INSTRUCTIONS FOR THE CARDIOSIGNAL SMARTPHONE APPLICATION - QUICK START GUIDE GENERAL & PRODUCT INFO INSTALLING & ACTIVATING TAKING A MEASUREMENT ...
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INSTRUCTIONS FOR
THE CARDIOSIGNAL
SMARTPHONE
APPLICATION QUICK START GUIDE
GENERAL & PRODUCT INFO
INSTALLING & ACTIVATING
TAKING A MEASUREMENT
SETTINGS
SECURITY & MANUFACTURER
Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.
INSTRUCTIONS FOR THE CARDIOSIGNAL SMARTPHONE APPLICATION
QUICK START GUIDE page 1/2
INSTALLING & ACTIVATING TAKING
APPLICATION A MEASUREMENT
→ Take note of restrictions on use. → Take note of things to remember
→ Install the CardioSignal when measuring atrial fibrillation.
application (from the Apple → Read carefully measurement
App Store or Google Play store). instructions.
→ Create user account. → Take a measurement.
→ Read privacy policy. → Check your result.
→ Accept terms of use.
→ Activate measurement feature. (You
can try the measurement feature 5
times for free or purchase a 1-month,
3-month or 12-month subscription.)
Restrictions on use
The application is intended for adults. The heart The measurement must not be performed Persons who have a cardiac pacemaker may
rate of children and young people can vary a lot in the following situations: the skin on the not use the application. Holding a phone pow-
according to respiration (sinus arrhythmia), in which chest is damaged in the measurement ered on close to a cardiac pacemaker can cre-
case irregular respiration has more effect on the area, the phone is connected to a char- ate electromagnetic interference (EMI), which
result and a normal rhythm might look irregular. ger, or the phone has a protective case. may cause a malfunction in the pacemaker.
Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.
INSTRUCTIONS FOR THE CARDIOSIGNAL SMARTPHONE APPLICATION
QUICK START GUIDE page 2/2
i Things to remember when measuring atrial fibrillation
i Take a measurement
Atrial fibrillation is the most common cardiac arrhythmia, which may occur oc- • Remove any thick clothing from your chest area.
casionally or in a sustained manner. In order to detect possible atrial fibrillation • Lay on your back and relax.
with the CardioSignal application according to the intended use, a measurement • Press the Start button in the CardioSignal application,
must be taken twice per 24-hour period, for example, in the morning and evening. which will begin the 10-second countdown period.
• Place the phone in the middle of your chest.
Follow the instructions below in order to achieve the best measurement result. • The measurement lasts for 60 seconds. You will hear
• Take the measurement while lying on your back, strive to be relaxed. a beep every 10 seconds and the end signal will sound
• Do not move, speak or cough. when the measurement
• Do not hold the phone. has been completed.
• Keep hands relaxed aside the body. For example putting • The measurement is dis-
palms under your neck may cause contractions of pectorals played after the analy-
(breast muscles) which affects the measurement. sis phase. The speed of
• Do not take the measurement after exercising, because your internet connection
your heart rate will be unnaturally high. affects the duration of
• Moving the phone or touching the screen during the 60-second the analysis phase.
measurement will interrupt the measurement.
What to do in the following situations?
? ATRIAL FIBRILLATION DETECTED
Repeat the measurement several times and en-
ATRIAL FIBRILLATION DETECTED BUT
I’M SURE THAT I DON’T HAVE IT
THE MEASUREMENT
FAILS
sure that you have followed the instructions The heart rate can vary a lot. Try holding your breath REPEATEDLY
If atrial fibrillation is detected in consecutive mea- during the measurement (for example, for 15 seconds) to Ensure that you have fol-
surements, contact a doctor or your care provider. reduce the effect of respiration on irregular heart rate. lowed the instructions.
MANUFACTURER: ■ Precordior Ltd. Aurakatu 6, 20100 Turku, Finland ■ Contact us: +358 102 021 200 ▶ support@precordior.com
Notified body:
Eurofins Expert Services Oy 0537
Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.
