User Manual for Android
Contents
1. Frequency Deviation ccccccsscccsssecsessecseseecssseeceeeeecseeeeceseeecseeecseeeeseeeeesaeeess 200 Hz mV Power Requirements Battery sic EE 3V Coin Cell Battery Difesa min 200 Hours Operational Time 12 months typical use Physical Characteristics AC 004 amp AC 007 UA A w Attachment Plate 28 grams 89 x 48 x 9 mm 10cm Electrode hie i 18 grams 82 x 32 x 3 5 mm 9 cm Electrode Environmental Specifications Operational 10 to 45 degrees Operational Humidity essere 1096 to 9596 non condensing Operational Altitude based on your smartphone or tablet specification Storage Temperature icccccsivivecssscevecssassvecedabeveessaveveessebesversaneveessevevee 20 to 60 degrees C Storage Humidity eoa va CR as Ia 1096 to 9596 non condensing User Interface Two stainless steel electrodes are exposed on the back of the Mobile ECG These electrodes make contact with the user s skin jui AliveCor 5 EUROPEAN AUTHORIZED REPRESENTATIVE Obelis SA BD General Wahis 53 1030 Brussels Belgium Tel 32 2 732 59 54 Fax 32 2 732 60 03 E Mail mail obelis net 6 ALIVECOR CONTACT INFORMATION AliveCor Inc 30 Maiden Lane 6 Floor San Francisco CA 94108 United States www alivecor com jui AliveCor 7 ELECTRICAL SAFETY Guidance and manufacturer s declaratio2. 009 With the AliveCor logo right side up the top of the smartphone or tablet should be at the top Caution The Mobile ECG must be less than 1 foot from the smartphone or tablet to ensure communication between devices 5 3 Download the AliveECG app e Using your smartphone or tablet search for AliveECG in the Google Play Store e Download and install the AliveECG app jui AliveCor 5 4 Set up an AliveCor Account You will use your AliveCor account to access print and save your ECG recordings stored on the AliveECG app and the AliveCor server Follow the instructions presented when you open the A iveECG app for the first time You can go back later and change your information if necessary Signing up for an AliveCor account also enables you to send an ECG for analysis ECG analysis can be used any time you want a medical professional to interpret your ECG recording and is required if you would like to view your recordings or utilize AliveCor s Detectors 6 RECORD ECG RHYTHMS USING THE MOBILE ECG Before taking each recording e Disconnect headphones charger cables or any other connected devices e Clean the two electrodes with alcohol based sanitizer e Using your smartphone or tablet launch the AliveECG app Rest two or more fingers it doesn t matter which fingers on the Mobile ECG your right hand should contact the electrode closest to the bottom of the smartphone or tablet and your left hand should contact the electrode cl
3. but since the AliveCor Mobile ECG is used by a large and diverse population the Normal Detector has been designed to be conservative with what it detects as normal If you have been diagnosed with a condition that affects the shape of your ECG e g intraventricular conduction delay left or right bundle branch block Wolff Parkinson White Syndrome etc experience a large number of premature ventricular or atrial contractions PVC and PAC are experiencing an arrhythmia or took a poor quality recording it is unlikely that you will be notified that your ECG is normal It is also important to note that the Normal Detector looks at the entire signal before determining if it can be declared to be normal If you experience a small number of PACs or PVCs in a recording of otherwise normal beats in normal rhythm the Normal Detector will likely declare this recording to be normal WARNING AliveCor cannot guarantee that you are not experiencing an arrhythmia or other health condition when labeling an ECG as normal You should notify your doctor of a possible change in your health jui AliveCor Interference Detector The Interference Detector in the AliveECG app determines whether a recording can be accurately interpreted or not After you take an ECG if interference is detected you will be notified within the app that your recording is Unreadable and given some suggestions for acquiring the best quality ECG recording You subsequently have
4. symptoms of atrial fibrillation are palpitations dizziness fast pulse rate irregularly irregular rhythm an abnormal heart sound S1 chest pain chronic shortness of breath abnormal jugular venous pressure fatigue and impaired exercise tolerance Other symptoms related to TIAs and strokes may be the initial symptoms of atrial fibrillation Some of the most common causes of atrial fibrillation are long standing hypertension congestive heart disease cardiac valvular lesions myocardial infarctions history of coronary artery bypass grafts hyperthyroidism alcohol abuse smoking diabetes mellitus and electrolyte imbalances jui AliveCor 14 e AFrecordings in ECG review screen and History List All tracings analyzed as positive for AF will have AF tagged for future review These tags will be visible on the ECG History List as well as on the ECG review screen e Activation of the AF Detector The AF Detector can be turned on or off in the settings of the AliveECG App 13 1 AF Normal and Interference Recordings in ECG review screen and History List All tracings analyzed as positive for atrial fibrillation normal or unreadable will have a tag for future review These tags will be visible on the ECG History List as well as on the ECG review screen 13 2 Activation of the Detectors All Detectors including AF Normal and Interference Detectors can be turned on or off in the settings of the AliveECG App ACCESSING HELP
