Humeds CARDEA-3 User manual

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CARDEA-3 Portable ECG recorder
User manual

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Human medical solution inc., Serbia
Disclaimer
This manual is written according to European Union Medical De ices
Directi e 93/42/EEC and GHTF Label and Instructions for use for Medical
De ices guide.
The information pro ided in this manual is based on the de ice actual at the
time of instruction creation. Your de ice might differ from one described
here.
For up-to-date user manual, isit www.humeds.com/cardea3
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 !"
Manufacturer: Human medical solutions inc.
Address: Milutina Milankovica 11b, Belgrade, Serbia
Phone: + 81 11 228-11-82
e-mail: [email protected]
Service: Human medical solutions inc., Serbia
European Union representative: HTEC Group Sweden Filial
Address: Lindholmspiren 5a, 41756 Gothenburg, SWEDEN
Phone: [phone]
e-mail: [email protected]
e-mail: [email protected]
Service: Human medical solutions inc., Serbia

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Safety requirements
The warning icon is used to alert the user that the erroneous
operation can result in erroneous test results.
The information icon indicates important information
The light bulb icon is used to indicate an illustration of scientific
information
Contraindications
There are no absolute contraindications for using Cardea-3 ECG recorder.
The relati e contraindications are the allergies on electrodes and the
case.
General method of operation
Press the Cardea-3 ECG recorder on the chest skin, symmetrically to the
breastbone. The potential on the different points are measured through the
electrodes, 3 leads of ECG signal are calculated, filtered, amplified and transmitted
to the smartphone application where it is recorded and uploaded.
Intended use
Cardea-3 is intended for fast detection of heart rhythm disturbances. It can be used
at homes or in clinics and hospitals, both by medical experts and by the general
population.
Clinical in estigation results
Clinical in estigation was performed in Uni ersity Children’s Hospital, Belgrade,
Serbia in August 2016. The in estigation showed that CARDEA-3 results are
equi alent with those recorded with standard clinical 12-leads electrocardiographs.
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 !"

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Residual risks:
1. The material of the recorder (electrodes and casing) were tested for
biocompatibility (cytotoxicity, hypersensitivity, irritation). Although the results
of these tests show that the material is safe for use, you might belong to
the small percentage of the population that is allergic to one or more
components used to manufacture electrodes and/or casing. If you
experience symptoms like rash, itching or redness of the skin, stop using
the device. These symptoms are mild and temporary.
2. The use of the device without proper disinfection, especially between
different patients, can lead to cross-infection. Refer to this manual to learn
about disinfection of the device.
. The loss of connectivity during data transfer can lead to losing the
information about your ECG. If this happens, try re-recording the ECG and
re-uploading it.
If you experience any side-effect, especially side effects not listed
here, report it to your doctor. You may also report them on
http://www.humeds.com/cardea3
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 !"

#
CARDEA-3 Portable ECG recorder operation manual
Note: this operation manual uses photos and screenshots from real device
and application. These may look different in your case, but these don’t affect
functionality or user experience.
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 !"

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Understanding CARDEA-3 portable ECG recorder
CARDEA-3 portable ECG recorder from Human Medical Solutions (Humeds),
Belgrade, Serbia
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 !"

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CARDEA-3 portable ECG recorder
Key functions
Power on: Press the button for 1.5 s.
Shutdown: Press the button for 3 s
The flashing blue light indicated that the de ice is switched on, and
looking for a smartphone application, or streaming data.
Flashing red light indicates low battery le el. The de ice should be
connected to the charger. The de ice has a built-in safety
mechanism for battery protection, and in the case of too low battery le el,
the de ice will turn off.
Continuous red light indicates battery charging.
A green light indicates that the de ice has been fully charged.
Unplug the charger from the de ice. The de ice is ready for use.
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 !"

