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Coala Life Coala User Manual

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USER MANUAL COALA HEART MONITOR
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  • Page 1 USER MANUAL COALA HEART MONITOR – 1 –...
  • Page 2 “Made for iPhone” mean that an electronic accessory has been designed to connect specifically to iPhone and has been certified 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.

  • Page 3: Table Of Contents

    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 ..............
  • Page 4 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 –...

  • Page 5: Product Description

    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...
  • Page 6 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 notifications from your Healthcare provider.
  • Page 7 • 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 first use and ensure that the battery is charged regularly.
  • Page 8 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).

  • Page 9: Indication For Use

    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.

  • Page 10: Cautions

    • 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.
  • Page 11 • 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°...
  • Page 12 • 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.

  • Page 13: Warnings

    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 confirmation by medical examination.
  • Page 14 ICD (Implantable Cardioverter Defibrillator) as this may disturb your implantable device. • Do not use the Coala with a defibrillator. The Coala is not defibrillator proof and may be damaged or reduce the effectiveness of the defibrillation.

  • Page 15: Before Using The Coala

    Unpack the Coala and Charge Station, and place it on a flat 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 first as illustrated.
  • Page 16 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.
  • Page 17 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...
  • Page 18 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 first, as illustrated below.

  • Page 19: Getting Started

    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...
  • Page 20 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.
  • Page 21 Coala profile setup Before you are able to record measurements with the Coala and Coala App you will be required follow the steps of initial set up. The initial set up includes steps to set up your personal Coala profile and your Coala Atlas participation.
  • Page 22 Coala Atlas The first step of initial set up is to approve or deny Coala Atlas: Participating in Coala Atlas will allow your heart data and recordings to be used for cardiac research. Read text and select to: Participate - you will contribute with your personal details and heart data.
  • Page 23 The next step of initial set up is to enter health data to your personal profile. This data will be available to your approved healthcare provider in the Coala Care Portal. Your health data may be edited at any time under ‘My Profile’. – 23 –...
  • Page 24 Profile setup complete When the Coala profile setup is complete you will have a choice to pair the Coala to your smartphone now or later. NOTE! To record measurements with the Coala and Coala App the Coala must be paired to your smartphone.
  • Page 25 Pair the Coala to a Smartphone To record measurements with the Coala and Coala App the Coala must be paired to your smartphone. Follow these steps to pair the Coala to your smartphone: 1. Ensure Bluetooth is enabled on your smartphone: Bluetooth is found under ‘Settings’...
  • Page 26 3. Power on the Coala by briefly pressing the Power button on top of the Coala. Your Coala should now be blinking green in rapid succession. LED- blinking green in rapid succession POWER BUTTON- press to power on the Coala 4.
  • Page 27 5. When the Coala is connected, the large circle in the app turns blue. This indicates successful pairing between the Coala and your smartphone. You are now ready to record your first measurement. Please read the next chapter: ‘Best practices’ before initiating your first measurement recording in order to ensure the most accurate result.

  • Page 28: Best Practices

    • Sit down comfortably during the entire recording. • Avoid lying down or standing up. • Be extra careful to; hold Coala steady, be completely still and do not talk during the measurement recording. Do not stand up or move around.
  • Page 29 For correct placement of the Coala for chest ECG and heart sound recordings, see diagram below. Hold the Coala between your thumb and middle finger. Place the Coala slightly to the left of your sternum (chest bone) as shown. It is important that the Coala is held upright (COALA text facing down).
  • Page 30 The diagram below shows incorrect placement of the Coala for chest ECG and heart sound recordings. – 30 –...
  • Page 31 For correct finger placement for thumb ECG recording. Place your thumbs on top of electrodes as shown in diagram below. For best possible recording, hold Coala in a relaxed position resting your forearms on a table or on your legs when sitting down.