5. that is less than 30 seconds neither the Atrial Fibrillation nor the Normal Detector will display a result Atrial Fibrillation Detector The Atrial Fibrillation AF Detector in the AliveECG app detects atrial fibrillation in an ECG tracing After you take an if atrial fibrillation is detected you will be notified within the app This finding is not a diagnosis it is only a potential finding You should contact your physician to review any ECG recording in which atrial fibrillation was detected or send it to ECG Analysis If you are experiencing any symptoms or concerns please contact a medical professional The AF Detector monitors for atrial fibrillation AF only It will not detect other potentially life threatening arrhythmias and it is possible that other cardiac arrhythmias may be present The AF Detector only monitors for AF while you are taking a recording It does not continuously monitor your heart and therefore cannot alert you if AF happens at any other time Normal Detector The Normal Detector in the AliveECG app notifies you when a recording is normal This means that the heart rate is between 50 and 100 beats per minute there are no or very few abnormal beats and the shape timing and duration of each beat is considered normal It isimportant to remember that there is a wide range of normal variability among different individuals Changes in the shape or timing of an ECG might be normal for a single individual
6. 2 ECGANALYSIS 11 13 DETECTORS ATRIAL FIBRILLATION NORMAL 11 14 ACCESSING HELP tenete nennen nennen titre tenetis 14 15 EDITING USER PROPFILE sse tenens 15 16 ACCESSING EDUCATION cccccccsccsesssscscssscscscsescsescsvsscscssscsesesesssescseenensacseseeeeeeeeess 15 17 PROVIDER DASHBOARD ccccscssssescsscscssssscsscscsesesesusscscscscsceecsesssescsesnessassssceeeeeaeess 15 18 ELECTRONIC HEALTH RECORD EHR INTEGRATION 16 19 TROUBLESHOOTING 17 20 ALIVECOR MOBILE ECG SPECIFICATIONG ccccccscssssssesessescscsescsescsesesesesneseacsesees 19 21 EUROPEAN AUTHORIZED REPRESENTATIVE seen 20 22 CONTACT INFORMATION en 20 23 ELECTRICAL SAFETY ccccccccscscscscsessssesescssescscscssescscsesescsssescasscaceucsessssscseeneneacsesees 21 24 SYMBOLS USED SYSTEM OR PACKAGE 25 jui AliveCor 1 PRODUCT DESCRIPTION The AliveCor Mobile ECG is a mobile clinical quality electrocardiogram ECG recorder The duration of the recording is established by the AliveECG App with a default setting of 30 seconds and a maximum time of 5 minutes The software application can store thousands of recordings on your smartp
7. ECG recordings you collected were automatically synced to the AliveCor server and will appear in list form and each transmission is stored as an Adobe Acrobat PDF file and can also be viewed in HTML Click on the VIEW ECG button jui AliveCor e Click the back button in your browser to return to your AliveCor account homepage 13 ECG ANALYSIS The AliveECG app includes the ability to request professional clinical interpretation and analysis of your ECG recordings Due to telemedicine restrictions your location may restrict your ability to use this service AliveCor does not know your location it is your responsibility to ensure this service is legal according to your local telemedicine laws This service is not intended to replace medical advice please seek professional medical assistance if you are suffering from any medical problem To request an ECG Analysis Report From the History list select and view the ECG recording that you would like reviewed Tap the Analysis button Select one of the listed Analysis Report options If you haven t already entered your name date of birth and gender you will be prompted to enter these details Enter the required details and tap Save 5 You will then be prompted to select or enter your credit card information Enter your card details and tap Next 6 Confirm that the purchase order is correct and tap Purchase to place the order Your order is then proc
8. OBILE ECG AND TAKE THE FIRST ECG RECORDING 5 1 Decide which smartphone or tablet to use Your Mobile ECG is compatible with all of the smartphones and tablets listed on AliveCor s website http www alivecor com compatibility including Samsung Note 3 Galaxy S3 S4 and S5 HTC One Jitterbug Touch 2 and Touch 3 The AliveECG App is compatible with the Android Operating System versions 4 0 4 4 You can use the Mobile ECG with Universal Attachment Plate on all compatible smartphones or tablets as listed on the Compatibility Chart The Mobile ECG for Samsung Galaxy S5 can also be used on all compatible smartphones or tablets by removing the oval shaped Mobile ECG from its case 1 4 If the Mobile ECG is currently attached to a Samsung Galaxy S5 remove the Mobile ECG and case from the phone Face the electrodes of the Mobile ECG away from you Gently push the left side of the Mobile ECG toward you while at the same time gently pulling the left edge of the case away from the Mobile ECG itself The Mobile ECG should then pop out of its case 5 2 Unpack the AliveCor Mobile ECG e Remove the Mobile ECG from the box e The Mobile ECG with Universal Attachment Plate can be attached to the smartphone or tablet directly or to the case of your choosing the surface should be smooth and flat o 001 AC 007 With the AliveCor logo right side up the top of the smartphone or tablet should be on the right o AC
