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02  Indication for use

The Coala Heart Monitor is intended for self-testing by 
patients to record, store, transfer and display surface ECG and 
sound to aid the detection of heart and respiratory conditions. 
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.

Содержание Coala

Страница 1: ... 1 USER MANUAL COALA HEART MONITOR ...

Страница 2: ...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 ...

Страница 3: ...3 06 Before using the Coala 15 07 Getting started 19 08 Best practices 28 09 Record the first measurement 32 10 My Journal 43 11 My Profile 48 12 My Coala 49 13 My Inbox 53 14 Coala LED indications 54 15 Coala ECG categorization 56 16 Troubleshooting 64 17 Storage 71 18 Cleaning and maintenance 72 19 Electrical safety 72 ...

Страница 4: ...es 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 ...

Страница 5: ...website www coalalife com device compatibility 01 Product description The Coala Heart Monitor is a patented medical device that records clinical quality ECG electrocardiogram and heart sounds simultaneously The device can be used by both healthcare professionals and health conscious individuals to record ECG in a home healthcare environment whenever they are feeling symptoms The ECG and heart soun...

Страница 6: ...artphone is used together with the Coala Heart Monitor to record transmit and view measurements directly in your smartphone 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 provi...

Страница 7: ...and storage The Coala Heart Monitor is intended to be used by a single individual to Record simultaneous ECG and heart sounds Annotate each recording with symptoms or free text Wirelessly transfer and receive results from detection of cardiac rhythm deviation Access previous Coala recordings from the Coala Care Portal server Print or save ECG recordings to a PDF format to send to your Clinician or...

Страница 8: ...ent of valves in the heart create heart sounds that can be used for assessing the mechanical condition of the heart 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 The unique Coala feature is the ability to record simultaneous ECG and heart sounds This comb...

Страница 9: ...on of heart and respiratory conditions 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 ...

Страница 10: ... 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 for use on infants less than 12 months old Due to chest size and electrode placement Coala Life does not recommend use on humans weighing less than 10 kg A successful chest recording may not be possible if the device is applied to a...

Страница 11: ... 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 flat position with stethoscope membrane turned down Note The Charge Station and USB cable do not carry an IP rating and are only to be used in a dry environmen...

Страница 12: ... 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 filters may distort baseline properties and high frequency response of the ECG signal The full signal without filters is available for healthcare professionals ...

Страница 13: ...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 Do not attempt self diagnosis or self treatment based on the recording results and analysis Always consult a medical professional This device is not intended to be operated by children or p...

Страница 14: ... not defibrillator proof and may be damaged or reduce the effectiveness of the defibrillation Do not use device in explosive environments mines oil rigs fueling stations oxygen rich environments such as hyperbaric chambers or in the presence of flammable anesthetics Do not connect the Coala Charge Station to any power source or external equipment other than described in this manual Do not dispose ...

Страница 15: ...listed on the Coala Life website www coalalife com device compatibility Unpack and charge 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 ...

Страница 16: ...nect 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 ...

Страница 17: ...ge 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 since the Coala Charge Station and connected USB power source are IO type equipment and do not carry the type BF Body Floating medical electrical safety rating that t...

Страница 18: ...ed the LED light will indicate a steady blue light Make sure the Coala is charged regularly and is fully charged before the first use 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 Do not use extensive force when lifti...

Страница 19: ... your smartphone to install the app Open the app and log in Open the Coala App on your smartphone and login using the email and password registered when signing up for the service or the details that were provided by your healthcare professional If you forgot your password see the next page The first time the Coala App is opened you will have to allow Coala notifications ...

Страница 20: ... To read the terms click on the text Coala User and Privacy Terms Press Log in when you are ready Ifyouforgotyourpasswordclickon Forgotmylogindetails andfollowthe on screeninstruction Alink validfor30 minutes willbesenttoyourregistered emailtoresetthepassword Ifyoudonot receivetheemail checkyourjunkmail folder Forsecurityreasonsyouwillnotbe abletologinintoCoalaAppfor20minutes ifyouhaveenteredthewr...

Страница 21: ...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 Follow the on screen instructions in the Coala App to set up your Coala profile The profile may be edited at any time under My Profile ...

Страница 22: ... 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 Participate anonymously you will contribute with your anonymized heart data Not to participate your heart data will not be used ...

Страница 23: ...xt 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 ...

Страница 24: ...mplete 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 ...

Страница 25: ...Coala to your smartphone 1 Ensure Bluetooth is enabled on your smartphone Bluetooth is found under Settings on your smartphone 2 Ensure to disable all Bluetooth connections to other devices when connecting your Coala for the first time Go to Settings on your smartphone to disconnect Bluetooth devices Pair the Coala to a Smartphone ...

Страница 26: ...er button on top of the Coala Your Coala should now be blinking green in rapid succession 4 In the Coala App press Connect my Coala now and follow the on screen instructions LED blinking green in rapid succession POWER BUTTON press to power on the Coala ...

Страница 27: ...s 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 ...