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Obtaining and installing of umeds ECG application
Android version of Humeds ECG application can be obtained and installed from the
regular Google Play service of your Android smartphone.
Login / free register
After the installation is complete, click on the Humeds icon to open the application.
Log in with your account details (if you have one), or register as a member.
Login methods
1) Log-in with username
After successful registration, insert your username
and password in the appropriate form fields. You
can choose the option for the application to store
your login credentials to be available for the
purpose of the next signing in. If the entered
information is correct, you will be transferred to the
application home screen.
2) Log-in with the social account
If you haven’t previously registered a new user
account, you can choose to sign in through the
some of the available social networks: Facebook,
Google, WeChat, Twitter, LinkedIn.
3) Offline mode
In case of unsuccessful sing in, in the absence of network connection (e.g. airplane
mode, network signal reception is poor, no network etc.), you can access the main
application content choosing the option “offline mode”. If you record signals while in
offline mode, you can upload them later, when you connect to the network.
Registration
Only as a registered user, you can use all features of the CARDEA- – uploading the
data, storing them online and having the data evaluated by a medical professional.
Also, only registered users can download their ECG.
Before accessing the registration form, it is necessary for you to select the country for
the application use, to determine the registration type – through the email address or
phone number.
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You need to provide a valid email for registration purposes, to be able to receive the
confirmation email which will contain the activation link to confirm registration.
Note: fields denoted with asterisk (*) are obligatory
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If you forgot your password
If you forgot your password, submit your username
(email address or phone number). In case of the
registration with an email address, you will receive
an email with the appropriate link to change the
password in the Web application. In case of the
registration with a phone number, you will receive
SMS with the temporary PIN to confirm the new
password.
Submit PIN and set up a new password
When the system sends an SMS with a verification
code to you, please enter the verification code into
the appropriate field, and enter the new password
and submit it. The next time you log in you can use
the new password.
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Connecting ECG recorder with the application
Before recording ECG, make sure that the recorder battery is not empty, and that the
power is turned on. Then turn on your Humeds application, log in with your
credentials, switch on the Bluetooth when prompted (if it’s not already on) and the
application will automatically search for Cardea- recorders in the range. When you
select your recorder, the ECG transmission will start automatically. Place the
recorder on the chest skin, and press the recording button in the application, to start
recording your -lead ECG.
CARDEA-3 Portable ECG recorder use
Place the electrodes of the ECG recorder on the upper chest position on the bare
skin. All four electrodes should have good contact with the skin. The on/off button
should be facing upwards. To have a good, uniform results, try to relax and stay still
during the recording. You may be in the sitting, standing or lying position
Note：The emotional reactions can interfere with the results
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 !"

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CARDEA-3 application home screen
Access to the Humeds ECG application interface is simple and clear, easy to operate
manage the data.
The appropriate options to access the main sections of the application content are
located on the application home screen. Home screen, together with the other
sections, is easily accessible through the navigation bar that is located on the screen
bottom.
1) Settings
In this menu, you can check and change the
basic settings of the application and the user
interface, and verify that the software on the
ECG monitor is up to date and, if necessary,
update it.
2) Profile
Within the Profile section, you can view and
edit basic information about your user profile
entered during the user account registration.
You can add an unlimited number of new
users to your account, to be able later to
separately record ECG signals for them.
3) Messages
Within this section, you can get in direct contact with the assigned doctor. The
conversation lists for all the users that have been added as a dependent in relation to
the main user account are available through this section. Within the individual
conversation, you can exchange text messages with the doctor and view sent ECG
recordings.
4) istory
You can view, share or download your ECG recordings. You will also find here the
local ECG recordings that have not been sent to the server (for example, when
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working in the offline mode without an internet connection), and upload them later.
5) Real-time recording
After accessing this section, the application will
prompt the user to turn on the Bluetooth on the
smartphone (if not already turned on). After that,
the application will start searching for Cardea-
recorders in proximity.
After finding the devices, the application will list
them on the screen. Each device has a unique
identifier, marked on the casing of the device.
Tap on your device to select it and proceed to the
real-time ECG recording
After accessing the screen from below, you will be notified that is necessary to place
the ECG recorder properly on the chest in order for the application to display valid
ECG signal.
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Wait some short time until the signal is stable, and then press the record button
to start recording. Minimal recording time is 15s. For the improved accuracy, consider
recording for at least 1 minute.
Note: the signals recorded are chest leads V1, V2, and V3
When the recording reaches the desired time, press stop button to stop
recording. At any time, parallel with your ECG recording you can see your real-time
heart rate at the upper right corner of the screen.
Note: the normal heart rate is around 60-100 beats/min
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 !"