9. OTES The Mobile ECG does not require a Wi Fi or mobile connection to record an ECG and save it to the smartphone or tablet however it does require one of these to sync automatically with the AliveCor server email or print directly from the AliveECG app If you do not have a Wi Fi or mobile connection at the time of the ECG recording you can email or print the data later when you have such a connection and the sync ill happen automatically at that time The Mobile ECG can be used up to a distance of 30 cm 1 ft from the smartphone or tablet Using the Mobile ECG at a distance greater than 30 cm 1 ft may lead to communication issues between the devices and your recording may not be successful In order to reduce muscle noise rest your arms on a flat surface to increase stability while you are recording You must maintain contact with the electrodes for at least 10 seconds for the recording to be saved If you remove contact after 10 seconds but before the selected recording duration is complete the ECG will be saved and you will be able to review it The recording must be at least 30 seconds long in order for the Detectors to work 7 ONCE THE RECORDING IS FINISHED Immediately after the recording is complete you will be prompted to save the ECG Select your name or Other User if your name is not listed If you do not wish to save the recording you can select Cancel After selecting your name the ECG will be saved with
10. To access Help press the Menu button and select the menu item Note For most smartphones or tablets the Menu button is a physical button on your smartphone or tablet however on some Android smartphones and tablets the Menu button will be an icon in the top right of the screen Learn more about using your AliveCor Mobile ECG from the following tutorials included in the AliveECG app Tutorials Review these tutorials to learn about to navigate all the features of the app Quick Tutorial Recording an ECG Tips and information on how to record an ECG AF Detection Information about the AF Detector Sending an ECG for Analysis Steps through the process of how to send your ECG to one of our partners for professional clinical interpretation and analysis Reviewing an Analysis Report A guide on how to view your analysis results o Alternative Recording Positions The AliveCor Mobile ECG is typically held in your hands to record an ECG Find out about alternative positions that may provide a clearer recording O e Reference Learn about ECG analysis access the user manual feedback and privacy and terms o What is ECG analysis o User Manual o Privacy Notice jui AliveCor 15 16 o Terms of Service EDITING USER PROFILE To access Settings press the Menu button and select the menu item Note For most smartphones and tablets the Menu button is a physical button however on some Android smartphones a
11. aracteristic ofa typical magnetic field location in a typical IEC 61000 4 8 commercial or hospital NOTE Uris the a c mains voltage prior to application of the test level environment jui AliveCor Guidance and manufacturer s declaration electromagnetic immunity The AliveCor Mobile ECG is intended for use in the electromagnetic environment specified below The customer or the user of the AliveCor Mobile ECG should assure that it is used in such an environment Immunity IEC 60601 Complian Electromagnetic environment guidance test test level ce level Portable and mobile RF communications equipment should be used no closer to any part of the AliveCor Mobile ECG including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 4 2 WP Vi Conducted RF 3 Vrms 3 5 61000 4 150kHzto ps Fg NP 6 80 MHz 7 d WP 800 MHz to 2 5 GHz 1 where P is the maximum output power rating Radiated 3 V m of the transmitter in watts W according to IEC 61000 4 80 MHz to 3 V m the transmitter manufacturer and d is the 3 25 GHz recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment ma
12. e If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 96 Ut gt 95 96 dip in Ur for 0 5 cycle 40 96 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles 5 96 Ur gt 95 96 dip in Ur for 0 5 cycle 40 96 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip for 25 cycles Mains power quality should be that of a typical commercial or hospital environment If the user of the AliveCor Mobile ECG requires continued operation during power mains interruptions it is recommended that the AliveCor Mobile ECG be lt 5 96 lt 5 96 powered from an gt 95 dip in gt 95 uninterruptible power for 5 sec for 5 sec supply or a battery Power frequency magnetic Power frequency fields should be at levels 50 60 Hz 3 A m 3A ch