  • Page 32: Record The First Measurement

    09 Record the first measurement Follow these steps to record your first measurement: 1. Power on the Coala by briefly pressing the Power button . Your Coala LED light should be blinking green in rapid succession. LED- blinking green in...
  • Page 33 2. The large circle in the main screen of the Coala App should turn blue to indicate that the Coala has connected (if the circle remains pink please see “Pair the Coala to your smartphone” . Sit down and relax for a few minutes before starting the recording to ensure that your heart rate is at rest and for the most accurate reading.
  • Page 34 3. Sit down (do not stand or lie down). Hold the Coala firmly against your upper chest slightly to right of sternum as shown in the image. Press the ’Heart button‘ on the Coala to start recording. – 34 –...
  • Page 35 Breathe calmly, relax and stay quiet. Do not talk and remain seated during recording. Continue to hold Coala firm and steady to your chest until recording is complete, and then remove the Coala from your chest. – 35 –...
  • Page 36 5. Place thumbs on electrodes and hold the Coala firmly to perform a 30 second thumb recording as shown. For the most accurate result; rest your forearms on a table, breathe calmly, relax and stay quiet. Do not talk during recording.
  • Page 37 6. Once the recording is complete, select description of how you felt before the recording. To enter free text in attachment to the recording select ‘Other, please specify’. – 37 –...
  • Page 38 Take caution to enter correct values and press ’Save‘. (To modify unit settings for weight and height entries in the Coala App go to ‘My Coala’). Press ‘Continue’ when your entry is compete. – 38 –...
  • Page 39 If not, the recording will be sent once you have sufficient internet access. Note: Coala Life is not responsible for any additional charges your cellphone provider may charge for sending recordings to Coala Care Portal.
  • Page 40 30 sec thumb recording. The visible ECG tracing in the app is from the thumb recording. Note that the result indicated in the Coala App is a combined analysis of the thumb and chest ECG. – 40 –...
  • Page 41 10. If the Coala detects an abnormal result, the user is informed of the deviating result by a pink circle indicating the average heart rate of the 30 sec thumb recording. There is also be a short description of the result below the ECG-tracing of the thumb recording.
  • Page 42 11. Your first recording is now complete. Find previous recordings along with measurement result under ‘My Journal’ in the Coala App on your smartphone. Note: Internet access is needed to access recordings. Please see the next chapter “My Journal” p. 40 for more information.

  • Page 43: My Journal

    10 My Journal To review previous recordings, return to the home screen in the Coala App and select ’My Journal‘. ’My Journal‘ displays all previously recorded measurements along with features for reviewing the recorded data. NOTE! Recordings are not stored on your smartphone, so Internet access is needed to view recordings.
  • Page 44 2. In the result screen; select the PDF symbol in the upper right corner to download a PDF file of the current measurement. Note: The smartphone used must have PDF reader, which does not come with the Coala App. – 44 –...
  • Page 45 3. The downloaded PDF can be can be saved on to your smartphone, printed or sent by text message or email. The first page of the PDF is the chest ECG tracing and the second page is the thumb ECG tracing. Default settings for ECG tracings in PDF file format will be: Chest measurement, 40 mm/...
  • Page 46 For more information about the ECG tracings and how to interpret them see the chapter “ECG Categorization”. – 46 –...
  • Page 47 Trend plot measurements Return to ’My Journal‘ and select the trend plot symbol (upper right corner) to trend plot; measurements, blood pressure and weight as shown in the diagram below. – 47 –...

  • Page 48: My Profile

    11 My Profile To edit your Coala profile, return to the home screen in the Coala App and select ’My Profile‘. ’My Profile’ contains all the information attached to the Coala profile. This was entered when logging in to the Coala App for the first time and may be edited at any time.

  • Page 49: My Coala

    12 My Coala To modify settings and obtain more information about the Coala Heart Monitor, return to the home screen in the Coala App and select ’My Coala‘. ’My Coala‘ contains information and settings as well as useful links to the Coala Life website for more information.
  • Page 50 Device information Here the user may review information about the Coala Heart Monitor and App. Note that the Coala Heart Monitor needs to be powered on and paired to your smartphone for information to be displayed. – 50 –...
  • Page 51 Activate to disable the recording of heart sounds. Health App integration* Here the user may connect the Coala App to Apple Health: Follow the on screen instruction to transfer your heart rate recorded with the Coala App to Apple Health on your iPhone.
  • Page 52 When the box to participate has been checked the option to participate anonymously will appear. Read the text and check the box to join Coala Atlas or not. – 52 –...

  • Page 53: My Inbox

    13 My Inbox To view messages sent to your Coala App from Coala Life or any approved healthcare provider, return to the home screen and select ’My Inbox‘. – 53 –...