TABLE OF CONTENTS
QUICK START QUIDE page TAKE A MEASUREMENT 14 SETTINGS 23
3 4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Things to remember when User profile
TABLE OF CONTENTS measuring atrial fibrillation Change password
Take a measurement Delete account
GENERAL 5 Signs of atrial fibrillation Log out
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PRODUCT DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 No signs of atrial fibrillation Language
Supported operating systems, Heart signal Sounds
devices and other requirements Unsuccessful measurement Vibration
⚠ Restrictions on use What to do in the Activation code and subscriptions
following situations?
Not activated or inactive subscriptions
INSTALL THE APPLICATION 7 Atrial fibrillation detected
2 . . . . . . . . . . . . . . . . . . . . . . . . .
Atrial fibrillation detected,
Valid subscription
iPhone application Feedback
but I’m sure that I don’t have it.
Android application Terms of Use
The measurement fails repeatedly
CREATE A USER ACCOUNT 8 Privacy policy
Interrupt a measurement
. . . . . . . . . . . . . . . . . . . . . . . . .
PRIVACY POLICY AND TERMS OF USE . . . . 9 Check the measurement Open source components
ACTIVATE THE ATRIAL FIBRILLATION history and features
MEASUREMENT FEATURE 10 Delete a measurement PRIVACY PROTECTION
5
. . . . . . . . . . . . . . . . . . . . . . . . . . .
5 free measurements AND USER DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Activate the measurement feature DATA SECURITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
with an Apple or Google subscription MANUFACTURER INFORMATION . . . . . . . . . . . 27
Subscription duration,
renewal and cancelation
Change the subscription type
Restore a subscription
Subscription price and duration
Simultaneous use of activation
with a link (Activation code)
and a subscription
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
–4– Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.
1. GENERAL • PRODUCT DESCRIPTION
GENERAL PRODUCT
were confirmed by 2 independent cardiol-
ogists, and a third cardiologist made the
final decision if interpretations diverged.
These instructions are provided in PDF for-
mat. You can request a paper version by
DESCRIPTION The institutional ethics review board ap-
proved the study protocol. The algorithm
developed beforehand analyzed the motion
sending an e-mail to support@precordior.com.
CardioSignal is a smart- data acquired by the smart phone and clas-
phone application to sified the rhythm to be either sinus or atrial
These instructions were updat-
monitor atrial fibrillation fibrillation. Electrocardiographic rhythm
ed on 6 January 2021 and they ap-
of the heart. The Car- classifications were blinded to the algorithm
ply to the CardioSignal iOS and An-
dioSignal smartphone and the algorithm developers. The result of
droid software version 2.0 or newer.
application and related this study is that the CardioSignal applica-
services are produced by tion is able to detect atrial fibrillation with
the Finnish company Pre- 95.3% sensitivity (identifies atrial fibrillation
cordior Oy. The CardioSignal application rhythm correctly) and the 96.0% positive
is a CE-approved medical device (class IIa) predictive value, as well as 96.0% specificity
which has a sales permit in the European (identifies sinus rhythm correctly) and 95.4%
Union region. The application is not avail- negative predictive value. the study popu-
able in all countries. You can check coun- lation presents a large variety of different
try availability at www.cardiosignal.com. person and body characteristics. Details
of the study are publicly available here:
The technology, measurement method and ▶ https://www.ahajournals.org/doi/
atrial fibrillation detection algorithms Car- full/10.1161/CIRCULATIONAHA.117.032804
dioSignal application uses have been vali-
dated in clinical trials. The study comprised ▶ https://clinicaltrials.gov/ct2/
show/NCT03274583
300 patients, 150 in atrial fibrillation and
150 age- and sex-matched patients in si-
nus rhythm (normal electrical activity of the
heart). Motion data recording was acquired
from each subject with a smartphone placed
on the sternum. A simultaneously obtained
electrocardiography recording was used as
the comparison method to assess rhythm.
