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Coala Life Coala User Manual

Heart monitor
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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

    Contraindications ............ 8 Cautions ..............9 Warnings ............... 12 Storage ..............15 Cleaning and Maintenance ........16 Using the Coala ............. 16 Coala LED indications..........50 10. ECG Categorization ..........51 11. Troubleshooting ............ 56 12. Electrical safety ............ 63 13.

  • Page 4: Product Description

    Coala Heart Monitor. 1. Product Description The Coala Heart Monitor is a patented medical device. It records clinical quality ECG (electrocardiogram) and heart sounds simultaneously. The device can be used by both healthcare professionals and health conscious individuals.
  • Page 5 • The Coala app that is installed on a smartphone and is used to perform measurement together with Coala, collect and view recordings. The Coala app transmitts recordings to the Coala Care Portal and receives analyzed results from the same server. It also features a messaging system where you can receive notifications from your Healthcare professional.
  • Page 6 The Coala Heart Monitor is intended to be used by a single individual to: • Record simultaneous ECG and heart sounds. • Recieve results from detection of cardiac rhythm deviation. • Annotate each recording with symptoms or free text. • Access recordings from the Coala Care Portal and download pdf file recordings.
  • Page 7 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 8: Indications 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. 3. Contraindications There are no known contraindications for Coala Heart Monitor.

  • Page 9: Cautions

    • 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 dustproof.
  • Page 10 • Do not use for any purpose other than to obtain ECG and sound recordings. • 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 using on humans weighing less than 10 kg.
  • Page 11 • The Coala should be applied only to intact, clean skin (e.g., not over open wounds, lesions, infected, or inflamed areas). • 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 12: Warnings

    • Contact Coala Life of any signs of malicious system behaviour, suspicions of malware or system cybersecurity violations. • Coala Life does not recommend using on individuals with a cardiac pacemaker, ICDs or other implanted electronic devices. • Maximum T-wave amplitude is 1.5 times the QRS amplitude for correct display of heart rate.
  • Page 13 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 14 • Do not connect the Coala Charge Station to any power source or external equipment other than described in this manual. • Do not dispose in fire. Contains lithium battery that may explode. Dispose as electronic waste according to local regulations.

  • Page 15: Storage

    6. 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 16: Cleaning And Maintenance

