Cardiac Designs ECG Check Universal User manual

ECG Check Universal
Wireless 1-Lead Cardiac Monitor for Home Use
in Prescription and Over the Counter Modes
Welcome. Thank you for selecting the ECG Check Universal cardiac monitor.
This user guide includes information and instructions about your new ECG Check and
will help familiarize you with the basic skills of using your ECG Check. For your safety,
please take a moment to read it carefully and in its entirety before you begin testing.
For the most up-to-date list of compatible devices, please refer to the supported list at
http://www.ecgcheck.com.
We care about what you think and want to keep you informed about its use and care.
FOR ASSISTANCE
If you have any questions about your new ECG Check, its setup, or its use, please
contact:
Cardiac Designs Inc.,
695 Minnesota Street
San Francisco, CA 94107
Tel: [phone]
Email: [e-mail] Website: www.ecgcheck.com.com

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Table of Contents
Symbols Glossary ...................................................................................................................3
Copyright Declaration ............................................................................................................4
Declaration of Conformity......................................................................................................4
Warnings ...............................................................................................................................4
Cautions ................................................................................................................................6
Precautions............................................................................................................................6
Prescription Mode: ............................................................................................................6
Over-the-Counter Mode:....................................................................................................6
Contraindications...................................................................................................................7
Indications for Use .................................................................................................................7
Description ............................................................................................................................7
General Description ...........................................................................................................7
Your ECG Check comes with the following: .........................................................................8
Device Functions................................................................................................................9
Setup and Use of the ECG Check ...........................................................................................10
Setup the ECG Check Device .............................................................................................10
Download the ECG Check Application and Create your Account ........................................10
General Information ........................................................................................................11
Before Recording .............................................................................................................11
Recording ........................................................................................................................11
Medical Records ..............................................................................................................14
Maintenance & Cleaning ......................................................................................................14
Rechargeable Battery.......................................................................................................14
Conditions of Use.............................................................................................................14
Caring for your ECG Check ................................................................................................15
Preventive Maintenance ..................................................................................................15
Mechanical Inspection.......................................................................................................... 15
Cleaning & Disinfection for the ECG Check device ............................................................... 15
Storage............................................................................................................................16
Troubleshooting ..................................................................................................................17
Cybersecurity.......................................................................................................................18
Wireless Technology ............................................................................................................18
Glossary...............................................................................................................................19
Technical Specifications .......................................................................................................20
Operating Components ........................................................................................................20
Heart Rate Calculation .........................................................................................................21
EMC Information .................................................................................................................21

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Symbols Glossary
Caution (0434A) Indicates the need for the user to consult the instructions for use for
important cautionary information such as warnings and precautions that cannot, for a
variety of reasons, be presented on the medical device itself.
Follow Instructions for Use.
RoHS Compliant
Date of Manufacture (2497) Indicates the date when the medical device was
manufactured.
Type CF Applied Part
Non-Ionizing Radiation
Authorized representative in the European Community Indicates the Authorized
representative in the European Community.
European Conformity
Serial Number (2498) Indicates the manufacturer’s serial number so that a specific
device can be identified.
Dispose of rechargeable batteries only in accordance with all applicable local laws
and regulations.
Keep Dry (0626) Indicates that ECG Check needs to be protected from moisture
Temperature limit (0632) Indicates the temperature limits to which the medical
device can be safely exposed.
Humidity limitation (2620) Indicates the range of humidity to which the medical
device can be safely exposed.

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Copyright Declaration
Copyright © 2012 Cardiac Designs, Inc.
All rights reserved.
iPhone, iPad, iPod, iOS and the Apple logo are either registered trademarks or
trademarks of Apple Corporation in the United States and/or other countries.
Cardiac Designs, Inc., Cardiac Designs logo, and ECG Check and ECG Web Center are
trademarks or registered trademarks of Cardiac Designs, Inc.
All other brand names and product names used in this document are trade names,
service marks, trademarks, or registered trademarks of their respective owners.
The information and screens provided in this manual are subject to change without
notice.
Cardiac Designs, Inc. SHALL NOT BE LIABLE FOR TECHNICAL OR EDITORIAL ERRORS OR
OMISSIONS CONTAINED HEREIN; NOR FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES
RESULTING FROM THE FURNISHING, PERFORMANCE, OR USE OF THIS MATERIAL.
Authorized Representatives:
USA
Cardiac Designs, Inc.
695 Minnesota Street
San Francisco, CA 94107
Tel: [phone]
EU
Medes, Ltd.
5 Beaumont Gate, Shenley Hill,
Radlett, Hertfordshire, WD7 7AR
England, UK
Declaration of Conformity
Conformance to Standards –non-clinical testing demonstrated conformance to
voluntary safety IEC 60601-1, and IEC 60601-1-2-2007 Class B.
Type CF Applied Part. Complies with Part 15C of FCC Rules for Class B Digital Devices.
Cardiac Design, Inc.’s Quality System conforms to 21 CFR 820 and ISO 13485:2016

