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Coala Life HEART MONITOR Rx User Manual

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USER MANUAL COALA HEART MONITOR Rx
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  • Page 1 USER MANUAL COALA HEART MONITOR Rx – 1 –...
  • Page 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.

  • Page 3: Table Of Contents

    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 .......
  • Page 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 –...

  • Page 5: Product Description

    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...
  • Page 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.
  • Page 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 first use and ensure that the battery is charged regularly.
  • Page 8 Chest and thumb ECG Coala measurements consist of two consecutive recordings; the chest recording and the thumb recording. The chest recording is executed first by pressing the Coala membrane firmly to the chest, slightly to the left of your sternum. The thumb recording is executed by firmly pressing both thumbs onto the electrodes located on the bottom of the Coala.

  • Page 9: Indication For Use

    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 fibrillation (when prescribed or used under the care of a physician).

  • Page 10: Cautions

    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 inflamed areas). • Not suitable for direct cardiac application (intact skin only). •...
  • Page 11 • 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 first. •...
  • Page 12 • 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.

  • Page 13: Warnings

    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. •...
  • Page 14 • Interpretations made by this device are potential findings, 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.
  • Page 15 • It is not recommended to place a mobile phone directly next to a pacemaker or ICD (Implantable Cardioverter Defibrillator) as this may interfere 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 16: Before Using The Coala

    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.
  • Page 17 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 first as illustrated below. Unpack the supplied Wall Adapter and connect the USB Cable between the Charge Station (small USB plug) and Wall Adapter (large USB plug).
  • Page 18 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.
  • Page 19 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.
  • Page 20 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 first as illustrated below. Do not use extensive force when lifting the Coala out of the Charge Station, this will damage the device –...

  • Page 21: Getting Started

    07 Getting started Download the Coala App Download the Coala App from App Store or Google Play. Search for the ’Coala App‘ and follow the instructions on your Smartphone to install the app. Open the app and log in Open the Coala App and login using the details that were provided by your Healthcare professional (email and...
  • Page 22 Coala’s user and privacy terms. To read the terms click on the text: ‘Coala User and Privacy Terms’. Click: ‘Log in’ when you are ready. The first time logging in to the Coala App on your Smartphone you will be asked to allow Coala notification and location requests.
  • Page 23 Coala profile setup Before you are able to record measurements with the Coala Heart Monitor and App you will be required to follow the steps of initial set up. The initial set up includes steps to set up your personal Coala profile and Coala Atlas participation.
  • Page 24 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 - to participate with your personal details and heart data.
  • Page 25 Health data The next step of initial set up is to enter health data to your personal Coala 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’.
  • Page 26 Profile setup complete When the Coala profile setup is complete you will have to confirm the entries you have made by clicking: ‘Ready’. This is the last step of setting up your personal Coala profile. NOTE! To record measurements with the Coala Heart Monitor and App your Coala must be paired to your Smartphone.
  • Page 27 Pair the Coala to your Smartphone When you have completed the steps of initial set up you will now have a choice to pair the Coala to your Smartphone; now or later. Follow the steps on the following pages to pair the Coala to your smartphone: 1.
  • Page 28 2. Ensure Bluetooth is enabled on your Smartphone. Bluetooth is found in your Smartphone under ‘Settings’. 3. Ensure to disable all Bluetooth connections to previously paired devices when connecting your Coala for the first time: Go to ‘Settings’ in your Smartphone to disconnect Bluetooth devices.
  • Page 29 4. 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 indicating it is ready for pairing to your Smartphone. LED- blinking green in rapid succession POWER BUTTON- press to power on the Coala –...
  • Page 30 5. Go back to the Coala App. 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 best quality recording.

  • Page 31: Best Practices

    08 Best practices Sit down and relax a few minutes before recording measurements with the Coala to ensure the most accurate reading. Before initiating the measurement recordings make sure to: • Sit down comfortably during the entire recording. • Avoid lying down or standing up. •...
  • Page 32 questions about your health contact your Healthcare provider. 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 firmly to the left of your sternum (chest bone) as shown.
  • Page 33 The diagram below shows incorrect placement of the Coala for chest ECG and heart sound recordings. – 33 –...
  • Page 34 For correct finger placement for thumb ECG recording, see diagram below. 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 35: Record Your First Measurement