Electrocardiographic rhythm classifications
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
–5– Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.
1. GENERAL • PRODUCT DESCRIPTION
Supported operating systems, • The application is intended for personal
devices and other requirements use by the holder of the user account. The
holder of the user account is responsible
The CardioSignal smartphone application for adequate locking of the phone on Restrictions on use
can be used on Apple iPhone and Android which CardioSignal is installed in order
The application is intended for adults.
smartphones. The following requirements are to prevent unauthorized use of the ap-
The heart rate of children and young
necessary for the application to operate: plication. This can be done, for example,
people can vary a lot according
using a biometric identifier or password.
to respiration (sinus arrhythmia), in
• The smartphone must have motion sen- ☐ which case irregular respiration has
sors (accelerometer and gyroscope). more effect on the result and a nor-
mal rhythm might look irregular.
• Android operating system ver-
sion 4.3 or newer, but we recom- The measurement must not be per-
mend that you always update to formed in the following situations:
the latest operating system. the skin on the chest is damaged in
the measurement area, the phone
• Please note that operations of the An- is connected to a charger, or the
droid application may vary depending phone has a protective case.
on the components used by the An-
droid phone manufacturer and chang- Persons who have a cardiac pacemaker
es made to the operating system. may not use the application. Holding a
phone powered on close to a cardiac
• Apple iPhone SE or newer phones. pacemaker can create electromagnet-
ic interference (EMI), which may cause
• iOS operating system 12.0 or newer. a malfunction in the pacemaker.
• The WiFi or Mobile-Internet connection
must be turned on when using the ap-
plication. Please note that the use of
mobile data may cause additional costs
depending on the phone subscription.
• A user account must be created
in order to use the application.
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
–6– Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.
2. INSTALL THE APPLICATION
INSTALL THE
APPLICATION
The CardioSignal application cannot be
installed on an incompatible phone. The IPHONE APPLICATION ANDROID APPLICATION
phone is incompatible when it does not
have the required motion sensors or the op- • Open the AppStore application on • Open the Google Play application
erating system is too old. There are known your iPhone and select the Search on your Android phone.
Android phone models which are blocked feature (magnifying glass).
regardless of having the required sensors • Write CardioSignal in the search field
or operating system version. These phone • Write CardioSignal in the search field and and press the magnifying glass icon.
models are listed at the CardioSignal Goo- press the Search button on the keyboard.
gle Play info screen. The easiest way to • Open the CardioSignal application
test the application’s compatibility is to try • Open the CardioSignal application information and press Install.
and install it from the application store. information and press the Get button.
• The application will be installed.
• The application will be installed.
Icon of the CardioSignal
smartphone application
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
–7– Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.
2. CREATE A USER ACCOUNT
CREATE A
Creating user account
USER
ACCOUNT
After starting the CardioSignal application,
select the Create new account option at
the bottom of the screen. A valid e-mail ad-
dress is required to create a user account.
Enter your e-mail address and password.
You have to enter the password twice in or-
der to ensure it is correct, and it must be at
least 8 characters long. The new account
must be verified by opening a verification
link sent to the user’s email address. ( 1–4)
1 2 3 4
→ Create new account
→ Enter your e-mail & password
→ Check your email & verify
→ Continue
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
–8– Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.
2. PRIVACY
privacy policy and terms of use POLICY AND TERMS OF USE
PRIVACY
Privacy Policy & Terms of Use
POLICY AND → Read Important section & accept
→ Read Terms of use & accept
TERMS OF USE
In order to use the CardioSignal applica-
tion, you must read the Important section
and privacy policy and accept the Terms
of Use. There is a direct link from the Im-
portant notice section to the privacy pol-
icy, which describes how data collected
by the CardioSignal application is used.
Press the I understand button to display
the Terms of Use. The user must accept the
Terms of Use in order to use the applica-
tion. Touch the checkbox with your finger
after you have read and understood the
Terms of Use; only then can you move for-
ward by pressing the I agree button. ( 5–6)
5 6
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
–9– Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.