  • Page 54: Coala Led Indications

    14 Coala LED indications LED- blinking green in rapid succession Blinking blue Coala is charging. Solid blue Coala has finished charging and is now fully charged. Slow blinking green Power on. Rapid blinking green Bluetooth pairing mode for pairing with a smartphone.
  • Page 55 Blinking yellow Low battery indication. Solid yellow Battery empty or internal error. Do not use Coala and consult Troubleshooting section of this manual. – 55 –...

  • Page 56: Coala Ecg Categorization

    If no heart rhythm deviations are detected in the recorded measurement the measurement will be categorized as Category 1 “Your results appear normal”. For more information on Coala ECG categorization go to ‘Category description’ under ‘My Coala’ in the Coala App. – 56 –...
  • Page 57 Your results appear normal Coala indicates signs of atrial fibrillation Coala indicates skipped heart beats Coala indicates a fast heart rhythm Coala indicates shorter sequences of faster or slower beats Coala indicates recurring extra heart beats Coala indicates recurring extra heart beats...
  • Page 58 Category 1 No Rhythm Deviation (Only insignificant irregular beats present). Category 2 Irregular Sequence (Unexplained irregularities, which may be AF or paroxysmal AF with or without detected P waves). – 58 –...
  • Page 59 Category 3 Coala has detected skipped beats, that may be AV Block II. Category 4 Coala has detected an increased heart frequency (tachycardia). – 59 –...
  • Page 60 Category 6 Coala has detected sudden sequences of faster or slower beats. Category 7 Coala has indicated the occurrence of extra beats with bigemini patterns and detected P waves. – 60 –...
  • Page 61 Category 8 Coala has indicated the occurrence of extra beats with trigemini patterns and detected P waves. Category 10 Coala has indicated the occurrence of more than 5 SVES (extra strokes) in the analysis. – 61 –...
  • Page 62 Category 11 Coala has indicated the occurrence of more than 5 VES (extra strokes) in the analysis. Category 12 -0.5 Your results appear normal, but Coala indicates a slightly irregular heart frequency, also known as arrhythmia. – 62 –...
  • Page 63 Individual categorization vs. combined categorization The result categories found in/for individual ECG s (chest ECG or thumb ECG), as available in the downloaded PDF are not the equivalent of the combined ECG categorization of the measurement as a whole. The combined result categorization is always the most accurate and takes into account both the chest and thumb ECG s recorded.

  • Page 64: Troubleshooting

    16 Troubleshooting The Coala App provides the user with step-by-step instructions on how to record and where to hold Coala when measurements are recorded. Issue Solution Unable login to the Coala Make sure that you have App. the correct user name and password.
  • Page 65 Issue Solution Unable to start a new Make sure that Coala unit is measurement recording. powered on and connected to the smartphone. The circle in the app needs to be blue before you can start a recording. Unable to find my previous All recordings are stored in recordings.
  • Page 66 Solution Unable to power on the Make sure that the battery Coala. hasn’t depleted. Place Coala into Coala Charge Station and connect to a power source. The Coala should start blinking blue indicating that it is being charged, if not contact Coala customer support.
  • Page 67 Issue Solution Unable to pair the Coala to Place Coala into the Charge smartphone. Station and connect the USB cable between the Coala and a power source. The Coala should start blinking slow blue. Hold down the power button for 8 seconds and take the Coala out of the Charge Station.
  • Page 68 Issue Solution The Coala LED indicates a Battery empty or the Coala steady yellow light followed has detected an internal by auto-power off. error. Place in Coala Charge Station for charging. If problem persists, do not use device and contact Coala customer support.
  • Page 69 This will enable normal ECG recording but heart sounds will not be recorded. Restart the measurement. Unable to open the PDF Make sure that smartphone measurement file. has a program to read PDF. This does not come with the Coala App. – 69 –...
  • Page 70 Issue Solution The Coala LED indicates a 1. Place the Coala into the steady yellow light or shows Charge Station and connect signs of internal error. to a power source. 2. Hold down both buttons (on/off button and heart button) for more than 10 seconds.

  • Page 71: Storage

    17 Storage Store the Coala indoors in the supplied travel bag with the cover to protect the membrane and the electrodes. Temperature +5 °C to +35 °C / 41 to 95 °F. Humidity 15 % to 90 %, non-condensing. Air Pressure 700 to 1060 hPa /10.2 to 15.4 psi.