    7. Cleaning and Maintenance Use only a wet cloth or alcohol to clean the Coala and accessories. Do not use other solvents like acetonce och petroleum based chemicals. There are no parts that need regular service or maintenance. Cleaning and maintenance: For Multi use Coala please clean the Coala between different users with 70% Alcohol.
  • Page 17 If not, repeat the steps above and make sure that the Coala has been correctly placed in the Coala Charge Station. The Coala will show a steady blue light once it is fully charged (up to about 2 hours charging time).
  • Page 18 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 wall adapter are IO type equipment and do not carry the type BF (Body Floating) medical electrical safety rating that the Coala does.
  • Page 19 Enter the username and password you chose when you signed up for the service. Follow the intuitive instructions in the app to set up your personal Coala account. If you wish to be included in the Coala Atlas, enter your personal details.
  • Page 20 8.5. Pair the Coala to your phone Use these steps to connect your Coala to the Coala App on your phone. 1. Make sure that your bluetooth is not connected to another device when you make recordings with the Coala Heart Monitor.
  • Page 21 Place the Coala slightly to the left of your sternum (chest bone) and slightly above your nipple as shown below. It is important that the Coala is upright (Coala text facing down). Press the heart button with your index finger to start a recording and hold the Coala steady during the recording.
  • Page 22 See below the wrong location of Coalan for breast measurement. – 22 –...
  • Page 23 For more tips, see www.coalalife.com NOTE! Ohis user manual is found in the Coala App under My Coala -> Manual. Ohe serial number and manufacturing date of your Coala is found under My Coala box. – 23 –...
  • Page 24 A deviating result could occur with high heart rate from physical activity or from other factors. Click on the Start button in Coala App. Press the Coala against the chest. Push the ”Heart” button on the Coala to start the recording.
  • Page 25 8.10. Device settings and data transfer To modify device settings and obtain more information on the Coala device, click on “My Coala” from the main menu of the Coala App. The settings that can be changed is related to sound recording.
  • Page 26 You will also be able to Connect to Health see instruction under “Connect to the Health app”. – 26 –...
  • Page 27 For security reasons you will not be able to login to Coala App for 20 minutes if you have entered the wrong password 3 times. You have to check: I agree and accept Coala User and Privacy Terms.
  • Page 28 Before you can connect your Coala and perform your first measurement you will be prompted to fill in some health data. Start by pressing Continue. – 28 –...
  • Page 29 The first question is if you would like to participate in the Coala Atlas. If you would like to participate anonymously, make sure that you scroll down to the link in the text shown above. Anonymization can also be changed in the app settings later.
  • Page 30 Next step is to start filling in Select gender. your heath data. – 30 –...
  • Page 31 Input your length. Scroll up or Input your weight. Scroll up down and press next. or down and press next. – 31 –...
  • Page 32 Medication status. If yes, fill in Press Add Medication. the following steps. – 32 –...
  • Page 33 Select the medication type that Add the medication that you you have. You cannot fill in the have by pressing Add more exact name of your pre-scripted medications. Once done medication. press next. – 33 –...
  • Page 34 Smoking status. Pacemaker status. – 34 –...
  • Page 35 This is a summary of all the inputs you have done. Confirm by pressing Ready. – 35 –...
  • Page 36 Switch on your Coala by pressing the On-button, , on the Coala. Ensure you have Bluetooth enabled on your smartphone (this is found under “settings” on your smartphone). – 36 –...
  • Page 37 When the Coala is connected, the large circle turns blue. Relax and sit down for a minute before starting a new recording to ensure that your heartrate is at rest. This is important in order for the analysis to be accurate. Tap “Start” to start a new recording.
  • Page 38 Sit down comfortably (do not stand or lie down). Hold the Coala fi rmly against your chest as indicated on the picture. Place and hold the Coala against your upper chest slighly right of the sternum according to the picture. Press the ”Heart”...
  • Page 39 The Coala fi rst checks for proper skin contact and then starts the 30 second recording with a visual countdown. Breathe calmly, relax and stay quiet. Do not talk during recording. Remain seated during recording. Continue to hold the Coala fi rmly and steadly to your chest.
  • Page 40 Next step is to perform a 30 second thumb-recording. Hold the Coala fi rmly as instructed in the picture. For the most accurate result rest your forearms on a table. Breathe calmly, relax and stay quiet. Do not talk during recording.
  • Page 41 Once the recording is completed, specify how you felt prio to the recording. – 41 –...
  • Page 42 You can also enter the blood pressure (Systolic and Diastolic) and weight. Take caution to enter correct values. – 42 –...
  • Page 43 Your recording is now sent for analysis in the Coala Care Portal. Ensure you have suffi cient internet access. If not, the recording will be held in a queue. Try again later to send the recording. Note that Coala Life is not responsible for any additional extra cost to your internet provider.
  • Page 44 10. The analysis is ready. If a normal result is found, then the user is informed and a blue circle appears with average heart rate of the 30 sec thumb recording. Displayed heart rate is an average of the 30 second recording.
  • Page 45 11. If Coala detects an abnormal result, the user is notifi ed of the result. In such case, always conduct a second recoding to verify the results and pay particular attention in holding the Coala steady during the recording. – 45 –...
  • Page 46 12. All your recordings are saved in your Journal which is easily accessed from the Trend plot Main Menu. Note: Internet access is needed to access recordings. 13. Click on the trend plot symbol (upper right corner) then you have the possibilty to trend measurements, blood pressure and weight see...
  • Page 47 14. To access your ECG in a PDF-format, click on the symbol in the right upper corner of the results screen. The mobile device used needs to have a pdf reader. This does not come with the Coala application. – 47 –...
  • Page 48 The mobile device used needs to have a pdf reader. This does not come with the Coala application. The upper part of the PDF is the chest-ECG and the lower section the thumb-ECG.
  • Page 49 For more infomation about the ECG curve and how to interpret them see section 10. ECG Categorization. – 49 –...
  • Page 50 Close the App when not in use. My Inbox: Messages and caregiver access requests from your physican. My Profi le: Personal information and log out from Coala App. My Coala: Connected health care providers, device information, more information about analysis categories, Robust Recording...

  • Page 51: Coala Led Indications

    Bluetooth pairing mode for pairing with a smartphone. Steady green Active recording of ECG and heart sounds. Blinking yellow Low battery indication. Steady yellow Battery empty or internal error. Do not use Coala and consult the Troubleshooting section of this manual. – 51 –...