2. ACTIVATE THE ATRIAL FIBRILLATION MEASUREMENT FEATURE
ACTIVATE
5 free measurements
→ Select 5 free measurements
THE ATRIAL → Take a measurement (see chapter 3)
FIBRILLATION
MEASUREMENT
FEATURE
After accepting the Terms of Use, the user
has the opportunity to take 5 free mea-
surements, purchase an automatically
renewed subscription, or enable the mea-
surement feature with an activation link.
5 FREE MEASUREMENTS
After accepting the Terms of Use, the user is
offered the possibility to take 5 free measure- 7 8
ments before subscribing to the service (
7–8). The measurement view is displayed when
the user selects the Get 5 free measure-
ments option. Only measurements for which
a result is obtained are included in the free Deleting measurements does not affect the
measurements. Interrupted measurements free measurements. Measurement errors
are not included in the free measurements. are included in the 5 free measurements.
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 10 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.2. ACTIVATE THE ATRIAL FIBRILLATION MEASUREMENT FEATURE
After 5 free measurements, the user is ▼
ACTIVATE THE MEASURE-
Please note that the prices presented in the image may
given the opportunity to enable the mea- differ from the prices displayed by the application. The
surement feature by subscribing. The user MENT FEATURE WITH AN
application always displays the up-to-date prices.
can also skip the subscription phase, and
then use the application normally with- APPLE OR GOOGLE SUB-
out the measurement feature. ( 9–11)
SCRIPTION
After accepting the Terms of Use, the user
Activation after 5 free measurements is given the opportunity to subscribe to the
service. When the user chooses the Select
subscription feature, the prices and dura-
→ Activate tions (1 month, 3 months and 1 year) of dif-
measurement ferent subscription options are displayed.
→ Go to After selecting a single subscription option,
subscription the user is asked to approve the subscrip-
selection tion in the manner offered by Apple or
→ Select a Google, for example, FaceID, fingerprint,
password, etc. A successful or unsuccess-
subscription ful subscription is clearly displayed to the
type user. The measurement view is displayed to
the user after successful payment. ( 12–14)
Subscription duration,
renewal and cancelation
An active subscription (1 month, 3 months,
1 year) is automatically renewed unless it is
canceled by the user. A subscription is au-
tomatically renewed unless it is canceled at
least 24 hours prior to the start of the next
subscription period (1 month, 3 months, 1
year). This may vary depending on the Goo-
9 10 11
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 11 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.2. ACTIVATE THE ATRIAL FIBRILLATION MEASUREMENT FEATURE
Selecting subcription Change the subscription type
→ Go to subscription The subscription type (1 month, 3 months,
selection 1 year) cannot be updated during a sub-
scription period. If you want to change a
→ Select a
subscription that is renewed every month
subscription type to a 3-month subscription, you can do so
in the manner offered by your iPhone or
Android phone. It is the responsibility of
the service provider (Apple or Google) to
provide any refunds in connection with a
change in the subscription type and Pre-
cordior cannot affect these matters. It’s a
good idea to open the link above and read
more about Apple and Google instructions
concerning a change in subscription.
Restore a subscription
If you have a valid subscription but, for ex-
Please note that the prices
presented in the image may differ
ample, you had to reinstall the CardioSig-
from the prices displayed by the nal application, you can restore the valid
application. The application always subscription. Log in to the CardioSignal
displays the up-to-date prices.
application with the user ID you creat-
12 13 14 ed earlier, select the Restore subscription
feature and try to restore the subscrip-
tion with the Apple ID. After restoring the
gle or Apple practices. Subscriptions cannot Cancel an Apple subscription: subscription, the measurement feature is
be canceled from the CardioSignal appli- ▶ https://support.apple.com/en-us/HT202039 available until the end of the subscription
cation, but must be done via the Google or period. For Android devices, restoring the
Cancel a Google subscription: subscription doesn’t require user actions.