  • Page 72: Cleaning And Maintenance

    18 Cleaning and maintenance Use only a wet cloth or alcohol to clean Coala and accessories. Do not use other solvents like acetone or petroleum-based chemicals. For Multi use Coala please clean the Coala between different users with 70% Alcohol.

  • Page 73: Transceiver Properties

    The maximum current on the noise suppression electrode is limited to <10 µA. 20 Transceiver properties The Coala device has an integrated radio transceiver with the properties: Frequency band: 2400 – 2483.5 MHz Maximum emitted radiation power: Less than 10 mW...

  • Page 74: Electrical Emission

    21 Electrical emission The Coala fulfills: CISPR 11 Class B (2009): Radiated and conducted emission IEC 61000-3-2 (2014): Harmonic current emission IEC 61000-3-3 (2013): Voltage fluctuations and flicker 22 Electrical immunity The Coala fulfills: IEC 61000-4-2 (2008): Immunity to electrostatic discharge Test level ±8 kV contact discharge ±2, ±4, ±8 and ±15 kV air...
  • Page 75 input port ± 2,0 kV IEC 61000-4-5 (2006): Surge immunity test Test levels on AC Power input port: AC Power input port, ±0,5 kV and ±1,0 kV differential mode. IEC 61000-4-6 (2014): Immunity to conducted disturbances in the frequency range 0,15 – 80 MHz Test levels on AC Power input port: 6 Vrms with 80 % AM @ 2 IEC 61000-4-8 (2009): Immunity to power frequency magnetic fields...

  • Page 76: Warnings Related To Electromagnetic Compatibility

    Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (1 foot) to any part of the Coala, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

  • Page 77: Symbols Used In System And Package Label

    24 Symbols used in system and package label Type BF (Body Floating) Applied Part (Coala device). Note that the Coala Charge Station is IT- equipment and not type BF. Refer to instruction manual European Conformity Mark 0086 Radio transmitter Stand-by on/off IP22 IP (Ingress Protection) Class 22.
  • Page 78 WEEE – Properly Dispose of Electronic Waste Input/output voltage and current 300 mA Serial number. The serial number for your Coala is found under My Coala in Coala App. Batch number Manufacturer/manufacturing date. The manufacturing date of your Coala is found under My Coala in Coala App.
  • Page 79 Humidity limits Atmospheric pressure limits 106 kPa 70 kPa Keep dry Fragile, handle with care Do not use if package is damaged Consult instructions for use Part number FCC ID: 2ALO7CHM FCC ID – 79 –...

  • Page 80: Specifications

    25 Specifications Performance Characteristics ECG Channels Single channel with noise suppression electrode Frequency Response DC to 150 Hz (chest mode only) Amplitude Accuracy Better than 2% for a 500 µV signal Input Impedance > 100 MΩ Sampling Frequency 1 kHz Resolution 24 bit DC Input Offset Range...
  • Page 81 Battery Life Minimum of 40 recordings per charge. Make sure the battery is charged regularly and fully charged before first use Coala Charge Station 5 VDC, 300 mA minimum, Micro- Input USB type A connector. Any external USB wall adapter,...
  • Page 82 EN 301489-17. FCC 47 CFR Part 15.247 Subpart C Physical Characteristics Coala 49×51×18 mm, 36 grams / 1.93x2.01x0.71 in, 1.27 oz Coala Charge Station 71×73×12 mm, 50 grams / 2.80x2.87x0.47 1.76 oz USB Cable 1m length, USB in, type A to Micro-USB connectors...
  • Page 83 Body Interface Electrical safety Coala device is type BF (Body Floating) Three surgical-grade stainless steel (316L) ECG electrodes in contact with the skin. Membrane Polymer membrane in contact with the skin. Compatible with iPhone 5 or later with iOS8.x or later or smartphone with Android 4.4 KitKat and all later versions.

  • Page 84: Contact Information To The Manufacturer

    26 Contact information to the manufacturer Coala Life AB Riddargatan 18 114 51 Stockholm Sweden www.coalalife.com info@coalalife.com – 84 –...
  • Page 85 For the latest manual and current information on your product, please visit www.coalalife.com/manual. For support or a printed copy of this manual, please email support@coalalife.com or visit www.coalalife.com – 85 –...
  • Page 86 005052/A (EN) 2019-09-19 FOLLOW YOUR HEART ® For more support please visit www.coalalife.com – 86 –...

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