13. essed and you will be sent email confirmation Another email will be sent when the report is available NOTE The Analysis option is only visible if the analysis service is available in your country To view an ECG Analysis Report 1 Open the notification drawer and select the notification to view the report 2 Alternatively from the History list scroll or locate the ECG recording then tap the report icon or select the ECG and tap the ECG Analysis button 3 The analysis report will be listed under Analysis Reports showing the date ordered and the analysis result If the analysis report has not been received the report item will indicate Analysis in progress 4 Tap on the report item to view more details NOTE To view PDF reports on your smartphone or tablet you must have a PDF reader such as Adobe Reader built in or installed on your Android smartphone or tablet Support for printing depends on the built in printing options on your Android smartphone or tablet or you may need to install a printer app from the Google Play Store 14 DETECTORS ATRIAL FIBRILLATION NORMAL INTERFERENCE jui AliveCor NOTE If you are not enrolled in Alivecor s ECG Analysis service you will not be able to view the recording AliveCor will unlock this feature if you are under the guidance of a physician NOTE Your ECG must be at least 30 seconds long to use the Atrial Fibrillation and Normal Detectors If an ECG is recorded
14. evice function 3 STORAGE HANDLING AND MAINTENANCE Do not store the unit in Locations exposed to direct sunlight Locations subject to high temperatures and high humidity Wet or damp locations where water may get on the unit Dusty locations Near fires or open flames jui AliveCor Locations exposed to strong vibration or Locations exposed to strong electromagnetic fields No maintenance of this system is required except The battery should be replaced when necessary The electrodes should be cleaned using an alcohol based sanitizer before each use To prevent potential cross infection of diseases between users clean the device using alcohol prior to each use 4 WARNINGS This device is not designed or 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 This device records heart rate and heart rhythm only This device does not detect or measure all heart rate heart rhythm and heart waveform changes especially those related to ischemic heart conditions Do not attempt self diagnosis or self treatment based on the recording results and analysis Self diagnosis or self treatment may lead to deterioration of your health Users should always consult their physician if they notice changes in their health Do not use in the presence of flammable anesthetics drugs or pressurized oxyge
15. hone or tablet and these recordings are also accessible to authorized users on AliveCor Inc AliveCor servers www alivecor com Patients with known or suspected heart conditions and health conscious individuals can use the AliveCor Mobile ECG to record an ECG daily or whenever they are feeling symptoms and share their recordings with their physician Medical professionals can use the AliveCor Mobile ECG to quickly assess rate and rhythm screen for arrhythmias and remotely monitor and manage their patients who use the AliveCor Mobile ECG The device consists of three components 1 The Mobile ECG which attaches to your compatible smartphone or tablet and has electrodes to transmit ECG rhythms to the smartphone or tablet 2 The AliveECG mobile application AliveECG app is used to collect view save and wirelessly transmit recordings to the AliveCor server 3 Auser supplied compatible smartphone or tablet CAUTION The AliveCor Mobile ECG has features that are only available to users who are under the care of a physician These features are available to prescription users only The Mobile ECG enables users to e Collect and store single channel ECG recordings using the smartphone or tablet e Edit user information data associated with the recording e Wirelessly transmit ECG recordings to the AliveCor server Access ECG recordings stored on the AliveCor server e Print or save the recording in PDF format e Request professional c
16. ional account download the A iveECG app and follow the prompts to create a new account In order to view a patient s future recordings you must send them an invite via email To send an email invite 1 Goto www alivecor com 2 Click on SIGN IN in the upper right corner and enter your email address and password 3 Click on Invite a Patient 4 the patient s email address this must be the email address they use for their jui AliveCor AliveCor account 5 Click Send Email 2 ELECTRONIC HEALTH RECORD EHR INTEGRATION Send to EHR If you are a physician and your AliveCor account has been setup for integration with an Electronic Health Record system EHR you can send ECG recordings to your EHR Tap the Send to EHR icon to send the ECG jui AliveCor 3 TROUBLESHOOTING Problem My Mobile ECG is not working Solution Change the battery 1 Expose the battery door at the back of the Mobile ECG a Remove the case from the smartphone or tablet by pushing the iPhone through the camera cutout while peeling back the Mobile ECG from this corner OR b Remove the Mobile ECG from the plate 1 AC 001 AC 007 Place your thumbs on the electrodes and press down firmly Turn counterclockwise about 45 degrees to unlock the Mobile ECG Once it s unlocked the Mobile ECG can then be lifted out of the plate 2 AC 009 Use your thumbs to slide the Mobile ECG toward the open end of the plate 2 Remove the battery doo