    09 Record your first measurement Follow these steps to record your first measurement with the Coala Heart Monitor and App: 1. 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 36 3. 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” . Click ’Start‘ to start a new recording. –...
  • Page 37 4. Sit down (do not stand or lie down) and hold the Coala firmly against your upper chest, slightly to the left of your sternum as shown in the diagram. Click the ’Heart button‘ on the Coala to start recording. –...
  • Page 38 5. Before recording the Coala checks for adequate skin contact and then starts the 30 second recording with a visual countdown. 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...
  • Page 39 6. 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 40 7. Once the recording is complete, enter a “feeling” to describe how you felt before the recording. To enter free text in attachment to the recording select ‘Other, please specify’ and enter text. – 40 –...
  • Page 41 8. There is also an option to enter blood pressure (Systolic and Diastolic) and weight in attachment to the recording. Take caution to enter correct values and click ’Save‘. (To modify unit settings for weight and height entries in the Coala App go to ‘Settings’ under ‘My Coala’).
  • Page 42 9. The recording is now sent for analysis in the Coala Care Portal. Ensure you have sufficient internet access, so the recording can be sent to the server. If not, the recording can be sent once you have sufficient internet access. To resend the recording for analysis go to ‘My Journal’...
  • Page 43 10. When the analysis is complete, the result screen will be displayed in the Coala App indicating the result of the measurement analysis. If the result is normal, the result screen will display a blue circle enclosing the average heart rate of the 30 sec thumb recording.
  • Page 44 ECG tracing of the thumb recording. Click on the text to access a full description of the result on Coala Life’s website. When an abnormal result occurs, always conduct a second recording to verify the result and pay particular attention to holding Coala steady during the recording.
  • Page 45 12. Your first recording is now complete. Find previously recorded measurements along with the analyzed result under ‘My Journal’ in the Coala App. NOTE! Internet access is needed to access recordings. Please see the next chapter ‘My Journal’ for more information. –...

  • Page 46: My Journal

    10 My Journal Return to the home screen in the Coala App and select ’My Journal‘, to view the results of all your previously recorded measurements. ’My Journal‘ will display all your previously recorded measurements in a list format along with features for reviewing the recorded measurement data.
  • Page 47 Download measurement PDF Follow these steps to download your ECG measurement recordings in a PDF format to; print, save or share with your Healthcare professional: 1. Select a measurement of interest from the list in ‘My Journal’. This will display the result screen of the measurement recordings.
  • Page 48 The downloaded measurement PDF can be saved to your Smartphone, printed, or shared with your Healthcare professional or recipient of choice. The first page of the PDF is the measurement’s chest ECG recording and the second page is the thumb ECG recording. Settings for the measurement PDF file are: Chest recording, 40 mm/mV, 25...
  • Page 49 For more information about the ECG tracings and how to interpret them see the chapter ‘ECG Categorization’. – 49 –...
  • Page 50 Trend plot measurements Return to ’My Journal‘ and select the trend plot symbol in the upper right corner to trend plot recorded measurement data over time. You may chose to plot; measurements, blood pressure or weight. You may also filter data plotted by a specific a time period;...

  • Page 51: My Profile

    11 My Profile Return to the home screen in the Coala App and select ’My Profile‘ to view or edit your personal Coala profile. In ’My Profile’ all the information attached to your personal Coala profile will be displayed. Information attached to your profile was entered when logging in to the Coala App for the first time and may be edited at any time.

  • Page 52: My Coala

    Coala‘ to modify any settings for the Coala Heart Monitor and App and to access more information about your device. ’My Coala‘ will display information and settings along with links to more information on Coala Life’s website. – 52 –...
  • Page 53 My Pages Select ’My Pages‘ to view and edit your password, subscription type, or the contact information accessible to your Healthcare provider in the Coala Care Portal. Approved Healthcare providers Select ‘Approved Healthcare providers’ to view or edit approved Healthcare providers. Approved Healthcare providers will have access to your recorded measurement data and general health information in the Coala Care Portal.
  • Page 54 Robust recording mode Select ‘Robust recording mode’ to disable the recording of heart sounds. Activate to counteract strong radio interferences from other wireless devices. Health App integration* Select ‘Connect to Health app’ to connect the Coala App to Apple Health: Follow the on screen instructions to transfer your heart rate recorded with the Coala App to Apple Health on your iPhone.
  • Page 55 Settings Select ‘Settings’ to access settings for: • Units - for weight and height entries, may be set to; ‘US/ Imperial’ or ‘SI/Metric’. • Paper size - for the downloaded measurement PDF, may be set to; ‘Letter’ or ‘A4’. • ‘Show help texts’...

  • Page 56: My Inbox

    13 My Inbox Return to the home screen in the Coala App and select ‘My Inbox’ to access messages sent to your Coala App from Coala Life or any approved Healthcare provider in the Coala Care Portal. – 56 –...

  • Page 57: Coala Led Indications

    14 Coala LED indications LED- indicates the status of your Coala Blinking blue Coala is charging. Solid blue Coala has finished charging and is now fully charged. Slow blinking green Powered on and connected to your Smartphone. Rapid blinking green Bluetooth pairing mode - ready for pairing to a Smartphone.