Страница 28: ...nding 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 Keep your phone within reaching distance to ensure proper radio signal transmission from the Coala to the Coala App If Coala indicates an unreadable value make sure to perform another measurement A deviating value could occur without anything being wron...

Страница 29: ...ce 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 Press the heart button with your index finger to start recording and hold Coala steady during the entire recording Try to relax and breathe normally Avoid speaking during measurement to ensure best recording quality ...

Страница 30: ... 30 The diagram below shows incorrect placement of the Coala for chest ECG and heart sound recordings ...

Страница 31: ... 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 Avoid pressing the electrodes too hard just maintain a firm grip ...

Страница 32: ...ese 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 rapid succession POWER BUTTON press to power on the Coala ...

Страница 33: ...cate 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 Press Start to start a new recording ...

Страница 34: ... 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 ...

Страница 35: ...nd 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 from your chest ...

Страница 36: ...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 Continue to press thumbs firm and steady onto the electrodes until recording is complete ...

Страница 37: ... 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 ...

Страница 38: ...ssure Systolic and Diastolic and weight in attachment to the recording 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 ...

Страница 39: ... sufficient internet access so the recording can be sent to the server 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 ...

Страница 40: ...a App If the result is normal the user is informed by a blue circle indicating average heart rate of the 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 ...

Страница 41: ...esult 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 When a deviating result occurs always conduct a second recording to verify the result and pay particular attention to holding Coala steady during recording ...

Страница 42: ...w 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 ...

Страница 43: ...he 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 ...

Страница 44: ...lect a measurement of interest from the list in My Journal This will display the result screen shown at the end of a completed measurement 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 1 2 ...

Страница 45: ...rst 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 mV 25 mm s filters affecting signal representation enabled Thumb measurement 10 mm mV 25 mm s filters affecting signal representation enabled ...

Страница 46: ... 46 For more information about the ECG tracings and how to interpret them see the chapter ECG Categorization ...

Страница 47: ... 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 ...

Страница 48: ...ntains 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 Edit profile press on the row and enter the new value Select Save to edit If you would like to modify unit settings for weight and height entries go to My Coala Settings ...

Страница 49: ... 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 ...

Страница 50: ...w approved healthcare providers Approved healthcare providers will have access to your recorded measurement data and general health information Click the X next to the healthcare provider s name to revoke acceptance 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...

Страница 51: ... transfer your heart rate recorded with the Coala App to Apple Health on your iPhone Health app integration only available for Apple Health Reminders Here the user may set reminders Follow the on screen instruction to set regular reminders for recording measurements with the Coala or for taking your medications Reminders will send a notification to your smartphone and may be set to any time and fr...

Страница 52: ...elp texts guiding you through the measurement recording deactivate to hide help texts Coala Atlas Here the user may edit Coala Atlas participation Check the box to participate in Coala Atlas This will allow the your heart data to be used for cardiac research 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 ...

Страница 53: ... 53 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 ...

Страница 54: ...hed charging and is now fully charged Slow blinking green Power on Rapid blinking green Bluetooth pairing mode for pairing with a smartphone Solid green Active recording of ECG and heart sounds 54 14 Coala LED indications LED blinking green in rapid succession ...

Страница 55: ... 55 Blinking yellow Low battery indication Solid yellow Battery empty or internal error Do not use Coala and consult Troubleshooting section of this manual ...

Страница 56: ...rement consisting of both chest and thumb ECG is categorized based on any heart rhythm deviations detected 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 ...

Страница 57: ...equences of faster or slower beats 7 Coala indicates recurring extra heart beats 8 Coala indicates recurring extra heart beats 10 Coala indicates recurring extra heart beats 11 Coala indicates recurring extra heart beats 12 Coala indicates an irregular heart rhythm Note that the color annotations presented in the ECG tracings on the following pages are not visible in the PDF downloaded in the Coal...

Страница 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 ...

Страница 59: ... 59 Category 3 Coala has detected skipped beats that may be AV Block II Category 4 Coala has detected an increased heart frequency tachycardia ...

Страница 60: ... 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 ...

Страница 61: ...1 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 ...

Страница 62: ... Coala has indicated the occurrence of more than 5 VES extra strokes in the analysis Category 12 0 5 0 5 0 0 Your results appear normal but Coala indicates a slightly irregular heart frequency also known as arrhythmia ...

Страница 63: ...ion 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 For example if atrial fibrillation is detected only in chest ECG this should not be seen as an indicator of atrial fibrillation thus is not sufficient to get the overall result of atrial fibrillation The combined result categorization is al...

Страница 64: ...ala when measurements are recorded Issue Solution Unable login to the Coala App Make sure that you have the correct user name and password Note that password is cap sensitive Make sure that you have sufficient internet access Make sure that your subscription hasn t expired If problem persists contact Coala customer support ...

Страница 65: ... can start a recording Unable to find my previous recordings All recordings are stored in the Coala Care Server and are only accessible if the smartphone is connected to the Internet I forgot my password to login in to the app Press I forgot my login details on the login screen and follow the instructions You will receive an email to the email address you used to setup the Coala App ...