  • Page 52: Ecg Categorization

    Coala indicates an irregular heartbeat which may indicate atrial fibrillation (Cat. 2) Coala indicates skipped heart beats (Cat. 3) Coala indicates a fast heart rhythm (Cat. 4) Coala indicates signs of palpitation (Cat. 5) Coala indicates shorter sequences of faster or slower beats (Cat.
  • Page 53 Coala indicates recurring extra heart beats (Cat. 10) Coala indicates recurring extra heart beats (Cat. 11) 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 P waves)
  • Page 54 Category 3 Pause/AV Block II (or beats longer than 2.2s.) Category 4 Fast Regular (RR interval shorter than 600ms in entire signal.) Category 5 RR interval shorter than 600ms in entire signal and QRS duration larger than 120ms. – 54 –...
  • Page 55 Category 6 Fast/Slow Sequences (Shorter sequences of faster or slower beats) Category 7 Bigemini (patterns with P waves detected) Category 8 Trigemini (patterns with P waves detected) – 55 –...
  • Page 56 Category 10 More than 5 SVES detected over 30 seconds (only 10 seconds in the ECG above) Category 11 More than 5 VES detected over 30 seconds (only 10 seconds in the ECG above) Note that the color bars in the images above are not visible in the PDF presented in the app.

  • Page 57: Troubleshooting

    11. Troubleshooting 11.1. Troubleshooting The Coala App helps the user by step-by-step instructions how to perform a recording and where to apply the Coala. To access Device information such as firmware and software revisions, please see “Device Information” under “My Coala”...
  • Page 58 Issue Solution I can’t start a recording. Make sure that the Coala unit is powered on and connected to the mobile unit. The circle in the app needs to be blue before you can start a recording. I can’t find my previous All recordings are stored in recordings.
  • Page 59 Issue Solution I cannot power on the Coala. Make sure that the battery hasn’t depleted. Place the Coala in the charge station and make sure that the station is powered. The Coala should start blinking blue indicating that it is being charged, if not contact Coala customer support.
  • Page 60 The Coala cannot connect to Make sure Bluetooth is mobile device. enabled on the phone. Make sure, that the Coala is in connection mode. This is done by placing the Coala in the charge station. Make sure that the charge station is powered and the Coala is blinking blue.
  • Page 61 Issue Solution Steady yellow light followed Battery empty or the Coala by auto-power off. has detected an internal error. Place in the Coala Charge Station for charging. If problem persists, do not use device and contact Coala customer support. The recording stopped in the The Coala needs to have middle of the measurement.
  • Page 62 ECG- recording but no heart sounds will be recorded. Restart the measurement. I cannot open the PDF-files. Make sure that the mobile unit has a program to open pdf-files. This does not come with the Coala application. – 62 –...
  • Page 63 Issue Solution If the Coala have a steady Place the Coalan in your yellow light. charge station. 2. Hold down both buttons (on/off button and heart button) for more than 10 seconds. 3. When Coalan lights blue, release the “on/off button”...

  • Page 64: Electrical Safety

    12. Electrical safety The Coala Heart Monitor fulfills the Medical European Device Directive. • IEC 60601-1:2006 and amendment 1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. • IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance –...

  • Page 65: Transceiver Properties

    13. 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 R&TTE European Directive compliance statement: Coala-Life AB, declares that this Coala Heart Monitor is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.

  • Page 66: Electrical Immunity

    15. 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 67 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 68: Warning 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 feet) to any part of the Coala, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

  • Page 69: Symbols Used On System And Package Label

    17. Symbols used on 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 70 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 71 Humidity limits 106 kPa Atmospheric pressure limits 70 kPa Keep dry Fragile, handle with care Do not use if package is damaged Consult instructions for use Partnumber MR unsafe – 71 –...

  • Page 72: Specifications

    18. 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 73 Battery Life Minimum of 40 recordings per charge. Make sure the battery is charged regularly and charged to full at first use Coala Charge Station 5 VDC, 300 mA minimum, Micro- Input USB connector. Any external wall adapter used to...
  • Page 74 EN 300 328, EN 301489-1 and EN 301489-17 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...
  • Page 75 700 to 1060 hPa /10,2 to 15,4 psi Expected Service Life 1 year Shelf life 1 year 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.

  • Page 76: Contact Information To The Manufacturer

    19. Contact information to the Manufacturer Coala Life AB Riddargatan 18 114 51 Stockholm Sweden www.coalalife.com info@coalalife.com – 76 –...
  • Page 77 For the latest manual and current information on your product, please visit www.coalalife.com/usermanual. For support or a printed copy of this manual, please email support@coalalife.com or visit www.coalalife.com – 77 –...
  • Page 78 SP 16-002/F 2018-05-04 FOLLOW YOUR HEART ® For more support please visit www.coalalife.com – 78 –...

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