17. jui AliveCor AliveCor Mobile ECG User Manual for Android NOTE For the current information on your product please visit http www alivecor com user manual 2011 2015 AliveCor Inc All rights reserved US Patent No 8 301 232 and Patents Pending AliveCor is a trademark and trade name of AliveCor Inc in the United States and other countries O9LBOS Revision O MAY 2015 jui AliveCor Contents 1 PRODUCT DESCRIPTION cccccccsssssscsessescscscscescscsessscsesvsnescscsseseecsessscsesesneasscassceeeeeseees 3 2 GENERAL SAFETY PRECAUTIONS sse tenente tenen 4 3 STORAGE HANDLING AND MAINTENANCE 0000004142422 201 2000200 4 4 WARNINGS 24 4 41 0 2 0 5 5 SETUP THE MOBILE ECG AND TAKE THE FIRST ECG RECORDING 6 6 RECORD ECG RHYTHMS USING THE MOBILE 4422 7 7 ONCE THE RECORDING IS FINISHED cscscsscssssssscscsessesesescesescscscscecescssseseseanenescaseees 8 8 SETTINGS AND ADJUSTMENTS cccccscsssscsesesscscscscsccccsssesescsucscscscscecescsssesesesenessaceces 8 9 EMAIL PRINT OR DELETE RECORDINGS c ccccccssscscssssssesesessesescscsceescsesesestanenessaeeees 9 10 VIEW PREVIOUSLY RECORDED ECG RECORDINGS ON YOUR SMARTPHONE OR PREMO KC a 10 11 VIEW AN ECG RECORDING ON THE ALIVECOR SERVER 10 1
18. lar equipment may cause interference Please stay away from such equipment when you are recording Do not take recordings in a location where the unit will be exposed to strong electromagnetic forces such as near an arc welder high power radio transmitter etc Signal quality may degrade by detecting signals from other ultrasonic acoustic sources Do not use the device in close vicinity to other equipment emitting ultrasonic acoustics such as espresso machines some ventilation systems or another AliveCor Mobile ECG The smartphone or tablet power adapter may degrade signal detection Do not use the Mobile ECG while charging the smartphone or tablet Disperse any static electricity from your body before using the unit Do not take recordings in a moving vehicle Do not expose the unit to strong shocks or vibrations Do not disassemble repair or modify the unit Do not insert battery with polarity reversed Do not use batteries of a type other than that specified for use with the device Do not take a recording if the electrodes are dirty Clean them first Do not use for any purpose other than obtaining an electrocardiogram If the portion of the body where the electrode is applied has too much body fat body hair or very dry skin a successful recording may not be possible Some children and adults with very sensitive auditory ability may hear a high pitched hum or buzz emitting from the device when activated This is due to normal d
19. linical interpretation and analysis of your ECG recordings After a user has created an account on the AliveECG app and received an ECG analysis the Mobile ECG enables a user to e View ECG recordings real time and after the recording e View the output of the Atrial Fibrillation Normal and Interference Detectors 1 1 Indications for Use The AliveCor Mobile ECG is intended to record store and transfer single channel electrocardiogram ECG rhythms The AliveCor Mobile ECG also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm when prescribed or used under the care of a physician The AliveCor Mobile ECG is intended for use by healthcare professionals individuals with known or suspected heart conditions and health conscious individuals The device has not been tested for and it is not intended for pediatric use jui AliveCor 1 2 Contraindications There are no known contraindications for the Mobile ECG although care should be taken when considering using the device according to the warnings and precautions below 2 GENERAL SAFETY PRECAUTIONS The device should not be used near water or in a wet environment Do not use this unit in locations subject to high or low temperatures or humidity It should be used within the temperature and humidity range according to the product label Do not sterilize this unit with an autoclave or glass sterilizer Audio and video products and simi
20. mber SN Serial Number nma Direct Current Power Source
21. n electromagnetic emissions The AliveCor Mobile ECG is intended for use in the electromagnetic environment specified below The customer or the user of the AliveCor Mobile ECG should assure that it is used in such an environment flicker emissions IEC 61000 3 3 Emissions test Compliance Electromagnetic environment guidance The AliveCor Mobile ECG uses RF energy only for RF emissions Gauci its internal function Therefore its RF emissions CISPR 11 P are very low and are not likely to cause any interference in nearby electronic equipment RF emissi emissions class B CISPR 11 DNA The AliveCor Mobile ECG is suitable for use in all N A establishments other than domestic and those IEC 61000 3 2 f directly connected to the public low voltage power Voltage fluctuations EN supply network that supplies buildings used for N A domestic purposes jui AliveCor Guidance and manufacturer s declaration electromagnetic immunity The AliveCor Mobile ECG is intended for use in the electromagnetic environment specified below The customer or the user of the AliveCor Mobile ECG should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic Discharge ESD 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic til