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Warnings
WARNING: Equipment not suitable for use in the presence of flammable anesthetic
mixture with air or with Oxygen or Nitrous Oxide.
WARNING: The ECG Check is not a diagnostic device.
WARNING: This non-standard 1-lead electrocardiogram (ECG) measured using the ECG
Check, should not be used for diagnostics in comparison to the standard 12- lead ECG
obtained with standard electrode placement.
WARNING: This device should not be used with pacemakers or implanted cardiac
defibrillators (or other implanted electronic devices) and cannot predict or diagnose a
heart attack or be used for chest pain monitoring.
WARNING: The ECG Check is not a defibrillation-proof device.
WARNING: The ECG Check is not intended for use during magnetic resonance imaging
(MRI), cautery, and external defibrillation procedures.
WARNING: The ECG Check device must not be exposed to strong electromagnetic fields.
WARNING: Do not allow conductive parts of electrodes to come into contact with other
conductive parts including earth.
WARNING: Do not use the ECG Check if the electrodes appear to be damaged or
compromised.
WARNING: To prevent fire or shock hazard, do not expose the unit to rain or moisture. Do
no immerse the ECG Check device in any liquid. Do not attempt to open or repair your ECG
Check.
WARNING: The ECG Check device is not intended for use for infants weighing less than 10kg.
WARNING: Exposure of the wireless communications features of the device may be
interfered with by other devices that operate on the same frequencies even if they comply
with applicable regulations and standards.
WARNING: For proper operation, radios in the devices should be unadulterated, turned on,
and the ECG Check device within sufficient distance of the cellular device for a consistent
connection (within 10 meters).

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Cautions
CAUTION: Do not open or attempt to repair your ECG Check. Contact us at 844-324-2432 or
at www.ecgcheck.com if you require assistance with your ECG Check.
CAUTION: Do not drop your ECG Check or subject it to severe impacts. Bending the body can
damage the circuitry. Do not use extreme force when pressing the display or keys.
CAUTION: The ECG Check is not a waterproof or water resistant device. Do not
immerse the ECG Check in any liquid.
Precautions
Due to the possible seriousness of the abnormal heart rhythms that can be associated
with these conditions, persons with the following conditions should consult their
physician before using this device:
Coronary heart disease
Valvular heart disease
Heart transplant
Heart failure
This device is available in the USA in both over the counter mode (OTC) and prescription
mode (Rx).
Prescription Mode:
This device must only be used for the person for whom it has been prescribed and only
for the use for which it is intended.
Until a valid physician prescription is received from your physician, you will only have
access to the OTC mode of the system, described below.
Your agreement certifies you understand that this service is not a substitute for
physician care and that it is only a screening service.
Over-the-Counter Mode:
In the Over-the Counter Mode you will know that the 30-second recording occurs as the
'Progress Bar' fills up while the system records your ECG. If you chose Prescription

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Mode, after your prescription has been approved you will see your ECG displayed in real
time as it is recording. If you are in Over-the Counter mode you will see the 30-second
recording "Progress Bar" fill up while the system records your ECG after which the result
will be displayed as Green (Normal), Red (Irregular) or Yellow (Unable to read).
The ECG Check is not intended for diagnostic use and does not provide diagnostic
quality ECG data.
Contraindications
There are no potential adverse effects of the ECG Check on health.
Indications for Use
The ECG Check Universal family of devices is intended for self-testing at home. These 1-
lead cardiac monitors allow remote patients to display and transmit their EGG data to
medical professionals via a communication device to a remote server.
Specifically, the EGG Check Universal models are indicated for patients who are
concerned about their heart rhythm and have experienced the following symptoms that
are suggestive of abnormal heart rhythms:
Skipped Beats
Pounding Heart (Palpitations)
Heart Racing or Irregular Pulse
Lightheadedness or Faintness
History of Arrhythmias
Description
General Description
The ECG Check is a medical device that allows recording and sending of an ECG
recording (using Bluetooth technology). The recording is sent to a device (ECG Check
Application compatible cellular device). This allows you and your physician to monitor
your health information (ECG) from anywhere any time you wish.