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After the recording process is finished, press the upload button to upload
recorded data to the server for evaluation and storage. To delete the ECG recording
click on the delete icon .
If the user account used for recording have some dependent users activated, after
clicking on the upload icon, the list of all patients connected to this account will
appear. You can select a specific user to assign the recorded ECG signal or you
could even add a new user at that moment.
After uploading the recording to the server, the information that the report for the
uploaded signal will soon be available will be displayed. After receiving the report for
sent signal, a dialog box with options for downloading and sharing will appear.
Also, you can tap the record button to restart recording of the ECG.
Download and share menu
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1) Download
You can download your ECG report as a PDF file,
which you can view using your smartphone or
tablet applications.
2) Send via email
You can send your ECG to your family, friends or
doctor via email.
3) Share
You can share your ECG via social network
WeChat.
Note: share your medical data only
with people you thrust
If you are using the application in offline mode, it won’t be possible to upload signal to
the server, instead, the dialog with the option to choose to view locally generated
PDF report will appear.
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Access historical ECG records
On the home page of the application, click “History” to open the section that contains
the list of the previously recorded ECG signals.
1) Uploaded ECG signals
Within the first tab named „Uploaded signals“, the
list of ECG recordings that are successfully sent to
the server is placed.
For this signals, it is possible to download the
report as PDF document, send it to email or share it
through the social network WeChat.
It is possible to sort this signals by date or user,
view the complete list of recordings for the selected
time period, and to search recordings in relation to
the users.
2) Local ECG recordings
The second tab named „Local signals“ contains the
list of recordings that for some reason are not
uploaded to the server (e.g. because of the signal
recording in offline mode, unavailable Internet
connection or server error).
For these signals, you can view locally generated
PDF document that contains displayed ECG signal
and you can try to upload the signal when an
Internet connection becomes available.
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 !"

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Application settings
Click settings button to enter the Settings menu.
Two tabs are available on this screen, the first one that contains application settings
and the second one containing the device information and configuration for the
Cardea- device.
Within the application settings, you can select the appropriate options to adjust the
application user interface, the information that will be displayed during ECG recording
and to download the current application user manual.
In user interface settings you can customize:
1) Save user credentials
Choose this option if you want to save the login
data for the next login.
2) Automatic turn on Bluetooth
Select this option if you want the application to
automatically turn on the Bluetooth instead of
prompting you to turn it on.
3) Automatic reconnect to last device
If you enable this option, the device will
automatically reconnect to the last device you
used, instead of searching for the available
devices.
Note: with this option checked, you
will have to manually connect to the device for the first time. After that,
the connection will be automatic.
4) Automatic start recording
Select this option if you want your device to start recording as soon as you start the
application.
5) Show push notifications
This option is turned on by default so you are able to receive push notifications for
new messages and information about received ECG reports.
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Within signal plotting personalization settings, you can configure:
1) Baseline wandering removal
If you select this option, the ECG baseline will be set to linear (the irregular baseline
will be removed).
2) Display of eart rate
Select/deselect this option to show/remove heartbeat rate from ECG display.
Note: By default, both options are on.
ECG Recorder information
1) About
The device ID is a unique identifier of the device.
Please give this ID to the technical support if
requested, for a faster response.
Here you can also find the battery status of the
device, and firmware and hardware versions.
2) Firmware update
In order to enhance the quality of ECG recording
and/or your user experience, Humeds will provide
updates from time to time. In this menu, you will
find information whether your firmware is up to
date. If there is a new version of firmware, you can
click “Update firmware” button to update your
device.
Note: use your application to download the most recent firmware
and install it on your device.

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 !"

&
Server connection settings
Here you can find basic information about the
connection to the server. It is strongly
recommended not to change these settings unless
otherwise told by the authorized service or Humeds
support, as you can lose connection with the
server.
Profile
In this section, you can view the basic information
about your user profile, provided during the
registration of the user account.
Click on the menu icon to access the form in
which you can update the profile information.
Click on the button to access the form for
creating a new user for which you will be able to
assign the recorded ECG signals later on.
By clicking on the user within the available list, the
application will automatically start ECG recording
for the selected user.

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 !"