Coala Life HEART MONITOR Rx User manual

– 1 –
USER MANUAL COALA HEART MONITOR Rx

– 2 –
© 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.

– 3 –
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

– 4 –
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

– 5 –
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.

– 6 –
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.

– 7 –
• 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.

– 8 –
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.

– 9 –
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.

– 10 –
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.