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Your ECG Check comes with the following:
ECG Check Device
ECG Check USB Charging Cord

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Device Functions
1. On/Record
If the device is off, pressing your fingers to the electrodes will turn the device on
and begin initiating a connection with the open application. NOTE: The ECG
Check device must be within 10 meters of the cellular device.
If the ECG Check application is not open, please start the application prior to
initiating a recording on the device. The device will not begin recording data
until the ECG Check application has been started and the blue ‘Make a New
Recording’icon has been pressed.
2. Standby / Power Off
The device will turn off automatically after the device has detected no skin
contact for 4 seconds. If there was an on-going test, the test will be invalidated
and need to be restarted.
NOTE: The device starts
recording when there is electrode contact with the sk in
AND the cellular device application has connected with the ECG Check device
via Bluetooth to begin recording.
The ECG Check is not waterproof. Do not
allow it to get wet. Remove before
bathing or swimming.
Do not use or store the ECG Check in
extreme heat or cold.

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Do not use or store the ECG Check outside
of stated humidity levels.
Setup and Use of the ECG Check
Setup the ECG Check Device
Your ECG Check comes fully assembled. You will need to fully charge your ECG Check
prior to first use by following these steps:
1. Unpack the USB cord that is provided with the ECG Check.
2. Connect the USB cord to the charging port of the ECG Check, which is located on
the side of the device.
3. Connect the USB end of the device to your computer, or to a wall adapter.
4. Allow to charge for a full 8 hours before first use. When charging is complete,
remove the USB cord from the ECG Check and the computer and store in an easy
to find location so you will have it easily accessible for recharging when
necessary.
Download the ECG Check Application and Create your Account
1. Download the ECG Check Application from the AppStore (iPhone) or Play Store
(Android).
2. Ensure the Bluetooth setting is turned ON for the cellular device (i.e. iPhone) you
are using. If the Bluetooth setting is not on, refer to the instructions for use of
the cellular device to determine how to turn the Bluetooth on. NOTE: Bluetooth
must be ON for the ECG Check to connect to the ECG Check application on the
cellular device.
3. Once downloaded, tap the ECG Check icon to open the application on the
smartphone.
ECG Check Application Icon
4. Create your user profile and account by following the prompts.
5. Keep the application open while making your ECG Recording with the ECG Check
device.

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Now the ECG Check is ready for use.
General Information
The ECG-Check is a single lead ECG recording device that uses the 2 built-in electrodes
(silver pads). Place your fingers on the electrodes to record and transmit your ECG to an
application via Bluetooth for display and analysis as shown below.
Before Recording
For your safety, read this instruction manual in its entirety before attempting a recording.
Pay careful attention to the electrode positions as instructed.
Recording
1. Start the ECG Check application by tapping the ECG Check icon (see below).
ECG Check Application Icon
2. Log in to your user account or choose ‘Keep me signed in’.

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ECG Check Application Log-in Screen
3. After you are signed in, the following screen will be displayed:
4. Press the BLUE CIRCLE icon at the top of the application to be prompted on how
to start recording.
5. The following screen will appear once you have established a connection and the
ECG Check device begins recording.
ECG Check Application Recording in Progress Screen
6. The application will present the screen below. Wait for the progress bar to fill up
while the system records your ECG. The countdown feature tells you how long
until the recording is complete.