22. n such as in a hyperbaric chamber ultraviolet sterilizer or oxygen tent Do not use this device during an MRI scan Keep out of reach of infants small children or anyone incapable of using the device properly The device has not been tested for use on infants weighing less than 10kg AliveCor does not recommend using on humans less than 10kg It is not recommended to place a mobile phone directly next to a pacemaker on the chest Do not use this device with a defibrillator AliveCor does not recommend using on individuals with a cardiac pacemaker ICDs or other implanted electronic devices Do not attempt ECG data acquisition while there is an external microphone plugged in to the smartphone or tablet ECG reports viewed or printed at any magnification other than 10096 may appear distorted and could lead to misdiagnosis The heart rate is based on the heart rhythm therefore the rate is only valid if there is a valid rhythm QRS complex visible The Interference Detector may incorrectly identify ventricular flutter ventricular bigeminy and ventricular trigeminy as unreadable If you have been diagnosed with one or more of these arrhythmias we recommend turning off the Interference Detector in your Settings AliveCor cannot guarantee that you are not experiencing an arrhythmia or other health condition when labeling an ECG as normal You should notify your doctor of a jui AliveCor possible change in your health 5 SETUP THE M
23. n to set the units for weight and height to Metric cm kg or Imperial Ib in PDF Reports Sets various options for the PDF report that you can View Print Email and share These settings affect the PDF report only They do not affect the ECG display on the device or the analysis reports that are provided by our analysis partners 9 EMAIL PRINT OR DELETE RECORDINGS You may email print recordings from either the AliveECG app or your account on the server www alivecor com You may print email or share a PDF report of the recording by tapping the Share icon and choosing your appropriate option Note Support for printing depends on the built in printing options installed on your smartphone or tablet Depending on your printer and Android smartphone or tablet you may need to install a printer app from the Google Play Store To email a recording from the server jui AliveCor 10 11 12 1 Goto www alivecor com 2 Click on SIGN IN in the upper right corner and enter your email address and password 3 Select the desired recording by clicking on the appropriate VIEW ECG button on the right 4 Email from your computer as you would any PDF To print a recording from the server 1 Goto www alivecor com 2 Click on SIGN IN in the upper right corner and enter your email address and password 3 Select the desired recording by clicking on the appropriate VIEW ECG button on the right 4 Print from your comp
24. nd tablets the Menu button will be an icon in the top right of the screen e name emailaddress com Email address of the current AliveCor account e User Profile Details of the account holder o For health professionals enter your name and organization which will be stored with each ECG recorded and printed on the reports o Forindividual users enter your name and other details that will be stored with each new ECG recording e Credit Cards Add or remove credit card details for purchasing ECG analysis reports e Sign In Log out Allows you to Log in or setup a new AliveCor account or to log out if you are already logged in ACCESSING EDUCATION To learn about different arrhythmias cardiac anatomy and ECGs e Tap the AliveECG icon in the top left of the screen or from the Record or History screen swipe the left edge of the screen to reveal the Navigation drawer e Tap Education NOTE The information contained within this section is for educational purposes only This information has been written and verified by medical professionals Do not attempt to use this information to interpret your own ECG This information is not intended to replace medical advice Please seek professional medical assistance if you are suffering from any medical problem PROVIDER DASHBOARD The Provider Dashboard allows medical professionals the ability to view their patients recordings automatically from their own account To create a medical profess
25. nimum distance between portable and mobile RF communications equipment transmitters and the AliveCor Mobile ECG as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum a output power of oe e 80 MHz to 800 MHz 80 MHz to 2 5 GHz transmitter Z 22 22 7 i d 4 d WP Vi E E 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people jui AliveCor 8 SYMBOLS USED SYSTEM OR PACKAGE LABELING Type CF Applied Part European Conformity Mark WEEE Properly Dispose of Electronic Waste Consult Instructions for Use User Manual Manufacturer Temperature Limits Operational Relative Humidity Limits Operational ASE 5 DAS REF Model Nu
26. osest to the top of the smartphone or tablet This is a Lead ECG You may also choose from two other placements e Fora Lead II ECG the left knee should contact the electrode closer to the top of the smartphone or tablet and the right hand should contact the electrode closer to the bottom of the smartphone or tablet e For an Anterior Precordial Lead the device be placed on the lower left side of the chest just below the pectoral muscle The bottom of the smartphone or tablet should be pointing towards the center of the body NOTE You will not be able to view your recordings or utilize any of AliveCor s Detectors until you are under the care of a physician To gain access to these features you must create an account on the A iveECG app Your first recording will then be automatically sent for a free analysis by a cardiologist Once you have received the ECG analysis you will have access to view that recording and subsequent recordings After your display is unlocked you may swipe your finger across the screen to scroll through each ECG recording Additionally you can add notes about the recording e Tap the Annotate icon in the upper right corner to add notes Medical Professional Add patient details such as Patient ID Name etc Individual User Add symptoms and activities e Tap Save to return to the review screen This information will automatically synchronize with the AliveCor server jui AliveCor N