Apple subscription management system. ▶ https://support.google.com/googleplay/
answer/7018481?hl=en&ref_topic=1689236
Please note that the links may be
changed by Apple or Google.
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 12 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.2. ACTIVATE THE ATRIAL FIBRILLATION MEASUREMENT FEATURE
Subscription price and duration
SIMULTANEOUS i
Please note that the price of the subscrip-
tion and the subscription types (1 month,
USE OF ACTIVATION
Problems activating
3 months, 1 year) may differ from the pric- WITH A LINK the measurement feature
es and subscription types presented in
this documentation. The application al- (ACTIVATION CODE) If you have problems activating the
ways displays the price separately for
each subscription type. Apple and Google
AND A SUBSCRIPTION measurement feature, contact
support@precordior.com and tell
will also ask you to confirm the purchase You cannot use an activation code and a them which phone you’re using, your
before you are charged. The purchase subscription at the same time. For example, user ID and activation code. The
price is separately displayed again to the if you need to change the activation code activation code is the last 9 numbers
user in conjunction with confirmation. to an automatically renewed subscription, or letters of the activation link.
you should wait until the activation code
expires before ordering the desired ser-
vice type. Similarly, if you want to change
an Apple or Google subscription to an
activation code, cancel the subscription,
wait until the end of the paid subscription
period and then use the activation code
to re-enable the measurement feature.
☐
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 13 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.3. TAKE A MEASUREMENT
TAKE A i
MEASUREMENT Things to remember
when measuring atrial fibrillation
After the measurement feature has been Atrial fibrillation is the most common
activated, the application displays the Press cardiac arrhythmia, which may
start to measure view. This view is the de- occur occasionally or in a sustained
manner. In order to detect possible
fault view after starting the application. atrial fibrillation with the CardioSignal
Before taking the first measurement, it’s a application according to the intended
good idea to read the instructions to ensure use, a measurement must be taken
the most reliable result. You can open the twice per 24-hour period, for example,
Instructions view by clicking on the Read in the morning and evening.
instructions text. Read the instructions Follow the instructions below in order to
carefully before taking a measurement in achieve the best measurement result:
order to ensure the best possible measure-
ment result. This document “CardioSignal • Take the measurement while lying
User Manual” can also be accessed via on your back, strive to be relaxed.
the application’s measurement instruc- • Do not move, speak or cough.
tions, at the end of the instructions view. • Do not hold the phone.
• Keep hands relaxed aside the body.
For example putting palms under
your neck may cause contractions
of pectorals (breast muscles) which
affects the measurement.
• Do not take the measurement after
exercising, because your heart
rate will be unnaturally high.
• Moving the phone or touching
the screen during the 60-second
measurement will interrupt
the measurement.
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 14 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.3. TAKE A MEASUREMENT
Start the measurement by pressing the Take a measurement
Start button in the middle of the screen.
After this, you have 10 seconds to place the
phone on top of your chest. During the count- → Read instructions
down, you’ll hear a beep every second and a → Press Start
start-up signal will indicate the beginning of to measure
the measurement. ( 15–17) → Place phone
on your chest
→ Measurement
starts
i
Take a measurement
• Remove any thick clothing
from your chest area.
• Lay on your back and relax.
• Press the Start button in the
CardioSignal application, which will
begin the 10-second countdown period.
• Place the phone in the
middle of your chest.
15 16 17
• The measurement lasts for 60 seconds.
You will hear a beep every 10 seconds
and the end signal will sound when the
measurement has been completed.
• The measurement is displayed after
the analysis phase. The speed of
your internet connection affects the
duration of the analysis phase.
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 15 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.3. TAKE A MEASUREMENT
The atrial fibrillation measurement lasts for Measuring procedure
60 seconds, during which you may not touch
the phone or move. Please note that speak-
→ Measurement
ing, coughing or moving your body can cause
a measurement error or unsuccessful mea- progress is displayed
surement. The vibration feature may cause → Please wait
a measurement error if, for example, you re- while analysing data
ceive a message during the measurement.
