience changes in your health.
• Do not attempt self-diagnosis or self-treatment based
on the recording results and analysis. Always consult a
medical professional.
• This device is not intended to be operated by children or
persons with physical or mental impairment. Let an able
accompanying adult operate the device.
• Keep out of reach of infants, small children and animals to
avoid strangulation by the supplied USB cable.

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• Not for pediatric use.
• The heart rate is based on the heart rhythm; therefore the
rate is only valid if there is a valid detected rhythm.
• It is not recommended to place a mobile phone directly
next to a pacemaker or ICD (Implantable Cardioverter
Debrillator) as this may disturb your implantable device.
• Do not use the Coala with a debrillator. The Coala is not
debrillator proof and may be damaged or reduce the
effectiveness of the debrillation.
• Do not use device in explosive environments (mines, oil
rigs, fueling stations, oxygen rich environments such as
hyperbaric chambers or in the presence of ammable
anesthetics).
• Do not connect the Coala Charge Station to any power
source or external equipment other than described in this
manual.
• Do not dispose in re. Contains lithium battery that may
explode. Dispose as electronic waste according to local
regulations.
• Not for use with high frequency surgical equipment.

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06 Before using the Coala
Check smartphone compatibility
The Coala Heart Monitor is compatible with smartphones
running iOS (iPhone 5 or later) or Android (4.4 KitKat or later)
listed on the Coala Life website:
www.coalalife.com/device-compatibility
Unpack and charge the Coala
Unpack the Coala and Charge Station, and place it on a at
surface and remove the instruction sleeve.
Apply light pressure on to the “COALA” text on the front of the
Coala using your thumb. Carefully tilt, and lift the front of the
Coala out of the Charge Station rst as illustrated.

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Unpack and connect the supplied USB cable to the Charge
Station using the small USB plug and connect the large USB
plug to a power source such as a; laptop, battery pack or other
power supply.
NOTE! The external USB power source, as a supply/wall adapter, must be
a CE- marked class II power supply (no connection to protective earth)
with an output voltage of 5VDC and capable of at least 300 mA of current.

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Charge the Coala by sliding it carefully into the Charge Station
as shown. Do not use extensive force when placing the Coala
into the Charge Station.
NOTE! The Coala should be carefully placed in the Coala Charge Station
by noting correct orientation and sliding it into place. Do not use force or
press straight down on the Coala to get it in place. For maximum electrical
safety the Coala cannot be used for obtaining recordings while charging
since the Coala Charge Station and connected USB power source are
IO type equipment and do not carry the type BF (Body Floating) medical
electrical safety rating that the Coala does.

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The Coala LED light should start blinking with a blue light to
indicate that it is charging. If not, repeat the previous steps
and make sure that the Coala has been correctly placed into
the Charge Station.
Once the Coala is fully charged the LED light will indicate a
steady blue light. Make sure the Coala is charged regularly and
is fully charged before the rst use.
To remove the Coala from the Charge Station apply light
pressure on to the “COALA” text on the front of the Coala using
your thumb. Carefully tilt and lift the front of the Coala out of
the Charge Station rst, as illustrated below.
Do not use extensive force when lifting the Coala out of the
Charge Station.

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07 Getting started
Download the Coala App
Download the Coala App from App Store or Google Play
depending on your smartphone.
Search for ’Coala App‘. Follow
instructions on your smartphone
to install the app.
Open the app and log in
Open the Coala App on your
smartphone and login using the
email and password registered
when signing up for the service
or the details that were provided
by your healthcare professional.
If you forgot your password see
the next page*
The rst time the Coala App is
opened you will have to allow
Coala notications.

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Ensure to enter the correct
region. If you signed up for the
account in the EU select Europe
as your region.
Check the box:“I agree and
accept Coala’s user and privacy
terms” to agree to Coala’s user
and privacy terms. To read the
terms click on the text:“Coala
User and Privacy Terms”.
Press:“Log in” when you are
ready.
*If you forgot your password click on
’Forgot my login details‘ and follow the
on-screen instruction. A link (valid for 30
minutes) will be sent to your registered
email to reset the password. If you do not
receive the email, check your junk mail
folder. For security reasons you will not be
able to login into Coala App for 20 minutes
if you have entered the wrong password
3 times.