27. r a AC 001 AC 007 Use a 1 6mm Phillips screwdriver press down firmly and turn counterclockwise to remove the screw in the battery door b AC 009 Insert a pen pencil or other similarly shaped object into the cutout next to the battery door to pop the battery door off 3 Remove the used battery and replace it with a new 3V coin cell battery matched to your model 4 Orient the battery with the positive terminal up so that you can see the writing Remove the protective sticker from the battery as applicable have a lot of artifact noise or interference in my recording Try the following tips for acquiring the best quality ECG recording Ensure that the Enhanced Filter is on Clean the electrodes on the Mobile ECG with alcohol based sanitizer e f hands are very dry use a water based lotion before recording When recording from the hands relax the arms and hands to reduce muscle noise Rest the forearms and hands on a flat surface and let the Mobile ECG rest on the hands Do not squeeze the Mobile ECG e Ensure that your smartphone or tablet is not charging syncing and you are not using headphones with your smartphone or tablet during the recording Make sure that both the smartphone or tablet and the user remain still during ECG recordings Movement during recordings will cause noise in the tracing Make sure Mains Filter is set appropriately for your geographical location This can be adjusted under the Ali
28. rked with the following symbol Q NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the AliveCor Mobile ECG is used exceeds the applicable RF compliance level above the AliveCor Mobile ECG should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the AliveCor Mobile ECG B Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m jui AliveCor Recommended separation distances between portable and mobile RF communications equipment and the AliveCor Mobile ECG The AliveCor Mobile ECG is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the AliveCor Mobile ECG can help prevent electromagnetic interference by maintaining a mi
29. st or last name in order to ensure you age is visible My credit card isn t being accepted In rare occasions the error message indicating that your credit card is incorrect or invalid is automatically cleared by rotating the phone from portrait to landscape or vice versa Please double check that your credit card information is valid before processing payments jui AliveCor 4 ALIVECOR MOBILE ECG SPECIFICATIONS Performance Characteristics ais Single Channel Input Dynamic 10mV Peak to Peak Memory length Practically Unlimited Recording Continuous sheer Estimated 2 years Circuitry Frequency Response 1 1 nn 0 5 Hz to 40 Hz CMRR 76 dB Input Impedance gt 100 MOhm Differential tdv md Od a D nina 5 mV A D Sampling Rate 300 samples second 16 bit DC Offset Correction 300 mV Output Modulation emp Frequency Modulated Ultrasonic Audio Tone Center Frequency nter in t Ree Rat ve reas e YER INVE FEX TX ERES EUR RA 19 kHz
30. the option to Save the recording or Try Again If the recording can be analyzed the AF and Normal Detectors will run on the ECG and inform you as described above WARNING The Interference Detector may incorrectly identify ventricular flutter ventricular bigeminy and ventricular trigeminy as unreadable If you have been diagnosed with one or more of these arrhythmias we recommend turning off the Interference Detector in your Settings What is Atrial Fibrillation The most common type of non sinus tachyarrhythmia is atrial fibrillation In this case disorganized electrical impulses that originate in the atria and pulmonary veins initiate the electrical activity in the conduction system of the heart This causes what are commonly termed as irregularly irregular heart beats When a heart is in atrial fibrillation its two upper chambers the right and left atria essentially quiver instead of beating efficiently This does not allow for complete emptying of the atria and thus blood may become stagnant and create blood clots This can lead to major problems namely strokes transient ischemic attacks TIAs and pulmonary emboli PEs depending which chamber of the heart has the blood clot in it Approximately 15 percent of strokes occur in people with atrial fibrillation As age increases in a population so too does the incidence of atrial fibrillation which peaks at about 3 596 in people over the age of 65 The most common presenting