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7. If you are in Prescription Mode, you will see your ECG displayed as it is recording
as shown below. If you are in Over-the-Counter Mode, you will only see a
progress bar as the recording progresses.
8. The system will automatically send the ECG for analysis by the backend
arrhythmia analysis algorithm.
9. Results will be returned to the application with one of the following:
Normal Heart Rate
Irregular Heart Rate
Unable to Read ECG Data

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Medical Records
Each ECG recording you make will be stored within the smartphone application for
future viewing.
To examine previous tests stored on the device:
1. Tap the recording date to open and view the previously recorded results.
2. Tap on the ‘Tap for archive recordings’to view older recordings than those
shown on the screen.
Maintenance & Cleaning
Rechargeable Battery
Warning: Do not dispose of the internal rechargeable battery in the normal
trash. Dispose of rechargeable batteries only in accordance with local law
and regulations
Conditions of Use
Your ECG Check conforms to international regulations insofar as it is used under normal
conditions and in accordance with the following instructions.

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Caring for your ECG Check
CAUTION: Do not open or attempt to repair your ECG Check. Contact us at 844-324-2432 or
at www.ecgcheck.com if you require assistance with your ECG Check.
CAUTION: Do not drop your ECG Check or subject it to severe impacts. Bending the body can
damage the circuitry. Do not use extreme force when pressing the display or keys.
CAUTION: The ECG Check is not a waterproof or water-resistant device. Do not
immerse the ECG Check in any liquid.
The Cardiac Designs, Inc. ECG Check devices are non-sterile devices for use in non-sterile
clinical and home environments. The following manual Cleaning and Disinfection
procedure below provides directions for cleaning and disinfecting the device. Failure to
follow these procedures may result in substandard recordings or the cross-
contamination among patients.
Preventive Maintenance
The following simple preventive maintenance tasks should be performed monthly (at
minimum)to ensure continued performance of your ECG Check device at maximum capacity,
and to reduce the possibility of a failure. Refer to the cellular device instructions for proper
maintenance of your cellular device.
Ensure your ECG Check device battery is charged. We recommend that you fully charge your
ECG Check device at least once per month according to the instructions in the ‘Set Up Your ECG
Check Device for Use’section of this manual.
Mechanical Inspection
Check for splits, cracks, or imperfections in the case. If you have any questions or doubts,
contact us at 844-324-2432 or at www.ecgcheck.com.
Do not use the device if it does not appear to be functioning properly or shows signs of
damage. Use of an ECG Check for a task other than that for which it is intended may
result in damage to the device, or provide unsatisfactory performance.
Cleaning & Disinfection for the ECG Check device
Always clean your ECG Check before disinfection. Clean & disinfect your ECG Check
Device each month or immediately after another person handles the device to prevent
the spread of germs or infection and to keep your ECG Check in good working order.

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Always clean the ECG Check first and then disinfect it according to the instructions
provided below.
We recommend use of the Sani-Cloth® HB cleaning & disinfecting wipes (or equivalent)
for cleaning and disinfection of the ECG Check device.
The ECG Check is not intended for sterilization.
Cleaning
Wipe all exterior surfaces with a fresh Sani-Cloth® HB cloth to remove any visible soil or
residue. Discard the Sani-Cloth® HB cloth immediately.
Do not allow any liquid to enter the case, and avoid pouring water or other
liquids on the device while cleaning.
Never use abrasives such as wire wool or metal polish.
Disinfection
Using a new Sani-Cloth® HB cloth after cleaning, wipe all exterior surfaces of the ECG
Check and allow to air dry for 10 minutes. It is crucial that these instructions be
followed EXACTLY for the desired effect. See instructions provided with Sani-Cloth® HB
for more information.
Never expose the device to temperatures in excess of stated temperature
limitations.
Storage
Store the ECG Check in a dry temperate location.
Caution:
Do not store the ECG Check in a damp area, or in areas that experience
extreme heat or cold. These conditions can damage the internal
components and case of the ECG Check.

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Troubleshooting
Problem
Possible Cause(s)
Solution
Device does not send ECG
to application
The battery is very low or
depleted
Re-charge battery
The Bluetooth radio is not
enabled on the cellular
device
Turn Bluetooth ON in the
cellular device
The ECG Check is out of
range with the cellular
device
Move closer to the cellular
device –the ECG Check
device and the cellular
device must be within 10
meters for ECG data
transfer.
The user has not touched
both electrodes.
Ensure both electrode pads
are in contact with the
user’s skin
ECG Data is not being
analyzed
There is no connection to
the internet
Turn on your cellular data
or connect to a WiFi access
point
ECG analysis comes back
with a bad recording
Too much noise or
movement in the
recording
Do not move & remain still
while the device is
recording
Not enough ECG data was
collected
Keep the device in contact
with the skin for 30
seconds
Cellular device is running
slowly
Too many applications
open
Manually close the
applications or restart your
cellular device.
ECG Check application
does not launch
Too many applications
open
Manually close the
applications not in use or
restart your cellular device.

