Coala Life HEART MONITOR Rx User manual

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USER MANUAL COALA HEART MONITOR Rx

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© 2019 Coala Life AB, and its subsidiaries. All rights reserved. Protected
by US Patents 8634570, 9498181, and additional Patents Pending. Coala,
Follow your Heart and Följ ditt Hjärta are registered trademarks and
trade names of Coala Life in various countries.
“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............................................ 16
07 Getting started ....................................................... 21
08 Best practices ........................................................ 31
09 Record your first measurement............................... 35
10 My Journal .............................................................. 46
11 My Profile ............................................................... 51
12 My Coala................................................................. 52
13 My Inbox ................................................................. 56
14 Coala LED indications ............................................. 57
15 Coala’s ECG categorization ..................................... 58
16 Troubleshooting ...................................................... 61
17 Storage ................................................................... 69
18 Cleaning and maintenance...................................... 70
19 Electrical safety...................................................... 70

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20 Transceiver properties ............................................ 71
21 Electrical emission ................................................. 71
22 Electrical immunity................................................. 72
23 Warnings related to electromagnetic compatibility. 74
24 Symbols used in system and package label ............ 75
25 Specifications......................................................... 78
26 Contact information to the manufacturer ............... 83

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Introduction
Congratulations on your new Coala Heart Monitor. Please read
this manual before use for important safety information about
your Coala and App.
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’s website:
www.coalalife.com/us/device-compatibility
01 Product description
The Coala Heart Monitor is an electrocardiogram (ECG) and
digital auscultation (stethoscope) recording system that can
be used both by medical professionals and health conscious
individuals in a home healthcare environment. Both ECG
and heart sound recordings can easily be shared with your
Healthcare professional through the Coala Care Portal.

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The Coala Heart Monitor and 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 recording is always
followed by a thumb ECG recording for the most accurate
detection.
• The Coala App: Installed on a compatible Smartphone,
together with the Coala Heart Monitor is used to record,
store, transmit, and view measurements directly in your
Smartphone. Measurements are transmitted from the
app to the Coala Care Portal server for analysis and the
analyzed result can be viewed 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 detection
of cardiac rhythm deviations, stores all your recorded
measurements and manages your Coala App account.

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• The Coala Charge Station: Used to charge the battery in the
Coala Heart Monitor. The Coala can be charged using the
supplied wall adapter or any compatible USB outlet (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 and App is intended to be used by a
single individual to:
• Record simultaneous ECG and heart sounds.
• Annotate each recording with symptoms or free text.
• Access previously recorded measurements from the Coala
Care Portal server.
• Print or save ECG recordings in a PDF format, to share with a
Healthcare professional or recipient of choice.
• Receive messages and notications from a Healthcare
professional if connected through the Coala Care Portal.

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Chest and thumb ECG
Coala measurements consist of two consecutive recordings;
the chest recording and the thumb recording.
The chest recording is executed rst by pressing the Coala
membrane rmly to the chest, slightly to the left of your
sternum.
The thumb recording is executed by rmly pressing both
thumbs onto the electrodes located on the bottom of the
Coala.
Simultaneous ECG and heart sound recordings
The chest recording; consists of both ECG and heart sound is
recorded by the Coala. The heart sound recording tracks the
mechanical movement of valves in the heart. This can be used
by a trained medical professional to make an assessment of
the mechanical condition of the heart (when prescribed or
used under the care of a Healthcare professional)
A 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 the heart.

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02 Indication for use
The Coala Heart Monitor is intended to record, store and
transfer single-channel electrocardiogram (ECG) rhythms and
heart sound.
The Coala Heart Monitor also displays ECG rhythms and
detects the presence of normal sinus rhythm or atrial
brillation (when prescribed or used under the care of a
physician).
The Coala Heart Monitor is intended for use by Healthcare
professionals and adults with known or suspected heart
conditions.
Rx ONLY.
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).
• Always protect the membrane from sharp objects such as
keys, pencils etc.
• 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 and it is not
intended for pediatric use.
• 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.

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• Do not use a device that shows signs of mechanical damage
or loose parts.
• 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, wall adapter 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.

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• Do not take recordings in the presence of strong
electromagnetic elds such as near an arc welder,
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

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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
conventional chest leads.
• Maximum T-wave amplitude is 1.5 times the QRS amplitude
for correct display of heart rate.
• This device is not intended to be operated by children,
elderly or persons with physical or mental impairment. Let
an able accompanying adult operate the device.
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.

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• Interpretations made by this device are potential
ndings, not a complete diagnosis of cardiac conditions.
All interpretations should be reviewed by a medical
professional.
• Do not attempt self-diagnosis or self-treatment based
on the recording results and analysis. Always consult a
Healthcare professional.
• Keep out of reach of infants, small children and animals to
avoid strangulation by the supplied USB cable.
• 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.
• Warning: MR-unsafe! Do not expose the device to a
magnetic resonance (MR) environment. The device may
present a risk of projectile injury due to the presence of
ferromagnetic materials that can be attracted by the MR
magnet core.Thermal injury and burns may occur due to
the metal components of the device that can heat during
MR scanning. The device may generate artifacts in the MR
image. The device may not function properly due to the
strong magnetic and radiofrequency elds generated by the
MR scanner.

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• It is not recommended to place a mobile phone directly
next to a pacemaker or ICD (Implantable Cardioverter
Debrillator) as this may interfere 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
Before using the Coala Heart Monitor ensure Smartphone
compatibility.
The Coala Heart Monitor and App is compatible with
Smartphones running iOS (iPhone 5 or later) and Android (4.4
KitKat or later). Compatible Smartphones are listed on Coala
Life’s website: www.coalalife.com/us/device-compatibility.
Unpack and charge the Coala
Unpack the Coala and Charge Station.
Read the instruction sleeve carefully before removing it. When
the sleeve has been removed place the Coala and Charge
Station on a at surface and remove the Coala from the
Charge Station by following the instructions on the next page.

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Unpack the supplied Wall Adapter and connect the USB Cable
between the Charge Station (small USB plug) and Wall Adapter
(large USB plug). Connect the Wall Adapter to a mains power
outlet.
NOTE! If an external power supply/wall adapter is used it must be a class
II power supply (no connection to protective earth) with an output voltage
of 5VDC and capable of at least 300 mA of current.
Apply light pressure onto the “COALA” text on the front of the
Coala using your thumb. Carefully lift, and tilt the front of the
Coala out of the Charge Station rst as illustrated below.
1.
2.

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Charge the Coala by sliding it carefully back into the Charge
Station as illustrated below. Do not use extensive force when
placing the Coala into the Charge Station.
NOTE! The correct orientation of Coala when placing it into the Coala
Charge Station. Do not use force or press straight down on to the Coala
when placing it into the Charge Station. For maximum electrical safety,
the Coala cannot be used while charging (Coala Charge Station and
connected wall adapter are IT 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.

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To remove the Coala from the Charge Station:
Apply light pressure 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, this will damage the device
1.
2.