31. toggle the filter ON or OFF Invert the ECG Recording In the event that the Mobile ECG was oriented improperly when the ECG was recorded it may appear inverted To change the polarity of the ECG tap on the center of the review screen and then tap on the Invert switch to toggle it ON or OFF 8 2 Adjustable Settings To access Settings press the Menu button and select the menu item Note For most smartphones and tablets the Menu button is a physical button however on some Android smartphones and tablets the Menu button will be an icon in the top right of the screen Recording Duration Recording Duration is the maximum length of time the AliveECG app will record a single ECG recording For example if the recording duration is set to 30 seconds the AliveECG app will automatically stop recording after 30 seconds of data has been collected The recording duration can also be set to Continuous where the system will record as long as the user maintains contact with the electrodes up to 5 minutes AC Mains Filter The AC Mains Filter removes any mains interference from the ECG usually you should leave this set to Auto where the app will select the appropriate frequency of the alternating current AC used in your country or region For the United States Canada and Mexico this is 60 Hz in most other countries it is 50 Hz If required you can override the auto selected value and set this to 50 Hz or 60 Hz Units Select this optio
32. uter as you would any PDF To delete the ECG recording 1 Tap the Trash icon 2 Confirm that you want to delete the recording Deleting a recording from the AliveECG app also deletes it from the server Deleted recordings cannot be retrieved VIEW PREVIOUSLY RECORDED ECG RECORDINGS ON YOUR SMARTPHONE OR TABLET NOTE If you are not enrolled in Alivecor s ECG Analysis service you will not be able to view the recording AliveCor will unlock this feature if you are under the guidance of a physician To see a list of all your saved ECG recordings tap the AliveECG icon in the top left of the screen and select ECG History from the menu or from the Record screen swipe the page from right to left To view a recording in the list Scroll the list and then tap the ECG recording you wish to view The ECG will then be displayed for reviewing To search for a recording Tap the Search icon and enter the patient s first name last name ID or notes As you type the list will be filtered to only show matching items VIEW AN ECG RECORDING ON THE ALIVECOR SERVER NOTE If you are not enrolled in Alivecor s ECG Analysis service you will not be able to view the recording AliveCor will unlock this feature if you are under the guidance of a physician e On your web browser go to www alivecor com and click on SIGN IN e Enter your email address and the password you created when you set up your AliveCor account Click Sign In The
33. veECG app Settings Try recording from the chest right under the pectoral muscle in the mid line The ECG rhythms appear upside down In the future ensure that the left hand contacts the electrode closer to the top of the smartphone or tablet and the right hand contacts the electrode closer to the bottom of the smartphone or tablet To invert a recording on your smartphone or tablet see Invert the ECG recording under Recording Adjustments forgot my password and l m unable to reset it To reset your password go to www alivecor com and click on SIGN IN in the upper right corner and click on the Forgot your password link below the Password field On the Forgot Password screen enter your email address and click Submit Follow the reset instructions in the email Please note the reset link contained in the email is only active for a short while jui AliveCor Problem Solution The ECG was lost when I was recording it can t see my age in the PDF report Rotating your phone while recording so that the screen flips from portrait to landscape mode will automatically stop the recording and that ECG will not be saved Please do not rotate your phone while recording as this will impact the quality of your recording If your first and last name are longer than 35 characters combined your age may be covered due to size restrictions in the PDF report Please consider using initials for your fir
34. your details and you will then be prompted to enter notes and select symptoms and activities After entering these details tap Save in the upper right of the screen or Cancel if you do not want to record any notes or symptoms The ECG will then be displayed for reviewing The review screen allows you to scroll through the ECG by swiping your finger across the screen and you can pinch and zoom to scale the ECG There are also options to edit the details and patient information delete the recording review previous or next recordings and to view email print and share a PDF report You can also order an ECG analysis report to have your ECG recording reviewed by a professional see ECG Analysis for details When you have finished reviewing the ECG recording either press the Home button to exit the app or press the Back key to return to the Record screen where you can then record another ECG 8 SETTINGS AND ADJUSTMENTS 8 1 Recording Adjustments Sweep Speed Sweep speed of the ECG in the PDF report be set to 12 5mm s 25mm s or 50mm s This option is only available to health professionals jui AliveCor Gain Gain of the ECG in the PDF report can be set to 5bmm mV 10mm mvV or 20mm mvV This option is only available to health professionals Enhanced Filter The Enhanced Filter suppresses noise in the ECG To enable or disable the Enhanced Filter tap the review screen and then tap on the Enhanced Filter switch to
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