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Cybersecurity
Cardiac Designs, Inc. takes the protection of personal information very seriously. The
ECG Check device system uses data encryption for all points of data transmission and
storage from the point of ECG recording, through return of analyzed ECG data back to
the ECG Check application.
To be certain your ECG Check data remains secured, we recommend that you do not
share your log-in and password information for your ECG Application with anyone.
Follow the manufacturer recommendations for security for your cellular device.
If you are concerned that your cellular device may have been compromised, follow the
cellular device manufacturer recommendations. Once your cellular device has been re-
secured, contact Cardiac Designs, Inc. for any questions or assistance you may need with
the ECG Check application. Our contact information is shown below:
Cardiac Designs Inc. Tel: [phone]
Email: [e-mail] Website: www.ecgcheck.com
Wireless Technology
The ECG Check device system uses wireless technology to transmit data from the ECG
Check Device to the ECG Check application on the cellular device. The cellular device
transmits data to and from the back-end analysis engine using the cellular network.
For proper operation of your ECG Check, do not attempt to open the ECG Check or
otherwise tamper with the Bluetooth radio. The Bluetooth on the cellular device must
be unadulterated, turned on, and within sufficient distance of the ECG Check device (no
more than 10 meters) to allow for a consistent connection. You must have a cellular
signal for transmission to and from the back-end analysis engine. If you do not have a
cellular signal, the recordings will be saved on the cellular device and transmitted once a
cellular signal is detected.
If you experience wireless connection issues, please refer to the Troubleshooting section
of this manual.
The ECG Check device system is suitable for use in the U.S. and the EEC (European
Economic Community). The ECG Check device system may not function properly in

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countries outside of the U.S. and EEC due to possible wireless technology and technical
parameter differences.
Glossary
Communication Device
Cellular device.
ECG
Electrocardiogram; a representation of the heart's electrical
activity recorded from electrodes on the body surface.
Heart Rate
Number of beats per minute, measured as bpm.
Bluetooth (BT)
Wireless communication protocol.
ECG Check
ECG Check wireless ECG monitor.
PC
Personal computer.
ECG Check Application
Cardiac Designs, Inc. proprietary software program for
measuring, storing, displaying, and transmitting data
gathered from the ECG Check medical device.
ECG Check Homepage
ECG Check Application main page.
ECG Check Web Center
Cardiac Designs, Inc. proprietary internet-enabled program
for storing and retrieval of patient records. For use by
physicians and medical professionals.

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Technical Specifications
Input Impedance
1.1 mohm
Input dynamic range
+/- 3.5mV
Maximum Current consumption
55mA
CMRR
75db
DC offset correction
+/- 200mV
Bandwidth
0.5Hz –25Hz
Recording
30 second, single-lead ECG
Sample Rate
200 Hz
Transmission Period
Instant, dependent on cellular device
Transmission mode
Bluetooth™ - Low Energy
Modulation
Digital
Radiated RF Power
1W
Frequency Band
2.4 GHz ISM (Industrial, Scientific, and
Medical)
Average QRS Sensitivity
99.87%
Average QRS Predictability
99.77%
Average VEB Sensitivity
93.91%
Average VEB Predictability
94.12%
Battery Type
3.7V x1 Lithium ion rechargeable battery
Battery Life
8 hours (approximately 480 recordings)
Operating Temperature
+10 to +40oC (50 to 104oF)
Transport & storage temperature
-20 to +65oC (-4 to 149oF)
Relative humidity
30 to 85%
Device Casing Material
ABS/PC Plastic
Electrode Material
Copper Plating AG/CL
Dimensions
87 x 49 x 7mm
Net Weight
33 (grams)
FCC Identifier
RP4ECGC4S001
Operating Components
PCB
1
Electrode Sensors
2
LED Status Indicators
(Bluetooth Connection Status &
Charging Status)
2