You will hear a beep every 10 seconds during
the measurement, and the end of the mea-
surement is indicated by an end signal if
the vibration feature is turned on. You can
change the vibration setting in the appli-
cation settings. After the measurement,
the measurement data will be analyzed
for a short time. The duration of the anal-
ysis phase may vary depending on the
speed of the internet connection. ( 18–19)
CardioSignal will display the measure-
ment result after the analysis phase. The
application can provide 2 different mea-
surement results: Signs of atrial fibrillation
or No signs of atrial fibrillation. 18 19
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 16 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.3. TAKE A MEASUREMENT
Measurement results
SIGNS OF ATRIAL FIBRIL-
LATION → View results
Signs of atrial fibrillation were detected in → More information
the user. If the CardioSignal application de- → New measurement
tects atrial fibrillation, the measurement must
be repeated to confirm the result. ( 20–21)
Please note that performing the measure-
ment in a way that conflicts with the instruc-
tions (moving, talking, incorrect measure-
ment position or holding the phone) may also
cause a Signs of atrial fibrillation measure-
ment result. Make sure that you followed the
instructions and repeat the measurement a
few times.
If you obtain the same measurement several
times, contact your doctor or care provider.
NO SIGNS OF ATRIAL
FIBRILLATION 20 21 22
No atrial fibrillation was detected. The result
also shows the average heart rate during the
measurement. A successful measurement
result does not require any further action.
However, remember to continue taking daily Regular measurement is important because
measurements. We recommend measure- atrial fibrillation can also occur occasionally,
ments in the morning and in the evening. which makes it difficult to recognize. ( 22)
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 17 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.3. TAKE A MEASUREMENT
Heart signal Viewing heart signal
It is possible to check the heart signal for
every successful measurement. When → Select Heart signal
you select Heart signal at the top of the → Please wait while loading
measurement result view, the application → View heart signal
will begin loading the curve depending → Get more information with the button
on the speed of your internet connection,
it can take 2-10 seconds to load. You
can check the heart signal for the entire
60-second measurement by scrolling
the signal image. You can obtain more
information about the details of the heart
signal by pressing the button. ( 23–26)
Please note that the heart curve
is not an ECG curve, because
the method used by the applica-
tion is based on motion sensors.
23 24 25 26
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 18 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.3. TAKE A MEASUREMENT
Unsuccessful measurement (examples)
tects excessive movement during the
→ Read instructions measurement, the measurement will
again be interrupted as unsuccessful.
→ Take a new
measurement • The measurement data cannot be inter-
preted. The data produced by the motion
sensors is unreadable for some reason. In
this case, the data is not analyzed and the
measurement is declared unsuccessful.
• The phone was in the wrong position
during measurement. The phone must be
in the most horizontal position possible.
• The measurement has been per-
formed, for example, from a table and
the heart signal was not detected.
• Your heart rate is outside the 30-160 beats
The images show some examples
per minute range. You can measure your
of unsuccessful measurements.
Please note that there can be
heart rate in some other way (for exam-
more error situations than those
ple, taking your pulse by hand) in order
presented in the images.
to ensure that this is not the reason.
27 28 29
• Reboot your phone. Some phone
models are reported to provide er-
UNSUCCESSFUL sure that you have performed the mea-
surement according to the instructions.
roneous sensor data but reboot-
ing the phone fixes the problem.
MEASUREMENT An unsuccessful measurement can be
caused by several different reasons: • If the measurement fails repeatedly, you
If the measurement is unsuccessful, re- can contact Precordior’s customer ser-
peat the procedure ( 27–29). Check • You have moved your phone during vice by e-mail at support@precordior.com
the measurement instructions to en- the measurement. If the phone de- or by calling +358(0)10 202 1200.
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 19 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.3. TAKE A MEASUREMENT
What to do in the following situations?