  • Page 58: Coala's Ecg Categorization

    Blinking yellow Low battery indication. Solid yellow Battery empty or internal error. Do not use Coala and consult Troubleshooting section of this manual. 15 Coala’s ECG categorization The result of Coala’s measurement analysis is categorized into an ECG categorization number. The ECG categorization indicated in the Coala App is based on the combined result of chest and thumb ECGs recorded for maximum accuracy.
  • Page 59 Category Description Poor quality (Difficult to follow the beat sequence) Your results appear normal Coala indicates an irregular heartbeat which may indicate atrial fibrillation (Cat. 2) Coala indicates an unclassified heart rhythm (Cat. 99) Category 1 No Rhythm Deviation (Only insignificant irregular beats present) –...
  • Page 60 Category 2 Irregular Sequence (Unexplained irregularities, which may be AF or paroxysmal AF without detected P waves). Individual vs. combined categorization The ECG categorizations found in/for individual recordings (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.

  • Page 61: Troubleshooting

    16 Troubleshooting The Coala App provides you with step-by-step instructions and best practices when recording measurements with the Coala Heart Monitor. For a list of current Software Anomalies see: www.coalalife.com/us/softwareanomalies Issue Solution Unable login to the Coala Make sure that you have App.
  • Page 62 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 on recordings.
  • Page 63 Issue Solution Unable to power on the Make sure that the battery Coala. has not 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 64 Issue Solution The Coala does not indicate Check that the USB cable a blue charging light when is correctly connected placed in the Coala Charge between the Charge Station Station. and a power source. Check that the Coala is correctly placed in the Charge Station.
  • Page 65 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 66 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 67 Issue Solution Recording failed-notification This means that your in app “The phone failed to smartphone does not receive enough data. Robust support enough data recording mode will be transfer to record the heart activated and the recording sounds. The application restarted”.
  • Page 68 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 69: Storage

    17 Storage Store 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. Do not store the device in: •...

  • Page 70: 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. There are no parts that need regular service or maintenance.

  • Page 71: Transceiver Properties

    Noise suppression electrode: A voltage is applied to the noise suppression electrode for active noise suppression of the sensing electrodes. 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 –...

  • Page 72: Electrical Immunity

    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 discharge. IEC 61000-4-3 (2006 + A1 + A2): Immunity to radiated electromagnetic fields in the frequency range 80 – 1000 MHz and 1,0 –...
  • Page 73 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 Test level: 30 A/m, 50 Hz and 60 Hz IEC 61000-4-11 (2004): Voltage Dips and Interruptions Test levels on AC Power input port: Test frequency: 50 Hz.

  • Page 74: Warnings Related To Electromagnetic Compatibility

    23 Warnings related to electromagnetic compatibility Coala is designed to withstand expected electromagnetic interference. If Coala is exposed to electromagnetic interference exceeding what is expected corrupted measurements could occur or even permanent failures. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.

  • Page 75: 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 Radio transmitter Stand-by on/off IP22 IP (Ingress Protection) Class 22.
  • Page 76 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 77 Keep dry Fragile, handle with care Do not use if package is damaged Consult instructions for use Part number MR unsafe FCC ID: 2ALO7CHM FCC ID – 77 –...

  • Page 78: Specifications

    25 Specifications Performance Characteristics ECG Channels Single channel with noise suppression electrode Frequency Response DC to 150 Hz (raw data in Coala Care Portal) Amplitude Accuracy Better than 2% for a 500 µV signal Input Impedance > 100 MΩ Sampling Frequency 1 kHz Resolution 24 bit...
  • Page 79 Heart sound Frequency Range 20 – 500 Hz Sampling Frequency 4 kHz Power Requirements Battery Type Internal rechargeable lithium- polymer (Non replaceable) 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...
  • Page 80 Frequency Band 2.400-2.4835 GHz Maximum Emitted < 10 mW Radiation Power Radio Protocol Bluetooth Transceiver Compliance EN 300 328, EN 301489-1 and EN 301489-17. FCC 47 CFR Part 15.247 Subpart C FCC NOTE: This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
  • Page 81 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 3 ft length, USB in, type A to Micro-USB connectors Environmental Specifications Operating Temperature +5 °C to +35 °C / 41 to 95 °F Operating Humidity 15 % to 90 %, non-condensing Operating Air Pressure...
  • Page 82 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 83: Contact Information To The Manufacturer

    26 Contact information to the manufacturer Coala Life AB Kålsängsgränd 10B 753 19 Uppsala Sweden www.coalalife.com/us info@coalalife.com – 83 –...
  • Page 84 For the latest manual and current information on your product, please visit www.coalalife.com/us/manual. For support or a printed copy of this manual, please email info@coalalife.com or visit www.coalalife.com/us/support – 84 –...
  • Page 85 005009/E 2020-04-01 FOLLOW YOUR HEART ® For more support please visit www.coalalife.com/us – 85 –...

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