Страница 66: ...e The Coala should start blinking blue indicating that it is being charged if not contact Coala customer support The Coala does not indicate a blue charging light when placed in the Coala Charge Station Check that the USB cable is correctly connected between the Charge Station and a power source Check that the Coala is correctly placed in the Charge Station ...

Страница 67: ...urce The Coala should start blinking slow blue Hold down the power button for 8 seconds and take the Coala out of the Charge Station The Coala should now be blinking green in rapid succession Enable Bluetooth on your smartphone and try to connect the Coala to your smartphone again If problem persists do not use device and contact Coala customer support ...

Страница 68: ...ce in Coala Charge Station for charging If problem persists do not use device and contact Coala customer support The recording stopped in the middle of the measurement Coala needs to have full contact with skin on chest or thumbs If the skin contact is lost the recording will stop Make sure to follow the instructions given in instructions for recording ...

Страница 69: ...t your smartphone does not support enough data transfer to record the heart sounds The application will automatically be set to Robust recording mode This will enable normal ECG recording but heart sounds will not be recorded Restart the measurement Unable to open the PDF measurement file Make sure that smartphone has a program to read PDF This does not come with the Coala App ...

Страница 70: ... Hold down both buttons on off button and heart button for more than 10 seconds 3 When Coala LED shows a blue light release the on off button and hold down heart button until a steady yellow light is shown 4 Remove the Coala from the Charge Station 5 Shut off the Coala by holding down the on off button for at least 10 seconds 6 Restart Coala by briefly pressing power on ...

Страница 71: ... 15 4 psi Do not store the device in Locations exposed to direct sunlight Locations subject to high temperatures such as in vehicles high and low temperatures and high humidity Wet or damp locations where the device may be in contact with water Dusty locations Near fires or open flames Locations exposed to strong vibration Locations exposed to strong electromagnetic fields Locations exposed to che...

Страница 72: ...d regular service or maintenance 19 Electrical safety The Coala Heart Monitor fulfills the European Medical 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 Collateral Sta...

Страница 73: ...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 2483 5 MHz Maximum emitted radiation power Less than 10 mW Hereby Coala Life AB declares that the radio equipment type Coala Heart Monitor is in compliance with D...

Страница 74: ...ostatic 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 2 7GHz Test levels 80 1000 MHz 10 V m with 80 AM 2 Hz 1 0 2 7 GHz 10 V m with 80 AM 2 Hz IEC 60601 1 2 2014 Table 9 up to 28 V m pulse modulation at frequencies in ISM bands IEC 61000 4 4 2012 Immunity to f...

Страница 75: ... frequency range 0 15 80 MHz Test levels on AC Power input port 6 Vrms with 80 AM 2 Hz 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 Test voltages 100 and 230 V 100 for cycle positive and negative half period 60 for 10 cycles 30 for 25 cycles...

Страница 76: ...ment and the other equipment should be observed to verify that they are operating normally Use of accessories transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation Portable RF communications equipment including pe...

Страница 77: ...bel 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 0086 European Conformity Mark Radio transmitter Stand by on off IP22 IP Ingress Protection Class 22 ...

Страница 78: ...voltage and current SN Serial number The serial number for your Coala is found under My Coala in Coala App LOT Batch number Manufacturer manufacturing date The manufacturing date of your Coala is found under My Coala in Coala App Manufacturer 40 C 10 C Temperature limits ...

Страница 79: ...79 90 15 Humidity limits 106 kPa 70 kPa Atmospheric pressure limits Keep dry Fragile handle with care Do not use if package is damaged Consult instructions for use Part number FCC ID 2ALO7CHM FCC ID REF ...

Страница 80: ...e 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 300 mV Heart rate range 30 to 200 BPM Pacemaker Compatible No Heart sound Frequency Range 20 500 Hz Sampling Frequency 4 kHz ...

Страница 81: ...ly charged before first use Coala Charge Station Input 5 VDC 300 mA minimum Micro USB type A connector Any external USB wall adapter battery pack or laptop used to power the Charge Station must be a Class II power supply no connection to protective earth and have a CE mark attached Warning Only use the supplied 1m long USB cable Radio Transceiver Properties Frequency Band 2 400 2 4835 GHz ...

Страница 82: ...la 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 Environmental Specifications Operating Temperature 5 C to 35 C 41 to 95 F Operating Humidity 15 to 90 non condensing Operating Air Pressure 700 to 1060 hPa 10 2 to 15 4 psi Expected Service Life 1 year Shelf life 1 year ...

Страница 83: ...less 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 For a list of compatible devices see website www coalalife com device compatibility ...

Страница 84: ... 84 26 Contact information to the manufacturer Coala Life AB Riddargatan 18 114 51 Stockholm Sweden www coalalife com info coalalife com ...

Страница 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 ...

Страница 86: ... 86 For more support please visit www coalalife com 005052 A EN 2019 09 19 FOLLOW YOUR HEART ...

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