ATRIAL FIBRILLATION ATRIAL FIBRILLATION THE MEASUREMENT
DETECTED DETECTED, BUT I’M SURE FAILS REPEATEDLY
1. Repeat the measurement several times THAT I DON’T HAVE IT 1. Ensure that you have followed the
and ensure that you have followed the instructions presented in the Things
instructions in the Things to remember 1. Especially with children, young people to remember when measuring
when measuring atrial fibrillation section. and athletes, the heart rate can vary a lot atrial fibrillation section.
2. Also check the quick start guide in according to respiration (sinus arrhythmia), 2. The measurement is classified as
the CardioSignal application. in which case irregular respiration has unsuccessful if the measured heart rate is
more effect on the result and a normal less than 30 or over 160 beats per minute.
3. If atrial fibrillation is detected in rhythm might look irregular. Try holding Measure your heart rate and make sure that
consecutive measurements, contact your breath during the measurement (for it is between 30 and 160 beats per minute.
a doctor or your care provider. example, for 15 seconds) to reduce the
effect of respiration on irregular heart 3. Reboot your phone. Some phone models are
rate. reported to provide erroneous sensor data
but rebooting the phone fixes the problem.
2. All people have extra heartbeats at
some times. A small number of atrial 4. If none of the above-mentioned instructions
extrasystoles (also known as premature correct the measurement, contact
atrial contractions, PACs) is not a problem Precordior Oy’s customer service by
but having a lot of them can be harmful. e-mail at support@precordior.com
The application may have difficulty or call +358(0)10 202 1200.
differentiating between a large number of
atrial extrasystoles and atrial fibrillation.
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 20 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.3. TAKE A MEASUREMENT
The measurement history displays all the to scroll the measurement view down in or-
INTERRUPT user’s previous measurements by month. der to see the earlier measurements. You
A MEASUREMENT You can use the arrow buttons to change
the month. ( 31) Not all measurements are
can open the information for an individual
measurement by clicking on the desired
A measurement can be interrupted during the loaded at the same time, and the user has measurement result in the list. ( 32–33)
measurement by touching the screen or mov-
ing the phone. If the phone is moved during
the measurement, that measurement result is
unreliable. These measurement results should
be deleted from the measurement history.
Measurement history (examples)
CHECK THE
MEASUREMENT HISTORY
AND FEATURES
The CardioSignal application displays the
measurement result after the measurement
phase. The user can also check the measure-
ment history by selecting the History option
in the navigation menu at the bottom of the
view. ( 30)
→ Select History
→ Use < > buttons to select month
→ Scroll up & down
→ Select measurement to open
30 31 32 33
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 21 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.3. TAKE A MEASUREMENT
Delete a measurement Deleting a measurement
The user can delete a measurement result → Select trash bin icon
by selecting the Trash bin icon at the top up- → Confirm deletion
per corner of the measurement result. After
this, the user will be asked to confirm dele-
tion of the measurement result. Please note
that the measurement results can no longer
be restored after being deleted. ( 34-35)
☐
34 35
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 22 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.4. SETTINGS
SETTINGS
Settings / User profile / Change password / Delete account
The settings for the CardioSignal ap-
plication are opened from the Set-
tings option in the navigation menu at
the bottom of the application. ( 36)
User profile
The user profile settings can be opened
directly by touching the user profile in
the application menu and selecting
user ID in the Profile section. You can
change a password, delete a user or log
out in the user profile settings. ( 37)
Change password
In order to change a password, you need
to write the old password and enter the
new password twice. The Change pass-
word button is only enabled after the old
and new passwords have been validated. 37 38 39
Then you can change the password. ( 38)
36
Delete account
The Delete account feature deletes the user
account and all measurements associated
with that user account. The user will be asked
to confirm deletion of the user account be-
fore the account is deleted. ( 39) and all unique identifiers associated with after the user account has been deleted and
After a user account has been deleted, the the measurement data will be deleted. Pre- it can use (anonymized) measurement data
measurement data can no longer be restored cordior Oy will save the measurement data for service development and research work.
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 23 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.4. SETTINGS
Log out Logout / Language / Sounds / Vibration
The user can log out of the applica-
tion with the Log out button. The user
will be asked to confirm the log out
action prior to logging out. ( 40)
Language
The language of the CardioSignal applica-
tion can be changed by selecting the Lan-
guage option. The application will display
the language options and the language
that is currently in use. After a change in
language, the application will display the
measurement start-up view. ( 41–42)
Sounds
The Sounds setting specifies wheth-
er sound signals are used during the
measurement. The Sounds setting can
be turned on or turned off. ( 43)
40 42
Vibration
41 43
The Vibration setting specifies whether vi-
bration is used when starting, interrupting or
ending a measurement. The vibration set-
ting can be turned on or turned off. ( 43)
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 24 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.4. SETTINGS
Activation code and subscriptions Valid subscription
Not activated or inactive subscriptions with an activation link, the Settings view will If the user has an active subscription
display the Subscribe option. Selecting the or measurement feature enabled with
If the user does not have an active sub- Subscribe option will display the subscrip- an activation link, the remaining peri-
scription or a measurement feature enabled tion and activation code view. ( 44-45) od of validity is displayed. ( 46-47)
Subscriptions
45 47
44 46
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 25 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.4. SETTINGS 5. PRIVACY PROTECTION AND USER DATA • DATA SECURITY
The CardioSignal user account is personal,
Feedback
PRIVACY PROTECTION and therefore it is important for the account
The Feedback feature opens the default
e-mail program from which the user can
AND USER DATA holder to prevent any external parties from
gaining access to a device on which the
send feedback to the user support Learn more about the privacy notice for CardioSignal application is installed. Cardi-
address support@precordior.com the application at oSignal user IDs must never be shared with
provided by Precordior Oy. ▶ https://service.precordior.com/ external parties, and the application must
legal/en/privacy-policy.html always be installed from the official Apple
Terms of Use App Store or Google Play stores. For example,
there is no guarantee that the application
The Terms of Use section opens the Terms will function properly if it is installed on a Jail-
of Use for the CardioSignal application. DATA SECURITY broken or rooted device or on an emulator.
The user must ensure that the iOS or Android
CardioSignal utilizes commonly used and operating system is updated to a compati-
Privacy Policy proven encryption methods. All of the ble operating system version, which you can
The Privacy Policy section opens the priva- data that CardioSignal sends to Precor- check in the Supported operating systems,
cy policy for the CardioSignal application. dior’s cloud service is transferred over an devices and other requirements section.
encrypted connection and saved in an
encrypted database. The servers used to ☐
Open source components produce the database and service are
The Open source components section opens connected to a private network that can-
a list of the open source components used not be directly accessed from the internet.
in the CardioSignal application or Precordior Back-up copies of the data are taken on a
cloud service and the related licenses. daily basis. No measurement data is saved
in the mobile devices (iOS and Android)
☐
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 26 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.5. MANUFACTURER INFORMATION
MANUFACTURER
INFORMATION
Precordior Ltd. Notified body:
Aurakatu 6 Eurofins Expert Services Oy
20100 Turku, Finland
Company registration
0537
number 2800927-7
Contact us:
+358 102 021 200
▶ support@precordior.com
PRECORDIOR IN BRIEF
Precordior Ltd. provides unique cardiac monitoring
solutions based upon the user’s chest motion. Cardi-
oSignal™ is our CE IIa class medical device for detec-
tion of atrial fibrillation, which works on most modern
smartphones without any additional add-on devices.
Precordior’s technology is based upon comprehen-
sive scientific research in Finland in 2012–2021 and has
been validated with clinical trials. At Precordior, we
strive to provide reliable and user-friendly heart mon-
itoring solutions to smartphone users worldwide.
INSTRUCTIONS FOR THE CARDIOSIGNAL
SMARTPHONE APPLICATION
– 27 – Updated on 6 January 2021. – ©Precordior Ltd. 2017–2021. All rights reseerved.You can also read
